Abilify Mycite prior authorization

Prior authorization required: member must have documented diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia; documentation of worsening symptoms with oral aripiprazole; prescriber must be a psychiatrist; coverage duration 2 years; prerequisite Part D drug required.

• Document diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia
• Document worsening symptoms with oral aripiprazole
• Prescriber must be a psychiatrist
• Coverage duration: 2 years
• Prerequisite Part D drug required

Adalimumab products prior authorization

Prior authorization required with documented diagnosis appropriate to the indication and prescriber specialty/consultation (e.g., dermatologist, gastroenterologist, ophthalmologist, or rheumatologist); coverage duration 2 years; prerequisite Part D drug may be required as specified per indication.

• Document indication-specific diagnosis (e.g., Crohn's disease, plaque psoriasis, RA)
• Prescribed by or in consultation with appropriate specialist
• Coverage duration: 2 years
• Prerequisite Part D drug requirement varies by product

Armodafinil/Modafinil prior authorization

Prior authorization requires documented diagnosis of narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift‑work sleep disorder; exclusions: generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis; coverage duration 2 years.

• Document diagnosis of narcolepsy, OSA-associated hypersomnolence, or shift‑work sleep disorder
• Note exclusion: generalized fatigue, jet lag, non‑covered sleep deprivation
• Coverage duration: 2 years

Prior authorization requirement (general)

Prior authorization is required for listed specialty drugs and generally requires a documented diagnosis and product‑specific required medical information; coverage durations are commonly set (typically 2 years).

• Submit documented diagnosis matching product indication
• Include all product‑specific required medical information per policy
• Expect typical coverage duration of 2 years

Empaveli prior auth specifics

Initial PA requires documented diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); reauthorization requires demonstration of a positive clinical response to therapy; prescriber for initial PNH should be a hematologist/oncologist or nephrologist.

• Document diagnosis of PNH for initial approval
• For reauth, document clinical response to therapy
• Initial prescriber: hematology/oncology or nephrology

Exkivity - prior authorization

Prior authorization requires documented diagnosis of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation and progression on or after platinum‑based chemotherapy; prescriber must be an oncologist; coverage duration 2 years.

• Document EGFR exon 20 insertion mutation and disease status (locally advanced/metastatic)
• Document progression on or after platinum‑based chemotherapy
• Prescriber must be an oncologist
• Coverage duration: 2 years

Fasenra - prior authorization

Authorization requires documented severe eosinophilic asthma despite inhaled corticosteroid plus an additional controller OR eosinophilic granulomatosis with polyangiitis (EGPA); prescriber must be an asthma specialist or rheumatologist; criteria requires use of a prerequisite Part D drug; coverage duration 2 years.

• Document severe eosinophilic asthma despite inhaled corticosteroid + controller, or diagnosis of EGPA
• Prescriber: asthma specialist (allergist, immunologist, pulmonologist) or rheumatologist
• Criteria requires use of a prerequisite Part D drug
• Coverage duration: 2 years

Increlex - prior authorization

Authorization requires documented severe primary IGF‑1 deficiency: height SDS ≤ -3.0, basal IGF‑1 SDS ≤ -3.0, normal/elevated GH or GH gene deletion, and radiographs documenting open epiphyses if Tanner stage III or greater; prescriber must be an endocrinologist; coverage duration 2 years.

• Document severe primary IGF‑1 deficiency (height and IGF‑1 SDS criteria)
• Provide GH level or GH gene deletion and radiographs for epiphyseal status if Tanner stage ≥III
• Prescriber must be an endocrinologist
• Coverage duration: 2 years

Jaypirca — PA required

Prior authorization required with documentation of the indicated diagnosis and prior systemic therapy failures for chronic GVHD, myelofibrosis, polycythemia vera, or steroid‑refractory acute GVHD; coverage duration 2 years; subsequent authorization for myelofibrosis requires documentation of spleen size reduction or symptomatic improvement.

• Document diagnosis and prior lines of systemic therapy (as applicable)
• For myelofibrosis, provide evidence of spleen reduction or symptomatic improvement for reauth
• Prescriber specialty as indicated
• Coverage duration: 2 years

Jubbonti — PA and prescriber restriction

Prior authorization requires documentation showing relapsed/refractory mantle cell lymphoma with ≥2 prior systemic therapies including a BTK inhibitor, or CLL/SLL previously treated with a covalent BTK inhibitor; prescriber must be an oncologist; coverage duration 2 years.

