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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the PLATINUM-RESISTANT recurrent ovarian-cancer indication only (KEYNOTE-B96 / ENGOT-ov65), not platinum-sensitive relapse, 1L maintenance, or non-ovarian Keytruda settings. See all Keytruda indications →
OS positive; FDA approved Feb 2026. On label, but the row's scope is broader than the indication. Label 1.21 reads: 'in combination with paclitaxel, with or without bevacizumab... for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.' The row omits two real gates: the CPS >=1 biomarker requirement (PD-L1 IHC 22C3 pharmDx approved as companion diagnostic the same day) and the one-to-two-prior-lines ceiling - patients beyond second line are outside the label. Approved 2026-02-10 on KEYNOTE-B96 (643 enrolled; in the 466 CPS>=1 patients, median PFS 8.3 vs 7.2 months HR 0.72 p=0.0014, median OS 18.2 vs 14.0 months HR 0.76 p=0.0053). Row note 'OS positive' is supported. Modest absolute deltas - worth flagging in any uptake model.
All markets
Peak net revenue · modelled resistant-OC slice
$203M
CONCLUDED · modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled scenario · assumes approval · not guidance
No model change since the 20 Sep 2026 snapshot.
The 15-second read
KEYNOTE-B96 is a scientific landmark with a commercial window barely wide enough to matter. It is the first Phase 3 immunotherapy trial to improve overall survival in platinum-resistant ovarian cancer, a setting that had defeated every prior IO attempt, JAVELIN Ovarian 200 included, with PFS HR 0.70 in all-comers and OS HR 0.76 in PD-L1 CPS≥1 patients (18.2 vs 14.0 months). But the modelled slice cannot launch until roughly 2027 and pembrolizumab's US composition-of-matter exclusivity expires around 2028, so the ramp and the biosimilar cliff nearly overlap: $107M in 2027, a $203M peak in 2029, then decline to $161M by 2034. The honest read: this indication is worth about 1% of the ~$31B Keytruda franchise and is best understood as gynaecologic-oncology label breadth defended into the LOE, not as revenue.
Threats land:Regulators or payers restrict use to PD-L1 CPS≥1 patients where the OS benefit actually sits, FRα-high patients continue routing to Elahere, and the indication launches into biosimilar competition before it ever reaches the modelled peak.
Modelled path:US and EU approvals land around 2026-27, penetration matures near 30-35% of the addressable platinum-resistant pool in Western markets, and the slice peaks at ~$203M in 2029 before biosimilar erosion.
Levers land:Keytruda Qlex subcutaneous conversion retains administration and volume share through the post-2028 IV-biosimilar wave in this indication as elsewhere, holding the plateau closer to peak through the early 2030s.
Mature branded penetration of the addressable platinum-resistant pool, modelled at ~30-35% in the West and ~22% in China, is the figure most at risk, because it embeds a judgement that oncologists will use an all-comers label in a population where the survival benefit is concentrated in PD-L1-positive tumours. An Ormeval scoping estimate of prescribing behaviour against the evidence, not of the evidence itself.
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). Approved in 3 markets. Cross-checked against Merck & Co. disclosures and regulator databases.
The value here is strategic more than financial: KEYNOTE-B96 breaks a long run of IO failures in ovarian cancer, making pembrolizumab the first checkpoint inhibitor with a positive phase-3 OS result in the platinum-resistant setting. It extends the Keytruda label into gynaecologic oncology beyond endometrial cancer and validates a chemo-IO (± anti-angiogenic) template for a 'cold' tumour. Commercially it is a MODEST additive indication (~$0.2B modelled peak, ~1% of the franchise), meaningful as label breadth and a defense of Keytruda's gynae footprint, but immaterial next to lung/melanoma blocks and itself exposed to the ~2028 US biologic LOE.
Platinum-resistant recurrent ovarian cancer, disease progressing within 6 months of platinum, is a high-unmet-need setting where single-agent chemotherapy yields short responses and every prior immunotherapy trial had failed. KEYNOTE-B96 / ENGOT-ov65 (ESMO 2025) is the first phase-3 IO trial to improve OS here: pembrolizumab + weekly paclitaxel ± bevacizumab raised PFS (all-comers HR 0.70; PD-L1 CPS≥1 HR 0.72) and OS (CPS≥1 HR 0.76). It is a MODEST incremental Keytruda indication (~$0.2B modelled peak, a small fraction of the ~$31B franchise), gated by a small platinum-resistant pool and by the ~2028 US biologic LOE.
