Article type
Year
Abstract
Background: Between December 2013 and 2014, the FDA approved direct acting antiviral (DAA) treatments for chronic hepatitis C (HCV) under the new breakthrough therapy expedited review process. Approvals were based largely on non-randomized trials using historical comparators. The Center for Evidence-based Policy conducted three rapid reviews on the effectiveness and harms of DAA-based treatment with sofosbuvir; simeprivir; the two-drug combination Harvoni; and the four-drug combination Viekira Pak. These reviews were produced for state Medicaid agencies participating in the Medicaid Evidence-based Decisions (MED) collaboration.
Objectives: To review coverage decisions across 50 state Medicaid programs for costly drugs with low quality evidence of effectiveness.
Methods: In September 2014, we searched for Medicaid sofosbuvir treatment policies for all 50 states to identify coverage criteria, including requirements regarding medical conditions, patient populations, disease stage, sobriety, and specialty physician involvement. In May 2015, we will repeat the 50 state search, including all DAA treatments.
Results: By October 2014, 27 states had published specific sofosbuvir use criteria; seven had no restrictions; and 16 states had no available policy. Of the 27 states with criteria, 24 (89%) had disease severity requirements with 19 (70%) restricting use to severe disease; 22 (81%) included a sobriety requirement; and 10 (37%) required viral response data for continuation of treatment. The governor of Missouri, which has no restrictions, recently asked the legislature for USD 20 million to cover the unexpected costs of sofosbuvir. Results will be updated to include state policies as of May 2015.
Conclusions: Medicaid agencies are statutorily required to cover all FDA-approved medications. However, states may restrict coverage based on medical necessity. This analysis provides a description of the variation in coverage policies for costly drugs when there is low quality evidence and raises concerns about the impact of regulatory agencies’ fast track approval processes on policy decisions, patient safety, and drug costs to healthcare purchasers.
Objectives: To review coverage decisions across 50 state Medicaid programs for costly drugs with low quality evidence of effectiveness.
Methods: In September 2014, we searched for Medicaid sofosbuvir treatment policies for all 50 states to identify coverage criteria, including requirements regarding medical conditions, patient populations, disease stage, sobriety, and specialty physician involvement. In May 2015, we will repeat the 50 state search, including all DAA treatments.
Results: By October 2014, 27 states had published specific sofosbuvir use criteria; seven had no restrictions; and 16 states had no available policy. Of the 27 states with criteria, 24 (89%) had disease severity requirements with 19 (70%) restricting use to severe disease; 22 (81%) included a sobriety requirement; and 10 (37%) required viral response data for continuation of treatment. The governor of Missouri, which has no restrictions, recently asked the legislature for USD 20 million to cover the unexpected costs of sofosbuvir. Results will be updated to include state policies as of May 2015.
Conclusions: Medicaid agencies are statutorily required to cover all FDA-approved medications. However, states may restrict coverage based on medical necessity. This analysis provides a description of the variation in coverage policies for costly drugs when there is low quality evidence and raises concerns about the impact of regulatory agencies’ fast track approval processes on policy decisions, patient safety, and drug costs to healthcare purchasers.