Prior authorization required

Prior authorization is required for the drugs listed in this document; providers must submit the clinical information specified for the product (diagnosis, prior therapies, prescriber specialty, and coverage duration) when a drug shows "PA" in the Formulary Requirements column. Approvals follow the product-specific criteria provided in this policy.

• Provide diagnosis and required supporting documentation as specified for the drug.
• Document prior therapy trials or rationale why trials are inappropriate when required.
• Ensure prescriber specialty/consultation is documented when the criteria require it.

Rinvoq for Crohn's Disease

Rinvoq (upadacitinib) for moderate to severe Crohn’s disease requires prior authorization and documentation of inadequate response or intolerance to two of the following: adalimumab, ustekinumab, risankizumab, or upadacitinib (or documentation that a trial is inappropriate). The request must be prescribed by or in consultation with a gastroenterologist; coverage duration is typically 12 months.

• Document trials of two specified biologics/JAK agents or provide reason trials are inappropriate.
• Include gastroenterology consult/prescriber on the request.

Entyvio PA requirements

Entyvio (vedolizumab) prior authorization for moderately to severely active UC or CD requires either failure/intolerance to two listed agents (e.g., adalimumab, ustekinumab, upadacitinib, tofacitinib, risankizumab) or use as maintenance following IV induction; prescribe by or in consultation with a gastroenterologist and document duration (12 months).

• Provide documentation of two failed/ intolerant agents OR documentation of IV induction with Entyvio and plan for maintenance.
• Document gastroenterology prescriber or consultation.

Enbrel PA requirements

Enbrel (etanercept) prior authorization requires documentation of the indication and inadequate response or intolerance to the specified conventional DMARD(s) (e.g., methotrexate); prescriber must be or consult with the appropriate specialist (rheumatologist or dermatologist) and concurrent biologic DMARD therapy is excluded.

• Document failed or intolerant conventional DMARD(s).
• Do not combine with other biologic DMARDs; include specialist prescriber or consultation.

nr-axSpA PA requirements

For non-radiographic axial spondyloarthritis (nr-axSpA), prior authorization requires inadequate response or intolerance to Rinvoq or Cosentyx (or documentation that a trial is inappropriate) and failure of at least one NSAID; document prior trials and prescriber specialty as required.

• Document trial of Rinvoq or Cosentyx (or why trial inappropriate).
• Document trial of at least one NSAID (ibuprofen, meloxicam, naproxen) or rationale.

Sodium phenylbutyrate PA

Sodium phenylbutyrate for urea cycle disorders requires prior authorization with documentation of a confirmed UCD (enzymatic, biochemical, or genetic testing) and inadequate response to dietary protein restriction or amino acid supplementation; initial authorization is typically 6 months.

• Include confirmatory testing for CPS, OTC, or ASS deficiency.
• Provide documentation of dietary/dietary-supplement management and inadequate response.

UCD therapies PA

Urea cycle disorder therapies require prior authorization: initial approvals are for 6 months and reauthorization for 12 months, with documentation of positive clinical response (e.g., plasma ammonia or amino acid levels) and concurrent dietary management.

• Submit enzymatic/biochemical/genetic testing confirming UCD.
• Provide laboratory monitoring and evidence of clinical response for reauthorization.

TOBI PODHALER PA

TOBI PODHALER prior authorization requires a diagnosis of cystic fibrosis, evidence of Pseudomonas aeruginosa in the lungs, FEV1 between 25% and 75% predicted, and absence of Burkholderia cepacia colonization; prescriber should be a pulmonologist/CF specialist.

• Provide microbiology showing P. aeruginosa and susceptibility where applicable.
• Include recent FEV1 (25–75% predicted) and documentation excluding Burkholderia cepacia.

Kineret PA requirement

Kineret (anakinra) requires prior authorization for indicated uses; providers must document the diagnosis and prerequisite therapy failures or intolerances as specified (e.g., for RA, inadequate response or intolerance to two specified prior therapies) and include specialist prescriber/consultation.

• Document diagnosis and trials of required prior therapies (or rationale why trials are inappropriate).
• Include rheumatology prescriber or consultation when indicated.

Exenatide PA requirement

Exenatide prior authorization requires documentation confirming type 2 diabetes (chart notes or labs) and inadequate response or intolerance to a minimum 90-day supply of two preferred GLP‑1 receptor agonists (examples: Ozempic, Trulicity, Rybelsus, Mounjaro, liraglutide).

