Actimmune (interferon gamma-1b) and related specialty drug prior authorization criteria (partial)
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Portion of the payer's specialty drug prior authorization criteria listing products (including Actimmune and several biologics) with indications, required medical information, prescriber and coverage-duration rules affecting providers submitting PA requests for these products.
No material clinical or coverage changes in this revision.
Coverage Criteria (Initial and Continuation Rules)
Actimmune coverage criteria
Covered when ALL of the following are met
Required medical information: diagnosis of CGD or SMO
Continuation of prior therapy may be approved
Adalimumab-class biologics coverage criteria (examples from extract)
Covered when indication-specific requirements are met
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a dermatologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a gastroenterologist; initial coverage 6 months; reauth 12 months
Adbry (dupilumab) coverage criteria (partial)
Covered when ALL of the following are met
Trial and failure, contraindication, or intolerance to at least two topical therapies including a medium or higher potency topical corticosteroid (minimum 30-day supply; 14-day supply for topical corticosteroids); patient age >=12 years; prescribed by or in consultation with a dermatologist or allergist/immunologist; initial coverage 6 months; reauth 12 months
Prescriber: dermatologist or allergist/immunologist
Pulmonary hypertension therapies (partial)
Covered when ALL of the following are met
Prescribed by or in consultation with a pulmonologist or cardiologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a pulmonologist or cardiologist; initial coverage 6 months; reauth 12 months
Adempas Initial criteria
Adempas (riociguat) coverage for PAH or CTEPH
Prescribed by or in consultation with pulmonologist or cardiologist; Initial coverage duration 6 months; reauth 12 months.
Prescribed by or in consultation with pulmonologist or cardiologist; Initial coverage duration 6 months; reauth 12 months.
Afinitor Indications
Afinitor (everolimus) coverage by indication
Patient age >=1 year for SEGA; coverage duration 12 months
Coverage duration 12 months
Coverage duration 12 months
Coverage duration 12 months
Coverage duration 12 months
Aimovig Initial criteria
Aimovig (erenumab) coverage for migraine prevention
Initial coverage 6 months; reauth 12 months; medication will not be used in combination with another CGRP inhibitor
Initial coverage 6 months; reauth 12 months; monitor for medication overuse headache; not used with another CGRP inhibitor
Prolastin (AAT) criteria
Alpha-1 proteinase inhibitor (Prolastin-C) coverage for AAT deficiency
Coverage duration initial and reauth 12 months; reauth requires positive clinical response
Ampyra Initial Therapy
Ampyra (dalfampridine) — MS (Initial)
Prescribed by or in consultation with a neurologist; coverage duration initial 6 months, reauth 12 months
Arformoterol Coverage
Arformoterol Tartrate — COPD
Coverage duration 12 months
Arikayce Initial Therapy
Arikayce — MAC lung disease
Prescribed by or in consultation with an infectious disease specialist; coverage duration 12 months
Augtyro Coverage
Augtyro — NSCLC and NTRK/ROS1 indications
Coverage duration 12 months; approve continuation of prior therapy
Austedo Coverage
Austedo — Huntington's chorea and Tardive Dyskinesia
For tardive dyskinesia: persistent symptoms despite trial of dose reduction/tapering/discontinuation of offending medication OR not a candidate for such trial; prescriber restrictions apply; coverage duration initial/reauth 12 months
Avmapki Fakzynja Coverage
Avmapki Fakzynja — KRAS-mutant tumors
Continuation of prior therapy may be approved; prerequisite Part D drug required
Avtozma Coverage (RA, GCA, SJIA, PJIA, SSc-ILD)
Avtozma products — Rheumatologic indications
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months; prerequisite Part D drug required per section
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months
Prescribed by or in consultation with a specialist; initial coverage 6 months; reauth 12 months
Actimmune-related Coverage Durations and Reauthorization
Coverage durations and reauthorization requirements for selected Actimmune-related indications
Reauthorization requires demonstration of positive clinical response
No explicit exclusion conditions are provided in the excerpted criteria listings. The policy text for Actimmune and numerous specialty agents in this extract mark Exclusion Criteria or Off‑Label Uses as "N/A" for many entries, and where exclusions are specified they are narrow and product‑specific (examples: ciclopirox excludes lunula/matrix involvement; cinryze and icatibant are not to be used in combination with other approved prophylactic or acute HAE treatments; pyrimethamine is not authorized for malaria). Refer to the individual product sections for any named exclusions; absent such language, the extract does not list broad exclusion rules applicable across products.
