Blue Cross Blue Shield SC Part D Prior Auth Criteria | OpenPayer
CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A
2026 Pdp Pa Criteria
Part D prior authorization criteria for multiple drugs/products, specifying indications, required medical information, prescriber restrictions, coverage durations, prerequisite Part D drug requirements, age restrictions, and other criteria for initial and reauthorization approvals. This extraction covers Part 1 of 12 of the full document.
Policy Summary
PayerBlue Cross Blue Shield - South Carolina
Policy2026 Pdp Pa Criteria
Policy CodePolicy N/A
Change TypeN/A
Effective DateJun 1, 2026
Next Review DateN/A
Key ActionProviders must submit indication-specific documentation (diagnosis, prior trials/failures, mutation/test results, lab thresholds, and evidence of symptomatic disease or response) to support prior authorization for the listed drugs.
No material clinical or coverage changes in this brief (has_material_change = false).
14Formulary version
2026-06-01Effective date
12 moTypical coverage duration
VariedCoverage durations varied
SeveralPrerequisite Part D drug required
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SomeSpecialist prescriber required
Coverage Summary
This Part D prior authorization (PA) policy excerpt (Part 1 of 12) compiles PA criteria across multiple therapeutic areas including oncology, rheumatology, pulmonology, neurology, infectious disease, hematology, and dermatology. For each product the policy enumerates the medically‑accepted indications, the required medical information (diagnosis, tests, prior therapy trials and durations), prescriber or specialist requirements, age limits when specified, coverage durations for initial approvals and reauthorizations (commonly 12 months though some initial approvals are shorter), reauthorization requirements that generally require documentation of a positive clinical response, and whether a prerequisite Part D drug trial is required.
Formulary metadata
Formulary ID26220
Version14
Effective Date2026-06-01
Policy statusCURRENT
Last Updated2026-05-01
Scope summaryPart D prior authorization criteria for multiple specialty drugs listing indications, required medical information (diagnoses, test results, prior therapy trials), prescriber restrictions, age limits, coverage durations (initial and reauth), and prerequisite Part D drug requirements.
Initial Therapy Criteria (selected products)
Adempas (initial therapy for PAH and CTEPH)
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization OR patient is currently on therapy for PAH.
Prescriber is a cardiologist, pulmonologist, or PAH specialist, or therapy is prescribed in consultation with one of these specialists.
Operational: documentation of specialist consultation required if not prescriber.
Indication-specific
PAH: functional class II-IV symptoms; evidence of disease severity (eg, 6-minute walk test, imaging, biomarkers).
Reauthorization requirement nodes (documentation of positive clinical response or specified lab/clinical measures).
Adalimumab products - reauth by indication: Reauth criteria vary by indication: RA/PJIA: evidence of positive clinical response (eg reduction in total active joint count or symptom improvement). PsA: positive clinical response evidenced by reduction in joint count, symptom improvement, or BSA reduction. HS: reduction in abscess/inflammatory nodule count or symptom improvement. Uveitis, PsO, AS, CD/UC: demonstration of positive clinical response (eg mucosal healing, lab improvement, decreased BSA). Coverage reauth commonly 12 months.
Alyq/Adempas/Sildenafil/Ventavis - PAH reauth: Reauth criterion: Patient demonstrates positive clinical response to therapy (applies to PAH agents including Alyq, Adempas, Sildenafil, Bosentan, Ventavis). Coverage reauth generally 12 months after initial 6-month period.
Diagnosis confirmation by right heart catheterization may be required per initial criteria.
Arikayce - reauth:
Exclusions / Not Covered / Special Denials
Explicit exclusions and denial/exclusion statements
Explicit exclusions or 'will not be approved' statements drawn from policy.
Pyrimethamine - malaria exclusion: Requests for coverage of pyrimethamine for the treatment and/or prophylaxis of malaria are not authorized and will not be approved; CDC does not recommend use for malaria.
