CurrentCareSourcePolicy N/A

Part 1: CareSource drug prior authorization policy — product-specific coverage and PA criteria (multiple specialty drugs)

Part 1 of a multi-part CareSource drug prior authorization policy listing product-specific coverage and PA criteria including exclusions (concurrent biologic/DMARD use), required documentation, prescriber and age restrictions, coverage duration, and indication-specific approval rules. Part B vs Part D determinations deferred to PA review per CMS guidance for several products.

Policy Summary

PayerCareSource

PolicyPart 1: CareSource drug prior authorization policy — product-specific coverage and PA criteria (multiple specialty drugs)

Policy CodePolicy N/A

Change TypeN/A

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests with diagnosis, required test results (mutation/genetic or imaging/lab where specified), prior therapy history, and documentation of specialist prescriber or consultation as required per product.

40+Products detailed in part

ManyRequire specialist prescriber

SeveralRequire genetic/molecular tests

MultipleHave lab/diagnostic thresholds

ManyRequire prior therapy trials

Coverage Summary & Scope

Scope: Part 1 of a multi-part CareSource drug prior authorization (PA) file covering many specialty drugs. General stance: mixed — coverage is permitted for numerous agents but most require PA and often prior trials, specialist prescribers, diagnostic confirmation, or exclusions. Common themes: PA required; many entries require a specialist prescriber or consultation (e.g., rheumatologist, oncologist, pulmonologist); molecular/genetic or imaging/lab test confirmation is required for many oncology/precision therapies; explicit exclusions and concurrent-therapy prohibitions are frequent. Part B vs Part D: several oncology and infused agents defer Part B vs Part D determinations to PA review per CMS guidance. This part contains product-specific entries and operational criteria for categories such as oncology targeted therapies, autoimmune biologics, enzyme replacements, CFTR modulators, PAH agents, and related supplies.

Operational summary

Coverage duration commonTypically 1 year (some agents/indications have shorter initial authorizations)

Prior authorizationRequired for listed specialty products; submit diagnosis, prior therapies and supporting tests

Part B vs Part DBenefit (Part B vs Part D) determinations made at PA review for many oncology/infusible agents per CMS guidance

Specialist requirementMany agents require prescribed by or consultation with a relevant specialist (eg, rheumatologist, oncologist, pulmonologist) for initial therapy

Initial Therapy Criteria (by product / indication)

ACTEMRA INTRAVENOUS - Initial Therapy

Initial Therapy — ACTEMRA (intravenous)

ALL of the following

Diagnosis of an FDA‑approved indication for tocilizumab (ACTEMRA) documented in the medical record.
Prescribed by or in consultation with a rheumatologist for RA, SJIA, PJIA, or GCA (initial therapy only).
RA - initial (one of the following)
- Patient has tried ONE of the following: etanercept (Enbrel), a preferred adalimumab product (eg, Hadlima, Simlandi), upadacitinib (Rinvoq), or tofacitinib/XR (Xeljanz/XR).
- If the patient did not try a preferred agent above, prior trial(s) with: certolizumab (Cimzia), sarilumab (Kevzara), infliximab, golimumab SC/IV, abatacept (Orencia), or a non‑preferred adalimumab product will also count as meeting the requirement.

Continuation Therapy Criteria

Exclusions & Concurrent-use Restrictions

Some products explicitly state that the Part B versus Part D benefit determination will be made at prior authorization review per CMS guidance. Examples referenced in this part include ADSTILADRIN, BLENREP, COLUMVI, and multiple other oncology biologic/infusible agents; coverage and benefit assignment can depend on the drug, indication, and setting of care and will be decided during PA review.

Applicable Codes

Products listed in this part (examples)mixed

PRODUCT

Multiple named products appear (ACTEMRA IV, ACTEMRA ACTPEN, ACTEMRA SC, ACTIMMUNE, HADLIMA, SIMLANDI, BENLYSTA, ARIKAYCE, etc.). Specific CPT/HCPCS/NDC codes not provided in this part.

