The CEA Registry Blog

By CEA Registry Team on 6/15/2016 4:20 PM
 By Pei-Jung Lin, PhD.

Alzheimer’s disease and related dementias (ADRD) is a slow, progressive disease.  Many people with ADRD may live for years with the disease left unrecognized or untreated, in part because the early symptoms are mild and often mistaken as part of normal aging.  Our recent study1 in the Journal of the American Geriatrics Society (JAGS) found that ADRD patients may already use more health care services than those without dementia before they receive a formal diagnosis. Our findings suggest that ADRD patients’ Medicare expenditures may start to increase at least 12 months preceding their first diagnosis date (Figure 1).  We found that total Medicare expenditures are 42% higher among ADRD patients than matched controls during the year prior to diagnosis ($15,091 vs. $10,622), and 192% higher during the first year immediately following diagnosis ($27,126 vs. $9,274).  Our study also showed that ADRD patients’ Medicare expenditures increase substantially during the period...
By CEA Registry Team on 5/16/2016 8:41 AM

By CEA Registry Team

The Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry (www.cearegistry.org), will begin to display detailed information only for selected studies considered to be high impact economic evaluations. Starting with studies published in 2015, all CEA abstracts will be reviewed by two Tufts reviewers, who will make a determination by consensus on whether the study qualifies for an extended review based on: the study’s population, the medical intervention(s) being studied, novelty of treatment, as well as the generalizability of the study’s results, as inferred from the abstract. The selected studies will then be reviewed in full so the Registry team can collect detailed information on cost-effectiveness ratios, utility weights, and study methodology. The cost-utility studies not deemed to be high impact will continue to be included in the CEA Registry, but with limited information extracted only from the abstract, including country of study, intervention type, target population and interventions evaluated, without providing ratios, weights, or disaggregate cost and QALY data. Limited information on cost per life year studies will also be included in the Registry starting with studies published in 2015.

This change follows the rapidly growing publication rate of CUAs, with over 600 studies published in 2014 alone. The newer process allows the CEA Registry to provide valuable ratio and preference weight information for a select group of important studies to our users while continuing to provide a comprehensive list of cost per QALY and cost per life year studies published annually across different disease areas and interventions.  The Registry is currently updated through 2014 and contains 5,000 cost-utility studies with over 13,000 standardized cost-effectiveness ratios and 19,000 utility weights.

By CEA Registry Team on 2/12/2016 11:51 AM
By CEA Registry Team The Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.org) has now been updated to include published cost-utility studies or CUAs (studies that report findings in the form of cost per quality-adjusted life years (QALYs) gained) through 2014.  The database contains information on cost-utility analyses on a wide range of health and medical interventions published from 1976-2014, including over 13,000 standardized cost-effectiveness ratios. The current upload adds the following to the database: • 642 cost-utility analyses articles published in 2014 • 1,547 cost-effectiveness ratios • 2,964 utility weights The full Registry now includes: • 5,000 cost-utility analyses articles published from 1976 through 2014 • 13,462 cost-effectiveness ratios • 19,956 utility weights Online search capabilities allow for public access to a select set of data from the registry, including utility weights and ratios.  CEVR’s premium access subscribers can access and download both the entire CEA Registry and the Tufts National Coverage Determination database, which provides detailed information on each national coverage decision.  Premium access subscribers can conduct advanced searches of the Registry data....
By CEA Registry Team on 2/1/2016 9:59 AM

 

By Joshua Cohen, PhD, and Pei-Jung Lin, PhD

Newly approved cancer drugs in the U.S. now cost an average of $10,000 per month, with some therapies costing more than $30,000 per month.  Expensive oncology innovations present coverage and reimbursement challenges for payers who must contain costs while ensuring drug access.  High costs also pose substantial financial burdens on patients and families.  One of the most heated debates concerns treatment for chronic myeloid leukemia (CML). 

Our recent paper [1] in Medical Care found that, despite high costs, CML care may have provided reasonable value for money among older patients between 1995 and 2007.  This study, funded by The Leukemia & Lymphoma Society, analyzed how aggregate care costs and survival have changed over time based on real-world, population-level data from SEER-Medicare.  Our findings showed that for older adults, cancer care costs increased from $127,000 in 1995 to $278,000 in 2007 (2010 dollars), but that during the same period, survival increased from 2.2 years to 4.2 years.  The increase in CML care costs largely reflects the added cost of tyrosine kinase inhibitor (TKI) medications (see Figure below).  Dividing the added treatment costs between 1995 and 2007 of $151,000 by the corresponding survival gain of roughly 2 years yields an estimated incremental cost-effectiveness ratio (ICER) of $74,000/LY (2010 dollars) among Medicare patients with CML.  The clinical benefits of TKIs can also be described in more concrete terms: for many patients, these medications have transformed CML from a fatal disorder to a managed, chronic condition.

Estimated mean health care costs (simulation truncated at 15 years after diagnosis, 2010 dollars)


Despite the transformative impact of TKIs on CML and their arguably favorable cost-effectiveness (the value of a quality adjusted life year – a “QALY” – in the United States has been reported to range from $100,000 to $150,000 [2]), these medications remain tremendously controversial.  In 2013, an editorial signed by more than 100 CML experts argued that “prices of CML drugs are too high and unsustainable.”[3]  Why?

First, the prices of these drugs have increased substantially since their introduction in 2001.  At that time, the first TKI, imatinib, cost $30,000 per year for each patient.  By 2012, the price had tripled to $92,000 per year.  Indeed, our analysis has been criticized since it reflects drug price increases only through 2007. [4,5]

Second, there is a sense that the cost-effectiveness ratio alone is not a sufficient indicator for assessing whether the price for a drug is warranted. Payers and others feel that budget impact is also important.  They argue that the introduction of new, high priced drugs that are indicated for a large number of people (Sovaldi is a recent poster child) makes the health system “unsustainable”.  One notable drug valuation framework, developed by the Institute for Clinical and Economic Review (ICER), explicitly considers budget impact.[6]  In ICER’s framework, a highly cost-effective drug can be deemed too expensive if the population budget impact exceeds $904 million annually.

Our analysis of CML is limited by the fact that we have data only through 2007, and our work should be updated when new data become available.  But there are several points to keep in mind.  First, just as it makes sense to update prices for these drugs in our analysis, it also makes sense to take into account the fact that these drugs will likely become considerably less expensive in the not too distant future.  The patent for imatinib expired in 2015, and the patent for dasatinib is scheduled to expire in 2020.

Second, we would argue that if a (new) drug has a favorable cost-effectiveness ratio but an “unsustainable” impact on health care budgets, an advisable reaction is not necessarily rejection of coverage for that new drug.  Instead, it might make sense to look at whether resources should be diverted away from other, lower value therapies in order to fund access to the novel, higher value therapy. 

The response to this position might be that perhaps the government should instead limit the price of drugs or the duration of patent coverage.  How much innovation patent protection generates is not clear.  Then again, at some point (that must be better understood), cutting back on patent protection adversely affects innovation since it decreases the return on investment to drug manufacturers. 

It is critical to recognize that there will be tradeoffs, whether between a new treatment and a (lower value) existing treatment, or between more affordable treatment coverage now and possibly less innovation in the future.  We must better understand those tradeoffs and then consciously decide which benefits are most important to preserve.  Because these tradeoffs are so controversial, it is tempting to dismiss them.  But doing so does not make them go away.  On average, it just leads to worse outcomes.


1 Lin PJ, Winn AN, Parsons SK, Neumann PJ, Weiss ES, Cohen JT. Linking Costs and Survival in the Treatment of Older Adults with Chronic Myeloid Leukemia:  An Analysis of SEER-Medicare Data from 1995-2007. Medical Care 2016 Jan 12 [Epub ahead of print].
 
2 Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371:796–797.

3 Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013;121:4439–4442.

4 Prasad V, Mailankody S. How should we assess the value of innovative drugs in oncology? Lessons from cost-effectiveness analyses. Blood. 2015;126(15):1860-1861.

5 Saret CJ, Cohen JT, Parsons SK, Neumann PJ. Price and value in cancer care. Cancer 2015;121(22):4097-4098.

6 Neumann PJ, Cohen JT. Measuring the Value of Prescription Drugs. N Engl J Med 2015;373(27):2595-7.

By CEA Registry Team on 11/18/2015 5:26 PM
By: Joshua T. Cohen and Peter J. Neumann Rising drug prices continue to frustrate payers, physicians, and the public.  They grab the attention of the media and leading presidential candidates.  In response, private US organizations have recently developed drug evaluation schemes, and by doing so, hope to promote rational drug pricing and purchase decisions. In this week’s New England Journal of Medicine, we examine how five notable actors evaluate drug prices according to their value-based framework:  

American College of Cardiology     (ACC)/American Heart Association (AHA), American Society of Clinical Oncology (ASCO), Institute for Clinical and Economic Review (ICER), Memorial Sloan Kettering Cancer Center (MSKCC), and The National Comprehensive Cancer Network (NCCN). Framework details are available in our commentary.  But here’s what we learned.  First, these frameworks emphasize a drug’s value – in terms of patient benefits and in some cases population impacts – rather than a drug’s development and production cost.  That’s good because it incentivizes development of drugs that improve health.  It’s also consistent with how consumers think about other products.  After all, when we visit Starbucks, we’re thinking about coffee taste and possibly shop ambiance.  We’re certainly not thinking about the cost of the coffee beans, hot water, and barista service.  Admittedly, medication and coffee markets differ.  But the salience of product benefits spans both....
By CEA Registry Team on 9/25/2015 2:14 PM

By James D. Chambers, Ph.D.

Conventional wisdom in the U.S. suggests that private payers look to Medicare’s lead in making coverage decisions. However, in a new paper published in Health Affairs, my colleagues and I found that Medicare national coverage determinations (NCDs) disagreed with private policies for roughly half of the technologies included in our study.(1)

The Medicare program issues NCDs for technologies seen as especially significant; the remainder of coverage decisions are made by regional contractors. We identified medical devices in NCDs between February 1999 and August 2013 using the Tufts Medical Center National Coverage Determination Database.(2)

For each device, we examined whether it was covered by Medicare and each of the 18 largest private payers (excluding two that did not publish formal coverage policies online). If both Medicare and a private payer covered the device, we classified the NCD as equivalent to, more restrictive than, or less restrictive than the private payer policy.

Of the forty-seven medical devices included in our study, twenty-seven had 510(k) clearance, nineteen had pre-market approval, and one had a humanitarian device example. Medicare covered thirty-five (74%) of the devices. The sixteen payers we examined issued coverage policies for varying proportions of the devices; only two issued policies for fewer than half the devices, while one payer (Aetna) issued policies for all forty-seven.

NCDs were equivalent with private coverage in 51% of comparisons, more restrictive tin 23%, and less restrictive in 22% of cases (Exhibit 1). Twenty devices were coverage by Medicare and all private payers, while seven devices were not covered by Medicare or any private payers. Private payer coverage policies were inconsistent for the other twenty devices.

Exhibit 1

Exhibit 1. Source: Health Affairs.

This research was limited to technologies present in NCDs during the study period. We could not include payers without available coverage policies. In addition, in cases without a policy it was possible that payers made coverage decisions on a case by case basis. The study excluded devices coverage through Medicare’s coverage with evidence development program, which requires study while an intervention is made available to a limited population. This program lacked an analogue for comparison among private payer policies.  

