Utilization Management Policy Criteria: A Migraine Model Policy Case Study

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.

Background/Methods

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.

Migraine Model Policy Example

CRITERIA FOR INITIAL AUTHORIZATION

CRITERIA RATIONALE

Product X may be approved when ALL of the

following criteria are met:

  1. Individual is 18 years of age or older

  • Clinical trial data1

AND

  1. A confirmed diagnosis of ONE of the following types of migraine:

AND

  • Chronic migraine: ≥15 to ≤26 headache days per month, of which ≥8 are migraine days, for at least 3 months

  • Clinical trial data1

  • Episodic migraine: ≤14 headache days per month, with ≥4 migraine days per month

  • Clinical trial data2

AND

  1. The patient tried and had an inadequate response or intolerance to any TWO of the following:

  • Based on the AHS consensus statement, to achieve cost-effective care while ensuring access to patients most appropriate for these treatments, it is important that the indications for initiating treatment with anti-CGRP monoclonal antibodies (mABs) require trial and failure of 2 oral preventive treatments.4

  • Of the 37 plans in the payer policy analysis, all 37 plans specify a required trial and failure of oral migraine preventatives. Of which, 21 of the 37 payers (representing 62% of the commercial lives among the 37 payers) require a trial of two migraine preventives prior to therapy and an additional 6 payers require a trial of less than two migraine preventives (0 or 1) prior to therapy.3

  • Beta-blockers (e.g., metoprolol, propranolol, timolol (oral), nadolol, atenolol, nebivolol)

  • Based on the AHS consensus statement, to achieve cost-effective care while ensuring access to patients most appropriate for these treatments, it is important that the indications for initiating treatment with anti-CGRP mABs, include a trial of beta-blockers (e.g. metoprolol, propranolol, timolol, atenolol, nadolol) as an appropriate migraine prevention therapy step.4

  • Of the 37 plans in the payer policy analysis, 34 plans specified a required step failure prior to therapy and 3 of the 37 plans did not. Of the plans with specified step failure criteria, all 34 payers included a beta-blocker as an appropriate migraine preventive therapy step statement.3

  • Antidepressants (e.g., amitriptyline, venlafaxine)

  • Based on the AHS consensus statement, to achieve cost-effective care while ensuring access to patients most appropriate for these treatments, it is important that the indications for initiating treatment with anti-CGRP mABs, include a trial of tricyclic antidepressants (e.g. amitriptyline, nortriptyline) and serotonin-norepinephrine reuptake inhibitors (e.g. venlafaxine, duloxetine) as an appropriate migraine prevention therapy step.4

  • Of the 37 plans in the payer policy analysis, 34 plans specified a required step failure prior to therapy and 3 of the 37 plans did not. Of the plans with specified step failure criteria, all 34 payers included an antidepressant as an appropriate migraine preventive therapy step statement.3

  • Antiepileptics (e.g., valproate sodium, divalproex sodium, topiramate)

  • Based on the AHS consensus statement, to achieve cost-effective care while ensuring access to patients most appropriate for these treatments, it is important that the indications for initiating treatment with anti-CGRP mABs, include a trial of divalproex sodium/valproate sodium and  topiramate as an appropriate migraine prevention therapy step.4

  • Of the 37 plans in the payer policy analysis, 34 plans specified a required step failure prior to therapy and 3 of the 37 plans did not. Of the plans with specified step failure criteria, all 34 payers included an antiepileptic/anticonvulsant as an appropriate migraine preventive therapy step statement.3

  • Calcium channel blockers (e.g., verapamil)

  • Of the 37 plans in the payer policy analysis, 34 plans specified a required step failure prior to therapy and 3 of the 37 plans did not. Of the plans with specified step failure criteria, 18 of the 34 payers (representing 72% of the commercial lives among the 34 payers) included a calcium channel blocker as an appropriate migraine preventive therapy step statement.3

AND

  • Trial length was at least 6 weeks at generally accepted doses

  • Based on the AHS consensus statement, to achieve cost-effective care while ensuring access to patients most appropriate for these treatments, it is important that the indications for initiating treatment with anti-CGRP  monoclonal antibodies (mABs) give oral preventive treatments an adequate 6 week trial at a target or usual effective dose to optimize the possibility of a therapeutic response.4

  • Of the 37 plans in the payer policy analysis, 31 plans specified a step failure duration and 6 of the 37 plans did not. Of the plans with step failure duration criteria, 26 of the 31 payers (representing 91% of the commercial lives among the 31 payers) require a step failure duration of either 8 weeks (14 payers) or a ‘trial and failure’ (12 payers). An additional 2 payers require a step failure duration of less than 8 weeks.3

Length of Initial Approval: 6 months (two cycles of treatment)

  • Based on the AHS consensus statement, it is recommended that the benefits of anti-CGRP mAbs be assessed after 3 months of treatment for those administered monthly and 6 months after the start of quarterly treatments.4

  • Of the 37 plans in the payer policy analysis, 25 plans specified an initial authorization duration and 12 of the 37 plans did not. Of the plans with initial authorization duration criteria, 19 of the 25 payers (representing 60% of the commercial lives among the 25 payers) require an initial authorization duration of up to 6 months with an additional 5 payers (representing 39% of the commercial lives among the 25 payers) requiring an initial authorization duration of up to 1 year.3

CRITERIA FOR CONTINUATION OF THERAPY

Product X will be approved for continued use when

following criteria are met:

  1. Individual has improvement in migraine prevention (e.g. reduced migraine headache days, reduced migraine frequency, reduced migraine duration, reduced use of acute abortive migraine medication) with the requested agent

  • Based on the AHS consensus statement, evidence of treatment benefits may be provided by a reduction in mean monthly headache days of 50% or more relative to pretreatment baseline.4

  • Of the 37 plans in the payer policy analysis, 21 plans specified criteria for continuation of therapy and 16 of the 37 plans did not. Of the plans with continuation of therapy criteria, 20 of the 21 payers (representing 99% of the commercial lives among the 21 payers) require a reduction in the frequency, duration, and/or severity of monthly migraines for reapproval.

  • Of these 21 payers, 16 (representing 93% of the commercial lives among the 21 payers) request physician attestation.3

OR

  1. Individual has obtained clinical benefit deemed significant by individual or prescriber

  • Based on the AHS consensus statement, evidence of treatment benefits may be provided by a clinically meaningful improvement in a validated migraine-specific patient reported outcome measure or other documented benefits reported by clinician and patient.4

  • Of the 37 plans in the payer policy analysis, 21 plans specified criteria for continuation of therapy and 16 of the 37 plans did not. Of the plans with continuation of therapy criteria, 6 of the 21 payers (representing 35% of the commercial lives among the 21 payers) included a clinical benefit deemed significant as a possible requirement for continuation of therapy.3

Length of Reapproval: 12 months

Implications for Life Science Organizations

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).

Conclusion/Action Steps

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]

References

  1. ClinicalTrials.gov (Chronic Migraine)

  2. ClinicalTrials.gov (Episodic Migraine)

  3. Data on File; Internal payer policy analysis.

  4. 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

  5. Berchick RE, Barnett CJ, Upton RD. Health Insurance in the United States: 2018. U.S. Census Bureau.2019