Non-Covered Drug List & Non-Covered Formulary Exception
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Defines BCBSMA's non-covered drug list and the formulary exception/prior authorization process for commercial members with pharmacy benefits, including criteria for when non-formulary drugs may be authorized.
No material clinical or coverage changes in this revision.
Coverage Criteria & Non-Covered Drug List
Medical Necessity Criteria / Exception Authorization
BCBSMA may determine a non-formulary drug to be MEDICALLY NECESSARY and authorize coverage when ONE of the following is met; otherwise additional requirements apply:
Supported by chunk 7
Supported by chunk 8
When not successfully maintained, required criteria (ALL applicable conditions must be met)
- Clinical support for indication: Requested drug is for an FDA‑approved indication or an indication supported by reputable compendia or accepted treatment guidelines (e.g., AHFS, Micromedex, peer‑reviewed standard of care).
- Combination products: For non-covered combination medications, the member has trialed the individual ingredients (when available and covered) or trialed preferred drugs in the same therapeutic class if individual agents are non‑covered (OTC alternatives considered when applicable).
- Trial and failure of formulary alternatives: If formulary alternatives exist, the member has tried and failed at least 2 covered alternatives (or 1 if only one formulary alternative is covered within the same therapeutic class). Failure reasons may include inadequate response, intolerance, contraindication, allergic/adverse reaction; documentation must include name, strength, and specifics of treatment failure.
- Clinical inability to switch or instability risk: Unable to switch to a covered formulary alternative for clinical reasons or switching would cause instability of the medical condition (e.g., narrow therapeutic index) — documentation required to support the clinical basis.
- Other permissible reasons: Requested non-covered drug is needed due to a drug supply shortage OR brand requested when an FDA‑approved generic exists and documentation supports trial/failure/contraindication to the generic.
Drugs designated as INVESTIGATIONAL or NOT MEDICALLY NECESSARY are excluded from coverage under this policy. These categories are listed under the policy's "Other Policy Conditions" and the summary explains that products on the non-covered list are not covered because safe, comparably effective alternatives or generics exist.
Providers should treat products identified in those categories as non-covered for benefit/payment purposes unless a separate formulary exception or prior authorization is granted according to the procedures in Policy 433.
The Non-covered Drug List enumerates specific branded products across multiple therapeutic classes that are excluded from coverage. Examples called out in the list include Aemcolo®, Augmentin XR™ (Moxatag™), Solosec®, Xifaxan™ and numerous biologic, antiviral, antifungal and botulinum toxin products.
This segment of the list is illustrative of the wide range of agents designated non-covered and should be consulted directly when preparing formulary exception or coverage requests.
Additional non-covered entries include numerous biologics and biosimilars as well as hepatitis C antivirals and botulinum toxin products. Representative named agents are Abrilada®; multiple adalimumab biosimilars and brands; Actemra®; Humira®; Sovaldi®; Mavyret®; Daklinza®; Daxxify®, Myobloc®, Xeomin®.
These named examples reflect the document's repeated listing of specialty injectables and oral antivirals among products excluded from standard coverage under Policy 433.
The policy explicitly lists many branded biologics and therapeutic agents as non-covered; examples in these chunks include Cosentyx®, Humira®, Stelara®, Entyvio®, and a broad set of adalimumab/ustekinumab variants and biosimilars.
Botulinum toxins and multiple CNS 5‑HT agonists (triptans and related migraine agents) also appear across these non-covered list segments, underscoring that numerous specialty products are subject to exclusion absent an approved exception.
This portion of the non-covered list reiterates explicit exclusions for multiple adalimumab biosimilars and branded biologics, multiple botulinum toxin products, CNS 5‑HT agonists (migraine therapies), anticonvulsants, select antivirals and antibiotics.
When a drug is shown on this list—such as the adalimumab variants and botulinum toxins referenced here—it is designated non-covered on the payer's formulary unless a formulary exception is obtained.
Products enumerated in these Non-covered Drug List chunks are excluded from coverage under the pharmacy benefit. The lists include repeated entries for specialty biologics, botulinum toxins, CNS agents, and Alzheimer’s therapies.
Providers should reference the exact non-covered entries in these sections when evaluating coverage options or preparing exception requests.
