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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the perioperative resectable-NSCLC indication only (the KEYNOTE-671 neoadjuvant + adjuvant regimen), not the 1L metastatic (KEYNOTE-189/-407/-024), adjuvant-only (KEYNOTE-091), or non-lung Keytruda settings. See all Keytruda indications →
Verified on label; year was right, exact date added. Label 1.2: 'indicated for the treatment of patients with resectable (tumors >=4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.' Scope refinement for the row's generic 'Perioperative / neoadjuvant NSCLC': the label restricts to resectable tumours >=4 cm OR node-positive, so smaller node-negative resectable disease is out of label. Traditional approval, not accelerated - absent from all three FDA accelerated-approval registries. Distinct from KEYNOTE-091, which is adjuvant-only after resection and platinum chemo.
All markets
2026 net revenue · modelled periop slice
$1.02B
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled net revenue · sourced funnel
Whole-asset forecast, snapshot before vs after each event in this indication; bracketed, not attributed.
The 15-second read
KEYNOTE-671 gave Keytruda the first perioperative-IO regimen with an OS benefit (HR 0.72 on EFS HR 0.58), all-comers - but nivolumab (CheckMate-77T), durvalumab (AEGEAN) and toripalimab (NEOTORCH) share the slot. From the Oct 2023 launch: $1.02B in 2026, a $1.58B peak in 2029 - roughly 5% of the franchise - then $1.11B by 2034 as the ~2028 US / ~2029 EU LOE lands mid-ramp. Much volume substitutes from adjuvant-only KEYNOTE-091, and the fixed ~17-cycle course earns less per patient than until-progression use. The value is defensive: earlier entrenchment as the metastatic line expires.
Threats land:The 'is the adjuvant half necessary?' question resolves against the full perioperative continuum, neoadjuvant-only CheckMate-816 is simpler, cheaper and already approved, and surgery dropout plus toxicity already prevent some patients from completing the course, so the effective per-patient course shortens while nivolumab and durvalumab split the remaining share, and the 2029 peak lands well below $1.58B.
Modelled path:Perioperative IO builds as the new standard in driver-negative resectable Stage II–IIIB disease with pembrolizumab holding the OS-data lead but not the category, taking the curve to a $1.58B peak in 2029 before biosimilars erode the branded line to $1.11B by 2034.
Levers land:LDCT screening-driven stage migration pushes more patients into resectable disease faster than modelled while subcutaneous Keytruda Qlex converts a large share of the fixed one-year course ahead of the IV biosimilar wave, lifting the peak above $1.58B and flattening the post-LOE tail.
Pembrolizumab's uptake share of the addressable perioperative pool, the driver-negative, surgically fit, resectable Stage II–IIIB patients who actually receive perioperative IO. This is an Ormeval scoping estimate, and it is the single most exposed number on the page because, unlike the adjuvant RCC setting where rivals failed, three approved competitors are taking real share here from 2024 onward. The model sets branded penetration as a contested-category share rather than a default-to-leader share, but there is no published indication-level split to check it against; a five-point error in this fraction moves the peak by roughly $100M a year.
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.
KEYNOTE-671 moves Keytruda into curative-intent early-stage NSCLC and was the first perioperative-IO trial with a positive OS readout, a category-defining win that anchors a ~$1.6B slice and, crucially, extends the franchise's reach earlier in the disease course just as the metastatic line approaches LOE. Strategically it both grows the pie (treating relapse-risk patients who previously got chemo alone) and cannibalizes Keytruda's own adjuvant-only KEYNOTE-091 line. It set the perioperative template that nivolumab (CheckMate-77T), durvalumab (AEGEAN) and toripalimab (NEOTORCH) now contest, making this a genuinely competitive new SoC rather than a monopoly.
Resectable Stage II–IIIB NSCLC, operable but high-risk-of-relapse disease (~20–25% of NSCLC), was managed with surgery ± chemotherapy until perioperative IO. KEYNOTE-671 added neoadjuvant pembrolizumab + chemo before surgery and adjuvant pembrolizumab after, improving EFS (HR 0.58) and OS (HR 0.72) in an all-comers population. It opened the perioperative-IO category and cannibalizes the adjuvant-only setting (KEYNOTE-091); the large East-Asian EGFR-mutant fraction limits the addressable IO pool there.
