CurrentSelectHealthPolicy N/A

Coverage criteria for selected specialty medications (partial extract)

Coverage criteria and administrative requirements for multiple specialty medications including Actimmune and Akeega; defines prior authorization, documentation, step-therapy and continuation rules affecting prescribers and payers.

Policy Summary

PayerSelectHealth

PolicyCoverage criteria for selected specialty medications (partial extract)

Policy CodePolicy N/A

Change TypeMinor/none

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide required documentation (diagnosis, prior therapy history, and laboratory confirmation) for the requested specialty medication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2medications listed in this extract

Plan Yearcoverage duration (common)

Two levelstestosterone lab requirement

6 monthsinitial duration example

Coverage Criteria (Initial & Continuation)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Actimmune — Initial/General Coverage

Covered when ALL of the following are met

Actimmune criteria: 1) Indication corresponds to an FDA‑approved indication; 2) Diagnosis of chronic granulomatous disease OR severe malignant osteopetrosis; 3) No hypersensitivity to Actimmune or E. coli‑derived products; 4) Coverage duration: Plan Year.

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

Akeega — Initial/General Coverage

Covered when ALL of the following are met

Akeega criteria: 1) Indication corresponds to an FDA‑approved indication; 2) Diagnosis of deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC); 3) Contraindication, intolerance, or documented failure of Lynparza; 4) Coverage duration: Plan Year.

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

Alecensa — Initial Therapy

Covered when ALL of the following are met

Alecensa - Initial: 1) Indication corresponds to an FDA‑approved indication; 2) Documented diagnosis of non–small cell lung cancer that is ALK‑positive (tumors test ALK‑positive); 3) Coverage duration: Plan Year.

PA indicator = All FDA‑Approved Indications.

Radicava ORS — Initial Therapy

Covered when ALL of the following are met

Radicava ORS - Initial: 1) Indication corresponds to an FDA‑approved indication; 2) Documented diagnosis of amyotrophic lateral sclerosis (ALS) as defined by the revised El Escorial criteria; 3) Coverage duration: Plan Year.

PA indicator = All FDA‑Approved Indications.

ALUNBRIG (brigatinib) Initial Therapy

Covered when ALL of the following are met

ALUNBRIG coverage criteria: 1) Diagnosis of metastatic non‑small cell lung cancer (NSCLC); 2) Tumors are ALK‑positive; 3) Patient has failed, is intolerant to, or has a contraindication to Alecensa.

Prior failure/intolerance/contraindication to Alecensa required; PA indicator = All FDA‑Approved Indications.

Topical Testosterone Initial Therapy

Covered when ALL of the following are met

Topical testosterone coverage criteria: 1) Two separate serum testosterone levels drawn on different dates with values below 300 ng/dL; 2) Patient has at least ONE qualifying symptom: malaise, fatigue, lethargy, muscle loss, depression, or decreased libido.serum testosterone < 300 ng/dL

Two measurements required; PA indicator = All FDA‑Approved Indications.

Testosterone laboratory and symptom criteria

Covered when ALL of the following are met

Testosterone confirmation and symptoms: Two separate serum testosterone levels on different dates with serum testosterone < 300 ng/dL AND documentation of at least ONE symptom: malaise, fatigue, lethargy, muscle loss, depression, or decreased libido.serum testosterone < 300 ng/dL

Failure to provide two measurements or levels ≥300 ng/dL may result in denial.

Prior trial requirements for listed psychiatric indications

Covered when ALL of the following are met

Prior antipsychotic trials: History of trials on one or more of the following antipsychotics: aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, or ziprasidone; for Major Depressive Disorder (MDD) or schizophrenia, a previous trial on Rexulti is required.

Document prior medication trials as required.

LDL indication (familial/severe hypercholesterolemia)

Covered when ALL of the following are met

LDL and triglyceride labs: 1) Untreated, fasting LDL cholesterol > 500 mg/dL AND triglycerides < 300 mg/dL; 2) Patient meets genetic/family/xanthoma criteria (mutations in both alleles of LDL receptor genes OR both parents with untreated total cholesterol >250 mg/dL AND xanthomas before age 10); 3) Failed or currently taking at least ONE high‑intensity statin (atorvastatin, rosuvastatin, or simvastatin) or has documented statin intolerance; 4) Prior trial of Repatha OR Praluent.LDL > 500 mg/dL; TG < 300 mg/dL

Initial coverage duration: 6 months; reauthorization: Plan Year.

Niemann-Pick disease type C initial therapy

Covered when ALL of the following are met

NPC initial criteria: 1) Patient has tried and failed at least 3 months of miglustat therapy with lack of improvement; 2) Patient weight ≥ 15 kg; 3) Genetic confirmation by DNA sequence analysis (mutations in both alleles of NPC1 or NPC2) OR one‑allele mutation plus positive filipin staining or cholestane triol >2x ULN; 4) At least one neurologic symptom of NPC; 5) Patient ambulatory (independently or with assistance); 6) Functional test: either SARA gait subtest score within 2–7 OR 9‑Hole Peg Test (dominant hand) time between ≥20 and ≤150 seconds.weight >= 15 kg; cholestane triol > 2x ULN; HPT‑D 20–150 sec; SARA gait 2–7

Prescriber restriction: Neurologist; initial coverage duration: 6 months.

NPC reauthorization

Reauthorization covered when

NPC reauthorization: SARA score has remained stable or improved since initiation of therapy.

Used as the primary reauthorization assessment (coverage duration per policy).

Arcalyst — Covered with criteria

Covered when ALL of the following are met:

Arcalyst - Indication: Patient has a diagnosis of cryopyrin‑associated periodic syndrome OR recurrent pericarditis OR deficiency of Interleukin‑1 Receptor Antagonist (DIRA).