• Provide A1C ≥6.5% or FPG ≥126 mg/dL (or OGTT criteria) to confirm diagnosis.
• Document two 90-day trials of preferred GLP‑1 agents and reason for inadequate response or intolerance.

Nexletol/Nexlizet PA requirement

Nexletol/Nexlizet prior authorization requires documentation of HeFH or primary hyperlipidemia and LDL‑C thresholds after at least an 8‑week trial of moderate‑intensity statin (or documented statin intolerance), plus adjunctive ezetimibe therapy (≥8–12 weeks) or documented contraindication; include current LDL‑C value.

• Provide LDL‑C value from within the last 120 days and documentation of ≥8‑week statin trial or statin intolerance.
• Document at least 8–12 weeks of ezetimibe use or reason ezetimibe is not appropriate.

General PA acceptance criteria

Approve prior authorization requests when any of the general acceptance criteria are met: FDA‑approved indication/regimen, NCCN Drugs & Biologics Compendium Category 1 or 2A, supportive AHFS/Clinical Pharmacology narrative, Micromedex support, Lexi‑Drugs evidence level A, or peer‑reviewed literature support.

• Reference applicable supporting source(s) on the PA request.
• If none apply, provide peer‑reviewed literature or other justification per policy.

PAH prior authorization

PAH therapies require prior authorization with hemodynamic confirmation of PAH (mean PAP >20 mm Hg, PVR >2.0 WU, PCWP or LVEDP ≤15 mm Hg) documented by right‑heart catheterization or echocardiography; prescriber must be a cardiologist or pulmonologist; initial coverage is typically 6 months with continuation 12 months when stabilization or improvement is shown.

• Attach right‑heart catheterization or echocardiography reports showing required hemodynamics.
• Document WHO Group PAH diagnosis and NYHA Functional Class II–IV and specialist prescriber/consultation.

PCSK9 prior authorization

PCSK9 inhibitor requests (e.g., Praluent, Repatha) require prior authorization documenting the diagnosis (HLA/ASCVD/HoFH), LDL‑C values after ≥8‑week moderate‑intensity statin trial (or statin intolerance), and other lipid‑lowering therapy as applicable; initial duration commonly 6 months.

• Provide LDL‑C post‑statin value and documentation of statin trial or intolerance.
• For HoFH include untreated/treated LDL thresholds and evidence of other lipid therapies.

RINVOQ cGVHD prior authorization

RINVOQ (for chronic graft‑versus‑host disease) prior authorization requires diagnosis of cGVHD and inadequate response or intolerance to two or more systemic therapies; include that the request is prescribed by or in consultation with a hematologist/oncologist or transplant‑experienced physician; coverage is typically 12 months.

• Document prior systemic therapy trials and dates, and current cGVHD status.
• Include specialty prescriber or consultation and evidence of inadequate response.

SIGNIFOR prior authorization

SIGNIFOR (pasireotide) prior authorization for pituitary Cushing’s disease requires documentation that pituitary surgery is not an option or was not curative and that treatment is prescribed by or in consultation with an endocrinologist; coverage duration is typically 12 months.

• Provide surgical history and rationale why surgery is not an option or not curative.
• Include endocrinology prescriber or consultation.

TRACLEER prior authorization

Tracleer (bosentan) prior authorization for PAH requires documentation of PAH with hemodynamic confirmation and specialist prescribing; initial approval is typically 6 months with continuation 12 months contingent on demonstrated stabilization or improvement.

• Attach diagnostic hemodynamics and specialist prescriber/consultation.
• Document clinical response for reauthorization.

TAVNEOS prior authorization

TAVNEOS prior authorization for severe active ANCA‑associated vasculitis requires diagnosis documentation, use as adjunct to standard therapy including glucocorticoids, and concurrent immunosuppressant therapy with cyclophosphamide or rituximab; initial approval typically 6 months.

• Document BVAS or other disease activity measures and concurrent immunosuppressant use.
• Include prescriber specialty (nephrology, pulmonology, or rheumatology) on the request.

PAH products PA requirement

Prior authorization is required for PAH‑targeted products; initial approvals are commonly 6 months and continuation 12 months when diagnostic catheterization/echocardiography criteria and specialist oversight are documented.

• Provide right‑heart catheterization or echo with required hemodynamics.
• Confirm cardiology/pulmonology prescriber or consultation.

