Prior authorization required

Many specialty outpatient prescription products in this section require prior authorization before benefit consideration; providers must submit indication-specific documentation, prior therapy history (trial and failure/contraindication/intolerance), and prescriber specialty/consultation as specified for the drug and indication.

UC timing and documentation

Ulcerative colitis initial approvals have a shorter initial coverage duration (12 weeks) and require documentation of disease severity and prior therapy response; reauthorizations require evidence of clinical response and are typically 12 months.

Benefit determination required

For some agents the benefit must be determined as Part B versus Part D; prior authorization submissions should note which benefit applies when indicated (drug-specific entries note Part B vs. Part D review).

Benlysta prior authorization

Benlysta prior authorization requires documentation of active SLE or active lupus nephritis, autoantibody positivity, current standard‑of‑care treatment, and prescriber specialty; Benlysta initial and reauthorization approvals are for 6 months.

• Document active SLE or active lupus nephritis and ANA ≥1:80 or anti-dsDNA ≥30 IU/mL
• Prescribed by or in consultation with rheumatologist (SLE) or nephrologist/rheumatologist (lupus nephritis)
• Initial/reauth coverage: 6 months

Chenodal (Gaucher) PA requirements

Chenodal prior authorization requires documentation of the radiolucent gallstone diagnosis, oral cholecystography showing a well‑opacifying gallbladder, and documentation of trial and failure (or contraindication/intolerance) to ursodiol; the policy lists a 12‑month coverage duration.

• Provide oral cholecystography demonstrating a well‑opacifying gallbladder
• Document trial and failure, contraindication, or intolerance to ursodiol
• Coverage duration: 12 months

Cinryze PA requirements

Cinryze prior authorization for prophylaxis requires diagnostic confirmation of hereditary angioedema by the specified laboratory pathways and specialty prescriber; initial approval is for patients ≥6 years and coverage is 12 months.

• Document HAE diagnosis via low C4 plus C1‑INH antigenic or functional deficiency OR normal C4/C1‑INH with pathogenic mutation or family history
• Prescribed by or in consultation with an immunologist/allergist
• Initial age ≥6 years; coverage duration: 12 months

Cosentyx PA requirements

Cosentyx prior authorization requires meeting indication‑specific criteria (e.g., plaque psoriasis BSA or PsA/AS activity), documentation of required prior therapy trials or step therapy, and appropriate specialist prescribing; initial approvals are typically 6 months with 12‑month reauthorization.

• Document moderate‑to‑severe plaque psoriasis (≥3% BSA or special‑site involvement) or active PsA/AS per indication
• Provide trial and failure/TF/C/I to required topical or systemic therapies or two listed agents for certain PsA/AS presentations
• Prescribed by or in consultation with dermatologist or rheumatologist as specified
• Initial coverage: 6 months; reauth: 12 months

Pyrimethamine prior authorization

Pyrimethamine prior authorization is required for toxoplasmosis indications; submit documentation that therapy is for active treatment, secondary prophylaxis, congenital toxoplasmosis, or primary prophylaxis when TMP‑SMX intolerance/desensitization failure is documented; requests for malaria use are excluded.

• Document toxoplasmosis indication (active, secondary prophylaxis, or congenital)
• For primary prophylaxis, document TMP‑SMX intolerance and failed desensitization or life‑threatening prior reaction
• Coverage duration: 12 months; malaria treatment/prophylaxis with pyrimethamine is not authorized

Enbrel prior authorization

Enbrel prior authorization requires documentation of the indicated diagnosis and evidence of prerequisite conventional therapy trial and failure (e.g., minimum 3‑month TF/C/I to a conventional DMARD for RA); initial coverage durations are indication‑specific.

• For RA: document moderately to severely active RA and a 3‑month TF/C/I to methotrexate, leflunomide, or sulfasalazine
• Prescribed by or in consultation with a rheumatologist for rheumatology indications
• Initial coverage typically 6 months; reauth 12 months

Dupixent prior authorization

Dupixent prior authorization requires indication‑specific documentation (e.g., baseline eosinophil counts for eosinophilic asthma, prior controller therapy trials, histology and PPI/topical steroid trial for EoE) and prescriber specialty as specified.

