Prior Authorization Required — documentation and prescriber specialty

Prior authorization required for many products in this section. Requests must include indication‑specific documentation (diagnosis, prior therapy trials or contraindications/intolerances, prescriber specialty where required) and objective clinical measures where applicable. Failure to provide required documentation or to meet step‑therapy/prerequisite therapy requirements may result in denial or delay.

• Ensure prior authorization (PA) request documents the specific diagnosis and meets indication criteria.
• Include prescriber specialty or documentation of consultation when required (eg, rheumatologist for RA, neurologist for MS, gastroenterologist for IBD, immunologist/allergist for HAE, hepatologist/geneticist for bile acid disorders).
• Provide objective baseline and follow‑up clinical measures for initial and reauthorization requests (eg, joint counts, BSA for psoriasis, HINE‑2/HFMSE/CHOP‑INTEND for SMA, eosinophil counts for eosinophilic asthma, CRP/ESR/fecal calprotectin for IBD).

Documentation‑linked denials and prohibited combinations

Denials or requests held for clarification will be issued when documentation does not support the requested indication, requisite prior therapy trials, contraindication/intolerance, or required diagnostic/molecular testing. Provide complete supporting records (clinic notes, lab results, imaging, procedure reports) to avoid documentation‑linked denials.

• If prerequisite therapy is claimed as failed/intolerant/contraindicated, submit documentation of trial dates, dose, duration (minimum durations where specified), and reason for failure.
• For reauthorization, document positive clinical response per the indication (examples: reduction in swollen/tender joint count for RA/PJIA, reduction in abscess/inflammatory nodule count for HS, improvement in intestinal inflammation or labs for CD/UC).
• Missing prerequisite therapy documentation or required baseline measures is a common reason for denial.
• Requests that seek combination use specifically excluded by policy (eg, MS agents paired with another DMT, use of TTR agents combined with TTR silencers or stabilizers, concomitant chronic SMN‑modifying therapy with Evrysdi) will be denied.
• Therapies used in disallowed indications (eg, pyrimethamine for malaria) will not be approved.

Onychomycosis and Ciclopirox Nail Lacquer — documentation required

Onychomycosis (topical ciclopirox and oral antifungals): prior authorization requires confirmation of non‑matrix (lunula) involvement, microbiologic confirmation of fungal infection (KOH, culture, or histology), and documentation of trial and failure/contraindication/intolerance to oral terbinafine for required minimum durations (6 weeks fingernail; 12 weeks toenail) when applicable. For ciclopirox nail lacquer, confirm absence of matrix involvement and provide KOH/culture/histology.

• Document which nails are affected and severity (target nail description and BSA for skin vs nail involvement).
• If prescribing topical therapy instead of oral terbinafine, document medical justification (C/I or intolerance) with supporting records.
• Coverage durations and prerequisite therapy requirements must be met (eg, 48 weeks coverage noted for certain tadalafil products labeled in this block as topical/tabs — ensure correct product indication and formulary match).

Stelara Induction Dosing Requirement and Reauthorization

Stelara (ustekinumab) IV induction dosing is required for CD/UC prior to maintenance dosing; induction must follow FDA‑approved weight‑based schedule (260 mg ≤55 kg, 390 mg >55–85 kg, 520 mg >85 kg). Initial requests must indicate induction occurred or be for the IV induction dose; reauthorization requires evidence of clinical response.

• For infliximab and other IV biologics, include infusion records and weights to verify induction dosing.
• If induction dosing not documented, request may be denied or held pending verification.

Specialist Prescriber and Prerequisite Therapy — requirements

Specialist prescriber and prerequisite therapy requirements are enforced for many agents. If policy requires that the drug be prescribed by (or in consultation with) a specific specialist, include a consult note or attestation. Evidence of required step‑therapy or conventional DMARD trial (RA) must be documented with dates, doses, and reasons for failure/intolerance.

• Rheumatology: RA, PJIA, AS initial requests must be prescribed by or in consultation with a rheumatologist.
• Dermatology: Psoriasis, HS, and topical/dermatologic biologic starts should be from a dermatologist or with dermatology consult.
• Gastroenterology: CD and UC initial requests should be from or in consultation with a gastroenterologist.
• Neurology: MS and SMA agents require neurologist involvement; SMA agents require genetic testing and baseline motor scales.
• Document conventional DMARD trial for RA at maximally tolerated doses for at least 3 months (methotrexate, leflunomide, or sulfasalazine) unless clearly not appropriate.

