Actimmune (interferon gamma-1b) — Prior Authorization and Coverage Criteria
Customize your policy alerts
Sign up for all Blue Cross Blue Shield - South Carolina policy alerts
Know when Blue Cross Blue Shield - South Carolina releases new policies or updates existing guidance.
Monitor payer policy activity
This policy governs prior authorization, coverage criteria, and utilization controls for Actimmune (INJ 100MCG/0.5ML) for medically accepted indications (chronic granulomatous disease and severe malignant osteopetrosis) for Blue Cross Blue Shield - South Carolina members and providers.
No material clinical or coverage changes in this revision.
Coverage Criteria and Decision Logic
Initial and continuation coverage
Covered when ALL of the following are met
Prerequisite Part D drug is not required for initial approval.
PAH (Alyq) Initial Therapy
Alyq (PAH) — initial criteria
Prescribed by or in consultation with a pulmonologist or cardiologist; initial coverage 6 months; reauthorization 12 months; reauth requires positive clinical response.
PAH and CTEPH Initial Therapy (Adempas)
Adempas — initial criteria for PAH and CTEPH
Prescribed by or in consultation with a pulmonologist or cardiologist; initial coverage 6 months; reauth 12 months; reauth requires positive clinical response.
Initial coverage 6 months; reauth 12 months; reauth requires positive clinical response.
Everolimus Indication Criteria
Everolimus (Afinitor) — indication-specific criteria
Coverage 12 months; approve continuation of prior therapy.
Coverage 12 months.
Coverage 12 months.
Coverage 12 months.
Coverage 12 months.
Coverage 12 months.
Episodic and Chronic Migraine Criteria (Aimovig)
Aimovig — migraine prevention
Initial coverage 6 months; reauth 12 months; reauth requires positive response and decreased use of acute migraine medications; not to be used with another CGRP inhibitor for prevention.
Initial coverage 6 months; reauth 12 months; reauth requires positive response and monitoring for medication overuse headache.
Akeega Indication Criteria
Akeega — metastatic prostate cancer with BRCA mutation
Coverage duration 12 months; approve continuation of prior therapy.
NSCLC Product Criteria (Alecensa, Alunbrig)
ALCENSA and ALUNBRIG — NSCLC
Coverage duration 12 months; approve continuation of prior therapy.
Alpha-1 Antitrypsin Deficiency Criteria
Prolastin-c — AAT deficiency
Coverage 12 months initial and reauth; reauth requires positive clinical response and continued conventional treatment.
Dalfampridine (Ampyra) - Initial and Reauthorization
Dalfampridine (Ampyra) — initial and reauthorization
Initial coverage 6 months; reauth 12 months with physician confirmation of walking improvement for reauthorization.
Arikayce - Initial
Arikayce — initial criteria
Coverage duration 12 months; prescribed by or in consultation with an infectious disease specialist.
Augtyro - Indications
Augtyro — indications
Coverage duration 12 months; approve continuation of prior therapy.
Coverage duration 12 months; approve continuation of prior therapy.
Arformoterol - COPD maintenance
Arformoterol — COPD maintenance
Coverage duration 12 months; subject to Part B vs Part D review.
Avtozma - Rheumatology and SSc-ILD indications (partial)
Avtozma — rheumatology and SSc-ILD indications (partial)
Initial duration 6 months; reauth 12 months; prescribed by or in consultation with a rheumatologist.
Initial 6 months; reauth 12 months; prescribed by or in consultation with a rheumatologist.
Initial 6 months; reauth 12 months; prescribed by or in consultation with rheumatology.
Initial 6 months; reauth 12 months; prescribed by or in consultation with appropriate specialist.
Initial Therapy / Coverage conditions (examples)
Examples of initial therapy and coverage conditions
Specialist prescriber requirements apply as listed per indication.
Reauthorization requires demonstration of clinical benefit for specified indications.
Prescribed by or in consultation with a rheumatologist for initiation.
Continuation / Reauthorization
Continuation / reauthorization
Coverage duration 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Bronchitol Initial Therapy
Bronchitol — initial therapy
Prescribed by or in consultation with a pulmonologist or specialist; initial coverage 6 months; reauth 12 months; reauth requires positive clinical response.
Brukinsa Indication Criteria
Brukinsa — indication-specific criteria
Coverage duration 12 months; approve continuation of prior therapy; prerequisite Part D drug may be required per entry.
Coverage duration 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Cablivi Indication Criteria
Cablivi — aTTP criteria
Prescribed by or in consultation with a hematologist or oncologist; coverage duration 3 months.
Cabometyx Indication Criteria
Cabometyx — tumor-specific criteria
May require trial and failure, contraindication, or intolerance to sorafenib (Nexavar); coverage duration 12 months.
May require prior therapy documentation; coverage duration 12 months.
Age >=12 for DTC; coverage duration 12 months.
Coverage duration 12 months.
Calquence Indication Criteria
Calquence — indication-specific criteria
Coverage duration 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Caplyta Indication Criteria
Caplyta — indication-specific criteria
Coverage duration 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Caprelsa Indication Criteria
Caprelsa — medullary thyroid cancer criteria
Coverage duration 12 months.
Cayston Indication Criteria
Cayston — cystic fibrosis criteria
Reauthorization requires evidence of benefit (improvement or decreased pulmonary exacerbations); coverage duration per entry.
Cerdelga Indication Criteria
Cerdelga — Gaucher disease type 1 criteria
Coverage duration 12 months; approve continuation of prior therapy.
Cerdelga: Initial Therapy
Cerdelga — initial therapy
Coverage duration 12 months; prerequisite Part D drug not required.
Chenodal: Initial/Reauthorization
Chenodal — initial and reauthorization
Prescribed by or in consultation with a gastroenterologist; initial and reauth coverage 12 months; reauth requires re-evaluation (eg, oral cholecystogram or ultrasound).
