Abiraterone prior authorization

Prior authorization required for abiraterone acetate when used for metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer. Must be prescribed by an oncologist or urologist and used in combination with prednisone. Document the diagnosis and that the drug will be given with prednisone. Coverage duration is 2 years.

• Products: Abiraterone acetate (Yonsa, etc.)
• Prescriber restriction: oncologist or urologist
• Required documentation: metastatic CRPC or high-risk castration-sensitive prostate cancer; confirmation of combination with prednisone
• Coverage duration: 2 years

Akeega prior authorization

Prior authorization required for Akeega (for BRCA-mutated prostate cancer). Prescriber must be an oncologist. Document metastatic prostate cancer with deleterious or suspected deleterious BRCA mutation (BRCA1/BRCA2 as specified), use in combination with prednisone, and either use with a GnRH analog or evidence the patient has had bilateral orchiectomy. Coverage duration is 2 years.

• Products: Akeega
• Prescriber restriction: oncologist
• Required documentation: metastatic disease, deleterious/suspected deleterious BRCA mutation, concurrent prednisone, GnRH analog use or orchiectomy
• Coverage duration: 2 years

Cabozantinib (Cometriq) prior authorization — medullary thyroid cancer

Prior authorization is required for cabozantinib (Cometriq) when used for medullary thyroid cancer. Prescriber should be an oncologist or endocrinologist. Document progressive, metastatic medullary thyroid cancer and unresectable locally advanced or metastatic disease. Coverage duration typically 2 years. Lack of documentation of progression or unresectability may lead to denial.

• Products: Cometriq (cabozantinib)
• Prescriber restriction: oncologist or endocrinologist
• Required documentation: progressive, unresectable locally advanced or metastatic medullary thyroid cancer
• Coverage duration: 2 years

Cayston prior authorization — cystic fibrosis with Pseudomonas

Prior authorization required for Cayston (aztreonam) for cystic fibrosis. Document a diagnosis of CF and evidence of Pseudomonas aeruginosa in the lungs (sputum culture or other microbiologic evidence). Coverage duration generally 2 years. Missing microbiology or CF diagnosis documentation risks denial.

• Products: Cayston (aztreonam)
• Required documentation: confirmed cystic fibrosis diagnosis and presence of Pseudomonas aeruginosa in respiratory secretions
• Coverage duration: 2 years

Dupixent prior authorization and specialty prescribing

Dupixent requires prior authorization for its labeled indications. Prescriptions should be by or in consultation with an appropriate specialist (allergist, dermatologist, immunologist, otolaryngologist, pulmonologist, or gastroenterologist). For atopic dermatitis and other dermatologic indications document trial and failure, contraindication, or intolerance to required topical/systemic therapies as specified. Dupixent is not approved for relief of acute bronchospasm or status asthmaticus. Coverage duration is 2 years.

• Products: Dupixent
• Prescriber restriction: allergist, dermatologist, immunologist, otolaryngologist, pulmonologist, or gastroenterologist
• Required documentation: indication-specific prior topical/systemic therapy trials and failures/intolerance
• Exclusion: not for acute bronchospasm or status asthmaticus
• Coverage duration: 2 years

Ensacove prior authorization — ALK+ NSCLC, ALK-inhibitor naive

Ensacove (for ALK-positive NSCLC) requires prior authorization. Document ALK rearrangement-positive locally advanced or metastatic NSCLC and that the patient is ALK-inhibitor naïve (no prior ALK inhibitor therapy such as alectinib, brigatinib, lorlatinib, crizotinib, ceritinib). Prescriber should be an oncologist. Coverage duration is 2 years.

• Products: Ensacove
• Required documentation: ALK-positive NSCLC; locally advanced or metastatic disease; no prior ALK-inhibitor exposure
• Prescriber restriction: oncologist
• Coverage duration: 2 years

Jynarque prior authorization and liver monitoring

Prior authorization and liver monitoring are required for Jynarque (tolvaptan) in ADPKD. For initiation document diagnosis of rapidly progressing ADPKD. Liver tests (ALT, AST, bilirubin) must be measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months; for patients on therapy longer than 18 months, monitor ALT/AST/bilirubin at least every 3 months. Patients with significant liver impairment or injury are excluded. Coverage duration is 1 year for initial authorization; reauthorization requires clinical response and continued appropriate lab monitoring.