Product and Clinical Codes / Thresholds
| Actimmune INJ 100MCG/0.5ML | Actimmune product listing as affected product |
| Adalimumab-aaty 1-pen Kit | Adalimumab-aaty product |
| Adalimumab-adbm | Adalimumab-adbm product |
| Adbry | Adbry product listing |
| Alyq | Alyq product listing (tadalafil brand) |
| Tadalafil TABS 20MG | Tadalafil 20 mg tablet |
| Formulary ID: 26218 | Afinitor formulary identifier and version |
| Cosentyx INJ 150MG/ML | Product listed in policy |
| Cosentyx INJ 75MG/0.5ML | Product listed in policy |
| Cosentyx Sensoready Pen | Product listed in policy |
| Cosentyx Unoready | Product listed in policy |
| Cosentyx INJ 125MG/5ML | IV formulation listed |
| Formulary ID: 26218 | Formulary identifier listed in the document |
| Dupixent INJ 200MG/1.14ML | Dupixent injection presentation listed in product section |
| Dupixent INJ 300MG/2ML | Dupixent injection presentation listed in product section |
| Ebglyss 2 | Ebglyss product referenced |
| Emgality | Emgality product referenced |
Prior Authorization, Required Documentation, and Denial Risks
Actimmune prior authorization required
Actimmune requires prior authorization. Submit documentation confirming diagnosis of chronic granulomatous disease (CGD) or severe malignant osteopetrosis (SMO); approvals are issued for 12 months and continuation of prior therapy may be approved.
Follow indication-specific PA requirements for biologics
Biologic and specialty products listed require prior authorization per product-specific criteria — include the indication-specific diagnosis, required prior therapy trials (TF/C/I) or rationale why trials are inappropriate, prescriber specialty or consultation as indicated, and the coverage duration specified for the product/indication.
- Document disease-specific measures (e.g., BSA, CDAI, eosinophil counts) and prior trial/failure, contraindication, or intolerance to specified conventional therapies.
- Prescriber must be the required specialist or include documentation of specialist consultation when required.
- Include duration requested consistent with initial or reauthorization periods noted in the product criteria.
Adempas: specialist prescriber and time-limited approval
Adempas (riociguat) requires prior authorization; initial approvals are for 6 months with reauthorization for 12 months. Prescriber must be or consult with a pulmonologist or cardiologist and documentation must show PAH or inoperable/persistent CTEPH per the criteria (right heart catheterization confirmation or current PAH/CTEPH therapy when applicable).
Afinitor PA and prior‑therapy documentation
Afinitor (everolimus) requires prior authorization. Include indication-specific documentation and, where specified (eg, RCC or breast cancer), evidence of trial and failure, contraindication, or intolerance to the named prior agents; typical coverage duration is 12 months and continuation of prior therapy may be approved.
Aimovig: migraine frequency, no CGRP combination, and durations
Aimovig (erenumab) requires prior authorization. For initial approval (6 months) and reauthorization (12 months) document diagnosis of episodic migraine (≥4 days/month) or chronic migraine (≥8 days/month), consideration and discontinuation of medication overuse when applicable, and that the patient is not using another CGRP inhibitor.
Ampyra: MS diagnosis, walking impairment, and EDSS requirement
Ampyra (dalfampridine) requires prior authorization with physician confirmation of an MS diagnosis and objective evidence of difficulty walking (eg, timed 25-foot walk). Document EDSS ≤7 or that the patient is not wheelchair‑restricted; prescriber is or consulted neurologist. Initial coverage is 6 months; reauthorization 12 months.
Arformoterol PA: COPD diagnosis and 12‑month duration
Arformoterol tartrate requires prior authorization for maintenance treatment of COPD. Provide documentation of COPD diagnosis; typical coverage duration is 12 months.
Arikayce: MAC diagnosis and failed ≥6‑month multidrug regimen
Arikayce requires prior authorization for Mycobacterium avium complex (MAC) lung disease. Document MAC diagnosis, that the drug will be used as part of a combination antibacterial regimen, and that the patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of multidrug therapy; coverage duration 12 months.
Augtyro PA: required genomic evidence and prior‑therapy status
Augtyro prior authorization requires tumor genomic evidence (ROS1 rearrangement or NTRK gene fusion) and documentation that disease is locally advanced/metastatic or unresectable and has progressed after prior therapy or lacks satisfactory alternatives; coverage duration 12 months and continuation of prior therapy may be approved.
