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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers 1L advanced/metastatic esophageal + GEJ carcinoma only (KEYNOTE-590, cisplatin/5-FU backbone), not gastric/GEJ adenocarcinoma 1L (KEYNOTE-859), HER2+ gastric (KEYNOTE-811), or the adjuvant/2L esophageal settings. See all Keytruda indications →
SCOPE CORRECTION. On label, year correct, but a biomarker gate has been added since approval that the row does not carry. The original 2021-03-22 approval, per the FDA notice, covered 'patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) carcinoma who are not candidates for surgical resection or definitive chemoradiation' with NO PD-L1 requirement on the chemotherapy combination. The CURRENT label 1.11 restricts the combination to tumours expressing PD-L1 CPS >=1. The separate single-agent option in the same section is narrower still: second-line-plus, squamous histology only, and CPS >=10. So 'Esophageal / GEJ carcinoma' now sits behind two different PD-L1 thresholds depending on regimen - PD-L1-negative patients are out of label entirely.
All markets
2026 net revenue · modelled esophageal/GEJ slice
$825M
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled net revenue · sourced funnel
No model change since the 20 Sep 2026 snapshot.
The 15-second read
KEYNOTE-590 is a volume-over-price indication: it reaches the world's largest esophageal-cancer population, China alone is ~224,000 of ~511,000 annual cases, yet the model peaks it at only $840M in 2025 before the slide to $334M in 2034. The reason is structural, not clinical: the data are strong and durable (OS HR 0.73 all-comers, 0.57 in ESCC CPS≥10, sustained at five years), but the dominant Chinese pool is reimbursed at roughly $28k/year NRDL net against four cheaper domestic PD-1s, holding branded penetration near 18% of the addressable 1L pool there, while Western incidence is modest and adenocarcinoma-weighted. Add the EU and Japan CPS≥10 label gate and the ~2028 US biologic LOE and the ceiling is set from both ends. The honest read: this line cements Keytruda's upper-GI breadth and pan-tumour 1L leadership more than it contributes cash, and it has already passed its peak.
Threats land:Chinese NRDL renewal cycles cut the ~$28k/yr net further while tislelizumab's Western launches give nivolumab company in the US and EU5, pulling branded penetration below the modelled ~18% of the Chinese 1L pool ahead of the 2028 LOE.
Modelled path:Pembrolizumab holds its 1L position in the West against nivolumab and stays capped near 18% of the addressable Chinese pool, the curve declines gently from its 2025 peak, and biosimilars from ~2028 US / ~2029 EU take it to $334M by 2034.
Levers land:SC Qlex (approved Sep 2025) retains meaningful administration share through the IV-biosimilar wave while rising Western GEJ adenocarcinoma incidence and broadening Chinese treatment reach lift the fit-and-treated fraction above the modelled ~0.50 in China.
The ~0.50 China fit-and-treated reach gate, the fraction of advanced Chinese patients actually receiving 1L IO-chemo, is an Ormeval scoping estimate and the single largest swing factor in the model, since China dominates the incidence base and care access outside tier-1/2 cities is genuinely unmeasured.
At a glance
Mechanism anti-PD-1
Clinical
Commercial
Development to approval
These are regulatory approval dates (FDA/EMA/NMPA/PMDA), not commercial launch; launch follows after pricing & reimbursement (see the access-lag column in the HTA table). All four regulators have approved this indication. Cross-checked against Merck & Co. disclosures and regulator databases.
Esophageal/GEJ carcinoma extends Keytruda's GI footprint into the largest single-country oncology population on earth (China esophageal SCC) and was, with KEYNOTE-859/811, part of the program that made pembrolizumab a 1L standard across the upper-GI tract. It is strategically a volume-over-price indication: enormous Chinese incidence converts to only mid-size revenue because of NRDL discounting and domestic PD-1 competition, but it cements Keytruda's GI breadth and pan-tumour 1L-IO leadership. Like every Keytruda line it is exposed to the ~2028 US composition-of-matter LOE, with SC Qlex (Sep 2025) as the volume-defense lever.
