Pharmacy Prior Authorization Criteria

Besremi (ropeginterferon alfa-2b-njft)

For diagnosis of Polycythemia Vera
Indicated for the treatment of adults with polycythemia vera.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

Hemoglobin greater than 16.5 g/dL for men or hemoglobin greater than 16.0 g/dL for women
Hematocrit greater than 49% for men or hematocrit greater than 48% for women

AND

Bone marrow biopsy showing age-adjusted hypercellularity with trilineage proliferation (panmyelosis) including prominent erythroid, granulocytic, and megakaryocytic proliferation with pleomorphic, mature megakaryocytes (differences in size)

AND

Patient with sustained absolute erythrocytosis as demonstrated by one of the following:

AND

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

Patient demonstrates positive clinical response to therapy (e.g., improvement in hematological response, resolution of splenomegaly, absence of thromboembolic events) [2]

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

BESREMi (ropeginterferon alfa-2b-njft) [Prescribing Information]. Taipei, Taiwan. PharmaEssentia Corporation. November 2021.
Vannucchi A, Barbui T, Cervantes F et al. Philadelphia chromosome-negative chronic myeloproliferative neoplasms: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2015;26:v85-v99.
Barbui T, Thiele J, Gisslinger H et al. The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms: document summary and in-depth discussion. Blood Cancer J. 2018;8(2)
Abu-Zeinah, G., Krichevsky, S., Cruz, T. et al. Interferon-alpha for treating polycythemia vera yields improved myelofibrosis-free and overall survival. Leukemia 35, 2592–2601 (2021).
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myeloproliferative Neoplasms v1.2025. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed March 31, 2025.
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.

According to The International Consensus Classification of myeloid neoplasms and acute Leukemias, 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 follows: 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. [5,6]. 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 [5].

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.