CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Penpulimab-kcqx (penpulimab-kcqx) for nasopharyngeal carcinoma — Coverage Criteria

Defines medical necessity and prior authorization requirements for penpulimab-kcqx in adult patients with non-keratinizing nasopharyngeal carcinoma for first-line combination or later-line single-agent use; applies to providers submitting medication requests to Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPenpulimab-kcqx (penpulimab-kcqx) for nasopharyngeal carcinoma — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization through Evolent (J9999) and document FDA labeling, CMS-recognized compendia, or applicable guideline/supporting literature to support use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24maximum treatment duration

200single dose max (mg)

J9999billing code

First & latercovered indications

Coverage Criteria for Penpulimab-kcqx

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Covered Indications (Nasopharyngeal Carcinoma)

Covered when ALL of the following are met for adult members with non-keratinizing nasopharyngeal carcinoma:

First-line combination use: Penpulimab-kcqx is used in combination with cisplatin or carboplatin and gemcitabine for first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).

Guideline-specified first-line regimen.

Single-agent later-line use: Penpulimab-kcqx is used as a single agent for the treatment of metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

Guideline-specified later-line indication.

Coverage is NOT authorized when any of the following exclusion criteria apply: disease progression while taking penpulimab-kcqx; a single administered dose exceeds 200 mg; total treatment duration exceeds 24 months; or the requested use is investigational or for an off‑label indication that lacks sufficient supporting evidence or is not generally accepted by the medical community. The policy specifies elements that determine sufficiency of evidence (representation of the patient population and regimen in published studies, clinically meaningful outcomes such as ASCO-recommended effect sizes, appropriate study design, and the relative weight of non-randomized trials versus case reports or abstracts).

Off‑label uses of penpulimab-kcqx are considered investigational and will be denied unless the request is supported by adequate clinical evidence as defined by the policy. Acceptable support includes documentation showing that the indication, patient characteristics, and regimen are represented in the published evidence; that outcomes reported are clinically meaningful (for example, meeting ASCO‑recommended thresholds); and that the study design is appropriate. The policy explicitly notes that case reports and abstracts without full peer‑reviewed publications are insufficient, and that evidence cited should be consistent with CMS‑recognized compendia or acceptable peer‑reviewed literature.

Regimen	Indication	Coverage
Penpulimab-kcqx in combination with cisplatin or carboplatin and gemcitabine	First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)	Covered when criteria are met

Regimen	Indication	Coverage
Penpulimab-kcqx single-agent	Metastatic non-keratinizing nasopharyngeal carcinoma with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy	Covered when criteria are met

Line of Therapy Specifications

Line of Therapy: first-line | second-line

First-line: Combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic non-keratinizing NPC.

Guideline-specified first-line regimen.

Subsequent-line: Single-agent use for metastatic non-keratinizing NPC after progression on platinum-based chemotherapy and at least one additional prior line of therapy.

Guideline-specified later-line indication.

Billing and Coding

Applicable HCPCS CodesHCPCSCovered

J9999

penpulimab-kcqx

inv-05: Single dose limit — ≤ 200 mg.

Single dose maximum200 mg per single administered dose

Policy threshold typeHard exclusion — requests exceeding this single dose will be denied

Action for providersEnsure ordered single dose does not exceed 200 mg; document dosing in prior auth submission

inv-06: Maximum treatment duration — ≤ 24 months.

Maximum treatment duration24 months cumulative treatment

Policy consequenceTreatment beyond 24 months is an exclusion and may be denied

Provider documentationInclude start and anticipated stop dates in authorization requests to confirm duration ≤ 24 months

Provider Requirements and Authorization

Prior Authorization

Prior authorization required for penpulimab-kcqx (J9999)

Prior authorization through Evolent is required for requests for penpulimab-kcqx (HCPCS code J9999). Coverage is limited to the specified non-keratinizing nasopharyngeal carcinoma indications when all clinical criteria are met.

Submit prior authorization requests to Evolent for HCPCS code J9999 (penpulimab-kcqx).
Approval is contingent on meeting the coverage criteria for non-keratinizing nasopharyngeal carcinoma (first-line combination or later-line single-agent use).

Step Therapy

Conditions for continuation / re-authorization

Continuation (re-authorization) requests may be approved without a full new review only if the member has not experienced disease progression on penpulimab-kcqx, the medication was used within the last year without a lapse greater than 30 days of active authorization, and no additional medications are being added to the request.

No disease progression on the requested medication.
Previous use within the last 12 months with ≤30-day lapse from prior active authorization.
No new concomitant medications are being added to the continuation request.

Documentation Required

Required supporting clinical evidence

Support for the requested use must be documented by FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Acceptable sources include prescribing information, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed studies meeting CMS criteria.
References listed in the policy (e.g., prescribing information, clinical studies) may be used to support medical necessity.

Denial Risk

Exclusion conditions that trigger denial

Requests must be denied if any exclusion condition is met, including disease progression while on penpulimab-kcqx, dosing above the single-dose limit of 200 mg, treatment beyond the maximum duration of 24 months, or investigational/off-label use lacking sufficient evidence as defined by the policy.

Disease progression while taking penpulimab-kcqx.
Dosing exceeds the single-dose limit of 200 mg.
Treatment exceeds the maximum duration limit of 24 months.
Off-label or investigational uses without sufficient evidence or not accepted by the medical community per CMS compendia/peer-reviewed standards.

Background

Penpulimab-kcqx is an anti‑PD‑1 monoclonal antibody used in this guideline specifically for adult patients with non‑keratinizing nasopharyngeal carcinoma. It is authorized either in combination with cisplatin or carboplatin plus gemcitabine as first‑line therapy for recurrent/metastatic disease, or as single‑agent therapy for metastatic disease after progression on platinum and at least one additional prior line. Use must meet the policy’s coverage criteria and evidentiary standards.