WHA
 

Mimrylo (rusfertide) - PA, NF

Indications for Prior Authorization

Mimrylo (rusfertide)
  • For diagnosis of Erythrocytosis in Polycythemia Vera
    Indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV).

Criteria

Mimrylo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of polycythemia vera [A]
    • AND
  • Patient has absolute erythrocytosis (i.e., 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) [B]
    • AND
  • One of the following:
    • Presence of JAK2 V617F or JAK2 exon 12 mutation as detected by a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [C]
    • Patient has subnormal serum erythropoietin level [D]
    AND
  • Requested drug will be used for the treatment of erythrocytosis [E]
    • AND
  • Patient has inadequate hematocrit control with frequent phlebotomy or has intolerance to phlebotomy [2]
    • AND
  • Prescribed by or in consultation with a hematologist/oncologist
Mimrylo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy (e.g., hematocrit levels < 45%)
Mimrylo

Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of polycythemia vera [A]
    • AND
  • Submission of medical records (e.g., chart notes) confirming patient has absolute erythrocytosis (i.e., 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) [B]
    • AND
  • One of the following:
    • Both of the following:
      • Submission of medical records (e.g., chart notes, laboratory values) confirming presence of JAK2 V617F or JAK2 exon 12 mutation [C]
      • Provider attests mutation was detected by a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
      OR
    • Submission of medical records (e.g., chart notes, laboratory values) confirming patient has subnormal serum erythropoietin level [D]
    AND
  • Submission of medical records (e.g., chart notes) confirming both of the following:
    • Requested drug will be used for the treatment of erythrocytosis [E]
    • Patient has inadequate hematocrit control with frequent phlebotomy or has intolerance to phlebotomy [2]
    AND
  • Prescribed by or in consultation with a hematologist/oncologist
Mimrylo

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming patient does not show evidence of progressive disease while on therapy (e.g., hematocrit levels < 45%)

  • Guideline ID
    GL-732220

  • Formulary
    Premium

  • Effective date
    Nov 1, 2026

  • P&T approval date
    Oct 21, 2026

P & T Revisions

2026-10-13

  1. Mimrylo Prescribing Information. Takeda Pharmaceuticals America, Inc. Cambridge, MA. August 2026.
  2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myeloproliferative Neoplasms v1v3.2026. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed September 21, 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. Wolters Kluwer. Available by subscription at: https://www.uptodate.com. Updated November 27, 2024. Accessed September 22, 2026.
  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]
  5. The National Comprehensive Cancer Network (NCCN) recommends Mimrylo to be used instead of or in addition to cytoreductive therapy when frequent phlebotomy or phlebotomy intolerance is indicated. Mimrylo does NOT replace cytoreductive therapy when cytoreduction is otherwise indications (e.g., leukocytosis, thrombocytosis). [2]
  • 2026-10-13: New Program