Prior authorization required

Prior authorization is required for these products; submissions must include the patient diagnosis, documentation of required prior therapy trials (or contraindication/intolerance), prescriber specialty or consultation when specified, and the requested coverage duration (initial vs reauthorization).

• Include diagnosis matching the product-specific criteria.
• Provide evidence of required prior trials, failures, contraindication, or intolerance (TF/C/I) with duration when specified.
• Indicate prescriber specialty or consultation when the product requires it.

Prior authorization required (product list)

Prior authorization is required for the listed formulary products in chunks 18–37; approval typically requires the indication-specific documentation noted in each product entry and most approvals are for 12 months.

• Submit indication-specific documentation per product (diagnostic tests, labs, prior therapy history).
• Expect common approval duration of 12 months unless a product-specific shorter initial period is specified.

Cosentyx products — prior authorization

Cosentyx (secukinumab) requires prior authorization with disease-specific diagnostic documentation and evidence of required prior therapy trials; initial approvals are commonly limited to 6 months with reauthorization requiring evidence of clinical response.

• Provide diagnosis and disease-specific measures (e.g., BSA for psoriasis, objective inflammation for axial disease).
• Document trial and failure/contraindication/intolerance to required topical/systemic or NSAID therapies as applicable.
• Prescriber should be the specialist or consult (dermatologist, rheumatologist) as listed.

Cinryze — prior authorization

Cinryze prior authorization is required for HAE prophylaxis and must include confirmation of HAE by low C1‑INH antigenic or functional level; concomitant prophylactic HAE treatments are not permitted.

• Submit documentation of C1‑INH antigenic level below normal OR C1‑INH functional level below normal.
• Do not request combination prophylactic HAE treatments—policy excludes combination use.

Dupilumab prior authorization

Dupilumab requires prior authorization with indication‑specific documentation (e.g., eosinophil thresholds for eosinophilic asthma, eos/hpf for EoE) and evidence of prior controller therapy or specified trials per indication.

• For eosinophilic asthma: baseline blood eosinophils ≥150 cells/µL and prior controller therapy per age band.
• For EoE: ≥15 intraepithelial eosinophils per high‑power field and exclusion of other causes; prior PPI or topical steroid trial.

Enbrel prior authorization

Enbrel prior authorization is required for its rheumatologic and dermatologic indications and must document the diagnosis and required prior conventional DMARD trial (typically a 3‑month trial for RA) and prescriber specialty involvement.

• Provide diagnosis of the specific indication (RA, PJIA, PsO, etc.).
• Document minimum required conventional therapy trial duration (e.g., 3 months for RA; 6 weeks for PJIA; 4 weeks topical trial for PsO).
• Prescriber: rheumatologist or appropriate specialist or consultation.

Fasenra PA criteria

Fasenra prior authorization requires documentation of severe eosinophilic asthma criteria: baseline peripheral blood eosinophils ≥150 cells/µL, history of exacerbations or hospitalization in the past 12 months, and required prior controller therapy trials matched to age groups; reauthorization requires evidence of clinical response.

• Document baseline eosinophils ≥150 cells/µL.
• Provide history of ≥2 exacerbations requiring systemic corticosteroids or prior asthma‑related hospitalization in past 12 months.
• Show trials of required inhaled corticosteroid/controller regimens (age‑specific).

ALK-targeted therapy PA criteria

ALK‑targeted therapies (example: lorlatinib) require prior authorization with documentation of ALK rearrangement by an FDA‑approved or CLIA‑approved test and that the patient is ALK‑inhibitor naïve for initial approval.

• Provide molecular test result confirming ALK rearrangement (FDA‑approved or CLIA test).
• Confirm patient has not previously received an ALK inhibitor for initial approval.

Prior authorization required (general)

Prior authorization is required generally across the formulary; requests must include the listed diagnosis, product‑specific required prior trials/durations, prescriber specialty when specified, and evidence of response for reauthorization.

• Attach clinical records documenting diagnosis and prior therapy history.
• Indicate initial versus reauthorization and include requested duration.
• For reauthorization, provide objective evidence of clinical benefit per product criteria.

LEMS prior auth

LEMS initial therapy requires prior authorization documenting the diagnosis of LEMS, patient age ≥6 years, and that the medication is prescribed by or in consultation with a neurologist; coverage duration is 12 months with reauthorization contingent on positive clinical response.

• Submit documentation confirming LEMS diagnosis.
• Confirm patient is ≥6 years of age.
• Include neurologist involvement or consultation notes for the request.

Prior authorization and duration

Prior authorization submissions must include the diagnosis, required product‑specific documentation and history, and will commonly indicate coverage duration (initial and reauthorization timeframes are listed per product entries).

