CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY Oncology (Oral - Bruton's Tyrosine Kinase Inhibitor) - Jaypirca Prior

Prior authorization policy for oral Bruton's tyrosine kinase inhibitor Jaypirca (pirtobrutinib) for prescription benefit coverage under Cigna plans, defining medical necessity criteria for FDA-approved indications and other uses with supportive evidence, duration of approval, and exclusions.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY Oncology (Oral - Bruton's Tyrosine Kinase Inhibitor) - Jaypirca Prior

Policy CodePolicy N/A

Change TypeRevisions and additions to indications/criteria

Effective Date

Next Review Date

Key ActionPrior authorization is required; document age ≥18 and prior use of at least one BTK inhibitor (or required prior chemotherapy/prescriber statement) for approval, which is granted for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Chronic Lymphocytic Leukemia condition moved from Other Uses to FDA-Approved Uses due to new FDA labeling and criteria updated to require patient has tried at least one BTK inhibitor.

Marginal Zone Lymphoma condition and criteria were added to Other Uses with Supportive Evidence.

Mantle Cell Lymphoma requirement clarified to 'chemotherapy regimen' and removed language specifying frailty example.

Richter's Transformation criteria updated to include option for patient currently receiving at least one chemotherapy regimen.

3FDA-Approved Indications Covered

4Other Supported Indications Covered

Coverage Summary

Scope: Prior authorization policy for oral Bruton's tyrosine kinase inhibitor Jaypirca (pirtobrutinib) for prescription benefit coverage under Cigna plans, defining medical necessity criteria for FDA-approved indications and other uses with supportive evidence, duration of approval, and exclusions. Coverage stance: covered_with_criteria. Policy subject: Prior authorization policy for Jaypirca (pirtobrutinib) — covered with criteria; approvals for 1 year. Status: CURRENT. Effective/Last review date: Last review: 2025-12-10.

Applicable Codes

Drug (NDC)NDC

No codes listed

Relevant HCPCS/CPT/Diagnosis coding (informational)mixed

ICD-10 (examples)

Diagnoses include CLL, SLL, mantle cell lymphoma, marginal zone lymphoma, Richter's transformation, Waldenström macroglobulinemia (exact ICD-10 codes not specified in document)

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for Jaypirca prescription benefit coverage; approvals are provided for 1 year when criteria are met.

Documentation Required

Documentation of prior therapies

Provider must document that the patient is ≥ 18 years of age and prior use of at least one Bruton tyrosine kinase (BTK) inhibitor where required by the indication. For indications that require prior chemotherapy (e.g., mantle cell lymphoma, Richter's transformation), document prior use of at least one systemic/chemotherapy regimen or, where allowed, a prescriber statement that the patient is not a candidate for a chemotherapy regimen.

Denial Risk

Denial for non-listed uses

Claims for uses not meeting the policy criteria will be denied as not medically necessary.

Clinical Evidence & References

Evidence summary: Jaypirca is discussed in NCCN guidelines for B-cell malignancies. The policy cites NCCN recommendations across indications (including B-Cell Lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenström macroglobulinemia) noting category 2A listings and specific roles for Jaypirca in resistance or intolerance to covalent BTK inhibitors. The policy references the FDA prescribing information: Jaypirca tablets prescribing information, Eli Lilly; December 2025.

Background

Background: Jaypirca (pirtobrutinib) is a non-covalent Bruton's tyrosine kinase (BTK) inhibitor indicated for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults previously treated with a BTK inhibitor, and for mantle cell lymphoma (MCL) relapsed or refractory after at least two lines of systemic therapy, including a BTK inhibitor; the MCL indication is approved under accelerated approval based on response rate. Jaypirca is discussed in NCCN guidelines for B-cell malignancies and is recommended in several settings (including for management of resistance to covalent BTK inhibitors and use in marginal zone lymphoma and Waldenström macroglobulinemia). Other uses discussed in the policy with supportive evidence include marginal zone lymphoma, Richter's transformation, and Waldenström macroglobulinemia/lymphoplasmacytic lymphoma. Definitions: BTK inhibitor — Bruton tyrosine kinase inhibitors such as Imbruvica (ibrutinib), Calquence (acalabrutinib), Brukinsa (zanubrutinib); Systemic/chemotherapy regimen — regimens containing agents such as rituximab, cytarabine, carboplatin, cisplatin, oxaliplatin, cyclophosphamide, doxorubicin, vincristine, methotrexate, bendamustine, bortezomib, lenalidomide, etc., as cited.

Definitions

Term	Definition
BTK inhibitor	Bruton tyrosine kinase inhibitors such as Imbruvica (ibrutinib), Calquence (acalabrutinib), Brukinsa (zanubrutinib).
Systemic/chemotherapy regimen	Regimens containing agents such as rituximab, cytarabine, carboplatin, cisplatin, oxaliplatin, cyclophosphamide, doxorubicin, vincristine, methotrexate, bendamustine, bortezomib, lenalidomide, etc., as cited.

Revision History

12/13/2023revised

Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma conditions moved from Other Uses with Supportive Evidence to FDA-Approved Uses due to new FDA labeling; Richter's Transformation renamed to Diffuse Large B-Cell Lymphoma; new condition of approval and criteria added to Other Uses with Supportive Evidence.

06/19/2024added

Marginal Zone Lymphoma condition and criteria were added to Other Uses with Supportive Evidence.

06/26/2024revised

Mantle Cell Lymphoma requirement clarified to state trial of at least one systemic 'chemotherapy' regimen.