Keytruda Qlex (pembrolizumab SC + berahyaluronidase alfa-pmph) — HCPCS J9277

Keytruda Qlex SC vs. Keytruda IV FDA + CMS verified May 2026

Same active antibody, completely different billing infrastructure. J9277 became a permanent code on April 1, 2026; before that, Qlex billed under unclassified J3490 / J9999.

Merck offers pembrolizumab in two formulations: the original intravenous Keytruda (J9271, since 2014) and the subcutaneous Keytruda Qlex (J9277, since April 1, 2026). Same anti-PD-1 active ingredient, with berahyaluronidase alfa-pmph (manufactured by Alteogen) added to Qlex as a permeation enhancer that allows the entire dose to be delivered SC in 1 to 2 minutes.

Dosing & unit math FDA label Sept 2025

From Keytruda Qlex prescribing information (BLA 761467, FDA-approved September 19, 2025).

Adult monotherapy (fixed dose — no weight-based dosing)

• 395 mg SC every 3 weeks — 2.4 mL injected over 1 minute (most common; ~17 doses/year)
• 790 mg SC every 6 weeks — 4.8 mL injected over 2 minutes (extended interval; ~8–9 doses/year)
• Same total annual drug volume on either schedule
• 1 mg pembrolizumab = 1 unit — bill 395 or 790 units per dose
• Inject into thigh or abdomen; avoid the 5 cm radius around the navel; rotate injection sites

Pediatric (limited)

• Approved only for patients age ≥12 in select indications: MSI-H/dMMR solid tumors and Merkel cell carcinoma
• Same fixed adult dose (395 mg q3w or 790 mg q6w) — no weight-based dosing
• For pediatric patients <12 or for indications outside this list, use IV Keytruda (J9271) with weight-based 2 mg/kg q3w (max 200 mg)

Combination regimens

• NSCLC + chemo: Qlex 395 mg q3w + carboplatin/pemetrexed (or other approved backbone)
• HER2+ gastric + trastuzumab + chemo: Qlex 395 mg q3w + standard regimen
• Urothelial + Padcev (enfortumab vedotin): Qlex 395 mg q3w + Padcev
• Muscle-invasive bladder cancer (perioperative): Qlex + Padcev for cisplatin-ineligible adults
• Ovarian + paclitaxel ± bevacizumab (CPS ≥1 platinum-resistant): Qlex 395 mg q3w + chemo

Worked example — first-year billing for a 1L NSCLC patient (395 mg q3w mono)

No premedication routinely required

Like IV pembrolizumab, Keytruda Qlex does NOT require pre-injection methylprednisolone or antihistamine. The hyaluronidase component does not require premedication. Manage immune-mediated AEs per FDA label if they occur. Observe site for injection-site reactions during and immediately after the 1–2 minute injection.

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Subcutaneous antineoplastic injection — CPT 96401 is the primary code despite the 1–2 minute injection time.

Modifiers CMS verified May 2026

JZ — required on virtually every adult claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Keytruda Qlex is supplied in dose-matched single-dose vials (395 mg or 790 mg) administered in full with no remainder. JZ applies to virtually every Qlex claim.

JW — rare; exception scenarios only

Because Qlex vials are dose-matched (the 395 mg vial gives the 395 mg dose; the 790 mg vial gives the 790 mg dose), there is normally no waste. JW would only appear in the rare scenario where a vial is compromised after dose preparation — e.g., a vial is broken or partially aspirated and the remainder discarded. Bill the wasted units on a separate JW line; bill the administered units with JZ on the primary line.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the Qlex injection. Routine pre-injection clinical assessment is bundled into 96401 and does not justify a separate E/M.

340B modifiers (JG, TB)

For 340B-acquired Keytruda Qlex, follow your MAC's current 340B modifier policy. Merck's billing guide does not provide Qlex-specific 340B instructions; default to the same JG/TB convention you use for IV Keytruda.

ICD-10-CM by indication group FY2026 verified May 2026

Keytruda Qlex covers most adult solid-tumor indications of IV Keytruda. Hematologic indications (cHL, PMBCL) are NOT covered — use IV Keytruda (J9271) for those.

