The CEA Registry Blog

By CEA Registry Team on 1/28/2011 3:05 PM

Our colleagues at the neighboring Tufts Center for the Study of Drug Development (CSDD) have published an assessment of a Risk Evaluation & Mitigation Strategy (REMS) in the recent issue of their publication, Impact Report.  [1] [2]

Since March 2008, the FDA has required drug manufacturers to submit a REMs when determined that an assessment of a drug’s risk to benefit ratio is required. 

Payers, pharmacists, health care providers, patient advocates, and biopharmaceutical companies were surveyed to determine concerns regarding program implementation and the affect on the delivery of health care.

Of 47 surveyed, 28 provided responses (response rate=60%).

Among the findings:

  • 68% of respondents thought that REMS programs are a poor substitute for other improvements;
  • 86% thought that REMS communications did not contain balanced information  regarding risk and benefit information;
  • Only 22% of respondents though that REMS was an improvement over the existing risk-management system.

The take-away message seems to be that there is a stakeholder wariness regarding REMS.  Notably, few respondents considered REMS an improvement over existing risk-management strategies. 

It should be noted that this is one of the first studies evaluating REMS and the findings should be considered in perspective of the relatively small sample size.

 By James D. Chambers

1. U.S. healthcare stakeholders uncertain on benefits of risk evaluation strategy - Impact Report.  Tufts Center for the Study of Drug Development. Volume 13, Number 1 January/February 2011
2. Study: Healthcare companies think REMS in need of major overhaul.  Available here

By CEA Registry Team on 1/21/2011 5:07 PM

We had some interesting press coverage for our recent paper on whether people would pay for predictive testing for diseases, such as Alzheimer’s and cancer, even if told there were no immediate treatment implications, and even if the tests were not perfectly accurate. [1] [2]  In the study, my colleagues and I found that most people -- 70-80% of the 1500 or so respondents -- wanted the test (the precise percentage depended on the disease and particular scenario to which they were randomized).  On average, people were willing to pay several hundred dollars for testing.

The idea that people want to know their disease status seems to have resonated.  Both the New York Times and Wall St. Journal reported on the study. [3] [4]  The Times piece highlighted the question of whether the medical profession is too paternalistic.  That is, is there too much worry about whether the information is misleading, or about the fact that there is nothing one can do, or about whether people will be unsettled by the information?

Ours’ is one of a number of studies that have found that people seem to want to know their disease risks.  The reasons in part are non-medical ones – getting finances in order, planning for the future, etc.  People may also simply value the sense of having control over the information and their lives.

Our study does raise some cautions.  For one thing, 25% or so of respondents did not want the   tests, and they highlighted factors, such as the costs involved and the dread of living with the knowledge.  Interestingly, more educated respondents in our study sample were less inclined to want the predictive tests (even adjusting for income and other factors).  Several reporters asked me why.  In truth, I’m not sure, though possibly more educated people better understood the scenarios and decided against it.  However, the education effects were not that big.  The larger message of our study is that most people seem to value information for its own sake.

- Peter J. Neumann

1. Neumann PJ, Cohen JT, Hammitt JK, Concannon TW, Auerbach HR, Fang C, Kent DM.  Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents.  Health Econ. 2010 Dec 28. [Epub ahead of print]

2. Neumann PJ.  “Would you take a predictive test for Alzheimer’s disease?” CEA Registry blog.  Available here

3. Heavy Doses of DNA Data, With Few Side Effects.  New York Times.  January 17, 2011.  Available here

4. Would You Pay $479 to Learn if You’re Going to Get Alzheimer’s? Wall St. Journal. January 6, 2011.  Available here

By CEA Registry Team on 1/21/2011 9:50 AM

Twice each month we highlight recently published cost utility studies and selected reviews and editorials. The CEA registry includes every cost-utility study published and indexed in Medline (through April 2010).