IBD products PA requirement

Crohn’s disease and ulcerative colitis agents require prior authorization documenting inadequate response or intolerance to the specified biologics/JAK inhibitors (usually two agents) or documentation that induction IV therapy was given when Entyvio is being used as maintenance; include gastroenterology prescriber or consultation.

• List prior biologic/JAK trials with dates and reasons for failure/intolerance.
• If maintenance after IV induction, document induction dosing and timing.

IMFA (Xolair) prior authorization

Omalizumab (Xolair) prior authorization for IgE‑mediated food allergy (IMFA) requires documentation of diagnosis and clinical history (including prior severe allergic response/anaphylaxis), baseline serum total IgE and body weight for dosing, and that therapy will be used in conjunction with food allergen avoidance.

• Provide baseline serum total IgE and patient weight.
• Document history of severe allergic reaction/anaphylaxis and food avoidance plan.

Sodium oxybate prior authorization

Sodium oxybate prior authorization for cataplexy or excessive daytime sleepiness requires diagnostic confirmation by polysomnography (PSG) or multiple sleep latency testing (MSLT) or documented justification if testing is not feasible; for EDSN adults, document inadequate response or intolerance to modafinil or armodafinil prior to sodium oxybate.

• Attach PSG or MSLT reports or prescriber justification if testing not feasible.
• For EDSN in adults, include documentation of modafinil/armodafinil trial and failure or intolerance.

Miglustat (ZTALMY entry) prior authorization

Miglustat (ZTALMY entry) prior authorization requires documentation of mild‑to‑moderate Type 1 Gaucher’s disease and that enzyme replacement therapy is not an option due to allergy, hypersensitivity, or poor venous access; member must be ≥18 years.

• Provide diagnosis of T1GD and rationale why enzyme replacement therapy is not feasible.
• Include age verification (≥18 years).

Step therapy is used for some indications

Step therapy is used for many indications: providers must document inadequate response or intolerance to the specified prior agents (often two agents or named alternatives) before the requested product will be approved, unless documentation shows trials are inappropriate.

• List prior agents tried with dates, doses, and reason for failure or intolerance.
• If trials are inappropriate, provide clinical justification.

PJIA step therapy

For polyarticular juvenile idiopathic arthritis (PJIA), initial therapy prior authorization requires inadequate response or intolerance to two agents (examples include Orencia or Rinvoq) or documentation that a trial is inappropriate; document prior agent trials and include rheumatology prescriber/consultation.

• Provide documentation of two prior agent trials with dates and outcomes.
• Include rheumatology prescriber or consultation.

Biologic step therapy

Many biologic agents require step therapy: prior inadequate response or intolerance to the specified prior agents (commonly two TNF/biologic agents or methotrexate where noted) must be documented before approval; concurrent biologic therapy is excluded.

• Document prior biologic and DMARD trials with dates and reasons for failure.
• Do not prescribe concurrently with other biologic DMARDs per exclusion.

Exenatide step therapy

Exenatide step therapy requires failure or inability to tolerate two preferred GLP‑1 receptor agonists, each for a minimum 90‑day supply, before exenatide will be approved; include documentation of those trials.

• Document two 90‑day trials of preferred GLP‑1 agents and reasons for failure/intolerance.
• Provide diabetes diagnostic evidence (A1C or fasting glucose) as specified.

Nexletol/Nexlizet step requirements

Nexletol/Nexlizet step requirements: document prior statin therapy and at least 8–12 weeks of ezetimibe (depending on product) prior to approval, and include LDL‑C values demonstrating thresholds as required.

• Attach LDL‑C values after statin trial and ezetimibe trial duration.
• Document statin intolerance if relevant.

DMARD prerequisite for biologics

For many rheumatologic biologics, providers must document prior DMARD trial/failure (e.g., methotrexate, hydroxychloroquine, leflunomide, azathioprine, sulfasalazine) before biologic therapy is authorized; include specialist prescriber/consultation.

• List DMARD trials with doses and dates and reasons for inadequate response.
• Include rheumatology prescriber or consultation.

Therapy prerequisites for hematology agents

Hematology agents (e.g., eltrombopag/Promacta) require documentation of prior therapies—such as corticosteroids, immune globulin, splenectomy—or other indicated treatments and baseline laboratory values (e.g., platelet counts) prior to authorization.

• Provide baseline platelet count and prior therapy history with dates.
• Document indication‑specific laboratory thresholds (e.g., platelet <30,000/mcL for ITP).

