Endometrial cancer — Jemperli's signature indication FDA verified Aug 2024
RUBY trial established 1L combo as new standard of care — major billing volume driver in 2024-2026.
Endometrial cancer is the indication that put Jemperli on the gyn-onc map. The RUBY trial (NCT03981796), a Phase 3 study of dostarlimab + carboplatin/paclitaxel vs carboplatin/paclitaxel alone in primary advanced or recurrent endometrial cancer, showed a substantial PFS and OS benefit — particularly striking in the dMMR/MSI-H subgroup. The FDA acted on this in two stages:
- July 31, 2023 — accelerated approval of Jemperli + carboplatin/paclitaxel for 1L primary advanced or recurrent endometrial cancer, dMMR/MSI-H subgroup, followed by single-agent Jemperli maintenance until progression.
- August 1, 2024 — expansion to all primary advanced or recurrent endometrial cancer (regardless of MMR status), based on RUBY Part 1 final analysis, with the same combo + maintenance regimen. This is the volume-driving indication.
- NCCN Endometrial Cancer Guidelines list this regimen as a preferred 1L option for advanced or recurrent disease.
For billing, the practical implication is that any patient newly diagnosed with advanced/recurrent endometrial cancer is now a candidate for Jemperli + chemo. Universal MMR/MSI-H tumor screening at biopsy (ASCO/SGO-recommended) means the biomarker result is typically already available by the time the oncologist orders Jemperli — bill the biomarker test (CPT 88341/88342 for MMR IHC, 81525 for MSI PCR) on the same encounter as the biopsy, before the Jemperli claim.
Dosing & unit math FDA label Aug 2024
From the FDA prescribing information, label revised August 2024 (BLA 761174).
Adult fixed dosing (all indications)
- Cycles 1-4 (loading): 500 mg IV every 3 weeks — bill 50 units J9272 per dose
- Cycle 5 onward (maintenance): 1,000 mg IV every 6 weeks — bill 100 units J9272 per dose
- Continue maintenance until disease progression or unacceptable toxicity
- Both doses are fixed (NOT weight-based) — bill the full unit count regardless of patient weight
- 30-minute IV infusion (no special infusion-rate ramp)
1L endometrial combo regimen (RUBY-aligned)
- Combo phase (cycles 1-6, q3wk): Jemperli 500 mg + carboplatin AUC 5 + paclitaxel 175 mg/m² on Day 1 of each cycle
- Maintenance phase (cycle 7+, q6wk): Jemperli 1,000 mg single-agent until progression
- The dose transition (500 mg q3wk → 1,000 mg q6wk) happens at cycle 7 in the RUBY regimen, not cycle 5 — this differs from monotherapy schedules. Verify cycle-counting carefully on the patient's regimen sheet.
Worked example — first-year billing for 1L endometrial RUBY-combo patient
Jemperli 500 mg per cycle — bill 50 units x 6 = 300 units
HCPCS: J9272 · Modifier: JZ · Vial: 1 x 500 mg
Admin: 96413 (Jemperli) + 96415 (paclitaxel additional hour) + 96417 (carbo, sequential)
# Cycles 7-13 (maintenance phase, q6wk through week 60)
Jemperli 1,000 mg per cycle — bill 100 units x 7 = 700 units
HCPCS: J9272 · Modifier: JZ · Vials: 2 x 500 mg (zero waste)
Admin: 96413
# Year-1 totals (drug only, Jemperli line)
Total J9272 units: 1,000 (10,000 mg)
Total drug cost (Q2 2026 ASP+6%): ~$247,083 before sequestration
No premedication required for Jemperli alone
Unlike older mAbs (rituximab, anti-CD20 agents), Jemperli does not require pre-infusion methylprednisolone or antihistamine. Manage infusion reactions per FDA label if they occur. In the RUBY combo, premeds are driven by paclitaxel (dexamethasone, diphenhydramine, H2 blocker) — these are bundled into the chemo regimen, not the Jemperli line.
Dose-schedule transition FDA label Aug 2024
The hard transition from 500 mg q3wk to 1,000 mg q6wk is Jemperli's single most billing-relevant feature.
