Pembrolizumab and pembrolizumab/berahyaluronidase alfa (Keytruda, Keytruda Qlex) coverage
Clinical coverage and coding guidance for pembrolizumab and pembrolizumab/berahyaluronidase alfa across FDA-approved oncologic indications for Commercial, HIM, and Medicaid; informs providers requesting authorization or billing.
Keytruda Qlex (SC formulation) was added to the policy.
Multiple FDA‑approved indications and NCCN‑aligned pathways were added or updated across tumor types (e.g., gastric/GEJ, esophageal, HNSCC, HCC, endometrial, NSCLC, urothelial, BTC, MCC, pediatric extensions).
HCPCS coding updated: J9277 was added for pembrolizumab/berahyaluronidase alfa and older miscellaneous codes (C9399, J9999, J3590) were removed or replaced.
Initial approval durations for maintenance use were extended (example: MIBC maintenance initial approval extended from 6 to 12 months).
Added new SC formulation Keytruda Qlex to policy and added indication for neoadjuvant/adjuvant usage in locally advanced HNSCC per PI.
Updated Appendix G (including Tennessee and Indiana) and revised language; references reviewed and updated.
Added new FDA-approved indication for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per updated PI.
Converted 400 mg every 6-week dosing regimen in adults with cHL and PMBCL to full approval per PI and updated dosing/HCPCS coding (removed J3590/J9999; added J9277).
Added new indication for MIBC and extended initial approval duration from 6 to 12 months for maintenance medication.
HCPCS codes C9399 and J9999 removed (with J9277 added).
Coverage Criteria and Indication-Specific Rules
FDA-indication-based coverage
Covered when the requested use matches FDA-approved indications and any specified biomarker or prior-therapy conditions
General coverage requirement
- Indication examples: Includes but not limited to: unresectable/metastatic melanoma; multiple NSCLC settings (first-line with chemo, single agent for PD-L1 TPS ≥ 1%, adjuvant/neoadjuvant indications); malignant pleural mesothelioma in combination with pemetrexed/platinum; head and neck squamous cell carcinoma settings; urothelial carcinoma indications including single agent for platinum-ineligible or post-platinum progression and combination with enfortumab vedotin; MSI-H/dMMR solid tumors and MSI-H CRC; gastric, esophageal, and GEJ cancers in specified combinations; cervical cancer in CRT or systemic combinations; hepatocellular carcinoma after prior systemic therapy or first-line; biliary tract cancer with gemcitabine/cisplatin; Merkel cell carcinoma; renal cell carcinoma combinations and adjuvant use; endometrial carcinoma combinations; TMB-H solid tumors (≥10 mut/Mb); cutaneous squamous cell carcinoma not amenable to curative therapy; triple-negative breast cancer neoadjuvant/adjuvant and PD-L1 CPS ≥10 metastatic settings; ovarian cancer in platinum-resistant settings; pediatric hypermutant glioma (off-label); numerous NCCN-recommended off-label uses.
Each sub-indication may carry age, biomarker, combination, or prior therapy restrictions as stated in the policy.
Initial Therapy — Melanoma
Melanoma: Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or recommended by NCCN.
Initial Therapy — Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer: Covered when ALL of the following are met
Prior authorization may be required for some mutation scenarios; follow Appendix B for chemotherapy combinations.
Initial Therapy — Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma: Covered when ALL of the following are met
Approval durations and maximum duration commonly up to 24 months per indication.
Initial Therapy — Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma: Covered when ALL of the following are met
Neoadjuvant/adjuvant durations and dosing caps apply; Illinois HIM step exemptions may apply per IL HB 5395.
Initial Therapy — Classical Hodgkin Lymphoma
Classical Hodgkin Lymphoma: Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or recommended by NCCN.
Initial Therapy — Primary Mediastinal Large B-Cell Lymphoma
Primary Mediastinal Large B-Cell Lymphoma: Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or recommended by NCCN.
Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Covered when ALL of the following are met
Urothelial Carcinoma
Urothelial Carcinoma — Covered when ALL of the following are met
Prior authorization may be required for Padcev, Inlyta, and Lenvima; MIBC dosing and duration specifics apply.
MSI-H / dMMR Solid Tumors
MSI-H / dMMR Solid Tumors — Covered when ALL of the following are met
Limitations: pediatric CNS TMB-H safety/effectiveness not established per policy appendices; prescribed regimen must be FDA-approved or NCCN-recommended.
