Prior authorization requirements

Prior authorization requires documentation of diagnosis, prior medication trials as specified per indication, appropriate prescriber (see prescriber restrictions), and that continuation requests document clinical response; approvals are through the end of the plan year.

• Submit diagnosis, concurrent medications, and prior drugs tried.
• Continuation requests must document that the patient had a response to therapy.

Benlysta prior authorization

Benlysta (belimumab) requires prior authorization. For SLE initial therapy the patient must have autoantibody‑positive SLE (positive ANA and/or anti‑dsDNA) and Benlysta must be used concurrently with at least one other standard therapy unless the patient is intolerant; continuation requires documented response to Benlysta and concurrent use with at least one standard therapy.

• Age restriction: 5 years and older for initial SLE therapy.
• Prescriber: rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist (initial and continuation); lupus nephritis requires nephrologist or rheumatologist involvement.

Cosentyx prior authorization

Cosentyx (secukinumab) requires prior authorization with documentation of diagnosis and prior medication trials; initial therapy rules and age limits vary by indication and prescriber specialty restrictions apply. Continuation requires documented patient benefit and concurrent use with other biologics or targeted synthetic DMARDs is excluded.

• Plaque psoriasis initial: trial of ≥1 traditional systemic agent ≥3 months (or a non‑Cosentyx biologic counts) or contraindication to methotrexate.
• Hidradenitis suppurativa initial: tried at least one other therapy (e.g., systemic antibiotics, isotretinoin).
• Prescriber restrictions: dermatology or rheumatology depending on indication; age limits per indication (examples: PP ≥6 years, HS ≥18 years).

Prior Authorization Requirement

Prior authorization is required for listed products and must include documentation of diagnosis, prior treatment trials as specified, prescriber specialty when required, and objective measures where indicated; approvals are commonly limited to specified durations (e.g., up to 1 year or plan year).

• Provide diagnosis, prior medication history (including specific therapies tried), and relevant lab/genetic or objective test results when requested.
• Prescriber specialty documentation required when specified (e.g., neurologist for MS agents, pulmonologist for ILD/PAH).

Fasenra initial therapy requirements

For initial Fasenra therapy in asthma, prior authorization requires a blood eosinophil count ≥150 cells/µL within the prior 6 weeks, prior use of an inhaled corticosteroid plus at least one additional controller, and documentation of uncontrolled asthma (exacerbations, ED/hospital visits, reduced FEV1 or FEV1/FVC, or worsening with steroid taper).

• Age and prescriber limits: asthma initial—6 years and older; prescribed by or in consultation with an allergist, immunologist, or pulmonologist.
• Continuation requires evidence the patient has responded to therapy and continues ICS.

Exkivity prior authorization

Exkivity prior authorization requires that the patient has locally advanced or metastatic NSCLC with an EGFR exon 20 insertion mutation as determined by an approved test, and that the patient previously tried at least one platinum‑based chemotherapy.

• Document mutation status from an approved test and prior platinum‑based chemotherapy trial.

ESA/Retacrit prior authorization

Retacrit and other erythropoiesis‑stimulating agents require prior authorization with indication‑specific hemoglobin thresholds and prior therapy criteria; prescriber specialty requirements apply for MDS or myelofibrosis.

• Examples: CKD (not on dialysis) initial therapy if Hb <10.0 g/dL (adults) or ≤11 g/dL (children); continuation if Hb ≤12 g/dL.
• For chemotherapy‑induced anemia approve if patient is receiving myelosuppressive chemotherapy and Hb ≤12.0 g/dL.

General prior authorization requirement

Prior authorization is required for many listed specialty drugs and must include documentation of diagnosis, age, prescriber specialty when specified, and any product‑specific criteria; authorization durations are typically 1 year or as specified per product.

• Provide required clinical information demonstrating the member meets the listed diagnostic, biomarker, prior therapy, age, prescriber, and combination‑therapy criteria.
• Authorizations are commonly approved through the end of the plan year or for 12 months when noted.

Omnitrope prior authorization

When Omnitrope criteria are met, authorization will be issued for 12 months.

• Ensure submission includes diagnosis and any required growth‑hormone testing results as specified in product criteria.

Authorization duration and requirement

Prior authorization is required for most products and, where specified, will be authorized for up to 1 year; some indications have shorter initial authorization durations (examples: onychomycosis, ivermectin 30 days, Livtencity 2 months for treatment).

• Check product entry for indication‑specific authorization lengths (e.g., 4 months initial for some biologics, 6 months for certain induction regimens).

