Prior authorization and coverage duration

Prior authorization is required for most specialty products; approvals generally require submission of diagnosis, required clinical information (including molecular/diagnostic tests when specified), and documentation of prior therapy trials or contraindications. Coverage durations vary by product and indication (examples: many initial approvals 6 months, reauthorization commonly 12 months; some oncology/targeted agents 12 months; select entries list 3 or 48 weeks).

• Submit indication-specific diagnostic evidence and prior therapy history.
• Expect typical initial approval lengths of 6 months for many immunologic indications and 12 months for continuation.

Prior authorization requirement

All listed products require prior authorization per the formulary; approvals typically mandate documentation of diagnosis and, where applicable, required molecular markers or prescriber specialty. Many authorizations are issued for 12 months unless otherwise specified.

• Provide required medical information and test results noted in the product entry.
• Expect 12-month coverage for most indications unless product-specific durations listed.

Cablivi prior auth details

Cablivi requests must document a diagnosis of acquired TTP, that the first dose was/will be administered by a healthcare provider as a bolus IV injection, and use in combination with immunosuppressive therapy; plasma exchange status (concurrent or within 59 days) must be provided.

• Document first-dose administration by a healthcare provider (bolus IV).
• Document concurrent immunosuppressive therapy (e.g., rituximab, glucocorticoids) and plasma exchange timing (within 59 days if completed).

Product-level prior authorization

Prior authorization is applied at the product level per the formulary (Formulary ID 26218, Version 13); many product entries specify prerequisite Part D drugs and coverage durations that must be documented.

• Include Formulary ID/version references when submitting per internal process.
• Confirm whether a prerequisite Part D drug is required for the specific product entry.

Cosentyx prior authorization and durations

Cosentyx prior authorizations require documentation of disease-specific severity and required prior therapy trials (topical/systemic/NSAID/biologic as applicable); initial approvals are generally 6 months with reauthorization for 12 months and require documented clinical response.

• Provide BSA/SCORAD, joint counts, CRP or MRI evidence when applicable.
• Document prior topical/systemic/biologic trials and specialist involvement (dermatologist or rheumatologist).

Prior authorization required

Prior authorization is required for multiple formulary-listed products; submissions must include indication-specific criteria, age/prescriber restrictions, and requested coverage duration per product.

• Follow each product's 'Required Medical Information' fields exactly (labs, imaging, genetic tests).
• Note age or prescriber restrictions included in product entries.

PA required — L-glutamine PACK

Prior authorization for L‑glutamine (sickle cell disease) requires documentation of sickle cell diagnosis and that the patient experienced two or more painful sickle cell crises in the past 12 months; coverage and reauthorization are 12 months with demonstrated clinical response for reauth.

• Document number of painful crises in past 12 months (>=2).
• Provide evidence of positive clinical response at reauthorization.

PA required — Fasenra

Fasenra prior authorization requires documentation of severe eosinophilic asthma or EGPA per product criteria, including baseline peripheral blood eosinophil levels (e.g., ≥150 cells/µL) and prior controller therapy regimens; initial use often 6 months with reauth 12 months.

• Provide baseline eosinophil count and exacerbation/hospitalization history.
• Document prior controller regimens (medium/high‑dose ICS ± additional controllers) or corticosteroid use for EGPA.

PA required — Evrysdi

Evrysdi prior authorization requires genetic confirmation of SMA (SMN1 mutation/deletion and SMN2 copy number) and baseline motor exam scores (HINE-2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III Item 22); reauthorization requires documented positive clinical response.

• Submit SMN1/SMN2 molecular testing and baseline motor exam results.
• Document absence of concomitant chronic SMN‑modifying therapy and clinical response at reauth.

Prior authorization required; indication-specific evidence needed

Prior authorization requires submission of indication-specific diagnostic evidence (labs, imaging, genetic test results), documentation of prior therapy trials or contraindications, and prescriber specialty when required; many authorizations default to 12 months unless otherwise noted.

• Include diagnostic confirmations noted (e.g., C4/C1‑INH for HAE; FGFR2 fusion for cholangiocarcinoma).
• Provide TF/C/I documentation for required prior therapies.

