Abilify Mycite — prior authorization and psychiatrist prescriber required

Prior authorization is required. Submit documentation showing a diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia and evidence of worsening symptoms with oral aripiprazole; the prescriber must be a psychiatrist. Approval duration: 2 years.

Arikayce — prior authorization and specialist consult required

Prior authorization is required. Provide documentation of MAC lung disease, use as part of a combination antibacterial regimen, and failure to achieve at least two negative sputum cultures after ≥6 consecutive months of a multidrug background regimen; prescription must be by or in consultation with an infectious disease specialist or pulmonologist. Approval duration: 2 years.

Prior authorization required for listed specialty drugs

Prior authorization is required for many listed Part D specialty drugs; submit the documented diagnosis and any required prior therapy history per the product-specific criteria. Coverage durations are specified per product entry (frequently 2 years).

Prior authorization: document diagnosis and prior therapy failure

Prior authorization generally requires submission of a documented diagnosis and evidence of prerequisite therapy failure as specified for the product (for example, everolimus requires documented failure of letrozole or anastrozole).

• Include prior therapy trial/failure dates and outcomes where required

Prior authorization required — product-specific documentation needed

Prior authorization is required for many specialty products in this segment; include the indicated diagnosis, prescriber specialty when specified, and documentation of prior therapy status per the product-specific criteria.

Jynarque (tolvaptan) PA — mandatory liver test schedule

Prior authorization requires liver monitoring per the schedule: measure ALT, AST, and bilirubin prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months if receiving Jynarque ≤18 months; if >18 months, measure at least every 3 months. Document diagnosis of rapidly progressing ADPKD and absence of significant liver impairment.

• Pre-initiation and 2- and 4-week labs, then monthly x18 months (if ≤18 months)
• If on therapy >18 months, labs at least every 3 months
• Confirm no history of significant liver impairment/injury

Psychiatric agents — psychiatrist prescriber and documented diagnosis required

Prior authorization is required for listed psychiatric agents. Provide a documented diagnosis of schizophrenia or Bipolar I disorder and ensure the prescriber is a psychiatrist. Approval duration: 2 years.

Lynparza — mutation testing and prior therapy documentation required

Lynparza prior authorization requires documentation of the relevant mutation status (deleterious or suspected deleterious germline/somatic BRCA or HRR as applicable) and prior chemotherapy or endocrine therapy as specified by indication; prescriber must be an oncologist. Coverage duration: 2 years.

• Include molecular test reports demonstrating BRCA/HRR mutation status
• Document prior chemotherapy and/or endocrine therapy per indication

Lytgobi — FGFR2 fusion/rearrangement and prior treatment documentation required

Prior authorization for Lytgobi requires documentation that the tumor is unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements, and documentation of prior treatment status; prescribe by or in consultation with an oncologist.

• Submit FGFR2 fusion/rearrangement test results
• Document prior lines of therapy and disease status

Prior authorization — document prior trials and outcomes

Prior authorization for many specialty products requires documentation of the diagnosis and trials of specified conventional therapies; include prior trial details and outcomes per the product entry.

• Document names, doses, durations, and reasons for discontinuation of prior therapies

Rubraca — BRCA and platinum-response documentation; prerequisite Part D noted

Rubraca prior authorization requires documentation of a deleterious BRCA mutation (germline and/or somatic) and response to platinum-based chemotherapy for recurrent ovarian cancer; the product entry indicates a prerequisite Part D drug is required in context.

• Submit BRCA test report and platinum-response documentation
• Note prerequisite Part D drug relationship as indicated

Rydapt — FLT3 mutation confirmation and combination use required

Rydapt prior authorization requires documented FLT3 mutation-positive AML and that Rydapt will be used as first-line therapy in combination with cytarabine and daunorubicin induction and cytarabine consolidation; the criteria indicate Rydapt does not require a prerequisite Part D drug.

Trikafta — PA required; no prerequisite Part D drug

Trikafta prior authorization is required for cystic fibrosis: submit documentation of CF diagnosis and at least one responsive CFTR mutation; the policy states Trikafta does not require prior Part D drug use.

