Prior Authorization Required

Prior authorization is required for many specialty, biologic, oncology and pulmonary agents. For most products authorizations are granted for 12 months (or through the end of the plan year for select agents) when all clinical criteria are met. Prescribers must be specialists or consult with a specialist as indicated by product (for example: rheumatologist for many rheumatologic biologics; oncologist for cancer-directed therapies; pulmonologist or endocrinologist for select rare metabolic or respiratory agents). Required documentation at submission typically includes diagnosis, relevant diagnostic test results or biomarkers (tumor/molecular test results, genetic tests, baseline labs), concurrent medications, prior therapies tried with dates and clinical response, and prescriber specialty/consultation notes.

• General PA duration: authorizations commonly 12 months; some agents approved through end of plan year or shorter initial windows (e.g., Benlysta SLE initial 4 months, Lupus Nephritis initial 6 months).
• Prescriber requirement: many agents require prescription by or in consultation with a relevant specialist (examples in product-specific callouts).
• Required clinical documentation: diagnosis, concurrent medications, prior drug trials with dates and response, baseline labs/genetic or tumor biomarkers where specified (eg, Crysvita, Cystagon, oncology molecular testing, HAE C1-INH and C4 levels).

Specialty Drug Prior Authorization — Documentation & Exclusions

Specialty drugs and biologics require prior authorization and often have product-specific prerequisites, step therapy, and exclusion rules. Common denial risks include missing diagnostic labs or genetic confirmation, failure to document prior required therapies or intolerance/contraindication, and concurrent use of excluded agents (eg, concurrent biologic/tsDMARDs, concurrent CGRP inhibitors with Nurtec for prevention, concomitant calcitonin gene-related peptide agents, combination CFTR modulators).

• Specialty drug PA: submit diagnosis, prior therapies tried (with dates), concurrent medications, specialist prescriber or consultant note, and any required diagnostic tests.
• Concurrent biologic/tsDMARD exclusion: many rheumatologic/dermatologic biologic policies exclude concurrent use with another biologic DMARD or targeted synthetic DMARD (Otezla, other tsDMARDs).
• Concurrent therapy exclusions: product-specific (e.g., Orkambi — no combination CFTR modulator use; Opsynvi — exclude concurrent guanylate cyclase stimulator).

CIMZIA Prior Authorization and Step Therapy

CIMZIA (certolizumab pegol) — Prior authorization requires documentation of diagnosis and prior therapy trials as specified: for RA/PJIA/JIA indications initial therapy generally requires prior trials of specified agents (examples: Enbrel, preferred adalimumab products, Rinvoq, Xeljanz/XR; alternative prior agents such as Kevzara, infliximab, Orencia may count). Prescriber must be a rheumatologist or have rheumatology consultation for initial therapy. Concurrent use with other biologic DMARDs or targeted synthetic DMARDs is excluded. Approvals are commonly through the end of the plan year for those products following rheumatology criteria.

• Required documentation: diagnosis, concurrent medications, prior therapies tried with dates and responses.
• Step therapy: initial RA/PJIA requirements typically require trial of specified biologics or tsDMARDs (see examples above).
• Concurrent biologic exclusion: denials may be issued if concomitant biologic/tsDMARD is documented.
• Coverage duration: approve through end of plan year when criteria met.

Oncology Prior Authorization — FYARRO and Tumor-Directed Agents

FYARRO (sirolimus) and select oncology agents — Prior authorization required with oncology-specific documentation. Submit tumor diagnosis, prior cancer-directed therapies, objective evidence of disease, and required tumor/molecular test results when applicable. Denials are often triggered by missing tumor biomarker/mutation documentation, lack of prior therapy trials when required, or incomplete documentation linking therapy to an approved or medically-accepted indication.

• FYARRO denial triggers: missing oncology diagnosis, lack of prior systemic therapy where required, absent tumor/molecular testing or evidence of progression.
• Documentation-linked denials for oncology agents: absence of required tumor markers, mutation reports, or prior regimen history may lead to denial.
• Required clinical documentation for breast cancer and other tumor-directed agents: pathology, receptor (ER/PR/HER2) status, and prior lines of therapy as applicable.