Products listed in this segmentmixedCovered

BETASERON SUBCUTANEOUS KIT	Interferon beta-1b product listing
BEXAROTENE	Oral retinoid for cutaneous T-cell lymphoma and other indications
BIZENGRI	Targeted therapy for NRG1 fusion-positive tumors
BLENREP	Belantamab mafodotin - multiple myeloma
IBANDRONATE INTRAVENOUS	IV bisphosphonate for osteoporosis
AMBIRENSENTAN/BOSENTAN	Endothelin receptor antagonists
BOSULIF ORAL CAPSULE/TABLET (dasatinib)	Tyrosine kinase inhibitor
BRAFTOVI	Encorafenib (BRAF inhibitor)
BRIUMVI	Anti-CD20 monoclonal antibody for MS
BRUKINSA ORAL TABLET	Zanubrutinib

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Products listed in this segment (representative SKUs/labels)mixed

COSENTYX (2 SYRINGES)	secukinumab product listing from document
COSENTYX PEN	secukinumab pen
COSENTYX INTRAVENOUS	secukinumab IV
COTELLIC	cobimetinib
CRESEMBA ORAL	isavuconazole oral
CRYSVITA	burosumab
CYSTARAN	cysteamine ophthalmic
CYSTAGON	cysteamine oral
dalfampridine	dalpamarpridine
DATROWAY	datopotamab deruxtecan?

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No explicit CPT/HCPCS/ICD-10 codes listed in this partmixed

No codes listed

No codes listed in this partmixed

No codes listed

No codes listed in this partmixed

No codes listed

No procedure/CPT/HCPCS/ICD codes provided in this partmixed

No codes listed

Products listed in this section (medical/Part B drugs)mixedCovered

OPSUMIT	macitentan (product name listed as OPSUMIT)
OPSYNVI	iselin? (OPSYNVI product listed)
ORGOVYX	relugolix
ORKAMBI	lumacaftor/ivacaftor (oral granules/tablet)
ORSERDU	elacestrant
OTEZLA	apremilast
OXERVATE	cenegermin-bkbj ophthalmic
PADCEV	enfortumab vedotin-ejfv
PANRETIN	alitretinoin
PAVBLU	intraocular oncology drug

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Drugs mentioned (product list in this fragment)NDC|mixedCovered

treprostinil sodium	Product - PAH
REPATHA	evolocumab - PCSK9 inhibitor
REPATHA SURECLICK	Repatha autoinjector
RETEVMO ORAL TABLET 120 MG, 160 MG, 40 MG, 80 MG	selpercatinib
REVCOVI	PEG-ADA (enzyme replacement) for ADA-SCID
REVUFORJ ORAL TABLET 110 MG, 160 MG	acute leukemia agent
REZDIFFRA	Rezdiffra (product) - MASH/NASH
REZLIDHIA	Rezlidhia - IDH1 AML
REZUROCK	Rezurock - graft-versus-host disease
riluzole	ALS agent

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Drugs listed (by name) in this partmixed

SOFOSBUVIR-VELPATASVIR	Hepatitis C antiviral
diclofenac sodium topical gel 3%	Topical NSAID
SOMAVERT	Pegvisomant for acromegaly
sorafenib	Multi-kinase inhibitor
SPRAVATO NASAL SPRAY 56 mg/84 mg	Esketamine nasal spray
dasatinib	BCR-ABL TKI
STIVARGA	Regorafenib
STRENSIQ	Asfotase alfa
SUCRAID	Sucrose-isomaltase enzyme replacement
sunitinib malate	Multi-targeted TKI

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NDC-specific note (Pyzchiva only)NDC

61314*

Pyzchiva products only NDCs starting with 61314 per policy text

Products listed in this part (DRUG NAMES)mixed

tobramycin	tobramycin in 0.225% nacl; tobramycin inhalation
tolvaptan	tolvaptan
EUCRISA	crisaborole topical
pimecrolimus	topical calcineurin inhibitor
tacrolimus topical	topical calcineurin inhibitor
tretinoin topical	topical retinoid
topiramate	oral capsule/tablet/solution
zonisamide	anticonvulsant
fentanyl patch	transdermal fentanyl 72 hour strengths
TRELSTAR	Trelstar intramuscular suspension for reconstitution

