Prior authorization required — submit diagnosis and supporting clinical information

Prior authorization is required for coverage of the products listed in this policy; submit the product-specific prior authorization request including the diagnosis and any required supporting clinical information. Many products specify a 2-year coverage duration when authorized.

• Include the documented diagnosis required by the product entry (e.g., CF, PAH, BRCA/HRR-mutated cancer).
• Provide supporting clinical information and any required mutation/genotype or test results as specified for the product.
• Note prescriber specialty when the product requires a specialist (e.g., oncologist, pulmonologist, cardiologist).

Prior authorization required for listed specialty drugs — supply required specialty documentation

Submit a prior authorization request for each specialty drug listed; include the indication-specific documentation, prescriber specialty attestation when required, and evidence of prerequisite therapies or part‑D drug trials if the product's criteria state so.

• For CF modulators and targeted oncology agents, include genotype/mutation test reports when required.
• When the product notes a prerequisite Part D drug, document prior use, intolerance, or contraindication.
• If a specialist prescriber is required, include that attestation or documentation of specialist consultation.

General prior authorization requirement — diagnosis and prescriber specialty

Most products in this segment require prior authorization; documentation must include the specific diagnosis and prescriber specialty when indicated. Coverage durations are commonly specified (typically 2 years).

• Verify the product entry for any additional documentation (e.g., prior therapy failure, lab values, imaging, biopsy).
• Attach prescriber specialty credentials or consultation note when required.

Genotropin prior authorization — pediatric GHD initiation documentation

For Genotropin (pediatric growth hormone initiation) submit radiographs showing open epiphyses, results of at least two standard GH stimulation tests, growth metrics (height >2 SD below mean), and documentation of the listed etiologies for short stature.

• Prescriber should be an endocrinologist per the product entry.
• Provide all specified test results and growth chart documentation with the request.

Product-specific prior authorization — include tests, prior therapy, and prescriber specialty

Follow the product-specific prior authorization instructions for each drug: include the required diagnosis, prior therapies or failures, relevant test results (mutation/genotype where applicable), and prescriber specialty per the product entry.

• Examples: CFTR mutation proof for CF modulators; FGFR2 fusion evidence for Pemazyre/Lytgobi; BRCA/HRR mutation reports for Lynparza.

Lynparza prior authorization — mutation status, prior therapy, oncologist prescriber

Lynparza requests require prior authorization with documentation of deleterious or suspected deleterious gBRCA or HRR gene mutations, the prior lines of therapy applicable to the indication, and prescriber attestation that the prescribing physician is an oncologist; coverage duration is commonly 2 years.

• For mCRPC use, document progression after enzalutamide or abiraterone when applicable.
• If used in combinations (e.g., with abiraterone/prednisone), include treatment details per the indication.

Lytgobi prior authorization — FGFR2 fusion documentation and oncology prescriber

For Lytgobi prior authorization submit documentation of a diagnosis of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements and attestation that the prescriber is an oncologist or consulted with one.

• Coverage duration is noted as 2 years in the product entry.

PAH agents prior authorization — right heart catheterization confirmation and specialist prescriber

PAH and CTEPH agents require prior authorization with documentation confirming the diagnosis by right heart catheterization (for PAH) or documentation of persistent/recurrent CTEPH post-surgical or inoperable status; the prescriber must be a cardiologist or pulmonologist.

• Include the right heart catheterization report or surgical/inoperable documentation with the PAH request.
• Coverage duration is commonly 2 years.

Genetic/mutation documentation required — attach test reports

When requested products depend on genetic or mutation status, include laboratory or genetic testing reports demonstrating the required mutation (for example, CFTR mutation for Orkambi/Trikafta/Kalydeco; BRCA/HRR status for Lynparza; IDH1 for Tibsovo).

• If genotype is unknown for CFTR modulators, submit an FDA‑cleared CF mutation test and verification sequencing when indicated.
• For oncology targeted therapies, attach the molecular pathology or genomic testing report.

