Prior authorization with diagnosis and trial/failure documentation

Submit a prior authorization that includes the member’s diagnosis and documentation of required prior trials or failures when specified; approvals are indication‑specific and often require specialty prescriber information and objective supporting data.

• Include diagnosis documentation for the requested indication.
• Provide evidence of trials/failures, contraindications, or intolerance to required prior therapies (TF/C/I) when listed.
• Note prescriber specialty or consultation when required (eg, rheumatologist, pulmonologist, infectious disease).

Prior authorization required

A prior authorization is required for these products; do not assume auto‑approval — submit clinical records demonstrating the diagnosis and indication‑specific criteria.

• PA is product‑level and required for each entry (Formulary ID: 25385).
• Coverage durations and clinical requirements are specified per product.

Product-level prior authorization

Each product entry is subject to a product‑level prior authorization — include the exact required medical information and note the listed coverage duration.

• Formulary identifier applies to entries (Formulary ID: 25385).
• Verify and include any exclusion criteria (eg, concurrent nitrates where noted).

Prior authorization required

Submit a prior authorization with indication‑specific clinical data, prescriber specialty, age limits, and evidence of prior therapy trials or contraindications as specified for the drug and indication.

• Include age and prescriber specialty when required (eg, CF specialist, pulmonologist, neurologist).
• Attach objective measures (labs, imaging, mutation testing) when requested.

Prior authorization required with supporting clinical data

Provide supporting objective clinical data with the prior authorization — labs, diagnostic testing, genetic or biomarker results, and prior therapy details are required when listed.

• When biomarkers are required, submit FDA‑approved or CLIA lab reports.
• Include recent laboratory values (eg, Hgb/Hct, ferritin, A1c) within the timeframe specified.

Prior authorization: diagnosis and supporting info required

For many targeted and oncology agents, prior authorization must include the specified diagnosis and the supporting clinical information (staging, mutation/fusion test results, prior systemic therapy) as listed for the product.

• Attach documentation of tumor mutation status or biomarker testing when required.
• Document prior systemic therapies and lines of treatment where specified.

Prior authorization requirement

Include diagnostic results, biomarker or molecular testing, and prior therapy history in the prior authorization; coverage durations are commonly 12 months unless otherwise noted.

• When a companion diagnostic is required, submit the FDA‑approved assay or CLIA lab report.
• State initial authorization duration and plan for reauthorization documentation.

Prior authorization and documentation

Attach documentation of diagnosis, prior therapies (when specified), and any relevant genetic/molecular test results performed by an FDA‑approved or CLIA‑certified laboratory as part of the PA submission.

• Ensure molecular testing reports (eg, KRAS, PIK3CA, EGFR, BRAF) are included when required.
• Document stage/extent of disease for oncology indications.

Braftovi combination — PA requirement

For BRAF‑mutant melanoma or NSCLC requests, submit documentation of the BRAF V600E or V600K mutation detected by an FDA‑approved test (THxID‑BRAF Kit) or a CLIA‑approved laboratory and confirm combination use with encorafenib where required.

• Provide the mutation test report and the treatment plan showing combination therapy with encorafenib.

Armodafinil — PA and reauth

Armodafinil prior authorization requires diagnostic confirmation (eg, sleep study for OSA or narcolepsy unless justification is provided) and documentation of response for reauthorization.

• If OSA, submit sleep study showing ≥15 events/hour or ≥5 events/hour with symptoms unless justified.
• Document symptomatic benefit at reauthorization.

Prior authorization required

Prior authorization requires documentation of diagnosis and prior treatment details (for example, prior intensive induction chemotherapy and achievement of CR/CRi for AML‑maintenance agents).

• Attach records verifying prior induction regimen and CR/CRi status.
• State inability to pursue further intensive curative therapy when applicable.

PAH prior authorization

For PAH therapies (eg, Opsumit, Orenitram), include confirmation of PAH by right heart catheterization or documentation that the patient is currently on PAH therapy, and ensure initial prescribing involves a pulmonologist or cardiologist.

• Submit right heart cath report or documentation of current PAH therapy.
• Indicate the specialty prescriber on the request.

Prior authorization and duration

Prior authorization and reauthorization require documentation of diagnosis and prior treatment history; authorization durations vary by product (commonly 6 months initial, 12 months reauthorization).

