Prior authorization required

Prior authorization is required for Actimmune; approve for 1 year if diagnostic criteria are met and prescriber restrictions are satisfied (e.g., CGD prescribed by or in consultation with an immunologist, hematologist, or infectious disease specialist; malignant osteopetrosis prescribed by or in consultation with an endocrinologist or hematologist).

PA required for specialty agents with indication evidence

Prior authorization is required for listed specialty agents and will be granted only when indication-specific evidence is provided (for example, ALK-positive status for ALK-targeted agents and required prior therapy trials where noted).

PA required for Actimmune/Arcalyst

Prior authorization is required for Actimmune and Arcalyst product lines with defined initial and continuation criteria including age and prescriber restrictions (e.g., DIRA requires confirmed bi-allelic IL1RN pathogenic variants and clinical benefit with anakinra; CAPS/pericarditis age and specialist requirements).

Arikayce prior authorization and documentation

Arikayce requires prior authorization for MAC lung disease; initial therapy is limited to patients 18 years and older and documentation must include diagnosis, prior medication history, and positive sputum culture for MAC with amikacin susceptibility where applicable.

Besremi (Actimmune) PA requirement

Besremi (Actimmune) requires prior authorization; requests must document diagnosis, the prescriber must be an oncologist or hematologist (or consult), patients must be 18 years or older, and approvals are for 1 year.

Betaseron PA and prescriber restriction

Betaseron requires prior authorization; prescriber or consultation with a neurologist or MS specialist is required and authorization is for 1 year; concurrent use with other disease-modifying MS agents is an exclusion.

Brinsupri PA requirement

Brinsupri for non‑CF bronchiectasis requires prior authorization with documentation of chest CT–confirmed bronchiectasis, exacerbation history per age group, pulmonologist or ID prescriber involvement, and is authorized for 1 year.

Haegarda PA and lab confirmation

Haegarda requires prior authorization for prophylaxis of HAE due to C1‑INH deficiency; baseline labs documenting functional C1‑INH <50% of normal and low serum C4 (or genetic/family-history criteria for HAE with normal C1‑INH) and a prescribing specialist are required; authorizations typically for 1 year.

Cabometyx prior authorization

Cabometyx requires prior authorization with indication-specific documentation (diagnosis, histology, RET rearrangement status where applicable), applicable age restrictions, prior therapy requirements, and typical authorization of 1 year.

Calquence PA and prerequisite therapy

Calquence requires prior authorization; coverage is typically for 1 year and prerequisite systemic therapy is required for certain indications (e.g., mantle cell lymphoma).

Prior authorization criteria (OCD/Panic/Autistic or Depression)

Prior authorization for clomipramine is required; approve only if either (A) prescribed for OCD, panic disorder, or autistic disorder with prior inadequate response/intolerance/contraindication to an SNRI or SSRI, OR (B) prescribed for depression with prior inadequate response/intolerance/contraindication to two of SNRIs, SSRIs, mirtazapine, or bupropion.

PA requirement for dalfampridine (MS)

Dalfampridine (for MS) requires prior authorization; initial and continuation approvals are for 1 year and requests must document the patient is ambulatory, that dalfampridine is being used to improve or maintain mobility, objective impaired ambulation (e.g., timed 25‑foot walk or MSWS‑12), and neurologist/MS specialist involvement.

PA plus prescriber and prerequisite therapy requirements

Many products require prior authorization and have prescriber restrictions; prerequisite therapy is often required and many indications demand the drug be prescribed by or after consultation with a relevant specialist (examples cited across indications).

PA with lab thresholds and prescriber restrictions

Some prior authorizations include explicit laboratory and prescriber requirements (for example, ESA/anaemia approvals require hemoglobin and, when applicable, serum erythropoietin thresholds; certain indications require hematologist/oncologist involvement).

Fabrazyme prior authorization and diagnostic confirmation

Fabrazyme requires prior authorization with genetic or laboratory confirmation of deficient alpha‑galactosidase A activity (or pathogenic GLA variant) and must be prescribed by or in consultation with an appropriate specialist; authorization is for 1 year.

Fingolimod PA and required prescriber/age

Fingolimod requires prior authorization; requests must document diagnosis of a relapsing form of MS, prescriber involvement of a neurologist or MS specialist, patient age 10 years or older, and authorizations are for 1 year.