Transplant documentation required — confirm transplant type and CMV risk

When a product's criteria reference post‑transplant CMV risk or transplant status (e.g., Prevymis, Livtencity), submit documentation of the transplant (allogeneic HSCT or kidney transplant) and evidence the member is at risk for or has CMV infection/disease.

• Include transplant type, date, and any relevant virology/genotypic resistance testing for CMV as applicable.

NASH staging documentation required for Rezdiffra — fibrosis F2–F3 confirmation and metabolic risk

For Rezdiffra (MASH/NASH) initial authorization submit non-cirrhotic disease documentation with fibrosis stage F2–F3 confirmed by the specified biomarker/imaging or a liver biopsy within the past 12 months, plus at least one metabolic risk factor (e.g., T2DM, hypertension, obesity).

• Provide the specific biomarker and imaging results (e.g., ELF, FIB‑4, FibroScan, MRI‑PDFF) or liver biopsy report used to stage fibrosis.

Rydapt prior authorization — FLT3+ AML documentation and prescriber specialty

Rydapt prior authorization requires documentation that AML is FLT3 mutation‑positive when used as first‑line therapy in combination with standard cytarabine/daunorubicin induction and cytarabine consolidation; the prescriber must be a hematologist/oncologist or allergist.

• Do not submit Rydapt for single‑agent induction AML use — the product entry excludes single‑agent induction.
• Include FLT3 mutation testing report and treatment plan showing combination induction/consolidation.

Skyrizi prior authorization — indication-specific diagnosis and specialist prescriber

Skyrizi prior authorization requests must include the indication‑specific diagnosis (e.g., moderate‑to‑severe plaque psoriasis with prior topical failure, psoriatic arthritis, Crohn's disease, ulcerative colitis) and documentation that the prescriber is a dermatologist, rheumatologist, or gastroenterologist as appropriate.

• For plaque psoriasis, include documentation of prior topical therapy failure as specified.
• Coverage duration is typically 2 years per the product entry.

Prior authorization and specialty prescriber — include specialist attestation or consult

When a product requires a specialist prescriber, include the specialist's attestation or consultation note with the prior authorization (examples: oncologist for many targeted agents; pulmonologist or CF center specialist for CF therapies).

• If the product entry names the required prescriber type, the request should show the prescriber meets that requirement or that a specialist consultation has occurred.

Prior authorization and prerequisite Part D therapy — document prior Part D drug use or intolerance

If the product's criteria specify prerequisite Part D therapy or 'Criteria DOES require use of a prerequisite Part D drug', document prior use, intolerance, or contraindication to the named Part D agent(s) before approval.

• Examples include Lynparza, Nexletol/Nexlizet, Piqray and others that explicitly require prior Part D drug use.
• Attach medication history, pharmacy fill records, or prescriber attestation of intolerance/contraindication.

Part B vs Part D determination — provide use and setting details

When the drug may be covered under Medicare Part B or Part D depending on use and setting, submit information describing the drug's use and the clinical setting to allow correct Part B vs Part D determination.

• Include administration site (office, infusion center, hospital outpatient, pharmacy), and whether the drug is administered incident to a physician service or as an outpatient prescription.

Prerequisite therapy / step requirements — document trials and failures or attestations

Document trial and failure, contraindication, or intolerance to specified conventional or topical therapies when the product's criteria list step therapy requirements (examples: RA agents, certain biologics, topical therapies for psoriasis).

• Provide dates, doses, and reasons for discontinuation (lack of response, adverse effects, contraindication) or attestation that trials are clinically inappropriate.
• For rheumatologic indications, detail TNF inhibitor trials and conventional DMARD trials when required.

Step therapy / prerequisite therapy requirements — evidence of required Part D trials

For specific step therapy rules where the product indicates 'Criteria DOES require use of a prerequisite Part D drug' (e.g., Fasenra, Ibrance, Lynparza in some entries), include evidence of the required prior Part D medication trial or a clinician attestation of contraindication/intolerance.

• Attach pharmacy fill records, medication administration records, or prescriber statement indicating prior use and outcome.