Epithelial ovarian cancer (~90% of ovarian malignancy, high-grade serous dominant) usually presents at advanced stage; despite high initial platinum response, the large majority recurs. At recurrence, disease is classified by platinum-free interval: relapse within 6 months of the last platinum defines PLATINUM-RESISTANT disease, a poor-prognosis subset (median OS ~12-16 mo) treated with single-agent non-platinum chemotherapy (weekly paclitaxel, PLD, topotecan, gemcitabine), often with bevacizumab (AURELIA). Roughly a quarter of patients are platinum-resistant at first relapse and most recurrent patients ultimately become resistant, so the resistant pool accumulates below the incident base. Across the 8 modelled markets this platinum-resistant, paclitaxel-±-bev-eligible pool is on the order of tens of thousands of patients/year, the small pool this model sizes.
KEYNOTE-B96 / ENGOT-ov65 is the FIRST phase-3 immunotherapy trial to show a significant overall-survival benefit in platinum-resistant recurrent ovarian cancer, a setting where prior IO trials (JAVELIN Ovarian 200 with avelumab) had failed. In 643 patients, adding pembrolizumab (400 mg q6w) to weekly paclitaxel ± bevacizumab improved PFS in all-comers (HR 0.70; median 8.3 vs 6.4 mo) and in PD-L1 CPS≥1 (HR 0.72), and OS in the PD-L1-positive subset (HR 0.76; median 18.2 vs 14.0 mo). A modest but practice-relevant new indication that opens IO to a historically IO-refractory tumour, adding a small incremental slice to the Keytruda franchise.
As of mid-2026 this is a newly-positive phase-3 readout (ESMO 2025) pending regulatory review, guideline listing and label are anticipated, not yet finalized. PD-L1 CPS testing at platinum-resistant relapse is the key pre-treatment gate for the OS-benefiting population.
Phase 3, randomized, double-blind, placebo-controlled (n=643). Platinum-resistant recurrent epithelial ovarian / fallopian-tube / primary-peritoneal cancer randomized 1:1 to pembrolizumab 400 mg IV q6w or placebo, each added to weekly paclitaxel (80 mg/m² days 1/8/15 of a 3-week cycle) WITH OPTIONAL bevacizumab (10 mg/kg q2w, investigator's choice). Dual primary endpoint: PFS in PD-L1 CPS≥1 and in all-comers; key secondary: OS. Stratified by bevacizumab use and PD-L1 status.
Load-bearing 6/7 sourced. ASSUMED uptake is yours to change.
SCENARIO: KEYNOTE-B96 met its endpoints at ESMO 2025 (first IO OS win in platinum-resistant ovarian cancer) but is not yet approved. Revenue below is a forward scenario contingent on regulatory approval; peak is a MODEST ~$0.2B, a small incremental Keytruda indication.
This indication only, not Keytruda's total revenue
Platinum-resistant recurrent epithelial ovarian, fallopian-tube or primary-peritoneal cancer, pembrolizumab added to weekly paclitaxel, with OPTIONAL bevacizumab (the KEYNOTE-B96 / ENGOT-ov65 regimen). Platinum-resistant = disease progressing within 6 months of the last platinum-based therapy. All-comers eligible; benefit is strongest in PD-L1-positive (CPS ≥1) tumours.
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.
$0
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $203M · launch 2027 → 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.
This is a MODEST, NEW additive slice of the Keytruda franchise (FY2025 ≈ $31B). There is no reported indication × country revenue line for platinum-resistant OC, figures are MODELLED, and because the indication launches only after anticipated ~2026-28 approvals, essentially all revenue here is a FORWARD scenario contingent on approval. The modelled slice ramps from ~2027, reaches a modest ~$0.2B peak around ~2030-31, and, because launch nearly coincides with the ~2028 US composition-of-matter LOE, is quickly capped and eroded by pembrolizumab biosimilars (partly defended by SC Qlex). At peak the resistant-OC slice is ~1% of the franchise, a small indication that CANNOT and does not approach the whole. The 'today' marker splits (near-zero) modelled history from the forward scenario.
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 on that penetration and on the platinum-resistant fraction of recurrent disease (~45% per year, a key estimate) inside a funnel of epithelial histology (~90%) and reachable-and-treated rates from ~45% in China to ~72% in the West, only the pembrolizumab add-on is monetized, at a US ASP of ~$11.8k per 200 mg (~$205k/yr list) over roughly 0.7-1 patient-years given a median PFS near 8 months.
