Cigna Keytruda Qlex Prior Auth Coverage

Coverage Criteria and Form-Driven Determinations

Indication- and biomarker-specific coverage criteria (form-driven)

Coverage assessment is indication- and biomarker-dependent; the form collects branching clinical criteria for each listed diagnosis to support a medical necessity determination.

Indication selection: Patient must have one of the listed diagnoses selected on the form (multiple solid tumor and selected sarcoma indications).

See checklist of diagnoses on the form

MSI-H / dMMR pathway: If tumor is MSI-H or dMMR, provider must indicate tumor type (CRC vs non-CRC). For non-CRC (excluding BTC, CRC, ovarian, pancreatic, thyroid, endometrial) the patient must have unresectable or metastatic disease, prior therapy status and progression documented, and absence of satisfactory alternative options as applicable.

Form asks CRC-specific and non-CRC branching questions

TMB-H pathway: For tumors queried for TMB-H (breast, chordoma, chondrosarcoma, osteosarcoma, selected solid tumors), provider must confirm TMB >= 10 mutations per megabase, document unresectable or metastatic disease where prompted, prior therapies and progression, and whether satisfactory alternatives exist.TMB >= 10 mut/Mb

Used to support eligibility for TMB-H indications

PD-L1 (CPS) pathway: For PD-L1–dependent indications (e.g., TNBC, NSCLC, cervical, ESCC, gastric/GEJ), provider must document PD-L1 CPS per the form (CPS >=10 for TNBC; CPS >=1 where queried for other tumors) and indicate intended use (single agent or combination) and line of therapy.CPS >=10 or CPS >=1 depending on indication

Form includes branching for PD-L1 status and intended combinations

Prior therapy and progression: Provider must document prior lines of therapy, prior exposure and progression on relevant agents (e.g., platinum-containing chemotherapy, TKIs, BCG) where required by indication to determine appropriateness for first-line, subsequent, or salvage use.

Several indication-specific prior therapy questions captured on form

Use intent and combinations: Provider must indicate whether therapy is single-agent, neoadjuvant, adjuvant, or used in combination with named agents (e.g., pemetrexed + platinum, carboplatin + paclitaxel/Abraxane, albumin-bound paclitaxel, gemcitabine + carboplatin, trastuzumab + fluoropyrimidine + platinum, axitinib or lenvatinib, cyclophosphamide + bevacizumab) per the relevant diagnosis branch.

Combination regimens queried on the form

Administration route and access considerations: Provider must indicate whether patient has tried and cannot take IV pembrolizumab or is unable to obtain IV access; these responses inform consideration of subcutaneous formulation when IV is not feasible.

Form asks about IV pembrolizumab trial/inability and IV access

Site-of-care and dispensing: Provider must select site-of-care/dispensing option (specialty pharmacy Accredo, prescriber office stock, retail, home infusion) and provide facility affiliation; plan-specific lowest-cost site-of-care rules may apply.

Selection may affect authorization based on plan rules

Form-based coverage determination inputs

Coverage assessment relies on combinations of disease site, stage, biomarker status, prior therapies, performance status, intent of use, and resectability as documented on this form.

Tumor types and indications captured: Form solicits indication-specific data across numerous tumor types (see form branches for NSCLC, BTC, ovarian, pancreatic, thyroid, endometrial, cervical, ESCC, gastric/GEJ, RCC, NMIBC, thymic carcinoma, UCC, SCLC, KS, PeM/MPM, sarcomas, melanoma and others).

See clinical branches in form chunks

Biomarker-dependent pathways: Form requires documentation of key biomarkers including PD-L1 (CPS >=1 where queried), ALK/EGFR/ROS1 mutation status, MSI-H/dMMR, and TMB-H to determine eligibility for specific indications and line-dependent use.PD-L1 CPS >=1 (where applicable)

Multiple branches query biomarker status

Prior therapy and progression: Provider must indicate prior exposure or progression on standard therapies (e.g., platinum chemotherapy, TKIs, BCG) where relevant; specific questions capture whether progression occurred on prior systemic therapy when required.