• Most products list initial durations (often 6 months) and reauthorization durations (commonly 12 months).
• Ensure charts show baseline metrics and planned monitoring to support the requested duration.

Prior authorization requirement

Prior authorization is required per formulary entries; approvals commonly require documentation of diagnosis and prior therapy failure/intolerance/contraindication where specified.

• Follow the product‑specific required medical information fields when preparing the PA submission.
• When a prior therapy trial is required, include dates, doses, and reason for failure or intolerance.

Prior authorization required (molecular testing)

Prior authorization is required and, when applicable, must include required molecular testing results, prior therapy history, and prescriber/specialist documentation as listed per product.

• Attach FDA‑approved or CLIA‑certified molecular test reports when molecularly targeted agents are requested.
• Include specialist consultation notes when the product requires a specialist prescriber.

Prior authorization requirement

Prior authorization is required with documentation of the listed diagnosis and disease‑specific criteria; coverage durations and any prescriber restrictions apply per drug entry.

• Provide disease‑specific labs, imaging or scores as required (e.g., BSA for psoriasis, CDAI for Crohn's).
• Confirm prescriber specialty or consultation if the entry requires it.

Orencia prior authorization

Orencia prior authorization requires documentation of the diagnosis (RA, PJIA, PsA) and a prior trial/failure or intolerance to specified conventional DMARDs (minimum 3 months for RA; 6 weeks for PJIA); prescriber specialty is required.

• Include documentation of TF/C/I to methotrexate, leflunomide, or sulfasalazine as applicable.
• Prescriber should be a rheumatologist or involve rheumatology consultation.

Praluent prior authorization

Praluent prior authorization requires documented diagnosis (HeFH, ASCVD, primary HLD, or HoFH), evidence of maximally tolerated statin therapy or documented statin intolerance, recent LDL values on therapy meeting policy thresholds, and genetic confirmation for HoFH when applicable.

• Attach LDL labs within the required timeframe (e.g., within 120 days) showing the threshold criteria.
• Document statin tolerance history or contraindication; for HoFH include genetic confirmation or specified LDL/xanthoma family history.

PAH therapies prior authorization

PAH therapies require prior authorization documenting symptomatic PAH confirmed by right heart catheterization or that the patient is currently on PAH therapy; initial prescribing should be by or in consultation with a pulmonologist or cardiologist.

• Provide right heart catheterization report or documentation that the patient is currently receiving PAH therapy.
• Include pulmonology or cardiology prescriber or consultation notes.

PA required for PCSK9 inhibitors

Prior authorization for PCSK9 inhibitors requires documentation of diagnosis, trial or maximally tolerated lipid‑lowering therapy (or statin intolerance), and recent LDL‑C values meeting the policy thresholds; initial approval is commonly 6 months with reauthorization at 12 months.

• Include LDL labs drawn while on maximally tolerated therapy (within last 120 days).
• Document statin use or intolerance (attempts with at least two statins when claiming intolerance).

PA required for eltrombopag

Eltrombopag prior authorization is required and must document the indication (ITP, SAA, HCV‑associated thrombocytopenia), baseline platelet counts (eg, <30,000/mcL for ITP), and specialist prescribing or consultation where specified.

• For ITP: include baseline platelet count <30,000/mcL and history of TF/C/I to corticosteroids, IVIG, or splenectomy.
• For other indications, include the diagnosis‑specific lab thresholds and specialist notes.

Prior authorization and therapy-failure requirements

Prior authorization requires evidence of diagnosis and prior therapy trials or failures where specified (for example, TNF inhibitor failure or conventional therapy TF/C/I) and prescriber specialty/consultation when required.

• Provide clear documentation of prior biologic or conventional therapy trials and clinical rationale for escalation.
• Attach specialist consult notes when the policy requires specialist involvement.

Prior authorization required (per product)

Prior authorization is required per product entries with documentation of diagnosis, required prior therapy trials or laboratory confirmation as specified; typical coverage durations and any prescriber consultation requirements are listed per product.

• Follow each product's 'Required Medical Information' and 'Other Criteria' fields exactly when preparing the PA.
• Note initial vs reauthorization duration as specified in the product entry.

Prior authorization and duration

Prior authorization submissions should indicate initial vs reauthorization; most oncology and specialty agents list 12‑month coverage durations for reauthorization and require documentation supporting continuation of prior therapy.

• For oncology/specialty agents, include prior therapy history and objective evidence supporting continuation.
• Expect reauthorization commonly set to 12 months.

Parathyroid hormones PA requirements

Parathyroid hormone products (e.g., teriparatide) require prior authorization documenting BMD/T‑score or fracture history and prior therapy failures; initial coverage is commonly 24 months and lifetime cumulative parathyroid hormone therapy must not exceed 24 months.

