MERCI

Medicaid Evidence and Review of Cost Initiative (MERCI)

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The Center for Evidence-based Policy (Center) created the Medicaid Evidence and Review of Cost Initiative (MERCI) to analyze drugs approved through the US Food and Drug Administration’s (FDA) accelerated approval pathway and inform budget and policy decisions by state and federal policymakers. The MERCI project will analyze 9 accelerated approval drugs and issue a series of policy briefs including information and evidence about:

  • The estimated prevalence of target diagnoses (the accelerated approval drug’s indication[s]) within states’ Medicaid populations; 
  • The clinical trial population used to support FDA approval, and how similar it is to the Medicaid population; and 
  • Projected drug costs for state Medicaid programs, including a breakdown of state and federal funds using the Federal Medical Assistance Percentage (FMAP), and where possible, identification of additional costs associated with the drug therapy. 

MERCI analyses include directly relevant national and state-level data where available.

Medicaid Background

In September 2023, 88 million people were enrolled in Medicaid in the US, covering 26% of the country’s population.[1] While state Medicaid programs are responsible for covering costs and generating health outcomes for a quarter of the US population, they do not have a role or any formal influence in the FDA review and decision-making process for new drugs brought to market. State Medicaid programs are, however, required to pay for FDA-approved drugs per the requirements of the Medicaid Drug Rebate Program (MDRP)[2].

Congress created the authorizing legislation for the FDA’s Accelerated Approval Program to encourage drug manufacturers to put resources into research and development of treatments for serious and often rare diseases to try to fulfill unmet clinical needs. This drug approval pathway allows for faster approval of such drugs by allowing surrogate endpoints to be submitted in lieu of direct measures of clinical benefit. Many therapies approved using this accelerated pathway are fully available in the US marketplace and covered by state Medicaid programs, as mandated by Federal MDRP regulations, often at extremely high cost and without robust evidence of meaningful clinical benefit to the patient.

MERCI Accelerated Approval Drug Briefs

Brief 1: Voxelotor (Oxbryta) for Sickle Cell Disease

Sample text; Sickle cell disease (SCD) is a serious, inherited, multisystem, and chronic blood disorder. The Centers for Disease Control and Prevention (CDC) estimates that SCD affects around 100,000 people in the US, with the disease most prominent in Black or African American populations. [Insert another 1-2 sentences with findings from the analysis including prevalence of SCD in Medicaid and the estimated costs of treating the Medicaid population with voxelotor.]

  • MERCI Brief 1: Voxelotor (Oxbryta) for Sickle Cell Disease
  • Methods for MERCI Brief 1

Brief 2: Exon-Skipping Pharmaceutical Treatments for Duchenne Muscular Dystrophy

Sample overview text: Duchenne muscular dystrophy (DMD) is a rare genetic condition characterized by progressive loss of muscle function due to mutations in the dystrophin gene, affecting multiple parts of the body. For individuals with DMD, the median life expectancy is 22 years; with people born more recently having a significantly increased life expectancy. In the US, the diagnosed incidence of DMD is approximately 17.24 per 100,000 live male births, corresponding to approximately 362 incident cases in 2019. [Insert another 1-2 sentences with findings from the analysis including prevalence of SCD in Medicaid and the estimated costs of treating the Medicaid population with exon-skipping drugs.]

  • MERCI Brief 2: Exon-Skipping Pharmaceutical Treatments for DMD
  • Methods for MERCI Brief 2

Brief 3: Sotorasib (Lumakras) for Non-Small Cell Lung Cancer

Sample overview text: Lung cancer is the leading cause of cancer-related mortality death in the US. Lung cancer is broadly divided into 2 main types: non-small cell lung cancer (NSCLC) which accounts for approximately 85% of lung cancer cases, and small cell lung cancer (SCLC) which accounts for the remaining 15% of lung cancer cases. According to the National Cancer Institute, there are 238,340 estimated new cases of lung cancer (including both NSCLC and SCLC) in 2023, with 127,070 estimated deaths from lung cancer. [Insert another 1-2 sentences with findings from the analysis including prevalence of SCD in Medicaid and the estimated costs of treating the Medicaid population with sotorasib.]

  • MERCI Brief 3: Sotorasib (Lumakras) for Non-Small Cell Lung Cancer
  • Methods for MERCI Brief 3

Brief 4: Tisotumab Vedotin-tftv (Tivdak) for Cervical Cancer

Sample overview text: Cervical cancer, or cancer to the cervix, starts in the cells of the cervix and usually develops slowly over time. Cervical cancer is most common in women between the ages of 35 to 44 years, with an average age at diagnosis of 50.2. In the US, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of this cancer every year. [Insert another 1-2 sentences with findings from the analysis including prevalence of SCD in Medicaid and the estimated costs of treating the Medicaid population with tisotumab vedotin-tftv.]

  • MERCI Brief 4: Tisotumab Vedotin-tftv (Tivdak) for Cervical Cancer
  • Methods for MERCI Brief 4

[1] Centers for Medicare & Medicaid Services. September 2023 Medicaid and CHIP Enrollment Trends Snapshot. https://www.medicaid.gov/media/168221. Accessed January 16, 2023.

[2] (SSA § 1927(d))