PA indicator = All FDA‑Approved Indications.

Arcalyst - Exclusion: Not to be used in combination with a TNF‑inhibitor.

Explicit exclusion listed in policy.

Arcalyst - Coverage Duration: Coverage authorized for the Plan Year.

Adbry / Cibinqo — Covered with criteria

Covered when ALL of the following are met:

Adbry/Cibinqo - Indication: Diagnosis of moderate to severe atopic dermatitis with ≥10% body surface area involvement.BSA >= 10%

PA indicator = All FDA‑Approved Indications.

Adbry/Cibinqo - Prior therapy: Failure of two of the following: topical corticosteroid; topical calcineurin inhibitor (eg tacrolimus 0.1%); phototherapy; oral immunomodulator (azathioprine, cyclosporine, mycophenolate); topical PDE‑4 (Eucrisa).failure of 2 listed therapies

Document prior therapy trials as required.

Adbry - Reauthorization: For reauthorization in patients <100 kg who achieved clear or almost clear skin, an every‑4‑week dosing trial must have been used.every 4 weeks trial for patients <100 kg

Reauthorization requirement.

Adbry/Cibinqo - Coverage Duration: Coverage authorized for the Plan Year.

Initial Therapy — Augtyro

Covered when ALL of the following are met

Augtyro initial coverage: 1) Diagnosis of locally advanced or metastatic ROS1‑positive NSCLC OR NTRK gene fusion‑positive solid tumor; 2) Contraindication, intolerance, or documented failure of Rozlytrek; 3) Indication corresponds to FDA‑approved use.

Coverage duration: Plan Year; PA indicator = All FDA‑Approved Indications.

Initial Therapy — Austedo

Covered when ALL of the following are met

Austedo initial coverage: 1) Diagnosis of chorea associated with Huntington's disease OR diagnosis of tardive dyskinesia; 2) Indication corresponds to FDA‑approved use.

Coverage duration: Plan Year; PA indicator = All FDA‑Approved Indications.

Initial/reauthorization criteria (Avapritinib co-pack)

Covered when ALL of the following are met

Avapritinib co-pack initial criteria: 1) Diagnosis of recurrent KRAS‑mutated, recurrent low‑grade serous ovarian cancer; 2) Prior therapy including platinum‑based therapy; 3) ECOG performance status 0 or 1; 4) Patient has been treated with Mekinist OR documented medical rationale why Mekinist would be inappropriate; 5) For reauthorization, documentation showing no disease progression per RECIST v1.1 (≥20% increase defines progression).

Coverage duration for initial authorization: 6 months; PA indicator = All FDA‑Approved Indications.

Covered indications (Ayvakit)

Covered when ANY of the following diagnoses are documented (per provided text):

Ayvakit covered indications: Diagnosis of unresectable or metastatic GIST with PDGFRA exon 18 mutation including PDGFRA D842V OR Advanced Systemic Mastocytosis (ASM/SM‑AHN/MCL) OR Indolent Systemic Mastocytosis.

PA indicator = All FDA‑Approved Indications.

Initial Therapy - BALVERSA

Covered when ALL of the following are met

BALVERSA initial coverage: 1) Diagnosis of locally advanced or metastatic urothelial carcinoma; 2) Confirmed FGFR3 genetic alteration; 3) Progression on or after at least one line of prior systemic therapy; 4) Indication corresponds to FDA‑approved use.

Coverage duration: Plan Year; PA indicator = All FDA‑Approved Indications.

Initial Therapy - RUFINAMIDE

Covered when ALL of the following are met

RUFINAMIDE initial coverage: 1) Indication corresponds to FDA‑approved use; 2) Patient has inadequate seizure control despite treatment with at least ONE anti‑epileptic drug.at least 1 anti‑epileptic drug

Coverage duration: Plan Year; PA indicator = All FDA‑Approved Indications.

Seizure control prerequisite

Covered when ALL of the following are met

Seizure control prerequisite: Patient has inadequate seizure control despite treatment with at least ONE anti‑epileptic drug.at least 1 anti‑epileptic drug

Documentation of inadequate seizure control required for authorization.

BENLYSTA - Lupus nephritis / SLE criteria

Covered when ALL of the following are met

BENLYSTA - Diagnosis: Diagnosis of lupus nephritis OR systemic lupus erythematosus with current active disease.

PA indicator = All FDA‑Approved Indications.

BENLYSTA - Prior therapy: Patient has previous treatment with at least TWO of the following: corticosteroids, antimalarials, or immunosuppressives.>=2 agents

Document prior treatments.

BENLYSTA - Concomitant therapy: Patient will continue concomitant standard therapy with at least ONE of corticosteroids, antimalarials, or immunosuppressives.>=1 agent

Required per documentation guidance.

Polycythemia vera (initial)

Covered when ALL of the following are met

Polycythemia vera coverage: 1) Diagnosis of polycythemia vera; 2) Inadequate response or intolerance to hydroxyurea; 3) Initial coverage duration limited to 6 months.

Reauthorization per policy: Plan Year.

Philadelphia chromosome–positive chronic myeloid leukemia

Covered when ALL of the following are met

Ph+ CML coverage: 1) Documented diagnosis of Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML); 2) Specify disease phase (newly diagnosed chronic phase OR chronic/accelerated/blast phase); 3) For chronic‑phase patients when required, prior failure or intolerance to imatinib must be documented.

Coverage duration: Plan Year.

Braftovi combination therapy criteria

Covered when ALL of the following are met:

Braftovi - Diagnosis: Diagnosis of BRAF V600E or V600K mutation‑positive unresectable or metastatic melanoma OR BRAF V600E‑positive metastatic colorectal cancer OR BRAF V600E‑positive metastatic NSCLC.