Resectable NSCLC is operable Stage II–IIIB disease, past the smallest Stage I tumours but still curative-intent with surgery, accounting for ~20–25% of NSCLC at diagnosis. Despite complete resection, relapse is common (Stage III 5-yr recurrence >50%), which is why perioperative systemic therapy is given to eradicate micrometastatic disease. Treatment now bifurcates on molecular testing: EGFR/ALK-driver-positive tumours (~15% West, ~40–50% East Asia) are routed to targeted adjuvant TKIs (osimertinib/ADAURA, alectinib/ALINA), NOT perioperative IO. The driver-negative remainder is the perioperative-IO setting. Across the 8 modelled markets ~70,000 patients/year are perioperative-IO-eligible, the pool this model sizes; the regimen is a fixed ~1-year course (neoadjuvant + adjuvant), not until-progression.
KEYNOTE-671 was the pivotal Phase 3 trial that established the full perioperative (neoadjuvant + adjuvant) pembrolizumab regimen as a new standard of care in resectable early-stage NSCLC, and the first such trial to show a statistically significant overall-survival benefit. Adding pembrolizumab to neoadjuvant chemotherapy and continuing it as adjuvant therapy improved event-free survival (HR 0.58) and, on the second interim analysis, overall survival (HR 0.72), shifting immunotherapy from the metastatic setting into curative-intent early-stage disease.
Molecular testing (EGFR/ALK) before treatment: driver-positive patients are routed to adjuvant TKIs (osimertinib/ADAURA, alectinib/ALINA) and excluded from the perioperative-IO pool, the carve-out is largest in Japan/China (~40–50% EGFR+). The perioperative regimen competes head-to-head with nivolumab (CheckMate-77T) and durvalumab (AEGEAN); the neoadjuvant-only vs full-perioperative question (CheckMate-816) is unresolved in guidelines.
Randomized, double-blind, placebo-controlled Ph3; n=797; resectable Stage II–IIIB (T3–4N2) NSCLC; neoadjuvant pembrolizumab 200 mg or placebo q3w + cisplatin-based chemotherapy ×4 cycles → surgery → adjuvant pembrolizumab or placebo q3w ×13 cycles; all-comers (no PD-L1 selection); dual primary EFS and OS.
Load-bearing 6/7 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Neoadjuvant pembrolizumab + platinum-doublet chemotherapy followed by surgery and adjuvant single-agent pembrolizumab, in resectable Stage II–IIIB NSCLC (the KEYNOTE-671 perioperative regimen), all-comers, no PD-L1 selection.
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.
$1.02B
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $1.58B · launch 2023 → 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 reported) and calibrated to Merck's reported Keytruda franchise (FY2025 ≈ $31.7B) and its growth SHAPE: the perioperative slice RISES from the Oct 2023 launch, partial 2023 → ~$0.6B (2024) → ~$1.3B (2026) → a ~$1.6B peak around 2029–30 ≈ ~5% of the franchise, a rising new-SoC slice, then meets the ~2028 LOE mid-ramp and erodes. Cannibalizes the adjuvant-only KEYNOTE-091 line. 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 headline rests hardest on two soft inputs: the EGFR/ALK driver carve-out rate (~15–20% in the West but ~45–50% in Japan and China, where adjuvant osimertinib and alectinib remove those patients from the IO pool entirely), and the resectable Stage II–IIIB fraction of NSCLC incidence, sensitised at 0.20–0.27. Price is the third: a ~$110k full-course US net derived from ~17 cycles at a ~$11.8k/200mg ASP, before per-market discounts and early-stop attrition. The clinical layer by contrast is verified and cited, the KEYNOTE-671 EFS and OS hazard ratios and the FDA, EU, Japan and China approval dates are all real.
