CurrentmhnPolicy CP.PHAR.732

Penpulimab‑kcqx (PD‑1 antibody) for non‑keratinizing nasopharyngeal carcinoma

Defines medical necessity and prior authorization criteria for penpulimab‑kcqx for adults with recurrent or metastatic non‑keratinizing nasopharyngeal carcinoma and related coverage rules across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyPenpulimab‑kcqx (PD‑1 antibody) for non‑keratinizing nasopharyngeal carcinoma

Policy CodePolicy CP.PHAR.732

Change TypeNo material change

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets all initial approval criteria (diagnosis, oncologist involvement, age ≥18, recurrent/metastatic disease, regimen, prior therapies, and no prior anti‑PD‑(L)1 therapy).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200 mgMaximum single dose

24 monthsMaximum treatment duration

Adult (≥18)Age requirement

Commercial/HIM/MedicaidLines of business

Coverage Criteria for Penpulimab-kcqx

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inv-01: Initial Approval — Non‑Keratinizing Nasopharyngeal Carcinoma

Covered when ALL of the following are met:

Initial approval criteria: 1. Diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC).

Initial approval criteria: 2. Prescribed by, or in consultation with, an oncologist.

Initial approval criteria: 3. Patient is an adult (age ≥18 years).

Initial approval criteria: 4. Disease is recurrent or metastatic.

Initial approval criteria: 5. Penpulimab-kcqx is prescribed in one of the following ways: a. In combination with cisplatin or carboplatin and gemcitabine; OR b. As a single agent for disease that has progressed on or after both (i) platinum-containing chemotherapy and (ii) at least one other prior line of therapy.

See Appendix B for definitions of prior therapies.

Initial approval criteria: 6. Member has not received prior treatment with an anti-PD-(L)1 antibody.

Initial approval criteria: 7. Requested dose/regimen meets one of the following: a. Combination regimen: dose does not exceed 200 mg IV every 3 weeks; b. Single-agent regimen: dose does not exceed 200 mg IV every 2 weeks; OR c. An off-label dose supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).200 mg

Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-02: Continuation/Duration

Criteria for continued therapy (must meet all):

Continuation criteria: 1. Member is currently receiving penpulimab-kcqx via the benefit, or documentation shows the member has received penpulimab-kcqx for at least 30 days for a covered indication.

Continuation criteria: 2. Member is responding positively to therapy (clinical benefit as documented by treating clinician).

Continuation criteria: 3. If request is for a dose increase, the new dose must meet one of the following: a. Combination with cisplatin or carboplatin and gemcitabine: new dose does not exceed 200 mg every 3 weeks for up to a total maximum of 24 months; b. Single-agent: new dose does not exceed 200 mg every 2 weeks for up to a total maximum of 24 months; c. Dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).24 months

Prescribed regimen must be FDA-approved or recommended by NCCN; approval durations differ by line of business (see below).

Requests for indications that are not FDA‑approved and not specifically addressed in this policy are excluded from coverage unless the provider submits adequate off‑label documentation per the referenced off‑label use policies. See CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for the required evidence of efficacy and safety that must accompany an off‑label request.

Use of penpulimab‑kcqx following prior anti‑PD‑(L)1 therapy is not authorized under the initial approval criteria; initial approval requires that the member has not received prior treatment with an anti‑PD‑(L)1 antibody. For requested uses that are not listed in the policy, the request will be evaluated against the off‑label and formulary/no‑coverage policies referenced in section B and will require sufficient documentation of efficacy and safety per those policies.

Initial Therapy Dosing and Regimen Limits

inv-15: Initial therapy dosing

Initial dosing and regimen limits:

Initial dosing options: a. Combination with cisplatin or carboplatin and gemcitabine: 200 mg IV every 3 weeks until disease progression or a maximum of 24 months.200 mg

Combination dosing frequency q3w; maximum single administration 200 mg.

Initial dosing options: b. Single-agent (previously treated disease): 200 mg IV every 2 weeks until disease progression or a maximum of 24 months.200 mg

Single-agent dosing frequency q2w; maximum single administration 200 mg.

Initial dosing options: c. Off-label dose: dosing supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).200 mg

Prescribed regimen must be FDA-approved or recommended by NCCN; maximum single dose 200 mg unless guideline-supported.

Continuation Approval Requirements

inv-16: Continuation therapy

Continuation approval requirements and durations by line of business:

Continuation approval (general): Member must have been receiving penpulimab-kcqx for at least 30 days for a covered indication and must be demonstrating clinical response to therapy.

Documentation (office notes, labs, imaging) should be provided to support continued benefit.