Quinine Sulfate - exclusion for nocturnal leg cramps: Use of quinine sulfate excluded if used solely for the treatment or prevention of nocturnal leg cramps. Requests for malaria treatment have specified prerequisites; coverage limited to malaria per sensitivity/resistance contexts and duration 7 days.
Xolair - restrictions/contraindications applied: Certain contraindications and prerequisites apply (e.g., IgE thresholds, age limits); reauth requires demonstration of clinical response. Not an approval for uses outside documented IgE-mediated pathways. Specific safety or combinational exclusions noted in product branches (eg not to be combined with other specified therapies as indicated).
Providers must submit indication‑specific documentation to support prior authorization requests: diagnosis, relevant labs/tests (e.g., genetic/mutation test reports, right‑heart catheterization for PAH, AAT phenotype and serum level, sleep study results), prior therapy trials and durations, and specialist consultation notes when required. Follow the drug entry-specific requirements (coverage durations, reauthorization evidence) in the Part D policy.
Document diagnosis and indication‑specific clinical criteria listed for the drug.
Attach required test results (mutation panels, HRCT/biopsy, lab thresholds, sleep studies) where specified.
Provide prior trial/failure/contraindication/intolerance evidence for prerequisite therapies.
Include specialist prescribing/consultation notes when the policy requires (eg, rheumatology, gastroenterology, pulmonology, hematology/oncology, neurology).
Nexletol / Nexlizet LDL-C thresholdsLDL-C within last 120 days: >=55 mg/dL with ASCVD; >=70 mg/dL without ASCVD
Jynarque (tolvaptan) monitoringALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for first 18 months; if on >18 months then at least every 3 months
Background
This Part D policy section compiles PA criteria for numerous medications across therapeutic areas. For each product the policy specifies the approved indications, the required supporting medical information (diagnosis, laboratory or genetic test results, prior therapy trials), any prescriber or specialist consultation requirements, applicable age restrictions, the coverage durations for initial and reauthorization periods, reauthorization evidentiary standards (typically documentation of positive clinical response), and a product‑specific flag indicating whether a prerequisite Part D drug trial is required.
Revision History
Definitions & Document Notes
Glossary — key definitions used in these extracted PA criteria: TF/C/I = trial and failure, contraindication, or intolerance; BSA = body surface area; CDAI = Crohn's Disease Activity Index; CLIA = Clinical Laboratory Improvement Amendments; FDA‑approved or CLIA‑certified test = laboratory/molecular tests performed with FDA clearance or at CLIA‑certified facilities; Prerequisite Part D drug = a required prior Part D medication trial that must be documented before approval; Reauth = reauthorization — continued approval contingent on documentation of positive clinical response to therapy. This extraction covers Part 1 of 12 of the full policy as noted in the scope summary.
Policy Summary
PayerBlue Cross Blue Shield - South Carolina
Policy2026 Pdp Pa Criteria
Policy CodePolicy N/A
Change TypeN/A
Effective DateJun 1, 2026
Next Review DateN/A
Key ActionProviders must submit indication-specific documentation (diagnosis, prior trials/failures, mutation/test results, lab thresholds, and evidence of symptomatic disease or response) to support prior authorization for the listed drugs.
Chronic thromboembolic pulmonary hypertension (CTEPH): documented diagnosis and consideration for pulmonary thromboendarterectomy or balloon pulmonary angioplasty with documentation of inoperability or residual/recurrent PH after surgery.
ALL of the following
For PAH: documentation of baseline WHO functional class and baseline 6-minute walk distance (if available).
For CTEPH: documentation of prior surgical evaluation and reason deemed inoperable or residual symptomatic disease after surgery.
No contraindications to therapy and no significant drug interactions documented.
Everolimus (tablets 2.5/5/7.5/10 mg and Everolimus TBSO) - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of a condition for which everolimus tablets are indicated (eg, certain solid tumors, neuroendocrine tumors, renal cell carcinoma) — specify diagnosis.
Prescriber is an oncologist, hematologist, or specialist appropriate to the diagnosis.
