Ubrogepant (Ubrelvy) — Coverage Criteria for Acute Migraine
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Defines medical necessity and prior-authorization criteria for ubrogepant (Ubrelvy) for the acute treatment of migraine in adults under Peach State Health Plan (Medicaid). Applies to providers requesting coverage through the Centene-affiliated benefit.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ubrogepant (Ubrelvy)
inv-01: Initial Therapy
Covered when ALL of the following are met
Prior authorization may be required for some prior therapies (see Appendix B).
inv-02: Continued Therapy
Covered when ALL of the following are met
Prior authorization may be required for some prior therapies (see Appendix B).
Requests for use of ubrogepant (Ubrelvy) for non‑FDA approved indications that are not specifically addressed in this policy will not be authorized unless the request is supported in accordance with the payer's off‑label use policy CP.PMN.53 (or applicable evidence of coverage documents).
Ubrogepant should not be prescribed concurrently with specified CGRP inhibitors. Per the 4Q2024 review, Zavzpret was added to the list of CGRP agents that should not be used at the same time as ubrogepant.
Hypersensitivity to ubrogepant is listed as a contraindication in the updated prescribing information (noted in the 4Q2023 review). Use of ubrogepant in patients with a known hypersensitivity to the drug is not authorized.
Coding and Dosing Limits
| NDC | Product NDCs referenced generically in policy and prescribing information |
Provider Actions, Prior Authorization & Documentation
Obtain prior authorization and show all criteria met
Prior authorization is required. Providers must demonstrate that all initial or continuation criteria are met, including documentation of prior failures of therapies and specialist consultation when required (for higher monthly quantities).
- Prior authorization may be required for prior therapies and for trials listed in Appendix B.
- Provider must confirm dosing limits (≤200 mg/day; ≤8 days/month) when requesting approval.
Check policy history and referenced step therapy policies
Follow the current policy and related step therapy policies; the policy history documents administrative changes and clarifications that affect continuation criteria and step therapy placement (see CP.CPA.83 and HIM.PA.109).
- Per 4Q2022 updates, Ubrelvy was removed from Commercial and HIM lines and step therapy placement is handled via CP.CPA.83 and HIM.PA.109.
Meet step‑therapy and failure requirements
For initial approval or dose increases above 1 box (10 tablets) per month, document failure of at least two formulary generic 5HT1B/1D‑agonist (triptan) agents unless intolerant or contraindicated; additional step requirements apply for higher monthly quantities.
- Higher monthly quantity requests require failure of two oral migraine prophylactic therapies (each 8 weeks, different classes) and a 3‑month trial of one CGRP inhibitor unless intolerant/contraindicated, and specialist involvement.
Follow 4Q2022 administrative placement and step therapy cross‑references
Note the administrative placement update: per 4Q2022 review, Ubrelvy was removed from Commercial and HIM lines and will be managed in step therapy policies CP.CPA.83 and HIM.PA.109; follow those policies for operational rules.
- Review CP.CPA.83 and HIM.PA.109 for step therapy placement and operational details.
Provide required supporting documentation
Submit supporting clinical documentation with the prior authorization: office chart notes, lab results, or other clinical information that demonstrate the member meets all approval criteria (including prior therapy trials and response to treatment).
- Include documentation of prior triptan trials, prophylactic therapy trials and CGRP inhibitor trial when applicable.
- Include evidence of positive response for continuation requests.
Cite prescribing information and references in requests
Use the references and Ubrelvy prescribing information cited in the policy to support the clinical rationale in prior authorization requests.
- Key reference: Ubrelvy Prescribing Information (Allergan; June 2023) and listed clinical trials/guidelines.
Do not request non‑covered/off‑label indications without CP.PMN.53 support
Requests for non‑FDA approved (off‑label) indications not addressed in this policy will not be authorized unless supported according to the off‑label use policy CP.PMN.53 (for Medicaid).
- When submitting off‑label requests, include sufficient documentation of efficacy and safety per CP.PMN.53.
Follow state Medicaid coverage provisions when applicable
For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy; consult the state Medicaid manual as discrepancies may result in denial.
- If state Medicaid rules differ from this policy, follow the state provisions.
Initial Therapy Criteria
inv-20: Initial Therapy
Initial coverage criteria for migraine
Prior authorization may be required for some prior therapies (see Appendix B).
Continuation Therapy Criteria
inv-21: Continuation Therapy
Criteria required for continued coverage
inv-22: Continuation therapy clarification — Policy history clarified continuation criteria regarding concurrent CGRP inhibitor use for members previously approved via Centene benefits.
Policy history clarification regarding concurrent CGRP inhibitor use for members previously approved via Centene benefit
Clarification added 2Q2021 as documented in policy review history.
Step Therapy and Prior Trial Requirements
| Requirement | Details |
|---|---|
| Failure of two oral migraine prophylactic therapies | |
| Each prophylactic trial must be ≥8 weeks and from different therapeutic classes (see Appendix B for examples) | |
| Failure of a 3-month trial of one CGRP inhibitor for migraine prophylaxis | |
| Member is being treated by or in consultation with a neurologist, headache, or pain specialist | |
| Must have failed at least two formulary generic 5HT1B/1D-agonist (triptan) agents for initial therapy; additional prophylactic/CGRP trials required for requests for monthly quantities >1 box of 10 tablets per month |
| Policy statement | Action / Reference |
|---|---|
| Ubrelvy placement and step therapy requirements were removed from Commercial and HIM lines of business and will be managed in separate step therapy policies. | |
| Refer to step therapy policies CP.CPA.83 and HIM.PA.109 for current placement and step therapy requirements (4Q2022 update). |
Quantity Limits and Maximums
Background
Ubrogepant (Ubrelvy) is an oral CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults. It is not indicated for migraine prevention. Standard dosing options include 50 mg or 100 mg orally as needed with the option for a second dose ≥2 hours after the first, and a maximum of 200 mg in 24 hours.
Definitions
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