Continuation approval (dose/duration limits): Dose must not exceed specified maxima (200 mg IV every 3 weeks for combination; 200 mg IV every 2 weeks for single-agent). Total treatment duration is limited to a maximum of 24 months unless additional duration is supported by guidelines or peer-reviewed literature.24 months

Approval duration by line of business: Medicaid/HIM: approvals provided for up to 12 months; Commercial: approvals for up to 6 months or to the member's renewal date, whichever is longer.

Renewal requests must continue to satisfy continuation criteria.

Product Coding and Limits

Product availability / NDCNDC

NDC not listed

Product available as solution in single-dose vial 100 mg/10 mL (no NDC provided in policy)

inv-06: Maximum single dose

Maximum single dose200 mg (authorized maximum per administration for listed regimens)

Combination regimen limit200 mg IV every 3 weeks (first‑line with cisplatin or carboplatin + gemcitabine)

Single‑agent regimen limit200 mg IV every 2 weeks (as single agent for previously treated disease)

inv-07: Maximum treatment duration

Maximum treatment duration24 months (total duration per regimen unless guideline-supported exception)

Combination therapy durationUp to 24 months or until disease progression (200 mg q3w)

Single‑agent therapy durationUp to 24 months or until disease progression (200 mg q2w)

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Provider must ensure the request includes documentation that the member meets ALL initial approval criteria (diagnosis of non-keratinizing nasopharyngeal carcinoma, oncologist involvement, age ≥18, recurrent or metastatic disease, specified regimen or prior therapies, no prior anti‑PD-(L)1 exposure, and dosing within specified limits).

Applies to initial requests for penpulimab-kcqx
Ensure regimen matches: combination with cisplatin or carboplatin + gemcitabine, or single-agent after required prior therapies
Dose limits: ≤200 mg q3 weeks (combination) or ≤200 mg q2 weeks (single agent)

Denial Risk

Non‑Approved Indication — Denial Risk

If the requested use is for an indication that is not FDA‑approved and not addressed in this policy, the request will be denied unless the provider submits sufficient documentation of efficacy and safety per the applicable off‑label use policies (commercial, marketplace, Medicaid) or the plan's evidence of coverage.

See off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)
Non‑FDA approved indications not addressed herein are not authorized without adequate supporting evidence

Documentation Required

Documentation Required with Request

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, pathology reports, radiology reports, and relevant laboratory results demonstrating the diagnosis, prior therapies, disease status, and rationale for use.

Include office notes documenting diagnosis and oncologist consultation
Provide records of prior platinum-containing chemotherapy and other prior lines of therapy when applicable (see Appendix B)
Attach dosing plan and prior anti‑PD-(L)1 therapy history

Step Therapy

Step / Alternative Therapy Guidance

Step/alternative therapy guidance: when penpulimab-kcqx is requested as a single agent, confirm member has progressed on or after a platinum-containing chemotherapy AND at least one other prior line of therapy per the policy. For requests that propose treatments or sequences not listed, follow the applicable off‑label or formulary/no‑coverage policies referenced in section IV/Appendix B.

Single‑agent use requires documented progression after platinum chemotherapy and ≥1 additional prior regimen
When ‘use not listed’ is requested, apply off‑label and formulary/no‑coverage policies in Appendix B/section IV

Step Therapy and Alternative Policies

Situation	Action / Policy to follow
Drug label changed within last 6 months or requested use not listed in this policy	Follow the referenced formulary/no-coverage or off-label use policies for the applicable line of business: - If drug is on the formulary/PDL: use the no coverage criteria policy (CP.CPA.190 for Commercial; HIM.PA.33 for Health Insurance Marketplace; CP.PMN.255 for Medicaid). - If drug is NOT on the formulary/PDL: use the non-formulary policy (CP.CPA.190 for Commercial; HIM.PA.103 for Health Insurance Marketplace; CP.PMN.16 for Medicaid). - If the requested use is not specifically excluded and the label change does not apply: refer to the off-label use policy (CP.CPA.09 for Commercial; HIM.PA.154 for Health Insurance Marketplace; CP.PMN.53 for Medicaid).

Situation

Action / Policy to follow

Drug label changed within last 6 months or requested use not listed in this policy

Follow the referenced formulary/no-coverage or off-label use policies for the applicable line of business: - If drug is on the formulary/PDL: use the no coverage criteria policy (CP.CPA.190 for Commercial; HIM.PA.33 for Health Insurance Marketplace; CP.PMN.255 for Medicaid). - If drug is NOT on the formulary/PDL: use the non-formulary policy (CP.CPA.190 for Commercial; HIM.PA.103 for Health Insurance Marketplace; CP.PMN.16 for Medicaid). - If the requested use is not specifically excluded and the label change does not apply: refer to the off-label use policy (CP.CPA.09 for Commercial; HIM.PA.154 for Health Insurance Marketplace; CP.PMN.53 for Medicaid).