Cholbam: Indication-specific criteria
Cholbam — indication-specific criteria
Initial coverage 4 months; reauth 12 months with evidence of clinical response.
Initial 4 months; reauth 12 months with demonstrated improvement in liver function; prescribed by specialist.
Ciclopirox: Onychomycosis criteria
Ciclopirox lacquer — onychomycosis criteria
Coverage duration 48 weeks; prerequisite Part D drug required.
Cinryze: HAE prophylaxis criteria
Cinryze — HAE prophylaxis criteria
Coverage duration initial and reauth 12 months; reauth requires positive clinical response.
Cobenfy: Coverage
Cobenfy — coverage
Prerequisite Part D drug required per entry.
Cometriq: Coverage
Cometriq — metastatic medullary thyroid cancer
Coverage duration 12 months; approve continuation of prior therapy.
Copiktra: Coverage
Copiktra — CLL/SLL coverage
Prerequisite Part D drug required per entry.
Cosentyx IV Initial Therapy
Cosentyx — initial therapy (selected indications)
Prescribed by or in consultation with a dermatologist; initial coverage 6 months.
Prescribed by or in consultation with a rheumatologist or dermatologist; initial coverage 6 months.
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months.
Reauthorization/Continuation Therapy
Cosentyx — reauthorization/continuation therapy
Reauthorization duration: 12 months.
Cosentyx IV Initial Therapy
Cosentyx IV — specific initial pathways
Prescriber: rheumatologist or dermatologist; initial coverage 6 months.
Prescriber: rheumatologist; initial coverage 6 months.
Prescriber: rheumatologist; initial coverage 6 months.
Initial and Off-Label Indications
Initial and off‑label indications (examples)
Coverage duration 4 weeks.
Coverage duration 12 months.
Coverage duration 4 weeks.
Prescriber must acknowledge anticholinergic risks.
Diacomit - Initial/Continuation
Diacomit — Dravet syndrome
Coverage duration 12 months; continuation of prior therapy allowed.
Doptelet - TPPP and ITP criteria
Doptelet — TPPP and ITP criteria (summarized)
Prerequisite Part D drug required for some criteria; prescriber typically hematologist.
Dupixent - Multiple indications and criteria
Dupixent — multiple indications and criteria (selected)
Prescribed by or in consultation with pulmonologist or allergist/immunologist; coverage durations per indication.
Prescriber: gastroenterologist or allergist/immunologist; reauth requires clinical or histologic improvement.
Prescriber: dermatologist or allergist/immunologist; coverage durations as listed.
Ebglyss - Atopic dermatitis
Ebglyss — atopic dermatitis
Prescribed by or in consultation with a dermatologist; initial coverage 6 months; reauth 12 months and requires documented positive clinical response.
Emgality - Migraine and cluster headache indications
Emgality — migraine and cluster headache indications
Reauth 12 months requires positive response and decreased use of acute migraine meds.
Reauth 12 months requires positive response.
Reauth 12 months requires documented positive response; not used with another injectable CGRP inhibitor.
Empaveli - PNH and glomerulopathy criteria
Empaveli — PNH and glomerulopathy criteria
Prescribed by or in consultation with a hematologist or oncologist; coverage duration 12 months; reauth requires positive clinical response.
Coverage duration 12 months; prerequisite Part D drug required per excerpt.
Empaveli / C3G/PNH criteria
Empaveli — Complement/PNH indications (initial and reauth)
Prescriber: hematologist/oncologist; coverage 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Enbrel initial criteria
Enbrel — initial criteria (selected indications)
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months.
Prescribed by or in consultation with a rheumatologist.
Prescribed by or in consultation with a dermatologist; initial coverage 6 months.
Prescribed by or in consultation with a rheumatologist.
Enbrel reauthorization
Enbrel — reauthorization
Coverage duration 12 months.
Coverage duration 12 months.
Coverage duration 12 months.
Endari criteria
Endari — sickle cell disease
Coverage duration per entry; approve for continuation of prior therapy.
Ensacove criteria
Ensacove — ALK-positive NSCLC
Coverage duration 12 months; approve continuation of prior therapy.
Epclusa criteria
Epclusa — chronic hepatitis C
Prescribed by or in consultation with specialist as listed; coverage duration 12–24 weeks per guideline.
Epidiolex criteria
Epidiolex — seizure disorder indications
Prescribed by or in consultation with a neurologist; coverage duration 12 months; continuation allowed.
Epoetin alfa criteria
Epoetin alfa — indication‑specific laboratory and clinical requirements
Coverage durations per indication; adequate iron stores required (ferritin >100 mcg/L and TSAT >20%).
Coverage initial 3 months; adequate iron stores required.
Coverage duration 1 month.
Reauthorization requires maintenance or improvement in Hct/Hgb per criteria.
Indication-specific initial and reauthorization criteria
Epoetin alfa — indication‑specific initial and reauthorization (examples)
Reauth rules specified in policy.
Asthma (initial)
Asthma — initial
Prescribed by or in consultation with a pulmonologist or allergist/immunologist; initial coverage 6 months.
Asthma (reauthorization)
Asthma — reauthorization
Coverage duration 12 months.
EGPA (initial)
EGPA — initial
Prescribed by or in consultation with pulmonologist, rheumatologist, or allergist/immunologist; coverage duration 12 months.
HES (initial)
HES — initial
Prescribed by or in consultation with allergist/immunologist or hematologist; coverage duration 12 months.
EGPA/HES (reauthorization)
EGPA/HES — reauthorization
Coverage duration 12 months.
Fruzaqla - Initial/Line therapy criteria
Fruzaqla — metastatic colorectal cancer initial/line therapy
Coverage duration 12 months; approve continuation of prior therapy.
Prerequisite Part D drug required per entry.