Initial Therapy — Gastric, Esophageal, and GEJ Cancer
Gastric, Esophageal, and GEJ Cancer — Covered when ALL of the following are met
Illinois HIM step therapy exemptions per IL HB 5395 and other state exceptions in Appendix G; prescribed regimen must be FDA-approved or NCCN-recommended.
Initial Therapy — Cervical Cancer
Cervical Cancer — Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or NCCN-recommended.
Initial Therapy — Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma (HCC) — Covered when ALL of the following are met
Prior authorization may be required for agents such as Nexavar, Lenvima, or Stivarga when used in combination contexts per policy notes.
Initial Therapy — Biliary Tract Cancer
Biliary Tract Cancer — Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or NCCN-recommended.
Initial Therapy — Merkel Cell Carcinoma (MCC)
Merkel Cell Carcinoma (MCC) — Covered when ALL of the following are met
Prescribed regimen must be FDA-approved or NCCN-recommended.
Initial Therapy — Renal Cell Carcinoma (RCC)
Renal Cell Carcinoma (RCC) — Covered when ALL of the following are met
Prior authorization may be required for Inlyta and Lenvima.
Initial Therapy - Renal Cell Carcinoma
Initial Therapy - Renal Cell Carcinoma — Covered when ALL of the following are met
Prior authorization may be required for Inlyta and Lenvima.
Initial Therapy - Endometrial Carcinoma
Endometrial Carcinoma — Covered when ALL of the following are met
See MSI-H/dMMR criteria for separate pathway.
Initial Therapy - Tumor Mutational Burden-High (TMB-H)
Tumor Mutational Burden-High (TMB-H) — Covered when ALL of the following are met
Limitations: pediatric CNS TMB-H safety/effectiveness not established per policy appendices.
Initial Therapy - Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma — Covered when ALL of the following are met
Dose/duration limits apply.
Initial Therapy - Triple Negative Breast Cancer
Triple Negative Breast Cancer — Covered when ALL of the following are met
Multiple duration specifics depending on setting.
Initial Therapy - Ovarian Cancer
Ovarian Cancer — Covered when ALL of the following are met
PD-L1 CPS ≥ 1 required for paclitaxel combination.
Initial Therapy - Pediatric Glioma (off-label)
Pediatric Glioma (off-label) — Covered when ALL of the following are met
This is an off-label indication and requires supporting evidence as noted.
Initial Therapy - NCCN Recommended Off-label Uses
NCCN Recommended Off-label Uses — Covered when ALL of the following are met
Specific lists distinguish first-line/subsequent and Keytruda vs Keytruda Qlex uses; confirm indication-specific requirements in full policy.
Uses not listed among the FDA‑approved indications in this document are not described in Section I and would require separate justification. Providers must follow the referenced coverage pathways when requesting authorization for diagnoses, ages, dosing regimens, or combinations not explicitly enumerated in the policy.
Section III of the policy lists diagnoses and indications for which coverage is NOT authorized. Refer to that section for specific non‑authorized conditions; non‑FDA approved indications are generally excluded unless supported through the off‑label use policies referenced in Section V (see policy cross‑references).
Step therapy exemptions apply in jurisdictions with regulations that prohibit redirection or step edits for oncology drugs. See Appendix G for state‑specific redirection and bypass rules (for example, Illinois HIM per IL HB 5395 and other state entries) and confirm whether step therapy requirements apply before implementing a step edit.
If the drug label has changed within the prior 6 months and the change is not reflected in this policy, providers must follow the payer's formulary or non‑formulary authorization pathways shown in the referenced policies (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/PDL; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary).
Requests for indications that are not FDA‑approved and are not addressed in this policy are excluded unless the prescriber provides sufficient documentation as required by the applicable off‑label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53). Note that pediatric CNS tumors with TMB‑H represent a documented limitation where safety and effectiveness have not been established.
The NCCN guidance does not support use of pembrolizumab (Keytruda) as first‑line or subsequent therapy for bladder carcinoma in situ (CIS) in the absence of documented Bacillus Calmette‑Guérin (BCG) failure. Requests for Keytruda in this setting without BCG failure may be considered not medically necessary.
Continued Therapy
Continued Therapy — Covered when ALL of the following are met
Duration limits: adjuvant melanoma/RCC monotherapy up to 12 months; high-risk early TNBC neoadjuvant up to 24 weeks then 27 weeks adjuvant; NSCLC adjuvant 12 months or neoadjuvant 12 weeks + adjuvant 39 weeks or other NSCLC requests 24 months; HNSCC neoadjuvant 6 weeks/adjuvant 1 year/other 24 months; MIBC neoadjuvant 3 doses/adjuvant 14 doses (q3w) or 7 doses (q6w); all other FDA-approved indications up to 24 months.