• Include CFTR genotype showing F508del or other responsive mutation

TIRF — PA required for breakthrough cancer pain; opioid-tolerant adults only

TIRF (fentanyl lozenges) prior authorization is required for management of breakthrough cancer pain in adult cancer patients who are opioid-tolerant and already receiving around-the-clock opioid therapy; prescriber must be an oncologist or pain management specialist. TIRF products are not covered for non-cancer pain.

• Document opioid-tolerant status (e.g., morphine 60 mg/day or fentanyl transdermal 25 mcg/hr equivalent)
• Confirm ongoing around-the-clock opioid regimen when using TIRF

Trikafta — age/formulation restrictions and CFTR mutation documentation required

Trikafta prior authorization requires CF diagnosis with at least one qualifying CFTR mutation and includes age- and formulation-specific restrictions (granules for 2 to <6 years; tablets for ≥6 years); prescriber should be a pulmonologist or CF specialist. Approval duration: 2 years.

• Specify formulation requested and patient age
• Provide evidence of positive clinical response on reauthorization

Voquezna — prerequisite therapy (bismuth quadruple or two PPIs) required for PA

Voquezna prior authorization is required for indicated pack types; for H. pylori, document trial and failure (or contraindication/intolerance) to bismuth quadruple therapy; for HRH/MHRH/NERD document trial and inadequate response/intolerance to two generic PPIs as specified.

• For H. pylori: document prior bismuth quadruple therapy trial and outcome
• For HRH/MHRH/NERD: document trials of two generic PPIs and inadequate response

Part D specialty drugs — submit product-specific medical information and prescriber specialty

Prior authorization for listed Part D specialty drugs requires submission of product-specific required medical information and, when specified, the prescriber specialty; many of these products have coverage durations frequently set to 2 years.

• Include all product-specified supporting evidence (e.g., labs, imaging, mutation tests)

Product-specific PA requirements — follow section cross-references

Many products in this policy are indexed; coverage and any prior authorization requirements depend on the product-specific section elsewhere in the full policy—check the index and submit the information requested for that product.

• Refer to the policy index for product-specific PA instructions

Dermatologic step therapy — prerequisite topical/systemic therapy required

For dermatologic indications (e.g., plaque psoriasis) requiring biologics, prior authorization commonly requires documented trial and failure, contraindication, or intolerance to specified topical therapies (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, or coal tar) before biologic approval.

• Document duration and outcome of topical/systemic therapy trials as specified

Step therapy examples — document failures or intolerances to listed prior therapies

Some products require documented failure or intolerance to specific prior therapies (e.g., Cosentyx requires failure/intolerance to listed topical therapies for plaque psoriasis or two NSAIDs for nr-axSpA). Include trial durations where specified.

• For nr-axSpA and ERA: document two NSAID trials at maximally indicated doses for at least one month

Prerequisite therapy — document prior systemic therapy trials/failures

Several products require prior trials or failures of specified therapies before approval (examples: everolimus requires failure of letrozole/anastrozole; Fotivda requires prior systemic therapies; Jakafi for chronic GVHD requires failure of one or two systemic therapies). Provide prior treatment details.

• List prior agents, durations, and reasons for discontinuation

Kineret (RA) — trial/failure of two alternatives required unless inappropriate

For Kineret in rheumatoid arthritis (initial), document trial and failure, contraindication, or intolerance to two specified alternatives (e.g., etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) unless attestation that trials are inappropriate; prescriber should be or consult with a rheumatologist.

• Provide attestation if trials are inappropriate instead of completed trials

Prerequisite Part D therapy — confirm and document per product

Some products explicitly require prior or prerequisite Part D drug(s); other products explicitly do not. Confirm per product entry whether a prerequisite Part D therapy is required and document use when indicated.

• When a product 'DOES require' a prerequisite Part D drug, submit documentation of that prior Part D therapy

Prerequisite conventional therapy trials for autoimmune agents

Many autoimmune and rheumatologic agents require trials of conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine) with documentation of trial and failure, intolerance, or contraindication prior to biologic or small-molecule therapy authorization.

