CurrentBlue Cross Blue Shield - MassachusettsPolicy 409

Commercial BCBSMA Pharmacy prior authorization / formulary coverage criteria for oncology drugs

This commercial BCBSMA Pharmacy (Rx) policy lists formulary status (PA required) and prior authorization clinical coverage criteria for numerous oncology medications for members with BCBSMA commercial formularies. It applies to outpatient retail pharmacy benefit; individual consideration instructions and documentation requirements for PA are provided.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCommercial BCBSMA Pharmacy prior authorization / formulary coverage criteria for oncology drugs

Policy CodePolicy 409

Change TypeAdministrative / formulary updates (policy history entries)

Effective Date

Next Review Date

Key ActionProviders must request prior authorization via BCBSMA Pharmacy Operations (phone/fax/Massachusetts eForm) and supply documentation of prior therapies and required FDA‑approved mutation test results when applicable.

POLICY UPDATE CHANGES

Ensacove and Ibtrozi added to the policy (1/15/2026 entry).

Multiple drugs and indications added across 2024-2026 (examples: Avmapki Fakzynja, Revuforj, Itovebi, Lazcluze, Lumakras new indication, Voranigo).

~90+Drugs listed with PA required (approx.)

CommercialApplies to

Specialty RxBenefit

Example drugs with criteria in part

manyPolicy history entries

Coverage Summary

This BCBSMA Commercial Pharmacy policy lists formulary status and prior authorization clinical coverage criteria for numerous oncology medications under the outpatient retail pharmacy benefit (specialty). It applies to BCBSMA commercial members and indicates that listed agents are PA Required per the formulary status; coverage is covered_with_criteria and subject to the specific drug-level clinical criteria in the policy.

Key threshold highlights

AgeVaries by drug; commonly ≥ 18 years (some agents ≥12, ≥2, or ≥1 depending on indication)

ECOG performance statusOften required; examples include ≤1 for repotrectinib (ROS1 NSCLC) and ≤2 for nirogacestat (DT/AF)

Platelet countSpecific low-platelet threshold for some agents — e.g., platelet count below 50 × 10^9/L required for pacritinib (Vonjo)

Prior therapies / treatment historyMany agents require prior systemic therapy or specific prior treatments (e.g., ≥1 prior systemic therapy, progression on platinum-containing chemotherapy, or ≥2 prior regimens for some hematologic agents); providers must document prior therapies and failures

Initial Therapy / Indication-Specific Criteria

General Prior Authorization / Documentation Requirements

Provider documentation and prior authorization requirements applicable to all agent-specific requests. Include these as a callout for Provider Actions; criteria groups below are agent/indication-specific initial coverage logic.

ALL of the following

Prior authorization is required for medications listed in this policy.
Provider must submit documentation supporting diagnosis, relevant biomarker testing results (e.g., FDA‑approved test for ALK, ROS1, NTRK, BRAF, EGFR, PDGFRA, FGFR, IDH1, KRAS, etc.), stage/extent of disease, and prior therapies tried and failed when applicable.
Documentation must include medication names, strengths, dates of trial and reason for discontinuation or intolerance of formulary alternatives if step therapy is claimed to be met.

Continuation Therapy / Usage Constraints

Continuation / Maintenance Criteria

Continuation / maintenance use: no distinct continuation tree present in the brief. Continuation/renewal criteria follow agent-specific FDA label and generally require documentation of prior response and may require PA renewal per Provider Actions.

Continuation / Maintenance: Continuation criteria per agent-specific FDA label; documentation of prior response and prior authorization renewal may be required

If distinct continuation/maintenance criteria exist, they are included in the specific agent criteria above

Applicable Codes

Formulary status - listed drugs (examples from part 1)mixed

Alecensa	alectinib — Standard Formulary; PA Required
Alunbrig	brigatinib — Standard Formulary; PA Required
Augtyro	repotrectinib — Standard Formulary; PA Required
Ayvakit	avapritinib — Standard Formulary; PA Required
Balversa	erdafitinib — Standard Formulary; PA Required
Braftovi	encorafenib — Standard Formulary; PA Required
Copiktra	duvelisib — Standard Formulary; PA Required
Cotellic	cobimetinib — Standard Formulary; PA Required
Ensacove	ensartinib — Standard Formulary; PA Required
Erlotinib	erlotinib — Standard Formulary; PA Required

