Prior Authorization Required

Prior authorization is required for many specialty, oncology, and high-risk medications. Approvals are typically granted through the end of the plan year or for specified durations in the criteria. Document the diagnosis, prior therapies/trials, relevant laboratory or genetic test results, prescriber specialty or consultation, and any required procedure evidence (e.g., right-heart catheterization for PAH). Denials may occur for concurrent biologic/tsDMARD use, missing diagnostic confirmation, disallowed drug combinations, drug-drug interactions, or failure to meet age/prescriber restrictions.

• Always include diagnosis, concurrent medications, prior drugs tried and length of trials.
• Document specialist consultation or that medication is prescribed by an appropriate specialist when required.
• If criteria are met, authorization durations are commonly 6–12 months or through the plan year as specified.

Part B vs Part D PA Determination

Part B vs Part D determinations for physician-administered or infusion/clinic-dispensed products (and some oral oncology agents) will be made at time of prior authorization review per CMS guidance. Indicate site of care, route of administration, and clinical rationale on the PA request to allow correct benefit routing.

• Examples in the formulary note that Part B/Part D determination will be made at PA review (e.g., Elrexfio, Firmagon, Talvey, Ruxience).
• Include documentation of infusion/administration setting when relevant.

Itraconazole — Indication-Specific Durations and Diagnostic Confirmation

Itraconazole oral systemic therapy durations differ by indication — ensure the correct duration is requested and documented.

• Systemic fungal infections: approval up to 12 months.
• Onychomycosis: fingernail therapy typically 2 months; toenail therapy typically 3 months.
• Confirm fungal diagnostic test (KOH, culture, or nail biopsy) for onychomycosis.

Long-Acting Opioids — PA and Documentation Requirements

Long-acting opioid agents require prior authorization for chronic, around-the-clock pain only. Acute pain and opioid-naive patients are excluded.

• Approval requires: evidence pain is chronic and severe enough to require daily, long-term opioid therapy; patient is not opioid naïve; non-opioid therapies have been tried and are being used in conjunction; PDMP check; prescriber discussed risks/benefits; and an opioid treatment plan with reassessment schedule is documented.
• Typical authorization duration: 12 months. Exemptions: cancer, hospice, sickle cell disease, long-term care residents.

PA for Colony Stimulating Factors (CSFs) — Tied to Febrile Neutropenia Risk

Colony-stimulating factors (CSFs) used for prophylaxis are authorized when the chemotherapy regimen confers a high risk of febrile neutropenia (≥20%) or when intermediate risk (<20%) with patient-specific risk factors; document chemo regimen and FN risk.

• Approve for patients receiving myelosuppressive anti-cancer meds associated with ≥20% FN risk, or for <20% risk with one or more physician-documented risk factors (eg, age ≥65, prior chemo/radiation, persistent neutropenia, bone marrow involvement, poor performance status, HIV).
• Document indication (prophylaxis vs treatment), chemotherapy regimen, and prescriber specialty (oncologist/hematologist).

Ofev — Diagnostic Confirmation and FVC Documentation Required

Ofev (nintedanib) and other antifibrotic/ILD agents require diagnostic confirmation and lung function thresholds for approval. Prescriber specialty and imaging/lab documentation must be provided.

• For IPF and ILD‑SSc: diagnosis confirmed by HRCT or biopsy as specified; FVC threshold commonly ≥40% predicted for initial approval (confirm per product criteria).
• Prescribed by or in consultation with a pulmonologist; include HRCT report and pulmonary function test (PFT) results in the PA.

Turalio — Prior Authorization Requirement

Turalio (pexidartinib) requires PA with documentation that the tumor is not amenable to surgery and prescriber documentation of diagnosis.

• Indication: Tenosynovial giant cell tumor (pigmented villonodular synovitis) — approve if tumor is not amenable to surgery per prescriber.
• Prescriber specialty documentation and treatment rationale should be included.

Budesonide (oral) — Prior Authorization and Prior Therapy Requirement

Oral budesonide delayed-/extended-release requires trial and failure/intolerance of an aminosalicylate for inflammatory bowel disease indications before approval; document prior trial.

• PA requires documentation of inadequate response or intolerance to a 4‑week trial of an aminosalicylate (eg, sulfasalazine, mesalamine).
• Coverage duration: 2 months initial.