• Document relapsed/refractory MCL with ≥2 prior systemic therapies including a BTK inhibitor OR CLL/SLL previously treated with a covalent BTK inhibitor
• Prescriber: oncologist or consult with one
• Coverage duration: 2 years

Jynarque — monitoring requirements

Initial authorization requires diagnosis of rapidly progressing ADPKD and specified liver enzyme monitoring: if ≤18 months on drug measure ALT/AST/bilirubin at baseline, 2 and 4 weeks, then monthly for first 18 months; if >18 months, measure at least every 3 months; reauthorization requires clinical response; coverage duration 1 year.

• Document diagnosis of rapidly progressing ADPKD
• Provide liver enzyme monitoring per schedule (baseline, 2w, 4w, then monthly for first 18 months; then at least every 3 months)
• Confirm no history of significant liver impairment (excluding uncomplicated polycystic liver disease)
• Coverage duration: 1 year

Kalydeco — genotype-based PA

Prior authorization requires documented diagnosis of cystic fibrosis and presence of at least one CFTR mutation responsive to Kalydeco (or FDA‑cleared mutation testing if genotype unknown); granules age ≥1 month; exclusion if homozygous for F508del; coverage duration 2 years.

• Document CF diagnosis and at least one CFTR mutation responsive to Kalydeco or provide FDA‑cleared mutation testing if genotype unknown
• Granules: patient ≥1 month of age
• Do not approve if homozygous for F508del mutation
• Coverage duration: 2 years

Kerendia — indication documentation

Prior authorization requires documentation of chronic kidney disease associated with type 2 diabetes OR heart failure with LVEF ≥40%; coverage duration 2 years.

• Document CKD associated with type 2 diabetes or HF with LVEF ≥40%
• Coverage duration: 2 years

Kesimpta — MS prescriber requirement

Kesimpta requires documented diagnosis of relapsing forms of multiple sclerosis; prescribing physician must be a neurologist; coverage duration 2 years.

• Document relapsing form of MS (CIS, relapsing‑remitting, active secondary progressive)
• Prescriber must be a neurologist
• Coverage duration: 2 years

Kineret — RA and NOMID criteria

Kineret PA for RA initial therapy requires trial/failure/contraindication/intolerance to two specified agents (or attestation that trials are inappropriate) or continuation of prior therapy; NOMID requires genetic confirmation OR clinical criteria plus elevated acute phase reactants; prescriber specialty and reauthorization requirements vary; criteria requires use of a prerequisite Part D drug.

• For RA: document diagnosis and trial/failure/contraindication/intolerance to two listed agents OR attestation OR continuation of prior therapy
• For NOMID: provide NLRP3 mutation or clinical criteria (two listed symptoms) plus elevated acute phase reactants
• Prescriber: rheumatologist (RA) or allergist/immunologist/pediatrician (NOMID)
• Reauth requires demonstration of positive clinical response

Koselugo — NF1 criteria

Koselugo PA requires documented diagnosis of neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas; patient age ≥1 year; prescriber must be a neurologist or oncologist; coverage duration 2 years.

• Document NF1 diagnosis and symptomatic, inoperable plexiform neurofibromas
• Patient age ≥1 year
• Prescriber: neurologist or oncologist
• Coverage duration: 2 years

Krazati — KRAS G12C criteria

Krazati PA for NSCLC requires KRAS G12C mutation and at least one prior systemic therapy; for CRC requires KRAS G12C mutation, prior fluoropyrimidine/oxaliplatin/irinotecan chemotherapy and use in combination with cetuximab; prescriber must be an oncologist; coverage duration 2 years.

• For NSCLC: document KRAS G12C mutation and prior systemic therapy
• For CRC: document KRAS G12C mutation, prior fluoropyrimidine/oxaliplatin/irinotecan chemotherapy, and planned combination with cetuximab
• Prescriber: oncologist
• Coverage duration: 2 years

Lapatinib — refractory HER2+ criteria

Lapatinib PA for HER2‑overexpressing advanced/metastatic breast cancer requires documented HER2 overexpression, failure of anthracycline and taxane and prior trastuzumab, and concurrent treatment with capecitabine; prescriber must be an oncologist; coverage duration 2 years.

• Document HER2‑overexpressing advanced/metastatic breast cancer
• Document prior failures of anthracycline, taxane, and trastuzumab
• Document concurrent capecitabine use
• Prescriber: oncologist
• Coverage duration: 2 years

Lazcluze — EGFR mutation and combo use

Lazcluze PA as first‑line NSCLC in combination with amivantamab requires EGFR exon 19 deletion or exon 21 L858R substitution mutation and use for locally advanced or metastatic disease; coverage duration 2 years; continuation of prior therapy approvable where applicable.