1–10 of 11

1/2

Provider Actions & Authorization Process

Prior Authorization

Prior authorization required

Prior authorization is required for outpatient retail pharmacy coverage of medications affected by this policy. Providers must request coverage through BCBSMA Pharmacy Operations by phone, fax, or the formulary exception/prior authorization form. Verbal requests may be made by calling BCBSMA Pharmacy Operations at 1-800-366-7778. Fax requests may be sent to 1-800-583-6289. Use the Massachusetts Standard Prior Authorization (eForm) when applicable (link available on the BCBSMA provider site). Patients must have pharmacy benefits under their subscriber certificates for PA requests to be considered.

Acceptable request methods: phone, fax, or completed formulary exception/prior authorization form (paper or Massachusetts eForm).
Physicians may request prior authorization verbally via Pharmacy Operations at 1-800-366-7778.
For MA Standard eForm (Massachusetts eForm) use the BCBSMA provider link to submit PA requests.

Clinical Evidence & References

References cited are primarily FDA package inserts and peer-reviewed studies; the source includes a numbered reference list (references 1–62+) documenting package inserts and literature. See the full policy reference list in the source for the complete citations.

Background

BCBSMA's formulary policy requires prior authorization for many oncology therapies under the pharmacy benefit for Commercial members; providers must request PA via BCBSMA Pharmacy Operations (call/fax or the MA standard PA form) and members with applicable commercial plans must fill through the BCBSMA retail specialty pharmacy network. Provider documentation must show prior therapies and reasons alternatives were not appropriate (names/strengths, dates, failure details); prescription claims may be used to establish prior use and BCBSMA may request additional supporting documentation. An Individual Consideration (exception) pathway is available for atypical cases where criteria are unlikely to be clinically effective and providers are encouraged to submit supporting clinical documentation for review.

Definitions / program terms

FDA-approved testDiagnostic assay approved by the US FDA for detecting specific mutations or rearrangements required to determine drug eligibility (many drugs require mutation/fusion confirmation by an FDA-approved test)

ECOG performance statusEastern Cooperative Oncology Group performance status scale used to assess patient functional status; specific required thresholds vary by drug (e.g., 0–1 or ≤2)

Individual Consideration / Exception RequestA provider-requested process to seek coverage when a patient does not meet standard policy criteria; requires supporting clinical documentation (notes, prior therapies and failures, literature, compendia/guideline references)

Revision History

1/15/2026policy update (non-material)Latest

Ensacove (ensartinib) and Ibtrozi (taletrectinib) added to the policy per November P&T review entry; listed as Standard Formulary with PA Required.

2024-2026 (multiple entries)historical policy updates (non-material)

Multiple drugs and indications were added across 2024–2026 (examples recorded in policy history include Avmapki Fakzynja, Revuforj, Itovebi, Lazcluze, new Lumakras indication, Voranigo); these are recorded as policy history updates without clinical criteria details in the history entries.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCommercial BCBSMA Pharmacy prior authorization / formulary coverage criteria for oncology drugs

Policy CodePolicy 409

Change TypeAdministrative / formulary updates (policy history entries)

Effective Date

Next Review Date

On This Page

Prescription claims history may be used by the payer to verify prior use of formulary alternatives; if claims data are insufficient, the provider must supply additional records.

Age and performance status requirements listed in the agent-specific criteria (e.g., minimum age, ECOG) must be documented where applicable.

Larotrectinib (Vitrakvi) and Entrectinib (Rozlytrek) NTRK Indications

Coverage criteria for Larotrectinib (Vitrakvi) and Entrectinib (Rozlytrek) for NTRK fusion-positive solid tumors.

ALL of the following

Tumor harbors an NTRK gene fusion as detected by an FDA‑approved test or validated molecular test (documentation required).
Disease is locally advanced or metastatic, or surgical resection is likely to result in severe morbidity.
There are no satisfactory alternative therapies, or the patient has progressed on or after prior therapy when established alternatives exist (document prior therapies).
Agent-specific
- Larotrectinib (Vitrakvi): patient meets the above and is age ≥ 12 years (or per FDA label) — use larotrectinib dosing per label.
- Entrectinib (Rozlytrek): patient meets the above and is age ≥ 12 years (or per FDA label) — use entrectinib dosing per label.