Formulation-specific
Everolimus tablets (2.5 mg, 5 mg, 7.5 mg, 10 mg): dosing consistent with FDA-approved indication and appropriate for body surface area/weight as applicable.
Everolimus TBSO (tumor biopsy/soluble oral formulation) where applicable: documented rationale why tablet formulation is not appropriate or unavailable.
ALL of the following
Documentation of prior therapies tried and reason for change if applicable (eg, progression on prior therapy, intolerance).
Baseline laboratory values appropriate to monitoring (eg, CBC, renal and hepatic function) are provided.
Covered when ALL of the following criteria are met for initial therapy:
ALL of the following
Diagnosis of alpha-1 antitrypsin deficiency with emphysema and serum alpha-1 antitrypsin level consistent with deficiency (eg, phenotype and quantitative level as documented).
Prolastin-C (INJ 1000 mg/20 mL) is prescribed by or in consultation with a pulmonologist or specialist experienced in AAT deficiency management.
Patient demonstrates emphysema attributable to AAT deficiency and is on appropriate supportive therapy (eg, smoking cessation, bronchodilators, vaccinations, pulmonary rehabilitation as indicated).
No contraindications to augmentation therapy documented.
ALL of the following
Baseline pulmonary function testing (eg, FEV1) and radiographic evidence of emphysema provided.
Dosing consistent with product labeling and monitoring plan in place (eg, infusion logistics, adverse effect monitoring).
Dalfampridine ER (initial therapy for MS-related walking difficulty)
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of multiple sclerosis (MS) with walking difficulty manifested as measurable impairment (eg, reduced timed 25-foot walk or other validated walking assessment).
Trial and inadequate response, contraindication, or intolerance to at least one disease-modifying therapy for MS when clinically appropriate, unless contraindicated.
Dalfampridine ER is prescribed to improve walking speed and patient has baseline ambulatory assessment to allow for evaluation of benefit.
No history of seizure disorder or renal impairment (creatinine clearance below product-recommended threshold).
ALL of the following
Prescriber documents plan to assess and document objective improvement in walking (eg, timed walk) within defined follow-up period.
Dosing consistent with product labeling and renal function monitoring planned.
Ayvakit (initial therapy for GIST and mastocytosis)
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of gastrointestinal stromal tumor (GIST) or systemic mastocytosis as applicable per FDA labeling or guideline-supported use.
For GIST: molecular testing confirming KIT or PDGFRA mutation status where relevant and prescriber is an oncologist.
For mastocytosis: documentation of disease burden and symptoms consistent with indication and prescriber is an appropriate specialist (eg, hematologist, allergist/immunologist).
Dosing and intent (eg, line of therapy) consistent with FDA-approved labeling or guideline-supported use for Ayvakit.
ALL of the following
Documentation of prior therapies tried and reasons for change if applicable.
Baseline labs and monitoring plan appropriate to Ayvakit therapy provided.
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of BRAF V600E-mutant metastatic colorectal cancer or other FDA-approved indication for encorafenib (Braftovi) in combination as specified by the indication.
Molecular testing confirming BRAF V600E mutation where required by the indication.
Prescriber is an oncologist and planned use is consistent with guideline-recommended combination regimens (eg, with cetuximab where indicated).
Dose requested corresponds to available product strength (Braftovi CAPS 75 mg) and regimen matches prescribing information.
ALL of the following
Documentation of prior therapies and line of therapy as applicable; rationale for use documented.
Baseline labs and monitoring plan consistent with safety profile (eg, hepatic function).
Brukinsa (zanubrutinib) - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis for which Brukinsa (zanubrutinib) is indicated (eg, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, or other approved hematologic malignancy).
Prescriber is a hematologist/oncologist experienced in treating the specific malignancy.
Dosing consistent with the FDA-approved indication and product labeling.
Documentation of prior therapies where required by the indication (eg, relapsed/refractory disease) or rationale for frontline use if applicable.
ALL of the following
Baseline labs (CBC, hepatic function) and infection risk assessment documented; monitoring plan in place.