Note: some Cigna plans require infusion of medication to occur in the lowest-cost, medically appropriate setting. The form therefore asks whether the infusion is occurring in a hospital outpatient‑affiliated facility and whether the patient is a candidate for redirection to an alternate setting (for example, ambulatory infusion site, home infusion, or other lower-cost options). Responses about physician in‑office infusion capability and home infusion candidacy are collected to support site‑of‑care decisions and potential re‑direction when clinically appropriate.

For non‑muscle invasive bladder cancer (NMIBC) the form specifically asks whether the patient is eligible to undergo cystectomy and whether the patient has elected not to undergo cystectomy. If the patient is eligible for cystectomy and there is no documented reason for avoiding surgery, eligibility for the requested therapy may be affected — the form therefore creates an implicit exclusion pathway when cystectomy is a viable, accepted standard option.

Complete documentation required: the form states that supportive documentation (genetic testing, chart notes, lab/test results, etc.) must be attached with the request. Failure to provide required attachments or to complete mandatory (asterisked) patient and prescriber fields may render the request administratively incomplete and can delay or prevent coverage determination.

Coverage depends on prior therapies and documented progression where required. The form queries prior exposure and disease progression (for example, progression on platinum‑containing chemotherapy, prior targeted TKIs for EGFR/ROS1/ALK, or prior BCG for NMIBC). If the patient lacks the required prior therapy or documented progression when those are prerequisites for the requested use, the request may not meet medical necessity.

Billing, Diagnosis, and Biomarker Coding

Prior Authorization

Prior Authorization Required

Provider action: Prior authorization required. Submit completed prior authorization form with all required supportive documentation attached (genetic testing, chart notes, labs, imaging, pathology, and any relevant test results). Incomplete submissions may delay review or result in denial.

Attach all supportive documentation for clinical answers (e.g., MSI/TMB/PD-L1 testing, prior therapy records, imaging, pathology)
Indicate whether patient tried and cannot take IV Keytruda or is unable to obtain IV access
If continuation of therapy, indicate response (responding vs. disease progression)
Complete patient weight, vial size, quantity, duration, directions, and J-code fields on the form

Documentation Required

Prior authorization submission and response / Attestation and signature required

Provider action: Prior authorization submission and response workflow — submit the completed and signed prior authorization form with all required attachments. The prescriber must attest to the accuracy of clinical information and sign the form. Responses will be issued per payer timelines; incomplete or unsigned forms may be returned or denied.

Provider Requirements, Submission, and Documentation

Note

Submission pathways and standard response time

Submit the request via the form; Cigna’s standard response time for prescription drug coverage requests is 5 business days, with expedited handling by phone for urgent requests. The form may be submitted online via CoverMyMeds or SureScripts in the EHR.

Standard response time: 5 business days.
If urgent, call to expedite the request.
Online submission options: CoverMyMeds or SureScripts.

Step Therapy

Document IV pembrolizumab trial or inability on the form

Answer the form question whether the patient has tried and cannot take intravenous (IV) pembrolizumab and whether the patient is unable to obtain IV access; these responses are collected to support use of the subcutaneous formulation when IV pembrolizumab is not feasible.

Question: Has your patient tried and cannot take Keytruda IV? (Yes/No)
Question: Is your patient unable to obtain IV access? (Yes/No)

Background and Product Summary

Background: Keytruda Qlex is a subcutaneous formulation that combines pembrolizumab with a hyaluronidase (berahyaluronidase alpha) to enable subcutaneous administration. The prior authorization form collects tumor and biomarker data (including MSI‑H/dMMR and TMB‑H defined as ≥ 10 mutations per megabase) as well as prior therapy, disease stage, and site‑of‑care information to determine appropriateness of use across multiple solid tumor and selected sarcoma indications.

Biomarker and Test Definitions

inv-21: MSI-H / dMMR — definition and form query

DefinitionMSI-H / dMMR: microsatellite instability-high or mismatch repair deficient tumor status as captured on the form (Yes / No).

