CurrentCentenePolicy CP PHAR.620

Pirtobrutinib (Jaypirca) coverage policy

Defines medical necessity criteria, covered indications (FDA and NCCN-supported off-label), dosing limits, prior authorization and approval durations for pirtobrutinib (Jaypirca) across Commercial, HIM and Medicaid lines of business for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyPirtobrutinib (Jaypirca) coverage policy

Policy CodePolicy CP PHAR.620

Change TypeAdded and revised indications/criteria (2023-2025)

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria; prior authorization may be required.

POLICY UPDATE CHANGES

RT4: added new indication for CLL and SLL per updated prescribing information and NCCN supported off-label uses.

2Q 2024 annual review: added maximum dose criteria for concomitant use with CYP3A inducers; updated Appendix B for therapeutic alternatives; references updated.

2Q 2025 annual review: added criteria for MZL and Waldenstrom macroglobulinemia per NCCN; Appendix B updated; references reviewed and updated.

3FDA or primary covered indications listed (CLL/SLL, MCL)

2NCCN-supported off-label indications added (MZL, Waldenstrom)

200/300Dose thresholds (mg/day)

Coverage Summary

Policy CP PHAR.620 (Pirtobrutinib, Jaypirca) covers the FDA-approved indications for adult patients with relapsed/refractory mantle cell lymphoma (MCL) after ≥2 lines of systemic therapy including a BTK inhibitor, and for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received ≥2 lines of therapy including a BTK inhibitor and a BCL2 inhibitor (accelerated approval). The policy also incorporates NCCN-compendium supported off-label uses (e.g., MZL, Waldenstrom) and defines prior authorization and clinical criteria. Coverage stance: covered_with_criteria. Policy number: CP PHAR.620. Scope summary: Defines medical necessity criteria, covered FDA and NCCN-supported off-label indications, dosing thresholds (200 mg/day standard; 300 mg/day with prescriber attestation for concomitant CYP3A inducers), prior authorization requirements, prescriber specialty expectations, and approval durations across Commercial, HIM and Medicaid lines of business.

Key thresholds

Age> 18 years

Minimum prior therapy for CLL/SLLAt least 2 lines including a BTK inhibitor and a BCL2 inhibitor

Minimum prior therapy for MCL>= 2 lines of therapy

Dose limit standard200 mg per day (2 tablets)

Dose limit with CYP3A inducer attestation300 mg per day (3 tablets) with prescriber attestation of inability to avoid concomitant CYP3A inducer

Provider Actions & Prior Authorization

Prior Authorization

Documentation required for prior authorization

Provider must submit clinical documentation supporting that the member meets all approval criteria when requesting pirtobrutinib prior authorization.

Office chart notes
Laboratory results
Other clinical information

Documentation Required

Prescriber specialty

Prescriptions must be written by or in consultation with an oncologist or hematologist.

Documentation Required

Prescriber attestation for CYP3A inducers

If a dose greater than 200 mg/day (up to 300 mg/day) is requested because the member is taking a concomitant CYP3A inducer, the prescriber must attest that the member cannot avoid the CYP3A inducer.

Examples of CYP3A inducers: carbamazepine, rifampin, ritonavir, St John's wort

Documentation Required

Off-label evidence submission

For NCCN-compendium or other off‑label uses, the prescriber must submit supporting evidence that the requested dose or use is supported by practice guidelines or peer‑reviewed literature.

Billing Rule

Approval duration

Approval durations differ by line of business: Commercial approvals are up to 12 months or the duration of the request (whichever is less); Medicaid and HIM initial approvals are typically 6 months (continued therapy and some Medicaid/HIM continued approvals list 12 months per section-specific rules).

Clinical Evidence & Guidelines

BRUIN phase 1/2 (Lancet 2021)Key trial supporting pirtobrutinib efficacy in relapsed/refractory B-cell malignancies (BRUIN)

Jaypirca prescribing information June 2024Regulatory: prescribing information for Jaypirca (pirtobrutinib)

NCCN B-cell Lymphomas and CLL/SLL compendia (2025)Guideline: NCCN compendia referenced for indications and off-label uses (2025)

Key evidence includes the BRUIN phase 1/2 trial demonstrating pirtobrutinib activity in relapsed/refractory B-cell malignancies (Lancet 2021), the Jaypirca prescribing information (June 2024) as the regulatory source, and NCCN B-cell Lymphomas and CLL/SLL compendia (versions 2025) for guideline recommendations and compendium-listed off-label uses. Per policy, NCCN-supported off-label uses are included, but when prescribers rely on off-label dosing or indications they must submit supporting practice-guideline or peer-reviewed literature to satisfy prior authorization documentation requirements.

Background & Definitions

Background: Pirtobrutinib is a highly selective, reversible (non-covalent) Bruton tyrosine kinase (BTK) inhibitor indicated by the FDA for relapsed/refractory MCL (after ≥2 lines including a BTK inhibitor) and for CLL/SLL after ≥2 lines including both a BTK and a BCL2 inhibitor (accelerated approval). The policy integrates these FDA approvals and incorporates NCCN Compendium–supported off-label indications (e.g., MZL, Waldenstrom) into coverage determinations and prior authorization criteria, including specified dosing limits and requirements for prescriber attestation and supporting evidence when off-label use is requested.

BCL2i: B-cell lymphoma 2 inhibitor (e.g., venetoclax).

BTK: Bruton tyrosine kinase.

NCCN: National Comprehensive Cancer Network.

Revision History

2023-12-07added

RT4: added new indication for CLL and SLL per updated prescribing information and NCCN supported off-label uses.

2024-02-12revised

2Q 2024 annual review: added maximum dose criteria for concomitant use with CYP3A inducers; updated Appendix B for therapeutic alternatives; references updated. (P&T 05.24)

2025-02-04addedLatest

2Q 2025 annual review: added criteria for MZL and Waldenstrom macroglobulinemia per NCCN; Appendix B updated; references reviewed and updated. (P&T 05.25)

Policy Summary

PayerCentene

PolicyPirtobrutinib (Jaypirca) coverage policy

Policy CodePolicy CP PHAR.620

Change TypeAdded and revised indications/criteria (2023-2025)

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria; prior authorization may be required.

On This Page

50 mg tablet	Pirtobrutinib tablet strength listed in product availability (50 mg)
100 mg tablet	Pirtobrutinib tablet strength listed in product availability (100 mg)

OpenPayer

Pirtobrutinib (Jaypirca) coverage policy

Coverage Summary

Initial Therapy Criteria — CLL / SLL

Initial Therapy Criteria — Mantle Cell Lymphoma (MCL)

NCCN Compendium Indications (off-label) — MZL & Waldenstrom

Continuation Therapy Criteria

Other Diagnoses / Exclusions

Provider Actions & Prior Authorization

Applicable Codes & Product Availability

Clinical Evidence & Guidelines

Background & Definitions

Revision History