Blue Cross Blue Shield - Iowa Pegasys Coverage

Coverage and Medical Necessity Criteria

inv-01: Initial and continuation authorization criteria by indication

Covered when the FDA‑approved or compendial indication is met and any approval criteria (including use of preferred HCV agents when applicable) are satisfied.

A Chronic HCV: Refer to the drug policy of the requested regimen for specific criteria and approval durations; the health plan's preferred HCV agents (Epclusa, Harvoni, Mavyret, Vosevi) must be used before non-preferred agents unless there are clinical circumstances that exclude preferred agents or the patient is already on a non-preferred agent.

See chunk 7 and 8 for preferred-agent requirement and regimen-specific criteria.

B Chronic HBV (including HDV coinfection): Authorization of up to 48 weeks total may be granted for treatment of chronic HBV infection, including HDV coinfection.<=48 weeks

C Myeloproliferative neoplasm: Authorization of 12 months may be granted for treatment of myeloproliferative neoplasms (essential thrombocythemia, polycythemia vera, symptomatic lower‑risk myelofibrosis).12 months

Continuation authorization may require evidence of benefit (see continuation criteria).

D Systemic mastocytosis: Authorization of 12 months may be granted for treatment of systemic mastocytosis.12 months

Continuation may require evidence of clinical benefit (see continuation criteria).

E Adult T-Cell Leukemia/Lymphoma: Authorization of 12 months may be granted for treatment of adult T‑Cell leukemia/lymphoma.12 months

F Mycosis Fungoides/Sezary Syndrome: Authorization of 12 months may be granted for treatment of Mycosis Fungoides/Sezary syndrome.12 months

G Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders: Authorization of 12 months may be granted for treatment of primary cutaneous CD30+ T‑Cell lymphoproliferative disorders.12 months

Hairy cell leukemia: Authorization of 12 months may be granted for treatment of hairy cell leukemia.12 months

Erdheim-Chester disease: Authorization of 12 months may be granted for treatment of Erdheim‑Chester disease.12 months

J Chronic Myeloid Leukemia in pregnancy: Authorization of 12 months may be granted for treatment of chronic myeloid leukemia in pregnancy.12 months

Continuation criteria for myeloproliferative neoplasm: Authorization of 12 months may be granted if the patient is experiencing benefit from therapy as evidenced by improvement in symptoms and/or disease markers (e.g., morphological response, reduction/stabilization in spleen size, improvement of thrombocytosis/leukocytosis).12 months

From chunk 17

Continuation criteria for systemic mastocytosis: Authorization of 12 months may be granted if the patient is experiencing benefit as evidenced by improvement in symptoms and/or disease markers (e.g., reduction in serum and urine metabolites of mast cell activation, improvement in cutaneous lesions, skeletal disease).12 months

From chunk 18

Reauthorization for other indications: Authorization of 12 months may be granted for reauthorization requests for other indications when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.12 months

From chunk 19

inv-02: Reauthorization — 12 months

Authorization of 12 months may be granted when the following are met:

Systemic mastocytosis reauthorization: Patient is experiencing benefit from therapy as evidenced by improvement in symptoms and/or disease markers (e.g., reduction in serum and urine metabolites of mast cell activation, improvement in cutaneous lesions, skeletal disease, bone).12-month authorization

From chunk 18

Other indications reauthorization: Patient has no evidence of unacceptable toxicity or disease progression while on the current regimen.12-month authorization

From chunk 19

inv-03: Dosing and Dispensing Conditions

Approval conditions may include adherence to dosing and dispensing limits:

Dosing limits: Approvals may be subject to dosing limits in accordance with FDA‑approved labeling, accepted compendia, and/or evidence‑based practice guidelines.as per labeling/compendia

From chunk 20

Quantity limit 180 mcg per week.180 mcg/week

From chunk 21

Dispensing limit: A 28‑day supply dispense limit applies to all targeted hepatitis C agents.28 days

From chunk 22

This policy’s applicability depends on the member’s benefits and contract terms. Benefit determinations are based on the applicable contract language in effect when services are rendered; exclusions, limitations, or exceptions in the contract may apply. The policy may not apply to Federal Employee Program (FEP) members, and benefits for FEP are determined by the Federal Employee Program. Providers should verify individual member benefits prior to requesting authorization.