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No specific CPT/HCPCS/ICD-10 codes listed in this partmixed

No codes listed

No CPT/HCPCS/ICD-10/modifier codes explicitly listed in this partmixed

No codes listed

Listed drug products and formulations (alphabetical segment: N-Z)NDC|product_name|formulation

mycophenolate mofetil (hcl)	listed, index 586
mycophenolate sodium	listed, index 586
nilotinib hcl oral capsule 150 mg, 200 mg	listed
NUCALA SUBCUTANEOUS AUTO-INJECTOR	listed, indexes 327, 328, 329
NUCALA SUBCUTANEOUS RECON	listed
NUCALA SUBCUTANEOUS SYRINGE 100 MG/ML, 40 MG/0.4 ML	listed, indexes 327, 328, 329
RADICAVA ORS	listed, indexes 386, 387
RADICAVA ORS STARTER KIT SUSP	listed
RELEUKO SUBCUTANEOUS	listed, indexes 390, 391
REPATHA SURECLICK	listed, indexes 396, 397

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No specific CPT/HCPCS/ICD-10 codes listed in this partmixed

No codes listed

No CPT/HCPCS/ICD-10/modifier codes explicitly listed in this partmixed

No codes listed

Listed drug products and formulations (alphabetical segment: N-Z)NDC|product_name|formulation

mycophenolate mofetil (hcl)	listed, index 586
mycophenolate sodium	listed, index 586
nilotinib hcl oral capsule 150 mg, 200 mg	listed
NUCALA SUBCUTANEOUS AUTO-INJECTOR	listed, indexes 327, 328, 329
NUCALA SUBCUTANEOUS RECON	listed
NUCALA SUBCUTANEOUS SYRINGE 100 MG/ML, 40 MG/0.4 ML	listed, indexes 327, 328, 329
RADICAVA ORS	listed, indexes 386, 387
RADICAVA ORS STARTER KIT SUSP	listed
RELEUKO SUBCUTANEOUS	listed, indexes 390, 391
REPATHA SURECLICK	listed, indexes 396, 397

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1/8

No specific CPT/HCPCS/ICD-10 codes listed in this partmixed

No codes listed

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization required for listed specialty products; submit diagnosis, prior therapies tried, specialist consult documentation, and any required test results.

Prior authorization required per product-specific criteria — include drug name, indication, and requested duration.
Include mutation/genetic test results for targeted therapies (BRAF, ALK, RET, NTRK, IDH1/2, FGFR, EGFR, MET, PIK3CA, BRCA).
Right‑heart catheterization results for PAH agents (e.g., hemodynamics: mPAP, PCWP/PAWP, PVR) when specified.
Baseline labs and diagnostic tests as required (examples: ferritin for iron products, serum phosphorus/TmP‑GFR for phosphate wasting agents, LDL‑C for certain lipid agents, eosinophil counts, CMV PCR where specified).
Document PDMP check and opioid risk documentation for long‑acting opioids and SPRAVATO as applicable.

Clinical Evidence & Measurements Needed

Clinical evidence requirements in this segment are operational and tied to diagnostic tests, lab thresholds, and objective response measures rather than lists of clinical trials. Examples of objective measures used for continuation or response include: improvement in alkaline phosphatase or bilirubin for LIVDELZI (primary biliary cholangitis), CMV PCR DNA reduction within 4 weeks for LIVTENCITY (CMV), spirometry/FVC ≥40% predicted for IPF or pirfenidone, and reduction in monthly migraine days or number of severe migraine days for CGRP agents (Aimovig/Emgality/Qulipta).

≥ 4Migraine days/month threshold for preventive therapy (Aimovig/Emgality/Qulipta/Qulipta)

≥ 150Blood eosinophil threshold used for asthma biologic eligibility (Dupixent/Nucala)

1 yearTypical authorization duration for many specialty/oncology agents

Background & Definitions

Background: This file is Part 1 of a multi-part CareSource drug prior authorization policy. Per the file entries, Part B vs Part D determinations are deferred to PA review for several products per CMS guidance. Entries commonly specify exclusions (for example, concurrent biologic or DMARD use), required documentation (diagnosis, labs, imaging, molecular tests), prescriber and age restrictions, coverage duration (often 1 year unless otherwise noted), and indication-specific approval rules (prior therapy trials, objective thresholds, and response criteria).

