Prior authorization criteria for select pharmacy drugs (EPSDT and gender-affirming care)
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Defines prior authorization review criteria for drugs used in gender-affirming care and for members under 21 (EPSDT), including a list of specific products with drug-specific criteria and authorization limits. Affects providers requesting PA for these pharmacy benefit drugs under Mass General Brigham Health Plan.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: General authorization conditions (Gender-affirming care and EPSDT)
Authorization of requested drug therapy may be approved when the following criteria have been met:
inv-02: Alternatives/formulary failure exceptions — ONE of the following must be met
One of the following must be met:
inv-03: Drug-specific criteria (examples — each drug requires all listed subcriteria)
Several listed drugs require specific diagnoses, age limits, prior trials, dosing limits, or formulation‑specific medical necessity.
This policy includes a documented prior review history that records creation and subsequent updates by the Pharmacy & Therapeutics (P&T) committee. Key entries include initial creation to support EPSDT review (9/13/23), expansion to address cosmetic agents and gender-affirming care procedures (12/13/23 and 04/10/24), additions of drugs and EPSDT-specific review updates (11/12/25 and 3/11/26), and the most recent formatting and approval-duration updates effective 07/01/2026. The policy does not enumerate universal exclusions beyond the requirements articulated elsewhere in the criteria (for example, alternative/formulary trial requirements and medical necessity for cosmetic agents).
Requests that do not meet the documented PA criteria may be considered not medically necessary and subject to denial. Specifically, denials may result when the request lacks the required diagnosis or age eligibility, fails to document prior trials or contraindications to specified formulary alternatives, exceeds stated dosing or quantity limits, or does not provide medical justification when a formulation-specific medical necessity (for example, an oral disintegrating tablet or injectable formulation) is required. The policy also requires documentation of rebate-eligible alternatives or a clinical rationale for use of non-rebate products; absence of this documentation is a basis for non-coverage under the listed criteria.
Initial Therapy Requirements
inv-14: Initial Therapy — general initial therapy expectations
General initial therapy expectations
Continuation and Reauthorization Requirements
inv-04: Continuation of Therapy (Reauthorization) — reauthorization requires physician documentation and listed criteria
Reauthorization requires physician documentation of continuation of therapy and the following criteria:
inv-15: Reauthorization — reauthorization requirements
Reauthorization requirements
Step Therapy and Required Prior Trials
| Drug | Step/Alternative therapy requirement |
|---|---|
| Arazlo (tazarotene 0.045% lotion) | Medical records documenting inadequate response or an adverse reaction to a topical tretinoin agent AND a topical tazarotene agent; prescriber must also submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product. |
| Aplenzin (bupropion hydrobromide ER) | Medical records documenting inadequate response (≥ 4 weeks) or adverse reaction to bupropion XL at an equivalent dose to the requested product; member must be ≥18 and <21; prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Cabtreo (clindamycin/adapalene/benzoyl peroxide gel) | Medical necessity for the combination product instead of separate commercially available agents; prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Xifaxan (rifaximin) 550 mg | Indication-specific requirements: e.g., for hepatic encephalopathy: member ≥18 and <21 and inadequate response/adverse reaction/contraindication to lactulose and requested quantity ≤2 units/day; for IBS‑D: inadequate response/adverse reaction to specified agents (e.g., bile acid sequestrant, bismuth subsalicylate, bulk-forming agent, diphenoxylate/atropine, loperamide, TCAs) and appropriate dosing (550 mg TID x14 days); for SIBO: inadequate response/adverse reaction to one listed antibiotic or contraindication. Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Jublia (efinaconazole) | One of: inadequate response or adverse reaction to itraconazole OR terbinafine oral tablets; OR medical necessity for topical formulation AND inadequate response (≥24 consecutive weeks) or adverse reaction to ciclopirox nail solution; OR contraindication to ciclopirox, itraconazole, and terbinafine. Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Tasmar (tolcapone) - brand only | Member concurrently taking carbidopa/levodopa and documentation of inadequate response, adverse reaction, or contraindication to entacapone AND opicapone (Ongentys). Prescriber must also provide medical records documenting inadequate response or adverse reaction to generic tolcapone and trials of alternatives with rebate or rationale for non-rebate use. |
| Zelapar (selegiline ODT) | Member concurrently taking carbidopa/levodopa and medical necessity for the ODT formulation (e.g., dysphagia); member not utilizing other solid oral formulations; requested quantity ≤2 units/day. Prescriber must document inadequate response/adverse reaction/contraindication to alternatives when applicable. |