Other diagnoses/indications
Other diagnoses/indications — Covered only if one of the listed conditions applies
Providers must follow CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary.
Off‑label requests require supporting practice guidelines or peer‑reviewed literature.
Indication-aligned dosing coverage
Coverage is aligned to indication-specific dosing regimens and durations; formulations (IV and SC) are covered when dosing matches listed regimens.
See dosing per indication in policy; SC formulation Keytruda Qlex dosing equivalents are specified for many indications.
Aggregate indication and criteria updates
Policy criteria have been expanded and revised over multiple RT4 updates to align with FDA PI and NCCN recommendations across indications.
See full policy sections for detailed AND/OR logic per indication.
Updated FDA Indications and Formulation Changes
Coverage updated for multiple FDA-labeled indications and formulations when consistent with product prescribing information and member benefit terms
Authorization and coding per Health Plan and current HCPCS guidance.
Previous policy versions removed certain prior approvals or uses during updates (for example, prior inclusion of small cell lung cancer monotherapy was removed). Providers should consult the current policy sections for the active, indication‑specific coverage rules.
Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage). This policy is a guide to medical necessity and does not guarantee payment or override benefit exclusions.
Use of pembrolizumab for pediatric central nervous system tumors with TMB‑H is not established. The prescribing information notes that safety and effectiveness in pediatric patients with TMB‑H CNS cancers have not been established; such requests are excluded from coverage under Section III.
See Section III (Diagnoses/Indications for which coverage is NOT authorized) for the full list of conditions and diagnoses that are not authorized for coverage under this policy. Specific non‑authorized items and any pediatric exclusions are detailed there.
For pediatric patients age < 18 years (specifically age ≥ 6 months to < 18 years) with MSI‑H/dMMR tumors, requests for first‑line therapy are not permitted under the MSI‑H/dMMR criteria set; subsequent‑line use and the age/weight thresholds described in the policy must be followed.
Uses that do not meet the specific criteria listed in each indication — including diagnosis, prescriber specialty, age/weight thresholds, biomarker results (PD‑L1, MSI, TMB), prior therapy requirements, dosing caps, and evidence submission for off‑label regimens — may be denied as not meeting medical necessity requirements.
Initial Therapy: Indication-Specific Criteria and Dosing
Continuation and Maintenance Therapy Rules
Coding, Dosing Caps, and Test Thresholds
| not listed in this section | Specific CPT/HCPCS/NDC codes are not present in the visible document portion. |
| 200 mg q3w; 400 mg q6w | Keytruda adult dosing limits as stated |
| 395 mg/4,800 units q3w; 790 mg/9,600 units q6w | Keytruda Qlex dosing limits as stated |
| 2 mg/kg up to 200 mg q3w | Pediatric pembrolizumab dosing limit for TMB-H pediatrics |
| maximum 24 months | Typical maximum duration for many adult indications |
| monotherapy adjuvant examples up to 12 months | Indication-specific monotherapy/adjuvant maximum durations (e.g., RCC, melanoma, selected adjuvant uses) |
Prior Authorization, Documentation, and Operational Guidance
Prior Authorization Required and Approval Duration
Prior authorization (PA) is required for pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa‑pmph (Keytruda Qlex) for indications listed in this policy. Approval durations vary by benefit: Medicaid/HIM approvals are issued for 12 months; Commercial approvals are issued for 6 months or to the member's renewal date, whichever is longer. Continued‑therapy requests must document current receipt of therapy for ≥30 days when applicable.
- PA required for listed oncology indications (see policy Sections I and IV)
- Approval duration — Medicaid/HIM: 12 months; Commercial: 6 months or to member renewal date
Prior Authorization: Confirm Indication, Formulation, Dose, and Duration
PA requests must confirm the exact FDA‑indication, formulation (IV Keytruda vs SC Keytruda Qlex), prescribed dose, and duration. Requests that exceed stated dosing limits or durations must include prescriber justification and supporting evidence. Off‑label dosing, dose increases above labeled amounts, or regimens not specifically listed require submission of supporting practice guidelines or peer‑reviewed literature.
