Clinical Policy: Ropeginterferon Alfa-2b-njft (BESREMi)

Reference Number: CP.PHAR.570
Effective Date: 03.01.22
Last Review Date: 02.26
Line of Business: Commercial, HIM, Medicaid

[ Coding Implications ](Coding Implications)
[ Revision Log ](Revision Log)

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

Ropeginterferon alfa-2b-njft (BESREMi®) is an interferon alfa-2b.

FDA Approved Indication(s)

BESREMi® is indicated for the treatment of adults with polycythemia vera (PV).

Policy/Criteria

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration:

Medicaid/HIM – 12 months
Commercial – 6 months or duration of request, whichever is less

B. NCCN Recommended Uses (off-label) (must meet all):

1. Diagnosis of one of the following (a, b, c, or d):
   a. Systemic mastocytosis;
   b. Myelofibrosis;
   c. Essential thrombocythemia;
   d. Chronic myeloid leukemia (CML);
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;
4. One of the following (a or b):
   a. For use as substitute for peginterferon alfa-2a due to product unavailability (e.g., drug shortages);
   b. For CML as initial treatment during pregnancy;
5. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*
   * Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration:

Medicaid/HIM – 12 months
Commercial – 6 months or duration of request, whichever is less

C. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

II. Continued Therapy

A. All Indications in Section I (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving BESREMi for a covered indication and has received this medication for at least 30 days;
2. Member is responding positively to therapy;
3. If request is for a dose increase, request meets one of the following (a or b):*
   a. For PV, one of the following (i or ii):
   i. For members with achievement of hematological stability for at least one year while on a stable dose of BESREMi, dose does not exceed 500 mcg every 4 weeks unless medical justification supports otherwise;
   ii. For members who have not yet achieved hematological stability, dose does not exceed 500 mcg every 2 weeks;
   b. New dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
   *Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration:

Medicaid/HIM – 12 months
Commercial – 6 months or duration of request, whichever is less

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

CML: chronic myeloid leukemia
FDA: Food and Drug Administration
NCCN: National Comprehensive Cancer Network
PV: polycythemia vera

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s):
  
  • Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt
  • Hypersensitivity to interferon, including interferon alfa-2b, or to any component of BESREMi
  • Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
  • History or presence of active serious or untreated autoimmune disease
  • Immunosuppressed transplant recipients
• Boxed warning(s):
  
  • Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders.

Appendix D: States with Regulations against Redirections in Cancer

Appendix E: General Information

• Per NCCN,
  
  • Low-risk PV: age < 60 years and no prior history of thrombosis
  • High-risk PV: age ≥ 60 years and/or prior history of thrombosis
• Per NCCN, for high-risk PV patients, preferred regimens for cytoreductive therapy include hydroxyurea or ropeginterferon alfa-2b-njft.
• Per NCCN, for low-risk PV patients, ropeginterferon alfa-2b-njft is the only preferred regimen for cytoreductive therapy. Other recommended regimens include hydroxyurea or peginterferon alfa-2a.
• Per Prescribing Information, hematological parameters are stabilized when hematocrit < 45%, platelets < 400 x 10⁹/L, and leukocytes less than 10 x 10⁹/L.
• Symptoms of disease progression include fatigue, early satiety, abdominal discomfort, inactivity, problems with concentration, night sweats, pruritus, bone pain (diffuse not joint pain or arthritis), fever (> 100 F), unintentional weight loss last 6 months.
• Poor tolerance to phlebotomy is defined as recurrent episodes of post-phlebotomy syncope despite appropriate preventive interventions.

V. Dosage and Administration

VI. Product Availability

Injection: 500 mcg/mL solution in a single-dose prefilled syringe

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.