Evrysdi — diagnostic and SMA‑specific documentation

Evrysdi and other SMA therapies: provide genetic confirmation (SMN1 mutation/deletion and SMN2 copy number) and baseline motor function testing appropriate to age (HINE‑2, CHOP‑INTEND, HFMSE, RULM, MFM‑32 or BSID‑III Item 22). Evrysdi is not to be used concomitantly with other chronic SMN‑modifying therapies (eg, nusinersen/Spinraza) and prior gene therapy must be documented with supporting records if applicable.

• Include genetic test reports showing SMN1 alteration and SMN2 copy number.
• Attach baseline motor function exam results and any prior SMA‑directed therapy records (including dates and outcomes).
• Requests indicating concurrent chronic SMN‑modifying therapy will be denied per policy.

HAE Diagnostic Documentation and Prescriber Requirement

Hem hereditary angioedema (HAE) therapies: diagnosis must be confirmed with appropriate complement testing (low C4 and C1‑INH antigenic or functional deficiency) or, for HAE with normal C1‑INH, documented pathogenic gene variant or family history. Prescriptions should be by or in consultation with an immunologist or allergist. Acute attack treatments are not to be combined with other acute HAE therapies.

• Provide lab reports for C4 and C1‑INH antigenic/functional levels or genetic testing results.
• For HAE‑nl‑C1INH, provide genetic testing demonstrating known pathogenic variants (eg, factor XII) or confirmatory family history.
• State whether request is for on‑demand/acute treatment vs prophylaxis and include prior therapy history.

Pyrimethamine — restricted indications (toxoplasmosis) and malaria prohibition

Pyrimethamine use is restricted. Approvals are limited to toxoplasmosis (active treatment, secondary prophylaxis, congenital or select primary prophylaxis when TMP‑SMX intolerance or life‑threatening reaction is documented). Pyrimethamine use for malaria treatment or prophylaxis is not authorized and will be denied.

• For toxoplasmosis, include indication (e.g., encephalitis, ocular, congenital), co‑therapy (eg, sulfadiazine) and prescriber specialty (infectious disease) or consultation note.
• If used for primary prophylaxis due to TMP‑SMX intolerance, submit documentation of desensitization attempt or prior life‑threatening reaction to TMP‑SMX.

Bile Acid / Peroxisomal Disorder and Livmarli / Cholbam — diagnostic evidence required

Bile acid synthesis disorders, peroxisomal disorders, Livmarli (maralixibat) and Cholbam: submit disease‑specific diagnostic evidence — abnormal urinary bile acid analysis by mass spectrometry or molecular genetic testing consistent with diagnosis. Peroxisomal disorder requests must document clinical features (eg, liver disease, steatorrhea, fat‑soluble vitamin malabsorption) and that use will be adjunctive. Prescriber should be a hepatologist, geneticist, gastroenterologist, or specialist in inborn errors of metabolism. Initial coverage durations and reauthorization response requirements apply.

• Attach urinary bile acid analysis results or molecular genetic testing reports.
• For peroxisomal disorders, document signs/symptoms (liver tests, steatorrhea, growth issues) and planned adjunctive use.
• Livmarli and similar agents require specialist prescriber attestation and documentation of prior therapies where specified.
• Initial coverage durations (eg, Cholbam 4 months initial, 12 months reauth) and demonstration of clinical response for reauthorization are required.

Antivirals, PAH agents, and prophylactic antifungals — required testing and contraindication checks

Antiviral and hepatic agents (Mavyret, Rebif, Ambrisentan, Posaconazole prophylaxis): PA requires indication confirmation, relevant lab testing, and contraindication/interaction checks. Mavyret requests must not conflict with contraindications listed in policy; missing contraindication‑related documentation may result in denial. Ambrisentan for PAH requires documentation of right‑heart catheterization or other supporting diagnostic evidence and risk‑benefit discussion (hepatotoxicity/pregnancy risk) as appropriate. Posaconazole prophylaxis must meet prophylaxis criteria.