Gavreto - Indication and biomarker criteria
Gavreto — indication and biomarker criteria
Coverage duration 12 months; approve continuation of prior therapy.
Age restriction for thyroid cancer: patient ≥12 years; coverage duration 12 months.
Gamastan - Immunization requirement
Gamastan — immunization requirement
Coverage per clinical indication; prerequisite Part D drug not required.
MS agents - Indication, prescriber, and reauthorization criteria
MS agents — indication, prescriber, and reauthorization criteria
Not used in combination with another disease‑modifying therapy for MS; coverage duration 12 months.
Coverage duration 12 months.
Gomekli - Indication criteria
Gomekli — indication criteria
Coverage duration 12 months; approve continuation of prior therapy.
Gleevec - Indications
Gleevec — labeled indications (examples)
Coverage duration 12 months; approve continuation of prior therapy.
Glycopyrrolate - Peptic ulcer criteria
Glycopyrrolate — peptic ulcer criteria
Initial and reauth coverage duration 3 months; reauth requires non-healing ulcer or symptomatic improvement.
Gomekli Coverage Criteria
Gomekli — PA coverage criteria (repeat for PA requirements)
Prescriber specialty and documentation per product; coverage duration 12 months.
Genotropin Coverage Criteria
Genotropin — growth hormone product criteria (overview)
Prescribed by or in consultation with an endocrinologist; coverage duration 12 months; reauthorization requires evidence of positive response and expected adult height not yet attained.
HER2-targeted NSCLC Agents Coverage Criteria
HER2‑targeted NSCLC agents — coverage criteria (examples)
Coverage duration 12 months; approve continuation of prior therapy.
Prerequisite Part D drug may be required; coverage duration 12 months.
Humira Coverage Criteria
Humira — selected indication-specific initial and reauthorization criteria
Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months.
Prescriber: dermatologist; initial coverage 6 months; reauth requires positive clinical response.
Reauth durations vary by indication (commonly 12 months).
Ibrance and Ibtrozi Coverage Criteria
Ibrance and Ibtrozi — oncology coverage examples
Coverage duration 12 months; approve continuation of prior therapy.
Coverage duration 12 months; approve continuation of prior therapy.
Products Affected and Code Listings
| Actimmune INJ 100MCG/0.5ML | Product formulation listed under Products Affected |
| Benlysta INJ 200MG/ML | Product listing as presented |
| Braftovi CAPS 75MG | Product listing as presented |
| Brivaracetam SOLN | Product listing as presented |
| Brivaracetam TABS | Product listing as presented |
| Briviact SOLN | Product listing as presented |
| Briviact TABS | Product listing as presented |
| Cosentyx INJ 150MG/ML | Product listing — SC formulation (150 mg/mL) |
| Cosentyx INJ 75MG/0.5ML | Product listing — SC formulation (75 mg/0.5 mL) |
| Cosentyx Sensoready Pen | Device presentation |
| Cosentyx Unoready | Device presentation |
| Cosentyx INJ 125MG/5ML | IV formulation listing |
| NDC/HCPCS/CPT not specified | Document lists product strengths but does not provide billing codes. |
| Dupixent INJ 200MG/1.14ML | Product and strength listed in document |
| Dupixent INJ 300MG/2ML | Product and strength listed in document |
| Ebglyss | Product name listed |
| Emgality | Product name listed |
| Empaveli | Product name listed |
| Diacomit | Product name listed |
| Doptelet | Product name listed |
| Dulera | Product name listed |
| Ebgllyss (Ebglyss) | Product name listed |
| Emgality | Product name listed |
| Empaveli | Product name listed |
| NDC/HCPCS not specified | Product listings provided (e.g., Enbrel formulations, L-glutamine pack, Sofosbuvir/velpatasvir, Epidiolex, Procrit) but exact codes not listed in this excerpt. |
| No codes listed |
| N/A | No specific CPT/HCPCS/ICD codes listed for Fruzaqla in this section |
| N/A | No specific CPT/HCPCS/ICD codes listed for Gavreto in this section |
| N/A | No procedure or diagnosis codes listed for fingolimod or glatiramer acetate here |
| Humira INJ 10MG/0.1ML | Humira injection 10MG/0.1ML |
| Humira INJ 20MG/0.2ML | Humira injection 20MG/0.2ML |
| Humira INJ 40MG/0.4ML | Humira injection 40MG/0.4ML |
| Humira INJ 40MG/0.8ML | Humira injection 40MG/0.8ML |
| Humira Pediatric Crohns Disease Starter Pack INJ 0, 80MG/0.8ML | Humira pediatric Crohn's starter pack |
| Humira Pen | Humira prefilled pen |
| Genotropin | Genotropin (growth hormone) |
| Genotropin Miniquick | Genotropin Miniquick |
| Gomekli | Gomekli product listing |
| Hernexeos | Hernexeos product listing |
| Hyrnuo | Hyrnuo product listing |
| Ibrance | Ibrance product listing |
| Ibtrozi | Ibtrozi product listing |
| Ibtrozi | Product name listed under 'Products Affected' |
| Iclusig | Product name listed under 'Products Affected' |
| Idhifa | Product name listed under 'Products Affected' |
| Igalmi | Product name listed under 'Products Affected' |
| Imbruvica CAPS/SUSP/TABS | Product names and formulations listed |
| Imkeldi | Product name listed under 'Products Affected' |
| Inbrija | Product name listed under 'Products Affected' |
| Increlex | Product name listed under 'Products Affected' |
| Inflectra | Product name listed under 'Products Affected' |
Prior Authorization, Documentation, and Denial Risks
Actimmune — prior authorization and duration
Prior authorization is required for Actimmune (INJ 100MCG/0.5ML); coverage duration is 12 months and continuation of prior therapy may be approved.