• Provide BMD T‑scores, fracture history, FRAX when applicable, and prior osteoporosis therapy trials.
• Note lifetime treatment duration limit of 24 months in authorization documentation.

Step therapy / prior medication trials

Many indications require documented step therapy: trial and failure, contraindication, or intolerance to specified conventional therapies (e.g., 3‑month TF/C/I to methotrexate/leflunomide/sulfasalazine for RA; topical therapy trial for psoriasis).

• Document dates, doses and reasons for failure/intolerance of prior therapies.
• Ensure minimum trial durations match the policy thresholds (e.g., 3 months for RA; 4 weeks topical for psoriasis).

Required trials before Caplyta

Caplyta authorization requires documented trial and failure/contraindication/intolerance to specified oral generic atypical antipsychotics: two agents for schizophrenia or specified agents for bipolar depression.

• For schizophrenia: document TF/C/I to two listed oral generic atypical antipsychotics.
• For bipolar depression: document TF/C/I to quetiapine or olanzapine as specified.

Step therapy for psoriasis/axial disease

For psoriasis and related axial disease indications, prior authorization and approval require trial and failure (or contraindication/intolerance) of specified topical, systemic, or NSAID agents as applicable before biologic approval; specific step requirements vary by product and indication.

• For plaque psoriasis: document ≥4‑week TF/C/I to topical therapies and BSA involvement per policy.
• For AS/nr‑axSpA: document NSAID trial(s) of specified duration prior to biologic therapy.

Dupilumab step therapy

Dupilumab step therapy requires prior use of inhaled corticosteroids plus additional controller therapy or maximized ICS/LABA regimens before approval in many asthma age‑groups; include documentation of controller regimens and exacerbation history.

• For asthma: show prior controller therapy per age group (e.g., medium/high‑dose ICS plus additional controller or maximized combination ICS/LABA).
• Include exacerbation history (eg, ≥2 exacerbations or prior hospitalization in 12 months).

Eucrisa step requirement

Eucrisa initial approval requires trial and failure (or contraindication/intolerance) to one prescription‑strength topical corticosteroid unless the affected area is sensitive.

• Document a minimum trial of a prescription topical corticosteroid (or documented contraindication/intolerance).

Conventional therapy trial for RA

RA initial therapy prior authorization requires documentation of a minimum 3‑month trial and failure/contraindication/intolerance to one conventional DMARD (methotrexate, leflunomide, or sulfasalazine) at maximally tolerated doses prior to biologic or advanced therapy.

• Provide treatment dates, doses, and rationale for failure/intolerance for the conventional DMARD trial.
• Ensure prescriber documentation (rheumatology) is included.

Psoriasis step therapy

For psoriatic disease and plaque psoriasis, prior authorization requires documented conventional therapy trials of defined durations (e.g., minimum 4‑week topical therapy trial for plaque psoriasis) before biologic approval.

• Include documentation of the topical/systemic therapy trial, duration (e.g., 4 weeks for topical), and reason for failure/intolerance.
• Record BSA or other severity metrics per the policy.

Therapeutic trial requirements

Several products require therapeutic trials or failures of specified alternative agents (for example, acute migraine dihydroergotamine requires prior trial/failure or contraindication to a triptan).

• Provide documentation of prior class‑specific trials (e.g., triptan trial for acute migraine agents).
• If contraindication, include clinical notes explaining rationale.

ACE/ARB and SGLT2 step requirements

Kerendia (for CKD with T2D) requires a minimum 30‑day trial of a maximally tolerated ACE inhibitor or ARB (unless contraindicated) and either concomitant SGLT2 inhibitor use or documentation of SGLT2 contraindication/intolerance.

• Document at least a 30‑day trial of ACE inhibitor or ARB at maximally tolerated dose, or document contraindication/intolerance.
• Show SGLT2 inhibitor use and plan to continue, or document contraindication/intolerance to SGLT2 agents.

Step or prior therapy requirements (selected)

Multiple products require prior trial and failure of specified agents before approval (examples: dihydroergotamine requires prior triptan trial; Lumakras requires prior systemic therapy and documented KRAS G12C mutation).

• Attach evidence of required prior systemic therapy trials where specified.
• Include molecular testing reports when targeted agents require mutation confirmation.

Step/step-up therapy

Many entries require trial and failure, contraindication, or intolerance to specified alternative agents (e.g., droxidopa requires trial of fludrocortisone or midodrine; Nucala/Nucala‑class agents require controller therapy trials and eosinophil counts).

• Document prior agent trials and outcomes (dates, doses, reasons for discontinuation).
• Include baseline lab values where required (e.g., eosinophil counts for eosinophilic indications).

