To help communicate a migraine manufacturer’s UM policy goals with payers, Qualia Bio developed a model policy for Product X using UM criteria drawn from a collection of clinically available data and current payer policies for migraine brands.
To achieve market access goals, biopharmaceutical manufacturers may seek to develop a “model policy” as a resource tool to inform proposed utilization management (UM) criteria for brands subject to prior authorization. The model policy is developed as an example of specific UM language which reflect appropriate use criteria for a specific branded biopharmaceutical product.
To help communicate a migraine manufacturer’s UM policy goals with payers, Qualia Bio developed a model policy for Product X using UM criteria drawn from a collection of clinically available data and current payer policies for migraine brands.
Model policy coverage criteria for Product X includes the following utilization management categories:
Initial Authorization Criteria: these may be used to establish the initial prescription approval for Product X. These criteria include baseline disease (patient age and diagnostic criteria), step-therapy (required use of other preventative therapies prior to approval of Product X) and the length in time of the initial prior authorization approval period
Continuation of Therapy Criteria: these criteria which document the patient response to therapy and the length in time of the prior authorization reapproval period
The methodology followed a “clinical-first” approach to populate the suggested coverage criteria for Product X. This means that clinical data sources were the primary data source in formulating Product X policy criteria; commercial payer policy data were used as a secondary source in the development of utilization management criteria.
Payer policy data were based on an analysis of the top 37 commercial insurers and/or PBM’s in the United States. The accounts selected for policy analysis are based on the top commercial payers by commercial lives. The 37 payers included in the analysis account for an estimated 175,628,022 commercial lives based on MMIT data sources. According to the U.S. Census Bureau, 217,780,000 lives are privately insured in the United States as of 2018, so the sample available in the policy database represents approximately 80% of commercial US payer lives.
CRITERIA FOR INITIAL AUTHORIZATION | CRITERIA RATIONALE |
Product X may be approved when ALL of the following criteria are met: | |
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Length of Initial Approval: 6 months (two cycles of treatment) |
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CRITERIA FOR CONTINUATION OF THERAPY | |
Product X will be approved for continued use when following criteria are met: | |
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OR | |
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Length of Reapproval: 12 months |
The model policy tool is designed to provide manufacturers with a resource for account managers and/or other personnel to engage in discussions with payers on appropriate utilization management criteria which might be applied to a particular biopharmaceutical brand.
The approach used to develop the migraine model policy allowed the manufacturer to have an evidence-based approach in which to have a constructive discussion on potential UM policy criteria which might be applied to a new-to-market migraine brand. While this was not the situation in this particular case study, the model policy can also be developed to inform potential changes in UM criteria for brands already on the market.
In addition, the model policy can also be utilized to identify UM criteria that manufacturers might consider for contracting purposes (e.g., UM criteria for which a manufacturer could be willing to provide a rebate offer based on the inclusion or exclusion of select criteria).
Through analysis of available clinical data and current payer policies for the migraine therapeutic class, Qualia Bio was able to define the optimum commercial UM policy criteria for Product X. This approach allowed account managers to have a consistent “on-brand” approach to potential UM policy criteria across discussions with multiple payer customers.
If you are interested in learning more about our Model Policy offerings, please contact [email protected]
ClinicalTrials.gov (Chronic Migraine)
ClinicalTrials.gov (Episodic Migraine)
Data on File; Internal payer policy analysis.
American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18. doi: 10.1111/head.13456
Berchick RE, Barnett CJ, Upton RD. Health Insurance in the United States: 2018. U.S. Census Bureau.2019