Product-specific prior authorization

Many individual products have product‑specific prior authorization criteria requiring diagnosis, test/mutation status when applicable, and prior therapy documentation; coverage durations commonly set to 12 months.

• For oncology agents include FDA/CLIA test results for companion diagnostics.
• For chronic therapies include prior therapy lines and objective baseline measures.

Prior authorization and specialty prescriber

Prior authorization often requires prescriptions be written by or in consultation with an appropriate specialist (e.g., rheumatologist, neurologist, gastroenterologist) and documentation of prior TF/C/I where specified; durations vary by indication.

• Ensure specialist involvement is documented when required.
• Include prior therapy trial durations and outcomes per the product entry.

Prior authorization required

Prior authorization is required and reviewers will request submission of indication‑specific required medical information and verification of prescriber/patient criteria as listed in the product entry.

• Provide required medical records and confirm patient meets listed age and clinical thresholds.
• Supply companion diagnostic reports when specified.

Product-specific prior authorization

Product-specific prior authorization rules apply requiring diagnosis, prior therapy history, and prescriber restrictions; coverage durations and reauthorization criteria are specified per product.

• Follow the product entry for exact prior therapy requirements and age/prescriber limits.
• Prepare to document clinical response for reauthorization.

Prior authorization required for listed products

Prior authorization is required for listed products and will request documentation of diagnosis, prior therapy trials when specified, prescriber specialty for certain indications, and required testing (genetic, biopsy, HRCT) depending on the product.

• Include genetic/molecular test results where listed (e.g., BRAF, FGFR2, RET).
• Provide imaging or biopsy reports when required (e.g., HRCT for IPF).

Prior authorization clinical submission

Most listed products require submission of clinical information (diagnosis, prior therapy trials, labs, imaging, genetic tests) for prior authorization; coverage durations and reauthorization criteria are product‑specific.

• Ensure documentation supports indication‑specific thresholds (e.g., CDAI>220, eosinophil counts).
• Document prior biologic/DMARD failures when required.

Standard prior authorization requirement

Standard prior authorization requests must include diagnosis, required trials or intolerance to specified therapies, patient age, and prescriber specialty as applicable; reauthorization requires evidence of clinical response.

• Provide objective measures of response at reauth (e.g., BSA reduction, joint counts, LDL reduction).
• Confirm documented TF/C/I durations per indication.

Prior authorization requirement (rheumatology/JAK context)

Prior authorization requires demonstration of diagnosis and prior adequate trials (TF/C/I) with durations specified per indication; for many inflammatory indications at least one TNF inhibitor trial may be required prior to approval of alternatives.

• Submit documentation of trials and outcomes to conventional therapies (e.g., methotrexate, leflunomide).
• Document failure or intolerance to TNF inhibitors where indicated.

Prerequisite Part D drug required (example: Skyrizi)

Some approvals require that a specified Part D prerequisite drug be tried and failed (or shown contraindication/intolerance) before approval of the requested product—e.g., Skyrizi is noted as a prerequisite in some entries.

• Provide records showing trial and failure or intolerance to the named prerequisite Part D product.
• Verify the prerequisite drug and formulation listed in the product entry.

Steqeyma prerequisite requirement

Steqeyma prior authorization for certain indications requires prior use of a specified prerequisite Part D drug; include documentation of that prior therapy trial or justification if not feasible.

• Attach evidence of prior prerequisite Part D drug use per product entry.
• If a trial was not completed, document contraindication or intolerance.

Step therapy requirements

Step therapy: many agents (including adalimumab-class products) require a documented trial and failure, contraindication, or intolerance to specified conventional therapies at maximally tolerated doses before initiating therapy.

• Document duration and outcome of conventional therapy trials (e.g., 3 months for RA methotrexate).
• Provide justification for skipping step therapy when contraindicated.

Step therapy examples

Examples: certain psychiatric agents require trials of specified generic alternatives (e.g., Caplyta requires trials of two listed atypical antipsychotics); some oncology/hematology agents also list prerequisite or prior-line therapy requirements.

