Prior authorization required

Prior authorization is required for initiation and reauthorization of listed specialty medications; submit indication-specific documentation including diagnosis, prior therapy trials (TF/C/I) at maximally tolerated doses where specified, prescriber specialty or consultation when required, and evidence of positive clinical response for reauthorization.

• Submit documentation of diagnosis and relevant test results per drug-specific criteria.
• Document prior trial and failure, contraindication, or intolerance to required conventional therapies where listed (TF/C/I).
• Include prescriber specialty or consultation notes when indicated (e.g., rheumatology, neurology, pulmonology).

Dalfampridine ER prior auth

For dalfampridine ER initial requests, the drug must be prescribed by or in consultation with a neurologist and the request must include physician confirmation of difficulty walking (e.g., timed 25-foot walk) plus either EDSS ≤ 7 or documentation the patient is not wheelchair-restricted.

• Initial approval duration: 6 months; reauthorization requires physician confirmation of improved walking and is 12 months.
• Include neurologist prescriber or consultation note and objective walking assessment.

Benlysta prior auth

Benlysta (IV/SC) initial and reauthorization requests must be prescribed by or in consultation with a rheumatologist (or nephrologist for lupus nephritis) and include documentation of active disease, positive autoantibody (ANA ≥1:80 or anti-dsDNA ≥30 IU/mL), and concurrent standard of care therapy.

• Coverage duration: initial and reauth 6 months; reauth requires demonstration of positive clinical response.
• Provide rheumatology (or nephrology) consult notes and relevant serology results (ANA, anti-dsDNA).

Arikayce prior auth

Arikayce prior authorization must document Mycobacterium avium complex (MAC) lung disease, use as part of a multidrug antibacterial regimen, and that the patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of multidrug background therapy; prescribed by or in consultation with an infectious disease specialist or pulmonologist.

• Coverage duration: 12 months.
• Include sputum culture history showing fewer than two negative cultures after ≥6 months of background therapy and specialist documentation.

Prior authorization required per product

Many products require prior authorization with documentation that the member tried and failed, or had contraindication/intolerance to, specified alternative or conventional therapies (TF/C/I) at required minimum durations before biologic or specialty agent initiation.

• Step therapy/TF/C/I must be documented at maximally tolerated doses where specified.
• Specify duration of prior trials when listed (e.g., 3 months for RA conventional therapy).

Prior authorization required for listed products

Prior authorization applies to certain listed products for muscle spasm and related uses; for patients age ≥65 PA applies and prescribers must acknowledge anticholinergic risks; some entries require use of a prerequisite Part D drug.

• PA applies to patients ≥65 years for muscle spasm indications.
• Prescriber must acknowledge anticholinergic risks and consider dose reduction or discontinuation of other anticholinergic medications.

Dupixent PA requirements

Dupixent requests require prior authorization with indication-specific documentation: document the diagnosis, relevant eosinophil thresholds (e.g., ≥150 cells/µL baseline for some asthma indications or ≥300 cells/µL for COPD), age- and therapy-specific controller medication trials, and specialist prescribing/consultation when indicated.

• Include baseline peripheral blood eosinophil count and prior controller therapy details.
• Prescriber should be pulmonologist or allergist/immunologist for asthma indications.

Empaveli PA requirements

Empaveli prior authorization requires documentation of the specific diagnosis (PNH or C3G/primary IC‑MPGN) and, for C3G/IC‑MPGN, evidence the patient has been treated with a maximally tolerated ACE inhibitor, ARB, or SGLT2 inhibitor for at least 12 weeks to reduce proteinuria; prescriber specialty (hematology or nephrology) must be documented.

• Coverage duration: 12 months; reauth requires positive clinical response.
• Provide documentation of 12-week maximally tolerated ACEi/ARB or SGLT2 trial where applicable and specialist consult notes.

Prior authorization required for listed specialty drugs

Many specialty drugs in this formulary section require prior authorization consistent with the listed required medical information, including diagnosis confirmation, prior therapy trials, prescriber restrictions, and supporting test results; follow the product‑specific submission requirements.

• Include specific supporting documents per product (e.g., genetic testing, pathology, lab thresholds).
• Document prescriber specialty or consultation when specified.

Enbrel prior auth requirements

Enbrel and its formulations require prior authorization with documentation of indication‑specific prior therapy trials and minimum durations (e.g., 3 months TF/C/I to conventional therapy for RA; 6 weeks for PJIA; 1 month NSAID trial for AS) and prescriber specialty consultation where listed.