• Eosinophilic asthma: baseline eosinophils ≥150 cells/mcL and prior exacerbation history as specified
• EoE: ≥15 eosinophils/HPF, exclusion of other causes, weight ≥15 kg, and failed 8‑week PPI or topical esophageal steroid
• Prescribed by or in consultation with appropriate specialist (pulmonologist, gastroenterologist, dermatologist/allergist)

General prior authorization

Many drugs require general prior authorization submissions that include diagnosis, prescriber specialty (when specified), evidence of prior therapy trials or response, and the specific required clinical information per product.

Evrysdi prior auth

Evrysdi prior authorization requires genetic confirmation of 5q SMN1 mutation/deletion and SMN2 copy number, baseline standardized motor function testing, and documentation that the patient is not receiving concomitant chronic SMN‑modifying therapy.

• Include genetic test confirming 5q SMN1 mutation/deletion and SMN2 copy number
• Provide baseline motor exam (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or Bayley Item 22)
• Do not use concomitantly with chronic SMN‑modifying therapy (e.g., Spinraza)

HAE (initial) prior authorization

Initial HAE acute‑attack treatments require prior authorization with laboratory diagnostic evidence (C4 and C1‑INH antigenic or functional levels) or documented pathogenic mutation/family history for HAE‑nl‑C1INH, and appropriate specialist prescribing.

• Document low C4 plus C1‑INH antigenic or functional deficiency OR normal C4/C1‑INH with pathogenic mutation or family history
• Prescribed by or in consultation with an immunologist or allergist
• Initial age requirement for some agents: 18 years or older (as specified)

Biologics prior authorization

Biologic agents require prior authorization documenting the indication, prerequisite therapy trials (TF/C/I) where applicable, specialist prescriber or consultation, and indication‑specific clinical measures; reauthorization requires evidence of clinical response.

• Document diagnosis consistent with the indication (RA, PsO, PsA, AS, CD, UC, etc.)
• Provide TF/C/I evidence for required conventional/topical therapies (durations vary by indication)
• Prescriber specialty and reauth response metrics as specified

Prior authorization required for Inflectra and similar agents

Inflectra and similar infliximab‑class agents require prior authorization with indication‑specific documentation (diagnosis, disease severity measures like CDAI or stool frequency), and evidence of TF/C/I to specified conventional therapies; initial approval durations differ from reauthorization (commonly 6 months initial, 12 months reauth).

• For Crohn's: document CDAI >220 or relevant clinical features and TF/C/I to immunomodulators or corticosteroids
• For UC: document disease severity (e.g., >6 stools/day, ulcers) and TF/C/I to corticosteroids and aminosalicylates/azathioprine/6‑MP
• Prescriber restrictions and durations: initial 6 months, reauth 12 months

Product-level prior authorization required

Product‑level prior authorization entries for targeted or genetically guided therapies require documentation of diagnosis, specific mutation or biomarker test results, prior therapy history when required, and information about planned combinations; coverage durations are typically noted (commonly 12 months).

• Submit FDA‑approved or CLIA‑certified test results for required mutations/biomarkers (e.g., PIK3CA, RET, ROS1, NTRK, FLT3, KRAS G12C)
• Document prior therapy exposure or combinations as specified
• Coverage durations commonly 12 months

Product-specific prior authorization

Providers must submit product‑specific prior authorization information: diagnosis, required biomarker or mutation results (when applicable), prior therapy history, and prescriber specialty/consultation as indicated by the product entry.

• Include required biomarker/mutation confirmation (FDA‑approved or CLIA test) where listed
• Provide prior systemic therapy history when prerequisite Part D drugs are required
• Indicate specialist prescriber or consultation per product

Prior authorization and coverage duration

Prior authorization submissions must include all required medical information specified for the product (diagnosis, labs, imaging, mutation tests, prior therapy); many products have set initial and reauthorization coverage durations (often initial 6 or 12 months and reauth 12 months).

• Provide required diagnostic, laboratory, imaging, and prior therapy documentation
• Expect coverage durations commonly set to 6 months initial (some) and 12 months reauthorization

Prior authorization required per drug-specific criteria

Prior authorization determinations are made against drug‑ and indication‑specific clinical criteria (diagnosis duration, lab thresholds, prior TF/C/I); ensure submitted evidence directly meets the listed criteria.

Prior authorization requirement

Certain agents require prior authorization with documentation of diagnosis, prescriber specialty where specified, and evidence of benefit or TF/C/I as detailed in each drug's criteria.

Prior authorization required

Prior authorization requests must include diagnosis, pertinent labs, and prescriber specialty when specified; initial authorization durations vary by indication (commonly 6 or 12 months).

