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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the 1L metastatic NSCLC indication only (KEYNOTE-024/-189/-407, driver-negative), not the perioperative (KEYNOTE-671), 2L, or non-lung Keytruda settings. See all Keytruda indications →
berahyaluronidase alfa co-formulation
Shared model · 2 pages
2026 net revenue · modelled 1L-NSCLC slice
$13.62B
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Whole modelled scope (1L metastatic NSCLC), not this setting alone
No model change since the 20 Sep 2026 snapshot.
The 15-second read
This is the largest single line in the platform, $13.62B modelled for 2026 and roughly 43% of the FY2025 Keytruda franchise, and it is a defense case rather than a growth case. The competitive layer is already settled and modelled flat: pembrolizumab holds 62% of the US addressable 1L-IO pool unchanged from 2022 through 2027, with nivolumab+ipilimumab frozen at 8% of that pool and atezolizumab at 5% of it, so what takes the line from $13.45B (2027) to $6.63B (2031) is biosimilars, not rivals. Subcutaneous Keytruda Qlex is the only defense in the model and it has no share lever of its own; it is folded inside the branded line as the reason biosimilars stop at 55% of the branded molecule slot instead of the 40-60% of volume within twelve months the mAb precedent implies. The honest read is that the entire shape of this curve is a bet on SC conversion, priced before any conversion evidence exists. A risk this model does not price sits outside that bet: ivonescimab (Summit/Akeso) already beat pembrolizumab head-to-head in China's HARMONi-2, and a matching result from Summit's global, still-recruiting HARMONi-3 trial followed by US approval would put the flat 62% US share at risk years before biosimilars are the story.
Threats land:US biosimilars launch on schedule in 2028 and take the mAb-precedent 40-60% of volume within twelve months while SC Qlex conversion lags, pulling the line below the modelled $8.75B in 2029. A second, independent bear case: HARMONi-3 reads out with a statistically significant OS benefit for ivonescimab and it wins US approval, which would erode the 62% US 1L-IO share this model holds flat through 2027 well before any biosimilar erosion begins.
Modelled path:Biosimilars enter ~2028 in the US and ~2031 in the EU (Merck FY2025 Form 10-K patent table) and settle at the modelled 55% of the branded molecule slot with SC Qlex holding the remainder, landing the line near $6.63B by 2031.
Levers land:SC Qlex conversion locks in administration share ahead of IV biosimilars and China branded penetration runs at the top of the model's stated 0.35-0.55 band, holding the line above the modelled $7.43B in 2030.
~$7.6B, about 56% of the modelled 2026 total, is the US line, and the model has biosimilars taking 55% of that branded molecule slot from ~2028, so roughly $4B of it is the genuinely contested slice. An Ormeval scoping estimate, not a company disclosure.
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.
1L metastatic NSCLC is the keystone of the Keytruda franchise: at ~$13.5B modelled peak it is ~35-45% of total Keytruda revenue and the largest indication inside a franchise Merck reports at $31,680M of Keytruda and Keytruda Qlex sales in CY2025, +7% (Merck FY2025 Form 10-K). It set the template (chemo-IO and PD-L1-selected monotherapy) that every subsequent 1L solid-tumour IO program follows. Strategically it is now a defense story: with the US composition-of-matter patent expiring ~2028, this is the single largest revenue line exposed to biosimilar erosion, and the subcutaneous Keytruda Qlex reformulation (approved Sep 2025) is Merck's principal lifecycle lever to retain volume past LOE.
Metastatic NSCLC without EGFR/ALK drivers, roughly half of NSCLC at diagnosis, minus the ~15% (West) to ~50% (East Asia) driver-positive who get TKIs, is the largest 1L immuno-oncology setting. Pembrolizumab ± chemotherapy (KEYNOTE-024 PD-L1≥50% mono; KEYNOTE-189 nonsquamous+chemo; KEYNOTE-407 squamous+chemo) is the dominant standard of care, with durable 5-yr survival (KN-189 OS HR 0.60; KN-407 HR 0.71; KN-024 HR 0.62). It is the flagship Keytruda indication (~35-45% of the franchise) and the principal asset exposed to the ~2028 US biologic LOE.