Caplyta (lumateperone) - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of schizophrenia in adults or bipolar depression per FDA-approved indications for Caplyta (lumateperone) or other approved psychiatric indications where applicable.
Prescriber is a psychiatrist or mental health specialist, or therapy is initiated in consultation with one.
Documentation of prior adequate trial(s) of standard therapies when guideline-recommended unless contraindicated or not tolerated, with rationale for using lumateperone.
ALL of the following
Baseline assessment of psychiatric status and monitoring plan for metabolic and extrapyramidal side effects documented.
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of medullary thyroid cancer or other FDA-approved indication for Caprelsa (vandetanib).
Prescriber is an oncologist or endocrinologist experienced in thyroid cancers.
Baseline ECG and corrected QT interval, electrolytes, and blood pressure documented given risk of QT prolongation; monitoring plan in place.
Dosing consistent with product labeling and rationale for initiation documented (eg, unresectable, metastatic disease).
ALL of the following
Documentation of prior therapies if applicable and reasons for selecting vandetanib.
Cayston (aztreonam for inhalation) - Initial Therapy (Cystic Fibrosis)
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of cystic fibrosis with Pseudomonas aeruginosa airway infection appropriate for inhaled aztreonam therapy (Cayston).
Prescriber is a pulmonologist or CF specialist or in consultation with one.
Patient is able to use and tolerate inhaled therapy and has no known hypersensitivity to aztreonam or formulation components.
ALL of the following
Microbiologic documentation of Pseudomonas aeruginosa colonization or clinical rationale for empiric inhaled therapy provided.
Plan for monitoring response and adverse effects (eg, bronchospasm) documented; pre-treatment bronchodilator use as indicated.
Cerdelga (eliglustat) - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Diagnosis of Gaucher disease type 1 where eliglustat (Cerdelga) is indicated, or other FDA-approved indication for eliglustat.
Patient is a CYP2D6 metabolizer with genotype testing results documented demonstrating poor, intermediate, extensive, or ultrarapid metabolizer status appropriate for eliglustat dosing, or alternative validated testing per labeling.
Prescriber is a specialist experienced in metabolic/genetic disorders or hematology, and dosing aligns with CYP2D6 metabolizer status.
ALL of the following
Documentation of disease manifestations (eg, splenomegaly, cytopenias, bone disease) and rationale for eliglustat vs enzyme replacement therapy.
Baseline labs and monitoring plan per product labeling provided.
Covered when ALL of the following criteria for initial therapy are met:
ALL of the following
Request for tadalafil tablets (2.5 mg or 5 mg) is for an FDA-approved indication (eg, pulmonary arterial hypertension) with dose and frequency consistent with labeling.
Diagnosis and supporting documentation (eg, right heart catheterization for PAH) provided when indication requires objective confirmation.
Prescriber is appropriate specialist (eg, cardiologist, pulmonologist) or in consultation with specialist when indicated.
ALL of the following
No contraindicated concomitant nitrates or strong CYP3A4 inhibitors without management plan documented.
For plaque psoriasis: documentation of moderate-to-severe disease (eg, BSA >=3% or involvement of scalp, palms/soles, face, or genital areas) and trial/intolerance/contraindication to topical therapies and phototherapy as clinically appropriate.
For PsA and axial spondyloarthritis: documentation of active disease and prior conventional therapy trial where guideline-recommended.
ALL of the following
Cosentyx INJ 125 mg/5 mL specific rules: dosing per label (loading doses then q4w maintenance) and prescriber documents plan for injection training and monitoring; if higher/concentrated presentations requested (eg, prefilled syringe, pen), provide rationale if different from standard presentation.
Cresemba (Isavuconazole) - Initial Therapy
Covered when ALL of the following initial therapy criteria are met:
ALL of the following
Diagnosis appropriate for Cresemba (isavuconazole) per FDA-approved indications (eg, invasive aspergillosis, mucormycosis) with supporting microbiologic or clinical evidence as available.