• Document NSCLC locally advanced or metastatic
• Document EGFR exon 19 deletion or exon 21 L858R mutation
• Document intended combination with amivantamab as first‑line therapy
• Coverage duration: 2 years

Lenalidomide — hematologic oncology criteria

Lenalidomide PA lists multiple hematologic oncology indications (FL, MCL, MZL, MM, MDS with 5q deletion) with required diagnosis‑specific regimen or combination details; prescriber must be a hematologist/oncologist; criteria requires use of a prerequisite Part D drug; coverage duration 2 years.

• Document precise hematologic diagnosis and intended combination/regimen per indication
• Prescriber must be a hematologist/oncologist
• Criteria requires use of a prerequisite Part D drug
• Coverage duration: 2 years

Lenvima — multiple oncology indications

Lenvima PA includes multiple oncology indications (advanced endometrial carcinoma pMMR/non‑MSI‑H with pembrolizumab after prior therapy; advanced RCC with specified prior antiangiogenic therapy or first‑line with pembrolizumab; unresectable HCC; radioactive iodine‑refractory thyroid cancer); prescriber must be an oncologist; criteria requires use of a prerequisite Part D drug.

• Document indication‑specific diagnosis and prior therapy per the listed pathways
• Prescriber must be an oncologist
• Criteria requires use of a prerequisite Part D drug
• Coverage duration: 2 years

Lidocaine patches — neuropathic pain prerequisite

Lidocaine patches require prior failure, adverse reaction, or contraindication to gabapentin for postherpetic neuralgia or diabetic neuropathy; can be approved for new members already well controlled on patches; coverage duration 2 years.

• Document prior failure/adverse reaction/contraindication to gabapentin for PHN or diabetic neuropathy
• If new member, document current pain control on lidocaine patches
• Coverage duration: 2 years

Livtencity — refractory CMV criteria

Livtencity requires PA demonstrating member ≥35 kg with documented post‑transplant CMV infection/disease refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet (with or without genotypic resistance); coverage duration 2 years.

• Document weight ≥35 kg
• Document refractory post‑transplant CMV infection/disease after listed antivirals (± genotypic resistance)
• Coverage duration: 2 years

Lonsurf — refractory GI cancer criteria

Lonsurf requires documented metastatic colorectal cancer or metastatic gastric/GEJ adenocarcinoma and prior lines of therapy as specified (fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy, anti‑VEGF biologic, and if RAS wild‑type an anti‑EGFR therapy for mCRC; specified prior chemo lines for gastric/GEJ); prescriber must be an oncologist; coverage duration 2 years.

• Document prior chemotherapy history consistent with indication (fluoropyrimidine, oxaliplatin, irinotecan; anti‑VEGF; anti‑EGFR if RAS wild‑type)
• Prescriber: oncologist
• Coverage duration: 2 years

Lorbrena — ALK+ NSCLC

Lorbrena requires documented metastatic NSCLC with ALK‑positive tumor; prescriber must be an oncologist; coverage duration 2 years.

• Document metastatic NSCLC with ALK‑positive tumor
• Prescriber must be an oncologist
• Coverage duration: 2 years

Lumakras — KRAS G12C NSCLC/CRC

Lumakras requires KRAS G12C‑mutated locally advanced/metastatic NSCLC after at least one prior systemic therapy, or KRAS G12C‑mutated metastatic CRC in combination with panitumumab after prior fluoropyrimidine, oxaliplatin, and irinotecan‑based chemotherapy; prescriber must be an oncologist; criteria requires use of a prerequisite Part D drug.

• Document KRAS G12C mutation and prior systemic therapy (NSCLC) or combination with panitumumab after listed prior chemo (CRC)
• Prescriber: oncologist
• Criteria requires use of a prerequisite Part D drug
• Coverage duration: 2 years

Lybalvi — psychiatric prescriber restriction

Lybalvi requires documented diagnosis of schizophrenia or Bipolar I disorder; prescriber must be a psychiatrist; coverage duration 2 years.

• Document diagnosis of schizophrenia or Bipolar I disorder
• Prescriber must be a psychiatrist
• Coverage duration: 2 years

Lynparza — BRCA/HRR-based indications

Lynparza requires documentation of deleterious or suspected deleterious BRCA or HRR/HRD status and prior lines of therapy as specified by indication (breast, ovarian, pancreatic, prostate); prescriber must be an oncologist; prior authorization required; coverage duration 2 years; criteria requires use of a prerequisite Part D drug.

• Provide germline or somatic BRCA/HRR/HRD mutation documentation per indication
• Document prior therapy history as specified for the cancer type
• Prescriber must be an oncologist
• Prior authorization required; coverage duration 2 years
• Prerequisite Part D drug required

Lynparza prior authorization

Prior authorization required with documentation of specific mutation status and prior therapy history for Lynparza; prescriber must be an oncologist; coverage duration 2 years.