• Include documentation of conventional therapy trials and outcomes

Genotype documentation required (Orkambi example)

For Orkambi and similar CF drugs, provide genotype documentation; Orkambi requires documentation that the member is homozygous for the F508del mutation.

• Attach genetic test reports confirming F508del homozygosity

Stelara — prior trial of Yesintek or Steqeyma required

For Stelara, document trial, intolerance, or contraindication to Yesintek or Steqeyma prior to approval; prescriber specialty is required for initial requests.

Skyrizi — prior topical/systemic therapy failure required for plaque psoriasis

Skyrizi prior authorization for plaque psoriasis requires documentation that the patient failed or was unable to tolerate at least one listed topical or systemic therapy prior to approval; include prior therapy details.

Biologic/small molecule step therapy — document trials/failures to listed agents

For many rheumatologic and pediatric autoimmune indications (RA, SJIA, PJIA), biologic or disease-modifying agents require documented trials and failures, contraindications, or intolerances to specified agents (e.g., Enbrel, adalimumab, Orencia, Rinvoq, Xeljanz) before approval.

• Document each prior agent tried, dose, duration, and reason for discontinuation

Abilify Mycite — submit diagnosis and oral aripiprazole worsening

For Abilify Mycite, include documented diagnosis (bipolar I disorder, major depressive disorder, or schizophrenia) and documentation that symptoms worsened with oral aripiprazole; the prescriber must be a psychiatrist. Approval duration: 2 years.

Balversa — FGFR3 alteration and prior progression documentation required

For Balversa, submit documentation of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, prior progression after at least one systemic therapy, and prior PD‑1/PD‑L1 inhibitor therapy or ineligibility for such therapy; prescriber must be an oncologist.

• Attach FGFR3 molecular testing and prior therapy history

Document diagnosis — include diagnostic evidence per product

A documented diagnosis is required for each product/indication listed; include clear diagnostic evidence in the submission (e.g., pathology, imaging, genetic test results) as specified by the product entry.

• Ensure documentation aligns with the product-specific required medical information

Dupixent — prior topical therapy trials and phenotype details required

For Dupixent, provide documentation of prior topical therapy trials for atopic dermatitis (minimum 30-day supply, or 14 days for topical corticosteroids in sensitive areas) or other phenotype-specific clinical details for asthma, COPD, or listed eosinophilic/immune conditions; prescriber specialty should be included.

• Specify duration and outcomes of topical therapy trials

Everolimus (TBSO) — document postmenopausal status, exemestane use, and prior AI failure

For everolimus (TBSO) in advanced HR+ breast cancer, submit documentation that the member is postmenopausal, is taking exemestane concurrently, and has documented failure of letrozole or anastrozole; include diagnosis and prior therapy details.

TSC-related products — document TSC-associated diagnosis and surgical ineligibility

For products in chunk 37 (e.g., for TSC-related indications), document the diagnosis of partial-onset seizures associated with TSC or SEGA associated with TSC and that the patient is not a candidate for surgical resection when indicated; prescriber should be a neurologist or oncologist.

Icatibant — confirmatory lab testing required for HAE Types 1 & 2

For Icatibant for HAE Types 1 & 2, confirm the diagnosis with laboratory testing (e.g., low C4, reduced C1 esterase inhibitor level or function) and document a history of at least one severe attack in the past six months.

• Attach C4 and C1 esterase inhibitor level/function test results

Tolvaptan (Jynarque) — liver monitoring schedule required

Measure ALT, AST, and bilirubin per the Jynarque monitoring schedule: prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months (if receiving ≤18 months); if >18 months on therapy, measure at least every 3 months. Document absence of significant liver impairment.

NOMID — mutation or clinical+lab confirmation required for Kineret

For NOMID initial approval with Kineret, provide confirmatory evidence via NLRP3 mutation testing OR documentation of two clinical features plus elevated acute phase reactants as specified.

• Submit genetic test results or clinical feature documentation with CRP/ESR values

Psychiatric drug documentation — diagnosis and psychiatrist prescriber required

For listed psychiatric drugs, include a documented diagnosis of schizophrenia or Bipolar I disorder and ensure the prescribing physician is a psychiatrist.