Prescriber is an infectious disease specialist or equivalent, or therapy initiated in consultation with one for invasive fungal infections.
Dosing and route (IV or oral prodrug) consistent with indication and product labeling; renal/hepatic function reviewed for dose adjustments.
ALL of the following
Documentation of prior antifungal therapy trials if clinically indicated and rationale for selecting isavuconazole provided.
Selected product-level and general initial therapy criteria (Dupixent, Enbrel, and others)
Covered when ALL of the following initial therapy criteria are met (selected biologic and specialty products):
ALL of the following
Dupixent (multiple presentations): diagnosis of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, or other FDA-approved indication with documented disease severity and prior therapy trials per indication-specific requirements.
Enbrel (multiple presentations): diagnosis of rheumatoid arthritis, PsA, AS, plaque psoriasis, or other approved indication with documentation of prior conventional therapy trials when required by indication.
General product-level authorization criteria: prescriber specialty appropriate to diagnosis, documentation of baseline disease severity measures, prior therapy trials or contraindications/intolerances when required, and monitoring plan per product safety profile.
Selected product-specific notes
Mifepristone 300 mg: use consistent with REMS and regulatory requirements; prescriber and dispensing site meet REMS program elements.
Lenvima (multiple strengths): prescriber documents indication, dosing per labeling, and baseline labs (eg, blood pressure monitoring).
Lidocaine topical products: diagnosis appropriate for topical anesthetic use (eg, localized neuropathic pain) and documentation of prior conservative measures when applicable.
Covered when ALL of the following criteria for initial therapy are met (selected oncology, hematology, and specialized agents):
ALL of the following
Piqray, Pemazyre, Piqray (alpelisib), Pemazyre (pemigatinib), Retevmo, Rydapt, Rezlidhia, Rezdiffra, Rezlidhia, etc.: molecular or biomarker testing confirming target alteration as required by the indication (eg, PIK3CA, FGFR2 fusions, RET fusions, FLT3 mutations, IDH1 mutations, NTRK/ROS1 where applicable).
Prescriber is an oncologist/hematologist; dosing and combination therapies align with labeling and guideline recommendations.
Documentation of prior lines of therapy when relevant and rationale for current regimen provided.
ALL of the following
Venclexta (venetoclax) and starting pack: ramp-up schedule documented, TLS risk assessment and prophylaxis plan in place, baseline tumor lysis labs and monitoring plan documented.
Xospata, Xtandi, Xalkori, and other targeted agents: appropriate mutation/biomarker confirmation and prescriber specialty documented.
Selected hepatic, infectious disease, and supportive care agents - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met (selected hepatic, infectious disease, and other agents):
ALL of the following
Mavyret (HCV): genotype-appropriate regimen documented, prescriber is infectious disease/hepatology or specialist, baseline HCV RNA and prior treatment history provided.
Posaconazole (prophylaxis/treatment): indication documented (eg, prophylaxis in neutropenic patients or treatment of invasive fungal infection), prescriber specialty and baseline labs provided.
Repatha (evolocumab): diagnosis (eg, clinical ASCVD, HeFH, HoFH) documented with LDL-C levels and prior lipid-lowering therapy trials per criteria; prescriber is cardiology/primary care or lipid specialist.
ALL of the following
Eltrombopag (ITP, chronic hepatitis C thrombocytopenia, severe aplastic anemia): diagnosis and prior therapy trials documented; baseline labs and monitoring plan per labeling provided.
Selected rare disease, neurology, and other specialty products - Initial Therapy
Covered when ALL of the following criteria for initial therapy are met (selected rare disease, neurology, and other specialty products):
ALL of the following
Pyrukynd (pyruvate kinase activator) for pyruvate kinase deficiency: confirmed diagnosis with genetic testing, baseline hemolysis parameters documented, and prescriber specialty documented.
Pulmozyme (dornase alfa): cystic fibrosis diagnosis with appropriate indication for mucolytic therapy and CF specialist involvement.