Part B vs Part D determination

Some products require a Part B versus Part D determination at prior authorization review per CMS guidance; the policy notes that certain agents (e.g., lapatinib) include a Part B prerequisite determination.

• If applicable, document the Part B prerequisite status so the PA reviewer can determine benefit routing.

Long-acting opioid PA

Long‑acting opioids require annual prior authorization and documentation that the patient is not opioid‑naive, that non‑opioid therapies have been tried, PDMP check completed, risks and benefits discussed, and a documented treatment plan with scheduled reassessments.

• Patients with cancer, in hospice, sickle cell disease, or in long‑term care are exempt from some criteria.
• Confirm indication is chronic/intractable pain prior to quantity exception reviews.

Livtencity PA

Livtencity prior authorization requires that the patient weighs ≥35 kg, is post‑transplant (HSCT or solid organ), and has CMV infection/disease refractory to at least one of cidofovir, foscarnet, ganciclovir or valganciclovir or has significant intolerance to ganciclovir/valganciclovir.

• Document weight, transplant status, and prior antiviral therapy or intolerance.

Lapatinib PA

Lapatinib prior authorization approves use for HER2‑positive recurrent/metastatic breast cancer when used with capecitabine or trastuzumab after at least two prior anti‑HER2 regimens, or when used with an aromatase inhibitor in appropriate HR+ patients per menopausal/ovarian suppression rules.

• Document metastatic disease status, HER2 and hormone receptor status, and prior anti‑HER2 regimen history.
• Note: Part B before Part D step therapy applies to MA‑PD beneficiaries per the lapatinib entry.

Prior authorization required for listed specialty drugs

Prior authorization for specialty drugs requires documentation of indication, mutation/test status (e.g., BRAF V600), prescriber specialty when specified, and prior therapies where indicated; approvals are commonly limited to defined durations (commonly 12 months or 1 year).

• Include molecular testing reports and prior systemic therapy history when applicable.
• Follow product‑specific prescriber specialty requirements.

Odomzo prior authorization

Odomzo prior authorization requires diagnosis and indication‑specific criteria; coverage durations vary by indication (example: 3 months for enterocutaneous fistula/diarrhea associated with chemotherapy; 1 year for most other indications).

• Document grade of diarrhea and prior antimotility therapy for chemotherapy‑associated diarrhea when applicable.

Otezla prior authorization

Otezla prior authorization requires documentation of prior systemic agents (or contraindication) and response for initial therapy and continuation; initial plaque psoriasis typically requires trial of at least one traditional systemic agent for ≥3 months unless intolerant.

• Document prior systemic agent trials, reason for intolerance or contraindication if applicable, and evidence of response for continuation.
• Prescriber specialty requirements apply for initial therapy in some indications.

Ofev prior authorization

Ofev (nintedanib) prior authorization requires diagnosis confirmation (HRCT or surgical biopsy for IPF) and forced vital capacity (FVC) thresholds for initiation and continuation (e.g., IPF FVC ≥40% predicted; chronic fibrosing ILD initial FVC ≥45% predicted).

• Ensure HRCT or surgical lung biopsy reports and FVC percent predicted are submitted.
• Prescriber: pulmonologist or consult with pulmonologist/rheumatologist where specified.

Lipid-lowering agents: LDL and trial requirements

Lipid‑lowering therapy prior authorization requires documentation of LDL‑C thresholds, phenotypic confirmation or diagnostic scoring (HeFH/HoFH) and trials of high‑intensity statins or documented statin intolerance prior to approval.

• Provide lipid panel results, evidence of prior statin therapy and response, and phenotypic or genetic confirmation where required (e.g., Dutch Lipid Network score).

Radicava ORS prior authorization

Radicava ORS initial approval requires a definite or probable ALS diagnosis per El Escorial (or revised Airlie House) criteria, ALSFRS‑R item scores of ≥2 on each item, adequate respiratory function per prescriber, and prior or current riluzole therapy.

• Submit ALS diagnostic documentation, ALSFRS‑R scores, respiratory assessment, and evidence of riluzole trial or use.

Rinvoq indication-specific prior auth

Rinvoq prior authorization is indication‑specific; initial therapy generally requires prior trials such as one TNFi for RA/PsA (or intolerance), a 90‑day trial of at least one systemic therapy for atopic dermatitis, and objective inflammation plus a 3‑month TNFi trial for non‑radiographic axial spondyloarthritis.

• Document prior biologic or conventional therapy trials and reason for intolerance if applicable.
• Continuation requires documented response to therapy.

Prior authorization required

Prior authorization is required for listed products; reviewers will verify diagnosis, age, prescriber specialty, mutation/test status, and prior therapies where applicable; coverage durations are commonly 1 year unless otherwise specified.