Concurrent Biologic or tsDMARD Use — Exclusion/Denial Risk

Concurrent use of biologic or targeted synthetic DMARDs (tsDMARDs) is routinely excluded and will trigger denial unless the policy explicitly allows combination therapy. Document any exceptions or rationale.

• Many biologic agents list 'Concurrent use with other biologic or targeted synthetic DMARD' as an exclusion (e.g., multiple anti-TNF, anti-IL products, or JAK inhibitors).
• If prior or concomitant biologic/tsDMARD use is clinically necessary, provide robust justification and specialist consultation notes.

Right‑Heart Catheterization Required for PAH Agents

Pulmonary arterial hypertension (PAH) therapies require hemodynamic confirmation via right‑heart catheterization (RHC). Include the RHC report with PA requests.

• PAH (WHO Group 1) must be confirmed by right‑heart catheterization to support initiation of PAH‑specific agents.
• Prescriber should be a cardiologist or pulmonologist or include consultation documentation.

Drug Interaction Denial Risk — Potent CYP3A4 and Other Contraindications

Some agents are denied when used with known interacting drugs. Check for potent CYP3A4 inhibitors and other contraindicated combinations and document medication reconciliation.

• Coverage will be denied for products with explicit interaction exclusions (eg, drugs contraindicated with potent CYP3A4 inhibitors such as ritonavir, nelfinavir, indinavir, clarithromycin, erythromycin).
• Provide a current medication list and, if interaction exists, an explanation why the concomitant medication cannot be changed.

Medicare Part D / ESRD Coverage — Denial Risk

Medicare Part D coverage exclusions apply for certain ESRD-related or dialysis-administered anemia products — verify benefit and document dialysis status.

• Some anemia/ESRD products have Medicare Part D/ESRD coverage restrictions; document dialysis status and indication.
• If product is excluded under Part D for dialysis patients, indicate in PA to avoid inappropriate approvals.

Geriatric HRM Acknowledgement and Prior Trials for Age ≥65

Geriatric high‑risk medication (HRM) prior authorization rules require prescriber acknowledgment and, in many cases, documentation of prior trials in patients 65+. Ensure the prescriber documents risk/benefit and prior alternatives tried.

• Many HRMs require prescriber acknowledgement that benefits outweigh risks for patients 65 years or older and documentation of inadequate response/intolerance to safer alternatives.
• Examples include anticholinergics, benzodiazepines, and select sedative/hypnotics.

Sofosbuvir‑Velpatasvir — Guidance‑Aligned Criteria and Combination Exclusion

Sofosbuvir‑velpatasvir (DAA) PA requires adherence to AASLD/IDSA guidance and excludes combination use with other direct‑acting antivirals; document genotype, prior HCV treatment history, and prescriber specialty.

• Exclude combination use with other DAAs (ribavirin is an exception where clinically indicated).
• PA applied consistent with current AASLD/IDSA guidance; include HCV genotype, prior therapies, and liver disease staging.

Opioid Therapy — Required Documentation

Opioid therapy approvals require thorough documentation of indications, prior pain therapies, PDMP checks, treatment planning, and risk mitigation counseling.

• Document pain type (chronic vs acute), prior pain medications/therapies tried, concurrent medications, PDMP review, risk/benefit discussion, and a written treatment plan with reassessment intervals.
• Exclude acute (non‑chronic) pain from long‑acting opioid approvals.

Genetic / Laboratory Documentation — Required for Many Specialty Agents

Genetic and laboratory test documentation is required for many enzyme-replacement, targeted oncology, and genetic disorder therapies — include specific test names, results, and dates.

• Examples: EGFR, PIK3CA, BRAF, FLT3, BRCA, GLA activity (Fabrazyme), alpha‑glucosidase (Lumizyme), TTR sequencing (Vyndaqel/Vyndamax), and sucrase‑isomaltase testing for Sucraid.
• Attach approved test reports and reference ranges; note test method and specimen source where relevant.

Growth Hormone — Diagnostic Testing and Baseline IGF‑1 Required

Growth hormone therapies require specific diagnostic testing and IGF‑1 documentation prior to approval; include stimulation test results or baseline IGF‑1 per indication.

• Pediatric GHD: growth metrics, failed stimulation tests (two tests), or algorithm-specified criteria; include pre‑treatment IGF‑1 as required.
• Adult GHD: failed two stimulation tests or IGF‑1 >2 SD below mean with supporting pituitary disease documentation.