• Follow product-specific lists of required comparators for step trials.
• Supply documentation of trials/failures per the product entry.

Required trials of multiple advanced therapies

For certain rheumatologic indications (PsA, AS, nr-axSpA), the policy requires trial and failure to multiple specified advanced therapies (e.g., Cosentyx, Enbrel, adalimumab, Rinvoq) prior to approval of alternatives or continuation under step rules.

• Document prior biologic/advanced therapy trials and outcomes per the product entry.
• Include specialist consultation notes supporting prior therapy failures.

Required prerequisite therapy

Many indications require prior trials of specified therapies—examples include high/medium‑dose ICS ± additional controllers for Dupixent and conventional DMARDs for Enbrel—document the trial type, duration, and outcome.

• Provide controller inhaler dosing and duration for asthma-related entries.
• Document DMARD trials and maximally tolerated dosing for rheumatology entries.

PA required — Epidiolex prerequisite anticonvulsant trials

Epidiolex requires documentation of trial and failure, contraindication, or intolerance to two formulary anticonvulsants for LGS or DS indications before approval.

• List the two anticonvulsants tried and duration/outcome of each trial.
• Provide neurologist consultation notes when applicable.

Pirfenidone initial criteria diagnostic exclusions

Pirfenidone initial requests require exclusion of other causes of ILD and HRCT or surgical lung biopsy demonstrating UIP or probable UIP pattern; include imaging or biopsy reports per the entry.

• Attach HRCT report showing UIP/probable UIP or surgical lung biopsy findings.
• Document exclusion of other causes of ILD.

Step therapy / prerequisite trials (general)

Step therapy/prerequisite trials are common: many biologic and specialty agents require TF/C/I to conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine for RA; topical therapies for psoriasis) before approval.

• Document trial durations (e.g., 3 months for RA methotrexate; 30 days topical for psoriasis).
• Provide chart notes showing inadequate response or intolerance.

Trials of prior therapies required (cGVHD, IVIG, neuromuscular)

For some indications (e.g., cGVHD, IVIG uses, neuromuscular autoimmune disorders), the policy requires trial and failure or contraindication/intolerance to specified prior lines of therapy before IVIG or alternative advanced therapies are approved.

• Include prior systemic therapy history and objective failure evidence.
• For IVIG, provide immunologic evaluation (IgG levels, vaccine responses) and objective improvement for renewals.

Step therapy / TF/C/I requirements (general)

Many indications require TF/C/I to specific prior therapies (e.g., corticosteroids plus immunosuppressants for some neuromuscular disorders; requirement for two biologic/targeted agent failures for select rheumatologic entries).

• Provide documentation of combination prior therapy regimens and intolerance or lack of efficacy.
• Include specialist notes supporting the clinical rationale.

Step therapy prerequisites (oncology/other examples)

Certain agents require prior chemotherapy or prior class-specific therapies (e.g., Lonsurf requires prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and prior anti‑VEGF therapy). Document prior chemo regimens and dates.

• Attach treatment history demonstrating required prior chemotherapy lines.
• Include pathology and prior regimen details when requested.

Prerequisite therapy requirements (examples)

Examples: many products require TF/C/I to interferons or intranasal corticosteroid plus antihistamine for Odactra; document the specific prior therapy trials and outcomes per the product entry.

• For Odactra, provide trial/failure of intranasal corticosteroid AND antihistamine.
• For MS agents, document prior interferon trials when applicable.

Step therapy / prerequisite trials (GI biologics examples)

GI biologics often require TF/C/I to first-line or conventional therapies (e.g., immunomodulators, corticosteroids); documentation should include disease severity metrics (e.g., CDAI >220 for Crohn's) and prior therapy outcomes.

• Provide CDAI scores, stool frequency, endoscopic findings, and prior immunomodulator/corticosteroid trial details.
• Include gastroenterologist consultation notes.