Term	Definition
BCG-unresponsive	Refers to high-risk non-muscle invasive bladder cancer that does not respond to Bacillus Calmette-Guerin therapy (as used in ADSTILADRIN/ANKTIVA criteria).
NYHA	New York Heart Association functional classification for heart failure symptoms
PAH	Pulmonary arterial hypertension (WHO Group 1)
High-intensity statin	Atorvastatin >= 40 mg daily or rosuvastatin >= 20 mg daily.
Statin intolerance	Experiencing statin-related rhabdomyolysis or skeletal-related muscle symptoms while receiving separate trials of atorvastatin and rosuvastatin with symptom resolution upon discontinuation.
Transfusion-dependent anemia	Requires transfusion of >= 4 red blood cell units over an 8-week period (Rytelo criteria).
Part B versus Part D determination	Determination at prior authorization time whether the drug is reimbursed under Medicare Part B (medical benefit) or Part D (prescription drug benefit) per CMS guidance.

Revision History

noteLatest

No dated revision entries in this part — changes tracked at document-level across multi-part policy.

Policy Summary

PayerCareSource

PolicyPart 1: CareSource drug prior authorization policy — product-specific coverage and PA criteria (multiple specialty drugs)

Policy CodePolicy N/A

Change TypeN/A

Effective Date

Next Review Date

On This Page

OR patient has heart failure or a previously treated lymphoproliferative disorder (meets alternative exception).

PJIA - initial (one of the following)

Patient has tried ONE of the following: etanercept (Enbrel), upadacitinib (Rinvoq), tofacitinib (Xeljanz), or a preferred adalimumab product.
If the patient did not try a preferred agent above, prior trial(s) with sarilumab (Kevzara), infliximab, abatacept (Orencia), or a non‑preferred adalimumab product will also count.
OR patient has heart failure or a previously treated lymphoproliferative disorder.

Systemic‑onset JIA (SJIA): initial therapy is approved (per policy).

Giant cell arteritis (GCA): patient has tried or is currently taking a systemic corticosteroid, or corticosteroid therapy is contraindicated.

Age restrictions (initial therapy): GCA/RA: ≥18 years; PJIA/SJIA: ≥2 years (document age).

Concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded (do not approve).

Coverage duration: approve through end of plan year (initial authorization).

ACTEMRA INTRAVENOUS - Other Indications

Other Indications — ACTEMRA (intravenous)

ALL of the following

Diagnosis of the specific indication documented in the medical record (FDA‑approved indications accepted).
Other covered indications
- Systemic‑onset JIA (SJIA) — initial: approve.
- Cytokine release syndrome (CRS) associated with CAR‑T cell therapy — approve.
- Giant cell arteritis (GCA) — see initial criteria; for continuation see continuation rules.
Prescriber restriction: for RA, SJIA, PJIA, GCA prescribed by or in consultation with a rheumatologist (initial therapy).
Age restrictions: PJIA/SJIA ≥2 years; GCA/RA ≥18 years (initial therapy).
Note: preferred adalimumab products referenced in policy include Hadlima and Simlandi.
Concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded (do not approve for concurrent use).

