RESUMO
DISCLOSURES: No funding supported the writing of this letter. Preblick, Ali, and DasMahapatra are employees and shareholders of Sanofi Genzyme. Gray is a postdoctoral fellow at Sanofi Genzyme and Rutgers University.
Assuntos
Hemofilia A , Fator VIII , Humanos , Estudos RetrospectivosRESUMO
BACKGROUND: In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented the newly established Medicare Part D program that required plan sponsors to offer a medication therapy management (MTM) program. The MTM program requirements have become more prescriptive over the past decade in the attempt to address low beneficiary enrollment rates, improve the quality of services provided, and address gaps in meeting the needs of enrollees. OBJECTIVE: To describe changes to the requirements for the Medicare Part D MTM program since its inception in 2006 and the impact of these changes to inform future program enhancements. METHODS: We obtained publicly available information extracted from the Medicare Part D MTM program fact sheets for the years 2008 through 2018, in addition to searching indexed literature through PubMed and additional literature through Internet searches. We then categorized the program's requirement changes annually, and described the Part D MTM program characteristics and reported statistics. DISCUSSION: Significant changes to the Part D MTM program requirements occurred in 2010, 2013, and 2016 regarding eligibility criteria, MTM services, and reporting requirements. Thresholds to determine beneficiary eligibility have been lowered. Specific MTM services now include an annual comprehensive medication review, followed by a written summary using the Standardized Format. Quarterly targeted medication reviews are also required. Reporting requirements now include comprehensive medication review completion rates and the number of prescriber interventions, among others. Despite more prescriptive MTM program requirements, the low utilization of the MTM program continues. CONCLUSION: Low beneficiary enrollment rates in the Medicare Part D MTM program led CMS to lower thresholds required for eligibility to expand the beneficiary pool. More prescriptive MTM service requirements enhanced service standardization. Despite these changes, MTM enrollment and comprehensive medication review rates remain low, likely, in part, from a lack of financial incentives. The Enhanced MTM program is a 5-year test model that is providing participating Part D plans regulatory flexibility and financial incentives to design their own MTM programs, to evaluate the impact of different program designs on beneficiary engagement and outcomes.
RESUMO
BACKGROUND: In therapeutic areas with uncertainty regarding clinical outcomes that are dependent on high-cost specialty medications, outcomes-based contracts can be a tool to reduce financial risk for payers and for drug manufacturers. With a high treatment cost, large number of therapy choices, and variability of responses to therapy across patients, multiple sclerosis is a compelling therapeutic area to support outcomes-based contracts. OBJECTIVE: To identify the necessary conditions to support the widespread adoption of outcomes-based contracts for high-cost drug therapy, with a focus on disease-modifying therapies for multiple sclerosis. METHODS: We conducted a series of in-depth, semi-structured phone interviews during fall 2018 with 17 healthcare stakeholders representing payers, manufacturers, and industry consultants, all of whom had some involvement in outcomes-based contract development or evaluation. The qualitative data management program from QSR International, N-VIVO 11, was used to store, organize, categorize, analyze, and produce visualization tools to explore, map ideas, and understand themes from the data. RESULTS: Overall, payers and manufacturers agreed that outcomes-based contracts are an effective vehicle to mitigate financial risk and deliver value for disease-modifying therapies for multiple sclerosis, but they noted that the widespread adoption of outcomes-based contracts was tempered by 5 broad categories of challenges, including data-related issues, outcome measurement and confounding factors, regulatory barriers, levels of risk mitigation, and patient adherence. The majority of participants were receptive to using blood-based clinical biomarkers as outcomes-based contract end points, as long as the biomarkers are validated, accurately predict clinical outcomes, are well-established in the therapeutic area, and are readily accessible to various stakeholders. CONCLUSION: Our findings indicate there is general support from payers and drug manufacturers to adopt outcomes-based contracts for disease-modifying therapies for multiple sclerosis. However, some conditions need to be met to allow their widespread adoption, including resolving data issues, ensuring patient adherence to therapy, having a level of risk mitigation that is significant for both parties to make the endeavor economically worthwhile, and fostering a supportive regulatory environment. Blood-based clinical biomarkers that meet certain criteria could be viable end points in outcomes-based contract for disease-modifying therapies for multiple sclerosis and can address many of the necessary conditions regarding data issues, including timeliness.