• State initial and intended authorization durations.
• Provide objective measures for reauthorization as required.

Prior authorization and coverage duration

Include indication, prior therapy trials as specified, prescriber specialty when required, and age limits in the PA; many products authorize initial coverage for 6 months and reauthorization for 12 months unless noted otherwise.

• Confirm age and prescriber specialty.
• Attach evidence of TF/C/I to required prior agents.

Prior authorization requirement

Submit a prior authorization that documents the specific diagnosis, demonstrates the patient meets indication‑specific severity/step criteria (including weight or age limits where listed), and includes specialty prescriber information when required.

• For biologics, include severity metrics (eg, BSA, CDAI) where required.
• Include weight or age documentation for formulations with thresholds.

Osteoporosis therapies PA

For osteoporosis therapies (Tymlos, teriparatide and similar), prior authorization must include BMD T‑scores, fracture history, and documentation of trial and failure/contraindication/intolerance to prior osteoporosis treatments or FRAX scores where applicable.

• Provide lumbar spine, femoral neck, total hip, or one‑third radius BMD T‑scores.
• Include FRAX 10‑year probabilities when requested (major ≥20% or hip ≥3%).

Trulicity PA

Trulicity (and related GLP‑1 agents) prior authorization requires submission of medical records confirming type 2 diabetes mellitus or qualifying laboratory evidence (A1c ≥6.5% or FPG ≥126 mg/dL or OGTT criteria).

• Attach chart notes or lab reports (A1c, FPG, or OGTT) supporting T2DM diagnosis.
• Document prior diabetes management as applicable.

Lapatinib prior authorization

Lapatinib prior authorization must include documentation of HER2‑positive advanced/metastatic/recurrent breast cancer and the concomitant agent to be used (trastuzumab, capecitabine, or an aromatase inhibitor).

• Provide pathology or testing confirming HER2 positivity and treatment plan showing combination agent.
• Coverage commonly authorized for 12 months.

Vyvgart Hytrulo prior authorization

Vyvgart Hytrulo PA requires documentation of anti‑AChR antibody‑positive generalized myasthenia gravis and evidence of trial and failure (or contraindication/intolerance) to the required immunosuppressive therapies or plasmapheresis/IVIG per the criteria.

• Include antibody testing confirming anti‑AChR positivity.
• Document TF/C/I to two immunosuppressive agents or one agent plus IVIG/plasmapheresis.

Conventional therapy trial required

Many biologic and specialty drug indications require documentation of trial and failure, contraindication, or intolerance (TF/C/I) to conventional therapies at maximally tolerated doses before approval.

• Document the specific agents tried, durations, and reasons for failure/intolerance.
• If continuing prior therapy, indicate prior authorization history.

Caplyta prior trial requirement

For Caplyta requests, document trial and failure, contraindication, or intolerance to two listed generic atypical oral antipsychotics prior to approval.

• List the two antipsychotics tried and provide clinical notes showing inadequate response or intolerance.
• Include diagnosis (schizophrenia or bipolar disorder) per product criteria.

Tadalafil BPH prior therapy requirement

For tadalafil for BPH, include documentation of trial and failure, contraindication, or intolerance to an alpha‑blocker or a 5‑alpha reductase inhibitor as required by the PA criteria.

• Document which alpha‑blocker or 5‑alpha reductase inhibitor was tried and reason for failure or intolerance.
• Include BPH diagnosis in submitted records.

Step therapy and trial/failure requirements

Many products require trial and failure of specified agents before approval (step‑therapy); submit documentation of the exact comparators tried and the clinical rationale for failure/intolerance.

• For dermatology and psychiatric agents, list topical/systemic agents tried and durations.
• For biologics, provide evidence of prior DMARDs or TNF inhibitor trials where required.

Step therapy / prior trial requirements

Submit documentation of TF/C/I to specified prior therapies (examples include inhaled controller optimization for biologic asthma agents or maximal ACEi/ARB/SGLT2 background for certain nephrology indications) when step requirements are listed.

• Summarize prior medication history and reasons for discontinuation or failure.
• Provide objective measures (exacerbation history, lab values) supporting the need for escalation.