Mutation must be documented by testing.

Braftovi - Combination therapy: Will be used as specified combination therapy: with binimetinib (Mektovi) for melanoma and NSCLC, or with cetuximab for metastatic colorectal cancer.

Planned combination must be specified in documentation.

Brukinsa coverage criteria

Covered when ALL of the following are met for the specified indication:

Brukinsa - Covered diagnoses: Diagnosis of mantle cell lymphoma (MCL) OR Waldenstrom macroglobulinemia OR relapsed/refractory follicular lymphoma (FL) OR chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) OR marginal zone lymphoma (MZL).

Specific prior therapy requirements apply to certain diagnoses.

Brukinsa - Prior therapy for MCL: Patient has received at least one prior therapy for mantle cell lymphoma.

Applies when treating MCL.

Brukinsa - Prior anti‑CD20 for MZL: Patient has been previously treated with an anti‑CD20–based regimen for marginal zone lymphoma.

Applies when treating MZL.

Brukinsa - Prior lines for FL with obinutuzumab: Patient has received two or more lines of therapy for follicular lymphoma and Brukinsa will be used in combination with obinutuzumab.

Applies to FL when used with obinutuzumab.

CABLIVI Initial and Reauthorization

Covered when ALL of the following are met

CABLIVI coverage criteria: 1) Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP); 2) Therapy was started inpatient in combination with plasma exchange; 3) Coverage duration limited to 3 months with a maximum of 58 days following the last day of plasma exchange for certain use periods; 4) Reauthorization requires evidence of persistent underlying disease (e.g., suppressed ADAMTS13) AND demonstrated positive clinical response (increase in platelet count, reduction in neurological symptoms, or improvement in organ‑damage markers).

Initial inpatient start in combination with plasma exchange required; PA indicator applies.

CABOMETYX Indication Criteria

Covered when ALL of the following per indication are met

CABOMETYX - HCC: Diagnosis of hepatocellular carcinoma with prior use of sorafenib as required.

PA indicator = All FDA‑Approved Indications.

CABOMETYX - Advanced RCC: Diagnosis of advanced renal cell carcinoma.

CABOMETYX - DTC: Diagnosis of locally advanced or metastatic differentiated thyroid cancer with progression following prior VEGFR‑targeted therapy and RAI‑refractory or ineligible status.

CABOMETYX - pNET: Previously treated, unresectable, locally advanced or metastatic well‑differentiated pancreatic neuroendocrine tumor with failure of everolimus or sunitinib.

CABOMETYX - epNET: Previously treated, unresectable, locally advanced or metastatic well‑differentiated extra‑pancreatic neuroendocrine tumor.

COVERAGE CRITERIA

Covered when ALL of the following are met

CALQUENCE initial coverage: 1) Member has diagnosis of mantle cell lymphoma; 2) Patient has been treated with at least one prior therapy; 3) PA indicator = All FDA‑Approved Indications; 4) Coverage duration = Plan Year.

Required medical information and prior therapy documentation necessary.

COVERAGE CRITERIA

Covered when ALL of the following are met

CAPRELSA initial coverage: 1) Member has diagnosis of symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic; 2) PA indicator = All FDA‑Approved Indications; 3) Coverage duration = Plan Year.

Required documentation of diagnosis per policy.

Medication-specific medical necessity

Covered when specified diagnosis/indication is provided and PA is obtained for FDA‑approved indications

Medullary thyroid cancer entry: Diagnosis of symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease.

PA indicated for all FDA‑approved indications for relevant agents.

Carglumic acid indication: Diagnosis of hyperammonemia due to N‑acetylglutamate synthase deficiency.

Document diagnosis per required medical information.

Sapropterin indication: Diagnosis of hyperphenylalaninemia due to BH4‑responsive phenylketonuria.

Document diagnosis per required medical information.

CHOLBAM entry: PA indicated for CHOLBAM for all FDA‑approved indications.

PA indicator = All FDA‑Approved Indications.

Coverage for Actimmune excludes members with documented hypersensitivity to Actimmune or to Escherichia coli–derived products.

No off‑label uses or specific exclusion criteria are listed in the referenced segments; these entries are documented as NIA (not applicable/not included) where applicable.

There are no explicit exclusion criteria provided in these chunks; the exclusion fields are marked NIA in the source.

A history of significant hepatic disease or documented alcohol abuse is listed as an exclusion and may preclude coverage.

Patients with significant hepatic disease or alcohol abuse are excluded from coverage; additionally, use of the medication in combination with Miplyffa is explicitly excluded.

Coverage excludes combination use with a TNF‑inhibitor; concurrent therapy with a TNF‑inhibitor is an explicit exclusion for Arcalyst.

Initial Authorization Requirements (by Drug)

Actimmune initial therapy

Covered when ALL of the following are met

Actimmune initial: FDA‑approved indication present AND diagnosis of chronic granulomatous disease OR severe malignant osteopetrosis AND no hypersensitivity to Actimmune or E. coli‑derived products.

Prior authorization required for all FDA‑approved indications; coverage duration: Plan Year.

Akeega initial therapy

Covered when ALL of the following are met

Akeega initial: FDA‑approved indication present AND diagnosis of deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC) AND contraindication, intolerance, or failure of Lynparza documented.

Prior authorization required for all FDA‑approved indications; coverage duration: Plan Year.

Alecensa Initial

Covered when ALL of the following are met

Alecensa initial: FDA‑approved indication present AND documented ALK‑positive NSCLC (tumors ALK‑positive).

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

Radicava ORS Initial

Covered when ALL of the following are met

Radicava ORS initial: FDA‑approved indication present AND documented diagnosis of ALS per the revised El Escorial criteria.