Onpattro (patisiran) for hATTR amyloidosis with polyneuropathy: genetic confirmation of transthyretin-mediated amyloidosis, neurologic assessment documenting polyneuropathy severity, and prescriber is neurology or specialty center experienced in hATTR management.
Nuedexta (PBA): diagnosis of pseudobulbar affect secondary to neurological condition and documentation of prior symptomatic management attempts where appropriate.
Reauth: patient demonstrates positive clinical response to therapy for MAC lung disease; continued use subject to 12-month reauthorizations.
Benlysta - reauth: Benlysta reauth (SLE, lupus nephritis): patient demonstrates positive clinical response to therapy. Coverage duration: reauth 6 months typically (init and reauth 6 months listed).
Age and prescriber requirements remain for pediatric dosing.
Brivaracetam/Briviact - reauth: Approve for continuation of prior therapy; coverage duration 12 months; reauth requires documentation of benefit or ongoing need.
Prescriber restrictions (CF center/pulmonologist) often apply for initial and reauth.
Dupixent - reauth (multiple indications): Reauth: indication-specific evidence of positive clinical response (eg AD: reduction in BSA or SCORAD; EoE: symptom and histologic improvement; CRSwNP: symptom or polyp response; asthma: reduction in exacerbations). Coverage reauth commonly 12 months.
Age and specialist prescribing requirements apply per indication.
Emgality/Aimovig/Emgality/Qulipta/Nurtec - migraine reauth: Reauth criteria: patient experienced positive clinical response to CGRP-targeted therapy (reduction in migraine days, decreased use of acute migraine meds). Coverage reauth 12 months; initial preventive typically 6 months.EM >=4 days/month; CM >=8 days/month for initial eligibility as applicable
Medication not used concomitantly with another CGRP inhibitor for prevention.
Empaveli (PNH, C3G/IC-MPGN) - reauth: Reauth: patient demonstrates positive clinical response to therapy; for C3G/IC-MPGN patient continues on maximally tolerated ACEi/ARB/SGLT2 and has not had kidney transplant for primary IC-MPGN. Coverage reauth 12 months.>=12 weeks of ACEi/ARB/SGLT2 prior to initiation required initially
Prerequisite Part D drug required.
Evrysdi - reauth (SMA): Reauth: patient demonstrates positive clinical response; must not receive concomitant chronic SMN-modifying therapy; documentation of baseline and follow-up motor exam scores. Coverage reauth 12 months.SMN1 genetic confirmation and >=2 copies SMN2 initially
Specialist neurologist involvement required.
Erythropoiesis agents (Procrit) - reauth: Reauth criteria include Hct/Hgb thresholds and demonstration of positive clinical response depending on indication (CKD, chemo, MDS, HCV, HIV). Adequate iron stores often required (ferritin >100 mcg/L and TSAT >20%). Coverage durations vary; reauth commonly 12 months for chronic indications.Hct/Hgb thresholds per indication (eg Hgb<10 g/dL or Hct<30%)
Failure to meet lab thresholds may lead to denial.
Jynarque - reauth and monitoring: Reauth requires positive clinical response and adherence to liver monitoring schedule: pre-init, 2 and 4 weeks after initiation, then monthly for first 18 months; after >18 months at least every 3 months. No history of significant liver injury. Coverage reauth 12 months.ALT/AST/bilirubin monitoring schedule specified
Specialist involvement may be required.
Kerendia - reauth (CKD/T2D, HF): Reauth: patient demonstrates positive clinical response. For CKD associated with T2D: continues on maximally tolerated ACE/ARB or has contraindication; for HF LVEF>=40%: continues on SGLT2 inhibitor or has contraindication. Coverage reauth 12 months.UACR>=30 mg/g; eGFR>=25 mL/min/1.73m2; potassium <=5.0 mEq/L initial
Prerequisite Part D drug required.
Kesimpta - reauth (MS): Reauth: patient demonstrates positive clinical response; not used with another DMT or B-cell targeted therapy. Coverage reauth 12 months.
Specialist (neurologist) prescribing required.