The decline is defended, not certain
The post-2029 fall is driven by pembrolizumab biosimilars from ~2028 in the US and ~2029 in the EU, a franchise-wide LOE that is a schedule rather than a forecast, but the depth is genuinely uncertain here because Keytruda Qlex (FDA September 2025) is modelled as a volume-retaining subcutaneous conversion, and how much administration share that actually holds against IV biosimilars is unproven.
What would change our mind
The base case is wrong if regulators grant only a PD-L1 CPS≥1 label rather than the all-comers indication the trial enrolled, because the modelled penetration assumes the broader population while the OS evidence supports only the narrower one. It is separately wrong if AbbVie's mirvetuximab soravtansine expands beyond FRα-high disease before 2029, since the model already concedes FRα-high patients to Elahere and any broadening would take the pool this slice is sized on.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Ovarian cancer incidence (2026) | 20k | 5.2k | 7.3k | 5.3k | 3.6k | 7.5k | 13k | 61k | 124k | GLOBOCAN 2022 |
New ovarian (incl. fallopian-tube / primary-peritoneal) cancer cases per year; +0.5%/yr net demographic drift. Shown for 2026: 2025 basis +1%/yr → ×1.005. Country-specific GLOBOCAN 2022 ovarian-cancer incidence, cross-checked to national registries (US ~19.9-20.9k/yr ACS; China ~61k GLOBOCAN 2022). Slow +0.5%/yr net drift (rising in Asia, flat/declining in the high-income West). | ||||||||||
| × Epithelial / high-gradeest | 90% | 90% | 90% | 90% | 90% | 90% | 90% | 90% | share, not summed | SEER · WHO |
Epithelial ovarian cancer (~90% of ovarian malignancy; high-grade serous dominant), the histology treated with platinum chemo and eligible for this regimen. Epithelial histology accounts for ~90% of ovarian cancers; germ-cell/stromal tumours are excluded. Broadly uniform across markets. | ||||||||||
| × Advanced & recurs after platinumest | 70% | 70% | 70% | 70% | 70% | 70% | 70% | 70% | share, not summed | SEER stage / relapse |
Advanced-stage (III/IV) at diagnosis or early relapse, the large majority of epithelial OC recurs after front-line platinum despite high initial response. Most epithelial OC is diagnosed advanced (Stage III/IV) and, despite high platinum response, the large majority recurs. Modelled at ~0.70 of epithelial cases entering the recurrent-treatment pathway (early-stage cured patients excluded). An ESTIMATE. | ||||||||||
| × Platinum-RESISTANTest | 45% | 45% | 45% | 45% | 45% | 45% | 45% | 45% | share, not summed | PROC cohorts |
Relapse within 6 months of the last platinum-based therapy, the platinum-resistant subset this regimen treats (distinct from platinum-sensitive relapse). ~25% of patients are platinum-resistant at first relapse and most recurrent patients eventually become resistant. Modelled at ~0.45 of the recurrent pool reaching a platinum-resistant, systemic-therapy-eligible line in a given year (blends first-relapse resistant + later resistant lines; per-year, not cumulative). A key ESTIMATE and the pool's main narrowing gate. | ||||||||||
| × Reachable & paclitaxel-±-bev-treatedest | 72% | 72% | 72% | 68% | 68% | 70% | 72% | 45% | share, not summed | treatment-rate lit. |
Fit for and receiving weekly-paclitaxel(±bev)-based systemic therapy at platinum-resistant relapse. Pembrolizumab UPTAKE of this reachable pool is the share row below (excluded here to avoid double-counting). Captures fitness for and receipt of an active weekly-paclitaxel(±bev)-based regimen at platinum-resistant relapse (excludes best-supportive-care / too-frail patients and, in China, large access gaps). ~0.65-0.75 in Western academic systems and Japan; ~0.45 in China (oncology access tier-concentrated). EXCLUDES pembrolizumab uptake (the competitive share layer below). | ||||||||||
| = Addressable platinum-resistant OC pool | 4.1k | 1.1k | 1.5k | 1.0k | 697 | 1.5k | 2.7k | 7.8k | 20k | computed |
Incidence × the rates above, platinum-resistant recurrent epithelial-OC patients reachable for weekly-paclitaxel(±bev)-based systemic therapy this year (the pool pembrolizumab add-on can penetrate). The platinum-resistant recurrent OC pool is broadly stable across the window, gated by stage, recurrence and the platinum-free-interval definition, with slow incidence drift roughly offset by rising PARP-maintenance use upstream (which can delay or reshape recurrence). Modelled flat; the model's revenue shape is driven by the post-approval launch ramp and the ~2028 LOE, not pool growth. | ||||||||||
| × Keytruda uptake (branded) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 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 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $176K | $88K | $93K | $83K | $78K | $86K | $74K | $29K | per patient, not summed | ASP · HTA · NRDL |