Fasenra step therapy — document prerequisite Part D drug use or attestation

Fasenra requests require documentation that the member has used the prerequisite Part D drug(s) indicated by the product entry, or provide a prescriber attestation that trials are inappropriate.

• Include prior medication history for inhaled corticosteroids plus additional controller trials as noted in the Fasenra entry when applicable.

Ibrance step therapy — document prerequisite Part D drug use

Ibrance prior authorization requires documentation of the prerequisite Part D drug use when the product's criteria indicate 'Criteria DOES require use of a prerequisite Part D drug'; include prior endocrine or other indicated therapies as appropriate.

• Attach medication history or pharmacy fill records showing prior therapy trials or prescriber attestation if trials are inappropriate.

Kineret RA prerequisite therapy — document two alternative therapy trials or attestation

For Kineret (anakinra) in RA initial therapy, document trial and failure, intolerance, or contraindication to two specified alternatives (examples: Enbrel, a formulary adalimumab product, Orencia, Rinvoq, Xeljanz) or provide an attestation that trials are inappropriate; prescriber should be or consult a rheumatologist.

• Include dates and reasons for discontinuation of the two alternatives or a prescriber's rationale for bypassing trials.

Therapy trial/failure required — submit prior therapy history and failure rationale

When the product entry requires documentation of a trial/failure of prior therapies (e.g., Rezurock, Rinvoq, Rezlidhia), submit records showing prior systemic or biologic therapy trials and the clinical rationale for failure or intolerance.

• Include prior medication names, durations, doses, clinical response, and adverse events leading to discontinuation.

Stelara step requirement — document trial/failure of Yesintek or Steqeyma

Stelara prior authorization requires documentation that the member has trialed and had intolerance/contraindication or failure of Yesintek or Steqeyma before approving Stelara for specified indications.

• Provide dates and clinical response to the preferred agents or prescriber attestation of contraindication/intolerance.

Skyrizi prerequisite therapy — document prior Part D drug trials or attestation

For Skyrizi, where criteria indicate a prerequisite Part D drug is required for some indications, document prior use, intolerance, or contraindication to the listed Part D therapy or provide a prescriber attestation.

• Include prior topical or systemic therapy trials for plaque psoriasis as specified when applicable.

Step/step-like therapy requirements — show prior therapy trials and outcomes

Several products require step or step‑like therapy: document trials and failures, intolerances, or contraindications to the specified prior therapies (e.g., TNF inhibitors, conventional DMARDs, topical agents, PPIs) before approval.

• Attach clinical notes, pharmacy fills, or prescriber attestations showing prior therapy attempts and outcomes.

Failure of prior therapies required for rheumatologic indications — document TNF and DMARD history

For rheumatologic indications requiring failure of prior therapies (e.g., ankylosing spondylitis, RA, psoriatic arthritis), document inadequate response or intolerance to TNF inhibitors and/or conventional therapies as specified in the product entry.

• Provide treatment history including agents, duration, and reasons for discontinuation or inadequate response.

Required medical information — attach documented diagnosis and disease-specific support

Providers must supply the documented diagnosis and the supporting disease‑specific medical information per product (examples: CF genotype for CFTR modulators; mutation status for targeted oncology agents; confirmation of PAH by right heart catheterization).

• Include laboratory, imaging, pathology, or genetic testing reports referenced in the product entry.

Required diagnosis documentation for medullary thyroid cancer agents — progressive/metastatic disease proof

For medullary thyroid cancer agents (e.g., Cometriq, Cabozantinib), include documentation of progressive or metastatic medullary thyroid cancer (unresectable locally advanced or metastatic disease) and, when specified, that an oncologist is the prescriber.

• Attach imaging, pathology, and oncologist treatment notes supporting the progressive/metastatic diagnosis.

Required infection documentation — provide culture or microbiology evidence

For infections related to specific products (example: Cayston), include documentation of the infection—e.g., diagnosis of cystic fibrosis and evidence of Pseudomonas aeruginosa in the lungs.