Product-specific prior authorization

Product‑specific prior authorization is required across multiple entries; providers must document diagnosis, required test results, and prior therapy as listed for the product to support approval.

Conventional DMARD trial required

For biologic therapy initiation in RA and related conditions, a trial and failure (or contraindication/intolerance) to conventional DMARDs (e.g., methotrexate, leflunomide, sulfasalazine) of specified minimum duration is required before approval.

• RA: minimum 3‑month trial and failure/TF/C/I to one conventional DMARD at maximally tolerated dose
• PJIA: minimum 6‑week trial and failure/TF/C/I to methotrexate or leflunomide

Caplyta step requirements

Caplyta step requirements (for psychiatric indications) mandate documented trial and failure, contraindication, or intolerance to specified generic antipsychotics prior to approval as outlined in the product entry.

Cosentyx step therapy

Cosentyx INJ 125 mg step therapy for certain PsA and AS presentations requires trial and failure/intolerance to two listed alternative agents (or continuation of prior therapy) before Cosentyx initial approval.

• TF/C/I to two agents among Cosentyx SC, Enbrel, a formulary adalimumab, Orencia, Otezla, Skyrizi, a formulary ustekinumab, Rinvoq, or Xeljanz/XR, or continuation of prior therapy

Onychomycosis step therapy

Topical ciclopirox nail lacquer requires documentation confirming onychomycosis (KOH, culture, or histology) and a documented trial and failure, contraindication, or intolerance to oral terbinafine (minimum 6 weeks for fingernails; 12 weeks for toenails) before approval.

• Provide positive KOH, culture, or histology confirming onychomycosis
• Document TF/C/I to oral terbinafine (6 weeks fingernail; 12 weeks toenail)

Dulera step therapy

Dulera requires prior trial and failure, contraindication, or intolerance to Breo Ellipta (fluticasone furoate + vilanterol) before initiation, per the product's step therapy requirements.

Empaveli step requirement

Empaveli for C3G/primary IC‑MPGN requires documentation that the patient has been treated with a maximally tolerated ACE inhibitor or ARB or an SGLT2 inhibitor for at least 12 weeks prior to initiation; provide nephrology prescribing/consultation.

• Document ≥12 weeks of maximally tolerated ACEI/ARB or SGLT2 inhibitor therapy prior to Empaveli initiation
• Prescribed by or in consultation with a nephrologist

Enbrel step therapy

Enbrel step therapy requires prior trials of conventional DMARDs (methotrexate, leflunomide, sulfasalazine) for RA and similar conventional therapy trials for PJIA before biologic initiation.

• Document TF/C/I to conventional DMARDs per indication (e.g., 3 months for RA)

Prerequisite therapy where required

Some indications specify prerequisite Part D drug use (documented prior therapy) before approval — for example, many rheumatology biologics and certain asthma indications require prior Part D drug therapy as noted in product entries.

Step therapy for biologics

Step therapy for biologics generally requires documented trial and failure, contraindication, or intolerance to specified conventional or topical therapies for minimum durations (e.g., topical trials for psoriasis, DMARDs for RA) prior to biologic approval.

• Topical therapy trial durations (e.g., 30 days topical; 14 days for topical corticosteroids) for psoriasis prior to biologic
• Conventional DMARD durations (e.g., 3 months for RA)

Step therapy / TF/C/I

Many biologic and advanced therapies require documented trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional agents before approval; providers must supply evidence of those prior attempts.

Antifungal step therapy

Itraconazole and other antifungal approvals require documented trial and failure (or contraindication/intolerance) to oral terbinafine for onychomycosis (fingernail: minimum 6‑week supply; toenail: minimum 12‑week supply) before approval.

• Document TF/C/I to oral terbinafine (6 weeks fingernail; 12 weeks toenail)
• Provide confirmatory KOH, culture, or biopsy as applicable

Step therapy / prior treatment requirements

Several oncology and supportive‑care products require prior trials or failures of specified prior systemic therapies (e.g., Lonsurf requires prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy and anti‑VEGF therapy for metastatic colorectal cancer).

• Document prior exposure to required chemotherapy regimens and anti‑VEGF therapy where listed

Step therapy / prior drug trials

Many products require trial and failure or intolerance to specified agents prior to approval (examples include requirement to trial a triptan before certain acute migraine agents or prior corticosteroid trials for eosinophilic conditions); support with documentation.