REZDIFFRA step therapy

REZDIFFRA (Rexulti entry) step therapy requires prior inadequate response or intolerance to specified alternative antipsychotics (schizophrenia: two agents; MDD adjunct: aripiprazole and quetiapine); document prior trials.

• Provide names, durations, and outcomes of prior antipsychotic trials.
• For MDD adjunct, document trials of aripiprazole and quetiapine.

TALTZ step therapy

TALTZ and related biologics require documented inadequate response or intolerance to specified biologics or DMARDs (usually two agents) for psoriasis, psoriatic arthritis, ankylosing spondylitis and nr‑axSpA prior to approval; include specialist prescriber/consultation.

• Document prior biologic/DMARD trials (names, dates, reasons for failure).
• Include dermatology or rheumatology prescriber/consultation as applicable.

Prior biologic/JAK failures required

Many immunologic and biologic agents require documented inadequate response or intolerance to prior biologic or JAK therapies (often two agents) before initial approval; providers must list prior biologic/JAK failures with dates and rationale.

• List prior biologic and/or JAK inhibitor trials and objective evidence of inadequate response or intolerance.
• If trials are inappropriate, include clear clinical justification.

Step therapy for sodium oxybate

For sodium oxybate (EDSN adults), prior authorization requires documentation of inadequate response or intolerance to modafinil or armodafinil before approval; for cataplexy and EDSN provide PSG/MSLT confirmation or prescriber justification if testing is not feasible.

• Attach PSG/MSLT or prescriber justification if unavailable.
• Document modafinil/armodafinil trial and failure for adult EDSN.

When a drug has 'PA' in the Formulary Requirements column providers must follow criteria

When a drug has "PA" in the Formulary Requirements column, providers must follow the criteria in this policy and supply required medical information such as diagnosis, prior therapies, prescriber consultation, and any specified supporting labs or test results.

• Ensure all requested supporting documentation (labs, imaging, procedure reports) is included with the PA submission.
• Use the product‑specific required medical information section in this document to confirm what to attach.

Baseline labs for Epidiolex

Epidiolex initiation requires baseline CBC, serum transaminases, and total bilirubin prior to starting therapy; requests should also document prior anticonvulsant trials and neurologist involvement.

• Attach baseline CBC, AST/ALT, and total bilirubin results.
• Document trial of at least one specified anticonvulsant (e.g., clobazam) and neurologist prescriber/consultation.

Diagnostic confirmation and monitoring for UCD

For UCD therapies (sodium phenylbutyrate), providers must document diagnostic confirmation by enzymatic, biochemical, or genetic testing and demonstrate inadequate response to dietary protein restriction or amino acid supplementation; reauthorization requires monitoring of plasma ammonia or amino acid levels and evidence of concomitant dietary management.

• Include confirmatory enzymatic/biochemical/genetic test results.
• Provide baseline and follow‑up plasma ammonia or amino acid levels for reauthorization and documentation of dietary measures.

UCD required documentation

For UCD initial requests include documentation of the diagnosis confirmed by enzymatic, biochemical, or genetic testing and that dietary protein restriction or amino acid supplementation was tried and found inadequate.

• Attach testing confirming CPS/OTC/ASS deficiency.
• Provide evidence of dietary management attempts and outcomes.

Growth hormone required documentation

Growth hormone therapy requests must include indication‑specific documentation such as height/height SDS, growth velocity, bone age, and abnormal provocative testing where required; prescriber should be an endocrinologist and reauthorization typically requires annual endocrinology re‑evaluation.

• Provide height SDS, growth velocity data, bone age study, and provocative test results when applicable.
• Include endocrinology prescriber/consultation and annual re‑evaluation documentation.

JYNARQUE baseline labs

JYNARQUE initiation requires baseline liver transaminases and bilirubin prior to starting therapy; include nephrology or transplant specialist prescriber/consultation documentation as required.

• Attach baseline AST/ALT and total bilirubin labs.
• Document prescriber specialty (nephrologist) and indication for ADPKD.

Required clinical documentation (example)

Provide required clinical documentation for products such as Kineret: for RA initial requests include diagnosis and documentation of inadequate response or intolerance to two specified prior therapies (examples listed) and rheumatology prescriber involvement.

• List specific prior therapies tried with dates and outcomes.
• Include rheumatology prescriber or consultation.