Concurrent therapy restriction (Evrysdi)

Do not combine Evrysdi with other chronic SMN‑modifying therapies; if prior gene therapy was given, provide documentation of inadequate response to support approval.

• State whether the patient has received prior gene therapy (eg, Zolgensma) and, if so, include objective evidence of inadequate response.
• Confirm absence of concomitant chronic SMN‑modifying therapy.

Step therapy / trials required

Many agents require documented trial and failure/contraindication/intolerance to specified conventional therapies prior to approval — include dates, doses, and clinical notes demonstrating inadequate response.

• For anti‑seizure, oncology, and immunologic agents, provide prior therapy history with objective assessments of response.
• If exempt (continuation of prior therapy), include prior authorization records.

Step therapy / trial requirements

Several agents require trial and failure/contraindication/intolerance to specified prior therapies (eg, terbinafine before itraconazole for onychomycosis or at least one DMT prior to Kesimpta); include trial duration and outcome.

• Provide lab or test confirmation (eg, KOH/culture) as required by the indication.
• Document durations of prior systemic/topical therapies and reasons for failure.

Required prior systemic therapy

Some oncology approvals require prior use of specific chemotherapies or targeted agents before considering the listed product; include prior regimens and dates.

• List prior lines of systemic therapy and supportive documentation (infusion records, oncology notes).
• For combination approvals, show planned or concurrent agents.

Opipza step requirements

Opipza approvals require documentation of TF/C/I to the listed prior antipsychotics (number varies by indication); provide evidence of trials and outcomes.

• For schizophrenia: document two failed or intolerant atypical antipsychotics.
• For MDD or autism irritability, include the specific agents and trial details per criteria.

Opusmit step requirements

Opusmit and similar antipsychotic entries require trial and failure or intolerance to specified listed agents (commonly two agents for schizophrenia); include medication lists and clinical justification.

• Attach prior psychiatry notes documenting inadequate response or intolerance.
• If clozapine was used, include rationale and response.

Required prior therapy trials

Some hematology products (eg, eltrombopag) require failure or intolerance to corticosteroids, IVIG, or splenectomy prior to approval; include hematology consultation notes and baseline labs.

• Provide baseline platelet counts and prior treatment dates/outcomes.
• Include hematologist recommendation when available.

Required prior therapy trials

Many dermatologic and rheumatologic therapies require TF/C/I to topical or systemic comparator therapies (topical corticosteroids, tacrolimus, TNF inhibitors, conventional DMARDs); provide trial details and clinical response measures.

• Document topical/systemic trial durations and objective severity (BSA, SCORAD).
• If contraindicated to comparators, include rationale in the chart notes.

Trial and failure requirements

For agents that require trial/failure of alternatives (eg, penicillamine before trientine; one osteoporosis therapy before teriparatide), include records of the prior agent and the reason therapy failed or was not tolerated.

• Provide dates, doses, and adverse event documentation or lack of efficacy.
• Include specialist notes supporting the step exemption when applicable.

TF/C/I requirements

Many oncology and specialty drugs require TF/C/I to listed alternatives; include documentation of each prior agent tried and the clinical reason for discontinuation.

• Summarize prior lines of therapy succinctly in the PA cover letter.
• Attach supporting oncology clinic notes or infusion records.

Tymlos step therapy

Tymlos prior authorization requires documentation of BMD T‑scores and either fracture history or TF/C/I to prior osteoporosis therapy for the applicable criteria set; observe the lifetime parathyroid hormone duration limit.

• Provide BMD reports and prior osteoporosis therapy history.
• Confirm total parathyroid hormone treatment will not exceed 24 months lifetime.

Ubrelvy step therapy

Ubrelvy for acute migraine requires documentation of trial and failure or intolerance to one triptan (or contraindication to all triptans) before approval.

• Include which triptan was tried and clinical notes showing inadequate response or intolerance.
• Confirm acute (not preventive) use and age ≥18.

Vyvgart Hytrulo step therapy

Vyvgart Hytrulo requires documentation of trial and failure or contraindication/intolerance to two immunosuppressive therapies (or one immunosuppressive therapy plus plasmapheresis/IVIG) before approval for gMG.

• Provide records of immunosuppressive agents tried and response.
• If plasmapheresis/IVIG used, include dates and response documentation.

