Ropeginterferon Alfa-2b-njft (BESREMi) Form

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.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that BESREMi ® is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Polycythemia Vera (must meet all):

1. Diagnosis of polycythemia vera;
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;
4. Failure of hydroxyurea or peginterferon alfa-2a, unless clinically significant adverse effects are experienced or all are contraindicated;
   *Prior authorization may be required for hydroxyurea and peginterferon alfa-2a
   5. Documentation of JAK2 V617F mutation;
5. Member meets one of the following (a or b): a. For males: Documentation of hemoglobin level > 16.5 g/dL or hematocrit level of > 49% or increased red cell mass; b. For females: Documentation hemoglobin level > 16 g/dL or a hematocrit level of > 48% or increased red cell mass;

6. Request meets one of the following (a or b): a. Dose does not exceed 500 mcg every 2 weeks; b. Dose 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: 6 months 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): Page 1 of 6

   CLINICAL POLICY Ropeginterferon Alfa-2b-njft 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. Polycythemia Vera (must meet all):
   3. 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;
   4. Member is responding positively to therapy;

7. If request is for a dose increase, request meets one of the following (a, b or c): a. 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; b. For members who have not yet achieved hematological stability, dose does not exceed 500 mcg every 2 weeks; c. New dose 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: 12 months 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 Page 2 of 6

   CLINICAL POLICY Ropeginterferon Alfa-2b-njft 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 FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network
   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.
   Drug Name Dosing Regimen hydroxyurea (Droxia®, Hydrea®) Pegasys®, Pegasys ProClick® (peginterferon alfa-2a)
   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. 15 to 20 mg/kg/day Varies Dose Limit/ Maximum Dose 20 mg/kg/day Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt o Hypersensitivity to interferon, including interferon alfa-2b, or to any component of BESREMi o Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment o History or presence of active serious or untreated autoimmune disease o Immunosuppressed transplant recipients • Boxed warning(s):
   o 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: General Information
   • Per NCCN, for high risk PCV patients, preferred regimens for cytoreductive therapy include hydroxyurea or peginterferon alfa-2a or ropeginterferon alfa-2b-njft.
   • Per Prescribing Information, hematological parameters are stabilized when hematocrit < 45%, platelets < 400 x 109/L, and leukocytes less than 10 x 109/L. Page 3 of 6

   CLINICAL POLICY Ropeginterferon Alfa-2b-njft V. Dosage and Administration
   Indication Polycythemia vera Dosing Regimen Starting dose: 100 mcg SC injection every 2 weeks (50 mcg if receiving hydroxyurea).
   Maximum Dose 500 mcg every 2 weeks Increase the dose by 50 mcg every 2 weeks until hematological parameters are stabilized (hematocrit < 45%, platelets < 400 x 109/L, and leukocytes less than 10 x 109/L). Maintain the two week dosing interval at which hematological stability is achieved for at least 1 year. After achievement of hematological stability for at least 1 year on a stable dose, the dosing interval may be expanded to every 4 weeks. VI. Product Availability
   Injection: 500 mcg/mL solution in a single-dose prefilled syringe VII.