- Coverage duration: 12 months
- Continuation of prior therapy allowed
Product-specific prior authorization required
Submit a prior authorization request with product-specific clinical documentation demonstrating the patient meets the product's indication-specific criteria and any prescriber restrictions noted.
- Product-specific criteria include documented diagnosis and any required prior therapy or specialty prescriber/consultation.
- Initial and reauthorization durations commonly specified (e.g., 6 or 12 months).
PA required for listed specialty drugs
Obtain prior authorization for specialty products listed in the policy; include indication-specific documentation and request the coverage duration indicated (often 12 months).
- Approval contingent on meeting the product's diagnostic and prior-therapy requirements.
- Many products allow continuation of prior therapy when prior approval criteria were previously met.
Avtozma — submit indication and diagnostic evidence
For Avtozma requests, provide documentation of the specific rheumatologic or SSc‑ILD diagnosis and required supporting tests (e.g., HRCT or biopsy for SSc‑ILD) and either trials/failures of listed agents or an attestation why trials are inappropriate.
- Prescriber: prescribed by or in consultation with a rheumatologist for RA, GCA, SJIA, PJIA; appropriate specialist for SSc‑ILD.
- Initial coverage typically 6 months; reauthorization 12 months with evidence of clinical response.
PA and prescriber restrictions for listed specialty products
Prior authorization is required for the specialty products in this section; initial SSc‑ILD and other indications may require specialist prescribing or consultation and the durations shown.
- Initial durations commonly 6 months for listed rheumatology indications; reauthorization 12 months.
- Document trials/failures or rationale for not attempting specified prior therapies when required.
Bronchitol — PA and BTT documentation
Prior authorization for Bronchitol requires documentation of a cystic fibrosis diagnosis and that the patient passed the Bronchitol Tolerance Test (BTT); initial approvals are for 6 months with reauthorization at 12 months.
- Include evidence the patient passed the BTT.
- Reauthorization requires demonstration of benefit.
- Prescribed by or in consultation with a pulmonologist or specialist.
Brukinsa — PA and prior‑therapy documentation
Prior authorization for Brukinsa requires documentation of the specific lymphoma/leukemia diagnosis and prior therapy history (e.g., prior therapy for MCL or anti‑CD20 regimen for MZL); coverage duration is 12 months.
- Document prior lines of therapy or intolerance/contraindication where required.
- Many Brukinsa indications require prior Part D prerequisite therapy per the entry.
Cablivi — PA must include administration and aTTP details
Prior authorization for Cablivi requires documentation of acquired thrombotic thrombocytopenic purpura (aTTP), confirmation that first dose will/were administered by a healthcare provider as a bolus IV injection, and combination therapy/plasma exchange details; coverage duration is 3 months.
- Document use in combination with immunosuppressive therapy and plasma exchange status (ongoing or completed <59 days).
- Prescribed by or in consultation with a hematologist/oncologist.
Cabometyx — PA and prior‑therapy evidence required
For Cabometyx prior authorization, provide diagnosis of the relevant malignancy and documentation of prior targeted therapy failures or contraindications (e.g., prior sorafenib for some RCC indications); coverage duration is 12 months.
- Document prior VEGFR‑targeted therapy failure for DTC or prior sorafenib where specified.
- Include tumor type and prior systemic therapy history.
Calquence — PA with diagnosis and prior‑therapy/transplant info
Prior authorization for Calquence requires documentation of the indicated diagnosis (e.g., mantle cell lymphoma, CLL/SLL) and prior therapy/transplant eligibility status as applicable; coverage duration is 12 months.
- Document whether patient is treatment‑naïve or previously treated and transplant eligibility when relevant.
- Approve continuation of prior therapy when criteria previously met.
Caplyta — PA requires documented prior antipsychotic trials
Caplyta PA requests must include the labeled psychiatric diagnosis and documentation of trial and failure, contraindication, or intolerance to the specified oral generic atypical antipsychotics per indication; coverage duration is 12 months.
- Specify which prior agents were tried and the reason for failure/contraindication/intolerance.
- Approve continuation of prior therapy when applicable.
Caprelsa — PA requires MTC diagnosis and disease status
Caprelsa prior authorization requires documentation of metastatic or unresectable locally advanced medullary thyroid cancer with symptomatic or progressive disease; coverage duration is 12 months.
- Document disease status (symptomatic or progressive) and prior treatments as applicable.
Cayston — PA requires pathogen evidence and age
Cayston prior authorization requires evidence of Pseudomonas aeruginosa in the lungs and age ≥7 years for initial CF use; reauthorization requires evidence the patient is benefiting from treatment.
- Provide microbiology demonstrating Pseudomonas aeruginosa.
- Document clinical benefit at reauthorization (improved outcomes or fewer exacerbations).
Cerdelga — PA requires CYP2D6 genotype and age
Cerdelga prior authorization requires a diagnosis of Gaucher disease type 1 and documentation of CYP2D6 metabolizer status by an FDA‑cleared test (EM, IM, or PM); coverage duration is 12 months and age ≥18 years.
- Include the FDA‑cleared CYP2D6 test result showing metabolizer status.
- Confirm diagnosis of Gaucher disease type 1 and patient age ≥18.
Cerdelga — CYP2D6 metabolizer result required
Include documentation of CYP2D6 metabolizer status (extensive, intermediate, or poor metabolizer) when requesting Cerdelga; PA approval is granted for 12 months when criteria met.
- Use an FDA‑cleared test result for CYP2D6 status.
- Document that patient meets disease and age criteria.
Chenodal — PA requires imaging, ursodiol trial, and surgery candidacy
Chenodal prior authorization requires diagnostic confirmation of radiolucent gallstones, visualization of a well‑opacifying gallbladder on oral cholecystography, documentation that the patient is not a surgical candidate, and trial/failure/contraindication to ursodiol; initial and reauthorization durations are 12 months.
- Provide oral cholecystogram or ultrasound evidence and documentation regarding surgery candidacy.
