James D. Chambers

Listening to Provenge — What a Costly Cancer Treatment Says about Future Medicare Policy

Shortly after the FDA approved the costly sipuleucel-T (Provenge) for treating prostate cancer, the Centers for Medicare and Medicaid Services opened a national coverage analysis for the drug, risking duplication of effort and impeded patient access.

Does Medicare have an implicit cost-effectiveness threshold?

Background. Despite the huge cost of the program, the Centers for Medicare and Medicaid Services (CMS) has maintained a policy that cost-effectiveness is not considered in national coverage determinations (NCDs). Objective. To assess whether an implicit cost-effectiveness threshold exists and to determine if economic evidence has been considered in previous NCDs. Methods. A literature search was conducted to identify estimates of cost-effectiveness relevant to each NCD from 1999—2007 (n = 103). The economic evaluation that best represented each coverage decision was included in a review of the cost-effectiveness of medical interventions considered in NCDs. Results. Of the 64 coverage decisions determined to have a corresponding cost-effectiveness estimate, 49 were associated with a positive coverage decision and 15 with a noncoverage decision. Of the positive decisions, 20 were associated with an economic evaluation that estimated the intervention to be dominant (costs less and was more effective than the alternative), 12 with an incremental cost-effectiveness ratio (ICER) of less than

Cost-effectiveness in the contemporary management of critical limb ischemia with tissue loss

50,000, 8 with an ICER greater than

Risk-Sharing Arrangements That Link Payment For Drugs To Health Outcomes Are Proving Hard To Implement

50,000 but less than

Factors Predicting Medicare National Coverage An Empirical Analysis

100,000, and 9 with an ICER greater than

What values do the public want their health care systems to use in evaluating technologies

100,000. Fourteen of the sample of 64 decision memos cited or discussed cost-effectiveness information. Conclusions. CMS is covering a number of interventions that do not appear to be cost-effective, suggesting that resources could be allocated more efficiently. Although the authors identified several instances where cost-effectiveness evidence was cited in NCDs, they found no clear evidence of an implicit threshold.

Medicare Covers The Majority Of FDA-Approved Devices And Part B Drugs, But Restrictions And Discrepancies Remain

BACKGROUND The care of patients with critical limb ischemia (CLI) and tissue loss is notoriously challenging and expensive. We evaluated the cost-effectiveness of various management strategies to identify those that would optimize value to patients. METHODS A probabilistic Markov model was used to create a detailed simulation of patient-oriented outcomes, including clinical events, wound healing, functional outcomes, and quality-adjusted life-years (QALYs) after various management strategies in a CLI patient cohort during a 10-year period. Direct and indirect cost estimates for these strategies were obtained using transition cost-accounting methodology. Incremental cost-effectiveness ratios (ICERs), in 2009 U.S. dollars per QALYs, were calculated compared with the most conservative management strategy of local wound care with amputation as needed. RESULTS With an ICER of

An Assessment of the Methodological Quality of Published Network Meta-Analyses: A Systematic Review

47,735/QALY, an initial surgical bypass with subsequent endovascular revision(s) as needed was the most cost-effective alternative to local wound care alone. Endovascular-first management strategies achieved comparable clinical outcomes but at higher cost (ICERs ≥

Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs

101,702/QALY); however, endovascular management did become cost-effective when the initial foot wound closure rate was >37% or when procedural costs were decreased by >42%. Primary amputation was dominated (less effectiveness and more costly than wound care alone). CONCLUSIONS Contemporary clinical effectiveness and cost estimates show an initial surgical bypass is the most cost-effective alternative to local wound care alone for CLI with tissue loss and can be supported even in a cost-averse health care environment.

Payer coverage policies for multigene tests

Risk-sharing agreements, under which payers and pharmaceutical manufacturers agree to link payment for drugs to health outcomes achieved, rather than the volume of products used, offer an appealing payment model for pharmaceuticals. Although such agreements have been widely touted, the experience to date mainly demonstrates how hard they are to implement. Barriers include high implementation costs, measurement challenges, and the absence of a suitable data infrastructure. Risk-sharing arrangements could gain traction in the United States as payers and product manufacturers acquire experience with the concept and as measurement techniques and information systems improve. For the foreseeable future, they are likely to remain the exception as drug companies pursue payment models unconnected to data collection or performance assessment.