PA required for all FDA‑approved indications; Plan Year coverage

Prior authorization is required for all FDA‑approved indications; when approved coverage is granted for the Plan Year.

Prior authorization submission must include diagnosis and prerequisite therapy

Submit a prior authorization request for the specialty medication named and include the supporting diagnosis and any required prerequisite therapy documentation listed in the policy.

Coverage duration when authorized: Plan Year

When prior authorization is approved, coverage duration for many listed agents is the Plan Year.

ALUNBRIG — prerequisite therapy required

Prior authorization for ALUNBRIG requires documentation showing the required prerequisite therapy (see the medication’s required medical information section).

PA requires documented prerequisite therapy/failure

Prior authorization is required and approval is contingent on documented prerequisite therapy or documented failure/intolerance/contraindication to required prior agents.

PA applies to all FDA‑approved indications

PA applies to all FDA‑approved indications for the listed medications; requests must match an FDA‑approved indication in the policy.

Initial coverage often 6 months; Alunbrig reauth Plan Year

Initial authorizations are commonly for 6 months with reauthorization intervals as specified (Alunbrig reauthorization noted as Plan Year).

PA indicator: All FDA‑Approved Indications for Aqneursa and Arcalyst

PA indicator for Aqneursa and Arcalyst is 'All FDA‑Approved Indications' — prior authorization must be requested for those agents.

PA required for FDA‑approved indications (indicator = 1)

Prior authorization is required for FDA‑approved indications (PA Indication Indicator = 1).

PA must show documented failure/intolerance/contraindication to required prior therapy

PA requests for agents with prerequisite therapy requirements must include documentation of failure, intolerance, or contraindication to the prior agents noted in the policy.

AVMAPKI FAKZYNJA — prior authorization required

AVMAPKI FAKZYNJA requires prior authorization for all FDA‑approved indications.

AYVAKIT — PA and Mekinist prerequisite documentation

AYVAKIT requires prior authorization for all FDA‑approved indications and documentation that the patient was treated with Mekinist or a medical rationale why Mekinist is inappropriate.

PA required and must align with FDA‑approved indication

Prior authorization is required for the listed agents and applies to all FDA‑approved indications; ensure the request aligns with the FDA‑approved use in the policy.

Authorized coverage duration: Plan Year

When authorized, coverage duration is often listed as 'Plan Year' in the policy.

BANZEL — PA and prerequisite therapy required

Prior authorization is required for BANZEL (rufinamide); prerequisite therapy is required as noted in the BANZEL entry.

BENLYSTA — PA applies to listed formulations

Prior authorization applies to listed BENLYSTA formulations identified in the policy.

BALVERSA listed — no additional criteria in this segment

BALVERSA appears in the medication list but this segment provides no additional criteria or prerequisites; include BALVERSA in PA submissions per the general PA instruction.

Banzel — documentation of diagnosis, active disease, prior therapies required for PA

Prior authorization for BANZEL requires documentation of the diagnosis (lupus nephritis or SLE), evidence of current active disease, prior treatments as specified, and plan to continue concomitant standard therapy.

Besremi — PA requires diagnosis and hydroxyurea failure/intolerance documentation

Prior authorization requests must include the required medical information for Besremi: diagnosis of polycythemia vera and documentation of inadequate response or intolerance to hydroxyurea.

PA requests must include medication‑specific required information

PA applies for all listed medications for FDA‑approved indications; include the medication‑specific required medical information and prerequisite therapy evidence when applicable.

Include evidence of prerequisite therapy when required

Where the policy indicates 'Prerequisite therapy required: YES', include evidence of the prior therapies tried (or documented contraindication/intolerance) in the PA submission.

CABLIVI — PA required; coverage duration 3 months

Prior authorization for CABLIVI requires submission for an FDA‑approved indication; coverage duration for CABLIVI is specified as 3 months.

PA required for listed drugs — document per required medical information

PA is required and set to cover all FDA‑approved indications for the listed medications; ensure supporting documentation aligns with the listed required medical information.

Caprelsa — PA must match FDA indication and include diagnostic documentation

Caprelsa is designated for all FDA‑approved indications; prior authorization must reflect an FDA‑approved use and include the required diagnostic documentation for medullary thyroid cancer.

Calquence — prerequisite therapy and prior treatment documentation required

Calquence requires evidence of prerequisite therapy before approval; include prior therapy history or transplant eligibility and planned combination therapy when applicable.

