CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pegasys (peginterferon alfa-2a) — Coverage Criteria (oncology)

Defines accepted indications, contraindications, exclusion criteria, and coding for Pegasys (peginterferon alfa-2a) for hematologic malignancies (myelofibrosis, polycythemia vera, essential thrombocythemia) and describes evidentiary sources required for authorization decisions; applies to providers submitting medication requests to Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPegasys (peginterferon alfa-2a) — Coverage Criteria (oncology)

Policy CodePolicy N/A

Change TypeTemplate conversionreplaced prior UM ONC_1497

Effective DateN/A

Next Review DateN/A

Key ActionSubmit Pegasys prior authorization requests to Evolent with supporting evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1497 Pegasys policy.

3hematologic indications named (PMF, PV, ET)

180 mcgsingle dose maximum

J3590listed billing code

Commercial/Exchange/Medicaidapplicable lines of business

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Coverage Criteria for Pegasys (peginterferon alfa-2a)

Covered Indications

Covered when the following disease-specific conditions are met:

Myelofibrosis (PMF): Pegasys (peginterferon alfa-2a) may be used as first-line or subsequent therapy for members with low-risk primary myelofibrosis.

Use permitted as first-line or subsequent therapy for low-risk PMF.

Polycythemia vera (PV): Pegasys (peginterferon alfa-2a) may be used as first-line or subsequent therapy for members with symptomatic low-risk polycythemia vera or high-risk polycythemia vera.

Use permitted as first-line or subsequent therapy for symptomatic low-risk or high-risk PV.

Essential thrombocythemia (ET): Pegasys (peginterferon alfa-2a) may be used as subsequent therapy for members with intermediate/high-risk essential thrombocythemia.

Use permitted as subsequent therapy for intermediate or high-risk ET.

The following situations are excluded from coverage for Pegasys (peginterferon alfa-2a): disease progression while taking Pegasys, concurrent use with other anticancer therapies, or dosing that exceeds a single dose of 180 mcg. Requests that meet any of these conditions should be denied unless compelling, well-documented justification consistent with the policy’s evidentiary standards is provided.

Off-label uses of Pegasys are considered investigational and not approvable when the indication lacks sufficient evidence or is not generally accepted by the medical community. The policy defines sufficient evidence as support from CMS-recognized compendia or acceptable peer-reviewed literature; factors used to judge sufficiency include whether the patient population and regimen are adequately represented in published studies, whether outcomes are clinically meaningful (ASCO guidance such as Hazard Ratio < 0.80 or survival benefits of at least 3 months for OS/PFS), and whether study design and data quality are appropriate. Case reports and meeting abstracts without a full peer-reviewed article are not adequate to establish support.

Billing and Coding

CodesHCPCS

J3590

peginterferon alfa-2a

Single dose limit

Single dose maximum180 mcg per dose

Associated billing codeJ3590 (peginterferon alfa-2a)

Policy consequenceDosing requests that exceed 180 mcg are listed as an exclusion and may be denied

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization and Continuation Requirements

Prior Authorization Required. Evolent is responsible for processing all medication requests from network ordering providers. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable. All initial and continuation requests for Pegasys (peginterferon alfa-2a) must be submitted to Evolent for prior authorization review.

Evolent processes all medication requests from network ordering providers.
Medication requests not authorized by Evolent may be not reimbursable.
Supporting evidence required: FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS criteria.

Documentation Required

Continuation Request Conditions

Continuation requests for a previously authorized medication that would otherwise be not-approvable are exempt from this policy only when all of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request. Continuation requests that do not meet these conditions must undergo full prior authorization review by Evolent.

Member must have no disease progression on the requested medication.
Use within last year with ≤30-day lapse from prior active authorization.
No additional medication(s) added to the continuation request.

Step Therapy

Permitted Lines of Therapy

Pegasys may be used as first-line or subsequent therapy for specific myeloproliferative neoplasms when supported by acceptable evidence. Examples of permitted lines of therapy in this policy: first-line or subsequent therapy for low-risk primary myelofibrosis (PMF); first-line or subsequent therapy for symptomatic low-risk or high-risk polycythemia vera (PV); and subsequent therapy for intermediate/high‑risk essential thrombocythemia (ET). Authorization decisions should align with documented diagnosis, prior treatments, and risk stratification.

PMF: first-line or subsequent therapy for low‑risk myelofibrosis.
PV: first-line or subsequent therapy for symptomatic low‑risk or high‑risk polycythemia vera.
ET: subsequent therapy for intermediate/high‑risk essential thrombocythemia.

Note

Acceptable Supporting Evidence

Acceptable supporting evidence for approval includes: FDA approved product labeling; CMS‑recognized compendia; NCCN and ASCO clinical guidelines; or peer‑reviewed literature that meets CMS Medicare evidence expectations. Evidence from peer‑reviewed literature must address applicability to the patient population and regimen, report clinically meaningful outcomes (ASCO definitions such as HR < 0.80 or ≥3 months OS/PFS benefit where applicable), and be from appropriate study designs (randomized trials preferred but well‑conducted nonrandomized trials may be supportive). Case reports and abstracts without full peer‑reviewed publication are insufficient.

FDA product labeling (Pegasys prescribing information).
CMS‑recognized compendia and Medicare Benefit Policy Manual Chapter 15 guidance.
NCCN and ASCO clinical guidelines and compendia.
Peer‑reviewed literature must adequately represent clinical characteristics, regimen, and clinically meaningful outcomes; case reports/meeting abstracts alone are insufficient.

Permitted Lines of Therapy

Line of Therapy — Myelofibrosis

Line of therapy — Myelofibrosis: First-line or subsequent therapy for low-risk primary myelofibrosis (PMF).

Line of Therapy — Polycythemia Vera

Line of therapy — Polycythemia vera: First-line or subsequent therapy for symptomatic low-risk PV or high-risk PV.

Line of Therapy — Essential Thrombocythemia

Line of therapy — Essential thrombocythemia: Subsequent therapy for intermediate/high-risk essential thrombocythemia (ET).

Definitions and Risk Stratification

IPSS / DIPSS / DIPSS‑plus risk factors for primary myelofibrosis

Age>65 years (1 point)

Constitutional symptomsPresence of constitutional symptoms (1 point)

Hemoglobin<10 g/dL (IPSS/DIPSS: 1–2 points depending on model)

White blood cell count>25 x 10^9/L (1 point)

Circulating blasts≥1% circulating blasts (1 point)

Red blood cell transfusion needRequirement for RBC transfusion (DIPSS-plus: 1 point)

Platelet count / KaryotypePlatelet count <100 x 10^9/L (1 point); unfavorable karyotype (1 point)

Background on Peginterferon alfa-2a

Peginterferon alfa-2a (Pegasys) is an interferon formulation used in certain myeloproliferative neoplasms. In these hematologic disorders it may induce hematologic and molecular responses and is an option for disease control in conditions such as primary myelofibrosis, polycythemia vera, and essential thrombocythemia when used according to the policy’s indication- and line-of-therapy criteria. Authorization decisions should be supported by the cited evidence sources referenced in the guideline.

Policy Revision History

2025-04operationalLatest