Orencia step therapy

Orencia step therapy requires documented TF/C/I to specified conventional DMARDs for RA and PJIA (e.g., 3 months for RA; 6 weeks for PJIA) prior to approval; prescriber restriction to rheumatology applies.

• RA: document 3‑month TF/C/I to methotrexate, leflunomide, or sulfasalazine
• PJIA: document 6‑week TF/C/I to methotrexate or leflunomide
• Prescribed by or in consultation with a rheumatologist

Step therapy for topical diclofenac

Topical diclofenac for knee osteoarthritis requires trial and failure, contraindication, or intolerance to at least two prescription‑strength topical or oral NSAIDs (or specified risk conditions) before approval.

• Document TF/C/I to ≥2 prescription‑strength topical or oral NSAIDs or presence of qualifying GI risk factors

Step therapy / prerequisite therapy

Many immunomodulatory and biologic agents (e.g., Rinvoq, Rinvoq Lq) require prior trials and failure, contraindication, or intolerance to specified conventional therapies and/or TNF inhibitors before approval; providers must document prior therapy attempts.

Topical therapy trial required for psoriasis indications

For plaque psoriasis and PsA biologics (e.g., Skyrizi, Stelara), a trial and failure of specified topical therapies is required before approval for many initial indications; document topical therapy trials per product notes.

• Provide evidence of topical therapy TF/C/I (minimum 30‑day supply or 14 days for topical corticosteroids) prior to biologic initiation

AAT deficiency diagnostic data

For alpha‑1 antitrypsin augmentation, document genotype (e.g., PiZZ) and pre‑treatment serum AAT level <11 µM/L (or corresponding mg/dL equivalents) and diagnosis of emphysema to support authorization.

• Include genotype (eg, PiZZ) and pre‑treatment serum AAT <11 µM/L
• Document diagnosis of emphysema

Migraine baseline and response

For CGRP preventive therapy for migraine, document baseline migraine days per month and decreased use of acute migraine medications on therapy for reauthorization (initial coverage 6 months; reauth 12 months).

• Document baseline migraine days/month (episodic ≥4; chronic ≥8)
• For reauth, show decreased acute medication use and clinical response

Benlysta required clinical info

Benlysta prior authorization requires documentation of active SLE or lupus nephritis, autoantibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), current standard‑of‑care therapy, prescriber specialty, and age eligibility for IV/SC formulations (≥5 years); initial/reauth coverage is 6 months.

• Document active SLE or active lupus nephritis and autoantibody positivity
• Prescribed by or in consultation with a rheumatologist (SLE) or nephrologist/rheumatologist (lupus nephritis)
• Age ≥5 years for IV/SC formulations; coverage 6 months

Tumor molecular testing

Tumor‑targeted therapies require submission of tumor type, the specified molecular alteration (e.g., ROS1, NTRK, RET, BRAF, KRAS G12C) detected by an FDA‑approved or CLIA‑certified test, and prior systemic therapy history or that no satisfactory alternatives exist.

• Attach FDA‑approved or CLIA‑certified test results confirming the genomic alteration
• Document disease extent (locally advanced/metastatic) and prior therapy exposure or lack of alternatives

Bronchitol tolerance test

Bronchitol prior authorization requires documented CF diagnosis and evidence of passing the Bronchitol Tolerance Test (BTT); initial coverage is 6 months and reauth 12 months with evidence of benefit.

• Provide documentation of CF diagnosis
• Include Bronchitol Tolerance Test (BTT) results showing passage

Gaucher disease testing

Gaucher disease entries require documentation of Gaucher disease type 1 and CYP2D6 metabolizer status determined by an FDA‑cleared test for product selection; some products list age and coverage duration requirements (e.g., 12 months).

• Provide diagnosis of Gaucher disease type 1
• Submit CYP2D6 metabolizer status from an FDA‑cleared test

Chenodal required imaging and therapy history

For Chenodal approval, provide oral cholecystography demonstrating a well‑opacifying gallbladder, documentation that ursodiol was tried and failed (or is contraindicated/intolerant), and confirmation that stones are radiolucent and patient is not a surgical candidate.