The decline is defended, not certain
The fall from $1.58B in 2029 to $1.11B in 2034 is a biologic patent cliff, and the LOE dates (~2028 US, ~2029 EU) are the best-evidenced part of the decline. What is uncertain is its slope, and the model's shape encodes a judgement that could break either way: perioperative therapy is hospital-administered and payer-directed, which argues for fast biosimilar substitution and a steeper drop, but a fixed one-year course is also the easiest place to convert patients to subcutaneous Qlex before an IV biosimilar arrives, which argues for a shallower one. The decline is defended by the calendar, not by the erosion rate.
What would change our mind
The base case is wrong if the adjuvant half of the regimen loses its justification. Specifically: if a randomised comparison or a pooled analysis shows that neoadjuvant-only pembrolizumab or nivolumab (the CheckMate-816 paradigm) matches the full perioperative continuum on EFS before 2030, the ~13 adjuvant cycles that carry most of the ~17-cycle course revenue become optional, and the modelled per-patient value, not the share, is too high by roughly half. A cleaner, dated second falsifier: if US pembrolizumab biosimilars do not launch in 2028, the curve's 2030 drop to $1.45B is mistimed and the peak extends. On the upside falsification, if durvalumab's AEGEAN regimen reports a significant OS benefit, pembrolizumab loses the OS-exclusivity argument that justifies its modelled share lead in the contested pool.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Lung cancer incidence (2026) | 231k | 51k | 63k | 45k | 31k | 52k | 139k | 1.08M | 1.69M | GLOBOCAN 2022 |
New lung-cancer cases per year; +1%/yr for ageing demographics. Shown for 2026: 2024 basis +1%/yr → ×1.020. Country-specific GLOBOCAN 2022 lung-cancer incidence, cross-checked to national registries; +1%/yr ageing trend. Same incidence base as the PACIFIC / 1L-NSCLC Keytruda models. | ||||||||||
| × NSCLC | 85% | 87% | 78% | 85% | 84% | 83% | 91% | 85% | share, not summed | KBP · SEER · ZfKD |
Non-small-cell histology (vs small-cell). Country-specific NSCLC fraction (~78–91%). Japan highest (~91%, adeno-dominant); Germany lowest (~78%). Same basis as the PACIFIC / 1L-NSCLC models. | ||||||||||
| × Resectable Stage II–IIIBest | 23% | 22% | 23% | 22% | 23% | 21% | 27% | 22% | share, not summed | NCDB · KBP · NCR |
Operable Stage II–IIIB at diagnosis (excludes Stage I, unresectable III, and Stage IV). Resectable Stage II–IIIB is ~20–25% of NSCLC: Stage II (~10–12%) plus the resectable portion of Stage III (T3–4N2 operable). Western markets ~0.22–0.24; Japan higher resectable share (~0.27, aggressive surgery / screening-driven earlier stage); China ~0.22. Excludes Stage I (mostly surgery-alone, not perioperative-IO) and unresectable III (the PACIFIC pool). | ||||||||||
| × No actionable driver (EGFR/ALK−)est | 82% | 85% | 85% | 82% | 80% | 85% | 55% | 52% | share, not summed | IFCT · PIONEER |
Excludes EGFR/ALK-positive tumours, routed to adjuvant TKIs (osimertinib/ADAURA, alectinib/ALINA), not perioperative IO. THE pool's geographic swing factor. The dominant geographic driver of the eligible pool. EGFR+ALK+ROS1 ~15–20% of NSCLC in the West (~80–85% driver-negative) but ~45–50% in Japan/China (~52–55% driver-negative), and in resectable disease these patients increasingly go to adjuvant osimertinib (ADAURA) or alectinib (ALINA). The East-Asian carve-out is the mirror of FLAURA/ADAURA. | ||||||||||
| × Perioperative-eligible & treatedest | 66% | 66% | 66% | 62% | 62% | 64% | 68% | 45% | share, not summed | MYLUNG · ESMO audit |
