Pharmacy Prior Authorization Criteria

Besremi (ropeginterferon alfa-2b-njft) - PA, NF

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 as confirmed by all of the following [A]:
• One of the following:
• 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
• Increased red cell mass
AND
• Bone marrow biopsy showing hypercellularity for age with trilineage growth (panmyelosis) including prominent erythroid, granulocytic and megakaryocytic proliferation with pleomorphic, mature megakaryocytes
AND
• One of the following:
• Presence of JAK2 or JAK2 exon 12 mutation
• Subnormal serum erythropoietin level
AND
• One of the following:
• For high-risk polycythemia vera only (patient greater than or equal to 60 years old and/or prior thrombosis history), trial and inadequate response, contraindication or intolerance to hydroxyurea
OR
• For continuation of prior therapy

Besremi

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]

Besremi

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of polycythemia vera as confirmed by all of the following [A]:
• One of the following:
• 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
• Increased red cell mass
AND
• Bone marrow biopsy showing hypercellularity for age with trilineage growth (panmyelosis) including prominent erythroid, granulocytic and megakaryocytic proliferation with pleomorphic, mature megakaryocytes
AND
• One of the following:
• Presence of JAK2 or JAK2 exon 12 mutation
• Subnormal serum erythropoietin level
AND
• One of the following:
• For high-risk polycythemia vera only (patient greater than or equal to 60 years old and/or prior thrombosis history), submission of medical records (e.g., chart notes) confirming trial and inadequate response, contraindication or intolerance to hydroxyurea
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy

P & T Revisions

2024-09-04, 2024-03-07, 2023-08-22, 2023-07-03, 2023-01-04, 2022-07-28, 2022-01-28, 2022-01-05

References

1. BESREMi (ropeginterferon alfa-2b-njft) [Prescribing Information]. Taipei, Taiwan. PharmaEssentia Corporation. November 2021.
2. 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.
3. 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)
4. 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).
5. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myeloproliferative Neoplasms v2.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed August 19, 2024.

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Revision History

• 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.

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