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

ALUNBRIG Initial Therapy

Covered when ALL of the following are met

ALUNBRIG initial: Metastatic ALK‑positive NSCLC AND documentation of prior failure, intolerance, or contraindication to Alecensa.

PA indicator = All FDA‑Approved Indications.

Topical Testosterone Initial Therapy

Covered when ALL of the following are met

Topical testosterone initial: Two separate serum testosterone levels <300 ng/dL on different dates AND at least one symptom (malaise, fatigue, lethargy, muscle loss, depression, decreased libido).testosterone < 300 ng/dL

Two measurements required; PA indicator = All FDA‑Approved Indications.

Initial prior medication requirements

Covered when ALL of the following are met

Initial prior medication requirements: Documentation of prior trials on listed antipsychotics (aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone); for MDD or schizophrenia, prior trial on Rexulti required.

Provide documentation of prior medication trials.

Initial therapy

Covered when ALL of the following are met

Initial therapy by indication: See LDL and NPC criteria sets: required labs, genetic testing, prior medication trials, functional measures, and other objective documentation as specified.

Initial coverage durations often 6 months; reauthorization per policy.

Adbry initial therapy criteria

Covered when ALL of the following are met

Adbry prior therapy requirements: Failure of two of the following prior treatments: topical corticosteroid; topical calcineurin inhibitor; phototherapy; oral immunomodulator (azathioprine, cyclosporine, mycophenolate); topical PDE‑4 (Eucrisa).failure of 2 therapies

Documentation required for prior therapy failures.

Augtyro initial therapy

Covered when ALL of the following are met

Augtyro initial therapy: Diagnosis of locally advanced or metastatic ROS1‑positive NSCLC OR NTRK fusion‑positive solid tumor AND contraindication, intolerance, or failure of Rozlytrek.

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

Austedo initial therapy

Covered when ALL of the following are met

Austedo initial therapy: Diagnosis of chorea associated with Huntington's disease OR diagnosis of tardive dyskinesia.

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

Initial therapy (Avapritinib co-pack)

Covered when ALL of the following are met

Avapritinib co‑pack initial: Diagnosis of recurrent KRAS‑mutated, recurrent low‑grade serous ovarian cancer; prior platinum‑based therapy; ECOG 0–1; prior Mekinist OR documented rationale why Mekinist is inappropriate; reauthorization requires no disease progression per RECIST v1.1 (≥20% increase).

Initial coverage duration: 6 months; PA indicator = All FDA‑Approved Indications.

BALVERSA

Covered when ALL of the following are met

BALVERSA initial: Diagnosis of locally advanced or metastatic urothelial carcinoma; confirmed FGFR3 genetic alteration; progression on or after at least one line of prior systemic therapy.

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

RUFINAMIDE

Covered when ALL of the following are met

RUFINAMIDE initial: Patient has inadequate seizure control despite treatment with at least one anti‑epileptic drug and the requested use corresponds to an FDA‑approved indication.at least 1 anti‑epileptic drug

Documentation required; PA indicator = All FDA‑Approved Indications.

BENLYSTA initial therapy criteria

Covered when ALL of the following are met

BENLYSTA initial criteria: Diagnosis of lupus nephritis or SLE with current active disease; prior treatment with at least TWO of corticosteroids, antimalarials, or immunosuppressives; plan to continue concomitant standard therapy with at least ONE of these agents.>=2 agents for prior therapy; >=1 agent for concomitant therapy

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

Initial therapy durations

Covered when ALL of the following are met

Initial therapy durations: Initial coverage durations vary by entry (examples: Polycythemia vera initial: 6 months; many oncology and specialty agents: Plan Year).

See each agent's criteria for specific duration.

BRAFTOVI initial therapy

Covered when ALL of the following are met

BRAFTOVI initial: Documented BRAF V600E or V600K mutation and planned use in the specified combination regimen (encorafenib with binimetinib or encorafenib with cetuximab) for the appropriate diagnosis.

PA indicator = All FDA‑Approved Indications.

BRUKINSA initial therapy

Covered when ALL of the following are met

BRUKINSA initial: Documented diagnosis per listed hematologic malignancies and required prior therapy history per indication (eg, ≥1 prior therapy for MCL; prior anti‑CD20 regimen for MZL; ≥2 prior lines for FL when combined with obinutuzumab).

PA indicator = All FDA‑Approved Indications.

CABLIVI initial therapy

Covered when ALL of the following are met

CABLIVI initial: Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) AND therapy initiated inpatient in combination with plasma exchange.

Coverage duration: 3 months; maximum 58 days following last plasma exchange for certain use periods.

CABOMETYX initial therapy

Covered when ALL of the following per indication are met

CABOMETYX initial per indication: Documentation of the specific oncologic diagnosis and prior therapy history as required per indication (eg, prior sorafenib for HCC; prior VEGFR therapy for DTC; failure of everolimus or sunitinib for pNET).

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

CALQUENCE initial therapy

Covered when ALL of the following are met

CALQUENCE initial therapy: Diagnosis of mantle cell lymphoma AND patient has been treated with at least one prior therapy.

PA indicator = All FDA‑Approved Indications; coverage duration: Plan Year.

Initial authorization

Covered when ALL of the following are met

PA requirement: Prior authorization is required for all FDA‑approved indications for the listed agents.

PA indicator = 1 (All FDA‑Approved Indications).

Reauthorization / Continuation Rules

Reauthorization

Reauthorization covered when

Continuation / reauthorization: Reauthorization rules apply as specified per agent (examples: initial approvals often 6 months with reauthorization by Plan Year or criteria‑based assessment).

See individual agent reauthorization nodes (eg, NPC SARA stability, Avapritinib RECIST criteria).