Required clinical documentation for CMV

For CMV treatment with Livtencity, include documentation of CMV diagnosis, transplant status, prior inadequate response to at least one prior therapy (e.g., oral valganciclovir), and pediatric weight/age criteria when applicable; prescriber should be a transplant/infectious disease/oncology specialist.

• Provide transplant type/status and prior antiviral therapy documentation.
• For pediatric members ≥12 years, include weight ≥35 kg if applicable.

PAH required documentation

PAH requests must include documentation of WHO Group PAH, NYHA Functional Class II–IV, and diagnostic confirmation by right‑heart catheterization or echocardiography with mean PAP, PVR, and PCWP/LVEDP values attached.

• Attach right‑heart catheterization or echocardiography reports with hemodynamic values (mean PAP >20 mm Hg, PVR >2.0 WU, PCWP/LVEDP ≤15 mm Hg).
• Document NYHA Functional Class and treating cardiologist/pulmonologist.

Hyperlipidemia required documentation

For hyperlipidemia/ASCVD PCSK9 requests, providers must supply diagnosis evidence and LDL‑C values obtained after ≥8 weeks of a moderate‑intensity statin (or documentation of statin intolerance) and any additional lipid‑lowering therapy information relevant to HoFH.

• Provide LDL‑C result after ≥8‑week statin trial and documentation of statin intolerance if claimed.
• Include information on other lipid‑lowering therapies used.

Thrombocytopenia / aplastic anemia documentation

For thrombocytopenia/aplastic anemia requests (e.g., eltrombopag/Promacta), include baseline platelet counts, prior therapy history (corticosteroids, IVIG, splenectomy), and laboratory criteria relevant to the indication.

• Attach baseline platelet count and prior treatment documentation.
• Document indication‑specific lab thresholds for reauthorization.

CF genotype documentation

For CF therapies such as Trikafta or Orkambi, providers must include documented CF diagnosis and CFTR genotype demonstrating at least one F508del mutation (or an FDA‑cleared CF mutation test when genotype is unknown); for inhaled antibiotics include FEV1 and microbiology evidence.

• Attach CFTR genotype test results or FDA‑cleared mutation test.
• Provide FEV1 values and microbiology evidence of Pseudomonas where applicable.

AAT deficiency documentation

For alpha‑1 antitrypsin (AAT) deficiency, include medical records confirming congenital AAT deficiency by genotype (e.g., PiZZ) and low serum AAT concentration (examples of thresholds are in the policy) plus clinical evidence of chronic emphysema.

• Provide genotype documentation and serum AAT concentration (e.g., <80 mg/dL radial immunodiffusion or other listed thresholds).
• Include clinical evidence of chronic emphysema without AAT‑related liver disease.

PAH diagnostic confirmation required

Right‑heart catheterization or echocardiography reports showing mean pulmonary arterial pressure, PVR, and pulmonary capillary wedge pressure/LVEDP must be attached to PAH requests to confirm hemodynamic criteria.

• Attach the actual catheterization or echo report with numeric hemodynamic values.
• If echo is used, include interpretation supporting PAH diagnosis.

Hyponatremia documentation

For hyponatremia (tolvaptan) requests, include serum sodium values meeting policy thresholds (<125 mEq/L or 125–134 mEq/L with symptoms), documentation that treatment was initiated or re‑initiated in a hospital within the past 30 days, and prior inadequate response to conservative measures.

• Provide recent serum sodium measurements and documentation of hospital initiation if applicable.
• Describe prior conservative measures tried and outcomes.

PAH testing documentation

For PAH testing documentation, attach the right‑heart catheterization or echocardiography report showing mean PAP, PVR and PCWP/LVEDP to support the diagnosis and meet hemodynamic thresholds required by policy.

• Include numeric hemodynamic values and date of testing.
• Document treating cardiologist/pulmonologist interpretation where available.

Trikafta genotype documentation

For Trikafta, provide CFTR genotype documentation showing at least one F508del mutation or an FDA‑cleared CF mutation test if genotype is unknown; include pulmonology/CF center prescriber information.

• Attach CFTR genotype test report or FDA‑cleared mutation test.
• Include prescriber specialty and clinical rationale.

Vowst testing and prep documentation

Vowst prior authorization requires documentation of at least two prior recurrent CDI episodes within 12 months, a positive stool test for C. difficile toxin or toxigenic C. difficile, completion of at least 10 days of oral vancomycin or fidaxomicin within 2–4 weeks prior, and completion of the recommended bowel prep before administration.