IBRANCE / NSCLC HER2 Prior Authorization — Biomarker Requirements

IBRANCE and NSCLC HER2-targeted therapies — Prior authorization requires prescriber specialty (oncology) and tumor molecular testing documentation. Approvals require demonstration of indicated biomarker (eg, HER2 expression/amplification or other specified mutation) using an approved test. Denials occur for eligibility mismatch (no documented biomarker), missing test results, or failure to meet prior therapy prerequisites.

• IBRANCE (breast cancer agents): provide HR/HER2 status and prior endocrine therapy history where appropriate.
• NSCLC HER2-directed therapy: provide tumor molecular testing confirming actionable HER2 mutation/amplification; missing biomarker documentation is a common denial trigger.
• Eligibility mismatch: requests without required positive biomarker test results will be denied.

Nurtec ODT Prior Authorization and Step Requirements

Nurtec ODT (rimegepant) — PA is required for both acute and preventive uses. For acute treatment, prior trial of at least one triptan is required unless contraindicated. For preventive use, ensure patient meets frequency criteria (≥4 and <15 migraine days/month) and document lack of benefit from other preventive measures if currently using Nurtec ODT, or significant clinical benefit if already on therapy. Concurrent use exclusions include other CGRP inhibitors when used for prevention.

• Triptan trial requirement for acute Nurtec ODT: document trial of ≥1 triptan or documented contraindication to triptans.
• Concurrent CGRP agent exclusion: prevent coverage for concurrent preventive CGRP monoclonal antibodies or gepants for prevention.
• Coverage duration: typically 1 year.

Pulmonary and Fibrotic Disease Prior Authorization (Octreotide, Ofev, Pirfenidone)

Octreotide acetate, Ofev (nintedanib), pirfenidone, and other pulmonary/rare disease agents — Prior authorization requires diagnosis confirmation and baseline testing/criteria. For IPF and other fibrosing lung diseases, document appropriate diagnosis (often by pulmonology), prior therapies, and relevant testing (eg, high-resolution CT, right-heart catheterization where required for PAH). Ofev and pirfenidone require prescriber specialty and documentation of diagnosis and prior response/intolerance to other treatments where specified.

• Pirfenidone and Ofev: document IPF or other approved indication, baseline pulmonary function tests, and prescriber specialty (pulmonologist).
• Right-heart catheterization: required documentation where policy indicates for PAH agents.
• Coverage duration: commonly 12 months.

Orkambi and CFTR Modulator Prior Authorization

Orkambi and other CFTR modulators — Prior authorization requires confirmation of CF diagnosis, relevant genetic testing demonstrating appropriate CFTR mutations, and exclusion of combination-modulator conflicts (no concurrent use of incompatible CFTR modulators). Prescriber should be a CF specialist or pulmonologist.

• Combination CFTR modulator exclusion: Orkambi requests must confirm patient is not receiving another conflicting CFTR modulator.
• Required documentation: CFTR mutation report, diagnosis, and specialist prescriber note.
• Coverage duration: product-specific (commonly 1 year).

Specialty Neurologic and Hematologic Agents — Prior Authorization

Eltrombopag, Radicava, Nyvepria and other specialty neurologic/hematologic agents — PA requires diagnosis confirmation, prior therapies tried where applicable, and documentation of benefit or response for continuation. Prescriber restrictions commonly require neurologist, hematologist or relevant specialist.

• Eltrombopag: document indication (eg, ITP), baseline labs (platelet counts), prior therapies and response.
• Radicava: ALS diagnosis, neurologist prescriber, and documentation of functional status and response for continuation.
• Nyvepria: product-specific hematologic documentation (eg, indication, prior therapy, blood counts).

Polivy and Oncology ADC Prior Authorization

Polivy (polatuzumab vedotin) and other oncology monoclonal antibody-drug conjugates — Require oncologist prescriber, confirmed diagnosis, prior regimen history, and tumor response documentation. Coverage may be denied if prior-line or combination therapy requirements are not met or if molecular/tumor testing is missing.

• Polivy PA: provide lymphoma subtype, prior lines of therapy, and treatment intent; missing prior therapy documentation is a common denial trigger.
• Concurrent use exclusion: verify there is no prohibited concurrent monoclonal antibody therapy unless specified.
• Coverage duration: typically aligned with oncology cycles; authorization often for 12 months depending on indication.