Required clinical documentation

Provide the required clinical documentation with the PA: diagnosis documentation, lab results, imaging, biomarker/molecular testing, and prior therapy history per the product‑specific requirements.

• Include copies of lab reports, imaging, pathology, and genetic/molecular testing.
• Chart notes should show clinical course and rationale for the requested therapy.

Submission of medical records for T2DM

For diabetes GLP‑1 and similar agents (eg, exenatide, Ozempic), submit medical records or lab evidence confirming type 2 diabetes mellitus (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL) as part of the PA.

• Attach the most recent A1c or fasting plasma glucose/OGTT results.
• Include diabetes treatment history and target glycemic goals.

Arikayce documentation of treatment failure

For Arikayce requests for MAC lung disease, include documentation that the patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen and provide infectious disease or pulmonology specialist notes.

• Attach sputum culture history showing persistent positive cultures despite ≥6 months of background therapy.
• Include the specialist consultation note and regimen details.

Onychomycosis required documentation

For topical onychomycosis products (eg, ciclopirox nail lacquer), submit confirmation of diagnosis (KOH, culture, or histology), documentation that the lunula (nail matrix) is not involved, and evidence of trial and failure/contraindication/intolerance to oral terbinafine for the required duration.

• Include KOH, fungal culture, or histology reports.
• Document terbinafine trial duration (≥6 weeks fingernail, ≥12 weeks toenail) or reason for contraindication.

Iron overload required documentation

For deferasirox (iron overload), submit baseline ferritin >1,000 mcg/L and transfusion history (≥100 mL/kg PRBCs) or LIC data for NTDT per the initial/reauthorization criteria.

• Provide baseline ferritin and transfusion volume history.
• Include LIC measurements where applicable (NTDT thresholds).

Doptelet required documentation

For Doptelet in ITP/TPPP, include baseline platelet count and documentation of planned procedure (TPPP) or prior TF/C/I to corticosteroids/IVIG/splenectomy for ITP, plus hematology consultation notes.

• Attach baseline platelet count (<50,000 for TPPP; <30,000 for ITP).
• Provide procedure scheduling for TPPP or prior therapy documentation for ITP.

Required laboratory documentation

Lab documentation is required for anemia and related indications — submit recent Hgb/Hct values within the specified timeframe and erythropoietin levels when applicable.

• Include Hgb/Hct within 30 days (CKD) or within 2 weeks (chemotherapy) as specified.
• Attach serum erythropoietin when required (≤500 mU/mL for some indications).

Baseline biomarker / diagnostic documentation

For biologics and other specialty agents that require baseline biomarkers or diagnostic testing (eg, blood eosinophils for eosinophilic asthma; histology for EoE), include the baseline test results with the PA.

• Attach blood eosinophil counts, biopsy/histology reports, HRCT, or other baseline biomarkers as required.
• Document any prior therapy optimization steps (eg, inhaled controller optimization).

Required medical information

Submit medical records that document diagnosis, prior therapy trials/failures, and supporting labs/tests per the indication (examples: Hgb/Hct, HRCT/biopsy for IPF, or genetic testing for inherited disease).

• Provide clear, dated clinical notes tying objective results to the request.
• Include specialist consult notes where required.

Required diagnostic test evidence

When diagnostic testing is required (EGFR, HER2, ROS1, KRAS, PIK3CA, MET, BRAF), include the test report performed by an FDA‑approved assay or a CLIA‑certified laboratory as part of the PA.

• Attach the molecular/pathology report showing the detected mutation/fusion.
• Specify the assay and performing laboratory (FDA‑approved or CLIA‑certified).

Required clinical documentation

Provide diagnosis, required biomarker/mutation test results (from FDA‑approved or CLIA labs), and prior therapy history where specified for oncology and targeted therapies.

• Include tumor staging and prior systemic therapy records.
• Ensure molecular testing reports are legible and dated.

Required diagnostic documentation

When molecular testing is required, submit documentation of diagnosis, stage (eg, locally advanced or metastatic), and results from an FDA‑approved or CLIA‑certified test (eg, KRAS G12C, EGFR exon 19/21, BRAF V600E/V600K).

• Attach both the clinical diagnosis note and the companion diagnostic report.
• For combination regimens, show the planned concomitant agents.