1. Reed SD, Scales CD Jr, Stewart SB, et al. Effects of Family History and Genetic Polymorphism on the Cost-Effectiveness of Chemoprevention With Finasteride for Prostate Cancer.  J Urol. 2011 Jan 14. [Epub ahead of print] PMID: 21239023 [PubMed - as supplied by publisher]Related citations

2. Roth JA, Carlson JJ. Cost-Effectiveness of Gemcitabine + Cisplatin vs. Gemcitabine Monotherapy in Advanced Biliary Tract Cancer. J Gastrointest Cancer. 2011 Jan 15. [Epub ahead of print] PMID: 21234709

3. You JH. Pharmacoeconomic evaluation of warfarin pharmacogenomics. Expert Opin Pharmacother. 2011 Jan 14. [Epub ahead of print] PMID: 21231897

4. Thuresson PO, Heeg B, Lescrauwaet B, et al.  Cost-effectiveness of atazanavir/ritonavir compared with lopinavir/ritonavir in treatment-naïve human immunodeficiency virus-1 patients in Sweden.  Scand J Infect Dis. 2011 Jan 13. [Epub ahead of print] PMID: 21231811

5. Corrieri S, Heider D, Riedel-Heller SG, et al.  Cost-effectiveness of fall prevention programs based on home visits for seniors aged over 65 years: a systematic review. Int Psychogeriatr. 2011 Jan 12:1-13. [Epub ahead of print] PMID: 21223626

6.  Akehurst R, Brereton N, Ariely R, et al.  The cost effectiveness of zoledronic acid 5 mg for the management of postmenopausal osteoporosis in women with prior fractures: evidence from Finland, Norway and the Netherlands. J Med Econ. 2011;14(1):53-64. Epub 2011 Jan 11. PMID: 21222506

7. Schwenkglenks M, Brazier JE, Szucs TD, et al.  Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of non-ST-segment elevation acute coronary syndromes. Value Health. 2011 Jan;14(1):24-33.PMID: 21211483

8. Cummins E, Asseburg C, Punekar YS, et al.  Cost-effectiveness of infliximab for the treatment of active and progressive psoriatic arthritis.  Value Health. 2011 Jan;14(1):15-23.PMID: 21211482

9.  Pollock RF, Valentine WJ, Pilgaard T, et al.  The cost effectiveness of rapid-acting insulin aspart compared with human insulin in type 2 diabetes patients: an analysis from the Japanese third-party payer perspective.  J Med Econ. 2011;14(1):36-46. PMID: 21192769

10.  Bós AM, Howard BV, Beresford SA, et al.  Cost-effectiveness analysis of a low-fat diet in the prevention of breast and ovarian cancer. J Am Diet Assoc. 2011 Jan;111(1):56-66.PMID: 21185966 [PubMed - indexed for MEDLINE]Related citations

11. Tsai AG.  A quality-adjusted life year of prevention: the cost-effectiveness of nutrition counseling. J Am Diet Assoc. 2011 Jan;111(1):53-5. PMID: 21185965

12. van Asselt AD, Nicolaï SP, Joore MA, et al; on behalf of the Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study Group. Cost-effectiveness of Exercise Therapy in Patients with Intermittent Claudication: Supervised Exercise Therapy versus a 'Go Home and Walk' Advice. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):97-103 PMID: 21159527

13. Dale W, Bilir SP, Hemmerich J, et al.  The prevalence, correlates, and impact of logically inconsistent preferences in utility assessments for joint health states in prostate cancer. Med Care. 2011 Jan;49(1):59-66. PMID: 21150801

14.  Affleck AG, Bottomley JM, Auland M, et al.  Cost effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate gel in the treatment of scalp psoriasis in Scotland.  Curr Med Res Opin. 2011 Jan;27(1):269-84. PMID: 21142836

15. Perez MV, Kumarasamy NA, Owens DK, et al.  Cost-Effectiveness of Genetic Testing in Family Members of Patients With Long-QT Syndrome. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):76-84. PMID: 21139095

16. Higgins KM. What treatment for early-stage glottic carcinoma among adult patients: CO2 endolaryngeal laser excision versus standard fractionated external beam radiation is superior in terms of cost utility? Laryngoscope. 2011 Jan;121(1):116-34.PMID: 21120828

17. Meng Y, Ward S, Cooper K, et al. Cost-effectiveness of MRI and PET imaging for the evaluation of axillary lymph node metastases in early stage breast cancer. Eur J Surg Oncol. 2011 Jan;37(1):40-6. PMID: 21115232

18. Dinh TA, Rosner BI, Atwood JC, et al. Health benefits and cost-effectiveness of primary genetic screening for Lynch syndrome in the general population. Cancer Prev Res (Phila). 2011 Jan;4(1):9-22 PMID: 21088223

