CurrentNeighborhood Health Plan of Rhode IslandPolicy 2139-A

Pegasys

Defines covered indications, limitations, authorization durations, and continuation criteria for Pegasys (peginterferon alfa-2a) across FDA-approved and selected compendial uses for commercial populations referenced by CVS/Caremark for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPegasys

Policy CodePolicy 2139-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization must be obtained to cover Pegasys; document benefit for continuation or absence of unacceptable toxicity or disease progression as applicable.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or eligibility criteria.

9Compendial/Additional Indications Listed

2FDA-Indicated Pediatric Age Thresholds

48wMax Authorization for HBV

12moCommon Authorization Duration

Coverage Summary & Initial Authorization

Policy 2139-A (payer: Neighborhood Health Plan of Rhode Island) has a mixed coverage stance for Pegasys (peginterferon alfa-2a). It covers FDA-approved uses for chronic hepatitis C and chronic hepatitis B when approval criteria are met and recognizes multiple compendial oncology and rare-disease indications for which authorization may be granted.

Covered Indications / Initial Authorization

The indications below are considered covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy.

ANY of the following

ALL of the following
- Chronic Hepatitis C (CHC) in adults with compensated liver disease when used in combination therapy with other HCV drugs; Pegasys monotherapy only if contraindication or significant intolerance to other HCV drugs.
- Chronic Hepatitis C in pediatric patients >= 5 years with compensated liver disease when used in combination with ribavirin.
- Chronic Hepatitis B (CHB): treatment of adults with HBeAg-positive and HBeAg-negative CHB with compensated liver disease and evidence of viral replication and liver inflammation.
- Chronic Hepatitis B: treatment of non-cirrhotic pediatric patients >= 3 years with HBeAg-positive CHB and evidence of viral replication and elevations in serum ALT.
- Compendial Uses (covered when criteria met)
  - Chronic hepatitis E virus (HEV) infection
  - Myeloproliferative neoplasms (essential thrombocythemia, polycythemia vera, or symptomatic lower-risk myelofibrosis)
  - Systemic mastocytosis
  - Adult T-cell leukemia/lymphoma
  - Mycosis fungoides/Sezary syndrome
  - Primary cutaneous CD30+ T-cell lymphoproliferative disorders

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Limitations and Not Recommended Uses

Limitations / Not Recommended

Specific scenarios where Pegasys is not recommended or restricted.

ALL of the following

Pegasys alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa.
Pegasys is not recommended for treatment of patients with CHC who have had solid organ transplantation.

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Authorization Durations and Quantity Limits

Authorization Durations / Quantity Limits

Typical authorization durations allowed when criteria are met.

ANY of the following

Chronic HBV infection (including HDV coinfection): authorization of up to 48 weeks total may be granted.
ALL of the following
- Member is a liver transplant recipient.
- Member has had an inadequate response, intolerance, or contraindication to ribavirin.
Myeloproliferative neoplasms: authorization of 12 months may be granted for treatment.
Systemic mastocytosis: authorization of 12 months may be granted.
Adult T-cell leukemia/lymphoma: authorization of 12 months may be granted.
Mycosis fungoides/Sezary syndrome: authorization of 12 months may be granted.
Primary cutaneous CD30+ T-cell lymphoproliferative disorders: authorization of 12 months may be granted.
Hairy cell leukemia: authorization of 12 months may be granted.
Erdheim-Chester disease: authorization of 12 months may be granted.
Chronic myeloid leukemia in pregnancy: authorization of 12 months may be granted.

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Prior Authorization

Authorization required per indication

Authorization must be obtained to cover Pegasys. Duration of approval depends on the indication — for chronic HBV (including HDV coinfection) authorization of up to 48 weeks total may be granted; many compendial and other non-HBV indications (for example chronic HEV in eligible transplant recipients, myeloproliferative neoplasms, systemic mastocytosis, various hematologic/oncologic indications) may be granted for 12 months when criteria are met.

Continuation of Therapy / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Requirements for continued therapy authorization.

ALL of the following

Indication-specific continuation evidence
- Myeloproliferative neoplasm: authorization of 12 months may be granted if member is experiencing benefit as evidenced by improvement in symptoms and/or disease markers (e.g., morphological response, reduction or stabilization in spleen size, improvement of thrombocytosis/leukocytosis).
- Systemic mastocytosis: authorization of 12 months may be granted if member 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, bone marrow mast cell burden).
- All other indications: authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

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Documentation Required

Clinical evidence for continuation

For continuation/reauthorization, document clinical benefit or lack of harm as applicable to the indication. For myeloproliferative neoplasms and systemic mastocytosis, document improvement in symptoms and/or disease markers (examples: morphological response, spleen size reduction or stabilization, improvement in thrombocytosis/leukocytosis; reduction in serum/urine mast cell activation metabolites, improvement in cutaneous lesions or bone marrow mast cell burden). For all other indications, document there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Provider Actions & Administrative Requirements

Prior authorization must be obtained to cover Pegasys; authorization durations vary by indication (e.g., up to 48 weeks for chronic HBV including HDV coinfection and typically 12 months for multiple compendial oncology/rare-disease uses).

Requests for continuation of therapy require documentation of benefit (for example symptom improvement or improvement in objective disease markers for myeloproliferative neoplasms and systemic mastocytosis) or documentation of absence of unacceptable toxicity or disease progression, as applicable to the indication.

Clinical Evidence & References

Evidence and references cited in the policy include the Pegasys package insert (Genentech, March 2021), the Sovaldi package insert (December 2024), and compendia and guideline sources such as the NCCN Drugs & Biologics Compendium and NCCN clinical practice guidelines. The policy notes compendial support for multiple oncology and rare-disease uses where authorization may be granted when criteria are met.

Background and Definitions

Pegasys (peginterferon alfa-2a) is an interferon-based antiviral and immunomodulatory agent with FDA-approved indications for chronic hepatitis C (in adults in combination with other HCV drugs and in pediatric patients ≥5 years in combination with ribavirin) and chronic hepatitis B (treatment of adults with HBeAg‑positive and HBeAg‑negative CHB with compensated liver disease and certain pediatric patients ≥3 years). The policy also recognizes multiple compendial oncology and rare-disease uses (for example myeloproliferative neoplasms, systemic mastocytosis, various T‑cell lymphomas, hairy cell leukemia, Erdheim‑Chester disease, and chronic myeloid leukemia) for which authorization may be granted.

Compensated liver disease: liver disease without evidence of decompensation (policy assumes the standard clinical definition; specific diagnostic criteria are not enumerated in this document).

Policy-specific stats

Compendial/Additional Indications Listed9 compendial oncology/rare-disease uses (e.g., chronic HEV, myeloproliferative neoplasms, systemic mastocytosis, various hematologic/skin malignancies, Erdheim‑Chester disease, chronic myeloid leukemia)

FDA-Indicated Pediatric Age Thresholds2 pediatric age thresholds: CHC ≥5 years (with ribavirin); CHB ≥3 years (non-cirrhotic, HBeAg‑positive with viral replication and ALT elevations)

Max Authorization for HBVUp to 48 weeks total for chronic HBV (including HDV coinfection)

Common Authorization Duration for Compendial IndicationsMany compendial indications may be authorized for 12 months (e.g., chronic HEV in transplant recipients when criteria met; myeloproliferative neoplasms; systemic mastocytosis; multiple listed malignancies)