- Confirm formulation: IV (Keytruda) vs SC (Keytruda Qlex)
- If dose or duration exceeds policy limits, prescriber must submit supporting evidence (guidelines or peer‑reviewed literature)
Use Outside Listed Indications May Trigger Denial
Use outside the listed indications or without required prior therapies may be denied. Non‑FDA approved indications not addressed in this policy will be denied unless adequate off‑label justification is provided per the line‑of‑business off‑label use policy. Newly added FDA label changes (within the last 6 months) may follow formulary or non‑formulary routing as specified in Section IV.B.
- Off‑label requests must follow CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable
- If an indication was added to the label <6 months ago, refer to the no coverage/non‑formulary routing policies listed in Section IV.B
Documentation Requirement — What to Submit
Provider must submit documentation (e.g., office chart notes, pathology/lab reports, biomarker test results, prior therapy documentation) that supports the member meets all approval criteria for the requested indication. Failure to submit required documentation may result in denial or delay.
- Include tumor type, stage/setting, and FDA‑required biomarker results (e.g., PD‑L1 TPS or CPS, MSI‑H/dMMR, TMB)
- Include prior systemic therapy details and dates when required by indication (e.g., prior platinum therapy, targeted therapy for mutation‑positive NSCLC)
- Include medication administration records or infusion documentation showing ≥30 days of current therapy for continuation requests
Coverage Contingent on Meeting Listed Criteria
Coverage is contingent on meeting all listed criteria for the requested indication. Requests that do not meet the specific criteria (diagnosis, prescriber specialty, age, prior therapies, biomarker status, dose limits, and duration) may be denied.
- Prescriber must be an oncologist, hematologist, or appropriate specialist as specified for the indication
- Age and prior therapy requirements (see each indication criteria) must be met
- Prescribed regimen must be FDA‑approved or NCCN‑recommended
BCG Shortage — Keytruda Not Supported Without BCG Failure
For treatment of BCG‑unresponsive, high‑risk non‑muscle invasive bladder cancer (NMIBC) with CIS: the NCCN does not support use of pembrolizumab as first‑line or subsequent therapy in the absence of BCG failure. During BCG shortage, providers should prioritize BCG per NCCN guidance and use recommended alternatives; Keytruda is not supported as a substitute for BCG without documentation of BCG failure or ineligibility.
- BCG shortage guidance: prioritize BCG for induction of high‑risk patients, consider dose splitting per NCCN
- Keytruda is not an NCCN‑recommended substitute for intravesical BCG in the absence of BCG failure
Required Clinical Documentation
Required clinical documentation must support the specific FDA indication requested, including tumor histology, stage or resectability status, and relevant biomarker testing (e.g., PD‑L1 TPS or CPS, MSI‑H/dMMR, TMB). For indications requiring prior systemic therapy, include details of prior agents, doses, and dates.
- Tumor type and stage (e.g., resectable vs metastatic)
- FDA‑approved test results for PD‑L1, MSI/dMMR, or TMB where applicable
- Prior systemic therapy records when criteria require prior treatment
Supporting Clinical Documentation — Examples
Supporting clinical documentation should include office notes, pathology reports, imaging, laboratory results, operative reports, and prior treatment records to substantiate diagnosis, biomarker status, prior therapies, and clinical rationale for the requested regimen.
- Include copies of FDA‑approved biomarker test reports (e.g., PD‑L1 assay, MSI/dMMR test, TMB report)
- Provide operative or pathology reports for resectability/adjuvant indications
- Attach prior authorization approvals or drug administration records for continuation requests
Supporting Evidence Required for Off‑Label Dosing and Dose Increases
When prescribers request off‑label dosing or dose increases beyond policy limits, they must submit supporting evidence such as current practice guidelines (NCCN) or peer‑reviewed literature that justify the regimen. Dose increases should be supported by guideline recommendations or substantive literature.
- Off‑label dosing requests require citation of guideline or peer‑reviewed evidence
- Dose increases above labeled or policy maximums require explicit supporting literature
Reference Prescribing Information and Guidelines
Keytruda and Keytruda Qlex prescribing information and NCCN compendium citations are primary references for indication, dosing, and administration. Providers should reference the current PI for up‑to‑date safety, dosing, and labeled indications.
- Keytruda PI (Merck) and Keytruda Qlex PI (Merck) — see References section for links
- NCCN Drugs and Biologics Compendium for regimen and combination guidance
Billing Codes to Include on Claims
Include HCPCS J9271 (injection, pembrolizumab, 1 mg) and J9277 (injection, pembrolizumab, 1 mg and berahyaluronidase alfa‑pmph) on claims as applicable. Codes listed in this policy are for informational purposes only; coding inclusion does not guarantee coverage. Providers must verify current coding guidance prior to claim submission.