While some differences are expected amongst the many individual decisions made by Medicare and each of the private payers, we were surprised at the amount of variation among the payers in our study. One possible explanation is that the difference in age between the Medicare population and populations covered by private insurers leads to different policies; however, this difference would not explain the lack of agreement among private payers. It is possible that payers used different evidence and/or different criteria to make decisions. This variation in coverage policy can create a challenge for manufacturers developing evidence about new technology and may lead to unequal access to medical technology for patients.

References:

1. Chambers, JD, Chenoweth M, Thorat T, Neumann PJ. Private Payers Disagree with Medicare Over Medical Device Coverage About Half The Time. Health Affairs 2015;34(8):1376–1382.

By CEA Registry Team on 9/17/2015 9:33 AM

By Cayla Saret, B.A. 

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.
 
1: Xu X, Ma YY, Zou HD. Cost-Utility Analysis of Cataract Surgery in Advanced Glaucoma Patients. J Glaucoma. 2015 Sep 14. [Epub ahead of print] PubMed PMID: 26372156.
 
2: Puggina A, Broumas A, Ricciardi W, et. al. Cost-effectiveness of screening for lung cancer with low-dose computed tomography: a systematic literature review. Eur J Public Health. 2015 Sep 14. [Epub ahead of print] PubMed PMID: 26370440.
 
3: Polistena B, Calzavara-Pinton P, Altomare G, et. al. The impact of biologic therapy in chronic plaque psoriasis from a societal perspective: an analysis based on Italian actual clinical practice. J Eur Acad Dermatol Venereol. 2015 Sep 15. [Epub ahead of print] PubMed PMID: 26370321.
 
4: Boyd KA, Briggs AH, Bauld L, et. al. Are financial incentives cost-effective to support smoking cessation during pregnancy? Addiction. 2015 Sep 15. [Epub ahead of print] PubMed PMID: 26370095.
 
5: Juusola JL, Brandeau ML. HIV Treatment and Prevention: A Simple Model to Determine Optimal Investment. Med Decis Making. 2015 Sep 14. [Epub ahead of print] Review. PubMed PMID: 26369347.
 
6: Gooding S, Lau IJ, Sheikh M, et. al. Double Relapsed and/or Refractory Multiple Myeloma: Clinical Outcomes and Real World Healthcare Costs. PLoS One. 2015 Sep 14;10(9):e0136207. eCollection 2015. PubMed PMID: 26367874.
 
7: Pertile P, Poli A, Dominioni L, et. al. Is chest X-ray screening for lung cancer in smokers cost-effective? Evidence from a population-based study in Italy. Cost Eff Resour Alloc. 2015 Sep 12;13:15. eCollection 2015. PubMed PMID: 26366122.
 
8: Pei PP, Weinstein MC, Li XC, et. al. Prioritizing HIV comparative effectiveness trials based on value of information: generic versus brand-name ART in the US. HIV Clin Trials. 2015 Sep 14:1945577115Y0000000009. [Epub ahead of print] PubMed PMID: 26365741.
 
9: Shah M, Risher K, Berry SA, et. al. The epidemiologic and economic impact of improving HIV testing, linkage, and retention in care in the United States. Clin Infect Dis. 2015 Sep 11. [Epub ahead of print] PubMed PMID: 26362321.
 
10: Chit A, Becker DL, DiazGranados CA, et. al. Cost-effectiveness of high-dose versus standard-dose inactivated influenza vaccine in adults aged 65 years and older: an economic evaluation of data from a randomised controlled trial. Lancet Infect Dis. 2015 Sep 8. [Epub ahead of print] PubMed PMID: 26362172.
 
11: Tosanguan J, Chaiyakunapruk N. Cost-effectiveness analysis of clinical smoking cessation interventions in Thailand. Addiction. 2015 Sep 11. [Epub ahead of print] PubMed PMID: 26360507.
 
12: Svedbom A, Paech D, Leonard C, et. al. Is dibotermin alfa a cost-effective substitute for autologous iliac crest bone graft in single level lumbar interbody spine fusion? Curr Med Res Opin. 2015 Sep 11:1-32. [Epub ahead of print] PubMed PMID: 26359326.
 
13: Durkee BY, Qian Y, Pollom EL, et. al. Cost-Effectiveness of Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2015 Sep 8. [Epub ahead of print] PubMed PMID: 26351332.
 
14: Mullikin M, Tan L, Jansen JP, et. al. A Novel Dynamic Model for Health Economic Analysis of Influenza Vaccination in the Elderly. Infect Dis Ther. 2015 Sep 9. [Epub ahead of print] PubMed PMID: 26350238.
 
15: Kaimal AJ, Norton ME, Kuppermann M. Prenatal Testing in the Genomic Age: Clinical Outcomes, Quality of Life, and Costs. Obstet Gynecol. 2015 Sep 3. [Epub ahead of print] PubMed PMID: 26348190.
 
16: Burns DK, Wilson EC, Browne P, et. al. The Cost Effectiveness of Maintenance Schedules Following Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: An Economic Evaluation Alongside a Randomised Controlled Trial. Appl Health Econ Health Policy. 2015 Sep 7. [Epub ahead of print] PubMed PMID: 26346590.
 
17: Johnson MJ, Kanaan M, Richardson G, et. al. A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease. BMC Med. 2015 Sep 7;13(1):213. PubMed PMID: 26345362.
 
18: McBain RK, Salhi C, Hann K, et. al. Costs and cost-effectiveness of a mental health intervention for war-affected young persons: decision analysis based on a randomized controlled trial. Health Policy Plan. 2015 Sep 7. [Epub ahead of print] PubMed PMID: 26345320.
 
19: Le P, Rothberg MB. Cost-Effectiveness of Herpes Zoster Vaccine for Persons Aged 50 Years. Ann Intern Med. 2015 Sep 8. [Epub ahead of print] PubMed PMID: 26344036.
 
20: Nair SC, Welsing PM, Jacobs JW, et. al. Economic evaluation of a tight-control treatment strategy using an imaging device (handscan) for monitoring joint inflammation in early rheumatoid arthritis. Clin Exp Rheumatol. 2015 Sep 7. [Epub ahead of print] PubMed PMID: 26343274.
 
21: Lichtenberg FR. The impact of pharmaceutical innovation on premature cancer mortality in Switzerland, 1995-2012. Eur J Health Econ. 2015 Sep 5. [Epub ahead of print] PubMed PMID: 26342826.
 
22: Siribumrungwong B, Noorit P, Wilasrusmee C, et. al. Cost-utility analysis of great saphenous vein ablation withradiofrequency, foam and surgery in the emerging health-care setting of Thailand. Phlebology. 2015 Sep 4. [Epub ahead of print] PubMed PMID: 26341394.
 
23: Meads DM, Marshall A, Hulme CT, et. al. The Cost Effectiveness of Docetaxel and Active Symptom Control versus Active Symptom Control Alone for Refractory Oesophagogastric Adenocarcinoma: Economic Analysis of the COUGAR-02 Trial. Pharmacoeconomics. 2015 Sep 4. [Epub ahead of print] PubMed PMID: 26340940.
 
24: Valencia WM, Florez HJ. A new angle for glp-1 receptor agonist: the medical economics argument Editorial on: Huetson P, Palmer JL, Levorsen A, et al. Cost-effectiveness of the once-daily glp-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway. J Med Econ 2015: 1-13 [Epub ahead of print]. J Med Econ. 2015 Sep 4:1-3. [Epub ahead of print] PubMed PMID: 26337323.
 
25: Gutzwiller FS, Pfeil AM, Ademi Z, et. al. Cost Effectiveness of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in the Treatment of Hyperphosphataemia in Patients Receiving Dialysis, from the Perspective of the National Health Service in Scotland. Pharmacoeconomics. 2015 Sep 3. [Epub ahead of print] PubMed PMID: 26334991.
 
26: Matter-Walstra K, Braun R, Kolb C, et. al. A cost-effectiveness analysis of trametinib plus dabrafenib as first-line therapy for metastatic BRAF V600-positive melanoma in the Swiss setting. Br J Dermatol. 2015 Sep 2. [Epub ahead of print] PubMed PMID: 26332527.
 
27: Karantana A, Scammell BE, Davis TR, et. al. Cost-effectiveness of volar locking plate versus percutaneous fixation for distal radial fractures: Economic evaluation alongside a randomised clinical trial. Bone Joint J. 2015 Sep;97-B(9):1264-70. PubMed PMID: 26330595.
 
28: Gimeno-Ballester V, Mar J, San Miguel R. Cost-effectiveness analysis of simeprevir with daclatasvir for non-cirrhotic genotype-1b-naïve patients plus chronic hepatitis C. Expert Rev Pharmacoecon Outcomes Res. 2015 Sep 1:1-10. [Epub ahead of print] PubMed PMID: 26327360.
 
29: Woo CY, Strandberg EJ, Schmiegelow MD, et. al. Cost-Effectiveness of Adding Cardiac Resynchronization Therapy to an Implantable Cardioverter-Defibrillator Among Patients With Mild Heart Failure. Ann Intern Med. 2015 Sep 15;163(6):417-26. PubMed PMID: 26301323.
 
30: Suen SC, Bendavid E, Goldhaber-Fiebert JD. Cost-effectiveness of improvements in diagnosis and treatment accessibility for tuberculosis control in India. Int J Tuberc Lung Dis. 2015 Sep;19(9):1115-24. PubMed PMID: 26260835.
 
31: Goffin JR, Flanagan WM, Miller AB, et. al. Cost-effectiveness of Lung Cancer Screening in Canada. JAMA Oncol. 2015 Sep 1;1(6):807-13. PubMed PMID: 26226181.
 
32: Li R, Qu S, Zhang P, et. al. Economic Evaluation of Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among Persons at Increased Risk: A Systematic Review for the Community Preventive Services Task Force. Ann Intern Med. 2015 Sep 15;163(6):452-60. PubMed PMID: 26167962.
 
33: Li M, Dick A, Montenovo M, et. al. Cost-effectiveness of liver transplantation in methylmalonic and propionic acidemias. Liver Transpl. 2015 Sep;21(9):1208-18. PubMed PMID: 25990417.
 
34: Vestergaard AS, Ehlers LH. A Health Economic Evaluation of Stroke Prevention  in Atrial Fibrillation: Guideline Adherence Versus the Observed Treatment Strategy Prior to 2012 in Denmark. Pharmacoeconomics. 2015 Sep;33(9):967-79. PubMed PMID: 25943684.
 
35: Fleeman N, Bagust A, Beale S, et. al. Dabrafenib for Treating Unresectable, Advanced or Metastatic BRAF V600 Mutation-Positive Melanoma: An Evidence Review Group Perspective. Pharmacoeconomics. 2015 Sep;33(9):893-904. PubMed PMID: 25906420.
 
36: Borisenko O, Adam D, Funch-Jensen P, et. al. Bariatric Surgery can Lead to Net Cost Savings to Health Care Systems: Results from a Comprehensive European Decision Analytic Model. Obes Surg. 2015 Sep;25(9):1559-68. PubMed PMID: 25639648.
By CEA Registry Team on 8/6/2015 3:00 PM

By Joshua T. Cohen, PhD

The New York Times writes that wider access to health insurance under the Affordable Care Act will drive up health care spending – despite claims to the contrary.  CEVR’s Josh Cohen comments in the article that greater access to screening often fails to save money because a large number of people must be screened to prevent one case of expensive disease.  That said, greater access to health care (and to prevention) can deliver good value.  But that’s not the same thing reducing overall health care costs.  Knowing which measures deliver good value depends on analyzing the options.  Generalizations about saving money are unhelpful.