Modafinil/Armodafinil - reauth (sleep disorders): Reauth: patient demonstrates positive clinical response to therapy for OSA, SWD, narcolepsy, idiopathic hypersomnia, MS fatigue. Coverage reauth typically 6-12 months depending on indication.OSA sleep study thresholds (>=15 events/hr or >=5 with symptoms) apply for initial; sleep study may be omitted with justification
Neulasta/Udenyca - reauth (FN prophylaxis/treatment): Reauth: for prophylaxis/treatment of febrile neutropenia, continued need documented (eg ongoing chemotherapy risk, history of FN) and positive clinical response where applicable. Coverage durations per indication (often 3 months or duration of treatment).Regimen-associated FN risk thresholds apply for initial
Prescriber: hematologist/oncologist typically required.
Onpattro/Vyndamax - reauth (ATTR, hATTR): Reauth: patient demonstrates positive clinical response to therapy; for Vyndamax ensure continued NYHA I-III and not combined with TTR silencers/stabilizers; coverage reauth 12 months.NYHA class I-III for ATTR-CM
Prescriber: cardiologist or neurologist as specified.
Pyrukynd - reauth (pyruvate kinase deficiency): Reauth: patient demonstrates positive clinical response to therapy; initial 6 months then reauth 12 months. Monitoring of hemoglobin and transfusion dependence expected. Prerequisite therapy: Criteria DOES NOT require prerequisite Part D drug.Hemoglobin <=10 g/dL initial
Prescriber: hematologist.
Qinlock, other oncology targeted agents - reauth: Reauth: Approve for continuation of prior therapy; documentation of response or ongoing benefit typically required (12-month reauthorizations). For targeted agents, molecular marker testing must be documented initially and ongoing disease control documented for reauth.Molecular markers per product (eg KIT, PDGFRA, BRAF, FGFR2, MET exon14)
Prerequisite Part D drug often required where specified.
Rinvoq and other immunomodulators - reauth: Reauth requires demonstration of positive clinical response per indication (eg reduction in joint counts, BSA, mucosal healing for IBD). Coverage reauth commonly 12 months after initial 6-month approval. Many products require prior trial/failure documentation of specified Part D drugs initially and for some reauths continuation of concomitant standard therapy.
Prescriber specialty and step therapy requirements apply.
IgE ranges and age thresholds apply
IVIG / Immune globulin - Part B vs Part D and denial risk: Immune globulin products subject to Part B vs Part D review; approvals may be denied if criteria for Part B met or documentation of required diagnoses/tests not provided. Non-oncology renewals require objective improvement and minimum effective dosing. Denials possible for missing trials/tests.
General denial risk for missing required prior trials/tests: Providers must document required prior trials, diagnostic confirmations (eg genetic tests, right heart catheterization, sleep studies) and lab thresholds; claims may be denied when such documentation or required prerequisite Part D drug trials are absent. Several product entries explicitly state prerequisite Part D drug requirements; lack of documented step therapy may lead to denial.
Prerequisite Part D drug requirement (step therapy)
When a policy indicates 'Criteria DOES require use of a prerequisite Part D drug,' providers must document prior Part D drug trials (drug name, dose, duration, dates, and reason for failure/ intolerance/contraindication). If the entry requires a specific minimum trial duration, include that documentation.
Record which prerequisite Part D drug(s) were used and exact trial durations.
State reason for discontinuation (failure, intolerance, contraindication).
For oncology/targeted agents, include prior systemic therapy lines if required.
Documentation Required
Specialist prescribing or consultation required for certain indications
Many initial approvals require the prescriber to be the listed specialist or to document consultation with one. Common required specialties include rheumatology (RA, PJIA, AS, nr-axSpA, GCA), dermatology (psoriasis, HS, severe AD), gastroenterology (CD, UC), pulmonology/cardiology (PAH, pulmonary fibrosis), hematology/oncology (PNH, MAC, malignancies), neurology (MS, SMA, epilepsy), and allergist/immunologist (HAE, asthma, IgE‑mediated food allergy). Document that the prescriber is the specialist or include a contemporaneous consult note.
