PA required for listed formulary drugs

Prior authorization is required for drugs listed in the formulary and must be obtained before coverage; PA may require meeting clinical and/or administrative criteria and is typically granted for one year unless otherwise specified.

• Submit required medical records and evidence of prerequisite therapy trials where applicable.
• Confirm coverage duration (commonly 1 year) and any product‑specific documentation or lab thresholds prior to submission.

Adbry PA and prerequisite therapy

Adbry requires prior authorization and a documented trial and treatment failure of one of the listed topical or systemic therapies for atopic dermatitis in patients 12 years and older; reauthorization requires documentation of a positive clinical response and dosing for patients <100 kg is limited to 300 mg every 4 weeks after 16 weeks unless clinical rationale is provided.

• Trial and failure of one: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
• Do not request Adbry in combination with another biologic or targeted DMARD for the same condition.

General prior authorization requirement

Obtain prior authorization with required clinical documentation (diagnosis, prerequisite therapy trials when specified) — most authorizations are for one year; some products may require initial shorter durations or lifetime coverage as noted per product.

• Include diagnosis, prior therapy trial dates, relevant labs/imaging, and prescriber information.
• Verify product-specific duration (e.g., Praluent = 3 years; many biologics = 1 year).

Reauthorization requires documentation of clinical response

For biologics and many specialty agents, reauthorization requires documentation that the patient has experienced a positive clinical response to therapy; include objective measures or clinician assessment in the request.

• Attach clinical notes demonstrating improvement or stability per the product’s reauthorization criteria.
• For Nucala and similar agents, explicitly state the clinical benefit observed since initiation.

PA: include diagnosis, prior trials and duration

Prior authorization requests must include diagnosis, documentation of required prior therapy trials where specified, and supporting labs or imaging; coverage durations are typically one year unless a different duration is specified.

• For drugs with lab thresholds (e.g., eosinophil counts, LDL, BMD), include the corresponding lab values and dates.
• If a prerequisite Part D drug is required, document the trial and dates in the chart or claim history.

Breast cancer: document required combination therapy

For HR‑positive, HER2‑negative advanced/metastatic breast cancer, ensure PA documents combination use with an aromatase inhibitor as initial endocrine‑based therapy or with fulvestrant after progression; include prior endocrine therapy history.

• Document regimen (aromatase inhibitor or fulvestrant) and prior endocrine therapy status.
• Include tumor receptor status and relevant prior treatment dates.

Ph+ ALL: combination with chemotherapy or mutation‑driven monotherapy

For newly diagnosed Ph+ ALL, submit prior authorization showing combination use with chemotherapy; for T315I‑positive Ph+ ALL or CML monotherapy may be allowed when no other kinase inhibitors are indicated — document mutation status and prior kinase inhibitor history.

• Provide cytogenetic/mutation testing results (T315I) and chemotherapy regimen details.
• If monotherapy requested, document absence of alternative indicated kinase inhibitors.

Lenvima: include combination and prior therapy details

When requesting Lenvima, include documentation of the required combination partner or prior therapy per indication (e.g., combination with pembrolizumab for first‑line RCC); specify tumor type and prior systemic therapies.

• Document prior lines of therapy and rationale for chosen combination.
• Include oncology treatment history and dates.

Formulation requirement: levetiracetam solution plus swallow impairment

For formulation‑specific requests (e.g., levetiracetam oral solution), provide BOTH a trial of the oral solution and objective documentation that the patient is unable to swallow tablets or capsules.

• Document trial of levetiracetam oral solution and evidence of swallowing impairment (e.g., clinician note).
• If requesting an alternative formulation, show why tablets/capsules are not feasible.

Liquid formulation: document inability to swallow and same indication criteria

Liquid formulations (e.g., Mekinist liquid) require documented inability to swallow tablets and otherwise meet the same mutation‑ and combination‑based indication requirements as the tablet formulation.

• Provide evidence of swallowing impairment and the same molecular testing or prior therapy documentation required for tablet use.
• Confirm the indication and any combination therapy specified for the tablet form.

mCRC: document required combination use and prior chemotherapies

For Lonsurf in mCRC, prior authorization must document combination use with bevacizumab and prior chemotherapy history including fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based regimens and anti‑VEGF therapy; for RAS wild‑type disease document prior anti‑EGFR therapy trial.