• Products: Jynarque (tolvaptan)
• Required documentation: diagnosis of rapidly progressing ADPKD
• Monitoring: ALT, AST, bilirubin prior to initiation, at 2 and 4 weeks, then monthly for 18 months; thereafter at least every 3 months if continued
• Exclusion: history of significant liver impairment/injury (except uncomplicated polycystic liver disease)
• Coverage duration: 1 year (initial)

Jubbonti (denosumab) prior authorization and denial triggers

Denosumab products used for osteoporosis (Jubbonti) require prior authorization and specific indication documentation. Approvals require the member to be at high risk of fracture or have had inadequate response or intolerance to traditional osteoporosis therapies (e.g., alendronate, ibandronate, risedronate, zoledronic acid) or be receiving aromatase inhibitor therapy with high fracture risk. Denosumab used for oncology indications (prevention of skeletal-related events, unresectable giant cell tumor of bone, hypercalcemia of malignancy refractory to bisphosphonates) must have supporting oncology documentation. Missing indication or prior therapy documentation may trigger denial.

• Products: Jubbonti (denosumab) and Wyost
• Required documentation (osteoporosis): high fracture risk OR inadequate response/intolerance to traditional therapies
• Required documentation (oncology): evidence of bone metastases, multiple myeloma, unresectable GCTB, or hypercalcemia of malignancy as applicable
• Coverage duration: 2 years
• Denial risk: requests lacking indication or prior therapy documentation

Pulmonary hypertension drugs prior authorization

Pulmonary hypertension agents require prior authorization. For pulmonary arterial hypertension, document diagnosis confirmed by right heart catheterization. For chronic thromboembolic pulmonary hypertension (CTEPH), document persistent or recurrent CTEPH after surgical treatment or inoperable disease. Prescriber should be a cardiologist or pulmonologist. Coverage duration is typically 2 years. Failure to submit hemodynamic confirmation or persistent/recurrent disease documentation may delay or prevent approval.

• Products: PAH agents (e.g., Adempas, Opsumit, Orenitram, ambrisentan, bosentan, sildenafil, tadalafil, epoprostenol formulations)
• Required documentation: right heart catheterization confirming PAH or documentation of persistent/recurrent CTEPH
• Prescriber restriction: cardiologist or pulmonologist
• Coverage duration: 2 years

Rinvoq prior authorization — failure/intolerance to specified therapies required

Rinvoq (upadacitinib) prior authorization is required. Document diagnosis-specific criteria including prior topical/systemic therapy trials where applicable and failure/intolerance to specified therapies (e.g., conventional DMARDs, TNF inhibitors) per indication. Prescribe by or in consultation with appropriate specialty (e.g., rheumatologist, dermatologist, gastroenterologist). Coverage duration is 2 years.

• Products: Rinvoq (tablets and liquid)
• Required documentation: indication-specific prior therapy failures/intolerance (see indication details)
• Prescriber restriction: appropriate specialist (rheumatology, dermatology, gastroenterology, allergist/immunologist)
• Coverage duration: 2 years

TIRF prior authorization — opioid-tolerant adult cancer patients only

Transmucosal immediate-release fentanyl (TIRF) products are limited to opioid-tolerant adult cancer patients for breakthrough pain and require prior authorization. Prescriber must be an oncologist or pain management specialist. Patients must be opioid tolerant (document around-the-clock opioid regimen meeting equianalgesic thresholds) and must remain on around-the-clock opioids while using TIRF. TIRF products are not covered for non-cancer pain. Coverage duration typically 2 years.

• Products: TIRF (transmucosal immediate-release fentanyl formulations)
• Indication: adult cancer patients who are opioid tolerant; pediatric approval limited (e.g., lozenges for ≥16 years)
• Required documentation: opioid tolerance (example equianalgesic thresholds) and prescriber specialty
• Exclusion: not covered for non-cancer pain
• Coverage duration: 2 years

Explicit denials / exclusions for non-covered uses

Some drugs are explicitly not covered for non-indicated uses. Armodafinil/modafinil will be denied for generalized fatigue, jet lag, or sleep deprivation not associated with a covered diagnosis. Quinine sulfate will not be approved for nocturnal leg cramps. Tadalafil is excluded for erectile dysfunction. Failure to match the requested use to an approved indication will result in denial.