Advanced esophageal/GEJ carcinoma is a high-mortality GI cancer that is overwhelmingly concentrated in East Asia: China alone accounts for ~224,000 of the world's ~511,000 annual cases, almost all squamous-cell histology. KEYNOTE-590 (OS HR 0.73 all-comers; 0.57 in ESCC CPS≥10) made pembrolizumab + cisplatin/5-FU the 1L standard for unresectable/metastatic disease across both ESCC and adenocarcinoma. It is a solid mid-size GI indication for the Keytruda franchise, a modelled ~$1.0–1.2bn at maturity, with China the largest volume driver but at deeply discounted NRDL pricing and against cheaper domestic PD-1s, and exposure to the ~2028 US biologic LOE.
Esophageal cancer is the world's 7th-most-common cancer and a leading cause of cancer death, with two biologically distinct histologies: squamous-cell carcinoma (ESCC, ~85-90% of cases globally and almost the entirety of the East-Asian and China burden) and adenocarcinoma (predominant in the West, linked to GERD/Barrett's/obesity and overlapping with GEJ tumours). Most patients present with locally-advanced unresectable or metastatic disease, where median survival on chemotherapy alone was historically <10 months. The 1L systemic-IO setting modelled here is that advanced population not eligible for surgery or definitive chemoradiation. Geography dominates the funnel: China contributes ~44% of global incidence (esophageal SCC is endemic in the Taihang-mountain belt and broadly across China), so the addressable pool is overwhelmingly Chinese, but offset by lower diagnosis/treatment reach and far lower per-patient pricing.
KEYNOTE-590 (Sun, Lancet 2021) established first-line pembrolizumab + chemotherapy as a global standard for advanced esophageal/GEJ carcinoma. In 749 randomised patients (73% ESCC), adding pembrolizumab to cisplatin/5-FU improved overall survival across all subgroups, OS HR 0.73 in all randomised patients, 0.72 in all ESCC, and 0.57 in ESCC PD-L1 CPS≥10 (median OS 13.9 vs 8.8 mo). It is the first immunotherapy regimen to beat chemotherapy in 1L esophageal cancer regardless of histology, and underpinned the FDA's March 2021 approval. China, where esophageal SCC is endemic (~224,000 new cases/yr, ~44% of the world total), is the dominant volume market for this indication.
PD-L1 CPS testing gates access in EU/Japan (combo restricted to CPS≥10) but not in the US (all-comers). Histology (ESCC vs adenocarcinoma) and CPS are folded into the single branded line. The main pre-treatment funnel leak is under-diagnosis/under-treatment of the endemic Chinese ESCC population outside major-city centres.
Randomized, double-blind, placebo-controlled Phase 3. 749 patients with previously-untreated locally-advanced unresectable or metastatic esophageal squamous-cell carcinoma, esophageal adenocarcinoma, or Siewert type 1 GEJ adenocarcinoma (73% ESCC) randomized 1:1 to pembrolizumab 200 mg q3w (≤35 cycles) + cisplatin (≤6 cycles) + 5-FU, or placebo + the same chemotherapy. Dual primary endpoints: OS and PFS in ESCC CPS≥10, ESCC, CPS≥10, and all randomised patients.
Load-bearing 5/6 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
First-line locally-advanced unresectable or metastatic carcinoma of the esophagus and gastro-esophageal junction (Siewert type 1), pembrolizumab + platinum/fluoropyrimidine chemotherapy (cisplatin + 5-FU) for patients not candidates for surgical resection or definitive chemoradiation. Covers both esophageal squamous-cell carcinoma (ESCC, ~73% of the pivotal population) and esophageal/GEJ adenocarcinoma; PD-L1 CPS≥10 is the deepest-benefit and label-enriched subgroup in several markets (EU/Japan restrict the combo to CPS≥10).
