Drug coverage criteria for specialty and outpatient medications
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This document lists products covered by Blue Cross Blue Shield - South Carolina and specifies indications, required medical information, prescriber restrictions, coverage durations, reauthorization requirements, and prerequisite therapy rules for each listed medication.
No material clinical or coverage changes in this revision.
Coverage Criteria (Initial and Reauthorization)
Initial autoimmune indications
Covered when ALL of the following are met for specified autoimmune indications
Prescribed by or in consultation with a rheumatologist
Prescribed by or in consultation with a rheumatologist
Prescribed by or in consultation with a dermatologist
Prescribed by or in consultation with a rheumatologist
Prescribed by or in consultation with a dermatologist or rheumatologist
Migraine prevention (Aimovig)
Reauthorization requires evidence of clinical response
Hurley Stage II or III required for initial therapy
Coding and Key Numeric Thresholds
| No codes listed |
| No codes listed |
| No codes listed |
| No codes listed |
| Tadalafil TABS 2.5MG, 5MG | Product listed in criteria |
| Cosentyx INJ 150MG/ML | Secukinumab formulation |
| Cosentyx INJ 125MG/5ML | Secukinumab formulation |
| Cosentyx Sensoready Pen | Secukinumab delivery device |
| Cosentyx Unoready | Secukinumab delivery device |
| Deferasirox | Iron chelator for chronic iron overload |
| Bivigam INJ 10%, 5GM/50ML | Product affected |
| Privigen | Product affected |
| Iwilfin | Product affected |
| Jakafi | Product affected |
| Jaypirca | Product affected |
| Jylamvo | Product affected |
| Jynarque | Product affected |
| Kalydeco | Product affected |
| Kerendia | Product affected |
| Kesimpta | Product affected |
| Kineret | Product affected |
| Kisqali | Product affected |
Prior Authorization, Documentation & Step Therapy
Obtain prior authorization with indication‑specific documentation
Prior authorization must be obtained and submitted with clinical documentation supporting the listed indication, relevant prior therapy trials or documented contraindications/intolerances, prescriber specialty when specified, and the requested duration (initial vs reauthorization).
Submit diagnostic, staging and biomarker evidence with PA
Prior authorization must include documentation of diagnosis, current disease status, and any required biomarker or genetic testing; coverage durations are product‑specific (commonly 12 months; some initial uses shorter).
Cosentyx PA: document diagnosis and required prior therapy trials
For Secukinumab (Cosentyx) prior authorization requires a documented diagnosis and trials of specified prior therapies (e.g., topical therapy for plaque psoriasis; NSAID trial for ankylosing spondylitis; specified systemic agents/biologics or continuation of prior therapy for PsA), with initial approvals typically 6 months and reauthorization 12 months.
Cinryze PA: provide laboratory confirmation of HAE and age
Prior authorization for Cinryze requires diagnostic laboratory confirmation of hereditary angioedema (eg, low C4 and C1‑INH antigenic or functional deficiency, or specified genetic testing/family history for HAE with normal C1‑INH) and is limited to prophylaxis in patients age ≥6 years; it must not be used in combination with other approved prophylactic agents.
Deferasirox PA: document ferritin, LIC and transfusion history
Prior authorization for deferasirox (iron chelation) requires documentation of the iron‑overload diagnosis and objective laboratory thresholds (e.g., baseline serum ferritin >1000 mcg/L and transfusion history ≥100 mL/kg for transfusional iron overload; LIC and ferritin criteria for NTDT), with reauthorization tied to reductions in ferritin or LIC.
Dupixent PA: include eosinophil counts and prior controller trials
Prior authorization for dupilumab requires documentation of the indication‑specific criteria (for example baseline peripheral eosinophil counts and history of exacerbations or prior controller therapy trials for eosinophilic asthma; histology and exclusion of other causes for EoE) and prescriber specialty as listed.
Enbrel PA: document required conventional therapy trials and specialist consult
Prior authorization for Enbrel requires documentation of prior trials, failures, contraindications, or intolerances to the specified conventional therapies for each rheumatologic or dermatologic indication and prescriber consultation with a rheumatologist or dermatologist when specified.
Follow product‑specific PA documentation requirements
Product‑specific prior authorization is required: providers must submit diagnosis, any required biomarker/genetic test results, and prior therapy history as specified in the product criteria to support approval.