Onychomycosis — Diagnostic Confirmation Required for Systemic Therapy

Onychomycosis (toenail/fingernail) systemic therapy requires fungal diagnostic confirmation before approving oral antifungals like itraconazole.

• Acceptable diagnostics: KOH prep, fungal culture, or nail biopsy demonstrating dermatophyte infection.
• Document prior topical therapies and reasons for systemic therapy if requested.

Baseline IGF‑1 and Endocrinology Documentation (Acromegaly)

Acromegaly therapies and other endocrine agents commonly require baseline IGF‑1 documentation and endocrinology consultation; include lab reference ranges and date of testing.

• Acromegaly initial approval requires a baseline IGF‑1 above the upper limit of normal for age and sex and documentation of prior surgery/radiotherapy attempts or contraindication.
• Attach lab reports with reference ranges and date.

Lapatinib — Diagnostic and Prior Therapy Documentation Required

Lapatinib and other targeted oncology agents require documentation of tumor biomarker status and prior therapy regimens (eg, HER2 status, prior anti‑HER2 regimens).

• Lapatinib: for HER2‑positive metastatic breast cancer, document HER2 status and that patient has tried at least two anti‑HER2 based regimens when used in combination with capecitabine or trastuzumab as specified.
• Include pathology/biomarker reports and prior oncology treatment history with dates.

Lumizyme — Diagnostic Testing Required

Lumizyme and similar enzyme‑replacement therapies require confirmatory enzymatic or genetic testing prior to approval.

• Provide laboratory demonstration of deficient enzyme activity (eg, acid alpha‑glucosidase) in blood, fibroblasts, or muscle tissue or a pathogenic molecular genetic test.
• Prescriber should be a relevant specialist (geneticist, metabolic disease specialist).

Livtencity — Clinical and Weight Documentation Required

Livtencity (and weight‑sensitive agents) approvals require clinical measures including weight and indication‑specific documentation.

• Document patient weight and clinical indications per product labeling; include any prior therapies required for the indication (eg, lifestyle interventions).
• Prescriber specialty and rationale for agent selection should be included.

ALS — ALSFRS‑R and Neurology Consultation Documentation

ALS‑specific therapies require ALSFRS‑R scores and neurology/ALS specialist documentation to support initiation and continuation.

• Provide ALSFRS‑R score components and overall function demonstrating retained activities of daily living as specified (eg, score of 2 or more on each item when required).
• Include neurologist or neuromuscular disease specialist consultation notes and respiratory function documentation.

Step Therapy / Prior Biologic Trials — Documentation Required

Step therapy and prior biologic trials are commonly required for immunology and rheumatology agents; document trials and durations of prior therapies.

• Policies frequently require trials of conventional systemic agents (eg, methotrexate for RA or plaque psoriasis) or trials of specified biologics/non‑preferred agents prior to approving newer agents.
• Examples: Cosentyx and other biologics often require trial of at least one traditional systemic agent or biologic depending on indication; RA agents may require trials of two TNFi or specified DMARDs.

ILD‑SSc and ILD — HRCT, Lab, and Prescriber Requirements

Interstitial lung disease associated with systemic sclerosis (ILD‑SSc) and other ILD indications require diagnostic confirmation (HRCT), elevated acute‑phase reactants where specified, and PFT documentation.

• Provide HRCT report confirming diagnosis and include FVC and other PFT values; some policies require elevated acute phase reactants as part of initial criteria.
• Prescriber should be pulmonologist or rheumatologist as specified.

Oncology Step Therapy and Prior Treatment Documentation

Oncology step requirements and prior therapies must be documented per regimen-specific criteria (eg, Jakafi, Mekinist/Tafinlar combinations, lapatinib combinations).

• Document mutation status (EGFR, BRAF V600, FLT3, BRCA, PIK3CA, etc.) and prior lines of systemic therapy with agents and dates.
• Example: Jakafi prior therapy/step requirements must be documented where specified; Mekinist/Tafinlar approvals require BRAF V600 mutation documentation and combination partner confirmation.

Jakafi — Step Therapy / Prior Treatments Documentation

Specific step therapy prior treatments for Jakafi (ruxolitinib) and similar agents must be documented when required by the policy.

• For GVHD or myelofibrosis indications where step rules apply, include prior conventional systemic treatments tried (eg, corticosteroids, other agents) and response/intolerance documentation.
• Attach prior treatment dates and prescriber specialty notes.