Austedo PA: diagnosis and trial/reduction documentation for TD
Austedo requires prior authorization for chorea of Huntington's disease and tardive dyskinesia. Document the diagnosis and either a trial of dose reduction/tapering of offending medication (or rationale why not feasible) for TD; prescriber specialty varies by indication; coverage initial and reauth 12 months.
Avmapki Fakzynja: KRAS mutation and prior systemic therapy required
Avmapki Fakzynja requires prior authorization with documentation of a KRAS mutation detected by an FDA‑approved or CLIA‑approved test and evidence of prior systemic therapy; continuation of prior therapy may be approved.
Avtozma PA: indication‑specific trials and rheumatology consult
Avtozma (and Avtozma SC) prior authorization requires indication‑specific diagnoses (RA, GCA, SJIA, PJIA, SSc‑ILD) and documentation of required prior therapy trials or attestation that trials are inappropriate; prescriber must be or consult a rheumatologist for many indications; initial coverage 6 months, reauthorization 12 months.
Actimmune‑related indications: 6‑month initial, 12‑month reauth
For selected Actimmune‑related indications (RA, GCA, SJIA, PJIA, SSc‑ILD) prior authorization is required with initial coverage of 6 months and reauthorization of 12 months; reauthorization requires demonstration of positive clinical response (eg, reduced swollen/tender joint count).
Ayvakit: required mutation/platelet documentation and 12‑month duration
Ayvakit coverage is authorized for 12 months. Document the diagnosis (eg, unresectable/metastatic GIST with PDGFRA exon 18 mutation including D842V, or AdvSM/ISM with platelet count ≥50 ×10^9/L); criteria allow continuation of prior therapy and do not require a prerequisite Part D drug.
Balversa: FGFR3 testing and 12‑month coverage
Balversa coverage duration is 12 months. Prior authorization requires documentation of locally advanced or metastatic urothelial carcinoma with a susceptible FGFR3 alteration detected by an FDA‑approved or CLIA‑approved test and prior systemic therapy/progression when specified.
Benlysta PA: autoantibody positivity, SOC therapy, and 6‑month duration
Benlysta requires prior authorization; initial and reauthorization approvals are for 6 months. For initiation document active SLE with autoantibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL) and current use of at least one standard‑of‑care therapy; reauthorization requires demonstration of positive clinical response.
Bronchitol PA: CF diagnosis, BTT, and benefit‑dependent reauth
Bronchitol requires prior authorization for cystic fibrosis initial use; include CF diagnosis and documentation that the patient passed the Bronchitol Tolerance Test (BTT). Initial coverage is 6 months; reauthorization 12 months contingent on clinical benefit.
Brukinsa PA: indication‑specific prior therapy documentation
Brukinsa requires prior authorization with coverage duration 12 months. Document diagnosis and prior therapy history specific to the labeled indication (eg, at least one prior therapy for MCL or prior anti‑CD20 regimen for MZL); continuation of prior therapy may be approved.
Cablivi PA: aTTP IV administration and 3‑month coverage
Cablivi requires prior authorization for aTTP; document aTTP diagnosis, that the first dose is/will be administered as a bolus IV by a healthcare provider, concomitant immunosuppressive therapy/plasma exchange status, and note coverage duration is 3 months.
Cabometyx PA: diagnosis, prior VEGFR therapy where specified, 12 months
Cabometyx requires prior authorization with coverage duration 12 months. Provide diagnosis (RCC, HCC, DTC, NET) and prior therapy history — some indications require trial/failure of sorafenib or other VEGFR‑targeted therapies; continuation of prior therapy may be approved.
Calquence PA: diagnosis and prior‑therapy status required
Calquence requires prior authorization with coverage duration 12 months. Include diagnosis and prior therapy status (eg, treatment‑naïve and HSCT ineligible vs prior therapy) as indicated by the criteria.
Caplyta PA: prerequisite antipsychotic trials and 12‑month coverage
Caplyta requires prior authorization with coverage duration 12 months. Document diagnosis and trial/failure, contraindication, or intolerance to the specified oral generic atypical antipsychotics per indication.
Caprelsa PA: metastatic MTC documentation and 12‑month duration
Caprelsa requires prior authorization with coverage duration 12 months; document metastatic or unresectable medullary thyroid cancer and evidence of symptomatic or progressive disease per criteria.
Cayston PA: CF age restriction (≥7 yrs) and reauth benefit requirement
Cayston requires prior authorization; initial CF use is restricted to patients ≥7 years and reauthorization requires demonstration of benefit (eg, fewer pulmonary exacerbations).