Step therapy / TF/C/I requirements (infliximab/Crohn's examples)

Infliximab entries require TF/C/I to specified conventional therapies (e.g., immunomodulators or corticosteroids) for Crohn's/UC and documentation of disease activity (CDAI, labs); include gastroenterology specialist documentation.

• Submit CDAI or other severity markers and prior therapy trial/failure documentation.
• Confirm specialist prescribing/consultation per the entry.

Step therapy requirements (Rezurock/infliximab examples)

Some agents (e.g., Rezurock) require trial and failure of two or more systemic therapy lines for cGVHD; others (e.g., infliximab) require TF/C/I to conventional therapies before approval.

• Document the number and nature of prior systemic therapy lines and objective failure evidence.
• Attach hematology/oncology consultation notes for cGVHD entries.

Prerequisite therapy and step therapy (rheumatology examples)

Rheumatology examples: many products require documented TF/C/I to conventional agents (methotrexate, leflunomide, sulfasalazine) and often failure of at least one TNF inhibitor prior to certain advanced therapies; combination therapy with other JAKs/biologics is disallowed.

• Provide trial durations and outcomes for conventional DMARDs and TNF inhibitors.
• Affirm no concurrent use with other JAK inhibitors or biologic DMARDs.

Topical therapy trial required (plaque psoriasis)

Plaque psoriasis initial approvals require prior trial and failure (or contraindication/intolerance) of topical corticosteroids, vitamin D analogs, tazarotene, or calcineurin inhibitors (minimum 30 days; 14 days for topical corticosteroids).

• Document topical therapy type, duration (30 days or 14 days for steroids), and outcome.
• Include dermatologist consultation when required.

Required medical information and response documentation

Providers must document diagnosis, duration and outcome of prior therapies (e.g., 3-month TF/C/I for RA; 6‑week TF/C/I for PJIA; 30‑day topical trial for psoriasis), objective disease activity measures (CDAI, CRP, BSA, joint counts), and evidence of positive response for reauthorization.

• Include dates and specifics of prior therapy trials and chart notes showing response or intolerance.
• Provide baseline and follow-up objective measures for reauthorization.

Benlysta required documentation

Benlysta initiation for SLE requires documentation of active SLE, positive autoantibody (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), and that the patient is receiving standard‑of‑care treatment (e.g., antimalarials, corticosteroids, or immunosuppressants).

• Attach ANA or anti‑dsDNA test results meeting thresholds.
• Document current standard‑of‑care therapies and clinical status.

Balversa required documentation

Balversa for GIST requires documentation of diagnosis (unresectable/metastatic) and presence of PDGFRA exon 18 mutation (including D842V) detected by an FDA‑approved or CLIA‑certified test.

• Provide molecular testing report showing PDGFRA exon 18 mutation.
• Include staging and prior therapy history per the product entry.

Deferasirox baseline iron metrics

For deferasirox (iron overload) submit baseline ferritin (>1000 mcg/L for transfusional overload) and transfusion history showing at least 100 mL/kg PRBCs (or LIC ≥5 mg Fe/g dw for NTDT); reauthorization requires reductions in ferritin or LIC.

• Attach baseline ferritin and transfusion volume documentation.
• Provide LIC results when applicable and reauth evidence of improvement.

Cotellic mutation testing and combination use

Cotellic for melanoma requires documentation of unresectable/metastatic melanoma with BRAF V600E or V600K mutation detected by an FDA‑approved or CLIA‑certified test and documentation of concomitant use with vemurafenib.

• Provide BRAF V600E/K test report and treatment plan showing combination use with vemurafenib.
• Include staging and prior therapy history per the entry.

Cyclobenzaprine geriatric anticholinergic acknowledgement

For cyclobenzaprine in patients ≥65 years, the prescriber must acknowledge anticholinergic risks and consider dose adjustments or discontinuation of other anticholinergic medications.

• Document prescriber's acknowledgement of geriatric anticholinergic risks.
• Note any dose adjustments or changes to concomitant anticholinergic drugs.

Iron overload required medical information

For iron overload entries submit baseline ferritin and transfusion history (mL/kg) or liver iron concentration (LIC) where applicable; reauthorization requires evidence of reduction from baseline.

