Limited Generalizability of a Retrospective Chart Review Comparing 3 Recombinant FVIII Products for Hemophilia A Prophylaxis.

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.

Outcomes-Based Contracting for Disease-Modifying Therapies in Multiple Sclerosis: Necessary Conditions for Paradigm Adoption.

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.

Evolution of the Medicare Part D Medication Therapy Management Program from Inception in 2006 to the Present.

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.