Most checkpoint inhibitors stay on a single fixed dose throughout treatment (Keytruda 200 mg q3wk; Opdivo 240 mg q2w or 480 mg q4w; Libtayo 350 mg q3wk; Tecentriq 1,200 mg q3wk). Jemperli is different: the loading dose is 500 mg given every 3 weeks for the first 4 doses, and then the dose doubles to 1,000 mg while the interval also doubles to every 6 weeks.
| Phase | Cycles | Dose | Interval | J9272 units | Vials |
|---|---|---|---|---|---|
| Loading | Monotherapy: 1-4 RUBY combo: 1-6 | 500 mg | q3 weeks | 50 | 1 x 500 mg |
| Maintenance | Monotherapy: 5+ RUBY combo: 7+ | 1,000 mg | q6 weeks | 100 | 2 x 500 mg |
- Continuing to bill 50 units when the dose has shifted to 1,000 mg (under-billing by 50 units — ~$12,354 lost per dose)
- Continuing the q3wk schedule when it should have shifted to q6wk (over-treatment + payer audit risk)
- Switching the dose but not the interval (or vice versa) — PA may be denied for off-label dosing
MMR / MSI-H biomarker testing ASCO/SGO + NCCN verified May 2026
Universal MMR tumor screening is now standard of care for endometrial cancer — bill the biomarker test on the biopsy encounter, before Jemperli PA.
Two biomarker pathways confirm mismatch repair deficiency: MMR IHC (immunohistochemistry for the four MMR proteins) and MSI PCR (microsatellite instability testing). Both are accepted by FDA and major payers as confirmatory for "dMMR" or "MSI-H" status. NGS-based MSI calls (e.g., FoundationOne CDx) are also accepted by most payers.
| Test | What it detects | CPT | Notes |
|---|---|---|---|
| MMR IHC (4-protein panel) | Loss of MLH1, MSH2, MSH6, or PMS2 protein expression | 88341 (each additional antibody) / 88342 (initial single antibody, IHC, manual) |
Most common pathway. Bill 88342 for the first protein + 88341 x 3 for the remaining proteins. Loss of any of the 4 = dMMR. |
| MSI PCR | Microsatellite instability at ≥5 mononucleotide loci | 81525 (MSI by PCR) / 81479 (unlisted molecular path) |
81525 is the preferred code where applicable. MSI-H = instability at 2+ of 5 markers (Bethesda panel) or ≥30% of NGS markers. |
| MSI by NGS | MSI calculated from large NGS panel | Panel-specific (e.g., 0244U for FoundationOne CDx, or large-panel NGS codes) |
Common when comprehensive genomic profiling has already been ordered; saves a separate MSI claim. |
Universal MMR screening at endometrial biopsy
ASCO and SGO both recommend universal MMR/MSI tumor screening on all endometrial cancer cases at the time of biopsy/hysterectomy — this is now standard practice in academic gyn-onc and most community oncology pathology workflows. Practical billing implication: by the time Jemperli is being considered for a patient with newly diagnosed advanced/recurrent endometrial cancer, the dMMR/MSI-H status is usually already known. Confirm the result is in the chart and accessible to the PA team before submitting the Jemperli authorization — missing biomarker documentation is the #1 PA denial reason for J9272.
Tumor-agnostic dMMR solid tumor indication
Jemperli's accelerated approval for recurrent or advanced dMMR solid tumors (any tissue origin) requires biomarker confirmation prior to treatment. Most payers require both an MMR IHC or MSI result PLUS documentation of progression on or following prior treatment with no satisfactory alternative. Bill the biomarker test on the encounter where the dMMR diagnosis was confirmed — often weeks before the first Jemperli dose.
81435 or 81436) and is often handled by genetic counseling — flag for the
PA team but it does not affect the Jemperli authorization itself.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
0173-0898-01 / 00173-0898-01 |
500 mg / 10 mL (50 mg/mL) single-dose vial — 1 vial per carton | 500 mg loading dose: 1 vial per dose. 1,000 mg maintenance: 2 vials per dose. |
Administration codes CPT verified May 2026
Jemperli is billed as chemotherapy administration despite being immunotherapy — consistent with all anti-PD-1/PD-L1 mAbs.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for Jemperli IV. 30-min standard infusion fits within 1-hour window. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Used when paired with carboplatin/paclitaxel on the same day in RUBY combo — paclitaxel infusion extends chair time beyond 1 hour. |
96417 |
Chemotherapy administration, IV infusion; each additional sequential infusion (different drug/substance), up to 1 hour | Use for the carboplatin infusion when given sequentially after Jemperli + paclitaxel in RUBY combo. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate for Jemperli. CPT classifies anti-PD-1 mAb administration under chemo codes. |
Modifiers CMS verified May 2026
JZ — required on virtually every Jemperli claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Jemperli's 500 mg dose uses one 500 mg vial with zero waste; the 1,000 mg dose uses two 500 mg vials with zero waste. Both fixed doses are exact whole-vial multiples — JZ applies to virtually every Jemperli claim.
