Clinical Policy: Ubrogepant (Ubrelvy)
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Policy governs medical necessity and prior authorization criteria for ubrogepant (Ubrelvy) for acute treatment of migraine in adult members under Delaware First Health (Centene-affiliated) Medicaid.
Added Zavzpret to list of CGRP inhibitors that should not be prescribed concurrently with Ubrelvy.
Revised initial approval duration from 6 to 12 months.
Updated contraindications to include hypersensitivity and concomitant use with strong CYP3A4 inhibitors.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
From Initial Approval Criteria section
inv-02: Continuation Therapy
Covered for continuation when ALL of the following are met:
From Continued Therapy section
Non‑FDA approved indications not specifically addressed in this policy are not authorized unless the prescriber submits sufficient documentation supporting safety and efficacy per applicable off‑label policies (see CP.PMN.53 for Medicaid) or other evidence‑of‑coverage guidance.
Requests for ubrogepant that involve concomitant use with strong CYP3A4 inhibitors are contraindicated and will be denied. This contraindication is explicit in the policy and applies to both initial and continuation requests.
Ubrelvy must not be prescribed concurrently with other CGRP inhibitors (examples listed include Aimovig™, Ajovy™, Emgality™, Nurtec® ODT, Qulipta™, Vyepti™, Zavzpret™). In addition, dosing is limited to a maximum of 200 mg per day (2 tablets) and use is limited to 8 days per month; requests exceeding these limits are not authorized.
Patients with a known hypersensitivity to ubrogepant are contraindicated and requests for therapy in such individuals are not appropriate.
Initial Therapy Criteria
inv-47: Antidepressant alternatives — dosing examples
Dosing examples for therapeutic alternatives cited in Appendix B.
Appendix B example of SNRI alternative
inv-48: Preventive therapy alternatives
Listed preventive dosing regimens for CGRP inhibitors and tricyclic option.
CGRP inhibitor preventive regimen
CGRP inhibitor preventive regimen
IV administration
Tricyclic antidepressant preventive option
inv-49: Listed therapeutic alternatives and doses (informational)
Listed therapeutic alternatives and doses (informational).
Appendix B dosing example
Appendix B dosing example
Appendix B dosing example
Appendix B dosing example
Appendix B dosing example
Continuation / Renewal Criteria
inv-51: Continuation Therapy — continuation/renewal rules
Covered for continuation when ALL of the following are met:
From Continued Therapy section; initial approval duration revised in policy history
inv-52: Continuation Therapy — continuation/renewal notes from policy history
Continuation/renewal notes from policy history.
From Reviews, Revisions, and Approvals (Appendix D)
Provider Actions & Documentation
Prior authorization required — submit documentation
Prior authorization is required. Provider must submit documentation demonstrating that the member meets all approval criteria, including required prior failures and specialist involvement when applicable.
- Prior authorization applies to initial approvals and to requests for monthly quantities >1 box of 10 tablets when additional failure requirements apply.
- Documentation examples: office chart notes, lab results, or other clinical information.
Appendix fragment does not define prior authorization
Appendix B does not specify prior authorization procedures, codes, or forms; it lists therapeutic alternatives and dosing only. Use the main policy criteria for authorization requirements.
- Appendix B provides dosing examples but does not define PA rules.
- Refer to sections I and II of the policy for PA requirements.
Therapeutic alternatives listed (informational)
Appendix B lists therapeutic alternatives and dosing examples (e.g., Aimovig, Ajovy, Emgality, Vyepti, Nurtec ODT) for preventive or alternative migraine therapies as informational guidance.
- Aimovig (erenumab) 70 mg SC monthly; may increase to 140 mg.
- Ajovy (fremanezumab) 225 mg SC monthly or 675 mg SC every 3 months.
- Emgality (galcanezumab) 240 mg loading then 120 mg monthly.
- Vyepti (eptinezumab) 100 mg IV every 3 months.
- Nurtec ODT (rimegepant) 75 mg PO as needed (acute).
Appendix B contains no PA instructions
Appendix B (the fragment provided) does not include explicit prior authorization specifications or PA codes; it should not be used as the source for PA procedures.