Metastatic NSCLC is incurable Stage IV disease (~50% of NSCLC at diagnosis) managed with palliative systemic therapy. Treatment first bifurcates on molecular testing: EGFR/ALK/ROS1-driver-positive tumours (~15% of NSCLC in the West, ~45-50% in East Asia) go to targeted TKIs, NOT immunotherapy. The driver-NEGATIVE remainder is the 1L-IO setting, sub-stratified by PD-L1 (TPS ≥50% → pembrolizumab monotherapy is an option; <50% → pembrolizumab + chemotherapy) and by histology (squamous vs nonsquamous chemo backbone). Across the 8 modelled markets ~300,000 patients/year are 1L-IO-eligible, the pool this model sizes, with the US and China the largest blocks (China's enormous incidence offset by lower access).
The KEYNOTE-024/-189/-407 program made pembrolizumab the global first-line standard for metastatic NSCLC without actionable driver mutations and built the largest single Keytruda indication. KEYNOTE-024 (PD-L1 ≥50% monotherapy) first beat chemotherapy on survival in 2016; KEYNOTE-189 (nonsquamous + chemo) and KEYNOTE-407 (squamous + chemo) then extended the benefit to PD-L1-unselected patients in 2018. Five-year updates confirm durable, practice-defining survival gains (KN-189 OS HR 0.60; KN-407 HR 0.71; KN-024 HR 0.62), anchoring ~35-45% of the Keytruda franchise.
Mandatory at diagnosis: EGFR/ALK (and broader NGS) plus PD-L1 IHC. Driver-positive patients are routed to TKIs and excluded from the IO pool; PD-L1 then selects monotherapy (≥50%) vs chemo-IO. Testing-completeness gaps (largest in China's lower tiers) are the main pre-treatment funnel leak.
Three pivotal randomized Phase 3 trials defining 1L metastatic NSCLC: KEYNOTE-024 (n=305; PD-L1 TPS ≥50%; pembrolizumab monotherapy vs platinum-doublet chemo), KEYNOTE-189 (n=616; nonsquamous, all-PD-L1; pembrolizumab + pemetrexed/platinum vs chemo + placebo, 2:1), KEYNOTE-407 (n=559; squamous, all-PD-L1; pembrolizumab + carboplatin + paclitaxel/nab-paclitaxel vs chemo + placebo). EGFR/ALK-positive patients excluded; pembrolizumab 200 mg q3w for up to 35 cycles.
Load-bearing 6/7 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
First-line metastatic non-small-cell lung cancer without EGFR/ALK driver alterations, pembrolizumab ± platinum-doublet chemotherapy by histology and PD-L1 (KEYNOTE-189 nonsquamous + pemetrexed/platinum; KEYNOTE-407 squamous + carboplatin/taxane; KEYNOTE-024 PD-L1 TPS ≥50% monotherapy). All three regimens are modelled within the single branded Keytruda line.
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.
$13.6B
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $13.8B · launch 2016 → 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 1L-NSCLC slice rises every year from the 2016 KN-024 launch, ~$1.3B (2016, partial) → ~$10B (2020) → ~$13.2B (2022) → a ~$13.5B plateau across 2024-2027, tracking the franchise's real climb rather than peaking mid-decade. At peak the 1L-NSCLC slice (KN-024 mono + KN-189/-407 chemo-IO) ≈ $13.5B ≈ ~43% of the FY2025 franchise, the single largest indication block, consistent with 1L NSCLC being widely cited as ~35-45% of Keytruda sales. The slice then erodes sharply from ~2028 as the US composition-of-matter patent expires and pembrolizumab biosimilars enter (EU ~2031), partly defended by SC Qlex conversion, falling toward ~$5-6bn by the mid-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 headline rests on four Ormeval estimates, all visible and editable in the funnel below: the EGFR/ALK driver carve-out that sizes the IO pool (~15-20% of NSCLC in the West, ~45-50% of NSCLC in Japan and China), the ~$180k/yr US net price before 2029, China branded penetration set at 0.45 against a stated 0.35-0.55 band, and, softest of all, the 55% biosimilar ceiling on the branded molecule slot that decides the whole post-2028 curve. From 2029 the US net price steps down to $122,000/yr: Merck's FY2025 Form 10-K states Keytruda is expected to be selected for Medicare price setting in 2027, with the negotiated price effective 1 January 2029, and this model applies a -25% Ormeval assumption against the ~$163k it otherwise reaches that year as a stand-in, since no maximum fair price has been published.
The decline is defended, not certain
The fall from $13.45B (2027) to $6.63B (2031) is a modelled biosimilar erosion, not a reported one: US composition-of-matter expiry ~2028 and EU ~2031 (Merck FY2025 Form 10-K patent table) are priced as gradual share loss rather than an overnight cliff, with SC Qlex conversion assumed inside the branded line. No pembrolizumab biosimilar has launched anywhere, so the shape is defended but unproven.