Eltrombopag Prior Authorization and Monitoring

Eltrombopag and thrombopoietic agents — Prior authorization requires indication-specific documentation (eg, chronic ITP), baseline and ongoing platelet counts, prior therapy trials (steroids, IVIG) and specialist prescriber (hematology). Continuation approvals require documented clinical benefit.

• Required documentation: diagnosis, platelet count history, prior treatments tried and response, hematology prescriber note.
• Concurrent therapy exclusion: ensure no contraindicated concurrent agents are in use.

Product-Specific Documentation Requirements and Denial Risks

Benlysta, Cinryze, Camzyos, ARIKAYCE, Deferasirox, Chemet and other product-specific documentation requirements — Each of these agents requires itemized clinical documentation at PA submission: diagnosis confirmation (often by biopsy or genetic testing where applicable), prior therapy history, specialist prescriber/consult note, and baseline labs/tests. Missing these items is a frequent cause of denial.

• Benlysta (SLE/Lupus Nephritis): autoantibody positivity (ANA and/or anti-dsDNA) for SLE; lupus nephritis requires biopsy-confirmed diagnosis and concurrent immunosuppressive regimen.
• Cinryze (HAE): baseline C1-INH functional level <50% and low C4 at baseline; missing HAE diagnostic labs can lead to denial.
• Crysvita: baseline serum phosphorus and TmP/GFR and genetic testing as applicable.
• Cystagon: genetic confirmation or elevated WBC cystine concentration.

Concurrent Therapy Exclusions and Denial Risks

Concurrent therapy and exclusion rules — Many policies explicitly exclude concurrent use of specific drug classes. Examples include: concurrent biologic/tsDMARD use for many rheumatology biologics (including exclusions with Otezla, Enbrel, Dupixent in specified contexts), concurrent CGRP agents with Nurtec for preventive use, concurrent guanylate cyclase stimulators with Opsynvi, and combination CFTR modulators with Orkambi. Noncompliance with these exclusions is a common denial reason.

• Concurrent biologic/tsDMARD exclusion (SC): document absence of concurrent biologic or tsDMARD; presence may trigger denial.
• Dupixent/Enbrel concurrent therapy exclusions: confirm no prohibited overlapping biologic therapy per product policy.
• CKD/Severe renal impairment exclusions: some products (eg, TIO agents) exclude patients with severe renal impairment or ESRD; provide labs to demonstrate renal function.

Step Therapy Requirements and Examples

Step therapy and prerequisite trials — Many agents require documented prior trials of specified therapies before approval (examples: CIMZIA, Cablivii, BLENREP, BALVERSA, Cosentyx, Enbrel, KINERET, Nurtec, Metyrosine, Qulipta). Lipid agents such as NEXLIZET require trials of a high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and ezetimibe unless statin intolerant. For Nurtec acute use, a triptan trial or documented contraindication is required.

• CIMZIA step therapy: initial RA/PJIA criteria generally require trials of specified biologics or tsDMARDs; prior alternative agents may count as exceptions.
• Cablivii/CIMZIA/Cosentyx/Enbrel step requirements: many rheumatology and dermatology products require 1–2 prior biologic or targeted therapy trials.
• Lipid agent step therapy (NEXLIZET): prior trial of high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) and ezetimibe, or documented statin intolerance.

Denial Risks — Missing or Noncompliant Documentation

Denial triggers and documentation shortfalls — Authorizations may be denied for failure to meet age or indication-specific requirements, missing diagnostic or biomarker testing (eg, HAE diagnostic labs, oncology tumor testing, Crysvita/Cystagon genetic tests), lack of required prior therapy trials or inadequate documentation of intolerance/contraindication, and concurrent excluded therapies. For oncology and rare disease agents, link documentation to intended use (pathology, mutation reports, prior regimens) to avoid denials.

• Missing diagnostic labs for HAE: absence of baseline C1-INH functional level and serum C4 commonly results in denial.
• NSCLC HER2/oncology denials: missing tumor mutation testing or prior-line therapy documentation triggers denial.
• FYARRO and other oncology denial triggers: missing oncology-specific documentation or failure to meet prior therapy requirements.