Required trials before specialty drugs

Specialty and high‑cost products routinely require prior trial and failure (TF), contraindication, or intolerance to specified agents (for example, antipsychotic trials for antipsychotics; DMARDs for RA) before authorization.

• Confirm and document the full history of standard therapy trials per the product's required sequence.
• Provide specialist consultation notes for complex indications.

Step therapy for infliximab

Infliximab initial authorization generally requires documentation of moderate‑to‑severe disease activity and prior trial/failure/contraindication/intolerance to specified conventional therapies (e.g., azathioprine, methotrexate, corticosteroids).

• Provide objective disease activity measures (CDAI>220, stool frequency, CRP, weight loss, endoscopy findings) as applicable.
• Document trials and outcomes of conventional immunomodulators or corticosteroids.

Step therapy for FN prophylaxis

Rolvedon for febrile neutropenia prophylaxis requires prior trial and failure or intolerance to specified pegfilgrastim/filgrastim biosimilars (Neulasta, Udenyca) before approval.

• Document prior use and inadequate response or intolerance to Neulasta/Neulasta Onpro or Udenyca/Udenyca Onbody.
• Include oncology/chemotherapy plan and FN risk justification.

Required prior therapy trials (dermatology/neurology examples)

Many dermatology and neurology agents require documented failure, contraindication, or intolerance to specified prior therapies (e.g., two anticonvulsants prior to certain adjunctive therapies; topical therapy trial before psoriasis biologics).

• Provide clear documentation of prior systemic or topical therapy trials with duration and reasons for failure.
• When policy requires two prior agents, include both trial records.

Referenced trial/failure requirements (oncology example)

Some oncology entries and targeted therapies reference required trial/failure of other therapies or specific combinations (e.g., erlotinib combinations); include prior systemic therapy history and molecular testing where applicable.

• Document prior systemic therapy lines and combination regimens.
• Attach molecular testing reports when targeted agents require specific mutations/rearrangements.

Required clinical documentation (general)

Providers must submit required clinical documentation with prior authorization requests: diagnosis confirmation, evidence of prior therapy trials (dates/doses/outcomes), and disease‑specific objective measures; reauthorization requires evidence of positive clinical response.

• Include chart notes, lab results, imaging, scores (e.g., BSA, CDAI, ALSFRS‑R) that directly support the diagnosis and response.
• When molecular tests are required, attach FDA‑approved or CLIA‑certified test reports.

Diabetes diagnostic documentation

For diabetes therapies (e.g., GLP‑1, tirzepatide), submit medical records confirming T2DM diagnosis or qualifying laboratory evidence (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL).

• Attach recent lab results meeting the diagnostic thresholds if chart notes are not sufficient.
• Specify the indication (T2DM vs MASH) and include relevant specialty consult when required.

Benlysta required documentation

Benlysta (SLE) prior authorization requires documentation of active SLE, positive serology (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), and current standard‑of‑care treatment.

• Include ANA or anti‑dsDNA lab results meeting the specified thresholds.
• Document current use of standard‑of‑care therapy (antimalarials, corticosteroids, immunosuppressants).

Cystic fibrosis required information

For cystic fibrosis products (e.g., Cayston), prior authorization must include confirmation of CF diagnosis and microbiologic evidence of Pseudomonas aeruginosa in the lungs.

• Provide culture or other microbiologic documentation confirming Pseudomonas aeruginosa.
• Include CF diagnostic evidence and specialist involvement (CF center/pulmonologist).

Cholbam — diagnostic documentation

Cholbam (chenodeoxycholic acid) requires diagnostic documentation of bile acid synthesis disorders by abnormal urinary bile acid analysis by mass spectrometry or molecular genetic testing; peroxisomal disorders require genetic testing or abnormal bile acid analysis plus clinical features.

• Attach mass spectrometry urinary bile acid analysis or molecular genetic test reports.
• Document related clinical features (e.g., liver disease, steatorrhea, fat‑soluble vitamin complications) for peroxisomal disorders.

Deferasirox — baseline labs and transfusion history

Deferasirox prior authorization for transfusional iron overload must include baseline ferritin >1,000 mcg/L and transfusion history of at least 100 mL/kg packed RBCs; NTDT entries require LIC thresholds per policy.

• Attach baseline ferritin >1,000 mcg/L lab result and documentation of cumulative transfusion volume (≥100 mL/kg).
• For NTDT, include LIC measurement (≥5 mg Fe/g dw initial) and serum ferritin per criteria.

Metyrosine diagnostic documentation

Metyrosine preoperative use requires biochemical confirmation of pheochromocytoma (plasma free metanephrines or urinary fractionated metanephrines) and documentation that the medication is intended for preoperative preparation.

• Attach plasma free or urinary fractionated metanephrines supporting the diagnosis.
• Document the planned surgical procedure and preoperative use rationale.