• Oral cholecystogram showing well‑opacifying gallbladder
• Document TF/C/I to ursodiol or surgical ineligibility
• Confirm stones are radiolucent (not calcified/radiopaque pigment stones)

Onychomycosis confirmation

Onychomycosis topical lacquer requires confirmation of onychomycosis by KOH, culture, or histology and documentation of trial and failure, contraindication, or intolerance to oral terbinafine (6 weeks for fingernails; 12 weeks for toenails) before coverage.

• Include positive KOH, culture, or histology confirming onychomycosis
• Document TF/C/I to oral terbinafine with duration per nail type

Cinryze lab/genetic documentation

Cinryze prophylaxis authorization must include C4 level and C1‑INH antigenic or functional level results; for HAE‑nl‑C1INH, include genetic testing demonstrating a pathogenic mutation or a confirmed family history.

• Submit C4 and C1‑INH antigenic or functional lab results
• For HAE‑nl‑C1INH, include genetic testing or confirmed family history

Deferasirox required baseline labs and transfusion history

Deferasirox initial authorization for transfusional iron overload requires baseline ferritin >1,000 mcg/L and documentation of transfusion history of at least 100 mL/kg of packed RBCs; reauthorization requires reduction from baseline in ferritin or liver iron concentration.

• Baseline ferritin >1,000 mcg/L
• Document transfusion history (≥100 mL/kg packed RBCs)
• Reauth: demonstrate reduction from baseline in ferritin or LIC

Dupixent EoE diagnostic documentation

Dupixent for EoE requires histologic confirmation (≥15 intraepithelial eosinophils per high power field), exclusion of other causes, weight ≥15 kg, and documentation of TF/C/I to an 8‑week PPI or topical esophageal corticosteroid prior to approval.

• Provide biopsy showing ≥15 eos/HPF and exclude other causes
• Document weight ≥15 kg
• Document TF/C/I to an 8‑week PPI or topical esophageal steroid

Empaveli prerequisite therapy documentation

Empaveli prior authorization requires documentation that patients with C3G or primary IC‑MPGN have been treated with a maximally tolerated ACEI/ARB or SGLT2 inhibitor for at least 12 weeks prior to initiation; for primary IC‑MPGN the patient must not have had a kidney transplant.

• Document ≥12 weeks of maximally tolerated ACEI/ARB or SGLT2 inhibitor
• Primary IC‑MPGN: confirm patient has not had kidney transplant

Rheumatology/psoriasis documentation

Rheumatology and dermatology biologics require documentation of diagnosis, specialist prescriber or consultation (rheumatologist/dermatologist), and evidence of prior therapy response or TF/C/I as applicable; reauthorization requires demonstration of clinical response.

• Document diagnosis and prescriber specialty (rheumatologist/dermatologist)
• Provide TF/C/I evidence for prerequisite therapies where required
• Reauth: supply indication‑specific response metrics (joint counts, BSA, etc.)

SMA documentation

Evrysdi documentation must include genetic testing confirming 5q SMN1 mutation/deletion, SMN2 copy number, baseline motor function test scores (HINE‑2, CHOP‑INTEND, HFMSE, RULM, MFM‑32, or Bayley Item 22), and records regarding prior gene therapy and response if applicable.

• Submit genetic confirmation of 5q SMN1 mutation/deletion and SMN2 copy number
• Provide baseline motor exam scores with an appropriate standardized tool
• If prior gene therapy given, include documentation of inadequate response

HAE diagnostic documentation

HAE diagnostic documentation for authorization must include a C4 level and C1‑INH antigenic or functional levels, or for HAE‑nl‑C1INH include genetic testing demonstrating a pathogenic mutation or a confirmed family history of recurrent angioedema.

• Provide C4 and C1‑INH antigenic or functional lab values
• For HAE‑nl‑C1INH include pathogenic gene mutation testing or confirmed family history

HAE diagnostic evidence

For HAE initial therapy, document either (1) low C4 plus C1‑INH antigenic or functional deficiency OR (2) normal C4/C1‑INH with a documented pathogenic mutation or confirmed family history; lack of these will trigger denial.

Biologic therapy documentation

Biologic therapy documentation must include indication‑specific diagnostic evidence and prior therapy trials as applicable; reauthorization requires documented positive clinical response (e.g., reduced swollen/tender joint count, BSA reduction for psoriasis).

• Submit indication‑specific diagnostic criteria and TF/C/I evidence
• Reauth: provide clinical response metrics relevant to indication

Growth hormone diagnostic documentation

Growth hormone product requests must include the specific growth disorder diagnostic criteria, bone age limits for initial therapy, and stimulation test results or growth metrics per indication; prescriber is typically an endocrinologist.

