Prior authorization required; 1-year approvals for CGD and malignant osteopetrosis

Prior authorization is required for Actimmune and many listed products; approvals for chronic granulomatous disease (CGD) and malignant osteopetrosis may be granted for 1 year when criteria are met.

PA criteria required; typical 1-year authorization

Submit a prior authorization request that documents the diagnosis and any indication-specific prerequisites; many agents authorize for 1 year when PA criteria are met.

• Provide diagnosis and required supporting test results where specified
• Authorization durations commonly set to 1 year

PA required for specialty products; approvals typically 1 year

Prior authorization is required for listed specialty products; approvals are typically for 1 year and contingent on meeting product-specific criteria (diagnosis, age, prescriber, mutation or prior therapy requirements).

Copiktra PA — prerequisite therapy documented; 1-year coverage

Copiktra requests require prior authorization and must document prior therapy: at least one Bruton tyrosine kinase inhibitor and at least one venetoclax-based regimen for CLL/SLL; coverage duration is 1 year.

• Document prior BTK inhibitor (e.g., ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib)
• Document prior venetoclax-based regimen

Cosentyx PA — indication- and prior-therapy–dependent

Cosentyx requires prior authorization; initial and continuation approvals depend on indication-specific prior therapy and evidence of benefit (e.g., prior trial of traditional systemic agent for plaque psoriasis).

• For plaque psoriasis: document trial of at least one traditional systemic agent for ≥3 months unless intolerant
• Continuation requires documented clinical benefit

Deferasirox PA — serum ferritin and hematology prescriber required

Deferasirox requires prior authorization and documentation of a serum ferritin level; the medication must be prescribed by or in consultation with a hematologist and approvals are typically for 1 year.

• Include current serum ferritin level with the PA request
• Prescriber must be a hematologist or consult a hematologist

Diacomit PA — age and neurologist prescriber required

Diacomit requires prior authorization; initial therapy is limited to patients 6 months and older and must be prescribed by or in consultation with a neurologist for initial therapy; authorization is for 1 year.

• Document diagnosis of Dravet syndrome
• Prescriber must be a neurologist or consult with one

Dimethyl fumarate PA — neurologist/MS specialist prescriber

Dimethyl fumarate requires prior authorization; prescriber must be a neurologist or MS specialist and authorization will be for 1 year when criteria for relapsing forms of MS are documented.

• Provide documentation of relapsing form of multiple sclerosis
• Prescriber must be or consult with a neurologist/MS specialist

Doptelet PA — hematology consultation and therapy prerequisites

Doptelet requests require prior authorization with age- and formulation-specific restrictions; chronic ITP initial therapy must be prescribed by or after consultation with a hematologist and document prior therapy as specified.

• For chronic ITP initial therapy: document platelet count and trial of one other therapy (e.g., systemic corticosteroids, IVIG, anti‑D, eltrombopag, romiplostim, fostamatinib, rituximab) or prior splenectomy
• Prescriber must be or consult with a hematologist for initial therapy

Dupixent PA — detailed indication-specific documentation required

Dupixent requires prior authorization; submit indication-specific documentation (diagnosis and required clinical measures) and prescriber specialty/consultation where specified; initial and continuation criteria vary by indication.

• Provide diagnosis and required objective measures per indication (e.g., eosinophil counts, biopsy, symptom duration)
• Prescriber should be or consult with specified specialist (allergist/immunologist, dermatologist, pulmonologist, or gastroenterologist as indicated)

Emgality PA — age ≥18 and ≥4 migraine days/month; 1-year coverage

Emgality prior authorization is required for adults (≥18 years); initial therapy requires documentation of ≥4 migraine headache days per month prior to initiating preventive therapy and coverage is for 1 year.

• Document patient age ≥18 years
• Document ≥4 migraine headache days per month prior to initiation

Enbrel PA — trial of preferred adalimumab product required

Enbrel initial therapy requires a trial of one preferred adalimumab product (a trial of a non-preferred adalimumab also counts) before approval; continuation requires evidence of response.