• Initial duration typically 6 months; reauthorization 12 months with demonstrated positive clinical response.
• Provide documentation of trials at maximally tolerated doses (e.g., methotrexate for RA).

Prior authorization required

Prior authorization is required with submission of drug-specific supporting documentation including diagnosis, prior therapies, relevant labs or test results, and prescriber specialty/consultation as specified for each medication.

• Reauthorization generally requires demonstration of positive clinical response per indication.
• Follow the product entry for exact documentation and duration requirements.

Prior authorization required

Prior authorization requests must include documentation of diagnosis, prior therapy trials or documented contraindications/intolerance, and prescriber specialty or consultation notes when required by the product criteria.

• For reauthorization, include objective evidence of positive clinical response compared to baseline as defined per indication.
• Ensure prior trials meet required minimum durations and were at maximally tolerated doses when specified.

Product-specific prior authorization required

Product-specific prior authorization is required per the criteria: include diagnosis confirmation, prerequisite therapy trials or contraindications, prescriber specialty requirements, and documented clinical response for reauthorization (most approvals are 12 months).

• Check each product entry for prerequisite Part D drug requirements and duration.
• Include molecular/genetic test results when required by the product.

Kesimpta prior authorization

Kesimpta prior authorization requires documentation of a relapsing form of MS, either trial and failure (minimum 4‑week supply), contraindication/intolerance to one disease‑modifying therapy or documentation of continuation of prior therapy, and prescriber is neurologist or neurologist consult; Kesimpta must not be used in combination with another DMT or other B‑cell targeted therapy.

• Coverage duration: 12 months; reauth requires demonstration of positive clinical response.
• Do not submit requests showing concurrent use with other DMTs or B‑cell targeted therapies.

Kineret prior authorization

Kineret prior authorization requires documentation of diagnosis (e.g., moderately to severely active RA or confirmed NOMID), and for RA initial therapy documentation of trial and failure (or contraindication/intolerance) to two listed agents unless attestation justifies omission; prescriber specialty must be documented.

• Initial coverage for RA/NOMID often 6 months; reauth 12 months and requires evidence of positive clinical response.
• Provide rheumatologist consult notes and records of prior agent trials and durations.

Prior authorization required with condition-specific documentation

Prior authorization requests must include diagnosis‑specific documentation, relevant test results (e.g., genetic/molecular testing, labs, imaging), prescriber specialty/consultation notes when required, and prior therapy history as specified by the product.

• Provide FDA‑ or CLIA‑approved test results when molecular testing is required.
• Include baseline disease measures cited by the product (e.g., BSA, CDAI, eosinophil counts).

Prior authorization required

Prior authorization is required with product‑specific clinical criteria — submit diagnosis confirmation, prior therapy trials or contraindication/intolerance documentation, prescriber specialty notes when specified, and note that many approvals default to 12 months.

• Follow each product entry for exact lab thresholds, imaging, or biopsy requirements.
• Include specialist consultation notes where the policy requires a specialist prescriber.

Onureg prior authorization

Onureg prior authorization requires documentation of AML diagnosis, prior intensive induction chemotherapy, achievement of CR or CRi, and that the patient is unable to complete intensive curative therapy; include required Part D prerequisite drug documentation.

• Coverage duration: 12 months; approve continuation of prior therapy.
• Submit detailed chemotherapy history and documentation of remission status (CR/CRi).

Orencia prior authorization

Orencia prior authorization for RA, PJIA, and PsA initial approvals requires diagnosis and documentation of trial and failure/intolerance to specified conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine) with initial duration 6 months and reauth 12 months; reauthorization requires demonstration of positive clinical response.

• Provide rheumatology consult notes and records of prior conventional therapy trials at maximally tolerated doses.
• Ensure prerequisite Part D drug documentation is included when required.

PAH agents prior authorization

PAH agents (Opsumit, Orenitram, Orenitram titration kits) require prior authorization with confirmation of symptomatic PAH by right heart catheterization or documentation that the patient is currently on PAH therapy; initial approvals are typically 6 months with reauthorizations at 12 months and specialist prescriber involvement (pulmonologist or cardiologist) for initiation.

• Submit right heart catheterization report when available or document current PAH therapy.
• Include pulmonology or cardiology consult notes for initial therapy.

Ozempic prior authorization

Ozempic prior authorization requires documentation for the intended indication: for T2DM submit diagnostic records or labs (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hr OGTT ≥200 mg/dL); for MASH submit diagnostic confirmation and fibrosis staging (FAST, MAST, or liver biopsy) and specialist consult when indicated.