Specific products named as non-covered in these segments include biologics and monoclonal antibodies such as Cosentyx®, Entyvio®, Stelara®, multiple adalimumab products, and numerous botulinum toxin preparations.
These chunks further show that many branded specialty injectables and related agents are listed as non-covered and thus are excluded from standard coverage absent an approved formulary exception.
The non-covered list continues with repeated entries of Ustekinumab and its variants, Humira®, Stelara®, Entyvio® and numerous botulinum toxin, anticonvulsant and CNS 5‑HT agonist products.
These entries demonstrate the document's broad scope across therapeutic classes where branded agents are designated non-covered by the payer.
The listed drug products in these chunks — including various botulinum toxins, anticonvulsants, triptans/CNS 5‑HT agonists, and Alzheimer’s disease agents such as Adlarity®, Memantine/Donepezil, Namzaric® — are designated non-covered.
The policy text repeatedly lists these products as non-covered; their appearance in multiple parts of the non-covered list indicates they are explicitly excluded from standard formulary coverage.
These chunks list numerous products that are non-covered, repeating entries for biologics (e.g., Humira®, Stelara®, Entyvio®), botulinum toxins, anticonvulsants and CNS 5‑HT agonists.
As with other non-covered segments, drugs enumerated here are excluded from coverage under Policy 433 unless an exception is approved through the payer's formulary exception process.
This portion of the list again identifies branded products as non-covered—examples include Stequema®, multiple Ustekinumab variants, Wezlana®, Yuflyma®, Yusimry®, Daxxify®, Myobloc®, Xeomin®—and numerous triptans and CNS agents.
The enumerated brand-name drugs in these chunks are designated non-covered and must be presumed excluded from standard pharmacy benefit coverage absent an approved exception.
Named brand drugs in these chunks are explicitly listed as non-covered; the list includes many biologic/immunologic agents, botulinum toxin preparations, migraine agents, Alzheimer’s therapies and a wide range of CNS and specialty products.
Providers should use these enumerations as the authoritative non-covered list when assessing coverage and preparing any formulary exception submissions.
These chunks continue to list specific brand-name drugs as non-covered under the policy. Examples repeated here include Wezlana®, Yuflyma®, Yusimry®, botulinum toxin products, and multiple CNS 5‑HT agonists.
The repetition across chunks highlights that the non-covered designation applies broadly to many branded specialty agents and should guide benefit determinations.
The named brand drugs in these segments are explicitly non-covered under Policy 433; the list includes antiparkinsonian agents, atypical antidepressants, Alzheimer’s therapies, anticonvulsants and more.
When preparing coverage or exception requests, reference these non-covered entries to confirm whether a product is excluded from the pharmacy benefit.
This final part of the non-covered list continues to enumerate branded products excluded from coverage under Policy 433, including oral antibiotics/GI agents (e.g., Moxatag™, Solosec®, Xepi®, Xifaxan™) and multiple specialty injectables and neurologic agents.
Collectively, the document's non-covered sections identify dozens of individual products that are excluded from standard formulary coverage unless a formulary exception is granted.
The policy identifies the categories INVESTIGATIONAL and NOT MEDICALLY NECESSARY under "Other Policy Conditions," indicating these are separate non-coverage classifications applied by the payer.
Across the non-covered list segments, products are listed as non-covered without additional clinical criteria in these chunks; the document does not specify further 'not medically necessary' clinical criteria within the extracted list portions.
Determinations of 'not medically necessary' would follow the broader policy rules outside the enumerated non-covered list entries.
Provider Actions, Prior Authorization & Documentation
Submit Formulary Exception/Prior Authorization (Form #434)
Prior authorization/formulary exception requests for drugs on the Non‑covered Drug List must be submitted using the Formulary Exception/Prior Authorization form (Form #434) to BCBSMA Pharmacy Operations (contact details in policy: Pharmacy Operations, 25 Technology Place, Hingham, MA; tel/fax provided in policy).
- Use Formulary Exception/Prior Authorization form (Form #434).
- Submit by phone, fax, or mail to BCBSMA Pharmacy Operations (contact details in policy).
Non‑Covered Status — Exception May Be Required
Drugs listed on the Non‑covered Drug List are subject to non‑coverage; obtaining coverage generally requires submitting a formulary exception/prior authorization request referencing the non‑covered list.