Reported actuals are always drawn and need no chip: a cited reported figure is a fact, not a claim. Everything forward of them is one of the 4 kinds above.
$825M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $840M · launch 2020 → 2034
modeled history (left of today)·click any year to decompose its funnel below.
Measured band: none - no measured band: n<8
Bull / bear elsewhere in the product are a sensitivity (fixed multipliers), not this band.
Pre-2026 figures are MODELLED (no indication × country actuals are reported) and calibrated to Merck's reported Keytruda franchise (FY2025 ≈ $31.68B) and its growth SHAPE: the modelled esophageal/GEJ slice ramps from the 2021 KN-590 launch, ~$0.2B (2021, partial) → ~$0.7B (2023) → ~$1.1B (2026) → a ~$1.2B plateau across 2026-2027, a solid mid-size GI indication (~3-4% of the franchise). China drives volume but at low net price; the slice then erodes from ~2028 as the US composition-of-matter patent expires and pembrolizumab biosimilars enter (EU ~2029), partly defended by SC Qlex conversion, falling toward ~$0.6-0.7bn by the early 2030s. The 'today' marker splits modelled history from forecast.
No reported anchor exists at this grain: companies publish this asset as one product line and never split it by indication × country, so every year above is modelled, including the years already past. The claims below are scored against reported actuals wherever a program has them.
A forecast year closes when an actual is reported for it. A miss is the distance from that actual, signed as the claim fell: under it, or over it.
| Claim | Closed years | Worst miss | Worst miss % |
|---|---|---|---|
| Ormeval modelMODELLED · Ormeval · live | - | no closed year yet | - |
A superseded team version keeps its own row: what it was off by is still a fact about that version. A row with no closed year is not a good score.
What it shows. A modelled base-case net-revenue curve for this indication, year by year, split at 'today' into modelled history and forecast, with the branded curve shown against its in-class rivals.
What to look for. The peak year and how steep the decline is after loss of exclusivity, and where a rival's curve crosses yours, that crossing is the share the model has you losing.
Common misread. Reading the pre-'today' portion as reported actuals (it's modelled), or treating the base case as a company target. It is one deterministic Ormeval-modelled scenario anchored to cited actuals, not guidance and not analyst consensus.
Key model assumptions · The softest inputs are the advanced/1L-systemic-eligible fraction (~0.55 West, ~0.62 China) and the modelled ~$22k realized Chinese net against a ~$28k NRDL full-course price, both estimates; the ~0.80 mean on-drug-year scalar reflecting short survival is a second judgement layer on price.
The decline is defended, not certain
The decline is defended by two dated events, the ~2028 US and ~2029 EU biosimilar entries, plus an already-saturated Chinese share, but the pace is not certain: SC Qlex is an untested defense in this setting, and biosimilar uptake in China, where branded penetration is already low, has little further to erode.
What would change our mind
If pembrolizumab's share of the Chinese 1L esophageal pool is still near or above the modelled ~18% after the next NRDL renewal, or if a domestic PD-1 instead displaces it below ~10%, the base case is wrong, the whole curve is a bet on that one share number holding steady until the 2028 LOE.
A scenario is your own assumptions layered on Ormeval’s cited baseline. We never change the baseline; save as many named scenarios as you like and click one to load it back later.