| Relistor (methylnaltrexone) | For opioid‑induced constipation (OIC): inadequate response, adverse reaction, or contraindication to one agent from three of four traditional laxative classes (osmotic, stimulant, saline, osmotic, etc.) is required; for chronic non‑cancer pain additional trials (e.g., inadequate response/adverse reaction/contraindication to Movantik and Symproic and to Linzess AND lubiprostone). For the injection formulation, medical necessity for injection instead of tablet must be documented. Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Trulance (plecanatide) | Documentation of trials of alternatives with rebate or clinical rationale for non-rebate product; medical necessity required when exceeding quantity limits and appropriate diagnosis (CIC or IBS‑C). |
| Bryhali (halobetasol) | Inadequate response or adverse reaction to ALL topical corticosteroids of the same formulation and potency range available without prior authorization (examples listed in policy) OR medical necessity for requested formulation; prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Duobrii (halobetasol/tazarotene) | Inadequate response or adverse reaction to ONE superpotent or potent topical corticosteroid available without prior authorization; medical necessity for combination product instead of separate agents; prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Siliq (brodalumab) | For plaque psoriasis: inadequate response/adverse reaction/contraindication to conventional therapies OR to one biologic DMARD, appropriate dosing, AND inadequate response/adverse reaction/contraindication to Stelara, Skyrizi, and Taltz AND to one or all anti‑TNF agents. For PRP: inadequate response/adverse reaction to one topical corticosteroid or contraindication to ALL topical corticosteroids and clinical rationale for use instead of Stelara and Taltz. Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Uceris (budesonide rectal foam) - brand only | Inadequate response (≥3 weeks) or adverse reaction to ONE or contraindication to BOTH hydrocortisone enema AND hydrocortisone foam; member must be ≥18 and <21; prescriber must provide documentation of inadequate response/adverse reaction to generic budesonide rectal foam and trials of alternatives with rebate or clinical rationale for non-rebate product. |
| Luzu (luliconazole) cream | When listed under EPSDT drugs, prescriber must meet drug‑specific criteria including documentation of inadequate response, adverse reaction, or contraindication to appropriate formulary alternatives as required by the policy; prescriber must submit trials of alternatives with rebate or clinical rationale for non‑rebate product. |
Quantity Limits by Product
Provider Responsibilities and Authorization Process
Prior authorization required — apply P&T‑approved guidelines first
Prior authorization is required for the drugs and situations listed; if a P&T‑approved coverage guideline exists for the requested drug and indication, the request must be reviewed against that guideline first.
Step/alternative therapy requirements — document trials or contraindications
Many drug-specific criteria require trials of and documentation of inadequate response, adverse reaction, or contraindication to specified formulary alternatives (often enumerated per drug); prescribers must submit documentation of trials of alternatives with rebate information or clinical rationale for non‑rebate products when requested.
- Examples: Xifaxan 550 mg requires documented inadequate response/adverse reaction to listed agents per indication (e.g., lactulose for hepatic encephalopathy; loperamide/TCAs/etc. for IBS‑D) and appropriate dosing (550 mg TID x14 days).
- Jublia requires documented inadequate response/adverse reaction to itraconazole or terbinafine OR ≥24 weeks failure of ciclopirox topical, or contraindication to listed agents.
- Many topical/combination products require documentation that combination product is medically necessary instead of separate agents.
Provide medical record documentation of alternative trials and reasons for failure
Submit medical records documenting inadequate response, adverse reaction, or contraindication to all available appropriate formulary alternatives and/or standard‑of‑care drugs when required by the criteria; documentation must include drug name, dose, duration of therapy, and reason for failure or discontinuation.
- For drug‑specific requests the prescriber must also submit documentation of trials of alternatives with rebate information or a clinical rationale for use of a non‑rebate product.
Denial risk for not meeting P&T‑approved guideline criteria
Failure to meet applicable P&T‑approved guideline criteria for the requested drug and indication when such guidelines exist may result in denial of the request.
- If a P&T‑approved coverage guideline exists for the requested drug/indication, that guideline must be applied first and requests reviewed against those criteria.
Key Definitions
Site of Care Considerations
Document medical necessity for Relistor injection
For Relistor injection, providers must document medical necessity for the injection formulation instead of the tablet formulation.
- Injection formulation medical necessity is required when requesting site‑of‑care infusion or parenteral administration.
Background and Scope
This policy establishes the review procedures for prior authorization requests for gender-affirming drug therapies and for drugs used in members under age 21 subject to EPSDT review. It defines conditions for authorization, documents required provider attestations and clinical rationale for gender-affirming indications, and specifies that drugs for members <21 years require EPSDT consideration per the criteria and approval-duration rules.
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