Tepotinib (Tepmetko) Indications

Coverage criteria for Tepotinib (Tepmetko) for MET exon 14 skipping-mutant NSCLC.

ALL of the following

Diagnosis of locally advanced or metastatic non‑small cell lung cancer (NSCLC).
Tumor harbors a MET exon 14 skipping mutation as detected by an FDA‑approved test or validated molecular test (documentation required).
Patient is an adult (per label) and has ECOG performance status as required by the label (documented).
Used according to FDA‑approved dosing and administration.

Ivosidenib (Tibsovo) Indications

Coverage criteria for Ivosidenib (Tibsovo) for IDH1-mutant malignancies.

ALL of the following

Documented IDH1 mutation in tumor (or hematologic malignancy) specimen as detected by an FDA‑approved or validated test (documentation required).
Indications per agent label
- Ivosidenib for relapsed/refractory acute myeloid leukemia (AML) with susceptible IDH1 mutation when used per FDA‑approved indication and dosing.
- Ivosidenib for other IDH1‑mutant indications supported by FDA approval or recognized compendia, with documentation of prior therapies as required by the labeled indication.

Capivasertib (Truqap) Indications

Coverage criteria for Capivasertib (Truqap) for AKT-mutant/indication-specific uses.

ALL of the following

Indication and biomarker consistent with FDA approval or compendia-supported use (document AKT pathway alteration if required).
Used in combination or as monotherapy per the FDA‑approved regimen for the specific tumor type (documentation of combination partner drug required if applicable).
Patient meets age and prior-therapy requirements per the agent label; prior endocrine or systemic therapies documented when relevant (e.g., HR+/HER2‑ breast cancer combinations).

Quizartinib (Vanflyta) Indications

Coverage criteria for Quizartinib (Vanflyta) for FLT3‑ITD mutant acute myeloid leukemia (AML).

ALL of the following

Diagnosis of acute myeloid leukemia (AML).
Documented FLT3‑ITD mutation as detected by an FDA‑approved or validated test (documentation required).
Used in populations and lines of therapy consistent with FDA approval or compendia guidance; prior therapy history documented.

Pacritinib (Vonjo) Indications

Coverage criteria for Pacritinib (Vonjo) for myelofibrosis.

ALL of the following

Diagnosis of myelofibrosis (primary, post–polycythemia vera, or post–essential thrombocythemia).
Indication aligns with FDA approval (e.g., thrombocytopenic myelofibrosis) with documented platelet counts and prior therapy history as required by label.

Vorasidenib (Voranigo) Indications

Coverage criteria for Vorasidenib (Voranigo) for IDH‑mutant glioma.

ALL of the following

Diagnosis of a non‑enhancing, IDH1‑ or IDH2‑mutant low‑grade glioma for which vorasidenib is indicated per FDA approval or trial-based label (document mutation status).
Patient meets age and prior-therapy criteria per the approved indication; imaging and neurologic status documented as required.

Crizotinib (Xalkori) Indications

Coverage criteria for Crizotinib (Xalkori) for ALK/ROS1/MET-altered cancers per label.

ALL of the following

Diagnosis consistent with an FDA‑approved indication for crizotinib (e.g., ALK‑positive or ROS1‑positive metastatic NSCLC).
Presence of the relevant genetic alteration (ALK, ROS1, or other biomarker indicated) confirmed by an FDA‑approved or validated test (documentation required).
Used according to FDA‑approved dosing and prior‑therapy requirements per label.

Gilteritinib (Xospata) Indications

Coverage criteria for Gilteritinib (Xospata) for FLT3‑mutated AML.

ALL of the following

Diagnosis of relapsed or refractory acute myeloid leukemia (AML).
Documented FLT3 mutation (FLT3‑ITD or TKD as applicable) by an FDA‑approved or validated test (documentation required).
Used per FDA‑approved indication and dosing; prior therapy history documented.

Vemurafenib (Zelboraf) Indications

Coverage criteria for Vemurafenib (Zelboraf) for BRAF‑V600 mutation‑positive cancers.

ALL of the following

Diagnosis consistent with an FDA‑approved indication for vemurafenib (e.g., unresectable or metastatic melanoma with BRAF V600 mutation, or other approved indications).
BRAF V600 mutation confirmed by an FDA‑approved or validated test (documentation required).
When used in combination regimens, documentation of combination partner and indication (e.g., with cobimetinib) is required.