• Attach prior chemotherapy regimen details and dates, and confirmation of bevacizumab combination.
• For RAS wild‑type mCRC, include prior anti‑EGFR therapy trial documentation.

Age‑restricted prior authorization — confirm patient age

Certain prior authorizations apply only for patients under age 30 — confirm patient age and include it in the PA request when the product entry specifies this restriction.

• Verify patient date of birth and include age in the PA submission.
• If age restriction applies, document rationale if requesting an exception.

Nucala: include eosinophil counts, diagnosis and prior controller trials

Nucala PA requires indication‑specific documentation (e.g., eosinophil counts, diagnosis confirmation, prior controller therapy trials); reauthorization requires documentation of positive clinical response.

• Include eosinophil count at initiation (≥150 cells/µL for eosinophilic asthma; ≥300 cells/µL for COPD add‑on maintenance where applicable).
• Provide evidence of prior controller therapies and clinical response for reauthorization.

GAA deficiency drugs: diagnostic assay and genetic confirmation

Drugs for enzyme deficiency (GAA/Pompe) require PA with documentation of diagnostic confirmation by serum assay showing decreased acid alpha‑glucosidase activity and genetic testing demonstrating a GAA mutation; include symptom documentation and history of ERT response.

• Attach serum assay results showing decreased enzyme activity and genetic testing confirming a GAA mutation.
• Document symptomatic manifestations and lack of improvement on current ERT.

Posaconazole DR: document prior azole trials and high‑risk status

Posaconazole DR prior authorization for prophylaxis or treatment requires documentation of high‑risk status or prior fungal infection and trials of two alternative azoles (fluconazole, itraconazole, or voriconazole); coverage duration is 6 months for prophylaxis.

• Include prior azole trial dates and responses.
• For prophylaxis, document HSCT/GVHD status or prolonged neutropenia indication.

Praluent: document high‑intensity statin trial and LDL lab values

Praluent PA requires documentation of LDL values while on a high‑intensity statin within the last 120 days and a trial of at least 12 weeks on high‑intensity statin (or documented statin intolerance); reauthorization requires continued statin therapy (or intolerance) and evidence of LDL reduction.

• Provide LDL while on high‑intensity statin (LDL ≥55 mg/dL with ASCVD or LDL >70 mg/dL without ASCVD).
• Document statin trial duration and any statin intolerance details.

PA duration: verify and document product‑specific coverage length

Most specialty PAs are granted for one year; verify product‑specific duration and include this in the PA request (some agents specify different durations such as 3 years or lifetime).

• Check the product entry for coverage duration (e.g., Praluent = 3 years; many psychiatric long‑acting injectables = lifetime).
• Plan requests and renewal timing accordingly.

Retevmo: include RET genetic test and prior radioactive iodine when required

Retevmo prior authorization requires documentation of RET gene fusion or RET mutation detected by an FDA‑approved test for RET‑altered cancers; some thyroid indications also require trial and failure with radioactive iodine where appropriate.

• Attach the FDA‑approved test result documenting RET fusion/mutation.
• When applicable, provide evidence of trial and failure with radioactive iodine.

Tolvaptan: document absence of liver disease and prior treatments

Tolvaptan PA requires documentation that the patient does not have underlying liver disease and evidence of trial of at least two alternative treatments (e.g., furosemide, demeclocycline, fluid restriction).

• Include liver evaluation documenting absence of underlying liver disease.
• Document trials of at least two listed alternative treatments and responses.

Skyrizi: 1‑year PA and reauthorization with clinical response; no combination biologics

Skyrizi PA requires a 1‑year authorization and reauthorization must include documentation of positive clinical response; do not request Skyrizi in combination with another biologic or targeted DMARD for the same condition.

• Provide diagnosis‑specific documentation (e.g., active PsA, plaque psoriasis, CD/UC activity) and clinical response for renewal.
• Confirm absence of concurrent biologic/targeted DMARD therapy for the same condition.

Tafinlar: prior therapy and swallowability requirement for liquid

Tafinlar (including liquid) requires prior authorization with 1‑year coverage; certain indications require prior therapies (e.g., vemurafenib + cobimetinib for BRAF V600E/V600K melanoma) and liquid formulation requests must document inability to swallow capsules.

• Document prior BRAF‑targeted therapy trials and combination therapy history as required by indication.
• For liquid formulation, include clinician documentation of swallowing impairment.