By CEA Registry Team on 7/17/2015 3:27 PM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Nwachukwu BU, McLawhorn AS, Simon MS, et. al. Management of End-Stage Ankle Arthritis: Cost-Utility Analysis Using Direct and Indirect Costs. J Bone Joint Surg Am. 2015 Jul 15;97(14):1159-72. PubMed PMID: 26178891.

2: Rosselli D, Rueda JD, Diaz CE. Cost-effectiveness of kidney transplantation compared with chronic dialysis in end-stage renal disease. Saudi J Kidney Dis Transpl. 2015 Jul-Aug;26(4):733-738. PubMed PMID: 26178546.

3: Sharma M, Sy S, Kim JJ. The value of male human papillomavirus vaccination in preventing cervical cancer and genital warts in a low-resource setting. BJOG. 2015 Jul 14. [Epub ahead of print] PubMed PMID: 26176301.

4: Hsieh HM, Gu SM, Shin SJ, et. al. Cost-Effectiveness of a Diabetes Pay-For-Performance Program in Diabetes Patients with Multiple Chronic Conditions. PLoS One. 2015 Jul 14;10(7):e0133163. eCollection 2015. PubMed PMID: 26173086.

5: Pandya A, Sy S, Cho S, et. al. Cost-effectiveness of 10-Year Risk Thresholds for Initiation of Statin Therapy for Primary Prevention of Cardiovascular Disease. JAMA. 2015 Jul 14;314(2):142-50. doi: 10.1001/jama.2015.6822. PubMed PMID: 26172894.

6: Rudmik L, An W, Livingstone D, et. al. Making a case for high-volume robotic surgery centers: A cost-effectiveness analysis of transoral robotic surgery. J Surg Oncol. 2015 Jul 14. [Epub ahead of print] PubMed PMID: 26171771.

7: Babović I, Arandjelović M, Plešinac S, et. al. "Vaginal delivery or caesarean section at term breech delivery-chance or risk?" J Matern Fetal Neonatal Med. 2015 Jul 14:1-10. [Epub ahead of print] PubMed PMID: 26169706.

8: Vallejo-Torres L, Castilla I, Couce ML, et. al. Cost-Effectiveness Analysis of a National Newborn Screening Program for Biotinidase Deficiency. Pediatrics. 2015 Jul 13. [Epub ahead of print] PubMed PMID: 26169436.

9: Simpson SA, McNamara R, Shaw C, et. al. A feasibility randomised controlled trial of a motivational interviewing-based intervention for weight loss maintenance in adults. Health Technol Assess. 2015 Jul;19(50):1-378. doi: 10.3310/hta19500. PubMed PMID: 26168409.

10: Li R, Qu S, Zhang P, Chattopadhyay S, et. al. Economic Evaluation of Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among Persons at Increased Risk: A Systematic Review for the Community Preventive Services Task Force. Ann Intern Med. 2015 Jul 14. [Epub ahead of print] PubMed PMID: 26167962.

11: Shafiq M, Frick KD, Lee H, et. al. Management of Malignant Pleural Effusion: A Cost-Utility Analysis. J Bronchology Interv Pulmonol. 2015 Jul;22(3):215-25. PubMed PMID: 26165892.

12: Rosenthal VD, Udwadia FE, Kumar S, et. al. Clinical impact and cost-effectiveness of split-septum and single-use prefilled flushing device vs 3-way stopcock on central line-associated bloodstream infection rates in India: a randomized clinical trial conducted by the International Nosocomial Infection Control Consortium (INICC). Am J Infect Control. 2015 Jul 8. pii: S0196-6553(15)00655-0. [Epub ahead of print] PubMed PMID: 26164769.

13: Reilly CM, Butler J, Culler SD, et. al. An Economic Evaluation of a Self-Care Intervention in Persons with Heart Failure and Diabetes. J Card Fail. 2015 Jul 8. [Epub ahead of print] PubMed PMID: 26164214.

14: Mangen MJ, Rozenbaum MH, Huijts SM, et. al. Cost-effectiveness of adult pneumococcal conjugate vaccination in the Netherlands. Eur Respir J. 2015 Jul 9. pii: ERJ-00325-2015. [Epub ahead of print] PubMed PMID: 26160871.

15: Banz K, Delnoy PP, Billuart JR. Exploratory cost-effectiveness analysis of cardiac resynchronization therapy with systematic device optimization vs. standard (non-systematic) optimization: a multinational economic evaluation. Health Econ Rev. 2015 Dec;5(1):57. Epub 2015 Jul 11. PubMed PMID: 26160650.

16: Kvizhinadze G, Wilson N, Nair N, et. al. How much might a society spend on life-saving interventions at different ages while remaining cost-effective? A case study in a country with detailed data. Popul Health Metr. 2015 Jul 8;13:15. eCollection 2015. PubMed PMID:  26155199; PubMed Central PMCID: PMC4493819.

17: Forster A, Young J, Chapman K, et. al. Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care. Stroke. 2015 Jul 7. [Epub ahead of print] PubMed PMID: 26152298.

18: van den Akker-van Marle ME, van Sorge AJ, Schalij-Delfos NE. Cost and effects of risk factor guided screening strategies for retinopathy of prematurity for different treatment strategies. Acta Ophthalmol. 2015 Jul 6. doi: 10.1111/aos.12798. [Epub ahead of print] PubMed PMID: 26149829.

19: Leggett LE, Hauer T, Martin BJ, et. al. Optimizing Value From Cardiac Rehabilitation: A Cost-Utility Analysis Comparing Age, Sex, and Clinical Subgroups. Mayo Clin Proc. 2015 Jul 3. pii: S0025-6196(15)00466-8. [Epub ahead of print] PubMed PMID: 26149321.

20: Schauwvlieghe AM, Dijkman G, Hooymans JM, et. al. Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study). BMC Ophthalmol. 2015 Jul 7;15(1):71. PubMed PMID: 26149170; PubMed Central PMCID: PMC4491889.

21: Cillo U, Spolverato G, Vitale A, et. al. Liver Resection for Advanced Intrahepatic Cholangiocarcinoma: A Cost-Utility Analysis. World J Surg. 2015 Jul 7. [Epub ahead of print] PubMed PMID: 26148521.

22: Foster Page LA, Beckett DM, Cameron CM, et. al. Can the Child Health Utility 9D measure be useful in oral health research? Int J Paediatr Dent. 2015 Jul 4. [Epub ahead of print] PubMed PMID: 26146798.

23: ESHRE Capri Workshop Group. Economic aspects of infertility care: a challenge for researchers and clinicians. Hum Reprod. 2015 Jul 3. [Epub ahead  of print] Review. PubMed PMID: 26141712.

24: Ledwidge MT, O'Connell E, Gallagher J, et. al. Cost-effectiveness of natriuretic peptide-based screening and collaborative care: a report from the STOP-HF (St Vincent's Screening TO Prevent Heart Failure) study. Eur J Heart Fail. 2015 Jul;17(7):672-9. PubMed PMID: 26139583.

25: Micieli A, Wijeysundera HC, Qiu F, et. al. A Decision Analysis of Percutaneous Left Atrial Appendage Occlusion Relative to Novel and Traditional Oral Anticoagulation for Stroke Prevention in Patients with New-Onset Atrial Fibrillation. Med Decis Making. 2015 Jul 2. [Epub ahead of print] PubMed PMID: 26139448.

26: Khan I, Morris S, Hackshaw A, et. al. Cost-effectiveness of first-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy. BMJ Open. 2015 Jul 2;5(7):e006733. PubMed PMID: 26137881.

27: Schurer JM, Rafferty E, Farag M, et. al. Echinococcosis: An Economic Evaluation of a Veterinary Public Health Intervention in Rural Canada. PLoS Negl Trop Dis. 2015 Jul 2;9(7):e0003883. eCollection 2015 Jul. PubMed PMID: 26135476.

28: Deng J, Gu S, Shao H, et. al. Cost-effectiveness analysis of exenatide twice daily (BID) versus insulin glargine once daily (QD) as add-on therapy in Chinese patients with Type 2 diabetes mellitus inadequately controlled by oral therapies. J Med Econ. 2015 Jul 2:1-32. [Epub ahead of print] PubMed PMID: 26134916.

29: Haasis MA, Ceria JA, Kulpeng W, et. al. Do Pneumococcal Conjugate Vaccines Represent Good Value for Money in a Lower-Middle  Income Country? A Cost-Utility Analysis in the Philippines. PLoS One. 2015 Jul 1;10(7):e0131156. eCollection 2015. PubMed PMID: 26131961.

30: Campbell JR, Sasitharan T, Marra F. A Systematic Review of Studies Evaluating the Cost Utility of Screening High-Risk Populations for Latent Tuberculosis Infection. Appl Health Econ Health Policy. 2015 Jul 1. [Epub ahead of print] PubMed PMID: 26129810.

31: Sonneville KR, Long MW, Ward ZJ, et. al. BMI and Healthcare Cost Impact of Eliminating Tax Subsidy for Advertising Unhealthy Food to Youth. Am J Prev Med. 2015 Jul;49(1):124-34. PubMed PMID: 26094233.

32: Long MW, Gortmaker SL, Ward ZJ, et. al. Cost Effectiveness of a Sugar-Sweetened Beverage Excise Tax in the U.S. Am J Prev Med. 2015 Jul;49(1):112-23. Review. PubMed PMID: 26094232.

33: Gortmaker SL, Long MW, Resch SC, et. al. Cost Effectiveness of Childhood Obesity Interventions: Evidence and Methods for CHOICES. Am J Prev Med. 2015 Jul;49(1):102-11. PubMed PMID: 26094231.

34: Cortesi PA, Mantovani LG, Ciaccio A, et. al. Cost-Effectiveness of New Direct-Acting Antivirals to Prevent Post-Liver Transplant Recurrent Hepatitis. Am J Transplant. 2015 Jul;15(7):1817-26. PubMed PMID: 26086300.

35: Kowada A. Cost-effectiveness of tobacco cessation support combined with tuberculosis screening among contacts who smoke. Int J Tuberc Lung Dis. 2015 Jul;19(7):857-63. PubMed PMID: 26056114.

36: Gu S, Deng J, Shi L, et. al. Cost-effectiveness of saxagliptin vs glimepiride as a second-line therapy added to metformin in Type 2 diabetes in China. J Med Econ. 2015 Jul 1:1-13. [Epub ahead of print] PubMed PMID: 25950193.

37: Zhang P, Yang Y, Wen F, et. al. Cost-effectiveness of sorafenib as a first-line treatment for advanced hepatocellular carcinoma. Eur J Gastroenterol Hepatol. 2015 Jul;27(7):853-9. PubMed PMID: 25919775.

38: Fox GJ, Oxlade O, Menzies D. Fluoroquinolone Therapy for the Prevention of Multidrug-Resistant Tuberculosis in Contacts. A Cost-Effectiveness Analysis. Am J Respir Crit Care Med. 2015 Jul 15;192(2):229-37. PubMed PMID: 25915791.

39: Cheung MC, Hay AE, Crump M, et. al. Gemcitabine/Dexamethasone/Cisplatin vs Cytarabine/Dexamethasone/Cisplatin for Relapsed or Refractory Aggressive-Histology Lymphoma: Cost-Utility Analysis of NCIC CTG LY.12. J Natl Cancer Inst. 2015 Apr 13;107(7). Print 2015 Jul. PubMed PMID: 25868579.