Cerdelga PA: Gaucher diagnosis and CYP2D6 testing
Cerdelga requires prior authorization with coverage duration 12 months and documentation of Gaucher disease type 1 plus CYP2D6 metabolizer status (EM/IM/PM) as detected by an FDA‑cleared test; age ≥18 for Gaucher disease.
Cerdelga (Gaucher disease) — required genotype documentation
For Gaucher disease, ensure documentation includes diagnosis of type 1 Gaucher disease and CYP2D6 metabolizer status (extensive, intermediate, or poor) per an FDA‑cleared test; coverage duration is 12 months.
Cholbam PA: diagnostic testing required and 4‑month initial approval
Cholbam prior authorization requires diagnostic confirmation for bile acid synthesis disorders (abnormal urinary bile acid analysis by mass spectrometry or molecular genetic testing); initial approval is 4 months with reauthorization for 12 months contingent on clinical response.
Ciclopirox PA: confirm onychomycosis, terbinafine trial, 48‑week duration
Ciclopirox prior authorization requires confirmation of onychomycosis (KOH, culture, or histology), absence of lunula involvement, and documented trial/failure/contraindication/intolerance to oral terbinafine (minimum 6 weeks for fingernails, 12 weeks for toenails); coverage duration 48 weeks.
Cinryze PA: HAE lab confirmation, specialist prescriber, and age limit
Cinryze prior authorization for HAE prophylaxis requires laboratory confirmation of HAE (low C4 with low C1‑INH antigenic or functional level, or confirmatory genetic/family history for HAE‑nl‑C1INH), prescriber is or consults an immunologist/allergist, age ≥6 years for prophylaxis, and reauthorization requires evidence of positive clinical response; not to be used with other prophylactic HAE treatments.
Cobenfy PA: intolerance to two listed antipsychotics required
Cobenfy prior authorization requires intolerance to two listed oral generic atypical antipsychotics before approval; continuation of prior therapy may be approved.
Cometriq PA: metastatic MTC diagnosis and 12‑month coverage
Cometriq prior authorization requires diagnosis of metastatic medullary thyroid cancer; coverage duration 12 months and continuation of prior therapy may be approved.
Copiktra PA: relapsed/refractory CLL/SLL and ≥2 prior therapy trials
Copiktra prior authorization requires CLL or SLL diagnosis that is relapsed/refractory and documentation of trial and failure, contraindication, or intolerance to at least two prior therapies for CLL/SLL.
Cosentyx PA: severity, prior therapy trials, and prescriber restrictions
Cosentyx prior authorization requires documentation of diagnosis and severity (eg, plaque psoriasis with ≥3% BSA or special-site involvement) and prior trial/failure/contraindication/intolerance to topical therapies or specified systemic/biologic agents as listed for each indication; prescriber specialty/consultation and coverage durations vary by formulation and indication.
Cosentyx SC/IV: prior‑therapy and specialist documentation required
Prior authorization for Cosentyx SC and IV formulations requires evidence of diagnosis, required prior therapy trials, and prescriber specialty or consultation where specified; IV formulation may require TF/C/I to two listed agents unless continuing prior therapy.
Roflumilast PA: COPD exacerbation history and two‑therapy step requirement
Roflumilast (DALIRESP) requires prior authorization; document COPD diagnosis, history of exacerbations (systemic steroids/antibiotics/hospitalization), and trial/failure/intolerance/contraindication to two prior COPD therapies; coverage duration 12 months.
Background and Scope
This extract compiles prior authorization requirements for specialty immunology and rheumatology drugs and related products. For the biologic and specialty agents shown, approvals are indication‑specific and typically require documented diagnosis, prescriber specialty or consultant involvement (eg, rheumatologist, dermatologist, pulmonologist), and evidence of prior standard therapy trials or intolerance when specified (commonly described as trial and failure, contraindication, or intolerance — TF/C/I).
Coverage durations and reauthorization expectations are routinely specified: initial approvals for many biologic indications are commonly 6 months with reauthorization contingent on demonstration of positive clinical response and typically renewed for 12 months. Providers submitting PA requests should include the required objective disease measures, prior therapy history and durations, and any molecular or laboratory test results called for by the product‑specific criteria.
Definitions and Clinical Thresholds
Policy Version & Revision History
Policy effective date set to 2026-08-01.
Policy last reviewed on 2026-07-02.
Next review scheduled for 2026-07-02.
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