- Document the trial/failure or intolerance to ursodiol.
Cholbam — PA requires metabolic/genetic testing and response data
Cholbam prior authorization requires specific diagnostic testing for bile acid synthesis disorders or peroxisomal disorders (abnormal urinary bile acid analysis by mass spectrometry or molecular genetic testing); initial coverage is 4 months with reauthorization at 12 months and evidence of clinical response.
- Submit urinary bile acid analysis by mass spectrometry or molecular genetic testing results.
- For reauth, provide evidence of improved liver function or clinical response.
Ciclopirox — PA requires mycologic confirmation and terbinafine trial
Ciclopirox nail lacquer PA requires confirmation of onychomycosis (KOH, culture, or histology), absence of lunula involvement, and documentation of trial and failure/contraindication/intolerance to oral terbinafine (≥6 weeks fingernails, ≥12 weeks toenails); coverage duration is 48 weeks.
- Provide laboratory confirmation (KOH, culture, or histology) and specify target nail involvement.
- Document duration and outcome of prior oral terbinafine therapy.
Cinryze — PA requires HAE diagnostic labs and specialist prescriber
Cinryze PA for HAE prophylaxis requires laboratory confirmation of HAE (low C4 and C1‑INH antigenic or functional deficiency) or diagnostic evidence for HAE‑nl‑C1INH (mutation or family history), specialist prescription/consultation, and age ≥6 years; coverage duration is 12 months.
- Include C4 and C1‑INH antigenic or functional levels or genetic testing/family history for HAE‑nl‑C1INH.
- Confirm prescriber is an immunologist or allergist and that Cinryze is not combined with other prophylactic HAE agents.
Cobenfy — PA requires intolerance to two listed antipsychotics
Cobenfy prior authorization requires documentation that the patient is intolerant to two listed oral generic atypical antipsychotics; continuation of prior therapy may be approved.
- List the two atypical antipsychotics attempted and reasons for intolerance.
- Indicate if request is for continuation of previously approved therapy.
Cometriq — PA requires documented MTC diagnosis
Cometriq PA requires documentation of metastatic medullary thyroid cancer diagnosis; coverage duration is 12 months and prior therapy continuation may be approved.
- Provide pathology/clinical documentation of metastatic MTC.
- Include prior therapy history when requesting continuation.
Copiktra — PA requires prior‑therapy failure documentation
Copiktra prior authorization for relapsed/refractory CLL/SLL requires diagnosis documentation and trial/failure or intolerance to at least two prior therapies; include prior therapy details.
- List prior CLL/SLL therapies tried and outcomes.
- Criterion indicates prerequisite Part D drug required.
Cosentyx — PA and required disease severity/prior trials
Prior authorization is required for Cosentyx products; include the indication, documentation of required diagnostic severity (e.g., BSA ≥3% for plaque psoriasis) and prior therapy trials or biologic comparators as specified.
- Initial coverage commonly 6 months; reauthorization 12 months.
- For some IV indications, document trial and failure/contraindication/intolerance to two specified agents or continuation of prior therapy.
Cyclobenzaprine — PA and prescriber risk acknowledgment for 65+
For cyclobenzaprine in patients aged 65+, prior authorization applies and prescriber must acknowledge anticholinergic risks and document the indicated diagnosis.
- PA applies to patients 65 years or older.
- Prescriber must acknowledge anticholinergic risks (confusion, dry mouth, blurred vision, constipation, urinary retention).
Diacomit — PA requires DS diagnosis, clobazam and weight/age
Diacomit prior authorization requires documentation of seizures associated with Dravet syndrome, concomitant clobazam use, patient weight ≥7 kg, patient age ≥6 months, and neurologist involvement; coverage is 12 months and continuation allowed.
- Include documentation that patient is taking clobazam and weight/age evidence.
- Prescriber: neurologist or consultation with one.
Doptelet — PA with platelet thresholds and prior therapy history
Doptelet prior authorization requires indication‑specific documentation: for TPPP document chronic liver disease, planned procedure, and baseline platelets <50,000/mcL (1‑month coverage); for ITP document baseline platelets <30,000/mcL and trial/failure of corticosteroids, immunoglobulins, or splenectomy (initial/reauth 12 months).
- Provide baseline platelet counts and prior therapy trials or contraindications.
- Reauthorization requires evidence of platelet response to avoid bleeding.
Dupixent — PA requires eosinophil counts and prior controller trials
Dupixent prior authorization requires indication‑specific laboratory/clinical thresholds (e.g., eosinophils ≥150 cells/mcL for eosinophilic asthma), prior controller therapy trials per age, and appropriate specialist involvement; document exacerbation history where indicated.
- Include baseline eosinophil counts and prior asthma controller regimens per age group.
- Reauthorization requires demonstrated clinical response.
Ebglyss — PA requires severity measures and prior topical therapy
Ebglyss prior authorization for moderate‑to‑severe atopic dermatitis requires diagnosis, patient ≥12 years and ≥40 kg, BSA ≥10% or SCORAD ≥25, and trial/failure of specified topical/systemic therapies; initial coverage 6 months, reauth 12 months.
- Provide weight, BSA or SCORAD, and prior topical corticosteroid trial details.
- Prescriber: dermatologist or consultation with one.
Emgality — PA requires headache frequency and exclusion of concurrent CGRP therapy
Emgality prior authorization requires diagnosis and frequency thresholds for migraine/cluster headache (e.g., ≥4 migraine days/month for episodic migraine; ≥8 for chronic), age ≥18 for EM/CM/ECH, and exclusion of concurrent injectable CGRP inhibitors; coverage durations vary (initial 3–6 months).
- Document migraine day frequency and prior acute medication use decrease at reauth.
- Do not combine with another injectable CGRP inhibitor for prevention.