• Include serial ferritin and LIC measurements and transfusion records.
• Document clinical response to therapy for reauth.

Dupixent diagnostics and baseline measures

Dupixent submissions must include baseline peripheral blood eosinophil count, exacerbation history, prior inhaled/oral corticosteroid use, and prior intranasal steroid trials for CRSwNP; for EoE include histologic confirmation (≥15 eos/hpf) and exclusion of other causes.

• Attach eosinophil counts and exacerbation/hospitalization records.
• Provide endoscopy/pathology reports for EoE with eosinophil counts.

Rheumatology prerequisite therapy documentation

For rheumatology indications (e.g., Enbrel, Humira, Orencia) document trials and failures of specified conventional therapies (methotrexate, leflunomide, sulfasalazine) at maximally tolerated doses and baseline disease activity measures.

• Include dates, doses, and outcomes of DMARD trials.
• Provide joint counts, CRP, ESR, or other objective disease activity markers.

Evrysdi baseline motor exam and genetic testing requirements

Evrysdi requires baseline motor exam scores (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III Item 22) and SMN1/SMN2 mutation documentation for initial requests.

• Attach baseline motor exam scores and genetic testing confirming SMN1 mutation/deletion and SMN2 copy number.
• Document ventilatory status and absence of concomitant chronic SMN therapy.

Icatibant diagnostic labs for HAE

Icatibant acetate for HAE attack treatment requires diagnostic labs confirming HAE (low C4 and low C1‑INH antigenic or functional levels) or genetic testing/family history for HAE‑nl‑C1INH.

• Provide C4 and C1‑INH antigenic/functional level results or genetic/family history documentation.
• Confirm indication is for acute HAE attacks and not combined with other acute HAE treatments.

Required diagnostic documentation (HAE example)

Provide diagnostic laboratory confirmation for HAE (C4 low and C1‑INH antigenic or functional level low) or genetic testing/family history to support HAE-related requests; include indication‑specific evidence as specified per product.

• Attach lab reports and genetic test results when applicable.
• Include specialist consultation notes supporting diagnosis.

Baseline and reauthorization clinical measures (rheum/derm)

For reauthorization of rheumatologic and dermatologic agents, submit prior trials/failures of conventional therapies, baseline disease activity measures (joint counts, BSA, CDAI, CRP), and objective evidence of clinical improvement for continuation.

• Supply baseline and follow‑up objective measures demonstrating response.
• Document any dose adjustments and specialist follow‑up notes.

Required documentation for IVIG/immune globulin

IVIG/immune globulin requests require diagnosis documentation, immunologic evaluation (for primary immunodeficiency include IgG levels and vaccine response), evidence of TF/C/I to listed prior therapies where required, and documentation of objective improvement for non‑oncology renewals; subject to Part B vs Part D review.

• Include IgG levels, vaccine response data, and prior therapy trial records.
• For renewals show objective improvement and minimum effective dosing strategy.

Required clinical documentation (prescriber/specialty)

Prescriptions must include diagnosis and documentation of required prior trials, specialty prescriber or consultation when specified, and objective evidence of response for reauthorization (e.g., reduced symptoms or lab markers).

• Attach specialist consultation notes where required.
• Provide objective response metrics at reauth.

Diabetes confirmation documentation

Mounjaro initial requests must include medical records confirming T2DM diagnosis or one qualifying laboratory value (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL).

• Attach relevant lab reports or chart documentation confirming T2DM.
• Document prior diabetes therapies and treatment rationale.

Companion diagnostic documentation

Products with biomarker requirements must include results from an FDA‑approved or CLIA‑certified test confirming the mutation/fusion (e.g., JAG1/NOTCH2 for ALGS, FGFR2 for cholangiocarcinoma, BRAF V600E/V600K), with reports attached to the prior authorization.

• Attach molecular testing reports and testing facility accreditation.
• For oncology, include prior systemic therapy history when required.

Documentation for FN prophylaxis

For febrile neutropenia prophylaxis include chemotherapy regimen details and FN risk (protocol or % incidence) and specify whether prophylaxis is primary or secondary; prescriber should be a hematologist/oncologist.