Until-progression IO: per-patient revenue is the annual net pembrolizumab cost while on-drug (a treated patient generates ~0.7-1 patient-year of revenue given median PFS ~8 mo). US ASP ≈ $11.8k/200mg (~$205k/yr list) net of ~10-15% physician-administered-biologic GTN → ~$180k/yr. EU nets ~$80-95k. Japan ~$75k (biennial NHI cuts). China NRDL-negotiated → ~$30k/yr net (anticipated). Bevacizumab and paclitaxel costs are NOT counted, only the branded pembrolizumab add-on is monetized. −2%/yr forward erosion into LOE; held flat before base year. SHOWN FOR 2026: the per-market figures in "Net pricing: assumptions & basis" below are the 2025 basis; this row applies -2%/yr from 2025 (×0.9800), so it is the same source value at a later date, not a second price. | ||||||||||
| = Net revenue / yrOutput | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | 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, platinum-resistant recurrent ovarian cancer: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable platinum-resistant OC pool (patients fit for an active resistant-line regimen). The branded-pembrolizumab line shows a post-approval launch ramp (~2027) to a modest mature penetration, then the ~2028 LOE biosimilar erosion; the gap below the top line is patients on Elahere (FRα-high), single-agent chemo ± bev alone, or untreated. Only the branded pembrolizumab add-on line is monetized here.
Share of the 20k-patient addressable platinum-resistant OC pool this regimen is modelled to treat, by year
Keytruda is modelled at 0% of this pool in 2026, peaking at 11% in 2030; 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
Mirvetuximab soravtansine (Elahere) holds the largest rival share in 2026, 0% 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 = anticipated approval + reimbursement timing (US ~2026-27, EU ~2027, Japan ~2027-28, China ~2028+, all post-ESMO-2025); mirvetuximab/Elahere takes the FRα-high slice; single-agent chemo ± bev remains the untreated-by-IO residual; 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 this indication's revenue along with the rest of the franchise; SC Qlex partly defends volume
Elahere (mirvetuximab, AbbVie) and next-gen FRα ADCs continue to expand in FRα-high platinum-resistant OC, the leading competing agent to the pembrolizumab regimen
✓ = 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 the KEYNOTE-B96 win, platinum-resistant ovarian cancer remains lethal: median OS in the PD-L1-positive arm was ~18 months, and PD-L1-low/negative patients derive little IO benefit. The absolute PFS gain is modest (~2 months), most patients still progress, and there is no validated post-progression IO standard. FRα-targeted ADCs (mirvetuximab/Elahere in FRα-high tumours) and PARP inhibitors (upstream, platinum-sensitive) address different slices, leaving PD-L1-low resistant disease the core residual gap that keeps the setting competitive.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Platinum-resistant recurrent ovarian cancer)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Failed endpoint | Source |
|---|---|---|---|---|---|---|
| Mirvetuximab soravtansine (Elahere) (Live threat) | AbbVie (ImmunoGen) | Live threatwhyFDA/EMA-approved with an OS benefit (MIRASOL) in FRα-high platinum-resistant ovarian cancer, the leading competing agent for the FRα-high slice of the pool | not in the record | not in the record | - | MIRASOL, mirvetuximab soravtansine OS in FRα-high platinum-resistant OC (NEJM 2023) |
| Bevacizumab + single-agent chemo (AURELIA) (Live threat) | Roche / generics | Live threatwhyEntrenched, low-cost standard of care in platinum-resistant OC; bevacizumab is also the KEYNOTE-B96 combo backbone (incumbent regimen the IO add-on must improve on) | not in the record | not in the record | - | AURELIA (paclitaxel/PLD/topotecan + bev) |
| PARP inhibitors (olaparib/niraparib) (Pool erosion) | AstraZeneca-MSD / GSK | Pool erosionwhyUpstream in platinum-SENSITIVE maintenance, not resistant-line agents, but reshape/delay recurrence and compress the pool reaching the resistant IO setting | not in the record | not in the record | - | SOLO-2 / PRIMA (platinum-sensitive maintenance) |
| Avelumab (JAVELIN Ovarian 200) (Defeated) | Merck KGaA / Pfizer | DefeatedwhyFAILED, avelumab ± PLD did not improve PFS or OS in platinum-resistant OC; the prior IO failure that KEYNOTE-B96 overturned | not in the record | not in the record | PFS and OS (both missed) | JAVELIN Ovarian 200 (platinum-resistant OC) |
| Domestic Chinese PD-1s (China rival) | Innovent / Hengrui / BeiGene | China rivalwhyIf NRDL-listed in OC, cheaper domestic PD-1s would compress China branded share, a China-only structural threat | not in the record | not in the record | - | (China OC programs) |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, erodes the branded molecule in this indication almost as soon as it launches | 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
The model monetizes ONLY the branded pembrolizumab add-on (400 mg q6w IV, or SC Qlex), not the paclitaxel or bevacizumab backbone. Dosed until progression; in platinum-resistant OC (median PFS ~8 months) a treated patient generates ~0.7-1 patient-year of pembrolizumab revenue. US ASP is ~$11.8k per 200 mg (~$205k/yr list); net prices below are per-market, net of country discounts.