• Prepare to submit all required diagnostic, biomarker, and prior therapy documentation to support approval.

NSCLC – EGFR-targeted agents

NSCLC EGFR‑targeted agents require prior authorization with documentation of diagnosis, EGFR mutation testing results from an approved test, and prior therapies as specified by the NSCLC EGFR criteria (e.g., T790M requires prior EGFR TKI exposure).

• Attach approved test reports showing specific EGFR mutations (examples: exon 19 deletions, exon 21 L858R, T790M where applicable).
• Document prior EGFR TKI therapy and disease status per the product entry.

Tremfya prior authorization

Tremfya prior authorization requires evidence of prior systemic therapy (or documented intolerance) for plaque psoriasis and specialist involvement (dermatologist consultation or prescribing) for initiation; continuation requires documented response to therapy.

• Document prior conventional systemic therapy trials or reason for intolerance; for UC induction provide dosing/induction documentation and corticosteroid status.

Prior authorization required for listed specialty drugs

Prior authorization is required for specialty drugs and will be approved only when submitted clinical information demonstrates the member meets the listed diagnostic, biomarker, prior therapy, age, prescriber, and combination‑therapy criteria specific to the product.

• Failure to provide required documentation (diagnosis, labs, mutation status, prior therapy history) may result in denial.
• Follow the product‑specific checklist in the policy when submitting PA requests.

Prior authorization and prescriber requirements

Prior authorization requests must include supporting diagnosis, age, prescriber specialty, and documentation of prior therapy trials as specified for each drug and indication (examples: specialist prescriber for pouchitis or asthma biologics requiring allergist/immunologist/pulmonologist consultation).

• For indications requiring specialist input, include the specialist consultation note or prescribing provider credentials.
• Include objective test results when required (e.g., breath test for SIBO, biopsy results, mutation test reports).

Step therapy trials required

For rheumatoid arthritis and polyarticular JIA, step therapy typically requires trials of two specified biologic or targeted agents (or qualifying exceptions such as heart failure or prior lymphoproliferative disorder); providers must document prior biologic/targeted agent trials or the applicable exception.

• List prior biologic/targeted therapies tried and durations per the RA/PJIA initial therapy rules.
• Document any contraindications or exceptions that would bypass step therapy.

Cosentyx step therapy

For plaque psoriasis initial therapy with Cosentyx, the patient must have tried at least one traditional systemic agent for ≥3 months (or have a contraindication); a prior biologic that is not Cosentyx counts as a trial.

• Document the traditional systemic agent trial and duration or reason for contraindication.
• If a prior biologic was used, specify agent and dates of therapy.

HS step therapy

For hidradenitis suppurativa initial therapy with Cosentyx, prior authorization requires documentation that the patient tried at least one other therapy (e.g., systemic antibiotics or isotretinoin).

• Provide records of prior antibiotic or isotretinoin therapy and response or intolerance.

Step Therapy/Required Prior Trials

Many agents require trials of at least one alternative or conventional therapy before approval; providers must document prior medication trials (examples include trials of systemic antibiotics for HS, traditional systemic agents for plaque psoriasis, midodrine before droxidopa, or at least one conventional synthetic DMARD for RA).

• Include medication names, treatment durations, and reasons for discontinuation or intolerance where applicable.
• Failure to document required prior trials may result in denial.

Firmagon step requirement

Firmagon prior authorization requires that patients new to therapy try Eligard or Orgovyx prior to approval of Firmagon.

• Document prior trial of Eligard or Orgovyx or provide rationale for inability to try these agents.

Required prior therapy for certain oncology agents

Some oncology and hematology agents require prior trials of listed systemic regimens or conventional treatments; providers must document prior regimen history as specified (examples: Imatinib‑related indications or GVHD requirements).

• Attach prior chemotherapy or regimen details and dates; include mutation/test results when required.

Required prior therapies

Several oncology/hematology agents require trial of specified therapies (e.g., Jakafi requires prior hydroxyurea or peginterferon in certain PV patients); providers must document prior therapies and any applicable exceptions.

• Provide prior therapy names, durations, and documented intolerance if applicable.

Step therapy requirement for Ocrevus

For Ocrevus in relapsing MS, step therapy requires trial of generic dimethyl fumarate (or specified alternatives such as Tecfidera, Bafiertam, Vumerity) prior to approval for patients new to therapy unless other prior therapies permit bypass; document the trial or qualifying exception.

• If a biologic or alternative listed agent was previously tried (e.g., Copaxone, Lemtrada, Tysabri, Kesimpta), document dates to support bypass.

