Brand Humira prior authorization
This document governs prior authorization requirements for brand Humira (adalimumab) under UnitedHealthcare's Clinical Pharmacy Programs and affects providers requesting coverage for Humira when biosimilars are available.
New program requiring validation that the member is not an appropriate candidate for Humira biosimilars.
Coverage Criteria for Brand Humira (adalimumab)
Initial or continuation approval criteria
Brand Humira will be approved based on ONE of the following:
Supports approval if documented.
For Connecticut, Kentucky, and Mississippi business only a 30-day trial is required.
Authorization will be issued for 12 months if criteria are met.
For continuation requests, the requested dose must not exceed the indication‑specific limits. Per the policy, the maximum doses are: for rheumatoid arthritis or hidradenitis suppurativa, 40 mg per week or 80 mg every other week; for Crohn’s disease, ulcerative colitis, or uveitis, 40 mg per week; and the policy lists lower limits for pediatric and other indications (see dosing table). Requests to continue brand Humira that exceed these indication‑based dose limits are not permitted under the continuation criteria.
Brand Humira is not supported when the provider does not submit required biosimilar documentation. Specifically, requests for brand Humira will be denied if there is no medical record showing either: (1) an allergy or demonstrated intolerance to inactive ingredients in the specified biosimilars (Adalimumab‑adaz / unbranded Hyrimoz and Amjevita); or (2) prior successful treatment with brand Humira plus medical records documenting trials of Adalimumab‑adaz and Amjevita for the required duration with a documented decrease in effectiveness. Absence of these records means use of brand Humira is not authorized under the program.
Initial Therapy Criteria
Initial therapy — Initial approval pathways
Initial approval is granted when one of the initial therapy options below is met.
For CT, KY, MS business a 30-day trial per product is permitted.
Continuation Therapy Criteria
Continuation therapy — Continuation requests for established members
Continuation requests for established members will be approved when ALL criteria below are met:
Authorization will be issued for 12 months if criteria are met; dose limits vary by indication (see dose limits).
Step Therapy Requirements
| Step | Required trial(s) before Brand Humira | Trial duration | Exceptions / notes |
|---|---|---|---|
| 1 | Adalimumab-adaz (unbranded Hyrimoz) and Amjevita | 6-8 weeks per product | Unless documented allergy/intolerance to the biosimilars or continuation for an established member (>=28 days paid claim in past 120 days). For CT, KY, MS business a 30‑day trial per product is required. |
Provider Actions and Requirements
Prior authorization required for brand Humira
Prior authorization is required for Brand Humira (adalimumab). Approval is granted when the provider submits the required medical records that meet one of the program's approval pathways (allergy/intolerance to specified biosimilars; prior successful Humira treatment plus documented biosimilar trial with decreased effectiveness; or continuation documentation for an established member).
Required trial of Hyrimoz and Amjevita before brand Humira
Provider must document trials of two specified adalimumab biosimilars: Adalimumab-adaz (unbranded Hyrimoz) and Amjevita. Each product must be tried for 6–8 weeks with documentation of decreased effectiveness; for CT, KY, and MS business a 30‑day trial per product is acceptable.
- Trial duration per product: 6–8 weeks (standard)
- Exception: 30-day trial per product for Connecticut, Kentucky, and Mississippi
Medical records and claims required to support authorization
Submit medical records that document one of the following: (1) allergy or demonstrated intolerance to inactive ingredients in Adalimumab-adaz (Hyrimoz) and Amjevita; OR (2) prior successful treatment with brand Humira plus medical records of biosimilar trials showing decreased effectiveness; OR (3) paid claim evidence of at least a 28‑day supply in the prior 120 days for continuation requests.
- Allergy/intolerance documentation must reference inactive ingredients in the listed biosimilars.
- Documentation of prior Humira success plus biosimilar trials must show decreased effectiveness on each biosimilar tried.
- Continuation requests require a paid claim for >=28 days supply in the past 120 days.
Denial triggers for brand Humira requests
Requests lacking required documentation may be denied. This includes failure to document allergy/intolerance to the inactive ingredients of the listed biosimilars, absence of documented prior successful use of brand Humira when that pathway is claimed, or missing biosimilar trial documentation showing decreased effectiveness.
- No documentation of allergy/intolerance to Adalimumab-adaz and Amjevita inactive ingredients.
- No records showing prior successful treatment with brand Humira when relied upon.
- No medical records documenting the required 6–8 week (or 30‑day where applicable) biosimilar trials with decreased effectiveness.
Biosimilar Requirements and Exceptions
Member must be shown not appropriate for biosimilars or meet trial/continuation rules
For initial approvals, provider must show the member is not an appropriate candidate for the biosimilar (documented allergy/intolerance) or document a required trial of the biosimilar(s) with decreased effectiveness; continuation requests require paid claim evidence of at least a 28‑day supply in the prior 120 days and dose within indication limits.
- Initial: allergy/intolerance to Hyrimoz/Amjevita OR biosimilar trial failure documented
- Continuation: paid claim ≥28 days supply in past 120 days and dose within indication-based limits
Biosimilar suitability or trial failure required for Brand Humira
Member must be shown not appropriate for the biosimilar (documented allergy/intolerance) or must have completed the required biosimilar trial duration with documented decreased effectiveness to qualify for Brand Humira under the program.
- Documentation of allergy/intolerance to Hyrimoz and Amjevita OR
- Completed biosimilar trials with decreased effectiveness (6–8 weeks per product; 30 days for CT/KY/MS)
Coding and Claims
Definitions
Background
This prior authorization program is intended to limit use of brand Humira when interchangeable or preferred adalimumab biosimilars are available. Approval for brand Humira requires evidence that the member is not an appropriate candidate for the listed biosimilars — either by documented allergy/intolerance to biosimilar excipients, documented prior success on brand Humira followed by biosimilar trials (Adalimumab‑adaz and Amjevita) with decreased effectiveness, or continuation documentation for an established member. When criteria are met, authorization is typically issued for 12 months. UnitedHealthcare may also use claims and diagnosis data per automated processes where applicable.
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