• Coverage duration: 12 months; reauth requires positive clinical response.
• Include fibrosis stage (F2–F3) documentation for MASH and endocrinology/hepatology/gastroenterology consult notes as applicable.

Prior authorization requirement

Prior authorization is required generally with submission of indication‑specific documentation and evidence of prerequisite therapies or test results per the product entry; include prescriber specialty information where mandated.

• Check each product for prerequisite Part D drug requirements and include supporting lab/imaging/genetic results.
• For reauthorization, document improvement from baseline using the disease‑specific measures cited.

Prior authorization required

Prior authorization requires documentation of diagnosis-specific criteria (diagnosis, prior therapy trials, baseline disease measures) for initiation and reauthorization; follow the product entries for exact required measures and trial durations.

• Provide baseline disease measures (e.g., BSA, CDAI, eosinophil counts) and prior therapy histories including durations.
• Include prescriber specialty notes when required (e.g., dermatologist, gastroenterologist, rheumatologist).

Prior authorization required for specialty indications

For specialty indications, prior authorization requires documentation of diagnosis and prior therapy trials as specified (for example PJIA requires a minimum 6‑week TF/C/I to methotrexate or leflunomide and documentation of TNF inhibitor failure/intolerance where applicable).

• Initial coverage commonly 6 months with reauth 12 months and reauth requires demonstration of positive clinical response.
• Include rheumatology consultation notes and records of TNF inhibitor trials when applicable.

Step therapy requirements

Many products require step therapy: document trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional or topical therapies at maximally tolerated doses before approval of biologic or specialty agents.

• Confirm the required number and classes of prior agents (e.g., one conventional DMARD for RA, two agents for some Kineret indications).
• Document trial durations and reasons for failure, contraindication, or intolerance.

Caplyta step therapy

Caplyta step therapy requires documentation of trial and failure, contraindication, or intolerance to specified oral generic atypical antipsychotics depending on the indication (e.g., two agents required for certain MDD adjunctive uses).

• Provide documentation of trials of listed atypical antipsychotics and reason for failure or intolerance.
• Include prior Part D drug records when indicated.

Step therapy / TF/C/I requirements

Many products require step therapy (TF/C/I) of specified formulary alternatives—examples include oral atypical antipsychotics for Caplyta and topical or NSAID trials for dermatologic or rheumatologic biologics—document the trials, durations, and outcomes.

• Ensure documentation shows trials at maximally tolerated doses and minimum durations where specified (e.g., 30 days topical trial for psoriasis).
• If a prerequisite Part D drug is required, include that evidence.

Deferasirox — laboratory and transfusion prerequisites

Deferasirox initial and reauthorization criteria require laboratory thresholds and transfusion history: initial ferritin >1000 mcg/L and transfusion of ≥100 mL/kg packed RBCs for transfusional iron overload; NTDT requires LIC ≥5 mg Fe/g dw and ferritin >300 mcg/L; reauth requires reduction in ferritin or LIC.

• Include baseline ferritin and transfusion history or LIC by MRI when applicable.
• Reauthorization must show reduction from baseline in serum ferritin or LIC.

Enbrel step therapy

Enbrel step therapy requires documentation of prior trials of conventional systemic therapies or topical agents as specified per indication before initiation of Enbrel (e.g., 3 months TF/C/I to conventional therapy for RA; 6‑week trial for PJIA; topical trial for plaque psoriasis).

• Provide documentation of trial durations and outcomes at maximally tolerated doses.
• Include rheumatology or dermatology consult notes when applicable.

Prerequisite therapy variability

Prerequisite therapy requirements vary by product; some agents (e.g., Fasenra, Cosentyx) require use of a prerequisite Part D drug or documented escalation of controller therapy, while others do not—always follow the specific product entry.

• Check the product entry for whether a prerequisite Part D drug is required and document accordingly.
• Include controller therapy details and escalation attempts where relevant.

Step therapy / required prior medications

Many inflammatory and autoimmune agents require documented trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine for RA; NSAID trial for AS; topical therapy trial for plaque psoriasis) before biologic initiation.

• Document trials at maximally tolerated doses and record reasons for discontinuation or failure.
• Provide prescriber specialty notes (rheumatologist, dermatologist, gastroenterologist) as required.