40: Fergenbaum J, Bermingham S, Krahn M, et. al. Care in the Home for the Management of Chronic Heart Failure: Systematic Review and Cost-Effectiveness Analysis. J Cardiovasc Nurs. 2015 Jul-Aug;30(4 Suppl 1):S44-51. PubMed PMID: 25658188.

41: Quartuccio L, di Bidino R, Ruggeri M, et. al. Cost-Effectiveness Analysis of Two Rituximab Retreatment Regimens for Longstanding Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):947-55. PubMed PMID: 25581074.

42: Gaudette É, Goldman DP, Messali A, et. al. Do Statins Reduce the Health and Health Care Costs of Obesity? Pharmacoeconomics. 2015 Jul;33(7):723-34. PubMed PMID: 25576147; PubMed Central PMCID:PMC4490078.

43: Finkelstein EA, Kruger E, Karnawat S. Cost-Effectiveness Analysis of Qsymia for Weight Loss. Pharmacoeconomics. 2015 Jul;33(7):699-706. PubMed PMID: 24986038; PubMed Central PMCID: PMC4486409.

By CEA Registry Team on 7/2/2015 11:13 AM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Shih YT, Chien CR, Moguel R, et. al. Cost-Effectiveness Analysis of a Capitated Patient Navigation Program for Medicare Beneficiaries with Lung Cancer. Health Serv Res. 2015 Jun 26. [Epub ahead of print] PubMed PMID: 26119569.

2: Marques EM, Blom AW, Lenguerrand E, et. al. Local anaesthetic wound infiltration in addition to standard anaesthetic regimen in total hip and knee replacement: long-term cost-effectiveness analyses alongside the APEX randomised  controlled trials. BMC Med. 2015 Jun 26;13(1):151. [Epub ahead of print] PubMed PMID: 26116078.

3: Sharma P, Scotland G, Cruickshank M, et. al. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open. 2015 Jun 25;5(6):e007758. PubMed PMID: 26112222.

4: Giorgi MA, Caroli C, Giglio ND, et. al. Estimation of the cost-effectiveness of apixaban versus vitamin K antagonists in the management of atrial fibrillation in Argentina. Health Econ Rev. 2015 Dec;5(1):52. Epub 2015 Jun  26. PubMed PMID: 26112219.

5: Chen W, Krahn M. Disease burden of chronic hepatitis C among immigrants in Canada. J Viral Hepat. 2015 Jun 25. [Epub ahead of print] PubMed PMID: 26110922.

6: Koh R, Pukallus M, Kularatna S, et. al. Relative cost-effectiveness of home visits and telephone contacts in preventing early childhood caries. Community Dent Oral Epidemiol. 2015 Jun 25. [Epub ahead of print] PubMed PMID: 26110399.

7: Lang B, Wong CK. A cost-effectiveness comparison between early surgery and non-surgical approach for incidental papillary thyroid microcarcinoma (PTMC). Eur J Endocrinol. 2015 Jun 23. [Epub ahead of print] PubMed PMID: 26104754.

8: Chhatwal J, Mathisen M, Kantarjian H. Are high drug prices for hematologic malignancies justified? A critical analysis. Cancer. 2015 Jun 23. [Epub ahead of print] PubMed PMID: 26102457.

9: Painter JT, Fortney JC, Gifford AL, et. al. Cost-effectiveness of Collaborative Care for Depression in Human Immunodeficiency Virus Clinics. J Acquir Immune Defic Syndr. 2015 Jun 20. [Epub ahead of print] PubMed PMID: 26102447.

10: Karnon J, Partington A. Cost-Value Analysis and the SAVE: A Work in Progress, But an Option for Localised Decision Making? Pharmacoeconomics. 2015 Jun 23. [Epub ahead of print] PubMed PMID: 26100285.

11: Despiégel N, Anger D, Martin M, et. al. Cost-Effectiveness of Dolutegravir in HIV-1 Treatment-Naive and Treatment-Experienced Patients in Canada. Infect Dis Ther. 2015 Jun 23. [Epub ahead of print] PubMed PMID: 26099626.

12: Begum N, Stephens S, Schoeman O, et. al. Cost-effectiveness Analysis of Rivaroxaban in the Secondary Prevention of Acute Coronary Syndromes in Sweden. Cardiol Ther. 2015 Jun 23. [Epub ahead of print] PubMed PMID: 26099515.

13: Butzke B, Oduncu FS, Severin F, et. al. The cost-effectiveness of UGT1A1 genotyping before colorectal cancer treatment with irinotecan from the perspective of the German statutory health insurance. Acta Oncol. 2015 Jun 22:1-11. [Epub ahead of print] PubMed PMID: 26098842.

14: Gupta A, Mushlin AI, Kamel H, et. al. Cost-Effectiveness of Carotid Plaque MR Imaging as a Stroke Risk Stratification Tool in Asymptomatic Carotid Artery Stenosis. Radiology. 2015 Jun 17:142843. [Epub ahead of print] PubMed PMID: 26098459.

15: Tilden EL, Lee VR, Allen AJ, et. al. Cost-Effectiveness Analysis of Latent versus Active Labor Hospital Admission for Medically Low-Risk, Term Women. Birth. 2015 Jun 22. [Epub ahead of print] PubMed PMID: 26095829.

16: Svensson M, Nilsson FO, Arnberg K. Reimbursement Decisions for Pharmaceuticals in Sweden: The Impact of Disease Severity and Cost Effectiveness. Pharmacoeconomics. 2015 Jun 21. [Epub ahead of print] PubMed PMID: 26093889.

17: Katz G, Romano O, Foa C, et. al. Economic Impact of Gene Expression Profiling in Patients with Early-Stage Breast Cancer in France. PLoS One. 2015 Jun 18;10(6):e0128880. eCollection 2015. PubMed PMID: 26086912.

18: Losina E, Dervan EE, Paltiel AD, et. al. Defining the Value of Future Research to Identify the Preferred Treatment of Meniscal Tear in the Presence of Knee Osteoarthritis. PLoS One. 2015 Jun 18;10(6):e0130256. eCollection 2015. PubMed PMID: 26086246.

19: Feingold B, Webber SA, Bryce CL, et. al. Cost-Effectiveness of Pediatric Heart Transplantation Across a Positive Crossmatch for High Waitlist Urgency Candidates. Am J Transplant. 2015 Jun 16. [Epub ahead of print] PubMed PMID: 26082322.

20: Skedgel C, Rayson D, Younis T. Is febrile neutropenia prophylaxis with granulocyte-colony stimulating factors economically justified for adjuvant TC chemotherapy in breast cancer? Support Care Cancer. 2015 Jun 17. [Epub ahead of print] PubMed PMID: 26081595.

21: Schremser K, Rogowski WH, Adler-Reichel S, et. al. Cost-Effectiveness of an Individualized First-Line Treatment Strategy Offering Erlotinib Based on EGFR Mutation Testing in Advanced Lung Adenocarcinoma Patients in Germany. Pharmacoeconomics. 2015 Jun 17. [Epub ahead of print] PubMed PMID: 26081300.

22: Beikler T, Flemmig TF. EAO consensus conference: economic evaluation of implant-supported prostheses. Clin Oral Implants Res. 2015 Jun 15. [Epub ahead of print] PubMed PMID: 26077930.

23: Spolverato G, Vitale A, Ejaz A, et. al. Hepatic Resection for Disappearing Liver Metastasis: a Cost-Utility Analysis. J Gastrointest Surg. 2015 Jun 16. [Epub ahead of print] PubMed PMID: 26077902.

By CEA Registry Team on 6/19/2015 11:46 AM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Beikler T, Flemmig TF. EAO consensus conference: economic evaluation of implant-supported prostheses. Clin Oral Implants Res. 2015 Jun [Epub ahead of print] PubMed PMID: 26077930.

2: Bamber L, Muston D, McLeod E, et. al. Cost-effectiveness analysis of treatment of venous thromboembolism with rivaroxaban compared with combined low molecular weight heparin/vitamin K antagonist. Thromb J. 2015 Jun 11;13:20. eCollection 2015. PubMed PMID: 26074735.

3: Poonawalla IB, Parikh RC, Du XL, et. al. Cost Effectiveness of Chemotherapeutic Agents and Targeted Biologics in Ovarian Cancer: A Systematic Review. Pharmacoeconomics. 2015 Jun 14. [Epub ahead of print] PubMed PMID: 26072142.

4: Lévesque R, Marcelli D, Cardinal H, et. al. Cost-Effectiveness Analysis of High-Efficiency Hemodiafiltration Versus Low-Flux Hemodialysis Based on the Canadian Arm of the CONTRAST Study. Appl Health Econ Health Policy. 2015 Jun 14. [Epub ahead of print] PubMed PMID: 26071951.

5: Werner EF, Hamel MS, Orzechowski K, et. al. Cost-effectiveness of Transvaginal Ultrasound Cervical Length Screening in Singletons without a Prior Preterm Birth: An Update. Am J Obstet Gynecol. 2015 Jun 10. [Epub ahead of print] PubMed PMID: 26071914.

6: Handels RL, Joore MA, Tran-Duy A, et. al. Early cost-utility analysis of general and cerebrospinal fluid-specific Alzheimer's disease biomarkers for hypothetical disease-modifying treatment decision in mild cognitive impairment. Alzheimers Dement. 2015 Jun 9. [Epub ahead of print] PubMed PMID: 26071009.

7: Poncet A, Gencer B, Blondon M, et. al. Electrocardiographic Screening for Prolonged QT Interval to Reduce Sudden Cardiac Death in Psychiatric Patients: A Cost-Effectiveness Analysis. PLoS One. 2015 Jun 12;10(6):e0127213. eCollection 2015. PubMed PMID: 26070071.

8: Gheorghe A, Roberts T, Hemming K, et. al. Evaluating the Generalisability of Trial Results: Introducing a Centre- and Trial-Level Generalisability Index. Pharmacoeconomics. 2015 Jun 12. [Epub ahead of print] PubMed PMID: 26068945.

9: Joshi S, Kulkarni V, Gangakhedkar R, et. al. Cost-effectiveness of a repeat HIV test in pregnancy in India. BMJ Open. 2015 Jun 11;5(6):e006718. PubMed PMID: 26068507.

10: McMillan A, Bratton DJ, Faria R, et. al. A multicentre randomised controlled trial and economic evaluation of continuous positive airway pressure for the treatment of obstructive sleep apnoea syndrome in older people: PREDICT. Health Technol Assess. 2015 Jun;19(40):1-188. PubMed PMID: 26063688.

11: Nasef SA, Shaaban AA, Mould-Quevedo J, et. al. The cost-effectiveness of celecoxib versus non-steroidal anti-inflammatory drugs plus proton-pump inhibitors in the treatment of osteoarthritis in Saudi Arabia. Health Econ Rev. 2015 Dec;5(1):53. Epub 2015 Jun 11. PubMed PMID: 26061682.

12: Stephens S, Botteman MF, Cifaldi MA, et. al. Modelling the cost-effectiveness of combination therapy for early, rapidly progressing rheumatoid arthritis by simulating the reversible and irreversible effects of the disease. BMJ Open. 2015 Jun 9;5(6):e006560. PubMed PMID: 26059521.

13: Pichon-Riviere A, Glujovsky D, Garay OU, et. al. Oxytocin in Uniject Disposable Auto-Disable Injection System versus Standard Use for the Prevention of Postpartum Hemorrhage in Latin America and the Caribbean: A Cost-Effectiveness Analysis. PLoS One. 2015 Jun 9;10(6):e0129044. eCollection 2015. PubMed PMID: 26057930.