ACTEMRA ACTPEN / SUBCUTANEOUS - Initial Therapy

Initial Therapy — ACTEMRA ActPen / Subcutaneous

ALL of the following

Diagnosis of an FDA‑approved indication for subcutaneous tocilizumab documented in the medical record.
Prescribed by or in consultation with a rheumatologist for RA, GCA, PJIA, SJIA (initial therapy only). For interstitial lung disease associated with systemic sclerosis initial and continuation require prescriber or consultation by pulmonologist or rheumatologist.
RA - initial (one of the following)
- Patient has tried ONE of: etanercept (Enbrel), a preferred adalimumab product (eg, Hadlima, Simlandi), upadacitinib (Rinvoq), or tofacitinib/XR (Xeljanz/XR).
- If not, prior trial(s) with: certolizumab (Cimzia), infliximab, sarilumab (Kevzara), golimumab SC/IV, non‑preferred adalimumab product, or abatacept (Orencia) will count.
- OR patient has heart failure or a previously treated lymphoproliferative disorder.
PJIA - initial (one of the following)
- Patient has tried ONE of: etanercept (Enbrel), upadacitinib (Rinvoq), tofacitinib (Xeljanz), or a preferred adalimumab product.
- If not, prior trial(s) with sarilumab (Kevzara), infliximab, abatacept (Orencia), or a non‑preferred adalimumab product will count.
- OR patient has heart failure or a previously treated lymphoproliferative disorder.
Systemic‑onset JIA (SJIA): initial therapy is approved.
Giant cell arteritis (GCA): patient has tried or is currently taking a systemic corticosteroid, or corticosteroid therapy is contraindicated.
Interstitial lung disease associated with systemic sclerosis: initial requires (A) elevated acute phase reactants and (B) diagnosis confirmed by high‑resolution CT.
Concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded.
Coverage duration: approve through end of plan year for initial therapy.

ACTIMMUNE

ACTIMMUNE — Indication‑specific requirements and prescriber restrictions

ALL of the following

Diagnosis documented for an FDA‑approved indication for ACTIMMUNE (interferon gamma‑1b).
Chronic granulomatous disease: diagnosis must be established by a molecular genetic test identifying a pathogenic variant associated with chronic granulomatous disease.
Malignant osteopetrosis (severe): approve if radiographic (X‑ray) imaging demonstrates skeletal features of osteopetrosis or a molecular genetic test identifies a pathogenic variant linked to severe malignant osteopetrosis.
Prescriber restrictions: chronic granulomatous disease — prescribed by or in consultation with an immunologist, hematologist, or infectious disease specialist. Malignant osteopetrosis — prescribed by or in consultation with an endocrinologist or hematologist.
Coverage duration: 1 year per authorization.

Additional Initial Therapy Criteria (sample products)

Initial Therapy — selected additional products (each group below preserves initial-therapy rules where explicit)

ALL of the following

Hadlima / Simlandi — Initial Therapy: diagnosis documented; prescribed by appropriate specialist per product (eg, rheumatologist, dermatologist, gastroenterologist depending on indication); initial‑therapy age limits apply as listed in product entries (examples: CD ≥6 years, UC ≥5 years, JIA/UV/Behcet’s ≥2 years, HS ≥12 years). Prior therapy requirements vary by indication (e.g., JIA: trial of one systemic agent or biologic unless contraindicated; HS: trial of one other therapy; PP: trial of at least one traditional systemic agent unless intolerant). Concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded. Coverage duration: through end of plan year.
ADBRY (tralokinumab) — Initial Therapy for Atopic Dermatitis: patient age ≥12 years; prescribed by or in consultation with allergist, immunologist or dermatologist (initial). Patient has moderate‑to‑severe atopic dermatitis involving ≥10% BSA and has trialed at least one prescription medium‑to‑super‑high potency topical corticosteroid with inadequate efficacy. Coverage duration for initial authorization: 4 months.
ADEMPAS (riociguat) — Initial Therapy (PAH/CTEPH): prescribed by or in consultation with a cardiologist or pulmonologist. Exclude concurrent use with PDE‑5 inhibitors or other soluble guanylate cyclase stimulators. Coverage duration: 1 year.
ADSTILADRIN (instillation) — Initial Therapy for non‑muscle invasive bladder cancer (NMIBC): diagnosis documented; prescriber specialty per product (urologist) and prior intravesical therapy requirements per product entry (policy notes initial approval for indicated disease states).
AIMOVIG (erenumab) — Initial Therapy for migraine prevention: diagnosis documented; prescribed by appropriate specialist (e.g., neurologist or pain specialist) per product entry; prior preventive therapy trials as required by product policy where specified.
AKEEGA (olaparib) — Initial Therapy for prostate cancer (mCRPC/mCSPC): tumor genomic testing documenting eligible alterations (e.g., HRR gene alterations) as required by product labeling; prescriber specialty oncology; prior therapy requirements per product entry.
ALDURAZYME, ALECENSA, ALUNBRIG, ANKTIVA (nadofaragene firadenovec for NMIBC) and ARIKAYCE — initial therapy rules: follow the product‑specific initial criteria in the full policy brief (diagnosis documentation, prescriber specialty, prior therapy trials, and any mutation or testing requirements).