JW — rare for Jemperli
JW reports the discarded portion of a single-dose vial. Because Jemperli is fixed-dose (not weight-based) and both doses fill cleanly into 500 mg vials, JW almost never applies. The only scenarios that produce waste are dose reductions for toxicity (rare for checkpoint inhibitors, where dose interruption is preferred over reduction) or product damage. One of JZ or JW must be on every J9272 claim per the CMS single-dose container policy.
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 infusion. Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Jemperli, follow your MAC's current 340B modifier policy. GSK's billing guide does not provide 340B-specific instructions; defer to MAC LCAs.
ICD-10-CM by indication FY2026 verified May 2026
Endometrial cancer is the volume-driving indication. Tumor-agnostic dMMR requires both the underlying tumor C-code AND biomarker confirmation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Endometrial cancer (corpus uteri) | C54.x | Primary indication. C54.0 (isthmus), C54.1 (endometrium), C54.2 (myometrium), C54.3 (fundus), C54.8 (overlapping), C54.9 (unspec) |
| Uterus, part unspecified | C55 | When site cannot be specified to corpus uteri |
| Endometrial cancer, recurrent | C54.x + Z85.42 (personal hx of uterus malignancy) | For recurrent disease post-prior treatment |
| dMMR solid tumors (tumor-agnostic) | Any underlying C-code + biomarker confirmation | Document MMR IHC or MSI result in the chart; payer may require attachment |
| Common dMMR primaries (examples) | C18.x (colon), C19/C20 (rectosigmoid/rectum), C25.x (pancreas), C16.x (gastric), C61 (prostate), C50.x (breast) | For tumor-agnostic indication only — requires dMMR confirmation |
| Lynch syndrome (background) | Z15.09 | Genetic susceptibility to malignant neoplasm of digestive organs — document on encounter where germline testing positive |
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, and most major BCBS plans run aggressive site-of-care UM for immune checkpoint inhibitors as a class. Jemperli is included in these policies. Aetna CPB 0892 explicitly steers ICIs out of HOPD after the first 3 months unless on combo chemo or active toxicity management. For the 1L endometrial RUBY combo (Jemperli + carboplatin/paclitaxel), HOPD is more often acceptable during the chemo phase due to chair-time and toxicity-monitoring needs; once on q6wk maintenance monotherapy, payers typically push to office or AIC.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology / gyn-onc office | 11 | CMS-1500 / 837P | Preferred by commercial UM, especially for q6wk maintenance |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months on monotherapy maintenance; OK during combo phase |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Possible but rare for IV oncology IO; not standard for Jemperli |
Claim form field mapping GSK 2025
From GSK For You / Jemperli Together HCP coding & coverage guide (2025).
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00173-0898-01 + ML + total volume (10 mL for 500 mg, 20 mL for 1,000 mg) |
| HCPCS J9272 + JZ | 24D (drug line) | JZ on virtually every claim (no waste) |
| Drug units | 24G | 50 units (500 mg) or 100 units (1,000 mg) — remember 10 mg = 1 unit |
| CPT 96413 (admin line) | 24D (admin line) | 30-min infusion fits within 1-hour window |
| ICD-10 | 21 | Indication-specific (see ICD-10 table) |
| Biomarker test claim line (separate) | 24D | CPT 88341/88342 (MMR IHC), 81525 (MSI PCR), 0244U (FoundationOne CDx) |
| PA number | 23 | Required by all major payers |
Payer policy snapshot + biomarker requirements Reviewed May 2026
All major payers require biomarker testing for label-expanded Jemperli indications and regimen alignment for 1L endometrial combo.