14: Abend NS, Topjian AA, Williams S. Could EEG monitoring in critically ill children be a cost-effective neuroprotective strategy? J Clin Neurophysiol. 2015 Jun 3. [Epub ahead of print] PubMed PMID: 26057408.

15: Yin J, Ji Z, Liang P, et. al. The doses of 10µg should replace the doses of 5µg in newborn hepatitis B vaccination in China: A cost-effectiveness analysis. Vaccine. 2015 Jun 6. [Epub ahead of print] PubMed PMID: 26057138.

16: Bell JM, Shields MD, Agus A, et. al. Clinical and Cost-Effectiveness of Procalcitonin Test for Prodromal Meningococcal Disease-A Meta-Analysis. PLoS One. 2015 Jun 8;10(6):e0128993. eCollection 2015. PubMed PMID: 26053385.

17: Schechter MS, Trueman D, Farquharson R, et. al. Inhaled Aztreonam Lysine Vs. Inhaled Tobramycin in Cystic Fibrosis: An Economic Evaluation. Ann Am Thorac Soc. 2015 Jun 8. [Epub ahead of print] PubMed PMID: 26053185.

18: Rudmik L, Smith KA, Kilty S. Endoscopic Polypectomy in the Clinic (EPIC): A Pilot Cost-Effectiveness Analysis. Clin Otolaryngol. 2015 Jun 6. [Epub ahead of print] PubMed PMID: 26053107.

19: Hoshi D, Tanaka E, Igarashi A, et. al. Profiles of EQ-5D utility scores in the daily practice of Japanese patients with rheumatoid arthritis; Analysis of the IORRA database. Mod Rheumatol. 2015 Jun 8:1-24. [Epub ahead of print] PubMed PMID: 26052801.

20: Giannopoulou C, Sideris E, Wade R, et. al. Ipilimumab for Previously Untreated Unresectable Malignant Melanoma: A Critique of the Evidence. Pharmacoeconomics. 2015 Jun 5. [Epub ahead of print] PubMed PMID: 26043718.

21: Damm O, Ultsch B, Horn J, et. al. Systematic review of models assessing the economic value of routine varicella and herpes zoster vaccination in high-income countries. BMC Public Health. 2015 Jun 5;15:533. PubMed PMID: 26041469.

22: Koeser L, Donisi V, Goldberg DP, et. al. Modelling the cost-effectiveness of pharmacotherapy compared with cognitive-behavioural therapy and combination therapy for the treatment of moderate to severe depression in the UK. Psychol Med. 2015 Jun 4:1-13. [Epub ahead of print] PubMed PMID: 26040631.

23: Sastry P, Hughes V, Hayes P, et. al. The ETTAA study protocol: a UK-wide observational study of 'Effective Treatments for Thoracic Aortic Aneurysm'. BMJ Open. 2015 Jun 2;5(6):e008147. PubMed PMID: 26038360.

24: Coombes BK, Connelly L, Bisset L, et. al. Economic evaluation favours physiotherapy but not corticosteroid injection as a first-line intervention for chronic lateral epicondylalgia: evidence from a randomised clinical trial. Br J Sports Med. 2015 Jun 2. [Epub ahead of print] PubMed PMID: 26036675.

25: Pennington MW, Grieve R, van der Meulen JH. Lifetime cost effectiveness of different brands of prosthesis used for total hip arthroplasty: a study using the NJR dataset. Bone Joint J. 2015 Jun;97-B(6):762-70. PubMed PMID: 26033055.

26: Ho AL, Sussman ES, Pendharkar AV, et. al. Deep brain stimulation for obesity: rationale and approach to trial design. Neurosurg Focus. 2015 Jun;38(6):E8. PubMed PMID: 26030708.

27: Owusu-Edusei K Jr, Chesson HW, Gift TL, et. al. Cost-effectiveness of Chlamydia vaccination programs for young women. Emerg Infect Dis. 2015 Jun;21(6):960-8. PubMed PMID: 25989525.

28: Li T, Liu M, Ben H, et. al. Clopidogrel versus aspirin in patients with recent ischemic stroke and established peripheral artery disease: an economic evaluation in a chinese setting. Clin Drug Investig. 2015 Jun;35(6):365-74. PubMed PMID: 25985838.

29: Nelson RE, Stockmann C, Hersh AL, et. al. Economic analysis of rapid and sensitive polymerase chain reaction testing in the emergency department for influenza infections in children. Pediatr Infect Dis J. 2015 Jun;34(6):577-82. PubMed PMID: 25973935.

30: Petrou P. Cost-effectiveness analysis of axitinib through a probabilistic decision model. Expert Opin Pharmacother. 2015 Jun;16(8):1233-43. PubMed PMID: 25958963.

31: Taw MB, Reddy WD, Omole FS, et. al. Acupuncture and allergic rhinitis. Curr Opin Otolaryngol Head Neck Surg. 2015 Jun;23(3):216-20. PubMed PMID: 25943957.

32: Pennington B, Akehurst R, Wasan H, et. al. Cost-effectiveness of selective internal radiation therapy using yttrium-90 resin microspheres in treating patients with inoperable colorectal liver metastases in the UK. J Med Econ. 2015 Jun 9:1-8. [Epub ahead of print] PubMed PMID: 25941769.

33: Meier G, Gregg M, Poulsen Nautrup B. Cost-effectiveness analysis of quadrivalent influenza vaccination in at-risk adults and the elderly: an updated analysis in the UK. J Med Econ. 2015 Jun 1:1-16. [Epub ahead of print] PubMed PMID: 25903831.

34: Noordzij MA, Blanker MH. Re: Cost-effectiveness of prostate cancer screening: a simulation study based on ERSPC data. J Natl Cancer Inst. 2015 Apr 16;107(6):djv110. Print 2015 Jun. PubMed PMID: 25888716.

35: Huetson P, Palmer JL, Levorsen A, et. al. Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway. J Med Econ. 2015 Jun 1:1-13. [Epub ahead of print] PubMed PMID: 25853868.

36: Jódar-Sánchez F, Malet-Larrea A, Martín JJ, et. al. Cost-Utility Analysis of a Medication Review with Follow-Up Service for Older Adults with Polypharmacy in Community Pharmacies in Spain: The conSIGUE Program. Pharmacoeconomics. 2015 Jun;33(6):599-610. PubMed PMID: 25774017.

37: Chatterjee A, Kosowski T, Pyfer B, et. al. A Cost-Utility Analysis Comparing the Sartorius versus the Rectus Femoris Flap in the Treatment of the Infected Vascular Groin Graft Wound. Plast Reconstr Surg. 2015 Jun;135(6):1707-14. PubMed PMID: 25742522.

38: Naing C, Poovorawan Y, Mak JW, et. al. Cost-utility analysis of an adjunctive recombinant activated factor VIIa for on-demand treatment of bleeding episodes in dengue haemorrhagic fever. Blood Coagul Fibrinolysis. 2015 Jun;26(4):403-7. PubMed PMID: 25692521.

39: Spolverato G, Vitale A, Ejaz A, et. al. The relative net health benefit of liver resection, ablation, and transplantation for early hepatocellular carcinoma. World J Surg. 2015 Jun;39(6):1474-84. PubMed PMID: 25665675.

40: Haas M, De Abreu Lourenco R. Pharmacological management of chronic lower back pain: a review of cost effectiveness. Pharmacoeconomics. 2015 Jun;33(6):561-9. PubMed PMID: 25604096.

41: Wilson FA, Villarreal R, Stimpson JP, et. al. Cost-effectiveness analysis of a colonoscopy screening navigator program designed for Hispanic men. J Cancer Educ. 2015 Jun;30(2):260-7. PubMed PMID: 25168070.

By CEA Registry Team on 6/15/2015 8:35 AM

By Paige Lin, Ph.D and Joshua Cohen, Ph..D.

Hematopoietic stem cell transplant (HSCT) is considered to be the preferred treatment for eligible patients with multiple myeloma (MM).  Most transplanted patients are under age 65; indeed, there has been little evidence to support the effectiveness of HSCT among older MM patients.  In our new paper published in the Journal of the National Cancer Institute, my colleagues and I examined the real-world effectiveness of HSCT among older adults with MM. (1)

We compared the survival of MM patients who had an HSCT with the survival of those who did not.  Unlike previous studies based on small randomized clinical trial samples or data from individual medical centers, our study identified 263 MM patients age ≥66 years using the Surveillance, Epidemiology, and End Results (SEER)-Medicare program, which collects data on US cancer cases.  Another unique aspect of our study is that we used four different analytic approaches to assess the effectiveness of HSCT, including: traditional multivariable regression; propensity score matching, coarsened exact matching, and instrumental variable analysis.  The purposes were to minimize selection bias (i.e., transplant candidates may be healthier than rejected candidates) and to evaluate the robustness of our results. 

“Overall survival has increased among older patients with multiple myeloma who received HSCTs.” [Tweet this]

We found that survival has increased among older MM patients who received HSCTs.  Results from our four analytic approaches all showed a statistically significant improvement in survival, with hazard ratios ranging from 0.53 to 0.61.  The consistency of the HSCT survival benefits across statistical methods supports the robustness of our results.

Despite its clinical benefits, HSCT is costly.  As a result, it probably increases initial costs even though HSCT probably decreases average costs over the longer term following transplantation.  Our related work suggests that HSCT is cost-effective among older MM patients.(2)

Stay tuned for future posts on this topic by following us on Twitter, liking us on Facebook, or checking back at www.cearegistry.org.

References:

1.    Winn AN, Shah GL, Cohen JT, Lin PJ, Parsons SK. The real world effectiveness of hematopoietic transplant among elderly individuals with multiple myeloma. J Natl Cancer Inst. 2015 May 28;107(8).
2.    Shah G, Winn A, Lin PJ, et al. Cost-effectiveness of autologous hematopoietic stem cell transplantation for elderly patients with multiple myeloma using the SEER-Medicare database. Biology of Blood and Marrow Transplantation (in press).

By CEA Registry Team on 6/11/2015 9:30 AM

A recent review of the state of cost-utility analyses in Asia by Teja Thorat et. al. is this issue's featured Value in Health Regional Issues article. This post was originally published here.

By Teja Thorat, MSc, MPH

In our recently published paper in Value in Health Regional Issues, “The State of Cost-Utility Analyses in Asia: A Systematic Review,” my colleagues and I review and evaluate published, English-language, cost-utility analyses (CUAs) targeting populations in Asia.(1)

We analyzed data from the Tufts Medical Center Cost-Effectiveness Analysis Registry to summarize study features from these CUAs, such as country of study, disease area researched, study funder, and type of intervention. We also compared the Asian CUAs to CUAs focusing on non-Asian population across study features, methodological characteristics, and reporting practices, such as study perspective, discounting of costs and health benefits, time horizon, funding source, acceptability curves, and sensitivity analyses.

Asian CUAs account for 5.1% (n=175) of the total CUAs present in the CEA Registry from 2000-2012 (n=3,414). The number of Asian CUAs has steadily grown over the past years from 19 CUAs published in 2000-2004 to 107 CUAs in 2009-2012. Asian CUAs were most often set in Japan (33.1%), followed by Taiwan (15.4%), China (14.9%), Thailand (8.0%), and South Korea (6.9%).

Figure 1. Asian cost-utility analyses by country of study, 2000-2012.
 

Figure 1. Asian cost-utility analyses by country of study, 2000-2012.