Dupilumab EoE documentation

Dupilumab for eosinophilic esophagitis requires documentation of ≥15 intraepithelial eosinophils per high power field, exclusion of other causes of esophageal eosinophilia, weight ≥15 kg, and prior trial of PPI or topical esophageal corticosteroid.

• Include pathology report documenting ≥15 eos/hpf.
• Provide evidence of prior 8‑week PPI trial or topical steroid trial and exclusion of alternative causes.

Evrysdi required baseline documentation

Evrysdi prior authorization requires baseline motor function testing (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III Item 22) and genetic confirmation (SMN1 mutation/deletion and SMN2 copy number) before approval.

• Attach genetic testing (SMN1/SMN2) and baseline motor exam results appropriate to age.
• Document whether prior gene therapy was administered and rationale if combined therapies are considered.

Fabrazyme diagnostic documentation

Fabrazyme prior authorization must include molecular genetic testing demonstrating pathogenic GLA mutation or α‑Gal A enzyme deficiency testing (plasma, leukocytes, or DBS) or documentation of significant clinical manifestations consistent with Fabry disease.

• Provide GLA genetic test report or enzyme activity testing results.
• Include clinical documentation of Fabry manifestations when genetic/enzymatic testing is not the primary evidence.

Required medical documentation (general)

For prior authorization, submit medical records (chart notes, labs, imaging) documenting diagnoses, confirmatory testing (e.g., C1‑INH antigenic/functional levels for HAE; FDA‑approved or CLIA‑approved molecular tests for tumor markers), prior therapy history, and clinical response evidence for reauthorization.

• Include copies of specialist notes, lab/imaging reports, and detailed prior therapy timelines.
• For molecularly targeted agents attach the FDA‑approved/CLIA test report used to confirm mutation/rearrangement.

Pediatric growth documentation

Growth‑hormone related products require documentation of growth measurements, bone age, genetic testing when indicated, GH stimulation test results, and IGF‑1 monitoring as specified.

• Attach height/weight growth charts, bone age radiograph, and GH stimulation test results when required.
• Include genetics testing if the indication (e.g., SHOX deficiency) specifies it.

Genomic test documentation

For targeted oncology agents, include documentation of the tumor type and presence of specific actionable mutations/rearrangements detected by an FDA‑approved or CLIA‑certified test (e.g., KRAS G12C for Lumakras, RET fusion for Retevmo) and prior systemic therapy history when required.

• Attach molecular test report (FDA‑approved or CLIA) confirming the actionable mutation.
• Document prior systemic therapy lines and combination regimen details where policy requires prior therapy.

CFTR mutation testing

CFTR mutation testing must be submitted for cystic fibrosis therapies requiring a responsive CFTR mutation (e.g., ivacaftor/Kalydeco); include the FDA‑cleared or CLIA‑approved test report showing the eligible mutation.

• Provide the specific CFTR mutation test results demonstrating a mutation responsive to the requested CFTR modulator.
• Include CF diagnostic confirmation and specialist prescriber notes.

Lumakras required documentation

For Lumakras requests, include documentation of tumor type and stage, and confirm presence of KRAS G12C mutation by an FDA‑approved or CLIA‑authorized test; also provide prior therapy history consistent with the indication.

• Attach KRAS G12C test report (FDA‑approved or CLIA).
• Document prior systemic therapy exposures (e.g., one or more prior lines for NSCLC; prior fluoropyrimidine/oxaliplatin/irinotecan for mCRC).

Mavyret documentation

Mavyret prior authorization requires documentation consistent with current AASLD/IDSA guidance: HCV diagnosis or donor‑derived infection, absence of decompensated liver disease (Child‑Pugh B/C excluded), and not used with other HCV DAAs; specialist involvement is required for some patients.

• Provide HCV diagnosis evidence per guideline or transplant donor history.
• Document Child‑Pugh class to exclude decompensated liver disease when applicable.

Dihydroergotamine documentation

For dihydroergotamine authorization, document the migraine diagnosis and prior trial and failure (or contraindication) to at least one triptan.

• Attach migraine history and documentation of a triptan trial (dates, agent, outcome) or note contraindication to triptans.

Posaconazole documentation

Posaconazole prophylaxis requires documentation of indication (HSCT with GVHD or hematologic malignancy with prolonged neutropenia or prior fungal infection), age ≥13 for prophylaxis/OPC when specified, and trial/failure or resistance to fluconazole for OPC.

• Provide indication justification (HSCT with GVHD, prolonged neutropenia, or prior fungal infection).
• For OPC, include fluconazole trial failure or susceptibility report showing resistance.