Documentation and Benefit Governance
Providers must follow member benefit documents (EOC, certificate of coverage), state and federal requirements, and Health Plan administrative policies when submitting PA requests. Coverage decisions are subject to all benefit terms, exclusions, limitations, and applicable regulatory requirements.
- Verify member benefit terms and exclusions before submitting requests
- Adhere to state‑specific step therapy prohibitions and redirection rules (see Appendix G)
Prior Therapy Requirements — Examples
Some indications require prior systemic therapy failure or documented ineligibility before approval (e.g., prior platinum‑containing chemotherapy for urothelial carcinoma, prior targeted therapy for certain NSCLC mutation‑positive scenarios). If prior therapy is required by the criteria, provide treatment history and dates.
- Examples: prior platinum chemotherapy for urothelial carcinoma; prior targeted agents for EGFR/ALK/ROS1/other actionable NSCLC mutations when indicated
Step Therapy Requirement for Nasopharyngeal Carcinoma
For nasopharyngeal carcinoma, step therapy requires failure of Loqtorzi at maximally indicated doses unless contraindicated or clinically significant adverse effects occur. If the state has regulations prohibiting oncology step therapy/redirection (see Appendix G), the step requirement may not apply.
- Failure of Loqtorzi required unless contraindicated or adverse effects
- If state law prohibits redirection/step therapy for the cancer setting (Appendix G), provide documentation to bypass step requirements
Recent Label Change / Off‑Label Routing
If an FDA label change has occurred within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, new dosing), follow the routing described in Section IV.B: for formulary agents follow the line‑of‑business no‑coverage/non‑formulary policies; for non‑formulary agents follow the non‑formulary policies; otherwise, refer to the off‑label use policies.
- Refer to CP.CPA.190 (Commercial), HIM.PA.33 (HIM), and CP.PMN.255 (Medicaid) for formulary/no‑coverage routing
- Refer to CP.CPA.190 (Commercial), HIM.PA.103 (HIM), and CP.PMN.16 (Medicaid) for non‑formulary routing
State‑Level Step Therapy Prohibitions
State laws may prohibit step therapy or redirection for advanced/metastatic cancer in certain jurisdictions. Consult Appendix G for the list of states and applicability. Where state regulation prohibits step therapy/redirection, the policy step requirements do not apply.
- Appendix G lists states with regulations against redirection/step therapy and applicable notes
- Examples: FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX, etc. — see Appendix G for details and exceptions
Step Therapy Bypass for Illinois (HB 5395)
Per Illinois HB 5395, an IL‑specific step therapy bypass/redirection exception has been added for certain gastric, esophageal, and GEJ indications — see policy history and Appendix G for details and operationalization.
- IL HIM requests: step therapy requirements for gastric, esophageal, and GEJ cancers do not apply as of 1/1/2026 per IL HB 5395
- Refer to Appendix G and the policy change log for implementation details
Step Therapy and Prior-Therapy Requirements
| Requirement | What provider must document |
|---|---|
| Document prior systemic therapy failure or ineligibility when the indication specifies prior chemotherapy or targeted therapy (e.g., progression on platinum-containing chemotherapy for NSCLC or urothelial carcinoma) | |
| Clinical records confirming prior regimen (drug names, dates, dosing), reason for discontinuation (progression, intolerance, contraindication), and evidence of ineligibility if applicable |
| Step requirement | Exceptions / State considerations |
|---|---|
| For nasopharyngeal carcinoma, failure of Loqtorzi® at up to maximally indicated doses is required prior to Keytruda/Keytruda Qlex | |
| If the request is for a state with regulations against step therapy/redirection (see Appendix G), the step requirement may not apply |
| Step requirement | Notes / Exemptions |
|---|---|
| For specified HER2-negative gastric/GEJ adenocarcinoma or esophageal/GEJ squamous carcinoma regimens (platinum + fluoropyrimidine combinations), prior failure of Tevimbra® at up to maximally indicated doses is required before Keytruda/Keytruda Qlex | |
| Requests from states with regulations against step therapy (see Appendix G) or where Illinois HIM bypass applies (IL HB 5395) are exempt from the Tevimbra step requirement |
| Requirement | Context / Examples |
|---|---|
| Prior systemic therapy failure is required for certain combination regimens and indications (e.g., endometrial carcinoma with lenvatinib requires disease progression following prior systemic therapy) | |
| TMB-H coverage generally requires disease progression following prior treatment unless specified first-line exceptions (e.g., ampullary or pancreatic adenocarcinoma) |