• Provide chemo regimen protocol and historical FN incidence or patient risk factors.
• Document intent (primary vs secondary prophylaxis) and prior FN episodes if any.

Documentation for eosinophilic indications

For eosinophilic indications (Nucala, Fasenra, others) document diagnosis, baseline and historical eosinophil counts (e.g., baseline ≥150 cells/µL or ≥300 within 12 months), prior controller therapies and response, and specialist consultation when required.

• Attach eosinophil lab results and exacerbation/hospitalization history.
• Include prior inhaled/oral corticosteroid and controller therapy details.

Documentation for Odactra

Odactra prior authorization requires positive HDM‑specific IgE or skin test and trial/failure or intolerance to an intranasal corticosteroid AND an antihistamine; prescriber must be an allergist/immunologist for initial use.

• Provide in‑vitro IgE or skin testing reports and prior intranasal steroid/antihistamine trial documentation.
• Confirm patient age is within 5–65 years as listed.

Onpattro required baseline data

Onpattro initial requests must document hATTR with polyneuropathy, presence of a TTR mutation by FDA‑approved or CLIA test, baseline PND/FAP/NIS scores, and that the drug will not be used concurrently with a TTR silencer or stabilizer.

• Attach TTR mutation testing and baseline neuropathy scores (PND/FAP/NIS).
• Confirm no concomitant TTR silencer or stabilizer use.

Orencia documentation

Orencia initial requests for RA/JIA must document diagnosis, TF/C/I to conventional therapies (methotrexate, leflunomide, sulfasalazine) at maximally tolerated doses, and baseline disease activity.

• Provide dates and outcomes of DMARD trials and baseline joint counts or inflammatory markers.
• Include rheumatologist consultation when required.

Diabetes confirmation documentation (Ozempic)

For Ozempic (T2DM) submit medical records confirming T2DM diagnosis or laboratory evidence meeting diabetes thresholds (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL).

• Attach lab reports supporting diabetes diagnosis.
• Document prior diabetes management and rationale for therapy.

Molecular confirmation and prior therapy for Pemazyre

Pemazyre for cholangiocarcinoma requires documentation of unresectable locally advanced or metastatic disease and FGFR2 fusion/rearrangement detected by an FDA‑approved or CLIA‑certified test, plus prior line(s) of therapy.

• Attach FGFR2 fusion testing report and prior systemic therapy history.
• Include oncologist consultation notes and staging documentation.

Genetic and lab documentation for Pyrukynd

Pyrukynd initial requests must include molecular testing confirming at least two PKLR variant alleles (with required variant characteristics) and laboratory evidence of chronic hemolysis with hemoglobin ≤10 g/dL.

• Provide PKLR genetic testing results meeting the variant criteria.
• Attach labs showing hemolysis (LDH, bilirubin, reticulocyte count) and Hb ≤10 g/dL.

Required clinical documentation (migraine/infliximab examples)

For migraine and infliximab requests submit diagnosis, migraine days per month (EM ≥4, CM ≥8) and ensure medication overuse headache was considered for CM; for infliximab include disease severity measures (e.g., CDAI>220) and TF/C/I to conventional therapies.

• Include migraine diary or clinic notes documenting monthly migraine days.
• For GI biologics include CDAI, endoscopy, labs, and prior therapy trial documentation.

Molecular diagnostic documentation (Retevmo)

Retevmo and other RET‑directed therapy requests must include documentation of RET gene fusion or mutation detected by an FDA‑approved or CLIA‑certified test.

• Attach RET molecular testing reports with laboratory accreditation.
• Document disease stage and prior systemic therapy where required.

Required clinical documentation (rheum/derm examples)

For many immunologic and inflammatory agents, document baseline disease activity (joint counts, BSA/SCORAD, CDAI, stool frequency/labs) and prior TF/C/I to conventional therapies including at least one TNF inhibitor where specified; reauthorization requires evidence of positive clinical response.

• Provide baseline objective measures and follow‑up data showing improvement.
• Include documentation of prior TNF inhibitor use and outcomes when required.