Site of care & place of service Verified May 2026

Because Qlex is a 1–2 minute SC injection (no infusion chair time), commercial site-of-care UM favors the lowest-cost setting from day one. UnitedHealthcare, Aetna, and most BCBS plans steer Qlex away from HOPD and toward office or ambulatory infusion suite immediately on initiation — no first-3-months grace period as exists for IV ICIs.

Claim form field mapping Merck May 2026

From Merck Access Program HCP coding & coverage page for Keytruda Qlex.

Payer policy snapshot + biomarker requirements Reviewed May 2026

Major payers maintain a SINGLE combined Keytruda / Keytruda Qlex coverage policy. Biomarker rules apply to both formulations at parity.

Biomarker test billing (separate from drug claim)

Step therapy

Generally NOT required — payers reviewed (UHC, Aetna, BCBS) do NOT require a trial of IV Keytruda before approving Qlex for an FDA-labeled indication. Coverage parity is the norm. Step therapy through other ICIs is occasionally required in 2L+ settings (e.g., urothelial post-platinum); verify per-payer.

Medicare reimbursement CMS Q2 2026 (live)

J9277 became a permanent HCPCS code on April 1, 2026 with the Q2 2026 CMS HCPCS quarterly update. Quarterly ASP from CMS Part B Drug Pricing File refreshes automatically each quarter.

Coverage

No NCD specific to pembrolizumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9277 for FDA-approved on-label Qlex indications with appropriate ICD-10 and biomarker documentation.

Code history

• J9277 — permanent code, effective April 1, 2026 (CMS 2025 Q4 HCPCS application summary; published in Q2 2026 quarterly file)
• Pre-April 2026: Qlex billed under unclassified J3490 or J9999 with NDC, dose, and product documentation. Continue using unclassified codes for any DOS prior to April 1, 2026 that were not yet billed.

Patient assistance — Merck Access Program Merck verified May 2026

• The Merck Access Program for KEYTRUDA / KEYTRUDA QLEX: 1-855-257-3932 (Mon–Fri, 8 AM – 8 PM ET) — benefits investigation, prior authorization assistance, appeal support, switch-from-IV PA help
• Merck Co-pay Assistance Program for KEYTRUDA / KEYTRUDA QLEX: eligible commercially-insured patients pay the first $25 per administration; program covers up to $25,000 per patient per eligibility period. Excludes Medicare, Medicaid, and other federal-program patients.
• Merck Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements (administered through the Merck Patient Assistance Program, Inc., a 501(c)(3)). Apply at merckhelps.com/KEYTRUDA QLEX.
• Foundations for Medicare patients: PAN, HealthWell, CancerCare — verify open oncology funds quarterly
• Web (HCP): merckaccessprogram-keytruda.com/keytrudaqlex/hcp/affordability.html

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Keytruda Qlex?

Keytruda Qlex bills under HCPCS J9277 — "Injection, pembrolizumab, 1 mg and berahyaluronidase alfa-pmph." One milligram of pembrolizumab equals one billable unit. J9277 was issued in the CMS 2025 Q4 HCPCS quarterly update and became effective April 1, 2026. Before that date, Qlex billed under unclassified J3490 or J9999.

What is the difference between Keytruda and Keytruda Qlex?

Keytruda (J9271) is intravenous pembrolizumab, infused over 30 minutes. Keytruda Qlex (J9277) is the subcutaneous formulation that combines pembrolizumab with berahyaluronidase alfa-pmph — a permeation enhancer (from Alteogen) that allows the full dose to be injected SC in 1–2 minutes. Different doses (395/790 mg vs 200/400 mg), different NDCs, different admin CPTs (96401 vs 96413), different J-codes. They are not interchangeable for billing or substitution.

How many units do I bill for a 395 mg Keytruda Qlex dose?

Bill 395 units of J9277 per 395 mg dose; 790 units per 790 mg dose. The unit basis is pembrolizumab milligrams only — berahyaluronidase units are bundled in the J9277 descriptor and not separately counted. Each dose uses exactly one single-dose vial.

What is the CPT admin code for Keytruda Qlex?