For reauthorization requests, authorization of 12 months will be denied if there is evidence of unacceptable toxicity or disease progression while the member is on the current regimen. Reauthorization for "all other indications" is contingent on absence of such toxicity or progression during therapy.

Wellmark will only determine medical necessity when the member’s contract includes coverage for the therapy and there are no contract exclusions that preclude the benefit. If the benefit does not exist under the member’s contract, or exclusions/limitations apply, the therapy may be denied as not covered.

Procedures, Billing Codes, and Limits

Procedures and Billing Codes (general instruction)mixed

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnostic codes: - Code(s), if applicable

Referenced products and compendiaNDC

Pegasys [package insert]	Reference listing for peginterferon alfa-2a (Genentech) — March 2021
Olysio [package insert]	simeprevir package insert (Janssen) — November 2017
Sovaldi [package insert]	sofosbuvir package insert (Gilead) — March 2020

inv-09: Quantity limit — 180 mcg per week

Quantity limit180 mcg per week

Unit intervalPer week

Related dispense limit28-day supply dispense limit applies to targeted HCV agents (see dispensing limits).

Provider Requirements, Prior Authorization, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals and prior authorization durations vary by indication; refer to the drug-specific policy for the requested regimen for exact approval durations.

Authorization durations vary by indication; see indication-specific criteria
Refer to drug policy for regimen-specific approval length

Step Therapy

Preferred-agent Requirement for Chronic HCV

When requesting reauthorization for chronic hepatitis C (HCV) therapy, the plan requires use of the health plan's preferred agents (Epclusa, Harvoni, Mavyret, and Vosevi) prior to non-preferred agents unless there are documented clinical reasons the preferred agents are not appropriate or the patient is currently stable on a non-preferred agent.

Preferred agents: Epclusa, Harvoni, Mavyret, Vosevi
Exemption allowed for documented clinical contraindication or if member is currently receiving and benefiting from a non-preferred agent

Clinical Background and Indications

Pegasys (peginterferon alfa-2a) is an interferon product indicated for certain viral hepatitis and several compendial hematologic and oncologic conditions. The policy lists FDA-approved uses—such as treatment of chronic Hepatitis C in combination regimens and selected chronic Hepatitis B monotherapy scenarios—and multiple compendial indications for which authorization durations (commonly 12 months, with up to 48 weeks for chronic HBV) are provided. Providers should consult the specific indication criteria in the policy and verify member benefits prior to initiating requests.

Indication Definitions and Clinical Benefit

inv-19: Chronic Hepatitis C (HCV)

Indication (HCV)Pegasys in combination therapy with other HCV drugs for treatment of adults with compensated liver disease; with ribavirin for pediatric patients ≥5 years with compensated liver disease.

Preferred-agent requirementRefer to the requested regimen drug policy for specific criteria and approval durations; preferred HCV agents must be used before non-preferred agents when applicable.

Authorization durationApproval durations specified per regimen; many non-HBV indications typically granted up to 12 months.

inv-20: Chronic Hepatitis B (HBV)

Indication (HBV)Pegasys monotherapy is indicated for treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B; also for certain non-cirrhotic pediatric patients ≥3 years with HBeAg‑positive CHB and evidence of viral replication and elevated ALT.

OpenPayer

Pegasys (interferon alfa-2a) — Coverage Criteria

Coverage and Medical Necessity Criteria

Procedures, Billing Codes, and Limits

Provider Requirements, Prior Authorization, and Operational Notes

Clinical Background and Indications

Indication Definitions and Clinical Benefit