| Payer | PA? | Biomarker / regimen enforcement | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | dMMR/MSI-H biomarker docs required for endometrial dMMR/MSI-H + tumor-agnostic indications. RUBY-aligned regimen (Jemperli + carbo + paclitaxel) for 1L endometrial. | Aggressive: ICI steering away from HOPD via Optum-managed program; q6wk maintenance pushed to office |
| Aetna CPB 0892 + Medical Drug |
Yes | Similar: dMMR/MSI-H for tumor-agnostic + endometrial dMMR. RUBY combo regimen alignment for 1L endometrial. | Yes (separate Site-of-Care policy; ICIs steered out of HOPD after 3 months) |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN Endometrial Cancer Guidelines + FDA label biomarker requirements | Plan-specific; most have ICI site-of-care steering |
| Medicare (MAC LCDs) No NCD specific to dostarlimab |
No (Part B), but documentation expected | MAC LCDs cover J9272 for FDA-labeled indications with appropriate ICD-10 + biomarker documentation | Less aggressive than commercial; HOPD acceptable |
Biomarker test billing (separate from drug claim)
| Test | CPT | For Jemperli indications |
|---|---|---|
| MMR IHC (4-protein panel) | 88341 + 88342 | Endometrial 1L dMMR/MSI-H, tumor-agnostic dMMR |
| MSI by PCR | 81525 / 81479 | Tumor-agnostic dMMR, endometrial dMMR/MSI-H |
| MSI by NGS / FoundationOne CDx | 0244U or large-panel NGS codes | Multi-biomarker for tumor-agnostic indications |
Step therapy
Generally NOT required for the 1L endometrial RUBY-combo indication or for the tumor-agnostic dMMR indication. Some payers may require prior platinum failure documentation for the single-agent recurrent endometrial indication (post-platinum, any MMR status). For 1L endometrial all-MMR (Aug 2024 expansion), payers may steer toward Keytruda + chemo (KEYNOTE-868 / NRG-GY018) as a comparable alternative depending on contracting — verify per-payer.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9272
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Coverage
No NCD specific to dostarlimab-gxly. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9272 for FDA-approved on-label indications with appropriate ICD-10 and biomarker documentation.
Code history
- J9272 — permanent code for "Inj, dostarlimab-gxly, 10 mg" (10 mg per unit definition is unusual for the checkpoint inhibitor class)
Patient assistance — GSK For You / Jemperli Together GSK verified May 2026
- Phone: 1-844-468-2225 (1-844-GSK-2BCK)
- Jemperli Together (commercial copay): $0 first dose for eligible commercially-insured patients; co-pay support thereafter (excludes Medicare, Medicaid, federal program patients)
- GSK Bridges to Access: free Jemperli for uninsured / underinsured patients meeting income eligibility criteria
- Foundations (Medicare-eligible): for Medicare patients, refer to PAN, HealthWell Foundation, CancerCare — verify open gyn-onc / endometrial cancer funds quarterly
- Web: gskforyou.com / jemperli.com
Immune-mediated adverse reactions (irAEs) — treat as boxed-analog FDA W&P verified Aug 2024
Jemperli does not formally carry a boxed warning but the W&P section enumerates the same severe irAEs as Keytruda and Opdivo — clinical management is identical.
- Pneumonitis — suspect with new/worsening cough, dyspnea, hypoxia. Hold for grade 2+, permanently discontinue for grade 3+. Treat with high-dose steroids.
- Colitis — suspect with diarrhea, abdominal pain, blood/mucus in stool. Rule out infectious etiology. Hold for grade 2, permanently discontinue for grade 3-4.
- Hepatitis — monitor LFTs at baseline + every cycle. AST/ALT >3x ULN warrants hold; >5x ULN or bilirubin >3x ULN typically warrants permanent discontinuation.
- Endocrinopathies — thyroid (hypo/hyper), adrenal insufficiency, hypophysitis, type 1 diabetes. Most are managed with hormone replacement and treatment continuation; adrenal crisis is medical emergency.
- Nephritis with renal dysfunction — monitor creatinine. Hold for grade 2, permanently discontinue for grade 3-4.
- Dermatologic reactions — including SJS/TEN. Permanently discontinue for any grade 4 dermatologic AE or confirmed SJS/TEN.
- Infusion reactions — slow or interrupt infusion for grade 1-2; permanently discontinue for grade 3-4.