CPT 96401 — "Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic." Pembrolizumab is an antineoplastic mAb, so SC chemo-admin applies despite the 1–2 minute injection time. Do NOT use 96372 (therapeutic SC injection) or 96413 (IV chemo) for Qlex. A small subset of commercial payers require 96372 instead of 96401 for SC biologics — maintain a per-payer crosswalk.

Can I switch a patient from IV Keytruda to Keytruda Qlex mid-treatment?

Clinically yes — switching was studied in the MK-3475A-D77 registration trial. Operationally, most payers require a fresh PA for J9277 even when continuing the same patient on the same active ingredient. Document medical necessity (chair-time relief, peripheral access loss, patient preference) in the switch PA. Keytruda and Keytruda Qlex are separate BLAs with separate billing pathways.

Does the JW modifier apply to Keytruda Qlex?

Normally no — Qlex is supplied in dose-matched single-dose vials (395 mg or 790 mg) with no waste. Bill JZ on virtually every claim. JW only applies in the rare exception where a vial is compromised after dose preparation; bill the discarded units on a separate JW line. One of JZ or JW must be on every J9277 claim line.

Which Keytruda indications are NOT carried over to Qlex?

Three exclusions: (1) hematologic malignancies (classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma); (2) pediatric patients younger than 12 (Qlex uses fixed adult dosing only); and (3) pediatric TMB-H central nervous system cancers per payer policy. For these indications, continue using IV Keytruda (J9271) with weight-based or standard adult dosing.

What is the Medicare reimbursement for J9277?

For Q2 2026, the Medicare Part B payment limit for J9277 is $32.129 per mg of pembrolizumab (ASP + 6%). The 395 mg q3w dose reimburses at approximately $12,690.96 per administration; the 790 mg q6w dose at approximately $25,381.91. Annualized cost ~$215,747/year on either schedule. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. Next CMS update: July 1, 2026 for Q3.

Does Keytruda Qlex require biomarker testing for prior auth?

Yes for the same indications that require it on the IV side. PD-L1 IHC 22C3 for NSCLC 1L mono, HNSCC, gastric/GEJ, esophageal, cervical (CPS ≥1), TNBC, and ovarian (CPS ≥1). MSI-H/dMMR for tissue-agnostic and CRC. TMB-H ≥10 mut/Mb for tissue-agnostic TMB-H. Major payers maintain a combined Keytruda / Keytruda Qlex coverage policy with parity biomarker criteria.

Source documents

1. Merck Access Program — Keytruda Qlex HCP Coding & Coverage
   Manufacturer coding guide, May 2026
2. Merck — KEYTRUDA QLEX Prescribing Information (PDF)
   FDA-approved label, BLA 761467, approved September 19, 2025; current label rev May 12, 2026
3. DailyMed — KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection, solution
   setid 097d166f-b73b-41d3-9b37-7653cd2a0c41; 19 indications; no boxed warning
4. FDA — Approval announcement: pembrolizumab and berahyaluronidase alfa-pmph for SC injection
5. Merck press release — KEYTRUDA QLEX FDA approval (September 2025)
6. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026 (first J9277 inclusion)
7. CMS — 2025 HCPCS Application Summary Q4 (Drugs & Biologicals)
   J9277 application disposition, effective 4/1/2026
8. SEER CanMED — HCPCS J9277 reference
9. Aetna CPB 0890 — Pembrolizumab Products (Keytruda and Keytruda Qlex)
10. UnitedHealthcare — Oncology Medication Clinical Coverage Policy
11. KEYTRUDA QLEX HCP — Approved Indications & Dosing
12. FDA National Drug Code Directory

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit pass. Added DailyMed setid + label-revision date (May 12, 2026). Confirmed J9277, ASP, dosing, and indication scope.
• May 21, 2026 — Initial publication. ASP data: Q2 2026 (first quarter with J9277 on the CMS file). HCPCS J9277 effective 4/1/2026. FDA approval: September 19, 2025 (BLA 761467). Indications: most adult solid-tumor IV Keytruda indications; cHL/PMBCL and pediatric <12 explicitly excluded. Cross-linked to Keytruda IV (J9271) companion page.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents (Aetna CPB 0890 is the canonical combined Keytruda + Qlex policy reference). Indication list is verified against the current FDA label revision and the Merck-published Qlex HCP indication page. We do not paraphrase from billing-software vendor blogs.