Prerequisite trial requirements

Many products require documented TF/C/I to specified prior therapies (e.g., Kesimpta requires TF/C/I to one DMT; Kineret RA initial requires TF/C/I to two specified agents); submit records of prior agents tried and reasons for failure/intolerance.

• Include dates, doses, and duration of prior therapy trials (minimum durations where specified).
• If attestation is used to exempt a trial, include justification and supporting documentation.

Kineret step therapy requirement

Kineret for RA initial therapy requires documentation of trial and failure, contraindication, or intolerance to two listed agents (examples include etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) unless an attestation justifies omission.

• Provide documentation of the two prior agent trials or an attestation explaining why trials are inappropriate.
• Prescriber should be a rheumatologist or consult with one for initial requests.

Required trial and failure of specified agents

Some products require trial and failure of specified agents before approval (examples: trial of a triptan before dihydroergotamine for acute migraine); document the specific agent trials and outcomes.

• Include evidence of triptan trial and reason for failure or contraindication when required.
• Follow product-specific minimum durations for prior agent trials.

Step therapy / trial requirements

Many products require trial and failure or contraindication/intolerance to specific alternative agents (e.g., schizophrenia therapies before Opipza; intranasal corticosteroid and antihistamine before Odactra; fludrocortisone or midodrine before droxidopa); document prior agent trials and specialist consults as indicated.

• For Opipza, document trials of two specified antipsychotics and reasons for failure/intolerance.
• For Odactra, include positive specific IgE or skin testing and documentation of prior intranasal corticosteroid and antihistamine trial.

Opipza step therapy

Opipza (antipsychotic) requires trial and failure, contraindication, or intolerance to two specified antipsychotics for schizophrenia and other indicated diagnoses; include records of those trials.

• Document dates, doses, and reasons for discontinuation of the two prior antipsychotic trials.
• Include psychiatric specialist notes when available.

Step therapy requirements

Step therapy is required for multiple agents (e.g., Infliximab requires documented TF/C/I to specified conventional therapies; PCSK9 inhibitors require maximal tolerated statin/ezetimibe or documented statin intolerance); include prior therapy history and lipid/response labs where applicable.

• For PCSK9 inhibitors, include LDL‑C results and documentation of maximally tolerated statin or statin intolerance.
• For infliximab, provide records of conventional therapy trials and CDAI or other disease activity measures as applicable.

Step therapy / TNF inhibitor prerequisite

Many inflammatory indications require prior trial and failure, contraindication, or intolerance to specified conventional therapies and often at least one TNF inhibitor before approval of certain agents (e.g., Rinvoq/Rinvoq LQ, other advanced biologics); document prior TNF inhibitor use and outcomes.

• Include TNF inhibitor trial dates, doses, reasons for discontinuation, and prescriber specialty notes.
• Reauthorization requires demonstration of positive clinical response from baseline.

Step therapy / prerequisite trials

Several products require documented trial and failure or contraindication to specified topical, conventional, or biologic therapies before approval (e.g., topical therapy trials for plaque psoriasis, conventional DMARDs for PJIA); provide documentation of those prior trials and outcomes.

• For plaque psoriasis, document topical therapy trials (minimum 30 days; 14 days for topical corticosteroids) and BSA measurements.
• For PJIA, include 6‑week trial documentation of methotrexate or leflunomide.

Required clinical and prior therapy documentation

Providers must document diagnosis, prior trial and failure/contraindication/intolerance to required conventional therapies where specified, evidence of disease activity per indication (e.g., BSA for psoriasis, CDAI for Crohn's), and for reauthorization document positive clinical response compared to baseline.

• Include objective baseline and follow‑up measures (e.g., joint counts, BSA, CDAI, lab markers).
• Attach prescriber specialty consultation notes when required by the product criteria.

Augtyro required diagnostic and prior therapy info

Augtyro prior authorization requires documentation of tumor ROS1 rearrangement for NSCLC or NTRK gene fusion for solid tumors, stage (locally advanced or metastatic), prior therapy history (progression after prior treatment or lack of satisfactory alternatives), and specialist prescriber notes.

• Provide FDA‑ or CLIA‑approved molecular test results demonstrating ROS1 or NTRK fusion.
• Include oncology consult notes and prior line therapy documentation.

Balversa molecular and prior therapy documentation

Balversa prior authorization requires documentation of locally advanced or metastatic urothelial carcinoma with a susceptible FGFR3 alteration detected by an FDA‑approved or CLIA test, prior systemic therapy history including PD‑1/PD‑L1 exposure or documented ineligibility, and specialist prescriber notes.