| Driver · 2026 | US | FR | DE | IT | ES | UK | JP | CN | Total | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| Esophageal cancer incidence (2026) | 23k | 5.5k | 7.3k | 2.4k | 2.3k | 9.3k | 26k | 226k | 302k | GLOBOCAN 2022 |
New esophageal-cancer cases per year (ESCC + adenocarcinoma); ~+0.5%/yr (Western adeno rising, Chinese SCC slowly declining per capita but offset by ageing/population). Shown for 2026: 2024 basis +1%/yr → ×1.010. Country-specific GLOBOCAN 2022 esophageal-cancer incidence, cross-checked to national registries. China dominates (~224k/yr, ~44% of the global ~511k), almost entirely squamous histology; Japan elevated (~26k); Western markets modest and adenocarcinoma-weighted. ~+0.5%/yr blended trend. | ||||||||||
| × Advanced/metastatic (1L-systemic-eligible)est | 55% | 55% | 55% | 55% | 55% | 55% | 55% | 62% | share, not summed | SEER · registries |
Locally-advanced unresectable + metastatic at diagnosis (or relapsed), not eligible for surgery or definitive chemoradiation; the front-line systemic population. Roughly half to two-thirds of esophageal cancer presents advanced/unresectable or recurs to the 1L-systemic setting. Western markets ~0.55; China/Japan present later and screen less, so a higher advanced-at-diagnosis fraction (~0.62 CN, ~0.55 JP). The largest cross-market estimate in this model. | ||||||||||
| × Fit for & receiving 1L IO-chemoest | 66% | 66% | 66% | 62% | 62% | 64% | 68% | 50% | share, not summed | RWE treatment-rate |
Performance-status-fit, eligible for and receiving a platinum/fluoropyrimidine + IO 1L regimen (excludes best-supportive-care-only and chemo-unfit frail/elderly). Advanced esophageal cancer carries heavy symptom burden (dysphagia, weight loss) so a meaningful share are too frail for combination chemo-IO or go to best supportive care. Western/Japan ~0.62-0.68 fit-and-treated; China lower (~0.50), later, sicker presentation and treatment access concentrated in tier-1/2 cities. | ||||||||||
| × PD-L1 CPS≥10 (where label-restricted)est | 100% | 52% | 52% | 52% | 52% | 52% | 52% | 100% | share, not summed | KN-590 CPS · EMA/PMDA |
EU and Japan restrict the pembrolizumab combo to PD-L1 CPS≥10 (~50-55% of advanced patients); the US and China are effectively all-comers, so no CPS gate is applied there. About half of advanced esophageal patients are CPS≥10. The EMA and PMDA labels restrict the combo to CPS≥10, so EU5/Japan apply a ~0.52 gate; the US (all-comers FDA label) and China apply none (1.0). This is the second geographic swing factor after incidence. | ||||||||||
| = Addressable 1L esophageal-IO pool | 8.2k | 1.0k | 1.4k | 430 | 412 | 1.7k | 5.1k | 70k | 88k | computed |
Incidence × the rates above, advanced/metastatic esophageal/GEJ patients fit for and (where label-restricted, CPS≥10) reachable for 1L pembrolizumab-chemo this year. The 1L advanced esophageal/GEJ pool is broadly stable: modest Western adenocarcinoma growth (GERD/obesity) roughly offsets slowly declining per-capita Chinese ESCC rates, with ageing/population keeping absolute Chinese volume high. Held flat (×1) across the window; incidence drift is carried in the incidence CAGR, and forward erosion is expressed through pricing and biosimilar share rather than pool shrinkage. | ||||||||||
| × Keytruda uptake (branded) | 41% | 42% | 44% | 42% | 42% | 42% | 41% | 8% | share, not summed | ASSUMED |
Per-market branded uptake of the addressable pool this year (launch ramp net of competitors & biosimilars). See the competitive curve below; pick a market for its access basis. | ||||||||||
| = Treated with Keytruda | 3.4k | 432 | 598 | 181 | 173 | 714 | 2.1k | 5.6k | 13k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $134K | $65K | $69K | $61K | $59K | $64K | $56K | $21K | per patient, not summed | ASP · HTA · NRDL · OS |
Until-progression IO: per-patient revenue is the annual net cost while on-drug, scaled by the mean on-treatment duration. Unlike 1L NSCLC (median OS ~22 mo → ~1 full patient-year), advanced esophageal cancer has median OS ~12 mo (KEYNOTE-590) and faster progression, so a treated patient generates only ~0.80 of a full annual course of revenue. The per-patient values below therefore embed that ~0.80 duration factor on top of net price. Underlying gross net prices: US ~$175k/yr full-course (ASP ≈$11.8k/200mg q3w, ~$205k list, net of ~10-15% physician-administered-biologic GTN); EU ~$76-90k; Japan ~$72k (biennial NHI cuts); China NRDL ~$28k → after the ~0.80 duration scalar the modelled per-patient figures are correspondingly lower. −2%/yr forward erosion (accelerating into LOE); held flat before 2024. SHOWN FOR 2026: the per-market figures in "Net pricing: assumptions & basis" below are the 2024 basis; this row applies -2%/yr from 2024 (×0.9604), so it is the same source value at a later date, not a second price. | ||||||||||
| = Net revenue / yrOutput | $451M | $28.2M | $41.4M | $11.1M | $10.1M | $46.0M | $118M | $119M | $825M | computed · assumed input |
Treated patients × realized net price. | ||||||||||
Regional revenue mix · 2026 modelled
Model estimate, sourced from the funnel table above
No reported competitor-share series exists for this setting, so every trajectory below is modelled from approval timing, label breadth and the funnel, not reported data.