Fintepla PA and age/prior therapy

Fintepla requires prior authorization; initial therapy has an age restriction (2 years and older for Dravet) and prescriber restriction (neurologist consulted), prior/concomitant AED trial requirements for Dravet, and approvals are for 1 year.

Firmagon PA and billing determination

Firmagon requires prior authorization; prescriber must be or consult with an oncologist and a Part B vs Part D determination will be made at the time of PA; authorization duration is noted as 1 year in other sections.

EGFR-targeted TKIs prior authorization and mutation documentation

EGFR‑targeted TKIs (e.g., gefitinib, afatinib/Gilotrif) require prior authorization; approvals require documented sensitizing EGFR mutation by an approved test, age 18+, and are typically authorized for 1 year.

Oncology prior authorization and mutation proof

Prior authorization is required for listed oncology indications; for EGFR‑mutant advanced/metastatic NSCLC approval requires documented sensitizing EGFR mutation and is authorized for 1 year.

Glatiramer PA and prescriber requirement

Glatiramer products require prior authorization; approval is for 1 year and the prescriber should be or consult with a neurologist or MS specialist; concurrent use with other disease‑modifying MS agents is excluded.

Hernexeos PA and age requirement

Hernexeos requires prior authorization; documentation of diagnosis is required, patient must be 18 years or older, and authorization is for 1 year.

Hyrnuo PA, age and prerequisite therapy

Hyrnuo requires prior authorization; diagnosis must be provided, patient must be 18 years or older, authorization is for 1 year, and prerequisite therapy is required where specified.

High‑risk medications PA and age‑based rules

Multiple high‑risk medications require prior authorization with age‑based rules: patients <65 years generally approve; patients ≥65 years require additional criteria and prescriber risk‑benefit assessment documentation; coverage duration typically 12 months.

PA required — typical 1‑year authorization

Prior authorization is required for many products; where stated, authorizations are for 1 year and apply to patients 18 years and older unless otherwise specified.

PA and prerequisite therapy where specified

Prior authorization is required and prerequisite therapy is required for some indications; see product‑specific criteria for required prior regimens.

Inrebic prior authorization and age/diagnosis

Inrebic requires prior authorization; requests must document diagnosis, patient age ≥18 years, and approvals are for 1 year with indication‑specific criteria (e.g., higher‑risk myelofibrosis).

Itovebi PA and breast cancer criteria

Itovebi requires prior authorization with breast cancer–specific documentation (postmenopausal status or ovarian suppression, HR‑positive/HER2‑negative disease, PIK3CA mutation by approved test, prior endocrine therapy progression/recurrence within 12 months) and is authorized for 1 year.

Itraconazole PA and diagnostic documentation

Itraconazole (oral capsule) requires prior authorization; documentation must confirm intended oral use and diagnostic confirmation for onychomycosis (e.g., KOH, fungal culture, or nail biopsy); duration varies by indication (6 or 12 months).

Ivermectin PA and duration

Ivermectin (oral) requires prior authorization; coverage duration is 30 days and prerequisite therapy is required for some indications (per product criteria).

IVIG PA and authorization duration

IVIG (Gamunex‑C) requires prior authorization for medically accepted indications; authorizations are issued for 12 months and Part B vs D determination may apply per CMS guidance.

Jakafi PA and step therapy

Jakafi/Jakafi XR requires prior authorization; coverage is for 1 year and specific prerequisite therapies are required for indications (e.g., hydroxyurea or peginterferon for polycythemia vera; conventional systemic treatment for chronic GVHD).

Jaypirca prior authorization

Jaypirca requires prior authorization with documentation of diagnosis; coverage is for 1 year per the policy excerpt.

No prerequisite therapy required when stated

No prerequisite therapy required for some products; where the policy states 'No' for prerequisite therapy, no prior trials are required for initial approval.

Step therapy requirements and prior trial documentation

Some products require step therapy: providers must document prior trials of specified agents (for example, Alunbrig requires trial of Alecensa, Ensacove, or Lorbrena for NSCLC patients new to therapy; GLP‑1 anti‑obesity agents require failure of five preferred agents unless exceptions apply).