The most common diseases researched were cancer (24.6%) followed by infectious diseases (13.7%) and cardiovascular disease (8.6%). Most studies were funded by government agencies (29.1%) followed by pharmaceutical and device companies (21.7%). Asian CUAs focused mainly on pharmaceutical treatments (56%) followed by screening programs (19.4%) and immunizations (12.0%). Furthermore, a higher proportion of Asian CUAs evaluated primary prevention practices such as immunizations and screenings compared to non-Asian CUAs (21.7% vs. 16.5%, p=0.07). Also, fewer Asian CUAs were sponsored by pharmaceutical companies compared to non-Asian CUAs (p=0.001). In comparing the methodological and reporting practices between the two groups, we found that the majority of Asian CUAs adhered to good reporting practices; however, they lagged in reporting sensitivity analyses, disclosing funding status, and stating the currency year.  A full description of the CEA Registry and other recent trends can be found here.(2)

References

1.    Thorat T, Lin PJ, Neumann PJ. The State of Cost-Utility Analyses in Asia: A Systematic Review. Value Health Regional Issues. 2015 May 7–13.
2.    Neumann PJ, Thorat T, Shi J, et. al. The Changing Face of the Cost Utility Literature, 1990-2012. Value in Health 2015. 18(2):271-277.

By CEA Registry Team on 6/2/2015 1:21 PM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Selvapatt N, Ward T, Bailey H, et. al. Is antenatal screening for hepatitis C virus cost effective? A decade's experience at a London centre. J Hepatol. 2015 May 26. [Epub ahead of print] PubMed PMID: 26024832.

2: van der Schans J, Kotsopoulos N, Hoekstra PJ, et. al. Cost-effectiveness of extended-release methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder sub-optimally treated with immediate release methylphenidate. PLoS One. 2015 May 29;10(5):e0127237. eCollection 2015. PubMed PMID: 26024479.

3: Gaskin J, Rennie C, Coyle D. Reducing Periconceptional Methylmercury Exposure: Cost-Utility Analysis for a Proposed Screening Program for Women Planning a Pregnancy in Ontario, Canada. Environ Health Perspect. 2015 May 29. [Epub ahead of print] PubMed PMID: 26024213.

4: Takura T. Cost-effectiveness of hemodialysis in Japan. Contrib Nephrol. 2015;185:124-31. Epub 2015 May 19. PubMed PMID: 26023021.

5: Beyer SE, Hunink MG, Schöberl F, et. al. Different Imaging Strategies in Patients With Possible Basilar Artery Occlusion: Cost-Effectiveness Analysis. Stroke. 2015 May 28. [Epub ahead of print] PubMed PMID: 26022634.

6: de Koning HJ, Heijnsdijk E. Swiss Medical Board Mammography screening predictions for Switzerland: Importance of time-periods. J Med Screen. 2015 May 27. [Epub ahead of print] PubMed PMID: 26018779.

7: Simpson EL, Davis S, Thokala P, et. al. Sipuleucel-T for the Treatment of Metastatic Hormone-Relapsed Prostate Cancer: A NICE Single Technology Appraisal; An Evidence Review Group Perspective. Pharmacoeconomics. 2015 May 29. [Epub ahead of print] PubMed PMID: 26017401.

8: Henry N, Hawes C, Lowin J, et. al. Cost-effectiveness analysis of a low-dose contraceptive levonorgestrel intrauterine system in Sweden. Acta Obstet Gynecol Scand. 2015 May 25. [Epub ahead of print] PubMed PMID: 26015090.

9: Kovic B, Xie F. Economic Evaluation of Bevacizumab for the First-Line Treatment of Newly Diagnosed Glioblastoma Multiforme. J Clin Oncol. 2015 May 26. [Epub ahead of print] Review. PubMed PMID: 26014296.

10: Leppert MH, Campbell JD, Simpson JR, et. al. Cost-Effectiveness of Intra-Arterial Treatment as an Adjunct to Intravenous Tissue-Type Plasminogen Activator for Acute Ischemic Stroke. Stroke. 2015 May 26. [Epub ahead of print] PubMed PMID: 26012639.

11: Diwakar L, Roberts TE, Cooper N, et. al. An economic evaluation of outpatient versus inpatient polyp treatment for abnormal uterine bleeding. BJOG. 2015 May 25. [Epub ahead of print] PubMed PMID: 26011792.

12: Bang H, Zhao H. Median-Based Incremental Cost-Effectiveness Ratios with Censored Data. J Biopharm Stat. 2015 May 26. [Epub ahead of print] PubMed PMID: 26010599.

13: Hinde S, McKenna C, Whyte S, et. al. Modelling the cost-effectiveness of public awareness campaigns for the early detection of non-small-cell lung cancer. Br J Cancer. 2015 May 26. [Epub ahead of print] PubMed PMID: 26010412.

14: Meacock R, Doran T, Sutton M. What are the Costs and Benefits of Providing Comprehensive Seven-day Services for Emergency Hospital Admissions? Health Econ. 2015 May 22. [Epub ahead of print] PubMed PMID: 26010243.

15: Soini EJ, Hallinen T, Sokka AL, et. al. Cost-utility of first-line actinic keratosis treatments in Finland. Adv Ther. 2015 May;32(5):455-76. Epub 2015 May 26. PubMed PMID: 26006101.

16: Pietzsch JB, Garner A, Gaul C, et. al. Cost-effectiveness of stimulation of the sphenopalatine ganglion (SPG) for the treatment of chronic cluster headache: a model-based analysis based on the Pathway CH-1 study. J Headache Pain. 2015 Dec;16(1):530. Epub 2015 May 21. PubMed PMID: 26002638.

17: Ricci C, Casadei R, Taffurelli G, et. al. Laparoscopic Distal Pancreatectomy in Benign or Premalignant Pancreatic Lesions: Is It Really More Cost-Effective than Open Approach? J Gastrointest Surg. 2015 May 22. [Epub ahead of print] PubMed PMID: 26001367.

18: Spolverato G, Vitale A, Ejaz A, et. al. Net health benefit of hepatic resection versus intraarterial therapies for neuroendocrine liver metastases: A Markov decision model. Surgery. 2015 May 18. [Epub ahead of print] PubMed PMID: 25999251.

19: Manders SH, Kievit W, Adang E, et. al. Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial. Arthritis Res Ther. 2015 May 22;17:134. PubMed PMID: 25997746.

20: Douglas MP, Ladabaum U, Pletcher MJ, et. al. Economic evidence on identifying clinically actionable findings with whole-genome sequencing: a scoping review. Genet Med. 2015 May 21. [Epub ahead of print] Review. PubMed PMID: 25996638.

21: Carreon LY, Bratcher KR, Ammous F, et. al. Cost Effectiveness of Lumbar Epidural Steroid Injections. Spine (Phila Pa 1976). 2015 May 20. [Epub ahead of print] PubMed PMID: 25996536.

22: Konopka JF, Gomoll AH, Thornhill TS, et. al. The cost-effectiveness of surgical treatment of medial unicompartmental knee osteoarthritis in younger patients: a computer model-based evaluation. J Bone Joint Surg Am. 2015 May 20;97(10):807-17. PubMed PMID: 5995491.

23: Greving JP, Kaasjager HA, Vernooij JW, et. al. Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial. BMJ Open. 2015 May 20;5(5):e007128. PubMed PMID: 25995238.

24: Bish EK, Moritz ED, El-Amine H, et. al. Cost-effectiveness of Babesia microti antibody and nucleic acid blood donation screening using results from prospective investigational studies. Transfusion. 2015 May 21. [Epub ahead of print] PubMed PMID: 25995054.

25: Zhang E, Wartelle-Bladou C, Lepanto L, et. al. Cost-utility analysis of nonalcoholic steatohepatitis screening. Eur Radiol. 2015 May 21. [Epub ahead of print] PubMed PMID: 25994191.

26: Moriarty JP, Borah BJ, Foote RL, et. al. Cost-effectiveness of proton beam therapy for intraocular melanoma. PLoS One. 2015 May 18;10(5):e0127814. eCollection 2015. PubMed PMID: 25993284.

27: Grochtdreis T, Brettschneider C, Wegener A, et. al. Cost-effectiveness of collaborative care for the treatment of depressive disorders in primary care: a systematic review. PLoS One. 2015 May 19;10(5):e0123078. eCollection 2015. PubMed PMID: 25993034.

28: Carrato A, García P, López R, et. al. Cost-utility analysis of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine in metastatic pancreatic cancer in Spain: results of the PANCOSTABRAX study. Expert  Rev Pharmacoecon Outcomes Res. 2015 May 19:1-11. [Epub ahead of print] PubMed PMID: 25991037.

29: Li M, Dick A, Montenovo M, et. al. Cost-effectiveness of liver transplantation in methylmalonic and propionic acidemias. Liver Transpl. 2015 May 19. [Epub ahead of print] PubMed PMID: 25990417.

30: Pichon-Riviere A, Garay OU, Augustovski F, et. al. IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES. Int J Technol Assess Health Care. 2015 May 20:1-10. [Epub ahead of print] PubMed PMID: 25989703.

31: Alagoz O, Durham D, Kasirajan K. Cost-effectiveness of one-time genetic testing to minimize lifetime adverse drug reactions. Pharmacogenomics J. 2015 May 19. [Epub ahead of print] PubMed PMID: 25987241.

By CEA Registry Team on 6/1/2015 10:28 AM

By Cayla Saret, B.A. and Peter Neumann, Sc.D

On June 2nd, CEVR will host a webinar discussing the current ramifications of Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA), and possible future directions. Register here or see details below.

FDAMA Section 114 regulates promotion of health care economic information (HCEI) by pharmaceutical companies to payers. Below, we explore four key questions about the Section.

1.    Is the Section rarely used or rarely enforced?
•    In “What Ever Happened to FDAMA Section 114,” Dr. Neumann explores the first ten years after the statute took effect.
•    An analysis of FDA warning letters and notices of violation found no regulatory actions related to the Section.
•    Dr. Neumann explores possible reasons for the lack of enforcement, including a lack of relevant promotions (perhaps in part due to use of the Academy of Managed Care Format) or challenges faced by the FDA in monitoring and regulating such promotions. 

2.    Should the Section incorporate comparative effectiveness research (CER)?
•    A 2011 survey found that outcomes directors of pharmaceutical and biotechnology companies often consider the Section in their promotions, desire more guidance, and expect increased use of the Section related to greater focus on CER.
•    A flexible reading of the Section could permit wider use of HCEI analyses and models that contain CER if they are still restricted to health plans and similar entities.
•    In a 2013 New England Journal of Medicine perspective, Dr. Neumann suggests that Congressional legislation to expand the Section to include CER, though not without risks, could allow greater use of observational data and other studies of interest to payers.
•    Dr. Neumann also called for dialogue in a video interview from the National Pharmaceutical Council.

3.    When does the Section apply?

•    Our new paper in Value in Health examines ten case studies of HCEI promotions and whether they would potentially be permitted under the current statutes.

4.    What does the future hold for the Section?
•    In a 2013 survey, health outcomes and economics research (HEOR) department representatives in the pharmaceutical industry expressed optimism about the future of HEOR.
•    Last year, the FDA indicated the agency was considering draft guidance on the Section.
•    In a recent Health Affairs Blog post, we discuss a discussion draft of the 21st Century Cures Act that contains proposed changes to potentially expand FDAMA Section 114 and to allow promotion of HCEI using clinical assumptions beyond the label indication.

Webinar details & registration information

Registration is available here. During the one-hour webinar, we'll discuss hypothetical situations to explore whether various types of information could be shared by biopharmaceutical companies under current law; potential changes to FDAMA Section 114; and related provisions in the 21st Century Cures Act.