Empaveli — PA requires diagnosis and prior 12‑week RAAS/SGLT2 therapy for C3G/IC‑MPGN
Empaveli prior authorization requires documented diagnosis of PNH or C3G/primary IC‑MPGN; for C3G/IC‑MPGN the patient must have been treated with maximally tolerated ACE inhibitor/ARB or SGLT2 inhibitor for ≥12 weeks prior to initiation; coverage duration is 12 months.
- Include documentation of prior 12‑week RAAS or SGLT2 therapy when applicable.
- Prescriber: hematologist/oncologist for PNH; specialist for glomerulopathies.
PA required — common 12‑month duration and continuation allowance
Prior authorization is required for the specialty products in this excerpt; approvals are commonly for 12 months and continuation of prior therapy is often allowed when criteria have previously been met.
- Many products in the policy specify 12‑month approval durations.
- Document prior approvals and prior therapy history for continuation requests.
PA — include recent labs and treatment context for HCV/anemia
For HCV/anemia examples and similar products, submit indication‑specific documentation including recent lab values (e.g., Hct/Hgb within specified windows) and treatment context (e.g., concurrent ribavirin plus interferon); PA is required.
- Provide labs collected within required timeframes (e.g., within 30 days).
- Document concurrent antiviral regimen when applicable.
PA for asthma/EGPA/HES — include eosinophil counts and exacerbation history
For asthma, EGPA, and HES indications, prior authorization is required with specified initial durations (e.g., asthma initial 6 months) and reauthorization at 12 months; include baseline eosinophil levels and exacerbation/hospitalization history as required.
- Asthma: baseline eosinophils ≥150 cells/µL and documented exacerbation history.
- HES: pre‑treatment eosinophils ≥1000 cells/µL and FIP1L1‑PDGFRA negativity; rule out secondary causes.
Fruzaqla — PA requires prior chemo, anti‑VEGF and tumor RAS status
Fruzaqla prior authorization requires documentation of metastatic colorectal cancer and prior treatment with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy plus prior anti‑VEGF therapy; include RAS status and prior anti‑EGFR and later‑line therapy history as applicable.
- Document tumor RAS status (mutant vs wild‑type) and prior exposure to anti‑EGFR agents when RAS wild‑type.
- Coverage duration: 12 months.
Gavreto — PA requires RET fusion testing and disease context
Gavreto prior authorization requires documentation of the diagnosis and RET fusion‑positive tumor detected by an FDA‑approved or CLIA‑approved test; for thyroid cancer, document radioactive iodine‑refractory disease or that radioactive iodine is inappropriate; coverage is 12 months.
- Include the RET fusion test result and tumor site (NSCLC or thyroid).
- Age restriction for thyroid cancer: patient ≥12 years.
PA required — common 12‑month approvals (check exceptions)
Prior authorization is required for many products in this segment; typical approval durations are 12 months though some initial approvals are 6 months — always request the duration listed for the product.
- Check product entry for specific initial and reauthorization durations.
- Continuation of prior therapy is commonly approved when prior criteria were met.
PA required — typical 12‑month approvals with exceptions
Prior authorization is required for the products listed; approval durations are typically 12 months (exceptions such as shorter initial durations are noted in individual entries).
- Verify product‑specific durations (e.g., Igalmi 14 days).
- Provide documentation of prior therapy and disease severity per the product criteria.
Prerequisite therapy — verify product entry (Actimmune: none)
No prerequisite Part D drug is required for many product entries (including Actimmune) — verify the specific product entry to confirm whether a prerequisite Part D drug is required.
- Actimmune: criteria does NOT require use of a prerequisite Part D drug.
- Always confirm prerequisite therapy status in the product's entry.
Everolimus — document specified prior therapy trials/failures
For certain everolimus indications (e.g., renal cell carcinoma or hormone receptor‑positive breast cancer), document trial and failure, contraindication, or intolerance to the specified prior agents (sunitinib, sorafenib, letrozole, anastrozole) before approval.
- Include documentation of prior agent names, durations, and failure/contraindication details.
- Coverage duration typically 12 months.
Rheumatology — prerequisite trials or attestation required
For several rheumatologic indications (e.g., Avtozma/biologic entries), document trial and failure or contraindication/intolerance to two listed alternative agents or provide an attestation why trials are inappropriate.
- List prior biologics or DMARDs tried and outcomes.
- Attestation allowed when trials are inappropriate.
Prerequisite Part D drug — confirm and document when required
Some product entries explicitly require prior Part D drug therapy (e.g., everolimus, Besremi, Braftovi); confirm and document use of the prerequisite Part D drug when indicated.
- Actively check the product entry for 'Prerequisite Therapy' requirement.
- If required, document prior Part D drug names and trial outcomes.
Caplyta — prior trials of specified oral antipsychotics required
Caplyta requires a trial and failure, contraindication, or intolerance to specified oral generic atypical antipsychotics for labeled indications prior to approval.
- Document which oral atypical antipsychotics were tried and reasons they were unsuccessful or contraindicated.
Cabometyx — sorafenib trial/failure documentation required for some RCC uses
For Cabometyx in some RCC indications, document trial and failure, contraindication, or intolerance to sorafenib prior to approval.
- Provide details of prior sorafenib therapy and reasons for discontinuation.
Step therapy — document prior therapy trials and failures as specified
Many products require documented trial and failure (or contraindication/intolerance) to specific prior therapies (examples: Chenodal requires trial/failure of ursodiol; Ciclopirox requires trial/failure of oral terbinafine; Copiktra requires failure of at least two prior CLL/SLL therapies).
- Provide prior therapy names, dates, and reasons for failure/intolerance.
- If trials are inappropriate, include clinician attestation explaining rationale.
Cosentyx IV — two‑agent trial requirement for initial approval
Cosentyx IV initial approval requires trial and failure/contraindication/intolerance to two specified agents (examples include Cosentyx SC and other listed biologics) unless continuation of prior therapy is documented.