Verify if prerequisite therapy is N/A for the specific drug

Some medications have no prerequisite (step) therapy required; verify the policy entry for the specific drug (the policy lists 'N/A' where applicable).

Step therapy (Lynparza) required for BRCA‑mutated mCRPC

For BRCA‑mutated mCRPC, documentation must show contraindication/intolerance/failure of Lynparza before coverage unless an exception is documented.

ALUNBRIG — step therapy: Alecensa failure/intolerance/contraindication required

ALUNBRIG requires prior authorization and step therapy: the patient must have failed, be intolerant to, or have a contraindication to Alecensa prior to approval.

Document prior trials on specified agents per policy step requirements

Policy entries that indicate step or prerequisite therapy require documentation of prior trials on the specified agents and, when listed, trials of biologic PCSK9 inhibitors or statins as detailed.

Aqneursa — miglustat 3‑month trial required before PA

Aqneursa and Arcalyst require prerequisite therapy (YES). For Aqneursa, include documentation of at least a 3‑month trial and failure of miglustat.

Adbry — document failure of two prior therapies

Adbry requires failure of two prior therapies (examples listed). Include prior therapy history showing attempts with at least two of the listed agents/modalities.

Adbry — BSA threshold and reauthorization dosing requirement

For atopic dermatitis (Adbry) initial approval, document >=10% BSA involvement and failure of two listed therapies; for reauthorization include trials of every-4-week dosing for patients <100 kg who achieved clear or almost clear skin.

AYVAKIT — Mekinist prior treatment or documented rationale required

AYVAKIT requires prior treatment with Mekinist or a documented medical rationale explaining why Mekinist is inappropriate; absence of this documentation may lead to denial.

Prerequisite therapy flagged YES — include supporting documentation

Where the policy states 'Prerequisite therapy required: YES', ensure required prior therapies are documented in the PA request (policy details per drug).

BANZEL — prior AED trial required

BANZEL enforces step therapy — document that the patient has inadequate seizure control despite treatment with at least one anti‑epileptic drug.

BENLYSTA — document prior use of ≥2 therapy classes and plan to continue concomitant therapy

BENLYSTA requires prior treatments with at least two medication classes (corticosteroids, antimalarials, immunosuppressives) and continuation of concomitant standard treatment with at least one class; include records of prior use.

Include specific prior therapy details when 'YES' indicated

For agents with prerequisite therapy required (YES), include the specific prior therapies tried as described under each medication’s required medical information.

Bosulif — prior imatinib failure/intolerance documentation required

Bosulif requires prior failure or intolerance to imatinib for CML in chronic/accelerated/blast phases when applicable; document prior TKI history.

CABLIVI — no prerequisite therapy; document inpatient start with plasma exchange

CABLIVI has no prerequisite therapy requirement (listed as N/A); verify inpatient start with plasma exchange documentation per required medical information.

Cabometyx — include indication‑specific prior therapy documentation

Cabometyx prerequisite therapies vary by indication (e.g., prior sorafenib for HCC; prior VEGFR therapy for DTC); include prior therapy history specific to the requested indication.

Calquence — step therapy and prior treatment/transplant eligibility documentation required

Calquence is listed as requiring prerequisite therapy (YES); prior authorization must include prior treatment history or documentation of transplant ineligibility and planned combination use when applicable.

Actimmune — required diagnosis documentation

Documentation must include the diagnosis of chronic granulomatous disease or severe malignant osteopetrosis when requesting Actimmune.

Include diagnosis and medication‑specific required medical information

Provide the documented diagnosis and the specific required medical information for the requested agent (examples include ALK‑positive NSCLC documentation for Alecensa/Alunbrig and BRCA mutation documentation for Lynparza‑related indications).

Actimmune (ALS) — include revised El Escorial diagnostic documentation

For Actimmune (ALS indication) include documentation that ALS is diagnosed per the revised El Escorial criteria.

ALUNBRIG — document ALK‑positive NSCLC and Alecensa failure/intolerance/contraindication

ALUNBRIG PA must include documentation that metastatic NSCLC is ALK‑positive and that the patient failed, is intolerant to, or has a contraindication to Alecensa.

Document prior trials with dates and reasons; include labs/mutation testing as required

When prior trials on specific agents are required by the policy, provide documentation of each prior trial (agent name, dates, and reason for discontinuation) and any lab or diagnostic evidence requested (e.g., LDL values, mutation testing).