Otezla step therapy

Otezla requires a trial of at least one traditional systemic agent (e.g., methotrexate, cyclosporine, acitretin, PUVA) for at least 3 months for plaque psoriasis initial therapy unless the patient is intolerant; a prior biologic counts as a trial.

• Document prior systemic agent trial duration or intolerance; include prescriber specialty consultation when indicated.

Metyrosine step therapy

Metyrosine initial therapy requires prior trial of a selective alpha blocker (e.g., doxazosin, terazosin, prazosin); continuation approves if patient is currently receiving or previously received metyrosine.

• Document trial of a selective alpha blocker and prescriber consultation with an endocrinologist or pheochromocytoma specialist.

Step therapy and prior medication trials

Step therapy and prior medication trials apply in some situations (examples: chronic antibiotic‑dependent pouchitis requires trials of long‑term ciprofloxacin and metronidazole of at least 4 weeks each prior to Xifaxan approval).

• Provide documentation of prior long‑term antibiotic trials and recurrence pattern (e.g., ≥3 pouchitis episodes in 12 months).

Required documentation

Providers must submit required medical information with prior authorization requests including diagnosis, concurrent medications, and previous drugs tried; missing required clinical information (diagnosis, lab, or mutation status) may lead to denial.

• Include lab/genetic test results, prescriber specialty notes, and prior therapy details as specified by the product criteria.
• Examples of missing information that trigger denial: absent BRAF V600 status for BRAF‑dependent agents.

Right-heart catheterization requirement

For PAH WHO Group 1 agents (e.g., ambrisentan/bosentan), prior authorization requires results of right‑heart catheterization to confirm the diagnosis; include the right‑heart catheterization report in the submission.

• Prescriber must be a cardiologist or pulmonologist or include their consultation note.

HAE confirmation / response documentation

For Haegarda continuation, the prescriber must confirm the patient has had a favorable clinical response since initiating prophylactic therapy; baseline diagnostic labs for HAE (functional C1‑INH <50% and low serum C4) must be documented when applicable.

• Submit baseline functional C1‑INH and serum C4 results and a prescriber statement documenting favorable clinical response compared with baseline.

Required Documentation

Providers must include diagnosis, prior medication history (including the specific therapies tried), and relevant lab or genetic test results or objective measures (e.g., serum ferritin, BCR‑ABL mutation, blood eosinophil counts, biopsy results) when required by the product criteria.

• Attach objective test reports (imaging, lab values) and notes documenting responses to prior therapies.
• Failure to supply these documents may delay or result in denial.

Required diagnostic testing

Fabrazyme prior authorization requires laboratory evidence of deficient alpha‑galactosidase A activity in leukocytes or fibroblasts OR a molecular genetic test demonstrating pathogenic mutations in the galactosidase alpha gene; include the laboratory or genetic report.

• Prescriber should be a geneticist, endocrinologist, metabolic disorder subspecialist, or physician who treats lysosomal storage disorders.

General documentation

General documentation expectations: submit diagnosis and prescriber specialty for PA; many products also require objective test results, mutation reports, prior therapy history, and documentation of response for continuation requests.

• When specialist prescribing is required, include the consultation note or provider specialty credentials.
• For continuation authorizations, include evidence of clinical benefit as specified by the product entry.

Concurrent biologic/tsDMARD exclusion

Concurrent use of a Biologic DMARD or a Targeted Synthetic DMARD with the requested agent is an exclusion and may trigger denial; providers must not submit PA requests requesting concurrent biologic/tsDMARD use unless an exclusion exception is documented.

• Specific examples: Cosentyx, Otezla, Inflectra, Benlysta and others list concurrent biologic or targeted synthetic DMARD use as an exclusion.
• If concurrent therapy is medically necessary, provide explicit justification and supporting documentation; otherwise request will likely be denied.

Concurrent biologic/tsDMARD exclusion (Cosentyx)

Cosentyx requests with concurrent use of other biologic therapies or targeted synthetic DMARDs will be denied; ensure no concurrent biologic/tsDMARD is being used when submitting PA for Cosentyx.

• If prior biologic was used as a step‑trial, document dates and rationale; but concurrent ongoing biologic use is an exclusion.

Concurrent biologic exclusion (Benlysta)

Benlysta prior authorization has an exclusion risk for concurrent use with other biologics or with Lupkynis; PA requests showing concurrent biologic use without exception may be denied.

• Ensure Benlysta is being used concurrently only with standard non‑biologic therapies (antimalarials, corticosteroids, immunosuppressants) unless intolerance is documented.