PEPAXTO (melphalan flufenamide)

PEPAXTO (melphalan flufenamide)

OFFICE ADMINISTRATION – IV

Diagnosis considered for coverage:

• Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
  • Limitations of Use: Pepaxto is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials

Coverage Criteria:

For diagnosis of relapsed or refractory multiple myeloma:

• Dose does not exceed 40 mg administered once per 28-day cycle, AND
• Patient is 18 years of age or older, AND
• Patient has a documented diagnosis of relapsed or refractory multiple myeloma, AND
• Prescribed by or in consultation with an oncologist, AND
• Pepaxto will be used in combination with dexamethasone, AND
• Patient has tried and failed 4 prior lines of therapy including at least one drug from each of the following classes:
  • Proteasome inhibitor (e.g., bortezomib [Velcade®], carfilzomib [Kyprolis®], ixazomib [Ninlaro®])
  • Immunomodulatory agent (e.g., lenalidomide [Revlimid®], pomalidomide [Pomalyst®], thalidomide [Thalomid®])
  • CD38-directed monoclonal antibody (e.g., daratumumab [Darzalex®], daratumumab and hyaluronidase-fihj [Darzalex Faspro™], or isatuximab-irfc [Sarclisa®])

Reauthorization Criteria:

For diagnosis of relapsed or refractory multiple myeloma:

• Dose does not exceed 40 mg administered once per 28-day cycle, AND
• Prescribed by or in consultation with an oncologist, AND
• Pepaxto will be used in combination with dexamethasone, AND
• Chart notes document the patient had a positive response to therapy

Coverage Duration:

• Initial: 1 year
• 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:

• Recommended dose: 40 mg administered intravenously over 30 minutes on Day 1 of each 28-day cycle until disease progression or until unacceptable toxicity
• Consider providing a serotonin-3 (5-HT3) receptor antagonist or other antiemetics prior to and during the treatment with Pepaxto
• Administer dexamethasone 40 mg orally or intravenously on Days 1, 8, 15 and 22 of each cycle
  • For patients 75 years of age or older, reduce the dose of dexamethasone to 20 mg
• Warnings: Thrombocytopenia, neutropenia, anemia, infections, increased risk of mortality with Pepaxto at dosages higher than the recommended dosage, secondary malignancies, and embryo-fetal toxicity
• Pepaxto can cause fetal harm when administered to a pregnant woman
  • Advise females of reproductive potential to use effective contraception during treatment with Pepaxto and for 6 months after the last dose
  • Advise males with female partners of reproductive potential to use effective contraception during treatment with Pepaxto and for 3 months after the last dose

Policy Updates:

• 06/15/2021 – New policy approved by P&T

References:

• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology: Multiple myeloma. Version 7.2021 – April 26, 2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed April 26, 2021.
• Pepaxto [package insert], Waltham, MA: Oncopeptides Inc.; February 2021.