(213) What evidence packages did CMS consider for Maximum Fair Price determination? A comparative analysis of Apixaban, Rivaroxaban and Sacubitril/Valsartan
Background: : The Inflation Reduction Act (IRA) grants the Centers for Medicare & Medicaid Services (CMS) the authority to negotiate prices for high-expenditure Medicare drugs. As part of this process, manufacturers are required to submit comprehensive evidence packages to inform CMS’s determination of a drug’s Maximum Fair Price (MFP). Analyzing these submissions offers valuable insights into CMS’s negotiation strategies and MFP determination.
Objective: : To compare the evidence packages submitted for three cardiovascular drugs—apixaban, rivaroxaban, and sacubitril/valsartan—which together accounted for nearly 50% of total Medicare Part D spending among the first drugs selected for MFP negotiation.
Methods: : A systematic review was conducted to evaluate the evidence packages submitted by manufacturers for the three drugs. Submissions included data from pivotal clinical trials, real-world evidence (RWE), economic models, registry data, and network meta-analyses.
Results: : For apixaban and rivaroxaban, both indicated for nonvalvular atrial fibrillation (NVAF), manufacturers submitted data derived from Medicare Fee-for-Service (FFS) and administrative claims. Submissions also included evaluations from the Institute for Clinical and Economic Review (ICER), with ratings provided for both drugs. Economic models utilized Equal Value of Life Years (evLY) and cost per evLY metrics. Due to the absence of head-to-head trials, network meta-analyses were employed.
For sacubitril/valsartan, indicated for heart failure with reduced ejection fraction (HFrEF), the manufacturer asserted the absence of therapeutic alternatives. Evidence emphasized unmet need and clinical effectiveness, supported by RWE demonstrating reductions in cardiovascular mortality and hospitalizations. Additional studies highlighted improvements in health disparities among specific patient populations. Economic evaluations included both all-cause and disease-specific costs. Patient-reported outcomes, including health-related quality of life measured by the Kansas City Cardiomyopathy Questionnaire, were also submitted.
All three submissions incorporated RWE from Medicare FFS and registry data from both U.S. and international sources. Stakeholder input included perspectives from physicians, pharmacists, patient advocacy groups, and individual patients and caregivers.
Conclusions: : The CMS negotiation process revealed distinct evidence strategies across the three drugs. The submitted evidence packages underscored the critical role of real-world data (RWD) and RWE in supporting transparent, evidence-based pricing decisions under Medicare.