Idelalisib (Zydelig) Indications

Coverage criteria for Idelalisib (Zydelig) for B‑cell malignancies.

ALL of the following

Diagnosis consistent with an FDA‑approved indication for idelalisib (e.g., relapsed CLL in combination with rituximab, follicular lymphoma, small lymphocytic lymphoma) with documentation of prior therapies as required by the indication.
Patient age and comorbidity profile evaluated; monitor for labeled safety risks and document rationale if use is appropriate given risks.

Ceritinib (Zykadia) Indications

Coverage criteria for Ceritinib (Zykadia) for ALK‑positive NSCLC.

ALL of the following

Diagnosis of metastatic non‑small cell lung cancer (NSCLC) that is ALK‑positive as detected by an FDA‑approved or validated test (documentation required).
Used per FDA‑approved dosing and sequence (e.g., first‑ or subsequent‑line) consistent with the label; prior therapy history documented.

Documentation Required

Documentation of mutation / biomarker required

Documentation of a tumor-specific molecular alteration is required when the indication or label specifies a biomarker. The provider must document results from an FDA-approved test (or an equivalent validated test) demonstrating the presence of the actionable genetic alteration or biomarker listed for the requested therapy.

Required biomarkers (where applicable): ALK, ROS1, EGFR, BRAF, FGFR2, KRAS G12C, IDH1/2, PIK3CA, RET, NTRK, MET exon 14, FLT3.
Document the test name, testing laboratory, date of test, and the result showing the specific mutation or fusion.
If the requested agent is indicated for a biomarker-subset (e.g., ALK-positive NSCLC), include the FDA-approved test or equivalent used to determine biomarker status.

Documentation Required

Prior treatment history required

Prior treatment history must be documented to support that the requested agent is appropriate for the member. Provide details on prior therapies, lines of therapy, responses, and clinical rationale why alternatives are not appropriate when applicable.

List prior systemic therapies (drug name, dose, dates of therapy) and responses (progression, intolerance, adverse events).
Specify lines of therapy (e.g., first-line, second-line) and dates.
State the clinical reason why formulary alternatives or standard treatments are not appropriate for this patient (e.g., resistance mutation, intolerance, contraindication).

Billing Rule

Specialty pharmacy network fill requirement

Certain agents must be dispensed through the BCBSMA specialty pharmacy network for commercial members. Claims submitted outside the required specialty network may be denied unless an approved exception applies.

Commercial members: specialty pharmacy network fill requirement applies for specified drugs covered under pharmacy benefit.
Medex/Medicare plans: check member-specific benefit design — some Medicare or Medex products may be excluded from the specialty network requirement or follow different dispensing rules.
If a network dispensing requirement creates a barrier, providers may request an exception through the Individual Consideration pathway with supporting documentation.

Documentation Required

Use of prescription claims to establish prior use

BCBSMA may use prescription claims to establish prior use of formulary alternatives or to confirm whether step-therapy criteria have been met. If claims data are insufficient to determine prior use or medical necessity, the provider will be asked to supply supplemental documentation.

Claims may be used to verify prior fills, dates, and adherence to formulary alternatives.
When claims fail to establish required prior use, provide medical records or provider attestation documenting prior therapy and reason for discontinuation.
Supplemental provider information requested may include medication administration records, pharmacy records, or clinic notes.

Note

Exception (individual consideration) request

If the request does not meet clinical criteria in this policy, providers may submit an Individual Consideration (exception) request for the atypical patient. The request should include sufficient clinical documentation to support medical necessity.

Include pertinent clinical notes, relevant diagnostic test results, and rationale for why the patient is atypical or why standard criteria are not appropriate.
Provide documentation of prior therapies, treatment dates, and responses or adverse events when applicable.
Attach supporting literature, FDA labeling, or compendia references that support the requested use when available.

Prior Authorization

MA Standard Prior Authorization Form

Providers must use the Massachusetts Standard Prior Authorization Form (eForm) when applicable for PA requests. The eForm is available via the BCBSMA provider website and can be used in place of the paper formulary exception/prior authorization form.

Use the MA Standard eForm (Massachusetts eForm) to submit PA requests when applicable.
The eForm submission route is accepted in lieu of the paper prior authorization/formulary exception form.
For assistance locating or completing the eForm, contact BCBSMA Pharmacy Operations at 1-800-366-7778.