Ofev documentation

Ofev (nintedanib) prior authorization requires documentation excluding other ILD causes and HRCT or biopsy demonstrating IPF/SSc‑ILD or chronic fibrosing ILD with ≥10% fibrotic features and evidence of a progressive phenotype when applicable.

• Attach HRCT report demonstrating UIP/probable IPF or ≥10% fibrotic lung volume for chronic fibrosing ILD.
• Include clinical evidence of progression (decline in FVC, worsening symptoms, radiologic progression).

Ozempic — required documentation

Ozempic prior authorization requires medical records confirming T2DM diagnosis or qualifying lab values (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL); for MASH include noninvasive scoring (FAST/MAST) or liver biopsy with fibrosis stage F2‑F3.

• Provide diabetes lab evidence or chart documentation for T2DM.
• For MASH, attach FAST/MAST results or liver biopsy staging showing F2‑F3 fibrosis.

Piqray — required diagnostic testing

Piqray prior authorization requires documentation of PIK3CA mutation by an FDA‑approved or CLIA‑approved test and prior endocrine therapy for advanced/metastatic breast cancer.

• Attach PIK3CA mutation test report from an FDA‑approved or CLIA lab.
• Document prior endocrine therapy history and disease setting (advanced/metastatic).

ALS diagnostic documentation

Edaravone prior authorization requires submission of medical records and diagnostic testing supporting definite or probable ALS per the revised El Escorial criteria, ALSFRS‑R item scores ≥2, and %FVC ≥80% at treatment start.

• Attach documentation supporting ALS diagnosis per revised El Escorial criteria.
• Include baseline ALSFRS‑R item scores and percent FVC values meeting the policy thresholds.

Anemia laboratory documentation

For anemia indications (e.g., ESAs, Retacrit), include hemoglobin/hematocrit lab values within specified timeframes to support severity (CKD: within 30 days; chemotherapy: within 2 weeks) and verify iron status where required.

• Provide Hgb/Hct labs drawn within the timeframe required by the indication.
• Include iron studies and other workup to rule out alternative causes when specified.

Molecular test documentation

Targeted therapies require documentation of tumor molecular testing (FDA‑approved or CLIA‑certified) appropriate to the agent (e.g., RET fusion for Retevmo); include the test report with the PA request.

• Attach the molecular pathology/genomic test report showing the actionable alteration.
• Ensure the testing method meets FDA or CLIA requirements as specified.

Diagnostic and renal function documentation (Rivfloza)

Rivfloza initial authorization requires documentation confirming PH1 via elevated urinary or plasma oxalate plus genetic testing demonstrating AGXT mutation or liver biopsy showing reduced/absent AGT activity, and preserved renal function (eGFR ≥30 mL/min/1.73 m2).

• Provide urinary/plasma oxalate results and AGXT genetic testing or liver biopsy report.
• Include eGFR demonstrating ≥30 mL/min/1.73 m2.

Required diagnostic documentation (selected)

Required diagnostic documentation varies by product and indication; always include diagnosis confirmation, relevant lab values (A1c, LDL, eosinophils, platelet counts), and specialty prescriber notes when requested by the policy.

• Match submitted documentation to the exact 'Required Medical Information' fields in the product entry.
• For reauthorization include documented positive clinical response as defined by the product.

Immune globulin documentation

Immune globulin (IV/SC) prior authorization requires documentation showing the minimum effective dose/frequency, route (subcutaneous vs intravenous), the supporting diagnosis (e.g., CIDP or specified primary immunodeficiencies), and relevant immunologic evaluation (IgG levels and vaccine response when applicable).

• Provide IgG levels, vaccine response testing, and diagnosis supporting SCIG/IVIG use.
• Document dosing plan and rationale for minimum effective dose for maintenance.

GI agents — required clinical information

For Crohn's disease or ulcerative colitis biologic induction (IV), prior authorization requires documentation of diagnosis and objective disease activity measures (e.g., CDAI >220 for CD; stool frequency, ulcers, CRP for UC) and weight for FDA‑labeled induction dosing.

• Include CDAI score or equivalent objective disease activity measures for CD.
• Provide patient weight to support weight‑based IV induction dosing per label (≤55 kg, >55–85 kg, >85 kg).

Tegsedi documentation

Tegsedi (inotersen) requires documentation of hATTR with polyneuropathy, a pathogenic TTR mutation, and baseline neuropathy scores within specified ranges (PND ≤ IIIb, FAP stage 1–2, or NIS 10–130); prescriber should be a neurologist and reauthorization requires demonstrated clinical response.

• Attach TTR genetic test results and baseline neuropathy assessments (PND, FAP stage, or NIS).
• Include neurologist consultation notes and response evidence for reauth.

Missing required diagnosis or prior therapy

Failure to include the required diagnosis or documentation of prior therapy trials (where specified) will likely result in denial of coverage (examples: missing diagnosis for Actimmune; missing prior TF/C/I for therapies requiring such trials).