• Provide diagnostic criteria (PGHD, PWS, GFSGA, SHOX deficiency, AGHD, etc.)
• Include bone age limits (male <16 years; female <14 years) where applicable
• Attach GH stimulation test results when required

IBD documentation

IBD initial requests (Crohn's disease, ulcerative colitis) must include diagnosis, objective disease activity measures (e.g., CDAI >220, stool frequency, ulcers, abnormal labs), and documentation of TF/C/I to specified conventional therapies.

• For Crohn's: include CDAI >220 or clinical features and TF/C/I to immunomodulators/corticosteroids
• For UC: document stool frequency, presence of ulcers, labs, and TF/C/I to corticosteroids and aminosalicylates/azathioprine/6‑MP

Reauthorization response documentation

Reauthorization requests across inflammatory and biologic indications must document positive clinical response using indication‑specific metrics (e.g., joint counts for RA/PsA, BSA for psoriasis, improvement in inflammatory markers or mucosal healing for IBD).

• Provide objective measures of improvement versus baseline (e.g., reduced swollen/tender joint count, decreased BSA, mucosal healing, improved labs)

Immune globulin documentation

Immune globulin (IVIG/SCIG) authorizations must include diagnosis, evidence of minimum effective dosing and frequency, and immunologic evaluation (including IgG levels and vaccine response) when applicable; reauthorization requires objective improvement.

• Provide diagnosis meeting listed primary or secondary immunodeficiency or other approved condition
• Include IgG levels and vaccine response data where applicable
• Document minimum effective IVIG dosing/frequency and objective improvement for reauth

Liver monitoring for tolvaptan

Tolvaptan (Jynarque) prior authorization requires documentation of rapidly progressing ADPKD and adherence to the liver function monitoring schedule (baseline and periodic ALT/AST/bilirubin checks); reauthorization requires demonstration of benefit or absence of hepatic injury.

• Document rapidly progressing ADPKD
• Provide baseline and scheduled LFTs per monitoring schedule (2 and 4 weeks after initiation, then monthly for first 18 months or every 3 months after 18 months)

Essential clinical documentation

Providers must include essential clinical documentation for targeted and specialty agents: diagnosis, mutation/test results (e.g., KRAS G12C, EGFR, BRAF V600E/K), prior systemic therapy history when required, and specialty prescriber/consultation when requested.

Genetic testing documentation

For Livmarli in ALGS or PFIC, molecular genetic testing confirming the specified gene mutations (JAG1, NOTCH2, ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B) must be provided to support authorization.

• Attach molecular genetic testing confirming the listed gene mutation(s)

BRAF mutation test

When BRAF mutation‑directed therapies are requested, submit tumor testing demonstrating BRAF V600E or V600K mutation by an FDA‑approved or CLIA‑certified test as specified in the product entry.

Diagnosis and supporting records

Medical records confirming diagnosis and supporting data (e.g., T2DM labs for Mounjaro, chemotherapy regimen and febrile neutropenia risk for Neulasta) must be provided as specified by product criteria.

ILD diagnostic documentation

ILD diagnostic documentation for IPF and SSc‑ILD requires exclusion of other known causes and HRCT and/or surgical lung biopsy findings consistent with IPF or SSc‑ILD per the product criteria.

• Provide HRCT showing UIP/probable IPF pattern or surgical lung biopsy supporting IPF/SSc‑ILD
• Document exclusion of other known causes of ILD

hATTR diagnostic documentation

hATTR amyloidosis documentation must include a pathogenic TTR mutation detected by FDA‑approved or CLIA‑certified testing and baseline neurologic scores (PND ≤ IIIb, FAP stage 1–2, or NIS between 5 and 130) to support initiation.

• Submit confirmed pathogenic TTR mutation test result
• Provide baseline PND, FAP stage, or NIS per criteria

Required diagnostic documentation

Required diagnostic documentation for certain metabolic and systemic indications (e.g., T2DM, MASH) must include chart notes or lab evidence (A1c ≥6.5% or equivalent for T2DM; FAST/MAST or liver biopsy and FibroScan/FIB‑4 confirming F2‑F3 for MASH).