What would change our mind
The base case is wrong if the first US pembrolizumab biosimilar launches in 2028 and branded volume falls faster than the model's first-year step, which takes only 12 points off the branded share of the US 1L-IO pool (62% of that pool down to 50% of it) and 12% off total revenue: anything near the 40-60% of volume the mAb precedent implies makes both $11.64B (2028) and $8.75B (2029) too high. The mirror test is equally dated: if no pembrolizumab biosimilar is FDA-approved by end-2028, the entire curve is a year early and 2029-2031 are understated. A second, dated test: if HARMONi-3 reports a statistically significant OS benefit, the flat 62% US share is wrong from the approval year onward.
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/FLAURA 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%, adenocarcinoma-dominant); Germany lowest (~78%). Same basis as the PACIFIC/FLAURA models. | ||||||||||
| × Advanced/metastatic (1L-eligible)est | 55% | 55% | 55% | 55% | 55% | 53% | 50% | 50% | share, not summed | SEER · LUCAEUROPE · TTR |
Stage IV at diagnosis + advanced IIIB not for curative chemoradiation, the front-line systemic-eligible fraction. Roughly half of NSCLC presents advanced/metastatic. Western markets ~0.53-0.55 (SEER 51% Stage IV plus 1L-eligible IIIB). Japan/China registry Stage-IV figures are surgery-weighted and understate the true fraction, overridden to a ~0.50 developed-market proxy (same basis as FLAURA). The biggest cross-market estimate in this model. | ||||||||||
| × EGFR/ALK/ROS1-negativeest | 82% | 85% | 85% | 82% | 80% | 85% | 55% | 52% | share, not summed | IFCT · PIONEER · Zhang |
Excludes EGFR/ALK/ROS1-driver-positive tumours, which are routed to targeted TKIs, not immunotherapy. THE pool's geographic swing factor. SIMPLIFICATION: rarer actionable drivers (BRAF, MET, RET, KRAS G12C, NTRK, HER2), each a low single-digit % of NSCLC, are not separately carved out and stay inside this IO-eligible pool. The dominant geographic driver of the IO-eligible pool. Actionable-driver prevalence (EGFR ex19/L858R + ALK + ROS1) is ~15-20% of NSCLC in Western markets (so ~80-85% driver-negative → IO) but ~45-50% in Japan/China (so only ~52-55% driver-negative). This carve-out shrinks the East-Asian IO pool sharply, the mirror image of the FLAURA EGFR gate. Other actionable drivers (BRAF, MET exon 14, RET, KRAS G12C, NTRK, HER2), individually ~1-4% of NSCLC each, are not modelled separately and remain in the IO-eligible pool, slightly overstating the true IO-eligible fraction. | ||||||||||
| × IO-eligible & 1L-systemic-treatedest | 80% | 80% | 80% | 76% | 76% | 78% | 82% | 55% | share, not summed | MYLUNG · ESMO audit |
Biomarker-tested (PD-L1/driver), fit for and receiving an IO-based 1L systemic regimen. Branded pembrolizumab UPTAKE of this reachable pool is the share row below (excluded here to avoid double-counting). Captures PD-L1/biomarker-testing completeness and fitness for IO-based 1L systemic therapy (excludes ~⅕-¼ who get chemo-only, best supportive care, or are untested/unfit). Near-complete in Western academic systems and Japan (~0.76-0.82); markedly lower in China (~0.55, testing and oncology access concentrated in tier-1/2 cities, large rural under-treatment). Excludes pembrolizumab UPTAKE, which is the competitive share layer below. | ||||||||||
| = Addressable 1L IO pool | 71k | 16k | 18k | 13k | 8.6k | 15k | 29k | 132k | 302k | computed |
Incidence × the rates above, driver-negative metastatic NSCLC patients reachable for 1L IO-based therapy this year. The 1L metastatic IO pool is broadly stable into the mid-2020s, gated by stage and driver prevalence, with rising biomarker-testing access roughly offsetting incidence drift, then erodes slowly from ~2028 as perioperative/neoadjuvant IO (KEYNOTE-671-type) diverts some resectable patients to earlier-stage treatment and LDCT screening shifts diagnoses earlier. Modelled as a low single-digit %/yr Western headwind; East Asia (metastatic-at-dx-dominated) erodes slower. | ||||||||||
| × Keytruda uptake (branded) | 62% | 62% | 63% | 61% | 61% | 62% | 59% | 28% | 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 | 44k | 10k | 12k | 7.9k | 5.2k | 9.4k | 17k | 37k | 142k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $173K | $86K | $91K | $82K | $77K | $85K | $72K | $29K | per patient, not summed | ASP · HTA · PAP |