Fit for surgery + neoadjuvant chemo-IO, biomarker-tested, and receiving the perioperative regimen. Branded pembrolizumab UPTAKE is the share row below (excluded here). Captures surgical fitness, biomarker-testing completeness and receipt of a perioperative chemo-IO regimen (excludes those unfit for the cisplatin-based neoadjuvant backbone, surgery-ineligible after staging, or untested). Near-complete in Western academic centres and Japan (~0.62–0.68); markedly lower in China (~0.45, surgery/testing concentrated in tier-1/2 cities). Excludes pembrolizumab UPTAKE, the competitive share layer below. | ||||||||||
| = Addressable perioperative pool | 24k | 5.4k | 6.4k | 4.2k | 2.9k | 4.9k | 13k | 47k | 108k | computed |
Incidence × the rates above, driver-negative resectable Stage II–IIIB NSCLC patients reachable for perioperative IO this year. The perioperative pool is broadly stable-to-rising: LDCT screening shifts diagnoses into earlier, resectable stages (a tailwind unique to this early-stage setting, unlike the metastatic pools), partly offset late by expanding adjuvant-TKI carve-out of EGFR/ALK patients. Modelled as roughly flat with a slow late-decade drift; East Asia steadier given its smaller driver-negative base. | ||||||||||
| × Keytruda uptake (branded) | 22% | 16% | 17% | 16% | 16% | 17% | 18% | 11% | 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 | 5.3k | 892 | 1.1k | 690 | 477 | 825 | 2.3k | 5.2k | 17k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $106K | $58K | $62K | $56K | $53K | $58K | $50K | $21K | per patient, not summed | ASP · HTA · NRDL |
Fixed ~1-year perioperative course (~17 pembrolizumab cycles: ~4 neoadjuvant + ~13 adjuvant), NOT until-progression, so per-patient revenue is the full-course net, lower than the metastatic line's annual until-progression revenue. US ASP ≈ $11.8k/200mg × ~17 cycles ≈ ~$200k list, net of ~10–15% physician-administered-biologic GTN → ~$110k/course (some patients stop early post-surgery, lowering realized cycles). EU nets ~$55–65k. Japan ~$52k (NHI cuts). China ~$22k (self-pay/evolving NRDL). −2%/yr forward; 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 | $564M | $51.4M | $67.5M | $38.4M | $25.2M | $47.5M | $114M | $111M | $1.02B | 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, perioperative resectable NSCLC immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable perioperative pool (driver-negative resectable Stage II–IIIB NSCLC fit for perioperative IO). The branded-pembrolizumab line shows the launch ramp from the 2023 approval as the perioperative-IO category builds, contested by nivolumab/durvalumab/toripalimab; the gap below the top line is patients on competing IO regimens, chemo-only, or surgery-alone. Only the branded pembrolizumab line is monetized here.
Share of the 108k-patient addressable perioperative pool this regimen is modelled to treat, by year
Keytruda is modelled at 16% of this pool in 2026, peaking at 26% in 2029; 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
Nivolumab (CheckMate-77T/816) holds the largest rival share in 2026, 4% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (20%), 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 (US Oct 2023, EU Mar 2024, Japan Sep 2024, China Dec 2024); nivolumab (CheckMate-77T/816) and durvalumab (AEGEAN) take in-class share from ~2024; toripalimab (NEOTORCH) takes China share; pembrolizumab biosimilars timed to the ~2028 US / ~2029 EU LOE. Competitor trajectories are stated assumptions.