• Submit mutation testing results (germline or somatic BRCA/HRR)
• Document prior chemotherapy/endocrine therapy as required by indication
• Prescriber: oncologist
• Coverage duration: 2 years

Lytgobi prior authorization

Prior authorization required for Lytgobi with documentation of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements; prescriber involvement by an oncologist required; coverage duration 2 years.

• Document FGFR2 gene fusion or rearrangement in intrahepatic cholangiocarcinoma
• Document prior treatment history
• Prescriber: oncologist or consultation with one
• Coverage duration: 2 years

PAH and CTEPH drug prior authorization

PAH and CTEPH drugs require documented diagnosis confirmed by right heart catheterization for PAH or documented persistent/recurrent CTEPH after surgical treatment or inoperable status; prescriber must be a cardiologist or pulmonologist; coverage duration 2 years.

• For PAH: provide right heart catheterization confirmation
• For CTEPH: document persistent/recurrent disease after surgery or inoperable status
• Prescriber: cardiologist or pulmonologist
• Coverage duration: 2 years

Orkambi PA

Prior authorization requires documentation of cystic fibrosis and homozygous F508del mutation for Orkambi; coverage duration 2 years.

• Document CF diagnosis and homozygous F508del mutation
• Coverage duration: 2 years

Otezla PA

Prior authorization for Otezla requires documented diagnosis appropriate to the indication (PsA, plaque psoriasis, Behcet's) and prior topical/systemic treatment failures as specified; prescriber should be or consult a dermatologist or rheumatologist; coverage duration 2 years.

• Document diagnosis per indication and prior topical/systemic therapy failures where specified
• Prescriber: dermatologist or rheumatologist (or consult)
• Coverage duration: 2 years

Praluent/Repatha class PA

Praluent and similar PCSK9 inhibitors require PA documenting elevated LDL‑C despite high‑intensity statin therapy or statin intolerance and a diagnosis consistent with atherosclerotic cardiovascular disease or familial hypercholesterolemia; prerequisite Part D drug required.

• Document elevated LDL‑C despite high‑intensity statin or statin intolerance
• Provide diagnosis: ASCVD, HeFH, or HoFH per criteria
• Prerequisite Part D drug required

Rydapt (midostaurin) — AML and mast cell disease

Rydapt requires prior authorization when used as first‑line therapy in FLT3 mutation‑positive AML in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation; Rydapt will not be approved as single‑agent induction therapy for AML.

• Document FLT3 mutation‑positive AML and planned combination with standard induction and consolidation regimens
• Note: Rydapt will not be approved as single‑agent induction therapy for AML

Transmucosal Fentanyl (TIRF) prior auth conditions

TIRF products require documentation that the patient is an adult cancer patient already tolerant to around‑the‑clock opioid therapy for persistent cancer pain; pediatric approval for fentanyl lozenges limited to patients ≥16 years; TIRF products will not be covered for any non‑cancer pain indication.

• Document adult cancer diagnosis and opioid tolerance to around‑the‑clock opioids
• If fentanyl lozenges requested for pediatric patients, age ≥16 required
• TIRF products not covered for non‑cancer pain

Truqap — Prior authorization

Prior authorization for Truqap requires documentation of CF diagnosis, qualifying CFTR mutation, age/formulation limits, and specialist prescriber; coverage duration 2 years.

• Document CF diagnosis and qualifying CFTR mutation
• Provide age/formulation information (granules vs tablets as applicable)
• Prescriber: pulmonologist or CF care specialist
• Coverage duration: 2 years

Tukysa — Prior authorization

Tukysa prior authorization requires documented locally advanced or metastatic HR‑positive, HER2‑negative breast cancer with documented PIK3CA/AKT1/PTEN alteration, prior endocrine therapy criteria, and is to be used in combination with fulvestrant; criteria requires use of a prerequisite Part D drug; coverage duration 2 years.

• Document HR‑positive, HER2‑negative locally advanced/metastatic breast cancer
• Document PIK3CA/AKT1/PTEN alteration
• Document progression on or after at least one endocrine‑based regimen or recurrence within 12 months of adjuvant therapy
• Intended combination with fulvestrant
• Prerequisite Part D drug required
• Coverage duration: 2 years

Ubrelvy and similar products — Prior authorization

Prior authorization required for Ubrelvy and similar products with documentation of inadequate response/intolerance/contraindication to required comparators; some indications require prior Part D drug therapy; coverage durations commonly 2 years.

• Document inadequate response/intolerance/contraindication to required comparators per indication
• Note whether prior Part D drug therapy is required for the specific indication
• Coverage duration commonly 2 years

Prior authorization and prescriber restrictions

Prior authorization is required for listed specialty drugs; certain drugs have prescriber restrictions (e.g., oncologist required for specific oncology agents); providers must follow product‑specific prescriber requirements.

