WHA
 

Besremi (ropeginterferon alfa-2b-njft)

Indications for Prior Authorization

Besremi (ropeginterferon alfa-2b-njft)
  • For diagnosis of Polycythemia Vera
    Indicated for the treatment of adults with polycythemia vera.

Criteria

Besremi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of polycythemia vera [A]
    • AND
  • Patient has absolute erythrocytosis [B]
    • AND
  • Presence of JAK2 V617F or JAK2 exon 12 mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [C]
    • AND
  • Patient has subnormal serum erythropoietin level [D]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Hematologist
    • Oncologist
Besremi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-554204

  • Formulary
    Premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    Jan 19, 2022

P & T Revisions

2026-04-16, 2025-04-04, 2025-02-06, 2024-12-04, 2024-09-04, 2024-03-07, 2023-08-22, 2023-07-03, 2023-01-04, 2022-07-28, 2022-01-28, 2022-01-05

  1. Besremi Prescribing Information. PharmaEssentia Corporation. Taipei, Taiwan. April 2024.
  2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myeloproliferative Neoplasms v1.2026. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed March 4, 2026.
  3. Thiele J, Kvasnicka HM, Orazi A, et al. The international consensus classification of myeloid neoplasms and acute Leukemias: myeloproliferative neoplasms. Am J Hematol. 2023; 98(1): 166-179.
  4. Thiele J, Kvasnicka HM, Orazi A, et al. The international consensus classification of myeloid neoplasms and acute leukemias: Myeloproliferative neoplasms. Am J Hematol. 2023 Mar; 98(3):544-545. doi: 10.1002/ajh.26821. Epub 2023 Jan 4. Erratum for: Am J Hematol. 2023 Jan;98(1):166-179. doi: 10.1002/ajh.26751. PMID: 36600640.
  5. Tremblay D, Kreymanskaya M, Mascarenhas J, Hoffman R. Diagnosis and treatment of polycythemia vera: A review. JAMA. 2025; 333(2):153-160.
  6. Tefferi A, Barbui T. Polycythemia vera: 2024 update on diagnosis, risk-stratification, and management. Am J Hematol. 2023; 98(9):1465-1487.
  7. Khoury JD, Solary E, Abla O, et al. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and histiocytic/dendritic neoplasms. Leukemia. 2022; 36(7):1703-1719.
  8. Tefferi A, Larson RA, Rosmarin AG. Clinical manifestations and diagnosis of polycythemia vera. Available by subscription at: https://www.uptpdate.com. Updated November 27, 2024. Accessed January 26, 2026.
  9. Varda MM, Tomassetti S. Erythropoietin levels in patients with polycythemia vera and secondary erythrocytosis. Blood. 2022; 140(s1):12181-12182.
  1. According to the International Consensus Classification (ICC) system of myeloid neoplasms and acute leukemias and the World Health Organization (WHO), diagnosis of polycythemia vera requires meeting either all three major criteria or the first two major criteria and one minor criterion. The three major criteria are as follow: 1) Hemoglobin > 16.5 g/dL for men or hemoglobin > 16.0 g/dL for women, or Hematocrit > 49% for men or Hematocrit > 48% for women, or increased red cell mass; 2) Bone marrow biopsy showing age-adjusted hypercellularity with trilineage proliferation (panmyelosis) including prominent erythroid, granulocytic, and increase in pleomorphic, mature megakaryocytes without atypia; 3) Presence of JAK2 V617F or JAK2 exon 12 mutation. The minor criterion is subnormal serum erythropoietin level. Major criterion 2 (bone marrow biopsy) may not be required in patients with sustained absolute erythrocytosis (hemoglobin concentrations of >18.5 g/dL in men or>16.5 g/dL in women, or hematocrit values of >55.5% in men or >49.5% in women) if major criterion 3 and the minor criterion are present [2-4, 7].
  2. Erythrocytosis is a required diagnostic criterion of polycythemia vera that is not present in other myeloproliferative disorders, with hemoglobin and hematocrit levels of >16.5 g/dL and >49% for men and >16 g/dL and >48% for women. The ICC diagnostic criteria include increased red blood cell mass (RCM) as an additional indicator of erythrocytosis, but as the measuring technique of isotope dilution methodology is no longer available in many locations, the 5th edition of the World Health Organization has removed RCM as a diagnostic criterion. Instead, hemoglobin concentrations are often used as proxies to estimate RCM levels. [2-5, 7]
  3. An acquired activating Janus kinase 2 (JAK2) gene variant is present in more than 95% of patients with polycythemia vera. In polycythemia vera, JAK2 mutational frequencies are estimated to be 97% for JAK2 V617F (exon 14) and 3% for other JAK2 mutations, including JAK2 exon 12. The presence of JAK2 mutation helps in distinguishing polycythemia vera from secondary erythrocytosis or polycythemia, although these mutations may also be found in patients with essential thrombocythemia and primary myelofibrosis. [5, 6, 8]
  4. Low serum erythropoietin concentrations are highly specific for polycythemia vera and help to distinguish the disease from secondary erythrocytosis. [8, 9]
  • 2026-04-16: Annual Review 2026 - Replaced Hgb/Hct cutoffs with check for absolute erythrocytosis. Removed bone marrow biopsy requirement. Removed criteria for patients with sustained absolute erythrocytosis. Added prescriber requirement of hematologist/oncologist. Updated for standard genetic testing verbiage & oncology indications reauth verbiage. Background updates.
  • 2025-04-04: Updated diagnostic criteria as per latest NCCN guideline (Myeloproliferative Neoplasms v1.2025).
  • 2025-02-06: 2025 Annual Review. Updated language in diagnostic criteria to align with diagnostic criteria in NCCN guideline. Background updates.
  • 2024-12-04: Removed hydroxyurea trial requirement and removed NF criteria section.
  • 2024-09-04: Added continuation of therapy bypass for hydroxyurea trial requirement.
  • 2024-03-07: 2024 Annual Review. Updated criteria to reflect latest NCCN guidelines (v1.2024). Updated references.
  • 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-07-03: July P&T Oncology Updates
  • 2023-01-04: Annual review: No criteria changes. Updated references.
  • 2022-07-28: Removed submission of medical records or paid claims verbiage from PA criteria. Added NF criteria.
  • 2022-01-28: Updated interferon therapy trial and failure requirement to account for projected Intron A discontinuation.
  • 2022-01-05: New program.