Webinar speakers include:
     • Dr. Peter Neumann (Tufts Medical Center)
     • Dr. Eleanor Perfetto (University of Maryland)
     • Coleen Klasmeier (Sidley Austin)
     • Kimberly Westrich (National Pharmaceutical Council)

This invitation is for individuals in companies who subscribe to CEVR databases or are members of the National Pharmaceutical Council (NPC). We encourage you to share this invitation with others in your organization.

If you would like become a CEVR sponsor, please contact Julie Lannon at jlannon@tuftsmedicalcenter.org. Sponsorship includes full access to the Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.org) and Tufts Medicare NCD database, invitations to webinars and training workshops, and other benefits.

By CEA Registry Team on 5/22/2015 2:47 PM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Becerra V, Gracia A, Desai K, et. al. Cost-effectiveness and public health benefit of secondary cardiovascular disease prevention from improved adherence using a polypill in the UK. BMJ Open. 2015 May 9;5(5):e007111. PubMed PMID: 25991449.

2: Hur C, Choi SE, Kong CY, et. al. High-resolution microendoscopy for esophageal cancer screening in China: A cost-effectiveness analysis. World J Gastroenterol. 2015 May 14;21(18):5513-23. PubMed PMID: 25987774.

3: Jordan RE, Majothi S, Heneghan NR, et. al. Supported self-management for patients with moderate to severe chronic obstructive pulmonary disease (COPD): an evidence synthesis and economic analysis. Health Technol Assess. 2015 May;19(36):1-516. PubMed PMID: 25980984.

4: Donnay Candil S, Balsa Barro JA, Álvarez Hernández J, et. al. Cost-effectiveness analysis of universal screening for thyroid disease in pregnant women in Spain. Endocrinol Nutr. 2015 May 11. [Epub ahead of print] English, Spanish. PubMed PMID: 25977144.

5: Piñol C. Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain. Neurologia. 2015 May 11. [Epub ahead of print] English, Spanish. PubMed PMID: 25976942.

6: Valente M, Cortesi PA, Lassandro G, et. al. Health economic models in hemophilia A and utility assumptions from a clinician's perspective. Pediatr Blood Cancer. 2015 May 14. [Epub ahead of print] PubMed PMID: 25976056.

7: Pfeil AM, Reich O, Guerra IM, et. al. Cost-effectiveness analysis of sofosbuvir compared to current standard treatment in swiss patients with chronic hepatitis C. PLoS One. 2015 May 14;10(5):e0126984. eCollection 2015. PubMed PMID: 25974722.

8: Deogan C, Zarabi N, Stenström N, et. al. Cost-Effectiveness of School-Based Prevention of Cannabis Use. Appl Health Econ Health Policy. 2015 May 14. [Epub ahead of print] PubMed PMID: 25972235.

9: Borisenko O, Haude M, Hoppe UC, et. al. Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings. BMC Cardiovasc Disord. 2015 May 14;15(1):43. [Epub ahead of print] PubMed PMID: 25971307.

10: Zhang AY, Fu AZ. Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients. Psychooncology. 2015 May 12. [Epub ahead of print] PubMed PMID: 25963381.

11: Wong WW, Hicks LK, Tu HA, et. al. Hepatitis B virus screening before adjuvant chemotherapy in patients with early-stage breast cancer: a cost-effectiveness analysis. Breast Cancer Res Treat. 2015 May 12. [Epub ahead of print] PubMed PMID: 25962692.

12: Roze S, Smith-Palmer J, Valentine W, et. al. Cost-effectiveness of continuous subcutaneous insulin infusion versus multiple daily injections of insulin in Type 1 diabetes: a systematic review. Diabet Med. 2015 May 11. [Epub ahead of print] PubMed PMID: 25962621.

13: Isaranuwatchai W, Markle-Reid M, Hoch JS. Adjusting for Baseline Covariates in Net Benefit Regression: How You Adjust Matters. Pharmacoeconomics. 2015 May 10. [Epub ahead of print] PubMed PMID: 25957531.

14: Nazir J, Heemstra L, van Engen A, et. al. Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasia. BMC Urol. 2015 May 9;15(1):41. [Epub ahead of print] PubMed PMID: 25956727.

15: Drobniewski F, Cooke M, Jordan J, et. al. Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis. Health Technol Assess. 2015 May;19(34):1-188. PubMed PMID: 25952553.

16: Norton G, McDonough CM, Cabral H, et. al. Cost-utility of cognitive behavioral therapy for low back pain from the commercial payer perspective. Spine (Phila Pa 1976). 2015 May 15;40(10):725-33. PubMed PMID: 25950282.

17: Gu S, Deng J, Shi L, et. al. Cost-effectiveness of saxagliptin versus glimepiride as a second-line therapy added to metformin in Type 2 diabetes in China. J Med Econ. 2015 May 7:1-40. [Epub ahead of print] PubMed PMID: 25950193.

18: Gillett M, Brennan A, Watson P, et. al. The cost-effectiveness of testing strategies for type 2 diabetes: a modelling study.  Health Technol Assess. 2015 May;19(33):1-80. PubMed PMID: 25947106.

19: Ito K, Avorn J, Shrank WH, et. al. Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction. Circ Cardiovasc Qual Outcomes. 2015 May;8(3):252-9. Epub 2015 May 5. PubMed PMID: 25944633.

20: Barnett PG, Jeffers A, Smith MW, et. al. Cost-effectiveness of integrating tobacco cessation into Post-Traumatic Stress Disorder treatment. Nicotine Tob Res. 2015 May 4. [Epub ahead of print] PubMed PMID: 25943761.

21: Vestergaard AS, Ehlers LH. A Health Economic Evaluation of Stroke Prevention in Atrial Fibrillation: Guideline Adherence Versus the Observed Treatment Strategy Prior to 2012 in Denmark. Pharmacoeconomics. 2015 May 6. [Epub ahead of print] PubMed PMID: 25943684.

22: Butt T, Lee A, Lee C, et. al. The cost-effectiveness of initiating ranibizumab therapy in eyes with neovascular AMD with good vision: an economic model using real-world outcomes. BMJ Open. 2015 May 5;5(5):e006535. PubMed PMID: 25943370.

23: Tanajewski L, Franklin M, Gkountouras G, et. al. Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS). PLoS One. 2015 May 5;10(5):e0121340. eCollection 2015. PubMed PMID: 25942421.

24: Pennington B, Akehurst R, Wasan H, et. al. Cost-effectiveness of selective internal radiation therapy using yttrium-90 resin microspheres in treating patients with inoperable colorectal liver metastases in the UK. J Med Econ. 2015 May 5:1-18. [Epub ahead of print] PubMed PMID: 25941769.

25: Gallego CJ, Shirts BH, Bennette CS, et. al. Next-Generation Sequencing Panels for the Diagnosis of Colorectal Cancer and Polyposis Syndromes: A Cost-Effectiveness Analysis. J Clin Oncol. 2015 May 4. [Epub ahead of print] PubMed PMID: 25940718.

26: Peng S, Tafazzoli A, Dorman E, et. al. Cost-effectiveness of DTG+ABC/3TC versus EFV/TDF/FTC for first-line treatment of HIV-1 in the United States. J Med Econ. 2015 May 1:1-36. [Epub ahead of print] PubMed PMID: 25934146.

27: Cure S, Guerra I, Cammà C, et. al. Cost-effectiveness of sofosbuvir plus ribavirin with or without pegylated interferon for the treatment of chronic hepatitis C in Italy. J Med Econ. 2015 May 7:1-13. [Epub ahead of print] PubMed PMID: 25891129.

28: Wu JX, Beni CE, Zanocco KA, et. al. Cost-Effectiveness of Long-Term Every Three-Year Versus Annual Postoperative Surveillance for Low-Risk  Papillary Thyroid Cancer. Thyroid. 2015 May 7. [Epub ahead of print] PubMed PMID: 25851702.

29: Linas BP, Barter DM, Morgan JR, et. al. The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection. Ann Intern Med. 2015 May 5;162(9):619-29. PubMed PMID: 25820703.

30: Bamrungsawad N, Chaiyakunapruk N, Upakdee N, et. al. Cost-utility analysis of intravenous immunoglobulin for the treatment of steroid-refractory dermatomyositis in Thailand. Pharmacoeconomics. 2015 May;33(5):521-31. PubMed PMID: 25774016.

31: Kaplan RI, De Moraes CG, Cioffi GA, et. al. Comparative Cost-effectiveness of the Baerveldt Implant, Trabeculectomy With Mitomycin, and Medical Treatment. JAMA Ophthalmol. 2015 May 1;133(5):560-7. PubMed PMID: 25741886.

32: Schawo S, van der Kolk A, Bouwmans C, et. al. Probabilistic Markov Model Estimating Cost Effectiveness of Methylphenidate Osmotic-Release Oral System Versus Immediate-Release Methylphenidate in Children and Adolescents: Which Information is Needed? Pharmacoeconomics. 2015 May;33(5):489-509. PubMed PMID: 25715975.

33: Esteves S, Alves M, Castel-Branco M, et. al. A pilot cost-effectiveness analysis of treatments in newly diagnosed high-grade gliomas: the example of 5-aminolevulinic Acid compared with white-light surgery. Neurosurgery. 2015 May;76(5):552-62. PubMed PMID: 25714513.

34: Von Bargen E, Patterson D. Cost utility of the treatment of stress urinary incontinence. Female Pelvic Med Reconstr Surg. 2015 May-Jun;21(3):150-3. PubMed PMID: 25679355.

35: Wade R, Duarte A, Simmonds M, et. al. The Clinical and Cost Effectiveness of Aflibercept in Combination with Irinotecan and Fluorouracil-Based Therapy (FOLFIRI) for the Treatment of Metastatic Colorectal Cancer Which has Progressed Following Prior Oxaliplatin-Based Chemotherapy: a Critique of the Evidence. Pharmacoeconomics. 2015 May;33(5):457-66. PubMed PMID: 25616671.

36: Pietzsch JB, Liu S, Garner AM, et. al. Long-Term Cost-Effectiveness of Upper Airway Stimulation for the Treatment of Obstructive Sleep Apnea: A Model-Based Projection Based on the STAR Trial. Sleep. 2015 May 1;38(5):735-44. PubMed PMID: 25348126.

By CEA Registry Team on 5/15/2015 9:34 AM

Come find the CEVR team at booth #309 at the ISPOR International Meeting. Our researchers will be giving the following presentations:

Monday, May 18th

James Chambers: Poster presentation- “A systematic review of the methodological quality of network meta-analyses” 8:30 AM-2:15 PM
Peter Neumann and Cayla Saret: Poster presentation- “When can pharmaceutical companies communicate health economic claims to payers? 10 Case Studies” 3:45-7:45 PM
Matthew Chenoweth: Poster presentation- “Coverage of medical devices: Is Medicare consistent with private payers?” 3:45-7:45 PM
Peter Neumann, Teja Thorat, Cayla Saret: Poster presentation- “The changing face of the cost-utility literature, 1990-2012” 3:45-7:45 PM
Natalia Olchanski: Poster presentation- “Who is spending where: Analysis of healthcare spending by Medicaid and private payers in Massachusetts” 3:45-7:45 PM

Tuesday May 19th

Teja Thorat: Poster presentation- “Understanding QALY gains across different types of cancers and cancer-related interventions” 3:45-7:45 PM
Peter Neumann: Issue Panel, Moderator- “How should the FDA regulate the communication of health economic data by pharmaceutical companies to payers?” 11:00 AM- 12:00 PM
Joshua Cohen: Workshop- “Design of bundled payment in the ambulatory setting of care” 3:45-4:45 PM
Wendy Zhong: Poster presentation- “Costs of treating skeletal-related events among prostate cancer patients with bone metastases in a commercial insured population in the US” 3:45-7:45 PM

Wednesday May 20th

Pallavi Rane: Poster presentation- “Potential savings in health care spending on ‘low-value’ interventions: Case study of arthroscopic knee surgery” 8:30 AM- 2:45 PM
Paige Lin: Poster presentation- “Willingness to pay for newborn genetic testing for Spinal Muscular Atrophy” 8:30 AM-2:45 PM

By CEA Registry Team on 5/15/2015 9:02 AM

By  Peter Neumann, Sc.D. and Cayla Saret, B.A.
 