Tagrisso: PA with mutation and prior therapy documentation

Tagrisso prior authorization requires 1‑year authorization and indication‑specific documentation (adjuvant after resection, first‑line metastatic, or EGFR T790M after progression on EGFR TKI); include mutation testing and prior EGFR TKI therapy when applicable.

• Attach EGFR mutation testing results and prior therapy history.
• State the treatment setting (adjuvant vs metastatic) and prior therapy outcomes.

PA required — follow product‑specific prerequisites and documentation

Prior authorization is required for many specialty products; ensure the PA includes the product‑specific prerequisite therapies, diagnostic tests, and documentation outlined in the corresponding product entry.

• Consult the product entry for required prior lines of therapy or combination partners.
• Include all requested labs, imaging, genetic tests, and prior treatment documentation.

Ovarian maintenance: document response to platinum chemotherapy

Ovarian maintenance therapies require documentation of complete or partial response to first‑line platinum‑based chemotherapy before authorization; include chemotherapy regimen and response documentation.

• Attach records confirming platinum‑based chemotherapy and response (CR/PR).
• Include sequencing and dates of chemotherapy.

SCLC: document progression after platinum chemotherapy; confirm induction status for maintenance

For metastatic SCLC and maintenance extensive‑stage SCLC, document disease progression on or after platinum‑based chemotherapy; maintenance requests must confirm no progression following first‑line induction including atezolizumab when required.

• Provide prior platinum‑based chemotherapy details and progression documentation.
• For maintenance, document first‑line induction regimen and disease status post‑induction.

Zilbrysq MG: prior immunosuppressive therapy, antibody confirmation, and stable regimen

Zilbrysq PA for myasthenia gravis requires prior treatment courses of at least 12 weeks with one of the listed immunosuppressive agents, documentation of anti‑AChR antibody positivity and one confirmatory test, and confirmation the patient will continue a stable regimen.

• Include anti‑AChR antibody test result and one confirmatory test (edrophonium, response to cholinesterase inhibitors, or RNS/SFEMG).
• Document prior 12‑week immunosuppressive therapy course and plan to continue stable regimen.

Zonisade seizure criteria: document generic anticonvulsant trials or swallow inability

Zonisade PA requires either a trial of at least two generic anticonvulsants (one must be generic zonisamide) or documentation that the patient is unable to swallow tablets/capsules.

• Document trials of two generic anticonvulsants (including generic zonisamide) with dates and outcomes.
• If inability to swallow is claimed, include clinician documentation of swallowing impairment.

Zurzuvae PPD: onset timing and postpartum window documentation

Zurzuvae PA for postpartum depression requires diagnosis with symptom onset in the third trimester or within 4 weeks postpartum and that the member is ≤12 months postpartum; include timing of symptom onset and postpartum status.

• Document onset timing of depressive symptoms and the member’s postpartum age (≤12 months).
• Include relevant psychiatric assessment and prior therapies if applicable.

Combination biologic/targeted DMARD exclusion — confirm no concurrent biologic

Requests for certain products will be denied if used in combination with another biologic or targeted DMARD indicated for the same condition; verify and document that no concurrent biologic/targeted DMARD for the same condition is being used.

• Explicitly state concurrent medications and confirm absence of another biologic/targeted DMARD for the same condition.
• If combination therapy is clinically justified, include rationale — but coverage is typically excluded.

Drug‑drug exclusion: tadalafil with nitrates is not covered

Do not submit PA requests for tadalafil when the patient is receiving nitrate therapy; such requests are not covered.

• Confirm medication list for concurrent nitrate therapy and document in the PA request.
• If nitrates are present, indicate that tadalafil should not be used per exclusion.

Dalfampridine: wheelchair exclusion and T25FW documentation required

Dalfampridine is excluded for patients who are wheelchair bound or become wheelchair bound — document ambulation status and include baseline timed 25‑foot walk (T25FW) prior to initiation; reauthorization requires stability or improvement on T25FW.

• Submit baseline T25FW test results before initiation and include follow‑up T25FW for reauthorization.
• Document patient ambulatory status; wheelchair‑bound patients are excluded.

Weight‑loss exclusion: GLP‑1 agents not covered for weight‑loss only

Requests for GLP‑1 receptor agonists used solely for weight loss (without documentation of T2DM) are excluded; when used for diabetes include medical records or lab evidence (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour PG ≥200 mg/dL).