19. Siddiqui MR, Gay N, Edmunds WJ, et al. Economic evaluation of infant and adolescent hepatitis B vaccination in the UK. Vaccine. 2011 Jan 10;29(3):466-75. PMID: 21073988

20. Walensky RP, Wood R, Fofana MO, et al; Cost-Effectiveness of Preventing AIDS Complications-International Investigators. The clinical impact and cost-effectiveness of routine, voluntary HIV screening in South Africa. J Acquir Immune Defic Syndr. 2011 Jan 1;56(1):26-35.PMID: 21068674

21. Freeman JV, Zhu RP, Owens DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011 Jan 4;154(1):1-11. PMID: 21041570

22. Soini EJ, García San Andrés B, Joensuu T. Trabectedin in the treatment of metastatic soft tissue sarcoma: cost-effectiveness, cost-utility and value of information. Ann Oncol. 2011 Jan;22(1):215-23. PMID: 20627875

23. Jeyarajah S, Adams KJ, Higgins L, et al. Prospective evaluation of a colorectal cancer nurse follow-up clinic. Colorectal Dis. 2011 Jan;13(1):31-8. PMID: 19674021

By CEA Registry Team on 1/11/2011 4:39 PM

In November 2010 draft pharmacoeconomic guidelines for China were announced. (1) The guidelines are due to be finalized in 2011, with the English version to be available early 2012.

ISPOR has provided extensive comment on the draft guidelines and is available here. (2) There are, however, a number of aspects of the guidelines that are particularly noteworthy that I would like to draw attention to.

With respect to economic evaluation methodology, the guidelines mention the use of cost-effectiveness analysis (CEA), cost-benefit analysis (CBA), cost-utility analysis (CUA) and cost-minimization analysis (CMA). The inclusion of CUA is notable.

Accordingly, QALYs are considered in the guidelines with a full range of utility estimation methods stated (EQ-5D, SF-6D, VAS, TTO, SG, etc). However, there does not appear to be a preference for a particular utility estimation method.

The guidelines state that a cost-effectiveness threshold will be benchmarked to three times per capita GDP of China. This is the same method proposed by the World Health Organization (WHO) and similar methods have been proposed elsewhere. (3) (4) To my knowledge, no regulatory bodies currently use this method to set a cost-effectiveness threshold and it will be interesting to see if this makes it into the final guidelines.

By James D. Chambers


1. Summary of China pharmacoeconomic guidelines. Available here
2. ISPOR Asia Consortium comments on China pharmacoeconomic guidelines. Available here
3. Sachs JD. World Health Organisation (WHO): Macroeconomics and Health: Investing in Health for Economic Development. 12-1-2001. Geneva.
4. Williams A. What could be nicer than NICE? 2004. Office of Health Economics

By CEA Registry Team on 1/5/2011 2:07 PM

Predictive testing is one of the fastest growing areas of healthcare with applications from Alzheimer’s disease to cancer.  But are people willing to take and pay for a predictive test even if there are no immediate treatment consequences?

In a newly published paper, my colleagues and I report on a study we conducted to address this question.  We assessed how much, if anything, people would pay for a laboratory test that predicted their future disease status even in the absence of immediate consequences for treatment or prevention. (1) 

We administered an internet-based survey to a random sample of adult US respondents. Each respondent answered questions about two different scenarios, each of which specified: one of four randomly selected diseases (Alzheimer’s, arthritis, breast cancer, or prostate cancer); a hypothetical risk of developing the disease (randomly designated 10 or 25%); and test accuracy (randomly designated perfect or ‘not perfectly accurate’).

Of 1,463 respondents who completed the survey, most (70-88%, depending on the scenario) were inclined to take the test.  Inclination to take the test was lower for Alzheimer’s and higher for prostate cancer compared with arthritis, and rose somewhat with disease prevalence
and for the perfect versus imperfect test. Median WTP varied from $109 for the imperfect arthritis test to $263 for the perfect prostate cancer test (mean willingness to pay varied from $300-$600).

The study suggests that individuals have strong preferences for predictive testing, even in the absence of direct treatment consequences.  This seems to reflect both health and non-health related factors (e.g., seeking a second opinion and getting one’s finances in order).  The study also suggests that conventional cost-effectiveness analyses may underestimate the value of testing, which typically ignore this “value of knowing.”