• Check product entry for prescriber restriction (e.g., oncologist, neurologist, psychiatrist)
• Include specialist consultation documentation when required

Xdemvy prescriber requirement

Xdemvy must be prescribed by or in consultation with an ophthalmologist or optometrist for Demodex blepharitis; coverage duration 2 years.

• Document diagnosis of Demodex blepharitis
• Prescriber: ophthalmologist or optometrist or documented consultation
• Coverage duration: 2 years

Part B vs Part D coverage determination

Submit information describing the use and setting of the drug when requested to determine whether coverage is under Medicare Part B or Part D; failure to provide this may prevent correct coverage determination.

• Include details of drug use and care setting (infusion center, hospital outpatient, office, home, pharmacy) when requested
• Failure to submit may affect Part B vs Part D determination and coverage routing

Abilify Mycite: prerequisite therapy — requires use of a prerequisite Part D drug

Abilify Mycite requires use of a prerequisite Part D drug prior to approval when applicable; providers must document prior Part D therapy per product note.

• Document use of prerequisite Part D drug as indicated
• Include prior Part D therapy records with PA request

Various products: prerequisite Part D drug requirement

Some criteria explicitly require use of a prerequisite Part D drug while others do not; providers must follow the per‑product prerequisite Part D drug flag in the policy when submitting PA requests.

• Check product entry for 'Criteria DOES require use of a prerequisite Part D drug' or 'Criteria DOES NOT require'
• Include documentation of prior Part D drug when required

Step/conservative therapy requirements

Many biologics and specialty agents require failure, contraindication, or intolerance to specified topical, conventional, or biologic therapies prior to approval; document trials and outcomes (duration, doses, reasons for discontinuation) as required.

• Document trial and failure/contraindication/intolerance to specified prior therapies (e.g., topical corticosteroids, NSAIDs, methotrexate)
• Provide duration and clinical response details to prior therapies

Multiple products: prerequisite Part D drug flags

Multiple product entries explicitly note whether a prerequisite Part D drug is required; verify the product‑specific flag and provide prior therapy documentation or an attestation if trials are not feasible.

• Verify 'Criteria DOES require use of a prerequisite Part D drug' in the product entry
• Attach prior therapy documentation or prescriber attestation if trials are inappropriate

Prerequisite therapy requirements (various)

Several products require prior trials or failures of specified therapies (examples include hydroxyurea for polycythemia vera, BTK inhibitors for mantle cell lymphoma, gabapentin for lidocaine patches); include prior therapy details in PA submission.

• List prior therapies tried, durations, responses, and reasons for discontinuation
• Ensure documented failure/intolerance meets the product's specified requirement

Topical retinoid age-based requirement

Topical retinoids: authorization not required for patients 25 years or younger; for older patients, prior topical treatments are expected and PA applies.

• If patient >25 years, document prior topical therapies and responses
• No PA required for patients ≤25 years for topical retinoids

General required medical information

Providers must submit documented diagnosis and the product‑specific required medical information (e.g., mutation status, prior therapy history, monitoring plans) listed under 'Required Medical Information' for each drug; missing documentation may delay or trigger denial.

• Include diagnosis, relevant mutation or biomarker results, prior therapy details, and monitoring plans as listed per product
• Ensure documentation aligns with the product's 'Required Medical Information' section

Ensacove documentation

For Ensacove, submit NSCLC diagnosis with ALK rearrangement and documentation that the patient has not previously received an ALK‑inhibitor.

• Document NSCLC with ALK rearrangement
• Confirm no prior ALK‑inhibitor exposure

For Exkivity: documented diagnosis of locally advanced/metastatic NSCLC with EGFR exon 20 insertion and progression on or after platinum-based chemotherapy

For Exkivity, provide documentation of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation and progression on or after platinum‑based chemotherapy; prescriber must be an oncologist.

• Provide EGFR exon 20 insertion test results and disease stage
• Document progression on or after platinum‑based chemotherapy
• Prescriber: oncologist

For Fasenra: documented diagnosis of severe eosinophilic asthma or EGPA

For Fasenra, document severe asthma with eosinophilic phenotype despite inhaled corticosteroid plus an additional controller OR EGPA; prescriber must be an asthma specialist or rheumatologist.

• Document severe eosinophilic asthma phenotype and current controller therapy (ICS + additional controller) or diagnosis of EGPA
• Prescriber: asthma specialist (allergist, immunologist, pulmonologist) or rheumatologist

Genotropin pediatric GHD initiation: required documentation

For Genotropin pediatric GHD initiation, submit X‑ray confirming open epiphyses, results of at least two GH stimulation tests showing failure to respond, delayed bone age, and height >2 SD below mean; include relevant conditions and prescriber details.