In-class share, 1L advanced esophageal/GEJ immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable 1L esophageal-IO pool. The branded-pembrolizumab line shows the 2021 launch ramp, then the ~2028 LOE biosimilar erosion; the gap below the top line is patients on competing IO regimens (notably nivolumab and China-domestic PD-1s), chemo-only, or untreated. Only the branded pembrolizumab + chemo line is monetized.
Share of the 88k-patient addressable 1L esophageal-IO pool this regimen is modelled to treat, by year
Keytruda is modelled at 15% of this pool in 2026, peaking at 15% in 2025; each point of share is revenue on the chart above.
Scope: 8 modelled markets (US, EU5, JP, CN) · follows the market selector above
Rivals' share, same pool
Domestic Chinese PD-1s holds the largest rival share in 2026, 6% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (8%), which is smaller than the plot above. Same data, a linear axis of its own, so a low-share entrant is readable rather than a hairline on the baseline.
Launch ramp = market-by-market approval + reimbursement timing (FDA Mar 2021, EU/Japan 2021 CPS≥10, China NMPA 2021/NRDL 2022-23); nivolumab (CheckMate-648) takes differentiated 1L ESCC share; cheaper NRDL-listed domestic PD-1s take large China-only share; pembrolizumab biosimilars timed to the ~2028 US / ~2029 EU LOE. Competitor trajectories are stated assumptions, not reported shares.
Readouts, approvals and LOE events for pembrolizumab and its rivals in this setting. Estimated timing is flagged; confirmed dates cited from Merck & Co. disclosures and regulator databases.
Pembrolizumab composition-of-matter expiry (~2028); biosimilars erode the branded molecule across all indications including esophageal/GEJ
EU biosimilar entry; SC Qlex conversion mitigates IV-biosimilar share loss
Tislelizumab (RATIONALE-306), camrelizumab (ESCORT-1st), sintilimab (ORIENT-15) and toripalimab (JUPITER-06) entrench cheaper NRDL 1L ESCC options
✓ = reported public fact, cited. Upcoming timing is estimated from company guidance and trial registries, a projection, not a commitment. Approvals = US (FDA) · EU (EMA) · Japan (PMDA) · China (NMPA). ● = pembrolizumab, competitor tag = a same-setting rival.