• For T2DM: provide chart notes or labs showing A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hr OGTT ≥200 mg/dL
• For MASH: submit FAST/MAST or liver biopsy and fibrosis stage F2 or F3 via FibroScan/FIB‑4/equivalent

Genetic test documentation

For cystic fibrosis modulators (e.g., Orkambi), prior authorization requires documentation of homozygous F508del CFTR mutation confirmed by an FDA‑cleared or CLIA‑approved test and prescribing by a CF care center specialist or pulmonologist.

• Provide CFTR mutation testing confirming homozygous F508del
• Prescribed by or in consultation with CF care center specialist/pulmonologist

Genomic testing and disease documentation

Targeted therapy prior authorization requires submission of documentation of diagnosis, disease extent (advanced/metastatic), and presence of the required genomic alteration detected by an FDA‑approved or CLIA‑certified test.

Diagnostic and mutation status

For hematologic malignancy agents (e.g., Rydapt), include diagnostic confirmation and mutation status testing when specified; for Rydapt in newly diagnosed FLT3‑mutated AML, document FLT3 mutation by an FDA‑approved/CLIA test and concomitant use with standard induction/consolidation regimens.

• Submit FLT3 mutation test result (FDA‑approved or CLIA)
• Document planned or concurrent use with cytarabine/daunorubicin induction and cytarabine consolidation for AML

Rydapt — diagnostic and regimen documentation

Rydapt authorization specifically requires documentation of FLT3 mutation positivity detected by an FDA‑approved or CLIA‑certified test and concurrent use with standard cytarabine and daunorubicin induction and cytarabine consolidation for newly diagnosed AML.

Hizentra — required clinical documentation

Hizentra (SCIG) authorizations must include the diagnosis (CIDP or listed primary immunodeficiencies), baseline IgG levels and inadequate vaccine response when applicable, dosing at the minimum effective dose, and specialist prescribing or consultation.

• Provide diagnosis and baseline IgG
• Document inadequate vaccine response when applicable
• Prescribed by or in consultation with an appropriate specialist

Skyrizi — baseline and reauth documentation

Skyrizi and similar biologic prior authorization requires documentation of indication (psoriasis, PsA, CD, UC), baseline disease severity measures (BSA, CDAI, stool frequency, CRP), prior topical/systemic therapy trials when required, and response data for reauthorization.

• Include baseline BSA for psoriasis or CDAI for Crohn's disease
• Provide TF/C/I evidence for prior topical or systemic therapies as applicable
• Reauth: submit evidence of clinical response

Documentation of prior therapy

Failure to document TF/C/I to required conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine for RA) will risk denial; include dates, doses, and reasons for discontinuation.

• Document trial durations, doses, and objective evidence of failure or intolerance
• Include contraindication rationale if applicable

PAH diagnostic confirmation

For PAH agents, absence of right heart catheterization confirmation of diagnosis or lack of documentation that the patient is currently on PAH therapy may trigger denial; include hemodynamic confirmation or current PAH treatment evidence.

• Provide right heart catheterization results confirming PAH when available
• Or document that the patient is currently receiving PAH therapy

Documentation-based denials

Lack of documented diagnosis or failure to meet specific drug indication requirements (for example, MAC lung disease criteria for Arikayce) may result in denial; ensure required clinical evidence and specialist consultation are included.

Ursodiol trial required for Chenodal

Failure to document trial and failure, contraindication, or intolerance to ursodiol for radiolucent gallstones will trigger denial for Chenodal requests; include imaging and ursodiol trial details.

Diagnostic confirmation and terbinafine trial for Ciclopirox Nail Lacquer

Requests for topical ciclopirox lacquer will be denied if confirmation of onychomycosis (KOH, culture, or histology) or documentation of TF/C/I to oral terbinafine is absent; provide diagnostic test results and terbinafine trial history.

HAE diagnostic testing for Cinryze

Cinryze prophylaxis may be denied if laboratory confirmation of HAE (C4 and C1‑INH antigenic or functional levels) is absent or if required genetic testing/family history for HAE‑nl‑C1INH is not provided.

Pyrimethamine: malaria excluded

Requests for any pyrimethamine product submitted for malaria treatment or prophylaxis are not authorized and will be denied; pyrimethamine is only authorized per the toxoplasmosis criteria.

Diacomit combination/weight requirement

Diacomit must be used in combination with clobazam and the patient must weigh ≥7 kg for approval; lack of combination therapy documentation or weight threshold will risk denial.