| Policy consideration | Action for implementers |
|---|---|
| Many states have statutes prohibiting step therapy or redirection for advanced/metastatic cancer (Appendix G lists states and notes) | |
| Check state-specific redirection/step therapy prohibitions before applying step edits; follow Appendix G and local regulatory guidance |
| Regional rule | Implementation note |
|---|---|
| Step therapy bypasses and redirection rules updated; policy added regional bypass for IL HIM per IL HB 5395 | |
| Refer to Appendix G and the policy's redirection notes when applying regional step edits; IL HIM requests exempt from specified step requirements as noted |
| Legislative bypass | Scope / Effective note |
|---|---|
| Illinois HB 5395: step therapy bypass added for gastric, esophageal, and GEJ cancer for IL HIM requests per policy update | |
| Apply IL HIM bypass for relevant IL requests (per policy RT4 updates); ensure payer-specific HIM handling aligns with the stated exemption |
Dose and Quantity Limits
Site of Care and Administration Setting
Site‑of‑care: IV and SC formulations — document administration setting
The policy references both IV pembrolizumab and the SC combination product Keytruda Qlex; site‑of‑care may vary by formulation (IV infusion vs SC injection) and the prescriber should document appropriate administration setting as needed.
No explicit site‑of‑care restriction — oncology prescriber required
No specific site‑of‑care restriction is listed in this excerpt; ensure prescriber is or consults with an oncologist per policy requirements when requesting therapy.
Confirm oncology prescriber/consultation on PA requests
The policy does not impose an explicit site‑of‑care restriction; PA requests should confirm prescriber specialty (oncologist) or consultation with oncology as required by the indication criteria.
No explicit site‑of‑care restrictions provided
The policy provides no explicit site‑of‑care restrictions in this section; follow standard infusion or injection setting practices per product labeling and local payer rules.
Keytruda Qlex (SC) may be administered in clinic or injection setting
SC formulation (Keytruda Qlex) enables subcutaneous administration and may be suitable in clinic or designated injection settings per prescriber and PI; document formulation when requesting PA.
SC formulation addition may alter site‑of‑care and redirection rules
Keytruda Qlex addition may affect site‑of‑care decisions and potential redirections in some jurisdictions; verify Appendix G and payer redirection policies when submitting requests.
Follow PI and payer rules for infusion vs SC administration
No specific site‑of‑care restrictions are provided in the visible policy fragments; follow standard IV infusion or SC injection administration per product PI and payer requirements.
Background and Definitions
Background: Pembrolizumab is a programmed death receptor‑1 (PD‑1) blocking monoclonal antibody used across multiple tumor types as monotherapy or in combination with other agents. The subcutaneous product pembrolizumab/berahyaluronidase alfa (Keytruda Qlex) combines pembrolizumab with an enzyme to facilitate SC administration; both IV and SC formulations are covered when dosing and indications match the policy and prescribing information.
Policy Update Changes and Revision History
Multiple indication additions and criteria revisions across tumor types (esophageal/GEJ, gastric combo, cSCC, high‑risk early TNBC), removal of SCLC indication, and updates to MSI‑H/dMMR and endometrial criteria as recorded in the 3Q 2021 RT4 review.
Added new FDA‑approved indication for endometrial cancer in combination with carboplatin and paclitaxel followed by pembrolizumab as single agent per prescribing information.
Additional RT4 updates clarified continuation criteria, expanded NCCN off‑label uses, and added maximum duration criteria for continuation requests (3Q 2024 annual updates).
Added SC formulation Keytruda Qlex to policy; converted 400 mg q6w dosing in adults with cHL and PMBCL to full approval per PI; added IL HIM step therapy bypass per IL HB 5395 for gastric/GEJ and esophageal cancers.
Policy added Keytruda Qlex (pembrolizumab/berahyaluronidase alfa) SC formulation and reflected updated HCPCS coding (J9277) with modified prior authorization and approval duration processes referenced in the policy.
Added step therapy bypass for Illinois HIM per IL HB 5395 as a bypass for Tevimbra requirement in gastric/GEJ/esophageal indications and noted regional redirection rules in Appendix G.
Updated Appendix G language and state exceptions (including Tennessee) and added explicit redirection to Tevimbra for HER2‑negative gastric/GEJ and esophageal cancers; IL HB 5395 bypass entries reiterated in RT4 updates.
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