• Attach respiratory culture reports or clinical microbiology evidence demonstrating Pseudomonas aeruginosa.

Dupixent required medical information — include indication-specific trials and phenotype data

Dupixent prior authorization must include the indication‑specific documentation such as trial and failure of topical agents for atopic dermatitis, eosinophilic phenotype data for asthma, or inadequate control of CRSwNP—also note the prescriber specialty or consultation.

• Attach trial documentation for prior topical/systemic therapies, eosinophil counts, or ENT documentation for nasal polyps where applicable.

Diagnosis documentation (examples) — attach specialty notes and diagnostic findings

Provide diagnosis documentation examples per product entries (e.g., partial‑onset seizures with TSC for Exkivity-type entries; SEGA not a surgical candidate) when applicable to the requested therapy.

• Include neurologist or neurosurgeon notes confirming surgical candidacy or epilepsy diagnosis details.

Inqovi documentation — MDS subtype and IPSS risk group required

For Inqovi requests, include the documented diagnosis of MDS with the specified FAB subtypes and IPSS risk grouping as required by the product entry.

• Attach hematopathology reports, bone marrow biopsy results, and IPSS risk calculation documentation.

Indication-specific diagnosis — include prior therapy history and specialist confirmation

Ensure indication‑specific diagnosis documentation is attached (examples: chronic GVHD after failure of one or two lines for Jaypirca; intermediate or high‑risk myelofibrosis for myelofibrosis indications).

• Provide prior therapy details and specialist notes confirming the indication and prior treatment history.

Genotype documentation for Kalydeco — attach CFTR mutation test and verification

For Kalydeco (ivacaftor), submit documentation of a CFTR mutation responsive to the drug based on clinical and/or in vitro assay data or an FDA‑cleared mutation test result with sequencing verification when indicated.

• If genotype is unknown, include an FDA‑cleared CF mutation test and follow testing instructions for sequencing when recommended.

Lynparza required medical information — BRCA/HRR mutation reports and prior therapy documentation

For Lynparza, include documentation of deleterious or suspected deleterious germline BRCA or HRR gene mutations, prior lines of therapy relevant to the indication (chemotherapy, endocrine therapy where applicable), and the treatment setting (neoadjuvant/adjuvant/metastatic) as applicable.

• Attach genetic testing reports (germline and/or somatic) and clinical oncology treatment history to the PA request.

PAH documentation — submit right heart catheterization/hemodynamic confirmation

PAH therapy requests must include documentation confirming PAH by right heart catheterization or documentation that CTEPH is persistent/recurrent post‑surgical or inoperable.

• Attach hemodynamic data (mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output) from the catheterization report.

Orkambi required medical information — F508del homozygosity and CF diagnosis

For Orkambi (CF), include documentation that the member is homozygous for the F508del CFTR mutation and has a diagnosis of cystic fibrosis.

• Attach CFTR genetic testing demonstrating homozygous F508del and clinical CF diagnosis notes.

Otezla required medical information — diagnosis and prior topical therapy evidence

For Otezla, include the documented diagnosis appropriate to the indication (psoriatic arthritis, plaque psoriasis with prior topical failures, Behcet's with active oral ulcers) and prescriber specialty where required.

• Attach prior topical therapy trial documentation for plaque psoriasis when applicable.

Pemazyre required medical information — FGFR alteration testing and prior therapy

Pemazyre prior authorization requires documentation of FGFR2 fusion for cholangiocarcinoma or FGFR1 rearrangement for MLNs and prior treatments where specified; include the oncologist's notes and molecular testing reports.

• Attach pathology and molecular assay reports confirming FGFR2/FGFR1 alterations and prior therapy records.

PCSK9 inhibitors required medical information — LDL levels, statin history, and diagnosis confirmation

For PCSK9 inhibitors (Praluent/Repatha), submit documentation of elevated LDL‑C on high‑intensity statin therapy or statin intolerance, and the diagnosis (ASCVD, HeFH, HoFH) with genetic or clinical confirmation as applicable.