Reauthorization (Avapritinib co-pack)

Reauthorization covered when

Avapritinib reauthorization: Documentation showing patient does not have disease progression defined as ≥20% increase in the sum of diameters of target lesions per RECIST v1.1.>=20% increase per RECIST v1.1

Coverage duration for initial authorization: 6 months; reauthorization per criteria.

Continuation / Reauthorization

Reauthorization / continuation covered when

Continuation / Reauthorization: Reauthorization follows initial coverage durations; examples include polycythemia vera moving from initial 6‑month approval to reauthorization by Plan Year.

See specific agent entries for requirements.

CABLIVI continuation

Reauthorization covered when

CABLIVI reauthorization: Evidence of persistent underlying disease (eg, suppressed ADAMTS13) AND demonstrated clinical benefit (increase in platelet count, reduction in neurological symptoms, or improvement in organ‑damage markers).

Required for continued coverage beyond initial authorization window.

Coverage duration

Covered when ALL of the following are met

Coverage duration for many entries is specified as Plan Year for reauthorization/continuation unless otherwise noted.

Initial durations may differ (eg, 6 months) per agent.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Actimmune — Prior Authorization & Documentation

Prior authorization is required for Actimmune for all FDA‑approved indications. Documentation must include a diagnosis of chronic granulomatous disease or severe malignant osteopetrosis. Coverage is excluded for members with hypersensitivity to Actimmune or E. coli‑derived products.

PA applies to all FDA‑approved indications
Required documentation: diagnosis of chronic granulomatous disease or severe malignant osteopetrosis
Exclusion: hypersensitivity to Actimmune or E. coli‑derived products

Prior Authorization

Akeega — Prior Authorization, Required Diagnosis, and Step Therapy

Akeega requires prior authorization for all FDA‑approved indications. Approval requires documentation of deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer and evidence of contraindication, intolerance, or failure of Lynparza (step therapy).

PA applies to all FDA‑approved indications
Required documentation: diagnosis of deleterious or suspected deleterious BRCA‑mutated mCRPC
Step requirement: contraindication, intolerance, or failure of Lynparza

Documentation Required

Alecensa & ALUNBRIG — Diagnosis and Step Requirement

Alecensa (and ALK‑positive NSCLC entries) require documentation of an ALK‑positive NSCLC diagnosis (tumors must be ALK‑positive). ALUNBRIG requires prior failure, intolerance, or contraindication to Alecensa before approval.

Alecensa: document ALK‑positive NSCLC diagnosis (tumor ALK status)
ALUNBRIG: prior failure/intolerance/contraindication to Alecensa required

Documentation Required

Radicava ORS — Diagnostic Documentation Required

Radicava ORS prior authorization requires documentation of a diagnosis of amyotrophic lateral sclerosis (ALS) as defined by the revised El Escorial criteria. Lack of this documentation may trigger denial.

Required documentation: diagnosis of ALS per revised El Escorial criteria
Denial risk if diagnosis is not documented

Documentation Required

Testosterone Topical Products — Laboratory and Symptom Documentation

Testosterone topical products require two separate serum testosterone measurements drawn on different dates with levels < 300 ng/dL, plus documentation of at least one related symptom (e.g., malaise, fatigue, lethargy, muscle loss, depression, decreased libido). If labs or symptom documentation are missing or inconsistent (e.g., only one measurement or value ≥ 300 ng/dL), authorization may be denied.

Two separate serum testosterone levels on different dates, both < 300 ng/dL
Documentation of at least one symptom: malaise, fatigue, lethargy, muscle loss, depression, or decreased libido
Denial risk if only one measurement provided or levels are ≥ 300 ng/dL

Denial Risk

Exclusion Criteria & Combination‑Use Denials

Exclude coverage when specified exclusionary conditions are present (examples in source: significant hepatic disease or alcohol abuse). Also note other explicit exclusions such as combination use with specified agents (e.g., combination use with a TNF‑inhibitor for certain drugs, or use in combination with Miplyffa).

Common exclusions: significant hepatic disease, alcohol abuse
Drug‑specific combination exclusions: e.g., combination with Miplyffa or with TNF‑inhibitors where stated
Verify absence of exclusionary conditions to avoid denial

Documentation Required

Objective Measures, Genetic Testing, and Prior Therapy Documentation

For agents that require objective measures and prior therapy documentation, include laboratory results, genetic/mutation testing, prior medication trials, and disease‑specific objective assessments as listed. Failure to provide required objective measures or prior therapy history may result in denial.

Provide labs and objective measures where requested (e.g., LDL, triglycerides, SARA scores, ECOG status, RECIST progression data)
Provide molecular/genetic testing results when required (e.g., BRAF, FGFR3, ROS1, NTRK, PDGFRA, BRCA)
Document prior medication trials and reasons for discontinuation (failure/intolerance/contraindication)

Prior Authorization

Augtyro — Required Diagnosis and Step Therapy

Augtyro (entrectinib) requires documentation of locally advanced or metastatic ROS1‑positive NSCLC or NTRK gene fusion‑positive solid tumors and evidence of contraindication, intolerance, or failure of Rozlytrek (step requirement). Lack of this documentation may lead to denial.

Required diagnosis: ROS1‑positive NSCLC or NTRK fusion‑positive solid tumor
Step requirement: contraindication/intolerance/failure of Rozlytrek
Denial risk if diagnosis or prior therapy documentation is absent

Documentation Required

Austedo — Diagnosis Documentation Required

Austedo (including XR/titration packs) prior authorization requires documentation of diagnosis for the intended FDA‑approved use (e.g., chorea associated with Huntington's disease or tardive dyskinesia).

