Prior Authorization Required

Prior authorization is required for all FDA‑approved indications of covered medications listed in this policy. Providers must document the specific diagnosis that aligns with the requested FDA indication. Coverage is limited to FDA‑approved uses and non‑FDA uses may be denied.

• PA required: All FDA‑Approved Indications
• Provider must document diagnosis that matches the FDA indication

Exclusions That May Trigger Denial

Exclusion: Do not approve therapy for patients with known hypersensitivity to Actimmune or other E. coli–derived products. Combination use with a TNF‑inhibitor (where noted for specific agents) is excluded and may lead to denial.

• Exclusion: Hypersensitivity to Actimmune or E. coli‑derived products
• Exclusion: Combination use with TNF‑inhibitor (where specified)

Alecensa — Documentation Requirements and Risk

Alecensa requests must include documentation of ALK‑positive NSCLC. Lack of documentation confirming ALK‑positive tumor status or absence of required diagnostic information may result in denial.

• Required: Dx of NSCLC that is ALK‑positive; tumor ALK status documented
• Denial risk if ALK‑positive documentation is missing

Radicava ORS — Required Documentation

Radicava ORS (edaravone) requests must include documentation that the patient meets revised El Escorial criteria for ALS. Failure to provide El Escorial criteria documentation may result in denial.

• Required: Diagnosis of ALS as defined by the revised El Escorial criteria
• Denial risk if El Escorial documentation is missing

Testosterone — Required Testing and Symptom Documentation

Testosterone therapy requires two separate testosterone measurements (drawn on different dates) with serum testosterone < 300 ng/dL and documentation of at least one clinical symptom (for example: malaise, fatigue, lethargy, muscle loss, depression, decreased libido). Requests missing the two test results or symptom documentation may be denied.

• Two separate testosterone levels, on different dates, both < 300 ng/dL
• Document at least one symptom: malaise, fatigue, lethargy, muscle loss, depression, decreased libido
• Denial risk if required testing or symptom documentation absent

Prior Trial Documentation — Antipsychotics and Rexulti

For antipsychotic therapies where prior trials are required, document trials of relevant agents (for example: aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). Where Rexulti is indicated for MDD or schizophrenia, document a previous trial of Rexulti when specified.

• Document prior trials of listed antipsychotics as applicable
• For MDD or Schizophrenia indications: document previous trial on Rexulti when required

LDL‑Related Indication — Required Documentation and Prior Therapy

For the LDL‑related (homozygous familial hypercholesterolemia) indication, document untreated fasting LDL > 500 mg/dL and triglycerides < 300 mg/dL. Provide genetic/family history evidence (biallelic LDL receptor mutations OR both parents with untreated total cholesterol > 250 mg/dL OR xanthomas before age 10). Document prior trials of high‑intensity statin therapy and intolerance if applicable, and prior trial of PCSK9 inhibitor (Repatha or Praluent).

• Untreated fasting LDL > 500 mg/dL AND triglycerides < 300 mg/dL
• Genetic/family history: biallelic LDL receptor mutation OR parental hypercholesterolemia OR childhood xanthomas
• Document prior high‑intensity statin trial or documented statin intolerance
• Document prior trial of Repatha OR Praluent

AUGTYRO — PA Indication and Required Documentation

AUGTYRO (entrectinib/indication context) requests must include 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 when required by indication. Missing ROS1/NTRK or prior‑therapy rationale may trigger denial.

• Required: Dx of ROS1‑positive NSCLC or NTRK gene fusion‑positive solid tumor
• Document contraindication/intolerance/failure of Rozlytrek when applicable
• Denial risk if ROS1/NTRK or prior therapy rationale missing

AUSTEDO — PA Indication and Documentation

AUSTEDO (deutetrabenazine) requests must document the specific diagnosis: chorea associated with Huntington's disease OR tardive dyskinesia. Lack of a documented diagnosis for chorea or TD may result in denial.

• Required: Dx of chorea associated with Huntington's disease OR Dx of tardive dyskinesia
• Denial risk if required diagnosis is not provided

Medication‑Specific PA and Documentation Expectations

Medication‑specific prior authorization notes: include diagnosis, relevant mutation status or laboratory results, prior therapy trials or intolerances, and any indication‑specific exclusions. Failure to supply required medical information for the specific drug/indication may lead to denial.