• Attach stool toxin or toxigenic C. difficile test and records of prior CDI episodes.
• Provide antibiotic treatment dates and bowel prep completion evidence.

Required documentation for IMFA (initial)

For Xolair IMFA initial requests, include diagnosis and clinical history of IgE‑mediated food allergy, documentation of prior severe allergic response (including anaphylaxis if present), baseline serum total IgE level, and body weight for dosing calculations.

• Provide baseline serum total IgE and weight used to determine dosing.
• Document history of severe allergic reactions and confirm therapy is used with allergen avoidance.

Required documentation for sodium oxybate

For sodium oxybate requests include diagnostic confirmation by PSG or MSLT (or prescriber justification if testing is not feasible); for EDSN adults, document inadequate response or intolerance to modafinil/armodafinil. Reauthorization requires evidence of efficacy and yearly reevaluation.

• Attach PSG/MSLT or prescriber justification.
• Document modafinil/armodafinil trial and the clinical response to sodium oxybate for reauth.

Required documentation for miglustat

For miglustat in Type 1 Gaucher’s disease, document diagnosis of mild‑to‑moderate T1GD and that enzyme replacement therapy is not an option due to allergy, hypersensitivity, or poor venous access; reauthorization requires documentation of positive clinical response.

• Provide documentation that ERT is not feasible and that the patient meets T1GD diagnostic criteria.
• Include objective evidence of clinical response for reauthorization.

Failure to obtain prior authorization may result in plan not covering drug

Failure to obtain prior authorization may result in the plan not covering the drug; providers should submit PA requests and required documentation before dispensing to avoid denial of coverage.

• Submit PA prior to dispensing when "PA" is indicated on the Formulary.
• If urgent, contact the plan per instructions in this document for assistance.

Concurrent biologic therapy exclusion

Concurrent therapy with other biologic DMARDs or tumor necrosis factor antagonists is an exclusion for many biologic products; prescribing a biologic concurrently with another biologic will likely result in denial.

• Do not authorize or document concurrent biologic DMARD use for products that list this exclusion.
• If clinically necessary, provide rationale why concurrent therapy is required and any supporting evidence.

Seizure / renal impairment exclusion (dalfampridine)

Dalfampridine is excluded for members with a history of seizure or moderate to severe renal impairment (CrCL ≤ 50 mL/min); ensure absence of these contraindications before requesting PA.

• Document absence of seizure history and report current renal function (CrCL >50 mL/min).
• Attach relevant neurology consult or labs if available.

Urea Cycle Disorder documentation

Requests for UCD therapies that lack confirmatory enzymatic, biochemical, or genetic testing for CPS/OTC/ASS deficiencies or that fail to document inadequate response to dietary measures risk denial.

• Attach confirmatory testing results and documentation of dietary interventions tried.
• Provide plasma ammonia or amino acid levels when available.

Cystic Fibrosis eligibility for TOBI PODHALER

TOBI PODHALER requests without evidence of Pseudomonas aeruginosa in the lungs, without FEV1 between 25%–75% predicted, or with Burkholderia cepacia colonization may be denied; include microbiology and spirometry data.

• Provide microbiology confirming P. aeruginosa and FEV1 values.
• Document absence of Burkholderia cepacia colonization.

Immune globulin documentation

Immune globulin therapy requests missing diagnosis‑specific criteria (e.g., inadequate response to conventional therapy, platelet thresholds, IgG levels) may be denied; include indication‑specific lab values and prior treatment history.

• Attach baseline IgG or platelet counts and prior therapy documentation.
• Provide specialty prescriber consultation when indicated (hematology, immunology).

Concurrent biologic therapy exclusion (Kineret)

Some biologics (e.g., Kineret) exclude concurrent therapy with any other biologic DMARD; requests that include concurrent biologics risk denial unless a clear, documented exception applies.

• Do not list concurrent biologic DMARDs on the PA request for affected products.
• If concurrent therapy is claimed to be necessary, provide detailed clinical justification.

Concurrent immunosuppressive therapy exclusion

Concurrent use of other biologic DMARDs, JAK inhibitors, or potent immunosuppressants (e.g., azathioprine, cyclosporine) is an exclusion for certain products (e.g., Olumiant); document that such concurrent immunosuppression is not being used.