BRAF mutation test and combination use

For BRAF‑targeted combination use, include BRAF V600E or V600K mutation documentation by an FDA‑approved test (THxID‑BRAF Kit) or CLIA lab and confirm the combination regimen (eg, with encorafenib).

• Attach the THxID‑BRAF Kit or equivalent CLIA report.
• Provide the oncology treatment plan showing combination therapy.

Diabetes diagnostic documentation

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

• Include recent A1c or fasting glucose results.
• Document prior diabetes medications and response.

Fungal prophylaxis documentation

For posaconazole prophylaxis, include documentation of high‑risk status (eg, HSCT with GVHD or prolonged neutropenia) or prior invasive fungal infection history for secondary prophylaxis.

• Attach transplant or oncology treatment notes documenting neutropenia or GVHD.
• Include prior fungal infection culture or treatment history if secondary prophylaxis.

Arikayce required documentation

For Arikayce, include medical records documenting failure to achieve ≥2 negative sputum cultures after a minimum 6 months of a multidrug background regimen and the infectious disease/pulmonology consult.

• Provide sequential sputum culture results and dates of background antibiotics.
• Attach specialist consultation confirming refractory MAC lung disease.

Onychomycosis required documentation

For onychomycosis topical agents, include KOH/culture/histology confirmation, documentation that lunula/matrix is not involved, and evidence of oral terbinafine trial/failure or contraindication for the specified durations.

• Attach lab/biopsy reports and notes describing nail matrix involvement.
• Provide terbinafine treatment dates and reason for failure/intolerance if applicable.

Iron overload required documentation

Include baseline ferritin and LIC/transfusion history for deferasirox requests; reauthorization requires evidence of reduction in ferritin or LIC from baseline as specified.

• Provide baseline and follow‑up ferritin values and LIC when available.
• Document transfusion volumes (≥100 mL/kg) for transfusional iron overload.

Doptelet required documentation

For Doptelet requests include baseline platelet counts and evidence of planned procedure for TPPP or prior TF/C/I to corticosteroids/IVIG/splenectomy for ITP, plus hematology consult documentation.

• Attach platelet count labs and procedure scheduling documentation.
• Include hematologist recommendation for therapy.

Required laboratory documentation

Provide required laboratory evidence (eg, Hgb/Hct within required timeframe, erythropoietin levels) for anemia indications; requests missing these labs risk denial.

• Include Hgb/Hct within 30 days for CKD, within 2 weeks for chemotherapy indications.
• Attach serum erythropoietin when indicated (≤500 mU/mL).

Baseline biomarker / diagnostic documentation

When baseline biomarker or diagnostic documentation is required (eg, blood eosinophils, histology for EoE), include these results and prior therapy trials as part of the PA submission.

• Attach eosinophil counts, biopsy reports, HRCT, or other objective tests.
• Document prior trials of indicated therapies and outcomes.

Required medical information

For each indication, submit medical records documenting diagnosis and supporting labs/tests (examples: Hgb/Hct for anemia, HRCT/biopsy for IPF, genetic/enzyme testing for Fabry disease).

• Ensure all required test reports are included and dated within specified windows.
• If criteria include specialist involvement, attach the consult or prescribing provider specialty.

Required diagnostic test evidence

Attach diagnostic test evidence (eg, HER2, EGFR, ROS1, KRAS, PIK3CA) performed by FDA‑approved or CLIA‑certified tests when required for the requested targeted therapy.

• Include the assay name, result, and performing lab credentials.
• For combination regimens, indicate planned partner drug(s).

Required clinical documentation

Provide clinical documentation and biomarker/mutation reports from FDA‑cleared or CLIA‑approved tests for therapies requiring companion diagnostics (eg, EGFR, KRAS, PIK3CA, CFTR tests).

• Attach genetic/molecular reports that specifically identify the required mutation or genotype.
• Include oncology or specialty notes confirming use in the indicated setting.

Companion diagnostic requirement

When companion diagnostics are required (eg, PIK3CA for Piqray, therascreen), include the FDA‑approved assay report or CLIA laboratory result with the PA.

• Submit the therascreen PIK3CA RGQ PCR Kit report or equivalent CLIA result.
• Confirm planned combination therapy (eg, fulvestrant for Piqray).

