CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1476

Jaypirca (pirtobrutinib) — Coverage Criteria for Relapsed/Refractory B‑cell Malignancies

Defines clinical coverage criteria, exclusions, and coding for Jaypirca (pirtobrutinib) for members of Neighborhood Health Plan of Rhode Island; applies to utilization management of pirtobrutinib medication requests. Affects prescribing providers and UM reviewers processing authorization requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJaypirca (pirtobrutinib) — Coverage Criteria for Relapsed/Refractory B‑cell Malignancies

Policy CodePolicy UM ONC_1476

Change TypeNo material change

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionObtain prior authorization and document required prior therapies and supporting evidence per policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2distinct tumor-type indications listed

J9399billing code for pirtobrutinib

200 mgsingle dose maximum

30 / 60monthly maximums

Coverage Criteria for Jaypirca (pirtobrutinib)

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Mantle Cell Lymphoma (MCL) — Initial coverage criteria

Covered when ALL of the following are met:

MCL coverage requirements: Member has relapsed/refractory mantle cell lymphoma AND has received ≥2 prior lines of systemic therapy, including chemoimmunotherapy (e.g., R‑CHOP or bendamustine + rituximab) AND has received a Bruton Tyrosine Kinase (BTK) inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib).

Monotherapy with Jaypirca (pirtobrutinib) allowed.

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) — Initial coverage criteria

Covered when ALL of the following are met:

CLL/SLL coverage requirements: Member has chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) AND has received ≥2 prior lines of therapy including a BTK inhibitor (e.g., zanubrutinib, acalabrutinib, ibrutinib) AND a BCL‑2 inhibitor (e.g., venetoclax).

Monotherapy with Jaypirca (pirtobrutinib) allowed.

Continuation therapy

Covered when ALL of the following are met:

Continuation request criteria: Requested medication was used within the last year AND there has been no disease progression and no intolerance to the medication AND no additional medications are being added to the continuation request.

Continuation requests for a not‑approvable medication are exempt when criteria are met.

The following uses of Jaypirca (pirtobrutinib) are excluded from coverage: disease progression while on pirtobrutinib; dosing that exceeds a single dose of 200 mg; and treatment that exceeds the monthly tablet maximums of 30 tablets for the 50 mg strength or 60 tablets for the 100 mg strength. Requests exceeding these limits should be denied per policy.

Jaypirca (pirtobrutinib) is considered investigational and not medically necessary for off‑label indications that lack sufficient supporting evidence or are not generally accepted by the medical community. The policy defines insufficient evidence as limited or non‑representative patient/cancer characteristics, inadequate representation of the regimen, lack of clinically meaningful outcomes (for example, insufficient hazard ratios or survival benefit), inappropriate experimental design for the question, reliance on uncontrolled case reports, or abstracts without full peer‑reviewed publication. Uses that do not meet accepted evidence sources (e.g., CMS‑recognized compendia or acceptable peer‑reviewed literature) should be denied.

Indication	Regimen	Coverage status	Required prior therapies / notes
Relapsed/refractory Mantle Cell Lymphoma (MCL)
Jaypirca (pirtobrutinib) monotherapy
Covered with criteria
Member has received ≥2 prior lines of systemic therapy including chemoimmunotherapy (e.g., R‑CHOP or bendamustine + rituximab) AND a Bruton Tyrosine Kinase (BTK) inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib).

Billing and Coding

Medication HCPCSHCPCSCovered

J9399

pirtobrutinib

inv-07: Single dose limit — numeric limit (≤ 200 mg)

Single dose limit≤ 200 mg per dose

Source policy sectionExclusion if dosing exceeds single dose limit of Jaypirca (pirtobrutinib) 200 mg

Impact on authorizationRequests exceeding 200 mg single dose are excluded from coverage

inv-08: Monthly tablet maximums — 30 tablets (50 mg) or 60 tablets (100 mg) per month

Monthly maximum (50 mg strength)30 tablets per month (50 mg strength)

Monthly maximum (100 mg strength)60 tablets per month (100 mg strength)

Policy consequenceTreatment that exceeds these tablet limits is excluded from coverage

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required for Jaypirca

Prior authorization is required for Jaypirca (pirtobrutinib); coverage is permitted only when the member meets the policy-specified indication and prior therapy requirements for relapsed/refractory MCL or CLL/SLL.