Stelara induction dosing documentation

Stelara IV induction dosing requests must include patient weight to support the appropriate induction dose (260 mg for ≤55 kg, 390 mg for >55 to 85 kg, 520 mg for >85 kg).

• Provide measured patient weight at time of induction dosing.
• Attach GI specialist documentation for induction/maintenance plan.

Vyndamax diagnostic documentation

Vyndamax requests must include confirmation of transthyretin‑mediated amyloidosis (TTR mutation or biopsy or imaging plus absence of light‑chain amyloidosis) and NYHA Class I–III status.

• Attach TTR genetic test, biopsy, or imaging reports and NYHA functional class documentation.
• Confirm absence of light‑chain amyloidosis with appropriate testing.

Prerequisite therapy not met

A common denial risk is failure to document required prerequisite therapy trials (TF/C/I) to conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine for RA); lack of these records may result in denial.

• Ensure trial durations and outcomes are clearly documented in submitted records.
• If TF/C/I cannot be met, provide justification (contraindication/intolerance) with supporting evidence.

Onychomycosis prerequisite failure

Onychomycosis topical product requests risk denial if the required trial of oral terbinafine is not documented (minimum 6‑week supply for fingernail, 12‑week for toenail) or if diagnostic confirmation (KOH, culture, or histology) is missing.

• Provide KOH/culture/histology confirming onychomycosis.
• Document prior terbinafine trial duration and outcome per nail site.

Onychomycosis documentation and prior trial

Topical onychomycosis products may be denied if diagnosis is not confirmed by KOH, culture, or histology, or if the required oral terbinafine trial (6 weeks fingernail; 12 weeks toenail) was not documented.

• Attach diagnostic test reports and terbinafine trial documentation.
• Include rationale if terbinafine could not be used (contraindication/intolerance).

HAE diagnostic confirmation

HAE prophylaxis or treatment requests may be denied if laboratory confirmation (low C4 and low C1‑INH antigenic or functional levels) or genetic testing/family history documentation is not provided, or if prophylaxis is requested in combination with other prophylactic agents.

• Provide C4 and C1‑INH antigenic/functional lab results or genetic/family history evidence.
• Confirm no concomitant prophylactic agents are being used.

Immunologic disease prior therapy and severity

Biologic or advanced therapy approvals for psoriasis/PsA/AS/nr-axSpA/HS may be denied if required prior topical or NSAID trials, adequate disease severity measures (e.g., BSA, CRP, MRI), or specialist consultation are not documented.

• Attach evidence of topical/NSAID trials and objective severity measures.
• Include dermatology or rheumatology consultation notes as required.

Iron overload documentation

Denial risk for iron overload therapies exists when baseline lab or transfusion history criteria are not met (e.g., ferritin >1000 mcg/L and transfusion ≥100 mL/kg for transfusional iron overload).

• Provide baseline ferritin and transfusion volume documentation.
• If LIC used for NTDT, include LIC measurement and threshold evidence.

Dupixent eosinophilic asthma eligibility

Dupixent eosinophilic asthma requests may be denied if baseline blood eosinophil count ≥150 cells/mcL (or other exacerbation/hospitalization history) is not documented.

• Attach baseline eosinophil counts and exacerbation/hospitalization records.
• Document prior controller therapies and outcomes.

Diagnostic criteria not met (sickle cell example)

Requests may be denied if required diagnostic criteria are not met (for example, sickle cell disease without documentation of ≥2 painful crises in the past 12 months for L‑glutamine).

• Provide evidence of the stated diagnostic threshold (e.g., crisis counts).
• Include relevant hematology notes supporting indication.

Fasenra denial triggers

For Fasenra, authorization could be denied if eosinophilic phenotype criteria (baseline eosinophils ≥150 cells/µL) or exacerbation/hospitalization history are not documented.

• Include eosinophil counts and exacerbation/hospitalization documentation.
• Document prior controller therapies and response.

Combination therapy exclusion (HAE)

HAE acute treatment requests using a product in combination with other approved acute HAE treatments will be denied because combination use for acute attacks is not permitted.