• Include lipid panels, statin regimen details, and genetic testing or clinical criteria supporting familial hypercholesterolemia when required.

Tibsovo required information — IDH1 mutation and treatment setting documentation

For Tibsovo, include the documented diagnosis and susceptible IDH1 mutation status and specify the treatment setting (relapsed/refractory AML, newly diagnosed when ineligible for intensive induction, cholangiocarcinoma, or MDS).

• Attach molecular testing confirming IDH1 mutation and clinical notes documenting line of therapy and eligibility for intensive induction.

Trikafta required information — CF diagnosis, responsive CFTR mutation, and age-specific formulation

For Trikafta, include documentation of cystic fibrosis diagnosis and CFTR mutation responsive to the therapy; indicate age‑appropriate formulation (granules for 2 to <6 years; tablets for ≥6 years) and a pulmonologist or CF center specialist as prescriber or consultant.

• Attach CFTR genetic testing and pediatric age documentation when applicable.
• For reauthorization, provide evidence of clinical response (e.g., ppFEV1 improvement or fewer pulmonary exacerbations).

Required documentation — include mutation status, prior therapy, and specialist notes

Providers must submit the documented diagnosis and all supporting disease‑specific information required by the product entry (e.g., mutation status, prior endocrine therapy, PIK3CA/AKT1/PTEN alteration reports for Tukysa).

• Include molecular pathology, prior treatment history, and specialist consultation notes as applicable.

Required clinical documentation — diagnosis, prior therapies, and molecular markers

Submit required clinical documentation showing the specific diagnosis, prior treatment history, and molecular marker status when applicable (examples: ALK, ROS1, BRAF V600; prior therapy failures).

• Attach pathology, genomic testing reports, treatment timelines, and prescriber specialty attestations.

Submit drug use and setting information — required for Part B vs Part D determination

Include information describing the drug's use and setting to determine Medicare Part B versus Part D coverage (e.g., administration in infusion center or as an outpatient pharmacy fill), as failure to submit this may delay processing.

• Specify site of care (office, infusion center, hospital outpatient, pharmacy) and whether administration is physician‑administered or self‑administered.

Denial triggers from listed exclusions — verify indication against exclusions

Requests for uses explicitly excluded in the product entries will be denied; verify the indication against product exclusions prior to submission (examples: modafinil/armodafinil not for generalized fatigue/jet lag; Dupixent not for acute bronchospasm).

• Check product-level exclusion lists in the policy before submitting a PA request.
• Do not submit PA for indications explicitly stated as not covered.

Dupixent explicit denial risk — not for acute bronchospasm/status asthmaticus

Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; do not submit prior authorization for these excluded uses.

• Ensure the documented indication is one of the covered Dupixent indications before requesting authorization.

Icatibant exclusion — acquired angioedema or concurrent ACE inhibitor use

Icatibant is excluded for members with acquired angioedema or for those concurrently taking an ACE inhibitor; such requests will not be approved.

• Confirm HAE type and concomitant medications before submitting a prior authorization request for Icatibant.

Iclusig exclusion — not for newly diagnosed chronic phase CML

Iclusig will not be approved for members with newly diagnosed chronic‑phase CML; ensure the diagnosis and disease phase meet the product criteria before submission.

• For CML requests, include disease phase and prior kinase inhibitor history as indicated.

Jynarque liver monitoring and history — baseline and scheduled liver tests required

For Jynarque initial therapy, ensure baseline and scheduled liver tests (ALT, AST, bilirubin) are documented per the duration‑based schedule and confirm the member does not have a history of significant liver impairment; absence of required liver monitoring or a disqualifying liver history may preclude authorization.

• If patient has received Jynarque ≤18 months, document tests prior to initiation, at 2 and 4 weeks, then monthly for first 18 months; if >18 months on therapy, document testing at least every 3 months.
• Document absence of significant prior liver injury (excluding uncomplicated polycystic liver disease).