• X‑ray showing open epiphyses
• Results of ≥2 GH stimulation tests showing failure to respond
• Document delayed bone age and height >2 SD below mean
• Prescriber and specialty as indicated

Hematologic/immune diagnoses and prior therapy documentation

For hematologic and immune indications (e.g., chronic GVHD, myelofibrosis, PV), document diagnosis and prior therapy failures as specified (number and types of prior lines); for myelofibrosis reauthorization, include evidence of spleen size reduction or symptomatic improvement.

• Document diagnosis and prior systemic therapies (number and agents)
• For myelofibrosis reauth, provide spleen size reduction or symptomatic improvement data

Lymphoma/leukemia prior therapies

For lymphoma/leukemia agents (e.g., Jubbonti), document relapsed/refractory disease and prior systemic therapies including BTK inhibitor exposure where required.

• Document relapsed/refractory mantle cell lymphoma or CLL/SLL per criteria
• List prior systemic therapies and evidence of BTK inhibitor exposure

Prior therapy and monitoring

Document prior therapies and monitoring as specified for agents such as denosumab, Jynarque, and others; include monitoring schedules and duration where required to support authorization.

• Provide prior therapy trial details and monitoring results per product (e.g., liver enzyme schedule for Jynarque)
• Include durations and dates of monitoring tests

Refractory CMV documentation

For Livtencity, document member weight ≥35 kg and post‑transplant CMV infection/disease refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet (with or without genotypic resistance).

• Document weight ≥35 kg
• Provide evidence of refractory CMV after listed antivirals (± genotypic resistance)

Lynparza documentation

For Lynparza, include documentation of BRCA/HRR mutation status and prior lines of therapy as specified by the cancer indication; prescriber must be an oncologist for certain indications.

• Attach germline/somatic BRCA or HRR mutation test results
• Document prior chemotherapy/endocrine therapy timelines as required
• Prescriber: oncologist for indicated uses

Lytgobi documentation

For Lytgobi, document previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements and prescriber involvement by an oncologist.

• Provide FGFR2 fusion/rearrangement testing results
• Document prior treatment history
• Prescriber: oncologist or consultation with one

CF and mutation documentation

For Orkambi, submit documented diagnosis of cystic fibrosis and confirmation that the member is homozygous for the F508del mutation.

• Document CF diagnosis
• Provide genetic testing showing homozygous F508del mutation

Otezla diagnosis and prescriber

For Otezla, document the specific diagnosis (PsA, PsO, Behcet's) and prior topical/systemic therapy failures as specified; prescriber should be or consult a dermatologist or rheumatologist.

• Document diagnosis per indication and prior therapy failures
• Prescriber: dermatologist or rheumatologist or documented consultation

Pemazyre diagnosis

For Pemazyre, document unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement and prior treatment history; prescriber must be an oncologist.

• Provide FGFR2 fusion/rearrangement results and prior treatment documentation
• Prescriber: oncologist

Documentation must include mutation status (IDH1) for relevant agents

Documentation must include IDH1 mutation status for AML indications and details about treatment intent (monotherapy or combination with azacitidine) and patient fitness for intensive induction chemotherapy where applicable.

• Provide IDH1 mutation test results
• Specify intended use (monotherapy vs combination with azacitidine) and patient fitness for intensive chemo

For EGFR‑ or MET‑altered NSCLC agents: tumor mutation documentation

For EGFR‑ or MET‑altered NSCLC agents, include tumor mutation status (EGFR exon 19/21 or T790M; MET exon 14 skipping) in the submission to support eligibility.

• Attach tumor mutation test results (EGFR exon 19/21, T790M; MET exon 14 skipping)
• Include disease stage and prior therapy information as applicable

Cystic Fibrosis — required documentation

For cystic fibrosis initial requests (Trikafta/Truqap), document CF diagnosis and at least one CFTR mutation (F508del OR a CFTR mutation responsive based on clinical/in vitro data); include age/formulation limits and that the prescriber is a pulmonologist or CF specialist; coverage duration 2 years.

• Document CF diagnosis and qualifying CFTR mutation
• Provide age/formulation details (granules 2–<6 y; tablets ≥6 y)
• Prescriber: pulmonologist or CF care center specialist
• Coverage duration: 2 years

Breast cancer — required documentation

For breast cancer agents (e.g., Tukysa), document HR‑positive, HER2‑negative locally advanced or metastatic disease, PIK3CA/AKT1/PTEN alteration, and prior endocrine therapy progression or early recurrence; intended combination with fulvestrant must be documented; coverage duration 2 years.