• Confirm the request is for single‑agent acute HAE treatment and list any other acute HAE agents used.
• Provide lab/genetic confirmation of HAE as required.

IVIG Part B vs Part D review

IVIG requests are subject to Part B vs Part D review; if the patient meets Part B criteria or is in a long‑term care setting, the claim may be moved to Part B review or denied under Part D coverage rules.

• Indicate site of care and whether Part B criteria may apply.
• Provide documentation supporting Part D billing when appropriate.

Benefit determination / Part B vs Part D

If Part B criteria are met (or patient is in a setting covered by Part B), use may be shifted to Part B review; lacking required documentation of diagnosis, prior therapy, or response can lead to denial under the pharmacy benefit.

• Provide clear documentation of the setting of care and indication to support Part D coverage.
• If Part B is appropriate, coordinate medical benefit submission.

Missing required genetic confirmation

For therapies requiring genetic confirmation (e.g., Livmarli for ALGS/PFIC), lack of required molecular genetic testing confirming specified gene mutations will trigger non‑approval.

• Attach molecular genetic testing reports confirming required mutations (JAG1/NOTCH2 for ALGS; ATP8B1/ABCB11/others for PFIC).
• If testing unavailable, provide rationale and alternative evidence.

MS combination therapy exclusion

Use in combination with another disease‑modifying therapy for multiple sclerosis is an exclusion and may trigger denial; prior therapy documentation must show monotherapy status or continuation of prior therapy only.

• Confirm the patient is not receiving concurrent DMTs for MS.
• Provide prior therapy trial/failure documentation if monotherapy initiation is requested.

CGRP combination exclusion

Combination use of a CGRP inhibitor with another CGRP inhibitor for acute or preventive migraine is prohibited and may result in denial; ensure no other CGRP inhibitors are being used concurrently.

• Provide medication lists showing absence of other CGRP inhibitors.
• For reauthorization show decreased use of acute migraine medications and positive response.

Documentation and prerequisite therapy

Failure to document prerequisite trials (e.g., intranasal corticosteroid AND antihistamine for Odactra) or required prescriber specialty when listed may trigger denial; include testing and prior therapy records.

• Attach positive HDM IgE or skin test and prior intranasal steroid/antihistamine trial records for Odactra.
• Include allergist/immunologist consultation notes when required.

Incomplete clinical documentation for GI biologics

GI biologic requests lacking documentation of disease severity (e.g., CDAI >220 for Crohn's, UC severity markers) or failure/intolerance to required conventional therapies may be denied; include objective severity measures and prior therapy records.

• Provide CDAI, endoscopy, CRP, stool frequency, and prior immunomodulator/corticosteroid trial documentation.
• Attach gastroenterology consultation notes supporting disease severity.

CGRP combination use

Use of another CGRP inhibitor in combination for preventive migraine treatment will lead to non‑coverage/denial; verify the patient is not receiving concurrent CGRP agents.

• Provide full medication history to demonstrate no concurrent CGRP inhibitor use.
• Document migraine frequency and response metrics for reauth.

Prerequisite therapy trials

Failure to show required prerequisite therapy trials (e.g., conventional therapies for Crohn's/UC or NSAID trial for AS) may trigger denial—document the trial specifics and outcomes.

• Include dates, doses, and outcomes of prior conventional therapy trials.
• If trial not possible, provide contraindication/intolerance evidence.

Combination therapy exclusion (JAK/biologic)

Use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine) is disallowed for many agents and may trigger denial; ensure no prohibited concomitant therapy is present.

• Provide medication reconciliation showing absence of prohibited concomitant immunosuppressants.
• Document prior therapy trials required for monotherapy initiation.

Documentation triggers (psoriasis example)

Failure to document diagnosis severity (e.g., BSA ≥3% for plaque psoriasis) or lack of documented trial/failure/contraindication to required topical therapies may trigger denial for dermatology entries.

• Provide BSA or SCORAD assessments and topical therapy trial records.
• Include dermatologist consultation notes where required.