VONJO (pacritinib)

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.