• Document trial of one preferred (or non-preferred) adalimumab product
• Provide evidence of clinical response for continuation

Fingolimod PA — neurologist/MS specialist prescriber required

Fingolimod requires prior authorization and the prescriber must be a neurologist or consult with a neurologist/MS specialist; approval applies to relapsing forms of MS.

• Provide diagnosis of a relapsing form of multiple sclerosis
• Prescriber must be or consult with a neurologist or MS specialist

PA duration may be 3 months where specified by criteria

Some prior authorizations are limited to shorter durations per the criteria; when specified in the product entry, authorization duration may be 3 months.

• Confirm requested coverage duration matches PA criteria (e.g., 3 months where stated)

Itraconazole PA — oral use and fungal diagnostic confirmation required

Itraconazole oral capsule requires prior authorization and diagnostic confirmation for onychomycosis (KOH, fungal culture, or nail biopsy) when used for tinea unguium; include evidence that the drug will be used orally.

• Provide fungal diagnostic test result (KOH preparation, fungal culture, or nail biopsy) for onychomycosis
• Document intended oral route of administration

Ivermectin PA — diagnosis-specific criteria; 30-day coverage

Ivermectin oral requires prior authorization; approval criteria include specific diagnoses (e.g., pediculosis or scabies) and coverage duration is 30 days.

• Document diagnosis consistent with listed indications (e.g., head/body/pubic lice, classic or crusted scabies)
• Note coverage duration: 30 days

IVIG PA — prior authorization required; 12-month authorization when approved

IVIG (Gamunex-C) requires prior authorization; when approved, authorization will be for 12 months and include the required medical information as listed.

• Provide required medical information and indication details
• Be prepared for Part B vs D determination per CMS guidance when applicable

Jynarque PA — nephrologist prescriber and renal function documentation; 1-year coverage

Jynarque (tolvaptan) requires prior authorization; prescriber must be a nephrologist or consult with one, renal function must be documented, and the patient must not currently be receiving another tolvaptan product; coverage is for 1 year.

• Document diagnosis of rapidly-progressing ADPKD and renal function
• Confirm patient is not currently receiving another tolvaptan product
• Prescriber must be or consult with a nephrologist

Alunbrig step therapy — prior ALK inhibitor trial required

Alunbrig requires a prior trial of specific ALK inhibitors (Alecensa, Ensacove, or Lorbrena) for patients new to therapy for NSCLC before approval.

• Document trial of Alecensa, Ensacove, or Lorbrena prior to Alunbrig initiation for NSCLC

Prior systemic therapy required for selected oncology indications

Some oncology indications require prior systemic therapy trials before approval (examples include Avmapki-Fakzynja and other targeted agents); document prior systemic regimens as specified.

• Provide documentation of prior systemic therapy trials when required by the product-specific criteria

Bosentan step therapy for CTEPH — Adempas trial required unless contraindicated

For CTEPH, bosentan step therapy requires the patient to have tried Adempas, have a contraindication to Adempas, or be currently receiving bosentan.

• Document trial of Adempas or contraindication to Adempas, or confirm current bosentan use

Braftovi — combination/sequence requirements for colorectal indications

Braftovi coverage for certain colorectal cancer indications requires combination or sequence use with cetuximab/panitumumab and FOLFOX or prior chemotherapy per indication-specific criteria.

• Document combination regimen (e.g., with cetuximab/panitumumab and FOLFOX) or prior chemotherapy as specified

Cabometyx — prior systemic therapy required per indication

Cabometyx approvals require prior therapy per indication (e.g., prior sorafenib or lenvatinib for hepatocellular carcinoma); document prior systemic therapies as applicable.

• Provide prior systemic therapy history per the indication (e.g., sorafenib or lenvatinib for HCC)

Doptelet prerequisite therapy — trial of one other ITP therapy required

For chronic ITP, initial Doptelet therapy requires trial of one other therapy (e.g., systemic corticosteroids, IVIG, anti‑D, eltrombopag, romiplostim, fostamatinib, rituximab) or prior splenectomy before approval.