• Verify that the submitted diagnosis exactly matches the policy's required diagnosis.
• Ensure all required prior therapy trials and their durations/outcomes are documented.

Missing required diagnostic evidence

Coverage may be denied if required diagnostic evidence is not provided (e.g., for Benlysta, absence of ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL and current standard‑of‑care treatment documentation).

• Confirm autoantibody lab results meet the specified thresholds and include current SOC therapy documentation.
• If labs are missing, attach recent lab reports or explain why testing cannot be obtained.

Missing microbiologic evidence

Requests for CF therapies like Cayston may be denied if microbiologic evidence of Pseudomonas aeruginosa in the lungs is not provided; include culture or other microbiologic documentation with the PA.

• Include sputum or respiratory culture confirming Pseudomonas aeruginosa.
• If culture not available, provide clinical justification and prior microbiologic history.

Pyrimethamine — malaria not authorized

Requests for pyrimethamine products for malaria treatment or prophylaxis are not authorized and will be denied per policy; pyrimethamine use is limited to toxoplasmosis indications as specified.

• Do not submit PA requests for pyrimethamine for malaria treatment or prophylaxis—these uses are excluded.
• For toxoplasmosis, ensure infectious disease specialist documentation is provided.

Deferasirox documentation risk

Deferasirox requests lacking documentation of baseline ferritin >1,000 mcg/L and cumulative transfusion history (≥100 mL/kg packed RBCs) for transfusional iron overload will risk denial.

• Provide baseline ferritin >1,000 mcg/L laboratory report and transfusion records totaling ≥100 mL/kg.
• For NTDT include LIC measurements per policy thresholds.

Enbrel prior therapy requirement

Enbrel requests may be denied if the required prior conventional DMARD trial (e.g., methotrexate, leflunomide, sulfasalazine) of adequate duration (commonly 3 months for RA) is not documented.

• Include documentation of the conventional DMARD trial with duration and reason for failure/intolerance.
• Attach rheumatology consultation notes when applicable.

ALK-inhibitor naïve requirement (lorlatinib example)

ALK‑inhibitor therapies (e.g., lorlatinib) will be denied if the patient previously received an ALK inhibitor; initial approval requires ALK‑inhibitor naïve status and confirmed ALK rearrangement.

• Confirm absence of prior ALK inhibitor exposure for initial authorization.
• Attach ALK rearrangement test report (FDA‑approved or CLIA).

Combination prophylaxis exclusion

HAE prophylaxis agents (Cinryze, Haegarda) used in combination with other approved prophylactic HAE treatments are not permitted and such combination requests may be denied.

• Do not request concurrent prophylactic HAE agents in the same patient for the same prophylactic purpose.
• If combination therapy was used, provide justification and note policy exclusion.

Required trials for autoimmune indications

Failure to document required prior trials (including minimum durations) of specified conventional therapies for autoimmune indications (RA, PJIA, PsO, AS, etc.) may result in denial.

• Ensure prior conventional therapy trials meet the policy's minimum duration (e.g., 3 months for RA, 4 weeks topical for psoriasis, 1 month NSAID for AS).
• Provide documentation of failure, intolerance, or contraindication.

IVIG renewal requirement

IVIG non‑oncology reauthorization requires documentation of objective improvement and that therapy is at the minimum effective dose; failure to show these will risk denial.

• Provide objective clinical improvement measures and document dosing adjustments towards minimum effective dose for maintenance.
• Attach specialist evaluation supporting continued IVIG use.

Documentation and prior therapy gaps

Requests missing required diagnosis, prior therapy trials, or documentation of intolerance/contraindication to listed alternatives are at high risk for denial.

• Review each product's 'Required Medical Information' and ensure all fields are completed and supported by records.
• If prior therapy cannot be documented, include clinician explanation and supporting evidence.

Dihydroergotamine initial therapy

Dihydroergotamine initial therapy will be denied if the requester does not document prior trial and failure of a triptan (or documented contraindication to all triptans).

• Include records of triptan trial and outcome, or clear documentation of contraindication to triptans.

Lumakras molecular test and prior therapy

Lumakras requests for NSCLC or mCRC without documentation of KRAS G12C mutation (FDA‑approved or CLIA‑authorized test) or required prior therapy history will be denied.

• Attach KRAS G12C molecular test report and prior systemic therapy documentation (as required by indication).

Neulasta prophylaxis documentation

Neulasta prophylaxis requests must include documentation of the chemotherapy regimen's FN risk or prior FN history; missing this documentation may lead to denial.

• Provide chemotherapy regimen details and FN risk justification, or documentation of prior FN event if used as secondary prophylaxis.