Genetic testing requirement

Genetic testing requirements (eg, for Pyrukynd) must be met — include molecular testing confirming required variant alleles and relevant lab thresholds (eg, Hgb ≤10 g/dL) in the authorization.

• Attach full genetic report showing PKLR variants per criteria.
• Include baseline hemoglobin and clinical notes supporting symptomatic anemia.

Required medical records

Provide medical records documenting diagnoses, symptom severity metrics (BSA, SCORAD, CDAI, stool frequency), and prior treatment trials/failures/contraindications as required for the indication.

• Include objective severity measures (eg, CDAI >220 for Crohn's) when requested.
• Attach prior therapy histories and specialist notes.

Documentation for IV induction dosing

For IV induction dosing (eg, certain IBD induction products), include documentation of disease severity and that induction dosing will follow FDA‑labeled weight‑based schedules.

• Provide weight and dosing plan (260 mg ≤55 kg, 390 mg >55–85 kg, 520 mg >85 kg) for IV induction.
• Include CDAI or stool frequency/lab evidence supporting induction.

General documentation requirements

Ensure required medical information includes specific diagnosis, evidence of prior therapy failure when specified, patient weight/age limits, and documentation of specialty prescribing or consultation.

• Attach weight and age documentation where thresholds apply (eg, Steqeyma 90mg for >100 kg; Spevigo ≥40 kg).
• Include specialist consult notes when mandated.

Osteoporosis: required data elements

For osteoporosis PA requests, include BMD T‑scores from lumbar spine, femoral neck, total hip, or one‑third radius, fracture history, TF/C/I to prior osteoporosis therapy, and FRAX probabilities when applicable.

• Provide DEXA scan reports with exact T‑score readings.
• Include prior osteoporosis medication history and fracture documentation.

Testosterone: required labs and diagnosis

For testosterone therapy, submit diagnosis of hypogonadism (male at birth) and biochemical confirmation with two pre‑treatment total testosterone levels <300 ng/dL (or free/bioavailable criteria) or qualifying conditions per the policy.

• Include two baseline total T measurements and timing of draws.
• Document any SHBG‑altering conditions and calculated free T if applicable.

Tryngolza: required genetic and lab documentation

For Tryngolza, include genetic confirmation of biallelic pathogenic variants in FCS genes or a NAFCS score ≥45, baseline fasting triglycerides ≥880 mg/dL, and prior therapy history/intolerance documentation.

• Attach genetic testing or NAFCS scoring documentation.
• Provide fasting TG level and prior triglyceride‑lowering therapy history.

Lapatinib required information

For lapatinib, submit documentation of HER2‑positive advanced/metastatic/recurrent breast cancer and the concomitant agent planned (trastuzumab, capecitabine, or aromatase inhibitor).

• Attach HER2 testing report and treatment plan showing combination therapy.
• Document prior HER2‑directed therapy if relevant.

Tymlos documentation

Tymlos PA submissions must include BMD T‑scores and history of low‑trauma fracture or TF/C/I to prior osteoporosis therapy; note the lifetime parathyroid hormone duration limit (≤24 months).

• Provide DEXA reports and fracture records.
• State cumulative prior parathyroid hormone therapy duration.

Vowst documentation

For Vowst, include documentation of recurrent CDI with a positive stool toxin test, history of ≥2 recurrences in 12 months, completion of required antibiotic course 2–4 days prior, and completion or plan for magnesium citrate bowel prep.

• Attach stool toxin/toxigenic C. difficile test result and CDI history.
• Confirm antibiotic and bowel prep completion dates in records.

Missing required diagnosis information

Failure to provide the required diagnosis (eg, CGD or severe malignant osteopetrosis for Actimmune) or the required supporting documentation may result in denial of the request.

• Ensure diagnosis documentation is explicit and matches the listed criteria.
• Attach specialist notes when the product criteria require a specialist.

Lack of required diagnosis or failure to meet disease-specific criteria

Requests lacking the required diagnosis or failing to meet disease‑specific criteria (for example, COPD diagnosis for arformoterol or MAC lung disease criteria for Arikayce) risk denial.

• Confirm the requested product matches the documented diagnosis and disease criteria.
• For Arikayce, include sputum culture history and specialist consultation.