Form branching questionThe form asks: 'Does your patient have a microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumor?' and if yes, follows with tumor-type specific branching (CRC vs BTC vs ovarian, pancreatic, thyroid, endometrial, or other).

Follow-up queriesFor MSI-H/dMMR (non-CRC and non-specified tumor types) the form asks about unresectable/metastatic status, prior treatments, progression, and whether satisfactory alternatives exist.

inv-22: TMB-H — definition

DefinitionTMB-H: tumor mutational burden-high as queried on form; defined as 10 or more mutations per megabase.

Form context

Line of Therapy and Treatment Intent

first-line | second-line | salvage

Line of therapy selection: Form asks whether the requested use is first-line, second-line, subsequent, adjuvant, neoadjuvant, or continuation; provider must indicate the line to determine line-specific appropriateness.

Several indications require prior chemotherapy or documented progression on specific agents

first-line | second-line | subsequent (alternate grouping)

Line of therapy options: Form records whether therapy is being used as first-line or subsequent therapy and captures indication-specific distinctions (for example primary vs subsequent treatment in BTC, first-line adjuvant vs subsequent for RCC/ATC/pancreatic where prompted).

See BTC, pancreatic, RCC, and ATC branches

Required Biomarkers and Thresholds

inv-27: MSI-H / dMMR — biomarker requirement

RequirementMSI-H/dMMR status is required to be reported on the form (Yes / No) and triggers indication-specific branching (CRC vs BTC vs ovarian/pancreatic/thyroid/endometrial or other).

Tumor-type branchingIf MSI-H/dMMR is positive the form asks whether the tumor is colorectal cancer (CRC); for non-CRC tumors it enumerates BTC, breast, chondrosarcoma, endometrial, Ewing sarcoma, osteosarcoma, ovarian, pancreatic, thyroid, solid tumors, or other.

Subsequent queriesFor MSI-H/dMMR (non-specified types) the form asks about unresectable/metastatic disease, prior therapy, progression, and alternative options to assess appropriateness.

inv-28: TMB-H — threshold >= 10 mut/Mb

ThresholdTMB-H is defined as ≥ 10 mutations per megabase on the form.

Indication contexts

Indication-Specific Combination Regimens

Indication	Combination(s) queried / examples
Mesothelioma (MPM, PeM)
- Pemetrexed + platinum (carboplatin or cisplatin) (form asks if medication is/will be used in combination with pemetrexed and platinum chemotherapy)
Endometrial carcinoma
- Carboplatin + paclitaxel (form queries use with carboplatin and paclitaxel, followed by single-agent therapy in some pathways)
Triple-negative breast cancer (PD-L1+)
- Albumin-bound paclitaxel (Abraxane) or paclitaxel; gemcitabine + carboplatin (form lists these chemo agents as combination options for PD-L1+ TNBC)
HER2-positive gastric / gastroesophageal junction (GEJ) adenocarcinoma
- Trastuzumab + fluoropyrimidine (capecitabine or 5-FU) + platinum (carboplatin or cisplatin) (form asks if used in combination)

Setting / Indication	Combination(s) queried / examples
Non–small cell lung cancer (first-line, metastatic) — squamous subtype
- Carboplatin + paclitaxel OR carboplatin + Abraxane for the first 4 cycles (form specifically asks if used in this combination)
Non–small cell lung cancer (first-line, metastatic) — non-squamous subtype
- Pemetrexed (Alimta) + carboplatin for the first 4 cycles (form queries this combination for non-squamous NSCLC)
Renal cell carcinoma (RCC)
- Pembrolizumab used in combination with axitinib or lenvatinib (form asks whether patient will use with axitinib or lenvatinib)
Ovarian cancer
- Cyclophosphamide and bevacizumab (form lists combinations with cyclophosphamide and bevacizumab for ovarian cancer)

OpenPayer

Keytruda Qlex (pembrolizumab + berahyaluronidase alpha) subcutaneous injection — patient information / prior authorization form