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 eventually reach the perioperative line
EU biosimilar entry; SC Qlex conversion mitigates IV-biosimilar share loss
Maturing OS data across CheckMate-77T / AEGEAN / NEOTORCH could reshuffle perioperative share
✓ = 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 perioperative pembrolizumab, a substantial minority still relapse, EFS curves separate but plateau below cure for higher-stage disease, and OS benefit (HR 0.72), while significant, leaves room. PD-L1-low/negative patients benefit least; the optimal neoadjuvant-vs-adjuvant contribution is unresolved (the 'do you need both halves?' question vs neoadjuvant-only CheckMate-816); and EGFR/ALK-driver patients are carved out to TKIs. That residual relapse and the regimen-optimization question keep the perioperative setting intensely competitive.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Perioperative resectable NSCLC)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Nivolumab (CheckMate-77T / CheckMate-816) (Live threat) | Bristol Myers Squibb | Live threatwhyApproved, 77T perioperative (FDA Oct 2024) and 816 neoadjuvant-only (FDA Mar 2022); the principal direct competitor and the neoadjuvant-only alternative | Oct 2024, CheckMate-77T / CheckMate-816 | -12 (after) | CheckMate-77T, perioperative nivolumab (Cascone, NEJM 2024) |
| Durvalumab (AEGEAN) (Live threat) | AstraZeneca | Live threatwhyApproved perioperative regimen (FDA Aug 2024), positive EFS; AstraZeneca's competing periop entrant | Aug 2024, AEGEAN | -10 (after) | AEGEAN, perioperative durvalumab (Heymach, NEJM 2023) |
| Toripalimab (NEOTORCH) (China rival) | Junshi Biosciences | China rivalwhyChina-approved perioperative regimen; cheaper domestic option, structural China share pressure | not in the record | not in the record | NEOTORCH, perioperative toripalimab (Lu, JAMA 2023) |
| 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, - | -23 (after) | - |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, eventual erosion of the perioperative line | not in the record | not in the record | pembrolizumab LOE ~2028 (US) |
| Adjuvant TKIs (osimertinib/ADAURA, alectinib/ALINA) (Pool erosion) | AstraZeneca / Roche | Pool erosionwhyCarve the EGFR/ALK-positive resectable subpopulation OUT of the perioperative-IO pool (the funnel's driver gate) | not in the record | not in the record | ADAURA / ALINA |
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 across a fixed ~1-year perioperative course (~4 neoadjuvant + ~13 adjuvant cycles ≈ 17 cycles), not until-progression, so per-patient revenue is the full-course net, materially lower than the metastatic until-progression line. US ASP ≈ $11.8k/200mg; net prices below are per-market, net of country discounts and early-stop attrition.
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 across the KEYNOTE-671 perioperative course: ~4 neoadjuvant cycles before surgery + ~13 adjuvant cycles after, ≈ 17 cycles over ~1 year (NOT until-progression). US ASP ≈ $11,795/200 mg ⇒ ~$200k list for a full course, ~$110k net after ~10–15% physician-administered-biologic GTN and accounting for patients who stop early (surgery dropout, toxicity, progression, realized cycles < 17 for a fraction). EU nets are HTA-negotiated full-course: Germany AMNOG ~$65k, France/UK ~$60k, Italy ~$58k, Spain ~$55k (lowest Western). Japan: NHI-listed with biennial cuts → ~$52k/course. China is self-pay with an evolving NRDL pathway → ~$22k/course net, paired with the largest-but-most-restricted pool. −2%/yr forward net erosion; held flat before 2024. ALL net prices 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 | 16 Oct 2023 | reference | None (all-comers) | Neoadjuvant chemo + surgery | Medicare Part B (J9271); ~1-yr perioperative course; no PD-L1 prior-auth gate |
| Germany | G-BA / IQWiG | 2024 | ~0.4 yr | None | Chemo + surgery | Reimbursed near EU approval; AMNOG net below list; densest EU access |
| EU | EMA / EC | 28 Mar 2024 | ~0.5 yr | None | Chemo + surgery | Centralised approval; national reimbursement follows per market |
| France | HAS | 2024 | ~0.6 yr | None | Chemo + surgery | AAP/early access then reimbursement; SMR important |
| UK | NICE | 2024–2025 | ~1 yr | None | Chemo + surgery | Appraised post-EU; confidential PAS |
| Italy/Spain | AIFA / SEFH | 2024–2025 | ~1–1.5 yr | None | Chemo + surgery | Managed entry + regional formulary lag |
| Japan | PMDA / NHI | 25 Sep 2024 | ~0.9 yr | None | Chemo + surgery | NHI-listed; large EGFR/ALK carve-out (~45%) shrinks the pool; biennial price cuts |
| China | NMPA | Dec 2024 | ~1.2 yr | None | Chemo + surgery | Approved; faces toripalimab (NEOTORCH) and domestic PD-1s; NRDL status evolving |
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 material move on this page, newest first, the public fact, and what our model made of it.
What recently moved · last 90 days
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.