- Appendix B is an informational list of agents and doses; PA requirements are in the main policy sections.
Appendix lists alternatives and dosing only (no PA rules)
Appendix B provides only names and dosing regimens for alternative agents; it does not establish separate prior authorization rules within the appendix text.
- Therapeutic alternatives are presented for clinician reference only.
- Do not infer PA exceptions or authorizations from Appendix B alone.
Therapeutic alternatives only — no PA rules in appendix
The appendix lists therapeutic alternatives and dosing but does not include stepwise PA or step-therapy rules; follow the policy's criteria for required trials and failures.
- Appendix B is informational; step therapy requirements (where applicable) are in the policy body.
Authorization duration updated to 12 months
Initial approval duration has been revised to 12 months per policy history; prior reviews and P&T actions are documented in the References/Revision history.
- Policy history notes revision of initial approval duration from 6 to 12 months.
- References and revision notes are listed in Appendix D.
Required failures — ≥2 formulary triptans prior to approval
Before initial approval, the provider must document failure of at least two formulary generic 5HT1B/1D-agonist (triptan) agents at up to maximally indicated doses, unless contraindicated or adverse effects occurred.
- Examples of triptans: sumatriptan, rizatriptan, zolmitriptan.
- This requirement is part of the Initial Approval criteria for migraines.
Step therapy linkage — add Ubrelvy to CP.CPA.83 and HIM.PA.109
Policy history indicates Ubrelvy will be added to step therapy policies CP.CPA.83 and HIM.PA.109; implementers should link authorization logic accordingly.
- Change recorded in the 4Q2022 review notes.
- Step therapy linkage applies per prior revision guidance.
Documentation submission required with PA requests
Providers must submit supporting clinical documentation with PA requests — such as office chart notes, lab results, or other clinical information — to demonstrate the member meets all approval criteria.
- Documentation should support diagnosis, prior treatment failures, trial durations, adverse effects, or contraindications as applicable.
- Examples cited: office chart notes and lab results.
Off‑label indications require supporting evidence per CP.PMN.53
Requests for non‑FDA approved (off‑label) indications are not authorized by this policy unless the use is supported according to the plan's off‑label use policy (CP.PMN.53) or evidence of coverage documents.
- Providers seeking coverage for off‑label indications must supply sufficient documentation of efficacy and safety per CP.PMN.53.
- Non‑FDA indications are expressly excluded unless supported.
Contraindications that trigger denial — CYP3A4 inhibitors or hypersensitivity
Coverage is contraindicated (and will be denied) for requests involving concomitant use with strong CYP3A4 inhibitors or for patients with known hypersensitivity to ubrogepant; do not authorize these requests.
- Contraindications listed: concomitant use with strong CYP3A4 inhibitors; hypersensitivity to ubrogepant.
- Appendix C flags these as explicit contraindications.
References to support clinical rationale (Prescribing Info and trials)
Supporting references cited in the policy include the Ubrelvy Prescribing Information and peer‑reviewed trials and guideline publications; include these references when submitting clinical rationale if relevant.
- Ubrelvy Prescribing Information (Allergan); June 2025.
- Key trials: ACHIEVE II and NEJM trial; professional guidance from the American Headache Society are referenced.