• Document concomitant clobazam use
• Provide patient weight (≥7 kg)

Enbrel prerequisite therapy

Enbrel initial RA requests will be denied if there is no documentation of a 3‑month trial and failure/contraindication/intolerance to a conventional DMARD (methotrexate, leflunomide, sulfasalazine); include therapy dates and outcomes.

Rheumatology reauth denial triggers

Reauthorization for rheumatology/immunology biologics may be denied if providers fail to demonstrate positive clinical response at reauth (e.g., reduced swollen/tender joint count, symptom improvement) or fail to meet prescriber restrictions.

Evrysdi documentation denial triggers

Evrysdi requests lacking baseline genetic confirmation (5q SMN1 mutation/deletion and SMN2 copy number) or absence of required baseline motor exam results may be denied; supply genetic and baseline motor testing documentation.

HAE diagnostic documentation

Acute HAE attack treatment requests will be denied if the diagnosis of HAE is not documented by required laboratory evidence (low C4 plus C1‑INH antigenic or functional deficiency, or normal C4/C1‑INH with documented pathogenic mutation or family history).

RA prerequisite therapy

For RA biologic initiation, failure, contraindication, or intolerance to a 3‑month trial of a conventional DMARD (methotrexate, leflunomide, sulfasalazine) is required or the claim may be denied; include trial duration and outcome.

Documentation of prior conventional therapy

Failure to document required conventional therapy trials (e.g., for Crohn's disease: 6‑mercaptopurine, azathioprine, corticosteroids, methotrexate) may trigger denial for IBD biologics; include trial durations and reasons for discontinuation.

NSAID trial requirement

For ankylosing spondylitis and related indications, absence of a documented trial and failure or intolerance to an NSAID at maximally tolerated doses (minimum 1 month) may result in denial; include NSAID trial details.

Breast cancer targeted therapy — documentation required

Breast cancer targeted therapy requests (e.g., PIK3CA‑mutated HR+/HER2‑) will be denied if required diagnostic documentation (PIK3CA mutation) or documentation of prior adjuvant endocrine therapy/co‑therapies is missing.

PAH confirmation required

PAH agent requests lacking documentation of right heart catheterization confirmation or evidence that the patient is currently on PAH therapy may not meet initial coverage requirements and risk denial.

MS combination therapy exclusion

Use of multiple disease‑modifying therapies in combination for MS is excluded and may lead to denial; ensure requests indicate monotherapy or appropriate continuation of prior single DMT.

Eosinophil and prior therapy requirements

Failure to demonstrate required baseline eosinophil counts or prior treatment trials for eosinophil‑targeted agents (e.g., Nucala indications) may trigger denial; include baseline eosinophil values and prior therapy history.

• Provide baseline eosinophil counts (e.g., ≥150 cells/µL or ≥300 cells/µL in past 12 months as applicable)
• Document prior corticosteroid or other required therapy trials

HES documentation

HES authorizations will be denied if the diagnosis has not been present for at least 6 months, secondary causes are not ruled out, FIP1L1‑PDGFRA fusion status is not negative, or pre‑treatment eosinophils <1,000 cells/µL; include documentation per criteria.

Documentation-triggered denial risk

For MASH therapies, lack of documentation confirming diagnosis and fibrosis stage (F2 or F3) using FAST, MAST, FibroScan, FIB‑4, or liver biopsy may trigger denial; include the specified diagnostic test results.

Hemoglobin/Hematocrit thresholds for denial

Erythropoiesis‑stimulating agent (Retacrit) requests will be denied for off‑label uses (except MDS, HCV) when patient hemoglobin >10 g/dL or hematocrit >30%; ensure labs meet indication‑specific thresholds and adequate iron stores (ferritin >100 mcg/L and TSAT >20%) are documented.

• Provide recent Hgb/Hct meeting indication thresholds
• Document iron stores (ferritin >100 mcg/L and TSAT >20%) when required

Vigabatrin — prerequisite failure documentation

Vigabatrin for complex partial seizures requires documentation of failure, contraindication, or intolerance to two formulary anticonvulsants prior to approval; lacking this documentation risks denial.

• Document TF/C/I to two formulary anticonvulsants (names, durations, outcomes)

Octreotide — acromegaly prerequisite

Octreotide for acromegaly requires documentation of inadequate response to or ineligibility for surgery/radiation and trial/failure of a dopamine agonist at maximally tolerated doses prior to approval; absence of these will risk denial.