Figures below are 2025 net prices, the basis the model is anchored on. The funnel applies -2%/yr from 2025, 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 400 mg every 6 weeks IV (or subcutaneous Qlex), added to weekly paclitaxel ± bevacizumab and continued until progression. In platinum-resistant OC (median PFS ~8 months in the pembrolizumab arm) per-patient revenue is modelled as ~0.7-1 patient-year of the annual net pembrolizumab cost, the backbone chemo/bev cost is excluded. US ASP ≈ $11,795/200 mg (~$205k/yr list) ⇒ ~$180k/yr net after ~10-15% physician-administered-biologic gross-to-net. EU nets are HTA-negotiated: Germany AMNOG ~$95k, France ~$90k, UK NICE PAS ~$88k, Italy AIFA ~$85k, Spain ~$80k. Japan NHI-listed with biennial cuts → ~$75k/yr. China NRDL-negotiated (anticipated) far below Western levels (~$30k/yr net), competing with cheaper domestic PD-1s. −2%/yr forward net erosion into LOE; held flat before the base year. ALL net prices are ESTIMATES; the KEYNOTE-B96 clinical results are the verified anchor.
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 | ~2026-27 (anticipated; filing post-ESMO 2025) | reference | CPS≥1 (OS-defining subset); all-comers PFS | Paclitaxel ± bevacizumab | Anticipated filing on the KEYNOTE-B96 win; Medicare Part B (J9271) once approved; IO gross-to-net ~10-15% |
| Germany | G-BA / IQWiG | ~2027 (anticipated) | ~0.5 yr | CPS≥1 | Paclitaxel ± bevacizumab | AMNOG benefit assessment expected to weigh the modest PFS vs the OS gain in PD-L1+; net below list |
| Japan | PMDA / NHI | ~2027-28 (anticipated) | ~0.5 yr | CPS≥1 | Paclitaxel ± bevacizumab | NHI-listed once approved; biennial NHI price cuts apply; strong ENGOT/Japanese gynae-onc participation |
| France | HAS | ~2027 (anticipated) | ~0.7 yr | CPS≥1 | Paclitaxel ± bevacizumab | Possible early-access (AAP) given unmet need; SMR/ASMR pending OS maturity |
| UK | NICE | ~2027-28 (anticipated) | ~1.5 yr | CPS≥1 | Paclitaxel ± bevacizumab | Cost-effectiveness scrutiny on a modest PFS gain; confidential PAS likely |
| Italy | AIFA | ~2027-28 (anticipated) | ~1.5 yr | CPS≥1 | Paclitaxel ± bevacizumab | Class H; managed entry + regional formulary lag |
| Spain | SEFH / MoH | ~2028 (anticipated) | ~2 yr | CPS≥1 | Paclitaxel ± bevacizumab | Financing decision + 17-region formulary lag |
| China | NMPA / NRDL | ~2028+ (anticipated) | ~1.5 yr | CPS≥1 | Paclitaxel ± bevacizumab / domestic PD-1 | NMPA filing likely lags West; competes with cheaper domestic PD-1s if listed; NRDL negotiation would set a low net price |
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.
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.