• Include diagnosis, labs/genetic test results, prior therapies/intolerances as applicable
• Missing required medical information for a specific medication/indication may cause denial

CABLIVI — Prior Authorization and Reauthorization Requirements

CABLIVI (caplacizumab) initial authorization requires a 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 (for example suppressed ADAMTS13) and clinical response (increased platelet count, reduced neurologic symptoms, or improved organ‑damage markers). Max duration: 58 days following the last day of plasma exchange. Initial coverage duration: 3 months.

• Initial: Dx of aTTP AND inpatient start with plasma exchange
• Reauthorization: evidence of persistent underlying disease and demonstrated clinical response
• Max duration: 58 days following last plasma exchange
• Coverage duration (initial): 3 months

CABOMETYX — Required Diagnosis and Prior Therapy Documentation

CABOMETYX (cabozantinib) requests must document the specific indicated diagnosis (hepatocellular carcinoma with prior sorafenib use; advanced renal cell carcinoma; locally advanced/metastatic differentiated thyroid cancer with progression after VEGFR‑targeted therapy or radioactive iodine‑refractory; previously treated unresectable/metastatic well‑differentiated pNET with prior everolimus or sunitinib; or extra‑pancreatic NET). Provide prior therapy details (e.g., previous sorafenib for HCC) as applicable. Missing the specified diagnosis or prior‑therapy documentation may lead to denial.

• Document indicated diagnosis and prior therapies (e.g., prior sorafenib for HCC)
• Indication‑specific prior therapy requirements must be shown
• Denial risk if diagnosis or prior therapy documentation is missing

BRAFTOVI/MEKTOVI — Mutation Confirmation Required

BRAFTOVI (encorafenib) used with Mektovi requires confirmation of BRAF V600E or V600K mutation for the indicated malignancy (melanoma, metastatic colorectal cancer when combined with cetuximab, or metastatic NSCLC). Lack of documented BRAF mutation status may result in denial.

• Required: Documentation of BRAF V600E or V600K mutation for indicated uses
• Specify planned combination therapy (encorafenib with binimetinib or with cetuximab) per indication
• Denial risk if BRAF mutation confirmation missing

Ph+ CML — Prior Therapy Requirement

For Philadelphia chromosome‑positive (Ph+) CML indications, document the disease phase (chronic/accelerated/blast) and prior therapy history. For chronic phase (and other phases where indicated), prior failure or intolerance to imatinib must be documented before approval.

• Required: Dx of Ph+ CML and documentation of disease phase
• Document prior failure or intolerance to imatinib when required

Balversa and Rufinamide — Required Diagnostic and Prior Therapy Information

Balversa (erdafitinib) requires documentation of confirmed FGFR3 genetic alteration and progression on or after at least one line of prior systemic therapy. Rufinamide requests must show inadequate seizure control despite treatment with at least one anti‑epileptic drug.

• Balversa: Confirmed FGFR3 alteration and prior systemic therapy documented
• Rufinamide: Document inadequate seizure control despite ≥1 AED

Coverage Duration Requirements

Some indications have defined coverage durations: typical coverage is Plan Year unless otherwise specified. Example: initial coverage for select indications (e.g., polycythemia vera entry) may be 6 months with reauthorization per Plan Year; CABLIVI initial authorization and limits are specified separately.

• Default coverage duration: Plan Year
• Example exception: Initial 6 months with reauthorization Plan Year for select entries (e.g., polycythemia vera)
• CABLIVI: Initial coverage duration 3 months (max 58 days post plasma exchange)

Prior Therapy or Rationale Required

When a prior medication (e.g., Mekinist) is expected in the treatment sequence, either document prior use or provide a clinical rationale explaining why prior therapy would be inappropriate. Absence of prior therapy documentation or rationale may trigger denial.

• Document prior Mekinist treatment or provide documented medical rationale for not using it
• Missing prior therapy documentation or rationale may cause denial

FDA Indication Alignment

FDA‑indication alignment: Coverage is generally limited to FDA‑approved indications listed in this policy. Requests for uses outside FDA indications should include supporting clinical evidence; lack of FDA alignment or required supporting information may result in denial.

• Coverage limited to FDA‑approved indications unless compelling supporting documentation provided
• Non‑FDA uses subject to denial without adequate clinical justification