WHA
 

Jaypirca (pirtobrutinib)

Indications for Prior Authorization

Jaypirca (pirtobrutinib)
  • For diagnosis of 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.

  • For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
    Indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.

Criteria

Jaypirca

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Mantle Cell Lymphoma

  • Diagnosis of mantle cell lymphoma (MCL)
    • 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)] [1, 2]
Jaypirca

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  • Diagnosis of one of the following:
    • Chronic Lymphocytic Leukemia (CLL)
    • Small Lymphocytic Lymphoma (SLL)
    AND
  • Disease is one of the following:
    • Relapsed
    • Refractory
    AND
  • Patient has previously been treated with a covalent BTK inhibitor [e.g., Calquence (acalabrutinib), Brukinsa (zanubrutinib)]
Jaypirca

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

  • Guideline ID
    GL-489210

  • Formulary
    Premium

  • Effective date
    Mar 1, 2026

  • P&T approval date
    Apr 19, 2023

P & T Revisions

2026-01-05, 2025-04-01, 2024-04-03, 2024-02-15, 2023-06-26, 2023-04-17, 2023-03-09

  1. Jaypirca Prescribing Information. Lilly USA, LLC. Indianapolis, IN. December 2025.
  2. Clinical Consult with an oncologist March 9, 2023.
  3. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma. V1.2026. Available at https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed December 12, 2025.
  • 2026-01-05: Criteria update to align with updated FDA label for CLL/SLL – now suitable as second-line therapy following a covalent BTK inhibitor. Background updates including references.
  • 2025-04-01: 2025 Annual Review. Background updates only.
  • 2024-04-03: Annual review: Background and formatting updates.
  • 2024-02-15: Addition of new indication for adult patients with CLL/SLL. Updated references.
  • 2023-06-26: Removed specialist requirement.
  • 2023-04-17: New PA Criteria.
  • 2023-03-09: New PA Criteria