Benlysta concurrent therapy requirement

Benlysta for SLE must be used concurrently with at least one other standard therapy unless the patient is intolerant; continuation approvals require documented response while on concurrent therapy.

Bosentan step/sequence requirement

For CTEPH use of bosentan, the patient must have tried Adempas, have a contraindication to Adempas, or be currently receiving bosentan before approval is granted.

Brukinsa prerequisite therapy

Brukinsa for follicular lymphoma requires prior trial of at least two other systemic regimens before approval in combination with obinutuzumab.

Clobazam step therapy requirements

Clobazam initial therapy for Lennox‑Gastaut requires that the patient has tried or is concomitantly receiving one of specified AEDs; treatment‑refractory seizures require trial of at least two other antiepileptic drugs.

Step therapy is required where indicated

Yes — step therapy (prerequisite therapy) is required for many products as specified in the prior authorization criteria; providers must document trials, intolerances, or contraindications to required prior therapies.

No prerequisite therapy for specified products

No prerequisite therapy required for certain products where the policy explicitly states 'No' for prerequisite therapy (these requests still require PA and other documentation as noted).

Prerequisite/concomitant therapy requirements (immunology/respiratory)

Many immunology and respiratory indications require prerequisite or concomitant therapy documentation (for example, asthma requires prior use of inhaled corticosteroid plus another controller; CRSwNP requires prior oral corticosteroid use or prior surgery).

Prerequisite therapy required for selected indications

Some indications require product‑specific prerequisite therapy trials as listed in the criteria (examples include everolimus and other oncology agents where prior systemic regimens are required).

Fintepla step therapy for Dravet syndrome

Fintepla for Dravet syndrome requires that the patient has tried or is concomitantly receiving at least two other antiepileptic drugs or has tried/is receiving Epidiolex, Clobazam, or Diacomit prior to approval.

Fotivda step therapy for RCC

Fotivda for renal cell carcinoma initial approval requires prior use of at least two other systemic regimens (patient must have relapsed or Stage IV disease).

Fruzaqla prerequisite chemotherapy sequence

Fruzaqla (fragment) requires prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and an anti‑VEGF agent for colorectal/appendiceal cancer per the detailed criteria.

Platinum chemotherapy prerequisite (squamous NSCLC)

For metastatic squamous NSCLC approvals, disease progression after platinum‑based chemotherapy is required prior to approval.

Head and neck platinum progression requirement

Head and neck cancer approvals require disease progression on or after platinum‑based chemotherapy as a prerequisite for coverage.

Prerequisite therapy / alternatives for high‑risk meds

Many high‑risk medications require trials or intolerance to specified alternative (non‑HRM) agents before approval (for example, hydroxyzine requires trials of specified non‑HRM alternatives for rhinitis).

Prerequisite therapy required where indicated

Prerequisite therapy is required prior to approval for products where the policy indicates 'Prerequisite Therapy Required = Yes'; providers must document trials or contraindications as specified.

Prerequisite systemic therapies required per indication

Step therapy/prerequisite systemic treatments are required for certain indications; providers must follow the indication‑specific step sequences listed in the clinical criteria.

Jakafi step therapy (polycythemia vera)

For Jakafi in polycythemia vera, patients must have tried hydroxyurea or peginterferon alfa‑2a or Besremi prior to approval.

Jakafi step therapy (essential thrombocythemia)

For Jakafi in essential thrombocythemia, a trial of hydroxyurea, peginterferon alfa‑2a, or anagrelide is required before Jakafi will be approved.

Required diagnostic documentation (CGD, osteopetrosis)

Providers must submit required diagnostic documentation: medical record must document the diagnosis; for CGD provide a molecular genetic test identifying a pathogenic variant; for malignant osteopetrosis provide radiographic (X‑ray) imaging demonstrating related skeletal features.

Required documentation and confirmatory testing

Provide diagnosis and confirmatory testing results where applicable (examples: right‑heart catheterization results for PAH; ALK status for ALK‑targeted therapies; IL1RN bi‑allelic pathogenic variants for DIRA).

Required medical information including genetic confirmation

Required medical information must include diagnosis and, when applicable, genetic confirmation (e.g., confirmed bi‑allelic IL1RN pathogenic variants for DIRA) and documentation of prior response to therapy (e.g., clinical benefit with anakinra for DIRA).