Fruzaqla PA: document advanced RCC and ≥2 prior systemic therapies
Fruzaqla prior authorization requires documentation of advanced renal cell carcinoma that is relapsed/refractory and evidence the patient has received two or more prior systemic therapies; a prerequisite Part D drug is required.
Gavreto PA: include FDA/CLIA RET fusion test results
Gavreto prior authorization requires documentation of NSCLC or thyroid cancer with RET fusion‑positive tumor(s) as detected by an FDA‑approved or CLIA‑performed test; coverage is typically 12 months and continuation of prior therapy is approvable.
Humira PA: submit disease activity and conventional therapy trial evidence
Humira prior authorization requires indication‑specific documentation and prior therapy trials (for example trial and failure/contraindication/intolerance to at least one conventional DMARD for RA, topical therapy trial for psoriasis, NSAID trial for AS); initial and reauthorization durations vary by indication.
PA required — observe product‑specific approval durations
Prior authorization is required for listed products and approval durations are specified per product (commonly 12 months; some initial uses have shorter durations); providers must follow the product‑level duration and continuation rules.
Document required prior drug trials (step therapy)
Many indications impose step therapy: prior trial and failure (TF/C/I) of specified conventional or Part D drugs (e.g., methotrexate, leflunomide, topical agents for psoriasis) must be documented before advanced therapies are approved.
Complete required alternative therapy trials before PA
Several products require trials and failures of specified alternative agents prior to approval (for example trial/failure of listed agents or topical vs systemic alternatives); documentation of those prior agent trials is required.
Require conventional therapy trial for infliximab products
Infliximab and its biosimilars require documented trial and failure, contraindication, or intolerance to specified conventional therapies (e.g., immunomodulators, corticosteroids, aminosalicylates) for many indications prior to approval.
Provide iron‑overload labs (ferritin, LIC) and transfusion history
Providers must document diagnoses and objective laboratory thresholds for iron overload indications (examples: transfusional iron overload requires ferritin >1000 mcg/L and transfusion ≥100 mL/kg; NTDT and MDS have LIC/ferritin and transfusion thresholds).
Document IgG levels, vaccine response and prior therapies for IVIG/SCIG
For IVIG/SCIG requests, submit diagnosis‑specific immunologic evaluation and laboratory values (e.g., IgG levels, vaccine response), prior treatment history, and attest that IVIG will be dosed at the minimum effective dose and frequency.
Denial risk: missing prior therapy documentation for autoimmune indications
Failure to document trial and failure, contraindication, or intolerance to required conventional therapies for initial autoimmune indications (e.g., RA, PJIA, psoriasis) may trigger denial.
Denial risk: missing right heart catheterization confirmation for PAH
Requests for pulmonary arterial hypertension therapies may be denied if diagnosis is not confirmed by right heart catheterization or if the patient is not already on PAH therapy where required by the entry.
Background and Scope
This policy excerpt provides coverage criteria across a broad range of specialty medications used in immunology, rheumatology, pulmonology, oncology, neurology and related areas. It lists product‑specific initial and reauthorization requirements, typical prior authorization expectations, prescriber specialty guidance, and the objective laboratory or disease‑severity thresholds that must be documented in the medical record for approval (examples include CDAI >220 for Crohn's disease, ≥3% BSA for moderate‑to‑severe plaque psoriasis, and ferritin >1000 mcg/L for transfusional iron overload).
Across the specialty drug entries the policy consistently requires prior authorization with submission of diagnosis confirmation, relevant biomarker or molecular testing when applicable (FDA‑approved or CLIA‑performed tests), and documentation of prior trials, failures, contraindications, or intolerances to specified conventional or formulary therapies. Reauthorization is generally contingent on evidence of a positive clinical response (for example, reduced swollen/tender joint counts, reduced BSA, improved labs, or fewer exacerbations) and is commonly authorized for 12 months when response is documented.
The document also includes explicit exclusions and noncoverage directions where applicable — for example, several targeted oncology agents require demonstration of the defining genetic alteration (e.g., ROS1, RET, BRAF V600, FGFR2/3, KRAS G12C, PIK3CA) by an FDA‑approved or CLIA‑certified test, and some products will not be approved for use in combination with other agents of the same class (for example, CGRP inhibitors are not to be used together for migraine prevention).
For operational use, clinicians and billing staff should note that most approvals require specialist prescribing or documentation of specialty consultation, explicit numeric thresholds or trial durations for prior therapies, and that failure to provide the required diagnostic or prior‑therapy evidence creates a high risk for denial or delay of coverage.
Definitions and Terminology
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