Aqneursa — include miglustat trial, genetic/testing, neurologic status, SARA/HPT‑D, weight, and neurologist prescriber

For Aqneursa include documentation of a ≥3‑month trial and failure of miglustat, genetic confirmation (NPC1/NPC2 per policy) or supporting testing, neurologic symptom documentation, weight, SARA and functional test results, and prescriber specialty (Neurologist).

Provide documentation supporting the specific listed diagnosis for the requested agent

Documentation must support one of the listed diagnoses for the requested agent (examples include cryopyrin‑associated periodic syndrome, recurrent pericarditis, DIRA, or moderate‑to‑severe atopic dermatitis with ≥10% BSA for Adbry).

Document contraindication/intolerance/failure of specified prior therapies when required

Include diagnosis and evidence of contraindication/intolerance/failure of specified prior therapies when the policy requires it (e.g., Rozlytrek, Lynparza examples).

AVMAPKI FAKZYNJA — diagnosis, prior platinum therapy, ECOG 0–1, and reauth RECIST documentation

AVMAPKI FAKZYNJA PA must include diagnosis of recurrent KRAS‑mutated low‑grade serous ovarian cancer, prior platinum‑based therapy, ECOG 0–1, and for reauthorization documentation showing no RECIST v1.1 progression.

AYVAKIT — document Mekinist treatment or rationale for not using Mekinist

For AYVAKIT include documentation that the patient was treated with Mekinist or a documented medical rationale explaining why Mekinist is inappropriate.

Document specific Mekinist‑related diagnoses when applicable

Provide the specific diagnosis documentation for Mekinist‑related indications (e.g., unresectable/metastatic GIST with PDGFRA exon 18 D842V, advanced systemic mastocytosis subtypes) when requesting Mekinist‑related approvals.

BANZEL — document inadequate seizure control despite ≥1 AED

BANZEL PA must include evidence that the patient has inadequate seizure control despite treatment with at least one anti‑epileptic drug.

BENLYSTA — diagnosis, active disease, prior ≥2 therapy classes, and plan to continue concomitant therapy

BENLYSTA PA must include diagnosis of lupus nephritis or SLE, evidence of current active disease, records of prior treatment with at least two of corticosteroids/antimalarials/immunosuppressives, and plan to continue concomitant therapy.

BANZEL — approved coverage duration: Plan Year

If BANZEL is approved, coverage duration is for the Plan Year; include this context when planning reauthorization documentation.

Missing prerequisite therapy or diagnosis evidence may cause denial

When prior therapy or diagnosis documentation is missing (e.g., required prior therapies, diagnostic tests, or mutation testing), the request may be denied—confirm all required fields from the medication’s required medical information are present.

Bosulif — document Ph+ status and imatinib failure/intolerance when required

Provide documentation of Philadelphia chromosome‑positive disease and prior failure/intolerance to imatinib for Bosulif when applicable; absence of this evidence may lead to denial.

Braftovi/Mektovi — document BRAF mutation status and planned combination therapy

For Braftovi/Mektovi include documentation of BRAF V600E or V600K mutation‑positive status and the intended combination therapy plan (encorafenib/binimetinib or cetuximab combinations); missing mutation testing or combination plan may trigger denial.

CABLIVI — document aTTP diagnosis and inpatient initiation with plasma exchange

Include required documentation of diagnosis and treatment context for CABLIVI (diagnosis of aTTP and inpatient start with plasma exchange); missing these items may cause denial.

Cabometyx — include indication‑specific prior therapy documentation

Ensure required medical information and prior therapies are present for Cabometyx indications (e.g., prior sorafenib for HCC; prior VEGFR therapy for DTC); lack of these details may trigger denial.

Calquence — include prior therapy/transplant eligibility and planned combination therapy

For Calquence, include documentation of prior therapy status or transplant eligibility and planned combination therapy when applicable; failure to document prerequisite therapy may lead to denial.

Caprelsa — document unresectable locally advanced or metastatic medullary thyroid cancer

Caprelsa requests must include documentation of symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic; absence of this diagnosis documentation may lead to denial.

Exclusion: hypersensitivity to Actimmune or E. coli‑derived products

Presence of hypersensitivity to Actimmune or E. coli‑derived products is an exclusion that may trigger denial; screen and document absence of hypersensitivity when requesting Actimmune.