- Embryo-fetal toxicity — verify pregnancy status before initiation; effective contraception during and 4 months after the last dose.
Billing implication: irAE workups (labs, imaging, specialist consultations) are bundled into the office visit for the encounter that addresses the toxicity. Steroid administration (e.g., methylprednisolone IV pulse) bills under the appropriate J-code + admin. Document the irAE diagnosis with both the symptom ICD-10 (e.g., J84.111 immune-mediated pneumonitis) and an indicator that it is drug-induced (Y43.x or T-code where applicable).
Checkpoint inhibitor class comparison CMS Q2 2026 + FDA labels
Jemperli vs the other major anti-PD-1 and anti-PD-L1 inhibitors — pricing, dosing, signature indication.
| Drug | HCPCS | Target | Unit | Adult dose | Signature indication |
|---|---|---|---|---|---|
| Jemperli (dostarlimab-gxly) | J9272 |
anti-PD-1 | 10 mg | 500 mg q3wk x 4, then 1,000 mg q6wk | 1L endometrial cancer (RUBY combo) · /drugs/jemperli |
| Keytruda (pembrolizumab) | J9271 |
anti-PD-1 | 1 mg | 200 mg q3wk or 400 mg q6wk | NSCLC, melanoma, 30+ approved indications |
| Opdivo (nivolumab) | J9299 |
anti-PD-1 | 1 mg | 240 mg q2w or 480 mg q4w | Melanoma, NSCLC, 15+ indications |
| Libtayo (cemiplimab) | J9119 |
anti-PD-1 | 1 mg | 350 mg q3wk | Cutaneous SCC, advanced NSCLC, BCC |
| Tecentriq (atezolizumab) | J9022 |
anti-PD-L1 | 10 mg | 1,200 mg q3wk or 1,680 mg q4w | Triple-negative breast, NSCLC, urothelial |
| Imfinzi (durvalumab) | J9173 |
anti-PD-L1 | 10 mg | 1,500 mg q3-4wk (weight-tiered options) | Stage III NSCLC (PACIFIC), small cell lung |
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Unit count 10x too high | Billed 500 or 1,000 units (treating J9272 as 1 mg per unit, like J9271/J9299) | Resubmit with 50 units (500 mg) or 100 units (1,000 mg). J9272 = 10 mg per unit. |
| Wrong dose at transition | Cycle 5+ (mono) or cycle 7+ (RUBY combo) billed as 50 units instead of 100 units | Verify regimen sheet; resubmit cycle 5/7+ as 100 units (1,000 mg q6wk maintenance). |
| Wrong interval at transition | q3wk schedule continued past loading phase | Reschedule maintenance to q6wk; resubmit corrected claim. If overlapping doses billed, refund the duplicate. |
| Biomarker not documented | PA submitted for tumor-agnostic dMMR or endometrial dMMR/MSI-H without MMR IHC or MSI result | Submit biomarker test result + retroactive PA. Schedule MMR/MSI testing FIRST for any dMMR-required indication. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Dostarlimab-gxly is chemo admin per CPT classification despite being immunotherapy. |
| JZ missing on adult claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong NDC format | Vial NDC submitted instead of carton NDC, or wrong total volume | Use carton NDC 00173-0898-01 with ML qualifier and total volume (10 mL for 500 mg, 20 mL for 1,000 mg). |
| Site of care (HOPD) | HOPD administration after first 3 months on commercial plan with site-of-care UM, especially during q6wk maintenance | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| 1L endometrial regimen mismatch | Jemperli billed for 1L endometrial without carbo/paclitaxel co-administration documented | Submit complete regimen documentation showing RUBY-aligned combo (Jemperli + carboplatin + paclitaxel q3wk x 6) with Jemperli single-agent maintenance. |
Frequently asked questions
What is the HCPCS code for Jemperli?
Jemperli (dostarlimab-gxly) is billed under HCPCS J9272 — "Injection, dostarlimab-gxly,
10 mg." One billable unit equals 10 mg, so the 500 mg loading dose is 50 units and the 1,000 mg
maintenance dose is 100 units. 10 mg per unit is unusual for checkpoint inhibitors —
most (Keytruda J9271, Opdivo J9299, Libtayo J9119) use 1 mg per unit.
How many units do I bill for Jemperli?