• Document HR+/HER2‑ status and PIK3CA/AKT1/PTEN alteration
• Document progression on endocrine therapy or recurrence within 12 months of adjuvant therapy
• Document plan to combine with fulvestrant

Rheumatologic and interstitial lung disease — required documentation

For rheumatologic and interstitial lung disease indications, document the specific diagnosis and required trial/failure/contraindication/intolerance of prior therapies (e.g., biologics, methotrexate, NSAIDs, glucocorticoids) and prescriber specialty; reauthorization requires evidence of clinical response.

• Document diagnosis (RA, SJIA, PJIA, GCA, SSc‑ILD) and prior therapy trials with durations
• Provide prescriber specialty consultation documentation (rheumatologist/pulmonologist)
• For reauth, include objective evidence of clinical response

Required clinical documentation

Provider must submit documented diagnosis and evidence of specified prior therapies or treatment context per product (examples include VHL diagnosis, PD‑1/PD‑L1 plus VEGF‑TKI exposure for RCC, ALK/ROS1 mutation status for Xalkori); missing these items may lead to denial.

• Include diagnosis, biomarker/mutation results, and prior therapy history as specified
• Ensure documentation matches the product's 'Required Medical Information' to avoid denial

Required submission of use and setting

Information describing the drug's use and the care setting must be submitted when requested to determine whether the drug is covered under Medicare Part B or Part D; failure to provide this may lead to misrouted coverage determination or denial.

• Describe the use and setting (hospital outpatient, infusion center, office, home, pharmacy)
• Provide supporting documentation to enable correct Part B vs Part D assignment

Coverage will not be approved for generalized fatigue, jet lag, or sleep-deprivation

Coverage will be denied for armodafinil/modafinil requests for generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis.

• Do not submit armodafinil/modafinil for generalized fatigue, jet lag, or non‑covered sleep‑deprivation indications

Benlysta will not be approved as monotherapy or in listed excluded conditions

Benlysta will not be approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody‑negative members, or in combination with other biologics or IV cyclophosphamide.

• Do not request Benlysta as monotherapy or for excluded conditions
• Provide autoantibody‑positive test results where applicable

Specific exclusion for Dupixent

Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; ensure indication aligns with listed chronic indications and required prior therapy trials.

• Do not request Dupixent for acute bronchospasm or status asthmaticus
• Document chronic indication and prior topical/systemic therapy trials

Icatibant exclusion for acquired angioedema or ACE inhibitor use

Icatibant will be denied for members with acquired angioedema or those concurrently taking an ACE inhibitor; confirm HAE type and laboratory confirmation where required.

• Do not request icatibant for acquired angioedema or with concurrent ACE inhibitor use
• Provide laboratory confirmation for HAE Types 1 & 2 when applicable

Iclusig will not be approved for newly diagnosed chronic phase CML

Iclusig will not be approved for members with newly diagnosed chronic phase CML; ensure resistance/intolerance or T315I status per product criteria before requesting.

• Do not request Iclusig for newly diagnosed chronic phase CML
• Provide documentation of resistance/intolerance to prior kinase inhibitors or T315I mutation status as required

Genotype‑based exclusion (Kalydeco)

Kalydeco is not effective in patients homozygous for the F508del CFTR mutation; such genotype should not be submitted as eligible for Kalydeco.

• Do not request Kalydeco for patients homozygous for F508del
• Provide genotype testing results to confirm eligibility

Liver monitoring and impairment — Jynarque denial risk

For Jynarque initial use, lack of required liver enzyme monitoring (ALT/AST/bilirubin at baseline, 2 and 4 weeks, then monthly for first 18 months, then at least every 3 months) or history of significant liver impairment risks denial.

• Provide liver enzyme monitoring per schedule and exclude significant liver impairment (other than uncomplicated polycystic liver disease)
• Failure to document monitoring may lead to denial

Prior therapy exclusion for Mekinist

Mekinist will not be approved as a single agent for members who have received prior BRAF‑inhibitor therapy; verify prior BRAF‑inhibitor exposure before request.

• Do not request Mekinist monotherapy if member received prior BRAF‑inhibitor therapy
• Document prior therapy history

Specific refusal condition — Quinine Sulfate

Coverage will not be approved for treatment or prevention of nocturnal leg cramps (Quinine Sulfate); do not submit for this indication.

• Do not request quinine sulfate for nocturnal leg cramps

Concurrent therapy exclusion — Rubraca

Rubraca will not be approved for concurrent use with other chemotherapy agents; document monotherapy or maintenance context per policy.

• Do not request Rubraca for concurrent administration with other chemotherapy agents
• Document maintenance or monotherapy context as specified

Single‑agent induction exclusion — Rydapt

Rydapt will not be approved as single‑agent induction therapy for AML; for FLT3+ AML first‑line use, it must be combined with standard cytarabine and daunorubicin induction and cytarabine consolidation.