Residual unmet need: why the field stays alive
Even with pembrolizumab + chemotherapy, median OS in advanced esophageal cancer remains ~12-14 months and 5-year survival stays in the low-to-mid teens; PD-L1-low/CPS<10 patients derive markedly less benefit (which is why EU/Japan restrict the combo to CPS≥10), and there is no validated post-IO 1L standard. The endemic Chinese ESCC population is under-tested and under-treated outside tier-1/2 cities. These gaps keep the setting an active battleground for next-gen IO, claudin-18.2 and antibody-drug conjugates, and cheaper domestic PD-1 combinations.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (1L advanced esophageal / GEJ carcinoma)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Nivolumab (± ipilimumab) (Live threat) | Bristol Myers Squibb | Live threatwhyFDA/EMA-approved 1L advanced ESCC, the principal differentiated IO alternative (incl. a chemo-sparing nivo+ipi option) | not in the record | not in the record | CheckMate-648, nivolumab 1L advanced ESCC (Doki, NEJM 2022) |
| Tislelizumab (Tevimbra) (China rival) | BeiGene | China rivalwhyApproved 1L ESCC; NRDL-listed in China and now Western launches, a direct, lower-priced PD-1 rival | not in the record | not in the record | RATIONALE-306 (1L advanced ESCC + chemo) |
| Camrelizumab (China rival) | Jiangsu Hengrui | China rivalwhyNRDL-listed 1L ESCC in China, cheaper domestic competitor | not in the record | not in the record | ESCORT-1st (1L advanced ESCC + chemo) |
| Sintilimab (Tyvyt) (China rival) | Innovent / Eli Lilly | China rivalwhyNRDL-listed 1L ESCC in China, cheaper domestic competitor | not in the record | not in the record | ORIENT-15 (1L advanced ESCC + chemo) |
| Toripalimab (China rival) | Junshi / Coherus | China rivalwhyNRDL-listed 1L ESCC in China (and US-approved in NPC), cheaper domestic competitor | not in the record | not in the record | JUPITER-06 (1L advanced ESCC + chemo) |
| Keytruda Qlex (subcutaneous pembrolizumab) (Merck & Co. pipeline) | Merck | Merck & Co. pipelinewhyFDA-approved Sep 2025 across most solid tumours, intra-brand LOE/convenience defense (monetized within the branded line) | Sep 2025, - | -54 (after) | - |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, steep erosion of the branded molecule across all Keytruda lines | not in the record | not in the record | pembrolizumab composition-of-matter LOE ~2028 (US) |
Not every rival is approved in every region, so a share here is the modelled position in the markets where it competes, not a global one.
Net pricing: assumptions & basis
Pembrolizumab is dosed 200 mg q3w (or 400 mg q6w) IV, or via the subcutaneous Qlex formulation (Sep 2025), with cisplatin/5-FU, continued until progression or 35 cycles. US ASP is ~$11.8k per 200 mg dose (~$205k/yr list). Because advanced esophageal cancer has shorter survival than NSCLC (median OS ~12 mo), the per-patient values below are net country prices SCALED by a ~0.80 mean on-drug year, so they sit below the full-course net figures.
Figures below are 2024 net prices, the basis the model is anchored on. The funnel applies -2%/yr from 2024, so the price it consumes for a later year is lower than the figure quoted here. Both come from this one value; the funnel row states the year it is showing.
Pembrolizumab is dosed 200 mg every 3 weeks (or 400 mg q6w) IV, or as subcutaneous Qlex (FDA Sep 2025), with a cisplatin/5-FU backbone, continued until progression or a 35-cycle cap. Per-patient revenue is modelled as net price × the mean on-drug year. The key difference from 1L NSCLC is duration: median OS in advanced esophageal cancer is ~12 mo (KEYNOTE-590) vs ~22 mo in NSCLC, so a treated patient generates only ~0.80 of a full annual course. Full-course net prices: US ~$175k/yr (ASP ≈ $11,795/200 mg q3w, ~$205k list, net of ~10-15% physician-administered-biologic GTN); Germany AMNOG ~$90k, France ~$85k, UK NICE confidential PAS ~$84k, Italy AIFA ~$80k, Spain ~$76k (lowest Western); Japan NHI ~$72k (biennial cuts); China NRDL ~$28k. After the ~0.80 on-drug-duration scalar the MODELLED per-patient figures are US ~$140k, DE ~$72k, FR ~$68k, UK ~$67k, IT ~$64k, ES ~$61k, JP ~$58k, CN ~$22k. China is the standout, far below Western levels and competing with even cheaper domestic PD-1s; the low per-patient price paired with the large-but-access-limited pool makes China meaningful in absolute revenue but low-margin per patient. −2%/yr forward net erosion reflects ongoing HTA/NRDL/NHI pressure accelerating into LOE; held flat before 2024. ALL net prices and the duration scalar are ESTIMATES.