50 units per 500 mg loading dose (cycles 1-4 monotherapy or cycles 1-6 RUBY combo, every 3 weeks). 100 units per 1,000 mg maintenance dose (cycle 5+ monotherapy or cycle 7+ RUBY combo, every 6 weeks). One 500 mg vial fills the loading dose; two 500 mg vials fill the maintenance dose — both with zero waste, so JZ applies on virtually every claim.
What is the Jemperli dosing schedule?
Jemperli uses a dose-escalation schedule with a hard transition: 500 mg IV every 3 weeks for the first 4 doses (cycles 1-4 monotherapy) or 6 doses (cycles 1-6 RUBY combo), then 1,000 mg IV every 6 weeks beginning at cycle 5 (monotherapy) or cycle 7 (RUBY combo) and continuing until disease progression or unacceptable toxicity. Both doses are fixed (NOT weight-based) and infused over 30 minutes.
What administration CPT do I use for Jemperli?
CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single
or initial substance/drug." Despite being immunotherapy (anti-PD-1), Jemperli is billed under chemotherapy
administration codes per AMA guidelines for complex monoclonal antibodies. Standard 30-minute infusion
fits within the 1-hour 96413 window. Do NOT bill 96365.
Does Jemperli require biomarker testing for prior auth?
Yes for the FDA-labeled indications. dMMR or MSI-H confirmation is required for: (1) 1L endometrial dMMR/MSI-H subgroup (RUBY accelerated approval pathway), and (2) the tumor-agnostic recurrent/advanced dMMR solid tumor indication. The 2024 expansion to 1L endometrial regardless of MMR status does not require dMMR/MSI-H confirmation by FDA, but payers may still request it. Bill biomarker tests separately: MMR IHC = CPT 88341/88342, MSI by PCR = CPT 81525.
What is the Medicare reimbursement for J9272?
For Q2 2026, the Medicare Part B payment limit for J9272 is $247.083 per 10 mg unit (ASP + 6%) — roughly $24.71/mg, on the higher end for anti-PD-1 inhibitors. The 500 mg loading dose reimburses at approximately $12,354.15 per infusion; the 1,000 mg maintenance dose at approximately $24,708.30 per infusion. Year-1 monotherapy total ~$272,000.
What are Jemperli's FDA-approved indications?
As of the August 2024 label revision: (1) 1L primary advanced or recurrent endometrial cancer in combination with carboplatin and paclitaxel followed by Jemperli single-agent maintenance, regardless of MMR status (the volume-driving indication); (2) recurrent or advanced dMMR endometrial cancer that has progressed on or after platinum-containing chemotherapy and is not a candidate for curative surgery or radiation; (3) recurrent or advanced dMMR solid tumors (tumor-agnostic accelerated approval).
How does Jemperli compare to Keytruda for endometrial cancer?
Both are anti-PD-1 monoclonal antibodies approved for 1L advanced/recurrent endometrial cancer in combination with carboplatin/paclitaxel. Jemperli (J9272) is paired with the RUBY trial regimen (q3wk loading, q6wk maintenance). Keytruda (J9271) is paired with the KEYNOTE-868 / NRG-GY018 trial regimen. The two are clinically considered class peers in 1L endometrial — payer preference is contract-driven. See the checkpoint class comparison.
Source documents
- DailyMed — JEMPERLI (dostarlimab-gxly) Prescribing Information
- FDA — Jemperli + carbo/paclitaxel regular approval (Aug 2024 all-MMR endometrial)
- FDA — Jemperli accelerated approval, dMMR endometrial 1L (July 2023)
- GSK For You / Jemperli Together — HCP coding & coverage
- CMS — Medicare Part B Drug ASP Pricing File
- NCCN Endometrial Cancer Guidelines
- RUBY trial — Mirza et al, NEJM 2023 (NCT03981796)
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB 0892 — Immune Checkpoint Inhibitors
- SEER CanMED — HCPCS J9272 reference
- 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
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + biomarker test codes | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Change log
- — Initial publication. ASP data: Q2 2026 ($247.083 per 10 mg unit). Manufacturer source: GSK For You / Jemperli Together 2025 coding & coverage. FDA label: Aug 2024 revision (BLA 761174) including all-MMR-status 1L endometrial expansion. RUBY-aligned combo regimen documented.
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. Indication list is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.