• State clearly on the request whether concurrent immunosuppressants are being used.
• If concurrent immunosuppression is present, provide justification per policy.

PAH diagnostic confirmation

Lack of documentation confirming PAH diagnosis by right‑heart catheterization or echocardiography (including mean PAP >20 mm Hg, PVR >2.0 WU, and PCWP/LVEDP ≤15 mm Hg) may lead to denial of PAH therapy requests.

• Attach catheterization/echo reports with numeric hemodynamics.
• Document WHO Group PAH and NYHA Functional Class II–IV.

LDL-C / statin trial documentation

For lipid‑lowering therapies, absence of documented LDL‑C thresholds after an adequate trial of moderate‑intensity statin (minimum 8 weeks) or missing evidence of statin intolerance may trigger denial.

• Provide LDL‑C values after ≥8 weeks of statin therapy.
• If statin intolerance is claimed, include documentation per policy definitions.

REPLACED/REXULTI (chunk 90)

REPLACED/REXULTI product exclusions: requests for the product in chunk 90 may be denied if the member has IgA deficiency with known anti‑IgA antibody or is an active smoker; confirm these conditions are absent.

• Document IgA status and smoking status in the medical record.
• If either condition exists, provide clinical rationale if requesting an exception.

sildenafil (chunk 95)

Sildenafil products (for PAH or Raynaud’s Phenomenon) exclude concurrent nitrate use; providers must confirm the member is not taking nitrates to avoid denial.

• Document current medications and explicitly confirm absence of nitrates.
• If nitrates are necessary, explain clinical justification (note: policy exclusion applies).

tadalafil (chunk 99)

Tadalafil products used for BPH exclude concurrent nitrates; document medication list to confirm no nitrate use before requesting PA for tadalafil in BPH.

• Provide current medication list and state no nitrates are being used.
• If nitrates are present, include clinical rationale (may not meet policy criteria).

Biologic DMARD concurrency exclusions (chunks 96,109)

Concurrent use of other biologic DMARDs or TNF antagonists is an exclusion for multiple agents (chunks 96,109); documenting concurrent biologic therapy will generally result in denial unless policy allows an exception.

• Do not request concurrent biologic DMARD therapy for excluded products.
• If concurrent therapy is clinically necessary, provide detailed justification and supporting evidence.

PAH diagnostic confirmation required

PAH therapies require diagnostic confirmation by right‑heart catheterization or echocardiography with hemodynamic parameters (mean PAP >20 mm Hg, PVR >2.0 WU, PCWP/LVEDP ≤15 mm Hg); lack of these data may trigger denial.

• Attach diagnostic hemodynamic testing reports with numeric values.
• Document specialist prescriber involvement and functional class.

Vowst prerequisites

Vowst requests lacking documentation of at least two prior recurrent CDI episodes within 12 months, a positive stool test for C. difficile toxin, completion of the required antibiotic course (vancomycin or fidaxomicin), and bowel prep may be denied.

• Provide stool toxin test and history of two or more recurrent CDI episodes within 12 months.
• Attach records showing completion of the indicated antibiotic course and bowel prep.

Xolair concurrent biologic exclusion

Xolair (omalizumab) excludes concurrent use of other biologic agents for asthma/allergic conditions (e.g., benralizumab, dupilumab, mepolizumab); requests documenting concurrent biologics may be denied.

• Confirm no concurrent biologic therapy for asthma/allergic conditions when requesting Xolair.
• If concurrent therapy exists, provide detailed clinical justification.

Sodium oxybate exclusion that may trigger denial

Concurrent use of sedative hypnotics and alcohol is an exclusion for sodium oxybate and may trigger denial; confirm absence of sedative hypnotic use and counsel patients accordingly.

• Document medication list (sedative hypnotics) and alcohol use status.
• If present, provide justification for exception (policy exclusion applies).

Infusion / specialist oversight

Infusion‑capable or specialist‑supervised settings are expected for many specialty therapies; PAH therapies in particular require specialist oversight though site restrictions are not explicitly limited in the excerpt.

• Prescriber specialty required (cardiologist/pulmonologist)

Hospital outpatient / recent inpatient initiation

Some therapies require initiation in or shortly after a hospital stay (e.g., tolvaptan requires treatment initiated or re‑initiated in hospital within the past 30 days), so providers should document recent inpatient initiation when applicable.

• Prescriber: cardiologist, endocrinologist, or nephrologist for hyponatremia/tolvaptan