• Submit FGFR3 test results from an FDA‑approved or CLIA‑certified laboratory.
• Include prior systemic therapy records and oncology specialist documentation.

Cabometyx required information

Cabometyx prior authorization requires documentation of the specific diagnosis (RCC, HCC, DTC, neuroendocrine tumors), prior therapy trials (e.g., sorafenib or VEGFR‑targeted therapies) where applicable, and prescriber specialty notes.

• Provide prior therapy details and dates showing treatment sequence per indication.
• Include oncology specialist consultation notes.

Diagnostic testing documentation

For bile acid synthesis disorders or peroxisomal disorders, submit abnormal urinary bile acid analysis by mass spectrometry or molecular genetic testing consistent with the diagnosis and specialist prescriber documentation (hepatologist, geneticist, gastroenterologist, or inborn errors specialist).

• Include laboratory mass spectrometry reports or genetic testing results.
• Document specialist consultation and evidence of liver disease or fat‑soluble vitamin malabsorption where applicable.

HAE diagnostic documentation

For hereditary angioedema (HAE) prophylaxis and acute therapy, provide diagnostic testing documentation including C4 level and C1‑INH antigenic or functional level, or genetic testing/family history consistent with HAE‑nl‑C1INH as specified; prescriber should be an immunologist or allergist for many HAE entries.

• Include C4 and C1‑INH results or genetic testing reports.
• Document specialist prescriber involvement and history of HAE attacks when relevant.

Anticholinergic risk acknowledgement

When prescribing anticholinergic‑risk medications (e.g., cyclobenzaprine) prescribers must acknowledge anticholinergic risks and consider dose reduction or discontinuation of unnecessary medications, and note that PA applies for patients age ≥65 years.

• Document the prescriber's anticholinergic risk acknowledgement in the medical record.
• For patients ≥65, include justification for therapy and prior therapy trials where required.

Metyrosine — diagnostic confirmation and prescriber consult

For preoperative metyrosine, submit biochemical confirmation of pheochromocytoma (plasma free metanephrines or urinary fractionated metanephrines) and document specialist prescribing/consultation; trials of alpha and beta blockers may be required before therapy in many cases.

• Provide plasma or urine metanephrine test results and endocrinology or surgical consult notes.
• Document trials or contraindications to alpha‑ and beta‑adrenergic blockers as indicated.

Required diagnostic and treatment history

Provide diagnosis‑specific documentation as required by the product (e.g., PNH diagnosis for Empaveli; for C3G or primary IC‑MPGN include diagnosis, lack of prior transplant for primary IC‑MPGN, and evidence of at least 12 weeks of maximally tolerated ACEi/ARB or SGLT2 inhibitor therapy to reduce proteinuria).

• Include nephrology or hematology consult notes and medication dose/history showing 12-week maximally tolerated therapy.
• Attach laboratory or urine proteinuria measures supporting the diagnosis and treatment effect.

Genetic and baseline motor function documentation

For Evrysdi (SMA) prior authorization, submit genetic testing confirming SMN1 mutation/deletion and SMN2 copy number, baseline standardized motor exam results (e.g., HINE‑2, HFMSE, RULM, CHOP‑INTEND), and documentation regarding prior gene replacement therapy response if applicable.

• If prior gene therapy was given, submit medical records documenting inadequate response (e.g., sustained decrease in motor test score over 6 months).
• Include neurologist consult notes and baseline motor function assessments.

Fabrazyme diagnostic documentation

For Fabrazyme prior authorization, provide diagnostic confirmation of Fabry disease via pathogenic GLA mutation, deficient α‑Gal A enzyme activity, or significant clinical manifestations; include that Fabrazyme is not to be used in combination with other Fabry disease therapies.

• Patient age ≥2 years; coverage 12 months with reauth requiring positive clinical response.
• Attach genetic or enzyme assay results and specialist (neurology/cardiology/nephrology) consultation notes.

Fasenra required clinical data

For Fasenra and other eosinophil‑targeted therapies, include baseline peripheral blood eosinophil count (e.g., ≥150 cells/µL baseline for some asthma indications, ≥300 cells/µL for COPD), documentation of prior exacerbations or hospitalizations, and current controller therapy details appropriate for the patient's age.

• Provide prior controller therapy history and escalation documentation as required.
• Include specialist prescriber notes (pulmonologist or allergist/immunologist) and reauth evidence of positive clinical response.