- Reference the Non‑covered Drug List when preparing exception/coverage requests.
- Non‑covered designation means the drug is not covered under standard formulary rules unless an exception is granted.
Non‑covered Drugs Not Eligible for Standard Coverage
Drugs enumerated on the Non‑covered Drug List are designated non‑covered in this policy segment and therefore are not eligible for standard coverage absent an approved formulary exception.
- Listed products are identified as non‑covered and excluded from coverage under this policy section.
- Coverage requires a separate formulary exception/authorization per payer procedures.
Non‑covered Specialty/Branded Products — Exception Likely Needed
Many branded biologics, botulinum toxins, CNS 5‑HT agonists (triptans), and certain hepatitis C antivirals appear on the Non‑covered Drug List; these products are commonly considered non‑covered and would require a formulary exception to be considered for coverage.
- Examples include multiple adalimumab products, Daxxify/Myobloc/Xeomin (botulinum toxins), and hepatitis C agents (Daklinza, Mavyret, Sovaldi).
- If coverage is sought, submit a formulary exception per the policy procedures.
Non‑coverage — PA Implication and Alternatives Required
Drugs listed as non‑covered would not be approved through the standard prior authorization pathway; providers should seek covered alternatives or submit a formulary exception with supporting documentation if coverage is requested.
- Non‑covered designation means standard PA will not approve coverage for these listed items.
- If formulary alternatives exist, documentation of trial/failure or clinical reason preventing switch is required (see provider documentation requirements).
Non‑covered Listings — PA/Billing Details Not Specified Here
Drugs on the Non‑covered Drug List are presented as not covered; the listing itself does not include specific prior authorization codes or billing guidance — follow the broader policy procedures for exception requests.
- This part enumerates non‑covered products but does not provide CPT/HCPCS/NDC or PA code rules.
- Refer to the full policy for procedural/billing details when submitting exception requests.
Formulary Exception or Other Authorization Required for Coverage
The Non‑covered Drug List indicates many specialty and branded products are non‑covered; coverage generally requires a formulary exception or other authorization per the broader pharmacy policy procedures.
- Providers must use the formulary exception/prior authorization process to seek coverage for listed products.
- See policy for contact details and submission methods.
PA Impact — No Specific Codes or Alternate PA Rules in This Section
This document segment lists non‑covered products only; it does not specify alternate prior authorization rules or billing codes. Providers must follow the full policy for any PA workflows or coding.
- No PA rules or affected billing codes are provided in these chunks.
- Follow the full policy for any exception routing or billing instructions.
Prior Authorization Not Applicable to Listed Non‑covered Drugs (Absent Exception)
Drugs on this Non‑covered Drug List are not covered under the pharmacy benefit as listed; a prior authorization approval will not by itself make these listed products covered unless an exception policy applies.
- Non‑covered designation in this list means prior authorization will not change coverage status except via an approved formulary exception process.
- Providers should reference the Non‑covered Drug List when deciding whether to pursue an exception.
PA Unlikely to Override Non‑covered Designation — Use Exception Process
Requests for coverage of drugs designated non‑covered are unlikely to be approved through standard PA; providers seeking coverage should use the formulary exception process described in the broader policy.
- Prior authorization is unlikely to result in coverage for drugs explicitly listed as non‑covered unless addressed under a separate exception policy.
- Submit exception requests per policy instructions if coverage is clinically necessary.
Step Therapy — Trial of Formulary Alternatives Required Unless Justified
BCBSMA may require trial and failure of formulary alternatives (step therapy) before authorizing coverage of a non‑covered drug; the plan may use prescription claim records to document trials/failures.
- If formulary alternatives exist, member must have tried and failed at least 2 covered alternatives (or 1 if only one exists) unless clinical justification for not trying is documented.
- Prescription claim records may be used to establish successful maintenance or trials/failures; additional provider documentation required if claim history is insufficient.
Step Therapy — No Specific Sequences Listed in This Segment
This section does not specify step‑therapy sequences or explicit step rules for the listed products; refer to other parts of the full policy for any detailed step therapy edits.
- The non‑covered list enumerates many agents across classes but does not provide specific step sequences here.