A new discussion draft of the 21st Century Cures Act, the bipartisan initiative to accelerate development of new medical treatments, includes a section entitled “Facilitating Dissemination of Health Care Economic Information.” A previous version of the bill included only a placeholder heading for these issues. The section makes changes to Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114), which regulates promotion of health economic information by pharmaceutical companies to formulary committees, such as a claim that a drug reduces health care costs in a given population.

The Food and Drug Administration (FDA) has never commented on Section 114 and, as we note in a new paper in which we develop hypothetical case studies for Section 114, the lack of guidance about what the original statute allows has hampered the exchange of information. Together, the proposed changes would add clarity and flexibility for pharmaceutical companies to engage with health plans about the potential value of their products, though it will require careful ongoing monitoring by regulators.

Improved Communication

The discussion draft contains a number of changes that, in our view, would help foster better communication between drug companies and payers about the real-world impacts and economic consequences of using pharmaceuticals.

The existing language of Section 114, while vaguely worded, seems to restrict the promotion of health economic information only to information that drug companies collect in randomized clinical trials (RCTs), called “substantial evidence,” rather than information using “real-world” data. For example, it is unclear whether and in what circumstances a company could promote a study using an observational database that analyzes the costs of using the drug in real-world settings.

The new draft amends the clause requiring that a promotional claim “directly relate[s]” to the FDA-approved indication to the less restrictive term “relate[s].” The term, “relates,” would still require clarification, ideally in a future FDA guidance, but it suggests more flexibility around the type of health care economic information (e.g., from database analyses or economic models) that drug companies could provide proactively (as opposed to in responses to unsolicited requests) to health plan audiences.

For example, the “directly relates” language implies a strict standard — a company might not promote findings from a database study if the population differed, even in minor ways, from the population studied in the relevant randomized clinical trials. Under the proposed change, such an analysis might be deemed permissible, though again, the FDA will have to clarify the details.

The draft also adds a provision requiring, where applicable, pharmaceutical companies to provide “a conspicuous and prominent statement describing any differences between the information and the indication approved.” Such a disclosure (e.g., that a promotion is based on a database study, that the population under investigation might differ from those in RCTs, and that retrospective database analyses demonstrate associations but do not indicate causality) should increase transparency and help ensure that health plan audiences are informed and aware that the health care economic information being promoted is not necessarily based on substantial evidence from randomized clinical trials.

Furthermore, the existing statute provides a narrow definition of “health care economic information” regulated by the Section which limits the possible types of economic analyses permitted. The draft expands the definition to incorporate inputs and methods, including “clinical or other assumptions.” Because all health care economic analyses include clinical assumptions, this language would allow a much broader array of health economic analyses to be included, though again FDA clarity will be important.

Finally, the draft clarifies the permitted audience for health economic promotions. These promotions are currently limited to formulary committee members and the undefined phrase, “similar entities.” The draft includes “payor[s]” in addition to the “formulary committee[s], or other similar entit[ies]” covered by the existing statute. That is important because the original statutory language, from 1997, did not state whether payers would be included, although the draft still does not define what is meant by “similar entity” (e.g., does it include physicians working and making decisions for accountable care organizations?).

Preserving Guardrails For Public Health

Critically, the changes would continue to restrict these types of promotions to organizations (i.e., formulary committees and payers), not to general prescribers and consumers.

As we’ve argued before, that would “preserve key guardrails for public health. Promotion would be restricted to organizations that retain strong incentives to be informed and wary consumers of drug-company promotions and that increasingly employ their own experts, mine their own data, and request comparative effectiveness evidence from companies.”

It would confer upon health plans the responsibility to judge the usefulness and credibility of a wider range of health economic claims promulgated by drug companies, therefore providing more data to payers to inform coverage decisions.

As noted, several other conditions must hold if the new legislation is to be successful. First, FDA will need to clarify what types of clinical claims (either explicitly made or implied) are permissible in health care economic information.

An amendment posted to the discussion draft would require the Department of Health and Human Services (HHS) to “issue draft guidance on facilitating the dissemination of responsible, truthful, and non-misleading scientific and medical information not included on the label of drugs.”

Second, ongoing work is needed on standards for observational data and other real world studies. Third, it will be important for the FDA to monitor the field to ensure that health care economic promotions are not false and misleading.

This will be a challenging area for FDA to regulate. For one, various court cases surrounding drug companies’ promotion and First Amendment rights have raised issues about the FDA’s ability to regulate truthful, non-misleading claims. For another, it is challenging for FDA to know what types of promotional claims will be made under the new health economic promotion laws given that they are business-to-business communications.

The language in the Discussion Draft may continue to change as the bill works its way through the legislative process. Still, the proposal to date reflects a step in the right direction.

This piece was originally posted on the Health Affairs Blog.

By CEA Registry Team on 5/13/2015 9:09 AM

Health payers in the U.S. have often balked at using formal cost-effectiveness analysis in coverage and reimbursement decisions for medical technologies. The Medicare program, for example, does not consider cost or cost-effectiveness in its coverage decisions for new treatments, despite fiscal challenges and multiple initiatives to achieve better value.  Less well known, however, is that cost-effectiveness analysis has played a longstanding role in informing the addition of preventive services to Medicare.  It has provided Medicare officials information to help ensure that health gains are achieved at reasonable cost. Our new paper on the topic and other research highlights, as well as upcoming conferences and events, are described in our Spring 2015 newsletter: http://tinyurl.com/CEVR15S.

By CEA Registry Team on 5/6/2015 12:03 PM

By Cayla Saret, B.A.

Twice each month we highlight recently published cost-utility studies and selected reviews and editorials.

1: Bhanegaonkar AJ, Horodniceanu EG, Abdul Latiff AH, et. al. Economic value of atopic dermatitis prevention via infant formula use in high-risk Malaysian infants. Asia Pac Allergy. 2015 Apr;5(2):84-97. Epub 2015 Apr 29. PubMed PMID: 25938073.

2: Miquel-Cases A, Steuten LM, Retèl VP, et. al. Early stage cost-effectiveness analysis of a BRCA1-like test to detect triple negative breast cancers responsive to high dose alkylating chemotherapy. Breast. 2015 Apr 28. [Epub ahead of print] PubMed PMID: 25937263.

3: Brown GC, Brown MM, Turpcu A, et. al. The Cost-Effectiveness of Ranibizumab for the Treatment of Diabetic Macular Edema. Ophthalmology. 2015 Apr 29. [Epub ahead of print] PubMed PMID: 25935787.

4: Brusco NK, Watts JJ, Shields N, et. al. Is cost effectiveness sustained after weekend inpatient rehabilitation? 12 month follow up from a randomized controlled trial. BMC Health Serv Res. 2015 Apr 18;15(1):165. [Epub ahead of print] PubMed PMID: 25927870.

5: Goldhaber-Fiebert JD, Brandeau ML. Evaluating Cost-effectiveness of Interventions That Affect Fertility and Childbearing: How Health Effects Are Measured Matters. Med Decis Making. 2015 Apr 29. [Epub ahead of print] PubMed PMID: 25926281.

6: Burn E, Marshall AL, Miller YD, et. al. The cost-effectiveness of the MobileMums intervention to increase physical activity among mothers with young children: a Markov model informed by a randomised controlled trial. BMJ Open. 2015 Apr 29;5(4):e007226. PubMed PMID: 25926145.

7: Li Y, Bare LA, Bender RA, et. al. Cost Effectiveness of Sequencing 34 Cancer-Associated Genes as an Aid for Treatment Selection in Patients with Metastatic Melanoma. Mol Diagn Ther. 2015 Apr 30. [Epub ahead of print] PubMed PMID: 25926090.

8: Botteman M, Detzel P. Cost-effectiveness of partially hydrolyzed whey protein formula in the primary prevention of atopic dermatitis in high-risk urban infants in southeast Asia. Ann Nutr Metab. 2015;66 Suppl 1:26-32. Epub 2015 Apr 24. PubMed PMID: 25925338.

9: Lee JY, Kim Y, Lee TJ, et. al. Cost-effectiveness of para-aortic lymphadenectomy before chemoradiotherapy in locally advanced cervical cancer. J Gynecol Oncol. 2015 Apr 17. [Epub ahead of print] PubMed PMID: 25925292.

10: Zhang P, Yang Y, Wen F, et. al. Cost-effectiveness of sorafenib as a first-line treatment for advanced hepatocellular carcinoma. Eur J Gastroenterol Hepatol. 2015 Apr 22. [Epub ahead of print] PubMed PMID: 25919775.

11: Nghiem VT, Davies KR, Beck JR, et. al. Economic evaluation of DNA ploidy analysis vs liquid-based cytology for cervical screening. Br J Cancer. 2015 Apr 28. [Epub ahead of print] PubMed PMID: 25919612.

12: Imaz-Iglesia I, Miguel LG, Ayala-Morillas LE, et. al. Economic evaluation of Chagas disease screening in Spain. Acta Trop. 2015 Apr 25. [Epub ahead of print] PubMed PMID: 25917718.

13: Fox GJ, Oxlade O, Menzies D. Fluoroquinolone Therapy for the Prevention of Multi-drug Resistant Tuberculosis in Contacts: a Cost-effectiveness Analysis. Am J Respir Crit Care Med. 2015 Apr 27. [Epub ahead of print] PubMed PMID: 25915791.

14: Snowsill T, Huxley N, Hoyle M, et. al. A model-based assessment of the cost-utility of strategies to identify Lynch syndrome in early-onset colorectal cancer patients. BMC Cancer. 2015 Apr 25;15(1):313. [Epub ahead of print] PubMed PMID: 25910169.

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17: Meier G, Gregg M, Poulsen Nautrup B. Cost-effectiveness analysis of quadrivalent influenza vaccination in at-risk adults and the elderly: an updated analysis in the United Kingdom. J Med Econ. 2015 Apr 23:1-40. [Epub ahead of print] PubMed PMID: 25903831.

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24: Cure S, Guerra I, Cammà C, et. al. Cost-effectiveness of sofosbuvir plus ribavirin with or without pegylated interferon for the treatment of chronic hepatitis C in Italy. J Med Econ. 2015 Apr 20:1-26. [Epub ahead of print] PubMed PMID: 25891129.

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27: Wu AC, Gay C, Rett MD, et. al. Pharmacogenomic test that predicts response to inhaled corticosteroids in adults with asthma likely to be cost-saving. Pharmacogenomics. 2015 Apr;16(6):591-600. Epub 2015 Apr 16. PubMed PMID: 25880024.

28: Zucco F, Ciampichini R, Lavano A, et. al. Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study. Neuromodulation. 2015 Apr 16. [Epub ahead of print] PubMed PMID: 25879722.

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