Lytgobi documentation — FGFR2 fusion/rearrangement and disease status required

For Lytgobi, document unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements and that the drug is prescribed by or in consultation with an oncologist.

• Attach FGFR2 fusion/rearrangement molecular test report

LDL-C lowering agents — document LDL-C and statin tolerance/intolerance

For LDL-C lowering agents (Nexletol/Nexlizet), submit documentation of elevated LDL-C on maximally tolerated statin therapy or statin intolerance, plus diagnosis of heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease, or high cardiovascular risk as specified.

Autoimmune indications — document diagnosis and conventional therapy trial/failure

For selected autoimmune indications (e.g., rheumatoid arthritis), document diagnosis of moderately to severely active disease and trial and failure, contraindication, or intolerance to specified conventional therapies (methotrexate, leflunomide, sulfasalazine) as required.

Orkambi — homozygous F508del genotype documentation required

For Orkambi, attach genotype documentation showing the member is homozygous for the F508del CFTR mutation as required.

Piqray — PIK3CA mutation and progression on endocrine therapy required

For Piqray, submit documentation of HR-positive, HER2-negative, PIK3CA-mutated advanced/metastatic breast cancer, evidence of progression on or after an endocrine regimen, and planned use with fulvestrant.

Rezdiffra — fibrosis staging and metabolic risk documentation required

For Rezdiffra (MASH/NASH), document diagnosis without cirrhosis, fibrosis stage F2 or F3 confirmed by specified biomarker/imaging or liver biopsy within the past 12 months, and presence of at least one metabolic risk factor.

Rubraca — deleterious BRCA and platinum-response documentation required

Rubraca prior authorization requires documentation of a deleterious BRCA mutation (germline and/or somatic) and evidence of response to platinum-based chemotherapy for recurrent ovarian cancer; prescriber must be an oncologist.

Rydapt — FLT3 mutation and combination induction/consolidation documentation required

Rydapt prior authorization requires documented FLT3 mutation-positive AML and use as first-line therapy in combination with cytarabine and daunorubicin induction and cytarabine consolidation, or documentation of specified mast cell diagnoses where applicable.

Trikafta — CF diagnosis, responsive CFTR mutation, age/formulation, and specialist prescriber required

Trikafta requires documentation of CF diagnosis and a CFTR mutation responsive to therapy; include age- and formulation-specific information and specialist prescriber or consultation. Reauthorization requires demonstration of positive clinical response.

• Provide PPFEV1 or exacerbation data for reauthorization

TIRF documentation — opioid tolerance and cancer breakthrough pain required

For TIRF (fentanyl lozenges), document that the patient is an adult cancer patient with breakthrough pain who is already receiving and tolerant to around-the-clock opioid therapy (opioid-tolerant examples provided) and that the patient will remain on around-the-clock opioids when using TIRF.

• Document opioid-tolerant regimen and equivalent dosing (e.g., morphine 60 mg/day)

Trikafta — CF diagnosis and qualifying CFTR mutation required

Trikafta (CF) requires documentation of CF diagnosis and at least one qualifying CFTR mutation (F508del or other responsive mutation); provide age-appropriate formulation information and specialist prescriber details.

Venclexta (AML) — first-line combination use and patient fitness documentation required

Venclexta for AML requires documentation that the drug is used first-line in combination with azacitidine, decitabine, or low-dose cytarabine and that the patient is ≥75 years or unfit for intensive induction chemotherapy.

Required clinical documentation — include product-specific supporting evidence

Provide documented diagnosis and supporting evidence as specified per product (examples: ATTR-CM requires TTR mutation or biopsy or imaging plus absence of light-chain amyloidosis and NYHA Class I–III; metastatic biomarker-positive tumors require molecular test reports).

• Attach biopsy, imaging, or genetic testing as required by the product

Submit site-of-care details to determine Part B vs Part D coverage

Submit information describing the use and the setting of the drug (infusion center, office, hospital outpatient, or home) to determine whether the drug is covered under Medicare Part B or Part D; failure to submit this information may prevent correct benefit determination.