- Document two prior biologic/small molecule comparator trials and outcomes.
- Alternatively document continuation of previously approved IV therapy.
Prerequisite Part D drug — supply prior‑therapy details when required
When a product entry states a prerequisite Part D drug is required, include documentation of that prior Part D therapy (agent name, dates, and reason for failure/intolerance) with the PA request.
- Examples in the policy indicate some products do require prerequisite Part D drugs; confirm per product entry.
Empaveli — document ≥12‑week ACEi/ARB/SGLT2 trial for glomerulopathy indications
Empaveli for C3G/primary IC‑MPGN requires documentation that the patient was treated with a maximally tolerated dose of an ACE inhibitor, ARB, or SGLT2 inhibitor for at least 12 weeks prior to initiating therapy.
- Provide medication name(s), dosing, and documentation of the 12‑week trial.
- Confirm patient age ≥12 for these indications.
Dupixent — document prior controller therapy per age group
Dupixent PA for asthma/eosinophilic phenotypes requires documentation of prior controller regimens per age group (medium/high‑dose ICS plus additional controller or maximally dosed combination ICS/LABA) unless contraindicated.
- Include current inhaled controller regimen and justification if unable to trial required controllers.
- Provide exacerbation or hospitalization history as specified.
Ebglyss — prior topical corticosteroid trial required
Ebglyss PA requires prior trial/failure/contraindication/intolerance to medium or higher potency topical corticosteroids (and other listed topical agents) before approval.
- Document the topical corticosteroid trial duration and response or intolerance.
- Provide weight, BSA/SCORAD, and prescriber specialty information.
Step therapy — document required prior trials or provide attestation
Many products include step therapy or prerequisite therapy requirements (e.g., ACEi/ARB/SGLT2 for glomerulopathies; conventional DMARDs for RA; topical agents for psoriasis); document trials, failures, and reasons for intolerance or contraindication.
- List prior agents, trial durations, and objective evidence of failure/intolerance.
- If trials are not done, include clinician attestation explaining why.
Prerequisite Part D drug — verify when NOT required
Clarifying: several product entries explicitly state that a prerequisite Part D drug is not required for approval; verify the specific product block (e.g., Actimmune).
- Actimmune: criteria does NOT require use of a prerequisite Part D drug.
- Check each product entry for whether prerequisite Part D drug is required or not.
Asthma — document trials/intolerance to specified inhaled controller regimens
For asthma and related indications with step requirements, document trials, intolerance, or contraindication to the specified inhaled corticosteroid regimens and additional controller therapy per age group in the PA submission.
- For ages 6–11: medium‑dose ICS plus additional controller or medium‑dose ICS/LABA combination.
- For ≥12: high‑dose ICS plus additional controller or maximally‑dosed combination ICS/LABA.
Fruzaqla — document specified prior chemo, anti‑VEGF, and RAS‑dependent therapy
Fruzaqla requires prior use of specified chemotherapy regimens and an anti‑VEGF agent; include prior anti‑EGFR therapy and later‑line agents (trifluridine/tipiracil or regorafenib) when RAS wild‑type as applicable.
- Document prior fluoropyrimidine/oxaliplatin/irinotecan regimens and anti‑VEGF therapy.
- Provide tumor RAS status and subsequent therapy history per product logic.
Humira — document 3‑month conventional DMARD trial for RA initial requests
Humira initial RA requests require documentation of a minimum 3‑month trial and failure (or contraindication/intolerance) to a conventional DMARD (methotrexate, leflunomide, or sulfasalazine) at maximally tolerated doses.
- Provide DMARD trial dates, doses, and reason for failure/intolerance.
- Continuation requests require demonstration of positive clinical response.
Hyrnuo — prior systemic therapy documentation required
Hyrnuo criteria require prior systemic therapy; when the product entry indicates a prerequisite Part D drug is required, include documentation of that prior systemic therapy.
- Document prior systemic therapy names and outcomes.
- Confirm presence of HER2 activating mutation per testing when applicable.
Step therapy — supply detailed prior therapy history to support PA
Many products require trial and failure (or contraindication/intolerance) of specified prior therapies — provide detailed prior therapy history (agents, durations, outcomes) with the PA to avoid delays or denials.
- Examples include requirements for inpatient/outpatient oncology, psychiatric acute agitation agents, Parkinson's OFF episode agents, and conventional IBD therapies.
- If trials are inappropriate, include clinician attestation explaining rationale.
Actimmune — include required diagnosis documentation
Provide documentation of the primary diagnosis when requesting Actimmune: chronic granulomatous disease (CGD) or severe malignant osteopetrosis (SMO).
- Include clinical records confirming CGD or SMO as required medical information.
PAH products — document right heart catheterization or current PAH therapy
For PAH products (e.g., Adempas), document whether the diagnosis was confirmed by right heart catheterization or that the patient is currently on therapy for PAH when required by the product entry.
- Include right heart catheterization confirmation if available, or current PAH therapy details.
Dalfampridine — document MS diagnosis and walking impairment
For dalfampridine, include a diagnosis of multiple sclerosis and physician confirmation that the patient has difficulty walking (for example, a timed 25‑foot walk) to support the PA.
- Document the walking impairment assessment and any EDSS score if available.
Arikayce — document persistent MAC after ≥6 months multidrug therapy
For Arikayce, include documentation that MAC lung disease persists after at least 6 consecutive months of a multidrug background regimen and that sputum cultures did not achieve at least two negatives.
- Provide microbiology results and prior multidrug regimen details and duration (≥6 months).
Augtyro — include ROS1/NTRK testing and prior therapy history
For Augtyro, include tumor testing demonstrating ROS1 rearrangement for NSCLC or NTRK fusion for applicable solid tumors, and prior treatment history or lack of satisfactory alternatives when applicable.
