Overview

This document addresses the use of Besremi (ropeginterferon alfa-2b-njft), for subcutaneous use in the treatment of adults with polycythemia vera. Polycythemia vera causes a thickening of the blood and affects roughly 6,200 people each year in the United States. The disorder causes overproduction of red blood cells, slowing blood flow and increasing the chance for blood clots, stroke, and heart attack. BESREMi is a monopegylated long-acting interferon whose cellular effects occur in the bone marrow by binding to a transmembrane receptor. Binding to this receptor initiates a downstream signaling cascade through the activation of kinases, such as JAK1, TYK2 and activator of transcription (STAT) proteins, which reduce red blood cell production in the bone marrow.

The FDA approval is based on various studies that show after 7.5 years of treatment Besremi majority of individuals with polycythemia vera experienced a complete hematological response. The approval was based on the safety data from PEGINVERA and PROUD/CONTINUATION-PV studies and efficacy data from the PEGINVERA clinical trial.

Individuals take Besremi every 2 weeks, and if successful in lowering the production of red blood cells after a year, individuals can reduce dosing to once per month. Besremi has a black box warning as interferon alfa may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

The National Comprehensive Cancer Network® (NCCN) provides additional recommendations with a category 2A level of evidence for the following uses:

• Myeloproliferative neoplasms-polycythemia vera

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to prior authorization, the review will determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Besremi (ropeginterferon alfa-2b-njft)

Requests for Besremi (ropeginterferon alfa-2b-njft) may be approved when the following criteria are met:

1. Individual is 18 years of age or older; AND
2. Individual is using for the treatment of polycythemia vera (Label, NCCN 2A).

Requests for Besremi (ropeginterferon alfa-2b-njft) may not be approved for any of the following:

1. Individual has a moderate or severe hepatic impairment (Child-Pugh B or C); OR
2. Individual has a severe or unstable cardiovascular disease (e.g., uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction; OR
3. Individual has an eGFR <30 mL/min; OR
4. Individual has had a history of active serious or untreated autoimmune disease; OR
5. Individual is an immunosuppressed transplant recipient; OR
6. Individual has an existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt; OR
7. When the above criteria are not met and for all other indications.

Quantity Limits

Besremi (ropeginterferon alfa-2b-njft) Quantity Limits

Besremi 500 mcg/ml prefilled syringe

Drug

Coding

Limit

2 prefilled syringes per 28 days

The following codes for treatments and procedures applicable to this document are included below for informational purposes only.

Inclusion or Exclusion of Procedure, Diagnosis, or Device Codes

Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J3490 Unclassified drugs (when specified as BESREMi (ropeginterferon alfa-2b-njft))
• J3590 Unclassified biological (when specified as BESREMi (ropeginterferon alfa-2b-njft))
• J9999 Not otherwise classified, antineoplastic drugs (when specified as BESREMi (ropeginterferon alfa-2b-njft))
• C9399 Unclassified drugs or biologicals (when specified as BESREMi (ropeginterferon alfa-2b-njft))

ICD-10 Diagnosis

All diagnoses pend

Document History

Reviewed:

11/19/2023