Arikayce required documentation (MAC culture & susceptibility)

For Arikayce, documentation must include diagnosis, prior medication history, and a positive sputum culture for MAC with documentation of amikacin susceptibility when indicated.

Right‑heart catheterization documentation (PAH)

Right‑heart catheterization results are required to confirm pulmonary arterial hypertension (WHO Group 1) when documenting bosentan therapy.

Mutation test documentation required

Mutation status must be documented where required (for example, BRAF V600 mutation status for Braftovi).

Haegarda required baseline labs and continuation evidence

For Haegarda, document baseline functional C1‑INH level (<50% of normal) and low serum C4 for HAE Type I/II prophylaxis; for continuation include prescriber statement of favorable clinical response.

Cabometyx required documentation (diagnosis, RET status)

For Cabometyx, include diagnosis, histology, RET gene rearrangement status for NSCLC where applicable, and prior therapies per the indication requested.

Carglumic acid documentation (genetics or plasma ammonia)

For carglumic acid, provide genetic test results confirming N‑acetylglutamate synthase deficiency or plasma ammonia level ≥50 micromol/L for acute treatment indications.

Required documentation for psychiatric indications

Required documentation for psychiatric and related indications must include diagnosis and prior treatment failures/intolerance/contraindications to specified classes (e.g., SSRIs/SNRIs for OCD/panic/autistic disorder or two of SNRI/SSRI/mirtazapine/bupropion for depression).

Dalfampridine documentation (ambulatory status and objective measure)

For dalfampridine, documentation must show diagnosis of MS, that the patient is ambulatory, the drug is intended to improve or maintain mobility, and objective impaired ambulation measured by timed 25‑foot walk or MSWS‑12.

Documentation for immunology/respiratory indications

Provide diagnosis, relevant objective tests (e.g., blood eosinophil counts, endoscopic biopsy results, CT/endoscopy for nasal polyps), prior therapy trials and dates, and prescriber specialty/consultation for the immunology/respiratory indications.

Fabrazyme diagnostic documentation and specialist prescriber

Fabrazyme requests must include diagnosis and genetic/laboratory test results demonstrating deficient alpha‑galactosidase A activity in leukocytes or fibroblasts or a pathogenic GLA gene variant, plus specialist prescriber involvement.

ESA anemia lab documentation required

ESA anemia approvals require hemoglobin values consistent with the indication (e.g., Hb <10.0 g/dL for many initial therapies) and, when applicable, serum erythropoietin levels (≤500 mU/mL for certain indications).

Fingolimod required medical information

For fingolimod, required medical information includes diagnosis of a relapsing form of MS (including clinically‑isolated syndrome, relapsing‑remitting, or active secondary progressive) and prescriber specialty involvement.

Fintepla required documentation of prior/concomitant AEDs

Fintepla prior authorization requests must include diagnosis and documentation of prior or concomitant antiepileptic therapies for Dravet syndrome when applicable.

Firmagon required documentation and billing note

Firmagon prior authorization requires documentation of diagnosis and that the prescriber is or consulted with an oncologist; billing (Part B vs Part D) will be determined at time of PA.

Gavreto required mutation testing documentation

Gavreto requests must include diagnosis and RET fusion or mutation testing results where applicable for NSCLC and thyroid cancer indications.

EGFR mutation test documentation required

Documentation of a sensitizing EGFR mutation by an approved test (examples include exon 19 deletions, exon 21 L858R, L861Q, G719X, S768I) is required for EGFR‑positive NSCLC approvals.

Glatiramer MS documentation and prescriber requirement

For glatiramer products, document that the diagnosis is a relapsing form of MS and that the prescriber is a neurologist or MS specialist (or consulted) for prior authorization.

Hernexeos/Hyrnuo required diagnosis documentation

Provide diagnosis as required medical information for Hernexeos and Hyrnuo prior authorization requests; include other indication‑specific documentation as applicable.

Required documentation of prior systemic therapies

Prior authorization requests must include diagnosis and evidence of prior systemic therapies tried as specified by indication (examples shown in the product criteria).

