JAYPIRCA (pirtobrutinib)

JAYPIRCA (pirtobrutinib)

Self-Administration – oral

Diagnosis considered for coverage:

• Mantle Cell Lymphoma (MCL): Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton Tyrosine Kinase (BTK) inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Coverage Criteria:

For diagnosis of mantle cell lymphoma (MCL):

• Prescribed by or in consultation with an oncologist, AND
• Disease is one of the following: 
  • Relapsed 
  • Refractory, AND
• Patient has received at least two prior therapies for MCL, one of which is a Bruton Tyrosine Kinase (BTK) inhibitor therapy [e.g., Calquence (acalabrutinib), Brukinsa (zanubrutinib)]

Reauthorization Criteria:

• Patient does not show evidence of progressive disease while on therapy

Dosing:

• Pirtobrutinib is administered orally once daily until disease progression or unacceptable toxicity.

Coverage Duration: 

• Initial: 12 months
• Reauthorization: 12 months

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: 

• Pirtobrutinib is administered orally once daily until disease progression or unacceptable toxicity.
• NCCN B-cell lymphomas guidelines recommend brexucabtagene autoleucel or pirtobrutinib in the third-line/subsequent-line setting for r/r MCL, after prior BTK therapy. HCT may be considered for certain patients. 
• Doses should be reduced for patients with severe renal impairment.
• Avoid concomitant use of strong CYP3A inhibitors during treatment with JAYPIRCA. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the JAYPIRCA dosage.
• Avoid concomitant use of JAYPIRCA with strong or moderate CYP3A inducers. If concomitant use of moderate CYP3A inducers is unavoidable, increase the JAYPIRCA dosage.

Policy Updates:

• 08/15/2023 – New policy approved by P&T.

References:

1. Jaypirca Prescribing Information. Lilly USA, LLC. Indianapolis, IN. January 2023.
2. The NCCN Drugs and Biologics Compendium (NCCN Compendium™). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 8, 2023. 
3. Clinical Consult with an oncologist March 9, 2023.