• For Mavyret, include HCV genotype if relevant and prior HCV treatment history; document any contraindications or drug‑drug interactions.
• For Rebif and other MS agents, include MS diagnosis and neurologist involvement; combination with another DMT is not allowed.
• For Ambrisentan, include PAH diagnosis documentation (eg, right heart cath), NYHA class, and pregnancy testing/contraception counseling if applicable.
• For posaconazole prophylaxis, document high‑risk neutropenia or transplant status per policy criteria.

Armodafinil — diagnostic confirmation required (OSA, narcolepsy)

Armodafinil and other wakefulness agents: prior authorization requires diagnostic confirmation of the underlying disorder (eg, obstructive sleep apnea with documentation of ongoing excessive daytime sleepiness despite optimized OSA therapy, or narcolepsy diagnosis). Provide sleep study results or documentation of prior therapy trials. Requests lacking diagnostic confirmation will be denied.

• Attach polysomnography/overnight sleep study reports, multiple sleep latency test (MSLT) when applicable, and documentation of CPAP adherence or reasons CPAP is not effective/appropriate.
• State the diagnosis clearly (narcolepsy, OSA with residual sleepiness, shift work disorder) and include prior stimulant/modafinil therapy history.

IVIG — dosing, diagnosis, and monitoring documentation

Intravenous immune globulin (IVIG) and other immunoglobulin therapies: document the minimum effective dose and appropriate frequency, the specific diagnosis meeting policy criteria, prior therapy trials where required, and monitoring labs. Prescriber should have expertise in immunoglobulin management.

• Include baseline immunoglobulin levels (IgG, IgA) and infection history where indicated.
• For hematologic/autoimmune indications, document prior corticosteroid and immunosuppressant trials as specified.
• Provide recent Hct/Hgb and other labs for blood product alternatives (eg, Retacrit requests require Hct/Hgb documentation).

Molecular Testing and Oncology Prior Authorization

Molecular testing, tumor‑directed therapy, and oncology agents (eg, Tagrisso, Lumakras, Hyrnuo, Retevmo): include FDA‑approved molecular testing reports (EGFR, KRAS G12C, HER2, RET, ROS1, IDH2, etc.) performed in a CLIA‑certified laboratory, prior lines of therapy, performance status, and relevant imaging or pathology reports. Requests missing molecular confirmation or prior therapy documentation may be denied.

• Attach the specific test name, result, test date, and lab performing the assay.
• Document prior systemic therapies and response, and the line of therapy for which the requested agent is being used.
• For maintenance or continuation approvals, provide prior authorization records or treatment history verifying prior therapy.

Reauthorization — evidence of clinical response required

Reauthorization: submit interval clinical outcome data demonstrating benefit (symptom improvement, objective measures, reduced exacerbations/hospitalizations, lab or imaging improvement) and continued specialist management. Lack of documented clinical response may result in non‑renewal.

• Include comparison to baseline measures submitted at initial approval.
• For chronic therapies, document adherence and absence of unacceptable toxicity.
• Reauthorization intervals vary by product (commonly 12 months; some indications have 6‑month initial approvals).

Step‑Therapy / Prerequisite Trials — documentation and enforcement

Specific pharmacy‑managed exclusions and step therapy enforcement: many medications require documented trial and failure of specified first‑line agents (eg, conventional DMARDs for RA, topical/systemic trials for psoriasis biologics, two trials for Caplyta). If prerequisite therapy was not tried and documented, requests will be denied.

• Document names, doses, start/end dates, and reason for discontinuation for each prerequisite agent.
• Where step therapy is enforced (eg, topical or prior systemic trial for psoriasis biologics), include documentation that criteria were met prior to initiating the requested agent.

Prohibited Combination Therapy and Contraindication Checks

Contraindications and combination exclusions: requests for products used concurrently with explicitly prohibited therapies (eg, Evrysdi with other chronic SMN‑modifying therapies; ATTR‑CM agents used with TTR silencers or stabilizers; MS DMTs in combination) will be denied. For drugs with specific contraindications (eg, Mavyret interactions), include medication reconciliation and interaction checks.

• State concurrent medications and provide justification if overlapping mechanisms are claimed as necessary.
• If the request would create a prohibited combination, include clinical rationale and consult notes; absent compelling justification, these requests will be denied.