• Document prior trial of at least one listed therapy or prior splenectomy

Step therapy for high-risk medications — alternatives tried and prescriber risk/benefit confirmation

High-risk medications (HRMs) listed require prior trials or intolerance of specified alternative non‑HRM agents before approval; prescriber must confirm risk vs benefit.

• Document trials or intolerance of specified alternatives per HRM entry
• Prescriber must attest that risk versus benefit has been assessed

Prerequisite therapy required for select indications

Some indications require prerequisite therapy from specific drug classes (e.g., HRMs and other classes listed in product entries); provide documentation of prior agents tried as required.

• Supply records of prior medications/trials that meet the product-specific prerequisite therapy requirements

Required medical information — diagnosis and disease‑specific confirmatory tests (CGD, osteopetrosis)

Provide required medical information with PAs: diagnosis, and for CGD a molecular genetic test identifying a gene-related pathogenic variant; for malignant osteopetrosis, radiographic (X-ray) imaging demonstrating skeletal features.

• For CGD: include molecular genetic test confirming a pathogenic variant
• For malignant osteopetrosis: include radiographic imaging demonstrating skeletal features

Required diagnostic documentation — ALK, right‑heart cath and other molecular tests

Required diagnostic documentation commonly includes diagnosis and supporting test results — examples: ALK status for ALK-targeted agents and right‑heart catheterization results for PAH confirmation.

• Include ALK, ROS1, RET, IDH2, PDGFRA, or other mutation test results when indicated
• Include right‑heart catheterization results for PAH/WHO Group 1 where required

Haegarda — baseline functional C1‑INH and low serum C4 required

For Haegarda, baseline functional C1‑INH protein level (<50% of normal) and low serum C4 levels are required to confirm HAE type I or II prior to authorization.

• Provide baseline functional C1‑INH (<50% of normal) and baseline serum C4 levels

Deferasirox — serum ferritin required

Deferasirox PA requests must include a serum ferritin level to support iron‑chelation therapy.

• Include current serum ferritin value with the PA submission

Emgality — diagnosis and migraine days/month required

Emgality PA requires documentation of diagnosis and the number of migraine headache days per month (≥4 days prior to initiating preventive therapy); document clinical benefit for continuation.

• Document diagnosis of migraine
• Document number of migraine headache days per month (≥4 for initiation)
• For continuation, document clinical benefit from therapy

Diagnosis and condition‑specific documentation required (e.g., erlotinib, everolimus, Fintepla)

Provide diagnosis and condition‑specific documentation for agents such as erlotinib, everolimus, and Fintepla — include mutation status, histology, prior/concomitant therapies, or prior anticonvulsant trials as specified.

• Include EGFR mutation results for erlotinib where indicated
• Provide prior endocrine/systemic therapy documentation for everolimus when required
• Document prior antiepileptic drug trials for Fintepla in Dravet or LGS

Denial risk — missing diagnostic documentation or specialist prescriber

Lack of required diagnostic documentation or lack of required specialist prescriber where specified may trigger denial of the PA request.

• Ensure all required tests and specialist consultations are documented in the PA submission

Denial risk — missing PA criteria or required medical information

Failure to meet PA Criteria or to provide required medical information (per product entry) may result in denial.

Respiratory exclusion for Inbrija — asthma/COPD may trigger denial

Inbrija exclusion criteria include asthma, COPD, or other chronic underlying lung disease; presence of these conditions may result in denial.

• Confirm absence of asthma, COPD, or other chronic underlying lung disease in documentation

Ivermectin — diagnosis required to avoid denial

Ivermectin requests may be denied if the diagnosis is not provided or does not meet the listed indications (e.g., pediculosis or scabies criteria); include diagnosis documentation.

• Provide diagnosis consistent with approved indications (pediculosis or scabies) to support the PA

Tolvaptan exclusion — deny if another tolvaptan product is being received

Tolvaptan (Jynarque) requests may be denied if the patient is currently receiving another tolvaptan product; confirm no concurrent tolvaptan therapy and document renal function.

• Confirm patient is not receiving another tolvaptan product
• Provide renal function documentation to support ADPKD indication