By Peter J. Neumann

1. Neumann PJ, Cohen JT, Hammitt JK et al., Willingness to pay for predicted tests with no immediate treatment consequences:  a survey of US residents.  Health Economics, published online Dec 28, 2010

By CEA Registry Team on 1/3/2011 10:32 AM

Twice each month we highlight recently published cost utility studies and selected reviews and editorials. The CEA registry includes every cost-utility study published and indexed in Medline (through April 2010).

1. Ament JD, Stryjewski TP, Pujari S, et al. Cost effectiveness of the type II Boston keratoprosthesis. Eye (Lond). 2010 Dec 24. [Epub ahead of print] PMID: 21183944

2. Moeremans K, Hemmett L, Hjelmgren J, et al. Cost Effectiveness of Darunavir/Ritonavir 600/100 mg bid in Treatment-Experienced, Lopinavir-Naive, Protease Inhibitor-Resistant, HIV-Infected Adults in Belgium, Italy, Sweden and the UK. Pharmacoeconomics. 2010 Dec 23;28(S1):147-167 PMID: 21182349

3. Brogan A, Mauskopf J, Talbird SE, et al. US Cost Effectiveness of Darunavir/Ritonavir 600/100 mg bid in Treatment-Experienced, HIV-Infected Adults with Evidence of Protease Inhibitor Resistance Included in the TITAN Trial. Pharmacoeconomics. 2010 Dec 23;28(S1):129-146.  PMID: 21182348

4. Moeremans K, Annemans L, Löthgren M, et al. Cost Effectiveness of Darunavir/Ritonavir 600/100 mg bid in Protease Inhibitor-Experienced, HIV-1-Infected Adults in Belgium, Italy, Sweden and the UK. Pharmacoeconomics. 2010 Dec 23;28(S1):107-128. PMID: 21182347

5. Mauskopf J, Brogan A, Martin S, et al. Cost Effectiveness of Darunavir/Ritonavir in Highly Treatment-Experienced, HIV-1-Infected Adults in the USA. Pharmacoeconomics. 2010 Dec 23;28(S1):83-105 PMID: 21182346

6. Malmivaara K, Kivisaari R, Hernesniemi J, et al. Cost-effectiveness of decompressive craniectomy in traumatic brain injuries. Eur J Neurol. 2010 Dec 22. [Epub ahead of print] PMID: 21175999

7. Grima DT, Airia P, Attard C, et al. Modelled cost-effectiveness of high cut-off haemodialysis compared to standard haemodialysis in the management of myeloma kidney. Curr Med Res Opin. 2010 Dec 23. [Epub ahead of print]PMID: 21175375

8. Long EF, Brandeau ML, Owens DK. The Cost-Effectiveness and Population Outcomes of Expanded HIV Screening and Antiretroviral Treatment in the United States. Ann Intern Med. 2010 Dec 21;153(12):778-89. PMID: 21173412

9. Yiee JH, Baskin LS. Use of Internal Stent, External Transanastomotic Stent or No Stent During Pediatric Pyeloplasty: A Decision Tree Cost-Effectiveness Analysis. J Urol. 2010 Dec 18. [Epub ahead of print] PMID: 21172705

10. Luan FL, Kommareddi M, Ojo AO. Universal Prophylaxis is Cost Effective in Cytomegalovirus Serology-Positive Kidney Transplant Patients. Transplantation. 2010 Dec 16. [Epub ahead of print] PMID: 21169881

11. Leong RK, de Wachter SG, Joore MA, et al. Cost-effectiveness analysis of sacral neuromodulation and botulinum toxin A treatment for patients with idiopathic overactive bladder. BJU Int. 2010 Dec 16. [Epub ahead of print] PMID: 21166750

12. Lenoir-Wijnkoop I, van Aalderen WM, Boehm G, et al. Cost-effectiveness model for a specific mixture of prebiotics in The Netherlands. Eur J Health Econ. 2010 Dec 17. [Epub ahead of print] PMID: 21165666

13. Blumberg EA, Hauser IA, Stanisic S, et al. Prolonged prophylaxis with valganciclovir is cost effective in reducing posttransplant cytomegalovirus disease within the United States. Transplantation. 2010 Dec 27;90(12):1420-6. PMID: 21063245

By James D. Chambers

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