Pharmacy Prior Authorization Criteria

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 chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 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
• Patient has received treatment for CLL/ SLL with both of the following therapies:
• BTK inhibitor therapy [e.g., Calquence (acalabrutinib), Brukinsa (zanubrutinib)]
• B-cell lymphoma 2 (BCL-2) inhibitor therapy [e.g., Venclexta (venetoclax)]

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

P & T Revisions

2024-04-03, 2024-02-15, 2023-06-26, 2023-04-17, 2023-03-09

References

1. Jaypirca Prescribing Information. Lilly USA, LLC. Indianapolis, IN. December 2023.
2. Clinical Consult with an oncologist March 9, 2023.

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Revision History

• 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

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