- Submit FDA‑approved or CLIA‑approved test results for ROS1 or NTRK fusions.
- Document prior therapies and reasons for Augtyro selection.
Avtozma — supply diagnosis, HRCT/biopsy for SSc‑ILD, and prior trials
For Avtozma PA requests, provide diagnosis‑specific documentation (RA, GCA, SJIA, PJIA, SSc‑ILD) and, for SSc‑ILD, HRCT and/or biopsy consistent with SSc‑ILD; include trials/failures or attestation why trials are inappropriate.
- Prescriber: rheumatologist or appropriate specialist for initial therapy.
- Initial coverage commonly 6 months; reauth 12 months with clinical response.
Benlysta — include autoantibody results and concurrent SOC therapy
For Benlysta initiation in SLE, include documentation of active SLE, positive autoantibody (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), and current use of at least one standard‑of‑care therapy.
- Provide antibody titers and current standard‑of‑care medications.
Ayvakit — include PDGFRA exon‑18 mutation or platelet count for mastocytosis
For Ayvakit, include the diagnosis and PDGFRA exon 18 mutation (e.g., D842V) or AdvSM/ISM diagnosis and platelet count ≥50 x10^9/L where applicable.
- Submit genetic testing confirming PDGFRA exon 18 mutation when claiming GIST indication.
- Provide platelet count and disease subtype documentation for mastocytosis indications.
Balversa — include FGFR3 testing and prior systemic therapy
For Balversa, include urothelial carcinoma staging and documentation of a susceptible FGFR3 alteration by an FDA‑approved or CLIA‑approved test and prior systemic therapy history.
- Provide FGFR3 test results and prior systemic therapy dates and outcomes.
Bronchitol — include CF diagnosis and BTT results
For Bronchitol initial PA, include documentation the patient has cystic fibrosis and that they passed the Bronchitol Tolerance Test (BTT).
- Attach BTT results and CF diagnosis documentation.
- Prescriber: pulmonologist or specialist for initial therapy.
Brukinsa — include detailed prior‑therapy history per indication
For Brukinsa, provide diagnosis and prior therapy history appropriate to the specific indication (e.g., number and type of prior lines of therapy, anti‑CD20 exposure for MZL).
- List prior regimens and reasons for discontinuation or intolerance.
- Indicate prescriber specialty if required.
Cablivi — document aTTP, IV administration, and plasma exchange status
For Cablivi, include diagnosis of aTTP and documentation that the first dose was/will be administered by a healthcare provider as a bolus IV injection and concomitant immunosuppressive/plasma exchange details.
- Document timing of plasma exchange and immunosuppressive therapy.
- Confirm hematology/oncology prescriber involvement.
Cabometyx — include tumor diagnosis and prior targeted therapy failures
For Cabometyx, include diagnosis of the relevant malignancy and documentation of prior targeted therapy failures or contraindications (e.g., prior VEGFR‑targeted therapy or sorafenib as specified).
- Provide prior targeted therapy names, dates, and reasons for failure/intolerance.
- Include tumor type and staging documentation.
Calquence — include diagnosis and prior therapy/transplant eligibility details
For Calquence, provide diagnosis of mantle cell lymphoma or CLL/SLL and documentation of prior therapy status and transplant eligibility as applicable.
- Document whether patient is treatment‑naïve or previously treated and transplant eligibility details.
- Include prior therapy regimens and outcomes.
Caplyta — include psychiatric diagnosis and prior agent trial details
For Caplyta, include the labeled psychiatric diagnosis and documentation of trials and failures, contraindications, or intolerances to the specified alternative agents per indication.
- Document the specific agents trialed and the clinical rationale for Caplyta initiation.
- Indicate prescriber specialty if applicable.
Caprelsa — include MTC disease documentation
For Caprelsa, include documentation of metastatic or unresectable locally advanced medullary thyroid cancer with symptomatic or progressive disease.
- Provide imaging/pathology and clinical course supporting symptomatic or progressive MTC.
Cayston — include pathogen test and age; show benefit at reauth
For Cayston, include evidence of Pseudomonas aeruginosa in the lungs and patient age (≥7 years for initial CF use); at reauthorization, provide evidence of clinical benefit.
- Attach microbiology demonstrating Pseudomonas aeruginosa.
- Provide clinical response data at reauthorization (improved pulmonary outcomes or fewer exacerbations).
Cerdelga — include CYP2D6 test and Gaucher diagnosis
For Cerdelga, include an FDA‑cleared CYP2D6 test result showing EM, IM, or PM status and documentation of Gaucher disease type 1; age ≥18 years applies.
- Attach CYP2D6 test report and confirm patient age and diagnosis.
- Coverage duration: 12 months.
Cerdelga — required CYP2D6 diagnostic testing
Provide required diagnostic testing for Cerdelga requests: an FDA‑cleared CYP2D6 test demonstrating metabolizer status (EM/IM/PM) is required to support the PA.
- Test must be FDA‑cleared or performed at a CLIA‑approved facility.
- State the detected metabolizer phenotype in the documentation.
Policy Definitions and Background Notes
Actimmune (interferon gamma‑1b) is listed as a specialty product with narrow, indication‑specific coverage. The policy requires documentation of one of two defined diagnoses: chronic granulomatous disease (CGD) or severe malignant osteopetrosis (SMO). The Actimmune segment sets a standard coverage duration of 12 months, allows approval for continuation of prior therapy when previously authorized, and explicitly records that no prerequisite Part D drug is required for initial approval. Off‑label uses and exclusion lists are shown as N/A in this Actimmune entry in the excerpt.
Policy Revision History
Policy effective date updated to 08/01/2026; coverage criteria and product listings effective on this date.
Policy content last revised/reviewed on 07/02/2026 reflecting updates across product-specific criteria and Formulary ID 26216 (Version 15).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.