2025 Pharmacy Benefit — Brand Non‑Formulary Coverage Criteria
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Defines copay tiers, mail order copay structure, and prior authorization/medical necessity rules for brand drugs under the Health-New-England 2025 Pharmacy Benefit for HMO Gold A SG plan. Affects prescribers, pharmacists, and plan members in the plan's service area.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Rules
Brand Non-Formulary Medical Necessity Criteria
Covered when ALL of the following are met:
Required for coverage of Brand Non-Formulary drugs when generics exist.
Acceptable evidence of medical necessity (one or more):
- Inadequate therapeutic response to the FDA-approved generic alternative(s)
Document prior trial and outcome of generic(s)
- Allergic reaction or intolerance to the FDA-approved generic alternative(s)
Document nature of allergy/intolerance
- Failure of alternatives within the same drug class
Document trials of alternatives and outcomes
Coverage is contingent on review and approval of the submitted medical necessity documentation.
Coverage of brand name drugs that have FDA‑approved generic equivalents is contingent on documented medical necessity. Health New England will consider coverage when the prescriber submits a completed drug request form with supporting clinical documentation demonstrating medical necessity, such as inadequate response to the generic(s), an allergic reaction to the generic(s), or failure of alternatives in the drug class.
Brand name drugs that have FDA‑approved generics are not covered unless medical necessity has been demonstrated. If no documentation of medical necessity is provided, the brand product will be denied in favor of the available generic alternative.
Provider Submission, Authorization, and Documentation
Prior Authorization Required
Prior authorization required when Medical Necessity is claimed for a Brand Non‑Formulary (Tier 3) drug. Submit a drug request form and supporting documentation to Health New England for review.
- Fax drug request form to Health New England for review
- Applicable when a brand-name drug has an FDA-approved generic equivalent
Step Therapy Expectations (Implied)
Health New England expects that prescribers will first try appropriate, lower‑cost alternatives before requesting a Brand Non‑Formulary product. Examples of acceptable medical necessity reasons include inadequate response to one or more generics, allergic reaction to the generic(s), or documented failure of alternatives within the drug class.
- Try formulary/generic alternatives prior to requesting Brand Non‑Formulary
- Document trials, doses, and outcomes of prior therapies
Required Documentation for Brand Non‑Formulary Requests
When requesting a Brand Non‑Formulary (Tier 3) drug, the prescriber must provide the completed drug request form plus supporting clinical documentation demonstrating medical necessity (e.g., documentation of inadequate response, allergy, or intolerance to generic alternatives). Incomplete requests risk delayed or denied review.
- Include clinical notes, prior therapy history, and allergy documentation
- Attach prior authorization/drug request form with all supporting records
Denial Risk When Generic Available
If medical necessity is not documented — for example, no evidence of trial and failure of generics or no documented allergy/intolerance — the request for a Brand Non‑Formulary drug that has an available generic is subject to denial.
- Denial likely when supporting clinical documentation is absent or insufficient
- Brand Non‑Formulary requests for drugs with available generics require clear medical necessity to be approved
Clinical and Policy Background
Generic drugs are FDA‑approved equivalents to brand drugs, containing the same active ingredients and being as safe and effective, and are generally preferred because they usually cost less. For these reasons, Health New England requires evidence of medical necessity before authorizing coverage of a brand product when an FDA‑approved generic is available.
Formulary Tier Definitions
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