Denial risk: missing prerequisite therapy, intolerance, or contraindication documentation

If the policy requires prerequisite therapy (e.g., Lynparza, Mekinist, Alecensa), lack of documentation of prior therapy, intolerance, or contraindication may result in denial; include clear records of prior treatment attempts.

ALUNBRIG — denial risk if Alecensa failure/intolerance/contraindication not documented

For ALUNBRIG specifically, absence of documentation that the patient failed, is intolerant to, or has a contraindication to Alecensa may trigger denial.

Actimmune (ALS) — denial risk without revised El Escorial diagnostic documentation

For Actimmune (ALS), absence of diagnostic documentation per the revised El Escorial criteria may result in denial for the ALS indication.

Denial risk: excluded health conditions (hepatic disease, alcohol abuse)

Document any excluded health conditions listed for the medication (e.g., history of significant hepatic disease or alcohol abuse) because their presence may trigger denial.

Combination therapy exclusions (Miplyffa, TNF‑inhibitors)

Combination therapy exclusions: use in combination with Miplyffa (for Aqneursa) or with a TNF‑inhibitor (for Arcalyst) are explicit exclusions—document that excluded combinations are not being used.

Combination biologic exclusion — document absence of excluded biologics

Where the policy excludes combination use with another biologic (examples listed), document that the patient is not receiving those excluded biologics to avoid denial.

Adbry — denial triggers: <10% BSA or missing two prior therapy failures

Adbry denial triggers include not meeting the ≥10% BSA threshold or missing documentation of failure of two listed prior therapies; include BSA measurement and prior therapy records.

Reauthorization requires documentation of no RECIST v1.1 progression

For reauthorization of certain oncology agents, provide documentation demonstrating the patient does not have disease progression per RECIST v1.1 (≥20% increase in sum of diameters); lack of this data may lead to denial.

AYVAKIT — denial risk if Mekinist prior treatment or rationale missing

AYVAKIT prior treatment with Mekinist (or documented rationale why Mekinist is inappropriate) is required — omission of this information may result in denial.

Balversa — denial risk if FGFR3 alteration or prior systemic therapy progression not documented

Balversa denial triggers include absence of documented FGFR3 genetic alteration or lack of progression on/after at least one line of prior systemic therapy; include genetic testing and prior therapy history.

BANZEL — denial risk for missing AED trial documentation

BANZEL denial risk: failing to document inadequate seizure control despite treatment with at least one anti‑epileptic drug may trigger denial.

BENLYSTA — denial risk if prior ≥2 therapy classes not documented

BENLYSTA denial risk: failure to document prior use of at least two of corticosteroids, antimalarials, or immunosuppressives may result in denial.

Denial risk: insufficient prior therapy or diagnosis documentation

Insufficient prerequisite therapy or diagnosis documentation (e.g., missing diagnosis of lupus nephritis or SLE for Banzel, or missing prior hydroxyurea failure for Besremi) may result in denial.

Denial risk: missing diagnostic or prior therapy evidence (Ph+ CML, imatinib)

Missing diagnostic evidence (e.g., Ph+ CML status) or missing prior therapy evidence (e.g., imatinib failure) may trigger denial — include laboratory/pathology reports and prior treatment notes.

Braftovi/Mektovi — denial risk if mutation testing or combination plan missing

Absence of required molecular testing (BRAF V600E/V600K) or a documented plan for the required combination therapy may result in denial for Braftovi/Mektovi requests.

Denial risk: missing required diagnosis or treatment context (e.g., CABLIVI aTTP inpatient start)

Requests lacking the required diagnosis or treatment context (e.g., aTTP start inpatient with plasma exchange for CABLIVI) may be denied; include setting and treatment details.

Denial risk: missing required medical information or prior therapy (e.g., Cabometyx)

When required medical information or prior therapies are absent (e.g., prior sorafenib for HCC or prior VEGFR therapy for DTC), the PA request may be denied.

Calquence — denial risk if prior treatment/transplant eligibility not documented

For Calquence, failure to document prior treatment status (previously treated or transplant‑ineligible with planned combination) may result in denial.

Calquence — prerequisite therapy must be documented

Calquence requires prerequisite therapy; failure to document required prior therapies will risk denial of the PA request.

Caprelsa — required diagnostic documentation

Caprelsa requests must include the specified diagnostic documentation for symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic; omission may lead to denial.