• Do not request Rydapt as single‑agent induction for AML
• If used first‑line for FLT3+ AML, document planned combination with standard induction/consolidation

TIRF non‑cancer exclusion

TIRF products are not covered for any non‑cancer pain indication; ensure requests are for opioid‑tolerant adult cancer patients with documented breakthrough pain.

• Do not submit TIRF products for non‑cancer pain
• Document opioid tolerance and cancer‑related breakthrough pain

Tadalafil/Tafinlar specific exclusions

Tadalafil is excluded from coverage for erectile dysfunction; Tafinlar is not indicated for wild‑type BRAF mutations — verify indication and mutation status before submission.

• Do not request tadalafil for ED under this benefit
• Do not request Tafinlar for wild‑type BRAF tumors

Documentation missing for genetic eligibility (CF)

Lack of documentation of the required CFTR mutation (e.g., F508del or a CFTR mutation responsive to therapy) for cystic fibrosis drugs may trigger denial; include genetic test results.

• Attach CFTR mutation testing results showing required mutation or responsive mutation data
• Missing genotype documentation may result in denial

Molecular and prior therapy requirements (breast cancer)

Absence of documented PIK3CA/AKT1/PTEN alteration or lack of required prior endocrine therapy (where applicable) may trigger denial for the listed breast cancer agent; include molecular testing and prior therapy history.

• Provide molecular testing results (PIK3CA/AKT1/PTEN)
• Document prior endocrine therapy and progression or recurrence timeline

Failure to meet step/failure therapy requirements (RA, JIA)

Failure to document required trials of comparator therapies (e.g., biologics or JAK inhibitors for RA/JIA) — including reasons for failure, intolerance, or contraindication — may trigger denial for rheumatologic products.

• Document prior trials, durations, and reasons for failure/intolerance/contraindication
• Include prescriber specialty consultation when required

Missing required diagnosis or prior therapy

Requests lacking a documented diagnosis that matches the product's required medical information or lacking required prior therapy documentation (e.g., VHL diagnosis, PD‑1/PD‑L1 + VEGF‑TKI exposure for RCC) may be denied.

• Ensure submitted diagnosis matches the product's 'Required Medical Information'
• Include prior therapy documentation where specified to avoid denial

Documentation affects coverage determination

Failure to submit information describing the use and setting of the drug when requested may prevent determination of whether coverage is under Medicare Part B or Part D and could lead to denial or misrouted coverage.

• Provide use and setting details when requested (e.g., infusion in hospital outpatient vs Part D pharmacy)
• Omission may lead to coverage routing errors or denial

For Abilify Mycite: documentation of diagnosis and prior oral aripiprazole response

For Abilify Mycite, include documentation of diagnosis (bipolar I disorder, major depressive disorder, or schizophrenia) and evidence of worsening with oral aripiprazole; prescriber must be a psychiatrist.

• Document diagnosis and worsening with oral aripiprazole
• Confirm prescriber is a psychiatrist

For abiraterone: diagnosis and combination therapy documentation

For abiraterone (Yonsa), document metastatic castration‑resistant prostate cancer or metastatic high‑risk castration‑sensitive prostate cancer and that abiraterone is being used in combination with prednisone; prescriber must be an oncologist or urologist.

• Document metastatic CRPC or metastatic high‑risk castration‑sensitive prostate cancer
• Confirm use in combination with prednisone
• Prescriber: oncologist or urologist

For adalimumab products: documented diagnosis specific to the indication

For adalimumab products, provide diagnosis specific to the indication (e.g., ankylosing spondylitis, Crohn's disease, moderate‑to‑severe UC, hidradenitis suppurativa, plaque psoriasis with prior topical failure, RA with prior conventional therapy trial/failure); prescriber must be or consult with relevant specialist (dermatologist, gastroenterologist, ophthalmologist, or rheumatologist).

• Attach diagnosis documentation for the specific indication
• Include evidence of prior therapy trials or failures where required
• Document specialist prescriber or consultation

General required medical information (per‑product)

For listed products, required medical information must include a documented diagnosis per product‑specific indications (e.g., symptomatic/progressive medullary thyroid cancer for Cometriq); include the items enumerated in each product's 'Required Medical Information' when submitting PA.

• Provide the exact diagnostic and treatment criteria listed under 'Required Medical Information' for the product
• Omit nothing required by the product entry to avoid delays

Ensacove documentation (NSCLC ALK, no prior ALK‑inhibitor)

For Ensacove, include NSCLC diagnosis with ALK rearrangement and confirmation that the patient has not previously received an ALK‑inhibitor.

• Attach ALK rearrangement testing and prior therapy history showing no prior ALK‑inhibitor exposure