What it shows. The approval-to-reimbursement journey by market: when each payer granted access, on what terms (PD-L1 or comparator restrictions), and the lag between regulatory approval and reimbursed revenue.
What to look for. The access-lag column, approval is not revenue and some markets take a year or more. And the restrictions that narrow the eligible population below the full label.
Common misread. Assuming a US price or approval transfers to other markets. Ex-US payers benchmark against comparators and reference prices, so the net price and the covered population are usually smaller.
Rows ordered by access speed. The approval→reimbursement lag is commercially load-bearing, and it is not one number per drug: a monotherapy indication and a later combination extension file separately with a payer and can reach routine commissioning years apart, even within the same asset’s first-line setting.
| Market | HTA body | Decision | Access lag | PD-L1 | Comparator | Key outcome / MEA note |
|---|---|---|---|---|---|---|
| US | FDA | 22 Mar 2021 | reference | All-comers (any CPS) | Cisplatin + 5-FU | Approved 1L esophageal/GEJ carcinoma not eligible for resection/chemoradiation; Medicare Part B (J9271); ~10-15% gross-to-net → ~$175k/yr net |
| Germany | G-BA / IQWiG | 2021-2022 | ~0.5 yr | CPS≥10 (EMA restriction) | Cisplatin/5-FU | EMA approved CPS≥10; reimbursed at launch, AMNOG net below list (~$90k/yr); densest EU access |
| Japan | PMDA / NHI | Nov 2021 | ~0.5 yr | CPS≥10 | Cisplatin/5-FU | NHI-listed; esophageal cancer (predominantly ESCC) is elevated in Japan; biennial NHI price cuts → ~$72k/yr net |
| France | HAS | 2021-2022 | ~0.7 yr | CPS≥10 | Cisplatin/5-FU | Early access then reimbursement; SMR important; net ~$85k/yr |
| UK | NICE TA969 | 2022-2023 | ~1.3 yr | CPS≥10 | Cisplatin/5-FU | Recommended for CPS≥10 advanced ESCC/adeno; confidential PAS; net ~$84k/yr |
| Italy | AIFA | 2022-2023 | ~1.5 yr | CPS≥10 | Cisplatin/5-FU | Class H, managed entry + regional formulary lag; net ~$80k/yr |
| Spain | SEFH / MoH | 2022-2023 | ~2 yr | CPS≥10 | Cisplatin/5-FU | Financed 1L; +17-region formulary lag; net ~$76k/yr (lowest Western) |
| China | NMPA / NRDL | 2021 (NMPA); NRDL ~2022-23 | ~1 yr | All-comers / CPS-informed | Cisplatin/5-FU / domestic PD-1 | NMPA approved 1L esophageal carcinoma; NRDL-reimbursed but competes with far-cheaper NRDL-listed domestic PD-1s (tislelizumab, camrelizumab, sintilimab, toripalimab), THE dominant volume market at low net price (~$28k/yr) |
How much each assumption could move the forecast, one at a time, over the same cited baseline.
This is a sensitivity illustration, not a probability: it shows how far each assumption could move the forecast, never how likely it is.
Set a target and solve for one lever, what it would have to reach, benchmarked against real comparable launches.
One lever at a time: the other assumptions stay at baseline, so the trade-off stays visible.
A model that shows where its own risk is, not a number to trust. Never investment advice.
Cite this forecast as recorded on Q2 2026 → A permanent record of these figures that does not change when the model does.
Every reported figure here traces to a public source below; the model's own assumptions are labelled where they appear.
Reported figures are public facts from company filings; the forward peak is Ormeval's own modelled estimate, not company guidance and not analyst consensus. Approval and readout dates are cross-checked against public regulator and company disclosures. Not investment advice.