For ciclopirox nail lacquer, missing confirmed diagnostic testing

For ciclopirox nail lacquer, absence of diagnostic confirmation (KOH, culture, or histology), lack of documentation that the lunula/matrix is not involved, or missing evidence of oral terbinafine trial/failure can lead to denial.

• Provide KOH/culture/histology and a note addressing lunula involvement.
• Document terbinafine trial duration or contraindication with dates.

Diagnostic confirmation and nail matrix involvement

Requests for onychomycosis agents may be denied if diagnostic confirmation (KOH, culture, or histology) is not provided or if the patient has lunula (nail matrix) involvement that precludes topical therapy.

• Confirm nail matrix (lunula) involvement is absent in clinical notes.
• Attach diagnostic laboratory reports.

HAE diagnostic confirmation and monotherapy requirement

For prophylactic C1‑INH products in HAE, denials can occur if diagnosis is not confirmed by low C1‑INH antigenic or functional levels or if the product is used in combination with other prophylactic agents.

• Include C1‑INH antigenic and/or functional level reports below LLN.
• State that prophylaxis will not be combined with other approved prophylactic agents.

Prior therapy exclusion for ALK inhibitor-naïve requirement

Requests for ALK‑positive NSCLC that document prior exposure to an ALK inhibitor may be denied for indications requiring ALK inhibitor‑naïve status; verify prior ALK therapy history before submission.

• Document prior ALK agents and treatment dates; if previously treated, note indication for later‑line use only if criteria allow.
• Attach ALK testing report and staging information.

Documentation-based denials

Requests lacking required laboratory evidence (eg, Hgb/Hct within the specified timeframe) or missing diagnosis documentation for the indicated condition may be denied; submit labs and dated clinical notes as specified.

• Provide labs within the policy‑specified time window.
• Attach clinician notes confirming the diagnosis and rationale for therapy.

Missing required diagnostic evidence

Missing required diagnostic information (for example, absent molecular mutation testing for targeted agents) may trigger denial — include the test reports performed by FDA‑approved or CLIA‑certified labs.

• Attach the molecular diagnostic report showing the required mutation.
• If testing was not performed, provide justification and consider ordering the test prior to PA submission.

Missing required diagnostic or prior therapy documentation

Lack of documented tumor mutation status (eg, KRAS G12C) or absence of required prior systemic therapy where specified may result in denial for oncology targeted therapies.

• Provide mutation test report and prior systemic therapy records (lines of therapy).
• Document combination partner therapy when required.

Missing required diagnostic or treatment history

Requests missing required molecular testing or treatment history (eg, KRAS G12C testing, prior systemic therapy) may be denied; include the specific mutation test report and prior therapy details.

• Attach CLIA/FDA test report for the relevant mutation.
• Include prior therapy regimens and dates.

Missing required diagnostic test

Absence of the required diagnostic test documentation (eg, lack of documented BRAF V600E/V600K mutation by an FDA‑approved or CLIA‑approved test) for melanoma or NSCLC indications can trigger denial.

• Submit the THxID‑BRAF Kit or CLIA lab report confirming BRAF V600E/K status.
• If unavailable, document alternative validated testing per policy.

Missing sleep study documentation

For armodafinil in OSA, absence of sleep study confirmation of obstructive respiratory events (unless a justification is provided) may lead to denial; include polysomnography results when available.

• Attach sleep study showing ≥15 events/hour or ≥5 events/hour with qualifying symptoms, or provide documented justification if study not feasible.
• Include clinical notes describing daytime symptoms and prior management.

Missing required documentation of prior intensive induction and remission

For AML maintenance agents (eg, Opipza/Onureg contexts), lack of documentation of prior intensive induction chemotherapy and achievement of CR or CRi may trigger denial; include oncology treatment records confirming prior induction and remission status.

• Provide induction chemotherapy regimen details and documentation of CR/CRi.
• If unable to complete curative therapy, include treating oncologist rationale.

For PAH agents, missing right heart catheterization or current therapy documentation

For PAH agents, absence of right heart catheterization confirmation or lack of documentation that the patient is currently on PAH therapy may result in denial; include right heart cath reports or current PAH medication records.

• Attach right heart catheterization hemodynamics when available.
• Document current PAH therapy if catheterization is not recent.