Required documentation: diagnosis of chorea associated with Huntington's disease or diagnosis of tardive dyskinesia
Coverage duration: Plan Year (where specified)

Documentation Required

Oncology & Rare‑Disease Agents — Diagnosis, Prior Therapy, and Reauthorization Documentation

For specialty oncology and rare disease agents, required medical information often includes diagnosis, prior lines of therapy, performance status, specific prior agents (e.g., Mekinist), and reauthorization criteria (e.g., no disease progression). Examples include Avapritinib co‑pack, Ayvakit, BALVERSA, and others — ensure all listed prior therapies and objective response documentation are submitted.

Avapritinib (co‑pack): recurrent KRAS‑mutated low‑grade serous ovarian cancer, prior platinum‑based therapy, ECOG 0–1, prior Mekinist or rationale if inappropriate; reauthorization requires no disease progression by RECIST v1.1
Ayvakit: diagnoses including unresectable/metastatic PDGFRA exon 18 mutation positive GIST (including D842V), AdvSM, Indolent systemic mastocytosis
BALVERSA: locally advanced/metastatic urothelial carcinoma with confirmed FGFR3 alteration and progression on/after at least one line of systemic therapy

Documentation Required

Rufinamide — Prior Therapy & Inadequate Seizure Control Documentation

Rufinamide requires documentation that the patient has inadequate seizure control despite treatment with at least one anti‑epileptic drug. Providers must document prior anti‑epileptic therapy and insufficient response; absence of this documentation may trigger denial.

Required documentation: history of at least one prior anti‑epileptic drug trial with inadequate seizure control
Denial risk if prior therapy or inadequate control is not documented

Documentation Required

Braftovi/Mektovi — Molecular Testing and Combination Therapy Documentation

Braftovi (encorafenib)/Mektovi combination use requires molecular testing confirming BRAF V600E or V600K mutation and documentation the agent will be used in the specified combination regimen. Lack of mutation testing or intended combination documentation may result in denial.

Provide molecular confirmation of BRAF V600E or V600K mutation
Document planned combination regimen (e.g., encorafenib + binimetinib or encorafenib + cetuximab)
Denial risk if mutation or combination intent is not documented

Documentation Required

Brukinsa — Diagnosis and Prior Therapy Requirements

Brukinsa requires documentation of the specific hematologic diagnosis (MCL, Waldenström macroglobulinemia, FL, CLL/SLL, MZL as applicable) and prior therapies per indication (e.g., at least one prior therapy for MCL; prior anti‑CD20 regimen for MZL; two or more prior lines for FL; prior therapies for other indications). Lack of required prior therapy documentation may lead to denial.

Required diagnosis and prior therapy documentation per labeled indication
Denial risk if prior therapies (type and number) are not documented

Documentation Required

CABLIVI — Initial and Reauthorization Documentation

CABLIVI initial authorization requires diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and that therapy was started inpatient in combination with plasma exchange. Reauthorization requires evidence of persistent underlying disease (e.g., suppressed ADAMTS13) and demonstrated positive clinical response.

Initial: document aTTP diagnosis and inpatient start with plasma exchange
Reauthorization: document suppressed ADAMTS13 and clinical response (platelet increase, symptom reduction, organ markers)
Coverage duration: 3 months

Documentation Required

CABOMETYX — Diagnosis and Prior Therapy Documentation

CABOMETYX requires documentation of the specific diagnosis (HCC, advanced RCC, differentiated thyroid cancer with progression after VEGFR‑targeted therapy and RAI‑refractory/ineligible status, or previously treated pNET/epNET) and prior therapy history where applicable (e.g., prior sorafenib for HCC; prior VEGFR‑targeted therapy for DTC; prior everolimus or sunitinib for pNET). Lack of required prior therapy or diagnosis documentation may trigger denial.

Document specific diagnosis and prior systemic therapies per indication (e.g., prior sorafenib for HCC)
Denial risk if prior therapy or indication‑specific criteria are not documented

Documentation Required

Polycythemia Vera — Required Documentation

Polycythemia vera authorization requires documentation of the diagnosis and evidence of inadequate response or intolerance to hydroxyurea.

Required documentation: diagnosis of polycythemia vera
Document inadequate response or intolerance to hydroxyurea

Documentation Required

Ph+ CML — Diagnosis and Prior Therapy Documentation

Philadelphia chromosome‑positive (Ph+) chronic myeloid leukemia (CML) entries require documentation of Ph+ CML and the disease phase. For chronic‑phase CML (and other phases), document prior failure or intolerance to imatinib when applicable.

Document Ph+ CML diagnosis and disease phase
For chronic‑phase (and other specified phases), provide prior failure/intolerance to imatinib where required

Note

No Additional Criteria Specified (NIA) — Operational Note

Where policies list 'Other Criteria: NIA' or state no additional step therapy requirements, note that no further criteria are specified; however providers must still supply all required diagnosis, lab, genetic, and prior therapy documentation listed elsewhere in the request.

NIA indicates no additional criteria specified in that segment
Still submit all required medical information and objective measures listed for the agent

Medication Codes, Thresholds, and Key Values

Medications listed - BENLYSTA formulationsNDC

BENLYSTA 200 MGIML SOLN A-INJ	BENLYSTA 200 MGIML SOLN A-INJ
BENLYSTA 200 MGIML SOLN PRSYR	BENLYSTA 200 MGIML SOLN PRSYR

Medications listed - BESREMINDC

BESREMI

Medications listedNDC|DrugName

CALQUENCE 100 MG TAB

Medications listedNDC|DrugName

CAPRELSA

Medications listedNDC

CARGLUMIC ACID	CARGLUMIC ACID
SAPROPTERIN DIHYDROCHLORIDE 100 MG TAB	SAPROPTERIN DIHYDROCHLORIDE 100 MG TAB

Medications listedNDC

CHOLBAM

inv-57: Serum testosterone level — < 300 ng/dL

Serum testosterone thresholdSerum testosterone < 300 ng/dL (two separate measurements on different dates required)