Opioid tolerance documentation

For fentanyl oral transmucosal (breakthrough cancer pain), document the patient is taking a long‑acting opioid around the clock and has at least one week history demonstrating opioid tolerance at the specified minimum daily doses prior to approval.

• Specify the long‑acting opioid regimen and duration of tolerance (≥1 week) with minimum daily dose documentation per policy thresholds.
• Include pain or oncology specialist notes supporting use.

HAE diagnostic documentation

For icatibant acetate (HAE), submit diagnostic confirmation with C4 and C1‑INH testing or genetic testing/family history consistent with HAE‑nl‑C1INH; prescriber should be an immunologist or allergist for initial prescriptions.

• Include C4 and C1‑INH antigenic/functional assay results or genetic testing.
• Coverage duration: 12 months; reauth requires positive clinical response.

Required diagnostic and growth documentation

For growth‑related indications, include bone age criteria, growth measures (height SDS, percentiles), growth velocity, genetic testing where specified, and endocrinology consult notes; reauthorization should document expected adult height or treatment response.

• Provide bone age assessment and growth velocity data per product thresholds.
• Include endocrinologist consultation and prior therapy history when applicable.

Molecular testing documentation

For molecularly targeted therapies (e.g., Ibtrozi, Pemazyre, Retevmo, Piqray), provide FDA‑approved or CLIA‑certified test results confirming the required genomic alteration (ROS1, FGFR2/FGFR1, RET fusion/mutation, PIK3CA), plus prior treatment history and oncology specialist documentation.

• Attach molecular testing reports from FDA‑approved or CLIA‑certified labs.
• Include prior line therapy documentation and oncologist consult notes.

Required laboratory monitoring

Follow required laboratory monitoring documentation when mandated (e.g., Jynarque/Tolvaptan ALT/AST/bilirubin baseline and serial monitoring schedule; Kerendia baseline serum potassium, eGFR, and UACR), and submit test results and monitoring schedules with prior authorization requests.

• Include baseline labs and planned monitoring frequency per product guidance.
• Attach laboratory reports and specialty consult notes as applicable.

Kesimpta — required medical information

For Kesimpta initial requests include documentation of a relapsing form of MS and either trial and failure (minimum 4‑week supply), contraindication/intolerance to one DMT, or documentation that therapy is a continuation; prescriber must be a neurologist or document neurologist consultation for initial and reauthorization.

• Do not submit concurrent DMT or other B‑cell targeted therapy use; such requests risk denial.
• Reauthorization requires demonstration of positive clinical response to therapy.

Kineret — required medical information

For Kineret, include documentation of diagnosis (moderately to severely active RA or confirmed NOMID), required genetic or clinical confirmation for NOMID, prescriber specialty (rheumatologist, allergist/immunologist, or pediatrician as applicable), and evidence of clinical response for reauthorization.

• For RA initial, document TF/C/I to two listed agents or attestation if trials are inappropriate.
• Reauth requires documentation of positive clinical response; durations per product (initial often 6 months, reauth 12 months).

Required diagnostic and prescriber documentation

Provide medical records supporting diagnosis and prescriber specialty/consultation when required (e.g., CPP diagnostic criteria, advanced bone age, LH testing; endocrinology consults), and include required diagnostic details per product.

• Attach relevant test results (e.g., peak LH after GnRHa testing) and specialist consultation notes.
• Reauthorization must show positive clinical response as defined by the product.

Genetic/molecular testing documentation

Provide FDA‑ or CLIA‑approved genetic/molecular test results when indicated (e.g., BRAF V600E/V600K, H3 K27M) and detailed prior treatment history per product requirements.

• Include laboratory or pathology reports confirming the required mutation.
• Document prior therapy lines and reasons for discontinuation.

Required clinical documentation

Providers must submit diagnosis details, supporting test results (e.g., HRCT pattern, lung biopsy results, TTR mutation testing), and prior treatment history as specified for each product to support prior authorization decisions.

• Include imaging reports, biopsy pathology, and genetic test results when required.
• Provide specialist consultation notes and prior therapy documentation.

Allergy testing and prior therapy documentation

For Odactra, include positive specific IgE testing or skin testing and documentation of trial and failure, contraindication, or intolerance to an intranasal corticosteroid and an antihistamine before approval; prescriber should be an allergist/immunologist for initiation.

• Attach positive IgE or skin test reports and records of prior intranasal corticosteroid and antihistamine trials.
• Age requirement: 5–65 years for initial therapy.