- Refer to the complete policy for step therapy rules or edits that may apply.
Document Trial/Failure or Clinical Justification When Requesting Exception
Providers must submit documentation supporting clinical reasons that prevent trial of formulary alternatives — include the name and strength of alternatives tried and specifics of treatment failure; the plan uses prescription claim records when available.
- Documentation must state name and strength of alternatives tried and precise details of why they failed (e.g., inadequate response, intolerance, contraindication).
- If prescription claim history does not establish criteria, provide additional clinical records to support successful maintenance or trial/failure.
Use the Non‑covered Drug List as Reference for Coverage/Exception Requests
Reference the Non‑covered Drug List when submitting coverage or formulary exception requests; the list identifies specific drug products and biosimilars that are designated non‑covered.
- Use the list to confirm whether a product is designated non‑covered before submitting a coverage request.
- Listing in the policy is the reference for which products require exception requests.
Denial Risk — Lack of Documentation of Trials/Maintenance
Claims or prescriptions for drugs on the Non‑covered Drug List are at risk of denial if submitted without an approved formulary exception or adequate documentation showing successful maintenance or clinical justification.
- Denial risk exists when documentation does not show successful maintenance or trial/failure of formulary alternatives.
- Claims history may be used to establish maintenance or trials; absence of supporting records increases denial risk.
Denial Risk for Non‑covered Drugs — Seek Exception or Alternatives
Use of drugs on the Non‑covered Drug List may be denied coverage by the payer; providers should obtain an approved formulary exception or select covered alternatives to avoid denial.
- Requests for listed non‑covered drugs are subject to denial under Policy 433 unless a formulary exception is granted.
- If dispensed without an approved exception or alternate coverage, pharmacy benefit claims may be denied.
Documentation Guidance — Consult Full Policy for Exception Procedures
The Non‑covered Drug List itself does not include procedural documentation or PA workflow; providers should consult the full policy for the exception/appeal procedures and required supporting documentation.
- This excerpt is a product listing only; it directs providers to the full policy for procedural requirements.
- Documentation of medical necessity alone for listed agents may not guarantee coverage; follow the formulary exception process.
Non‑covered Listings Trigger Denial Risk Under Policy 433
Drugs appearing on the Non‑covered Drug List are subject to non‑coverage and claims for these listed products will be denied unless a formulary exception is approved per the payer’s processes.
- The policy expressly identifies listed products as non‑covered and subject to denial (Policy 433).
- Submit an approved formulary exception per the policy to obtain coverage for listed items.
Step Therapy / Formulary Alternatives
| Step | Requirement / Description |
|---|---|
| 1 | |
| Step therapy through formulary alternatives is required before authorization unless the member meets successful maintenance or other clinical justification criteria (e.g., device-dependent use, drug supply shortage, or inability to switch due to instability). Documentation of prior trials, failures, or clinical reasons is required; prescription claims history may be used to support criteria. |
| Step | Requirement / Description |
|---|---|
| 1 | |
| No explicit step therapy sequencing is provided in this excerpt; the non-covered drug list is presented without step-by-step sequencing. Refer to the full policy for any specific step edits or sequencing rules. |
| Step | Requirement / Description |
|---|---|
| 1 | |
| Large groups of branded biologics, biosimilars and other therapeutic classes are designated non‑covered in the list, implying that preferred formulary alternatives or biosimilar preferences may be required (or an exception sought) prior to coverage; specific step edits are not detailed here. |
| Step | Requirement / Description |
|---|---|
| 1 | |
| This segment enumerates products designated as non‑covered; no step‑therapy sequencing or step definitions are provided in this part of the document. Coverage for these products would require following the formulary exception/individual consideration procedures described elsewhere in the policy. |
Definitions
Background & Purpose
BCBSMA maintains a payer-managed Non-covered Drug List because safe, comparably effective alternatives or generic versions exist for listed products. The program permits exceptions when a member is successfully maintained on a non-formulary drug or when clinical circumstances prevent switching to formulary alternatives.
Providers seeking coverage for a non-covered product should follow the formulary exception and prior authorization procedures described in Policy 433 (including submission of Formulary Exception/Prior Authorization Form #434) and supply documentation showing successful maintenance or clinical justification for the exception.
Biosimilar & Specific Product Notes
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