• For diabetes indication, attach A1c, FPG, or OGTT results demonstrating T2DM.
• If obesity/weight‑loss use only, coverage will be denied.

Posaconazole: document trial of two alternative azoles or risk denial

Posaconazole prophylaxis requires documented trials of two alternative azoles (fluconazole, itraconazole, voriconazole); absence of these prior trials may lead to denial.

• Provide dates and outcomes for trials of two listed azoles.
• For treatment indications, include infectious disease specialist notes and culture/test results as appropriate.

Invega Hafyera: document prior paliperidone palmitate LAI use for required durations

Invega Hafyera authorization requires prior trial of 1‑month paliperidone palmitate for at least 4 months OR a 3‑month paliperidone palmitate cycle for at least one three‑month cycle; include prior long‑acting injectable history with dates.

• Attach prior paliperidone palmitate long‑acting injectable administration records with durations.
• If criteria not met, document clinical rationale or intolerance.

Praluent: statin trial and LDL lab documentation required

Praluent requests must show documented use of a high‑intensity statin for at least 12 weeks (or documented intolerance) and LDL values while on statin therapy; failure to document these will risk denial.

• Include statin prescription history and LDL values within prior 120 days.
• If statin intolerance claimed, provide supporting clinical documentation.

Rivfloza: transplant and combination exclusions — verify history

Rivfloza coverage is explicitly excluded for patients with a history of kidney or liver transplant or when used in combination with specified products (e.g., OXLUMO); verify transplant history and concurrent therapies.

• Document transplant history (kidney or liver) — presence excludes coverage.
• List current medications to confirm absence of excluded combination agents.

Combination therapy exclusions with potent immunosuppressants or another biologic

Do not request coverage when product entries prohibit combination with potent immunosuppressants or another biologic/targeted DMARD for the same condition (e.g., Rinvoq, Skyrizi, Xeljanz); such combinations may be denied.

• Confirm and document current immunosuppressive and biologic therapies.
• If combination is clinically necessary, include detailed justification though coverage is typically excluded.

Tetrabenazine: exclusions and CYP2D6 genotype requirement for higher doses

Tetrabenazine is not covered for patients with hepatic impairment, active suicidal ideation or untreated/inadequately treated depression, or concomitant use of MAO inhibitors or reserpine; for doses above 50 mg/day include CYP2D6 genotype documentation.

• Document hepatic function, psychiatric status, and concomitant medications (MAO inhibitors, reserpine).
• If dose >50 mg/day requested, include CYP2D6 genotype results.

Tafinlar liquid: document inability to swallow capsule formulation

Liquid Tafinlar requests must demonstrate inability to swallow capsules; include clinician documentation of swallow impairment when requesting the liquid formulation.

• Provide objective evidence or clinician note documenting inability to swallow capsules.
• Also include indication‑specific prior therapy documentation required for the capsule formulation.

H. pylori: document guideline‑recommended first‑line regimen trial

For H. pylori therapies (Voquezna), document a trial of a guideline‑recommended, generic first‑line regimen (e.g., clarithromycin triple therapy or bismuth quadruple therapy); lack of such trial may result in denial.

• Attach prescription records or clinician notes showing prior first‑line H. pylori regimen.
• If regimen contraindicated, include rationale.

Document trials of specified generics/alternatives to meet step requirements

If a PA requires demonstration of prior generic or alternative therapy (e.g., oral risperidone before risperidone ER/Rykindo; generic ER carbidopa/levodopa before Rytary; generic dapagliflozin before Farxiga/Jardiance), include trial documentation or intolerance evidence to avoid denial.

• Provide medication fill/claim history, dates, and reason for failure or intolerance.
• For Jardiance CV indication, note that step therapy does not apply for the cardiovascular mortality indication.

Claims history and site‑of‑care documentation (insulin lookback / Part B vs D)

Ensure PA submissions include any required claims history (e.g., a claim for an insulin product within the last 180 days for certain gauze/pad products) and site‑of‑care information when needed to determine Medicare Part B vs Part D coverage.

• Attach pharmacy/medical claims showing insulin product within 180 days when requested.
• State the intended administration setting to determine Part B vs D coverage if relevant.

Infusion/administration setting may affect coverage (Part B vs D)

For infusion products or drugs that may be billed under Medicare Part B or Part D, submit information describing the clinical use and site of care (infusion center, outpatient, or home) to determine the appropriate coverage pathway.