• Armodafinil/modafinil: not approved for generalized fatigue, jet lag, or non-covered sleep disorders
• Quinine sulfate: not approved for nocturnal leg cramps
• Tadalafil: excluded for erectile dysfunction

Benlysta explicit exclusions

Benlysta (belimumab) will not be approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody-negative patients, or in combination with other biologics or intravenous cyclophosphamide. Prescriber should be a nephrologist or rheumatologist and documentation of active, autoantibody-positive SLE or active lupus nephritis with concurrent standard therapy must be submitted.

• Products: Benlysta (belimumab)
• Exclusions: monotherapy, severe active lupus nephritis or CNS lupus, autoantibody-negative patients, combination with other biologics/IV cyclophosphamide
• Required documentation: active, autoantibody-positive SLE or active lupus nephritis plus concurrent standard therapy
• Prescriber restriction: nephrologist or rheumatologist
• Coverage duration: 2 years

Icatibant non-approval scenarios and required documentation

Icatibant will not be approved for acquired angioedema or for patients concurrently taking ACE inhibitors. For hereditary angioedema, documentation of diagnosis and at least one severe attack in the past six months is required; HAE Types 1 & 2 must be confirmed by laboratory testing (low C4, reduced C1 esterase inhibitor level or function). Prescriber should be an allergist, hematologist, or immunologist.

• Products: Icatibant
• Exclusions: acquired angioedema; concurrent ACE inhibitor therapy
• Required documentation: HAE diagnosis and recent severe attack; lab confirmation for HAE Types 1 & 2
• Prescriber restriction: allergist, hematologist, or immunologist

Iclusig non-approval scenarios and required documentation

Iclusig (ponatinib) will not be approved for newly diagnosed chronic phase CML. Indications approved require T315I-positive disease or resistant/intolerant disease after prior kinase inhibitors as detailed in the policy; prescriber should be a hematologist or oncologist. Documentation of mutation status and prior therapies is required.

• Products: Iclusig (ponatinib)
• Exclusion: newly diagnosed chronic phase CML
• Required documentation: T315I mutation status or evidence of resistance/intolerance to prior kinase inhibitors
• Prescriber restriction: hematologist or oncologist

Concurrent therapy exclusion — confirm allowable combinations

Concurrent therapy exclusions: certain agents (e.g., Rubraca) are not approvable for concurrent use with other chemotherapy agents unless specified. Verify concurrent therapy is allowed per the indication and submit supporting documentation. Requests for explicitly excluded concurrent combinations may be denied.

• Products: Rubraca and others with concurrent therapy restrictions
• Action: confirm allowable combinations; provide documentation if concurrent use is requested
• Denial risk: requests for excluded concurrent combinations

Medicare Part B vs Part D determination — submit use/setting details

Coverage determination may depend on Medicare Part B vs Part D. Submit information describing the drug use and clinical setting (e.g., administration site, infused/physician office vs outpatient pharmacy dispensing) so the payer can determine whether the drug is billed under Part B or Part D. Failure to submit setting and use details may delay correct coverage determination.

• Action: submit documentation of use and setting to determine Part B vs Part D coverage
• Risk: omission of setting/use details may prevent correct benefit determination

Required diagnostic and prior therapy documentation — mutation testing, microbiology, and disease-specific criteria

Ensure required diagnostic and treatment history documentation is provided for agents that mandate specific testing or mutation status: examples include Abilify Mycite (diagnosis and prior treatment documentation), Alecensa (document ALK-positive metastatic NSCLC or adjuvant use), Arikayce (sputum cultures and prior therapy documentation), Lynparza and other PARP inhibitors (BRCA/H RR testing and prior chemo/endocrine therapy), Lytgobi (FGFR2 fusion/rearrangement), Piqray (PIK3CA mutation and prior endocrine progression), Rezdiffra (fibrosis stage F2–F3 confirmed by listed tests or biopsy within 12 months), Tibsovo (IDH1 mutation), Trikafta/other CF modulators (CF diagnosis, genotype, age/formulation specifics), Truqap/Tukysa (molecular alterations PIK3CA/AKT1/PTEN; prescriber specialty), and many oncology targeted agents where missing mutation or staging documentation risks denial.

• Provide diagnostic tests/mutation reports (e.g., ALK, ROS1, EGFR exon 20, FGFR2, BRCA, PIK3CA, IDH1) where required
• Include prior lines of therapy, dates, and response/progression documentation
• Cystic fibrosis products: include CF diagnosis and genotype; age/formulation specifics
• Reauthorization: include clinical response metrics where applicable