Claims may be denied if required prior trials, diagnostic confirmations, lab thresholds, or specialist consultations are not documented. Examples include missing trial/failure evidence for topical/systemic priming therapies (psoriasis, onychomycosis), absent mutation/test reports (BRAF, KRAS, FGFR, RET, MET, EGFR, IDH, FLT3), lack of right‑heart catheterization or sleep study when required, or absent lab thresholds (AAT level, ANC, platelet counts, ferritin, LDL‑C, triglycerides).
Missing test/mutation reports (eg, BRAF, KRAS, FGFR2/3, RET, MET exon14, IDH1/2, FLT3) can cause denial.
Absent documentation of required trials (eg, terbinafine for onychomycosis; conventional DMARDs for RA) risks denial.
Failure to show specialist prescribing/consultation when required can cause denial.
Not meeting numeric thresholds (eg, AAT <11 µM/L; ANC, platelets, ferritin, LDL‑C, triglycerides) may lead to denial.
Billing Rule
Part B vs Part D review for IVIG and certain injectables
For IV immune globulin (IVIG) and certain products billed either under Part B or Part D (eg, some infused biologics, IVIG), providers must confirm the appropriate benefit (Part B vs Part D) and document the setting (infusion in clinic vs LTC). For IVIG specifically, include specialty physician documentation, indication justification, and minimum effective dosing; note that IVIG entries are subject to Part B vs Part D review.
Indicate whether service is billed under Part B or Part D and provide setting details.
For IVIG, include specialized physician consultation (immunologist, hematologist, neurologist) and diagnosis justification.
Provide dosing rationale showing minimum effective dose and duration per indication.
CFTR test requirement for CF therapiesCFTR mutation responsive to ivacaftor/triple-combination must be detected by FDA-cleared or CLIA test (eg Trikafta/Kalydeco entries)
SMN / SMA genetic requirement (Evrysdi)SMN1 homozygous deletion or compound heterozygous mutation AND >=2 copies of SMN2; baseline motor exam required; no concomitant chronic SMN-modifying therapy
FGFR/other gene test requirementsMany oncology agents require biomarker testing by FDA-approved or CLIA test (e.g., FGFR2 fusion for Lytgobi/Pemazyre; RET, NTRK, BRAF, KRAS, IDH, FLT3, MET exon14, EGFR as specified)
Procrit / anemia lab triggersAnemia lab thresholds commonly Hct <30% or Hgb <10 g/dL for CKD/chemo; preop Hgb >10 to <=13 g/dL; iron adequacy ferritin >100 mcg/L and TSAT >20%
Phenylketonuria monitoring (sapropterin)Measure blood phenylalanine after 1 week of therapy and periodically for up to 2 months; initial/reauth durations per policy
Platelet thresholds for Ayvakit in mastocytosis/AdvSM/ISMPlatelet count >= 50 x 10^9/L required for AdvSM/ISM indications
Baseline triglyceride threshold for Tryngolza (FCS)Baseline fasting triglycerides >=880 mg/dL; diagnostic scores NAFCS >=45 or Moulin >10 OR genetic confirmation of biallelic pathogenic variants
GIST prior therapy requirement (Qinlock)Advanced GIST: prior treatment with three or more kinase inhibitors, one of which must include imatinib
PAH confirmationPAH initial requires symptomatic PAH plus either right heart catheterization confirmation OR patient already on PAH therapy; initial coverage commonly 6 months
Each product entry requires indication‑specific diagnostic confirmation (for example, FDA‑approved or CLIA‑certified mutation or biomarker tests such as FGFR, BRAF, KRAS, EGFR, SMN1/SMN2, or CYP2D6 where listed). Reauthorizations are governed by documented clinical response metrics appropriate to the indication (e.g., reduction in joint counts or BSA, mucosal healing or lab improvement for IBD, improved FEV1 for CF, decreased migraine days, or other specified outcome measures).