Required documentationTwo separate serum testosterone levels drawn on different dates with values below 300 ng/dL

Clinical symptoms requiredDocumentation of at least one symptom: malaise, fatigue, lethargy, muscle loss, depression, or decreased libido

inv-58: Serum testosterone level — < 300 ng/dL

Serum testosterone thresholdSerum testosterone < 300 ng/dL (two separate measurements on different dates required)

Measurement timingTwo separate testosterone levels must be drawn on different dates

Associated symptom requirementAt least one qualifying symptom documented (eg, decreased libido, fatigue)

inv-59: LDL threshold — > 500 mg/dL

LDL thresholdUntreated, fasting LDL cholesterol > 500 mg/dL

Triglycerides requirementTriglycerides < 300 mg/dL (must be fasting)

Supporting evidenceGenetic, family history, or xanthoma findings required per criteria (see required medical information)

inv-60: Triglycerides threshold — < 300 mg/dL

Triglycerides thresholdTriglycerides < 300 mg/dL (fasting)

ContextUsed with LDL > 500 mg/dL to define severe untreated hypercholesterolemia

Required labsProvide documented LDL and triglyceride labs as part of required medical information

inv-61: Weight threshold for NPC medication — >= 15 kg

Minimum weight>= 15 kg

ContextWeight requirement for initiation of Niemann-Pick disease type C medication after failed miglustat trial

DocumentationWeight must be documented in required medical information

inv-62: Cholestane triol threshold — > 2x upper limit of normal

Cholestane triol threshold> 2x upper limit of normal

Use in diagnosisElevated cholestane triol (>2x ULN) may substitute when only one NPC allele mutation is found (supportive confirmatory testing)

Testing methodReported as cholestane triol/oxysterols in required medical information

inv-63: 9-Hole Peg Test (dominant hand) — >= 20 and <= 150 seconds

9-Hole Peg Test range (dominant hand)>= 20 and <= 150 seconds

RoleAcceptable functional test for NPC eligibility (alternative to SARA gait subtest) for initial authorization

DocumentationHPT-D time must be recorded in required medical information

inv-64: Disease progression threshold — >= 20% increase in sum of diameters per RECIST v1.1

Disease progression definition>= 20% increase in the sum of diameters of target lesions per RECIST v1.1

Use caseRequired for reauthorization assessment to document disease progression absence/presence for certain oncology agents

Reference criterionSpecified as RECIST version 1.1 in required medical information

inv-65: Coverage Duration — Plan Year

Standard coverage durationPlan Year

Initial vs reauthorization examplesSome initial authorizations list 6 months (see specific entries); many continuations/reauthorizations are for the Plan Year

DocumentationCoverage duration stated in each medication's required information (Plan Year unless otherwise noted)

inv-66: Coverage duration — Plan Year

Coverage duration (general)Plan Year

Notable initial-duration exceptionsSome agents specify an initial 6-month authorization prior to Plan Year reauthorization (chunk 136, 186)

SourceCoverage duration fields are explicitly listed in medication entries' required information

Step Therapy / Prior Trial Tables

Step requirement	Details
Akeega requires prior trial or documented intolerance/contraindication to Lynparza
Required medical information: diagnosis of deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer and documentation of contraindication, intolerance, or failure of Lynparza

Step requirement	Details
ALUNBRIG requires prior failure/intolerance/contraindication to Alecensa
Required medical information: diagnosis of metastatic NSCLC with ALK‑positive tumor and documentation that the patient has failed, is intolerant to, or has a contraindication to Alecensa

Step requirement	Details
Prior trial on Rexulti required before coverage of the requested agent for applicable psychiatric indications
Required medical information: documentation of prior trials on listed antipsychotics and prior trial on Rexulti for MDD or schizophrenia where applicable (aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone)

Step requirement	Details
Prior medication trials required before coverage for the LDL/familial hypercholesterolemia indication
Required medical information: untreated fasting LDL >500 mg/dL and TG <300 mg/dL, genetic/family/xanthoma evidence as specified, prior trial or current use of at least one high‑intensity statin (atorvastatin, rosuvastatin, or simvastatin) or documented statin intolerance, and prior trial of Repatha or Praluent

Step requirement	Details
Prior failure of specified therapies required before coverage
For Adbry: failure of two of the following is required — topical corticosteroid; topical calcineurin inhibitor (eg tacrolimus 0.1%); phototherapy; oral immunomodulator (azathioprine, cyclosporine, or mycophenolate); topical PDE‑4 (Eucrisa). Documentation of diagnosis (moderate to severe atopic dermatitis, ≥10% BSA) is required.

Step requirement	Details
Must document prior intolerance/contraindication/failure of Rozlytrek before coverage
Required medical information: diagnosis of locally advanced or metastatic ROS1‑positive NSCLC or NTRK gene fusion‑positive solid tumor AND documentation of contraindication, intolerance, or failure of Rozlytrek

Step requirement	Details
Prior treatment with Mekinist or documented rationale why Mekinist is inappropriate is required
Required medical information: diagnosis (recurrent KRAS‑mutated, low‑grade serous ovarian cancer), prior platinum‑based therapy, ECOG 0–1, and documentation that patient has been treated with Mekinist or that a medical rationale explains why Mekinist would be inappropriate

Step requirement	Details
Prior systemic therapy required before BALVERSA
Required medical information: diagnosis of locally advanced or metastatic urothelial carcinoma, confirmed FGFR3 genetic alteration, and evidence of progression on or after at least one line of prior systemic therapy

