VONJO (pacritinib)

Self-Administration – oral

Diagnosis considered for coverage:
  • Indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x 10^9/L.
Coverage Criteria:

For diagnosis of primary or secondary myelofibrosis:

  • Dose does not exceed 400 mg (4 capsules) per day; AND
  • Patient is 18 years of age and older; AND
  • Prescribed by or in consultation with a Hematologist or Oncologist; AND
  • Diagnosis of ONE of the following:
    • Primary myelofibrosis
    • Post-polycythemia vera myelofibrosis
    • Post-essential thrombocythemia myelofibrosis; AND
  • Disease is intermediate or high risk; AND
  • Documentation of pre-treatment platelet count below 50 x 10^9/L
Reauthorization Criteria:

For diagnosis of primary or secondary myelofibrosis:

  • Dose does not exceed 400 mg (4 capsules) per day; AND
  • Documentation of positive clinical response to therapy (e.g., symptom improvement, spleen volume reduction)
Coverage Duration:
  • Initial: 6 months
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Drug-Drug Interaction: Avoid use with moderate CYP3A4 inhibitors or inducers
  • Hepatic Impairment: Avoid use in moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
  • Renal Impairment: Avoid use in patients with eGFR <30 mL/min.
  • Thrombocytopenia: Hold Vonjo, restart at 50% of the last given dose after resolution. If toxicity recurs, hold Vonjo and restart at 50% of last given dose after resolution.
  • Hemorrhage:
    • Moderate bleeding: Hold Vonjo, restart at last given dose after resolution. If hemorrhage recurs, hold Vonjo until resolution then restart at 50% of last given dose
    • Severe bleeding: Hold Vonjo, restart at last given dose after resolution. If hemorrhage recurs, hold Vonjo until resolution then restart at 50% of last given dose
    • Life-threatening bleeding: Discontinue Vonjo
  • Pediatric use: safety and efficacy for Vonjo have not been established
  • Monitoring:
    • Perform a complete blood count, coagulation testing, and a baseline electrocardiogram (ECG), prior to starting VONJO, and monitor as clinically indicated while the patient is on treatment.
Policy Updates:
  • 08/16/2022 – New policy approved by P&T.
References:
  1. Vonjo Prescribing Information. CTI BioPharma Corp. Seattle, WA. February 2022.
  2. The NCCN Clinical Practice Guidelines in Oncology - Myeloproliferative Neoplasms. Available at https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf . version 1.2022 - February 28, 2022. Accessed April 2, 2022.
  3. UpToDate. Tefferi, A. Clinical manifestations and diagnosis of primary myelofibrosis. Available at https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-primary-myelofibrosis?sectionName=Secondary%20myelofibrosis%20(post-PV%20or%20post-ET)&topicRef=4531&anchor=H2861686207&source=see_link#H2861686207. Accessed April 2, 2022.
  4. Leukemia and Lymphoma Society. Myelofibrosis. Available at https://www.lls.org/myeloproliferative-neoplasms/myelofibrosis. Accessed April 2, 2022.

Last review date: August 16, 2022

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