Submit authorization requests for J9399 with clinical documentation demonstrating the member meets the relevant indication and prior therapy criteria.

Step Therapy

Required prior therapies (step therapy)

Authorization requires documented prior lines of therapy: for Mantle Cell Lymphoma (MCL), at least two prior systemic therapies including chemoimmunotherapy and a BTK inhibitor; for CLL/SLL, at least two prior lines including a BTK inhibitor and a BCL‑2 inhibitor.

MCL: ≥2 prior systemic therapies including chemoimmunotherapy (e.g., R‑CHOP or bendamustine + rituximab) AND a BTK inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib).
CLL/SLL: ≥2 prior lines including a BTK inhibitor (e.g., zanubrutinib, acalabrutinib, ibrutinib) AND a BCL‑2 inhibitor (e.g., venetoclax).

Documentation Required

Supporting documentation required

Authorization requests must be supported by accepted evidence sources such as FDA product labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature; refer to the FDA label/package insert for dosing and management details.

Provide citations and, when applicable, excerpts from FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or peer‑reviewed publications that directly support the requested use.

Denial Risk

Denial triggers and risks

Requests are at high risk of denial when any exclusion criteria are met, including disease progression on Jaypirca, dosing beyond single‑dose or monthly tablet limits, or investigational/off‑label uses lacking sufficient supporting evidence.

Denial triggers include: documented progression while on pirtobrutinib.
Single dose exceeding 200 mg or monthly supply exceeding 30 tablets (50 mg) or 60 tablets (100 mg).
Off‑label/ investigational indications not supported by CMS compendia or acceptable peer‑reviewed literature as defined in the policy.

Line-of-Therapy Designation

salvage

Line of therapy: MCL (salvage): Indication is designated as salvage therapy: member has received at least two prior systemic therapies including chemoimmunotherapy AND a BTK inhibitor.

Line of therapy corresponds to relapsed/refractory setting per policy.

salvage

Line of therapy: CLL/SLL (salvage): Indication is designated as salvage therapy: member has received at least two prior lines of therapy including a BTK inhibitor AND a BCL‑2 inhibitor.

Line of therapy corresponds to relapsed/refractory setting per policy.

Approved Regimens

Indication	Regimen	Coverage status	Required prior therapies / notes
Relapsed/refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Jaypirca (pirtobrutinib) monotherapy
Covered with criteria
Member has received ≥2 prior lines of therapy including a BTK inhibitor (e.g., zanubrutinib, acalabrutinib, ibrutinib) AND a BCL‑2 inhibitor (e.g., venetoclax).

Background

Pirtobrutinib (Jaypirca) is a noncovalent (reversible) Bruton tyrosine kinase (BTK) inhibitor developed for relapsed/refractory B‑cell malignancies. This policy governs utilization management for pirtobrutinib, tying coverage to specified indications and evidence sources and excluding use when progression on therapy occurs or when dosing and monthly tablet thresholds are exceeded.

Accepted Evidence Sources

inv-14: Accepted evidence sources — FDA labeling, CMS compendia, NCCN/ASCO guidelines, peer‑reviewed literature per CMS guidance

Primary accepted sourcesFDA approved product labeling / Jaypirca (prescribing information)

Compendia and guidelinesCMS‑approved compendia, NCCN Cancer Guidelines and Drugs & Biologics Compendium, ASCO clinical guidelines

Peer‑reviewed literatureAcceptable peer‑reviewed studies that meet CMS Medicare Benefit Policy Manual Chapter 15 criteria (e.g., BRUIN trial, Lancet 2021)

Documentation requirementRequests must be supported by one of the above evidence sources per policy

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJaypirca (pirtobrutinib) — Coverage Criteria for Relapsed/Refractory B‑cell Malignancies

Policy CodePolicy UM ONC_1476

Change TypeNo material change

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionObtain prior authorization and document required prior therapies and supporting evidence per policy.

SourceLink

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