Step requirement	Details
Must have failed or received previous treatment with ≥2 of the listed classes before BENLYSTA
Required medical information: diagnosis of lupus nephritis or SLE with current active disease; previous treatment with at least two of corticosteroids, antimalarials, or immunosuppressives; and plan to continue concomitant standard treatment with at least one of these agents

Step requirement	Details
Document prior failure or intolerance to imatinib for chronic‑phase CML patients before coverage
Required medical information: diagnosis of Philadelphia chromosome–positive CML and, for chronic‑phase patients when applicable, documentation of prior failure or intolerance to imatinib

Step requirement	Details
Documentation of prior therapies (as specified) required before coverage for certain Brukinsa indications
Required medical information: diagnosis (eg, MCL, Waldenstrom macroglobulinemia, FL, CLL/SLL, MZL) and documentation of prior therapies — at least one prior therapy for MCL; prior anti‑CD20–based regimen for MZL; two or more prior lines for FL when Brukinsa is used with obinutuzumab

Step requirement	Details
Prior use or failure of specified agents is required for certain CABOMETYX indications
Required medical information: documentation of the specific diagnosis per indication and prior therapy history as applicable (eg, prior sorafenib for HCC; prior VEGFR‑targeted therapy for DTC; prior everolimus or sunitinib failure for pNET)

Quantity Limits and Coverage Durations

inv-217: unspecified in chunks — coverage durations provided (Plan Year; 6 months)

Coverage durations presentPlan Year; 6 months

ContextPlan Year is standard; select entries list initial authorization of 6 months before reauthorization

Where foundCoverage Duration fields in multiple medication entries (examples: chunk 126 Plan Year; chunk 136 6 months)

Definitions and Terms

inv-157: Chronic granulomatous disease (CGD)

DefinitionChronic granulomatous disease (CGD)

ContextListed as an indication requiring documentation for Actimmune initial authorization

RequirementDiagnosis must be included in required medical information for coverage

inv-158: Indication terms — severe malignant osteopetrosis; BRCA‑mutated metastatic castration‑resistant prostate cancer

Indication terms (examples)Severe malignant osteopetrosis; Deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC)

UsageThese are specified diagnoses required in the required medical information for Actimmune and Akeega respectively

DocumentationMust be documented in the prior authorization submission per required medical information

inv-159: ALK-positive — Tumors that test positive for anaplastic lymphoma kinase (ALK) gene rearrangements

DefinitionALK-positive: tumors that test positive for anaplastic lymphoma kinase (ALK) gene rearrangements

RelevanceRequired diagnostic finding for Alecensa and ALUNBRIG coverage criteria

DocumentationDocumented ALK-positive tumor status must be provided in required medical information

inv-160: Revised El Escorial criteria — Diagnostic criteria used to define ALS

DefinitionRevised El Escorial criteria: diagnostic criteria used to define amyotrophic lateral sclerosis (ALS)

Clinical useRequired to document ALS diagnosis for Radicava ORS initial authorization

DocumentationDiagnosis per revised El Escorial criteria must be included in required medical information

inv-162: Low serum testosterone — Two separate serum testosterone levels drawn on different dates with values below 300 ng/dL.

Low serum testosterone definitionTwo separate serum testosterone levels drawn on different dates with values below 300 ng/dL

Associated symptomsAt least one symptom required (malaise, fatigue, lethargy, muscle loss, depression, decreased libido)

Documentation requirementBoth lab results and symptom documentation must be provided for topical testosterone coverage

inv-163: Genetic confirmation for NPC — Mutations in NPC1 or NPC2 by DNA sequence analysis or ancillary testing

Genetic confirmation for NPCMutations in both alleles of NPC1 or NPC2 by DNA sequence analysis OR one allele mutation plus positive filipin staining or elevated cholestane triol (>2x ULN)

RoleRequired confirmatory testing for Niemann‑Pick disease type C prior to coverage

Alternative testingPositive filipin staining or elevated cholestane triol used when only one allele mutation identified

inv-168: Disease progression (for reauthorization) — Defined as a ≥20% increase in the sum of diameters of target lesions per RECIST v1.1.

Reauthorization disease progression thresholdDefined as a >= 20% increase in the sum of diameters of target lesions per RECIST v1.1

UseApplied to reauthorization determinations for specific oncology entries (documented in required medical information)

DocumentationImaging measurements per RECIST v1.1 must be provided to support progression claim

inv-174: aTTP — acquired thrombotic thrombocytopenic purpura, diagnosis required for CABLIVI therapy

aTTP definitionacquired thrombotic thrombocytopenic purpura (aTTP)

RelevanceDiagnosis required for initial CABLIVI authorization

Authorization noteTherapy must be started inpatient in combination with plasma exchange for initial coverage

inv-175: oncology abbreviations — DTC, pNET, epNET definitions

AbbreviationsDTC = differentiated thyroid cancer; pNET = pancreatic neuroendocrine tumor; epNET = extra‑pancreatic neuroendocrine tumor

ContextUsed in CABOMETYX indication descriptions and required medical information

DocumentationSpecific tumor type and prior therapy history must be provided per indication

Site-of-Care Requirements

Note

CABLIVI inpatient initiation with plasma exchange

Therapy initiation for CABLIVI should be started inpatient in combination with plasma exchange (site‑of‑care requirement).

Background and Scope

Alecensa (alectinib) is indicated for ALK‑positive non–small cell lung cancer. Radicava ORS (edaravone oral suspension) is indicated for amyotrophic lateral sclerosis (ALS) as referenced in the document.

Policy Summary

PayerSelectHealth

PolicyCoverage criteria for selected specialty medications (partial extract)

Policy CodePolicy N/A

Change TypeMinor/none

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide required documentation (diagnosis, prior therapy history, and laboratory confirmation) for the requested specialty medication.

SourceLink

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