Lynparza denial risk — missing mutation status or prior therapy documentation may cause denial

Lack of documented BRCA/HRR mutation status, prior therapies, or relevant treatment setting for Lynparza may trigger denial; include genetic test reports and prior oncology treatment history when submitting a PA for Lynparza.

• Attach germline/somatic BRCA or HRR testing and oncology notes showing prior chemotherapy/endocrine therapy as applicable.

PAH products denial risk — absence of right heart catheterization confirmation

PAH product requests lacking right heart catheterization confirmation of PAH risk denial; submit the invasive hemodynamic confirmation to avoid denial.

• Include the catheterization report with measured hemodynamics supporting the PAH diagnosis.

Explicit exclusion denial risk — do not submit for excluded indications (e.g., quinine for leg cramps)

Coverage will not be approved for indications explicitly excluded (example: quinine sulfate for nocturnal leg cramps); do not request authorization for excluded indications.

• Review the product's exclusion statement before submitting any PA request to avoid an expected denial.

Rubraca concurrent therapy exclusion — ensure non-concurrent use with chemotherapy

Rubraca will not be approved for concurrent use with other chemotherapy agents; when requesting maintenance Rubraca, ensure the request documents that it will not be given concurrently with other chemotherapy.

• Include current chemotherapy status and planned treatment regimen to demonstrate non‑concurrent use.

Rydapt treatment modality exclusion — not for single-agent induction AML

Rydapt will not be approved as single‑agent induction therapy for AML; when requesting Rydapt for AML, document the appropriate combination induction and consolidation regimen or other approved indication.

• Attach treatment plan and FLT3 mutation testing supporting use in combination induction.

Tadalafil explicit exclusion — not covered for erectile dysfunction

Tadalafil is excluded from coverage for the treatment of erectile dysfunction; ensure requests for tadalafil are for covered indications (e.g., BPH with specified prior therapy failure) as described in the policy.

• If requesting tadalafil for BPH, include documentation of prior trials/failures of specified BPH medications per the product entry.

TIRF exclusion — only for breakthrough cancer pain in opioid‑tolerant patients

Transmucosal Immediate‑Release Fentanyl (TIRF) products will not be covered for any non‑cancer pain indication; submit PA only for management of breakthrough cancer pain in opioid‑tolerant adult cancer patients and document opioid tolerance.

• Document opioid tolerance (examples provided in the policy) and confirm patient remains on around‑the‑clock opioids while using TIRF.
• Lozenges approvable for pediatric patients 16 years and older only per the product entry.

Documentation-based denials — include all required diagnostic and prescriber documentation

Requests that lack required diagnostic documentation (e.g., CF genotype for CFTR modulators; documented PIK3CA/AKT1/PTEN alterations for Tukysa) or that are missing required specialist prescriber restrictions may be denied; ensure all specified diagnostic and prescriber documentation is attached.

• Review the product entry checklist and attach molecular testing, pathology, and specialist consultation notes as required.

Lack of documented diagnosis — confirm and attach indication-specific diagnostic evidence

Requests may be denied if the member does not have the documented diagnosis required for the specific drug (examples: von Hippel‑Lindau disease for Wyost indications, ALK‑positive NSCLC for Xalkori). Verify and attach diagnosis documentation.

• Attach disease‑specific diagnostic reports (e.g., genetic testing, pathology, imaging) supporting the covered indication.

Missing Part B/Part D use/setting information — include administration site and use details

Failure to submit information describing the use and setting of the drug may prevent determination of Medicare Part B versus Part D coverage and could delay processing; include site‑of‑care and administration details with the prior authorization.

• Specify whether the drug is physician‑administered (office/infusion/hospital outpatient) or dispensed as a pharmacy benefit, and include related treatment notes.

Medicare Part B vs Part D: submit setting

This drug may be covered under Medicare Part B or Part D depending on the circumstances; include documentation of the use and setting to allow correct coverage assignment.

• Possible settings include infusion center, office, hospital outpatient, or pharmacy.

Office setting: document use and setting

When requests involve office administration, providers must indicate the drug use and setting to support Part B/Part D determination and proper billing.