Step Therapy / Prior Trials
| Step | Requirement / Trials Required Prior to Approval | Notes |
|---|---|---|
| 1 | For requests for monthly quantities > 1 box of 10 tablets per month: failure of TWO oral migraine prophylactic therapies, each for 8 weeks and from different therapeutic classes; and failure of a 3-month trial of ONE CGRP inhibitor used for migraine prophylaxis; and member is treated by or in consultation with a neurologist, headache, or pain specialist. | See Appendix B for examples of prophylactic therapies and CGRP inhibitors; prior authorization may be required. |
| Step | Requirement / Trials Required Prior to Initial Approval | Notes |
|---|---|---|
| 0 | Failure of at least TWO formulary generic 5HT1B/1D-agonist (triptan) migraine medications at up to maximally indicated doses, unless clinically significant adverse effects or contraindications. | Examples of triptans listed in Appendix B include sumatriptan, rizatriptan, and zolmitriptan. |
| Step | Appendix B — Alternate Preventive Medications / Dosing Ranges | Step Therapy Sequence Specified? |
|---|---|---|
| 1 | Appendix B lists oral preventive agents with typical PO daily dosing ranges (e.g., topiramate, divalproex sodium ER, beta-blockers such as metoprolol and propranolol, venlafaxine XR 150 mg/day, amitriptyline 30–150 mg/day). | No formal step therapy sequence or required failures for these agents is specified in the appendix fragment. |
| Step | Appendix B — Alternative Agents (CGRP inhibitors / others) | Step Therapy Sequence Specified? |
|---|---|---|
| 1 | Appendix B lists CGRP inhibitors (e.g., Aimovig/erenumab 70 mg → 140 mg SC monthly; Ajovy/fremanezumab 225 mg monthly or 675 mg q3 months; Emgality/galcanezumab 240 mg loading → 120 mg monthly; Vyepti/eptinezumab 100 mg IV q3 months [some patients 300 mg]). | The appendix provides dosing examples but does not prescribe a required step-therapy sequence in the provided text. |
| Step | Appendix B — Additional Alternatives and Dosing | Step Therapy Sequence Specified? |
|---|---|---|
| 1 | Appendix B additionally lists Nurtec ODT (rimegepant) 75 mg PO as needed and reiterates preventive agent dosing such as amitriptyline 30–150 mg/day and the CGRP inhibitor regimens. | No required step therapy order is specified within these appendix fragments. |
| Step | Appendix B — Alternatives / Dosing (summary) | Step Therapy Sequence Specified? |
|---|---|---|
| 1 | Appendix B provides a consolidated list of therapeutic alternatives and dosing regimens (oral prophylactics, antidepressants, tricyclics, CGRP biologics, oral gepants) for provider reference. | The provided text lists alternatives and doses only; it does not define a formal step therapy sequence in the fragment. |
| Step | Appendix B — Alternatives (no sequence specified) | Step Therapy Sequence Specified? |
|---|---|---|
| 1 | Appendix B repeats acute and preventive treatment options with dosing (e.g., rimegepant 75 mg PO; erenumab, fremanezumab, galcanezumab, eptinezumab dosing regimens). | No step therapy sequence is specified in the appendix fragment; content is informational regarding alternatives and dosing. |
Quantity Limits & Dosing
Site of Care Notes
Infusion center — Vyepti IV q3 months
Eptinezumab (Vyepti) is administered intravenously every 3 months and is managed in an infusion setting.
- Recommended dosage: 100 mg IV every 3 months (some patients may receive 300 mg IV q3 months)
Infusion setting — Vyepti IV usually given in infusion/hospital outpatient
Vyepti IV administration is typically provided in an infusion center or hospital outpatient infusion setting per the appendix dosing guidance.
- Site of care: infusion center / hospital outpatient infusion
Home/outpatient — oral therapies administered in home setting
Oral therapies such as ubrogepant (Ubrelvy) and rimegepant (Nurtec ODT) are administered in the outpatient or home setting per product prescribing information.
- Ubrelvy dosing: 50 mg or 100 mg PO as needed; second dose ≥2 hours later if needed; max 200 mg/24 hours
- Nurtec ODT acute dose: 75 mg PO as needed
Definitions & Key Terms
Background
Ubrogepant (Ubrelvy) is an oral CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults. It is indicated for as‑needed use for acute migraine attacks (tablets available as 50 mg and 100 mg); dosing guidance includes a second dose if needed ≥2 hours after the first dose and a maximum of 200 mg per 24 hours. Ubrogepant is not indicated for preventive treatment of migraine.
References & Appendix
Supporting references — prescribing information and cited trials/guidelines
The policy references the Ubrelvy Prescribing Information and specific clinical trials and guidelines as sources supporting the criteria and dosing in the document.
- Ubrelvy Prescribing Information; ACHIEVE II and related trials; American Headache Society recommendations
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