Itraconazole documentation for onychomycosis

For oral itraconazole, documentation should include the intended oral route and fungal diagnostic confirmation for onychomycosis (e.g., KOH, fungal culture, or nail biopsy).

Itovebi required breast‑cancer documentation

Itovebi requests must include menopausal status or concurrent GnRH agonist use, HR/HER2/PIK3CA status, prior endocrine therapy history, and planned combination with palbociclib and fulvestrant where applicable.

Jakafi prior therapy documentation

Jakafi prior authorization must document prior therapies where specified (for example, hydroxyurea or peginterferon for PV; prior systemic treatment for chronic GVHD).

Diagnostic confirmation required — denial risk

Diagnostic confirmation is required where stated; lack of required diagnostic confirmation (e.g., molecular genetic test for CGD or radiographic evidence for malignant osteopetrosis) may trigger denial.

Anti‑obesity agent exclusions may cause denial

Concurrent use of more than one weight‑loss medication in the anti‑obesity drug class or combining a GLP‑1 anti‑obesity agent with a DPP‑4 inhibitor may trigger exclusion/denial for anti‑obesity agents.

Concurrent biologic therapy exclusion

Concurrent biologic therapy is listed as an exclusion for some products (for example, Arcalyst); concurrent biologic use may result in denial.

Benlysta concurrent biologic exclusion

Concurrent use of Benlysta with another biologic or Lupkynis is an exclusion; requests documenting concurrent biologic therapy risk denial.

Age restriction noncompliance may trigger denial

Requests risk denial if the patient is under age limits specified by the product (for example, many products require patients be 18 years or older).

Prescriber restriction noncompliance — denial risk

Denials may occur if required specialist prescriber involvement or consultation is not documented (examples: neurologist for Betaseron; cardiologist/pulmonologist for bosentan).

HAE diagnostic confirmation required for Haegarda

Lack of documentation confirming HAE Type I/II (functional C1‑INH <50% and low serum C4) at baseline may trigger denial for Haegarda prophylaxis.

Cayston culture requirement — denial risk

Absence of a Pseudomonas aeruginosa positive airway culture may result in denial for Cayston requests.

Lack of prerequisite therapy — denial risk

Requests that do not document trials, inadequate response, intolerance, or contraindication to required prior therapies risk denial (e.g., SSRIs/SNRIs for OCD/panic/autistic disorder or required oncology prior regimens).

Ambulatory status/objective measures missing — denial trigger

Requests may be denied if the patient is not ambulatory, the medication is not being used to improve or maintain mobility in MS, or no objective measure of impaired ambulation is provided (e.g., timed 25‑foot walk, MSWS‑12).

Failure to meet indication criteria — denial risk

Failure to meet indication‑specific criteria (for example, blood eosinophil thresholds for asthma/COPD, biopsy/PPI trial for EoE, prior therapies for CRSwNP/CSU/PN) may trigger denial for those indications.

Medicare Part D dialysis denial for ESA in dialysis

Anemia in patients with chronic renal failure on dialysis is denied under Medicare Part D; such claims should be submitted under the ESRD bundled payment benefit instead.

Fingolimod concurrent‑agent exclusion — denial risk

Concurrent use of fingolimod with other disease‑modifying MS agents is an exclusion and may trigger denial if documented.

Fintepla prerequisite therapy — denial risk

Fintepla initial approval for Dravet syndrome requires prior or concomitant trials of at least two other antiepileptic drugs or prior/concomitant Epidiolex, Clobazam, or Diacomit; absence of these prior therapies may risk denial.

Fotivda prerequisite therapy — denial risk

Fotivda for RCC requires relapsed or Stage IV disease and prior use of at least two other systemic regimens; lack of required prior therapies may trigger denial.

NSCLC squamous cell progression — denial trigger

For metastatic squamous NSCLC, lack of documentation of prior platinum‑based chemotherapy and disease progression may lead to non‑approval.

NSCLC unresectable/metastatic documentation — denial risk

For non‑small cell lung cancer with an activating mutation, absence of documentation that disease is unresectable or metastatic may trigger denial.

Itraconazole diagnostic confirmation — denial risk

Itraconazole for onychomycosis requires fungal diagnostic test confirmation; lack of diagnostic confirmation (KOH, culture, or biopsy) may lead to denial.