Diagnosis and disease status documentation

Requests lacking a documented diagnosis matching the policy's required medical information (e.g., specific cancer type or disease stage) or evidence of refractory/progressive disease may be denied.

• Ensure the submitted diagnosis and staging exactly match the product's Required Medical Information.
• Provide progression evidence or rationale when indicated.

Prior therapy requirement for droxidopa

Droxidopa requires prior authorization documenting failure/contraindication/intolerance to fludrocortisone or midodrine; absence of that documentation may result in denial.

• Provide trial records for fludrocortisone and/or midodrine including duration and reason for failure/intolerance.
• Include specialist consultation notes as required.

Eosinophil and prior therapy documentation

For eosinophilic/Type 2 condition biologics (e.g., Nucala, Fasenra), missing baseline eosinophil counts, prior exacerbation history, or documentation of required prior controller therapy may lead to denial.

• Attach baseline eosinophil lab result and exacerbation/hospitalization history in past 12 months.
• Include prior controller therapy documentation (ICS dose and additional controllers) per age group.

Orencia — RA/PJIA/PsA initial requirements

Orencia initial requests for RA, PJIA, or PsA may be denied if the diagnosis or required prior trial/failure of specified conventional therapies (with minimum durations) is not documented.

• Provide documentation of TF/C/I to methotrexate, leflunomide, or sulfasalazine with the specified minimum trial durations.
• Include rheumatology prescriber or consult notes.

Opsumit/Orenitram — PAH diagnostic confirmation

PAH therapy requests (Opsumit/Orenitram) lacking documentation of diagnosis confirmed by right heart catheterization or evidence the patient is currently on PAH therapy may be denied; prescriber should be a pulmonologist or cardiologist.

• Attach right heart catheterization report or documentation of current PAH therapy.
• Include pulmonology/cardiology prescriber notes or consultation.

Documentation for PCSK9 (Praluent)

Praluent requests missing documentation of the qualifying diagnosis (HeFH/ASCVD/Primary HLD/HoFH) or failure/intolerance to maximally tolerated statin therapy and other lipid‑lowering regimens will be denied.

• Provide LDL labs on maximally tolerated therapy and documentation of statin intolerance or contraindication where claimed.
• For HoFH include genetic confirmation or the LDL/xanthoma family history criteria.

Documentation for Eltrombopag

Eltrombopag requests without required baseline platelet counts (e.g., <30,000/mcL for ITP) or without documentation of prior corticosteroid/IVIG/splenectomy trials may be denied.

• Attach baseline platelet count demonstrating policy threshold.
• Provide prior therapy trial records (corticosteroids, IVIG, splenectomy) with outcomes.

Documentation for Infliximab

Infliximab requests missing objective diagnostic support of moderate‑to‑severe disease activity or documentation of failure/intolerance to required conventional therapies (e.g., azathioprine, methotrexate, corticosteroids) may be denied.

• Include CDAI, stool frequency, CRP, endoscopy, or other objective disease activity measures for IBD indications.
• Document prior immunomodulator or steroid trials and outcomes for rheumatologic/IBD indications.

Missing required medical information

Requests may be denied if required diagnostic labs or documentation (e.g., hemoglobin/hematocrit values for anemia indications) are not provided within the policy‑specified timeframes.

• Ensure labs are recent within the policy's timeframe (CKD anemia within 30 days; chemo‑related anemia within 2 weeks).
• Attach all supporting lab reports to the PA submission.

Documentation and prior trial risks

Failure to document required prior trials (including minimum durations) and prescriber consultation where required (e.g., topical therapy trial for plaque psoriasis) can result in denial for initial coverage.

• Confirm prior topical/systemic therapy trials and durations meet policy thresholds.
• Include dermatologist or relevant specialist consult notes when required.

GI biologic induction requirements

GI biologic induction (IV) requests for Crohn's or UC lacking required diagnosis or objective disease activity measures (e.g., CDAI >220 for Crohn's; >6 stools/day or steroid‑dependent disease for UC) may be denied.

• Provide CDAI score, stool frequency, ulceration evidence, CRP/ESR, and weight loss where applicable.
• Include gastroenterologist consultation and planned IV induction dosing per weight.

Tavneos diagnostic and concomitant therapy requirements

Tavneos prior authorization requires documentation of ANCA‑associated vasculitis subtype (GPA or MPA), positive ANCA or biopsy confirmation, and concurrent immunosuppressant therapy (cyclophosphamide or rituximab) plus glucocorticoid use or documented contraindication; absence of these will risk denial.

• Attach ANCA (PR3 or MPO) positive test or tissue biopsy report confirming GPA/MPA.
• Document concurrent use of cyclophosphamide or rituximab and glucocorticoid therapy or intolerance to glucocorticoids.