• Specify site of care and reason for administration when submitting requests

Documentation-linked denials — include all required evidence to avoid denial

Requests lacking required medical information (e.g., missing diagnostic confirmation, mutation test, biopsy, or required prior therapy documentation) may be denied; ensure all product-specified supporting evidence is included.

• Include tests, imaging, and prior therapy documentation per product criteria

Copiktra — document diagnosis and ≥2 prior therapies to avoid denial

Copiktra requires a documented diagnosis of relapsed or refractory CLL/SLL and at least two prior therapies; absence of these documented prior therapies would trigger denial.

CLL/MCL — document diagnosis and prior therapy/transplant status

For many hematology indications (e.g., CLL, MCL), document the diagnosis and, when applicable, prior therapies or transplant ineligibility; lack of these will risk denial.

Icatibant exclusion — do not submit for acquired angioedema or concurrent ACE inhibitor use

Icatibant will not be approved for members with acquired angioedema or those concurrently taking an ACE inhibitor; ensure exclusion criteria are considered before submission.

Iclusig exclusion — not for newly diagnosed chronic phase CML

Iclusig will not be approved for members with newly diagnosed chronic phase CML; ensure the patient meets the product's approved disease-stage criteria before requesting authorization.

Kalydeco genotype exclusion — F508del homozygous patients not eligible

Kalydeco is not effective for patients homozygous for the F508del CFTR mutation; therapy would be denied for that genotype—verify genotype prior to submission.

Lynparza — missing mutation or prior therapy documentation may trigger denial

Lynparza approvals depend on documented deleterious or suspected deleterious gBRCA or HRR mutation status and prior chemotherapy or endocrine therapy as specified; missing this documentation risks denial.

• Provide molecular reports and prior treatment history aligned with indication

Topical acne — cosmetic use excluded

Topical acne products will not be authorized for cosmetic purposes; ensure indication supports medical necessity before submitting a request.

Rubraca — concurrent chemotherapy is excluded

Rubraca will not be approved for concurrent use with other chemotherapy agents; do not submit requests for concurrent chemotherapy regimens.

Rydapt — not approved as single-agent induction for AML

Rydapt will not be approved as single-agent induction therapy for AML; authorization requires use in combination with standard induction agents per the product criteria.

Rubraca concurrent-use exclusion reiterated

Rubraca concurrent-use exclusion: do not request Rubraca when the patient is receiving other chemotherapy agents, as concurrent use is not approved.

Rydapt exclusion reiterated — require combination induction use

Rydapt exclusion reiterated: Rydapt is not approved as single-agent induction therapy for AML—ensure combination induction use is documented.

TIRF exclusion — not covered for non-cancer pain

Transmucosal immediate-release fentanyl (TIRF) products are not covered for any non-cancer pain indication; ensure submitted use is for cancer breakthrough pain in opioid-tolerant patients.

TIRF — non-cancer pain coverage exclusion

TIRF products will not be covered for any non-cancer pain indication—do not submit requests for non-cancer pain management.

Voquezna prerequisite therapies — bismuth quadruple or two-PPI trials required

Voquezna and Voquezna packs require trial and failure, contraindication, or intolerance to bismuth quadruple therapy for H. pylori; for HRH/MHRH/NERD require trial and inadequate response or intolerance to two generic PPIs—document prior therapy trials and outcomes.

Incomplete documentation may trigger denial

Requests lacking required medical information (e.g., diagnostic confirmation, mutation test, biopsy, or absence of disqualifying conditions) may be denied—include the full set of product-specified documents to reduce denial risk.

Submit site-of-care details to determine Part B vs Part D

Submit information describing the clinical use and the site/setting of the drug (infusion center, office, hospital outpatient, or home) so the plan can determine whether coverage applies under Medicare Part B or Part D.

• State intended site of administration and clinical indication on submissions

Site/setting of administration affects Part B vs Part D coverage

Coverage under Medicare Part B or Part D depends on the clinical use and the site/setting of administration; submit setting information (infusion center, hospital outpatient, office, or home) with the request to ensure correct benefit determination.