Documentation Required

Specialist prescriber documentation

Many agents require prescription by or consultation with a specified specialist for initial therapy; include consult notes or certification with PA submission.

Rheumatologist: RA, PJIA, SJIA, GCA (Actemra, biologics).
Oncologist: cancer agents and many targeted therapies (include oncology consult notes and prior systemic regimen history).
Pulmonologist/Cardiologist: CF, PAH, CTEPH agents — include specialist consult and confirmatory testing (eg, right‑heart cath).
Neurologist: MS, ALS, epilepsy agents.
Allergist/Immunologist/Dermatologist: atopic dermatitis agents (e.g., Adbry) for initial therapy.

Documentation Required

Genetic / molecular / diagnostic test results required

For targeted agents, attach approved-test reports confirming mutation/fusion/expression (examples provided).

ALK rearrangement (approved assay report).
ROS1 fusion.
RET fusion or rearrangement.
NTRK gene fusion (validated test report).
BRAF V600 mutation.
EGFR activating mutations.
KRAS G12C.
PIK3CA mutation.
FGFR2 fusions.
BRCA1/2 (germline or tumor as specified).
IDH1/IDH2 mutations.
FLT3 mutation.
HER2 IHC3+ or amplification where required.

Step Therapy

Prior therapy trials required

Many products require documented trials of specific prior systemic therapies or classes; submit agent names, dates, durations, and reason for discontinuation.

Document prior regimen history for oncology agents (e.g., BLENREP requires ≥2 prior systemic regimens including a proteasome inhibitor and an IMiD).
Biologics/targeted DMARDs: document trials of conventional DMARDs or specified biologics (e.g., trials of Enbrel, a preferred adalimumab product, Rinvoq or Xeljanz/XR for Actemra RA criteria).
Atopic dermatitis: document topical corticosteroid trials of appropriate potency and duration before approval for Adbry.
Hidradenitis suppurativa, psoriasis, IBD: list required prior conventional or biologic therapies per product criteria.

Denial Risk

Denied if exclusion criteria met

Claims will be denied if concurrent excluded therapies are present or required diagnostic/threshold criteria are not met.

Concurrent biologic/targeted DMARDs — e.g., two biologic immunomodulators concurrently — is exclusionary and will result in denial.
Concurrent use exclusions for specific classes (e.g., concurrent phosphodiesterase inhibitors with ADEMPAS; concurrent CFTR modulators where contraindicated).
Combination DAAs or other product‑specific prohibited combos per drug policy will be denied.
Concurrent use of tolvaptan with Jynarque and other listed exclusionary combinations will be denied.
Failure to provide required diagnostic testing, mutation reports, right‑heart catheterization, baseline labs, PDMP check (where applicable), or prescriber specialty documentation may result in denial.

Billing Rule

Coverage duration & Part B/Part D notes

Authorization durations vary by product; many oncology and biologic agents default to 1 year. For several parenteral/oncology products Part B vs Part D determination will be decided at PA review per CMS guidance.

Coverage duration examples: many biologics/autoimmune agents — approve through end of plan year or 1 year; Actimmune — 1 year; ADEMPAS — 1 year; topical/systemic medications may have shorter initial authorization periods (e.g., Adbry initial 4 months, continuation 1 year).
Part B vs Part D: determine billing pathway (Part B or Part D) during PA review for several parenteral/oncology products (e.g., BLENREP and other oncology injectables) per CMS rules.
When requesting continuation, submit response documentation and baseline labs/results demonstrating ongoing benefit to support renewal and meet coverage duration constraints.