ModifiedViva HealthPolicy IC-0821

Keytruda Qlex (pembrolizumab + berahyaluronidase) subcutaneous prior authorization

Defines prior authorization length, initial approval criteria, and indication-specific coverage rules for Keytruda Qlex (subcutaneous pembrolizumab with berahyaluronidase) for members of Viva Health.

Policy Summary

PayerViva Health

PolicyKeytruda Qlex (pembrolizumab + berahyaluronidase) subcutaneous prior authorization

Policy CodePolicy IC-0821

Change TypeModified — renewal durations clarified

Effective Date

Next Review Date

Key ActionSubmit prior authorization supporting documentation including applicable ICD-10 diagnosis code and evidence of prior IV pembrolizumab eligibility when requesting switch/substitution.

SourceLink

POLICY UPDATE CHANGES

Initial prior authorization validity provided for 6 months (180 days) with specific longer or shorter maximums depending on indication (neoadjuvant/adjuvant distinctions).

Universal requirement that intravenous pembrolizumab must be used for members weighing < 55 kg and that subcutaneous therapy will not be used concomitantly with IV pembrolizumab.

6 monthsInitial PA validity (default)

790HCPCS units per 6 weeks

24 monthsCommon maximum length

395 / 790 mgAvailable vial sizes

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multipleCovered ICD-10 codes

Coverage Criteria

Universal Criteria

Covered when ALL of the following universal criteria are met

Universal Eligibility: Member is at least 18 years of age unless otherwise specified; member has not received prior PD-1/PD-L1 therapy unless otherwise specified (note: not applicable when used as switch-therapy from IV pembrolizumab); therapy will not be used concomitantly with IV pembrolizumab; therapy will not be used concurrently with IV chemotherapy except for FDA‑approved combinations; intravenous pembrolizumab must be used for members weighing <55 kg.

Substitution/Switch-Therapy

Substitution/Switch-Therapy criteria (alternative pathway)

Substitution/Switch: Used as substitution for OR switch-therapy from intravenous pembrolizumab AND member has previously met criteria for IV pembrolizumab and has been receiving IV pembrolizumab with beneficial disease response and absence of unacceptable toxicity; OR member currently meets criteria for use of IV pembrolizumab.

See Keytruda IV policy IC-0209 or IC-0523 for IV criteria.

Biliary Tract Cancer

Biliary Tract Cancer (combination use)

Biliary Tract Cancer: Used in combination with gemcitabine and cisplatin; AND member has locally advanced unresectable or metastatic disease.

Urothelial Carcinoma

Urothelial Carcinoma — multiple use patterns

Combination with enfortumab vedotin: Used in combination with enfortumab vedotin AND member has locally advanced or metastatic urothelial carcinoma OR muscle invasive bladder cancer (MIBC) where member is cisplatin-ineligible; when used as neoadjuvant then continued as adjuvant, enfortumab is given for six doses then pembrolizumab continued as specified.

Single-agent BCG-unresponsive NMIBC: Used as single agent for BCG-unresponsive high-risk non‑muscle invasive bladder cancer with carcinoma in situ AND member is ineligible for or elected not to undergo cystectomy; adequate BCG defined per policy (see notes).

Adequate BCG defined in policy (see chunk 12).

Single-agent later-line metastatic: Used as single agent for locally advanced or metastatic urothelial carcinoma for disease that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant/adjuvant platinum OR for platinum-ineligible members.

TNBC

Triple-Negative Breast Cancer (TNBC)

Metastatic TNBC: Member has locally recurrent unresectable or metastatic disease AND used in combination with chemotherapy AND tumor expresses PD‑L1 (CPS ≥ 10) by an FDA‑approved or CLIA‑compliant test.CPS ≥ 10

High-risk early-stage TNBC: Used as neoadjuvant therapy in combination with chemotherapy OR used as adjuvant single agent following neoadjuvant combination therapy.

Cervical Cancer

Locally advanced CRT: Member has FIGO 2014 Stage III-IVA disease AND used in combination with chemoradiotherapy.

Recurrent/metastatic PD-L1+: Tumor expresses PD‑L1 (CPS ≥ 1) by an FDA‑approved or CLIA‑compliant test AND used as single agent for recurrent/metastatic disease with progression on/after chemotherapy OR used in combination with chemotherapy (with/without bevacizumab) for persistent/recurrent/metastatic disease.CPS ≥ 1

Esophageal / GEJ Cancer

Esophageal Cancer / GEJ

First-line PD-L1 ≥1: Locally advanced or metastatic esophageal or GEJ carcinoma with PD‑L1 CPS ≥1 AND disease not amenable to surgery/definitive chemoradiation AND used with platinum- and fluoropyrimidine-based chemotherapy.CPS ≥ 1

Later-line PD-L1 ≥10: PD‑L1 CPS ≥10 AND used as single agent after one or more prior lines of systemic therapy AND for tumors of squamous cell histology.CPS ≥ 10

Gastric / GEJ Cancer

Gastric / GEJ Adenocarcinoma

First-line: Locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma with PD‑L1 CPS ≥1 as determined by an FDA‑approved or CLIA‑compliant test AND used as first-line therapy; HER2-positive disease should be treated in combination with trastuzumab and chemotherapy, HER2-negative with chemotherapy plus pembrolizumab.CPS ≥ 1

HNSCC

Head and Neck Squamous Cell Cancer (HNSCC)

Neoadjuvant to adjuvant: Used as neoadjuvant therapy followed by adjuvant therapy for resectable locally advanced disease; tumor PD‑L1 CPS ≥1 required; may be single-agent neoadjuvant or adjuvant with radiotherapy (with/without cisplatin) then continued as single agent.CPS ≥ 1

First-line metastatic: Used first-line for metastatic/unresectable recurrent disease in combination with platinum and fluorouracil-containing chemotherapy OR as single agent if PD‑L1 CPS ≥1.CPS ≥ 1

Subsequent therapy: Used as subsequent therapy as single agent for recurrent/metastatic disease after progression on platinum-containing therapy.

HCC

Hepatocellular Carcinoma (HCC)

HCC: Used as a single agent; AND disease is secondary to hepatitis B; AND member has received prior systemic therapy other than a PD‑1/PD‑L1‑containing regimen.

RCC

Renal Cell Carcinoma (RCC)

First-line advanced RCC: Used as first-line therapy for advanced disease in combination with axitinib OR in combination with lenvatinib.

Adjuvant RCC: Used as adjuvant single agent for members with intermediate-high or high risk of recurrence following nephrectomy OR after nephrectomy and resection of metastatic lesions.

Hepatocellular Carcinoma (HCC)