Until-progression IO: per-patient revenue is the annual net cost while on-drug (a prevalent patient generates ~a year of revenue per forecast year, matching the incident-pool × annual-net structure used in PACIFIC/FLAURA). US ASP (CMS J9271) ≈ $11.8k/200mg q3w (~$205k/yr at ASP) net of ~10-15% GTN → ~$180k/yr. EU nets ~$80-95k. Japan ~$75k (biennial NHI cuts). China self-pay, net of patient-assistance support (Keytruda is NOT NRDL-listed) → ~$30k/yr net, an Ormeval estimate. −2%/yr forward erosion (accelerates 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 | $7.57B | $883M | $1.06B | $643M | $400M | $792M | $1.21B | $1.06B | $13.6B | 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 metastatic NSCLC immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable 1L-IO pool (driver-negative metastatic NSCLC fit for first-line IO-based therapy). The branded-pembrolizumab line shows the launch ramp to 1L-IO dominance, then the ~2028 LOE biosimilar erosion; the gap below the top line is patients on competing IO regimens, chemo-only, or untreated. The branded pembrolizumab line, monotherapy (KN-024) plus chemo-IO (KN-189/-407), IV and SC Qlex, is the only line this model monetizes.
Share of the 302k-patient addressable 1L IO pool this regimen is modelled to treat, by year
Keytruda is modelled at 47% of this pool in 2026, peaking at 47% 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
Other IO (cemiplimab/durvalumab/domestic PD-1) holds the largest rival share in 2026, 7% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (30%), 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 (KN-024 mono 2016-17, KN-189/-407 combo 2018, China combo 2019, self-pay, not NRDL-listed); nivolumab+ipilimumab (CheckMate-227/9LA) and atezolizumab/cemiplimab/durvalumab take in-class share; domestic Chinese PD-1s take China-only share; pembrolizumab biosimilars timed to the ~2028 US / ~2031 EU composition-of-matter 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.
Merck expects Keytruda to be picked for Medicare price setting in 2027 with the price effective January 2029 (FY2025 Form 10-K)
Summit's global Phase 3 of ivonescimab + chemo vs pembrolizumab + chemo (NCT05899608); Recruiting per CT.gov, primary completion estimated Dec 2028. A positive OS readout followed by US approval would be the first challenge to the 62% US 1L-IO share this model holds flat
Composition-of-matter expiry (~2028); pembrolizumab biosimilars erode the franchise's single largest revenue line (mAb precedent: 40-60% volume loss in 12 months)
EU biosimilar entry (Merck FY2025 Form 10-K patent table); SC Qlex conversion mitigates IV-biosimilar share loss
TIGIT/LAG-3/bispecific and ADC-partner 1L readouts could intensify or challenge the pembrolizumab-based standard
✓ = 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 on pembrolizumab-based 1L therapy, most metastatic-NSCLC patients still die within a few years, 5-yr OS is ~19% (KN-189 chemo-IO), ~18% (KN-407 squamous), and ~32% (KN-024 PD-L1≥50% mono). PD-L1-low/negative patients benefit least, primary and acquired IO resistance is near-universal, and there is no established post-IO standard. That residual mortality is why the setting still attracts intensive development (next-gen IO combinations, bispecifics, ADCs, and TIGIT/LAG-3 partners) despite pembrolizumab's entrenched dominance.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (1L metastatic NSCLC)
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; chemo-sparing (227) and chemo-light (9LA), the principal differentiated IO alternative to pembrolizumab | not in the record | not in the record | CheckMate-227 (NEJM 2019) / 9LA |
| Atezolizumab (Tecentriq) (Live threat) | Roche / Genentech | Live threatwhyApproved 1L for PD-L1-high monotherapy and chemo-IO niches; SC formulation adds a convenience play | not in the record | not in the record | IMpower110 / IMpower150 |
| Cemiplimab (Libtayo) (Live threat) | Regeneron / Sanofi | Live threatwhyApproved 1L PD-L1-high mono and chemo-IO, a smaller direct PD-1 competitor | not in the record | not in the record | EMPOWER-Lung-1 / POSEIDON / NMPA |
| Durvalumab + tremelimumab (POSEIDON) (Watch) | AstraZeneca | WatchwhyApproved 1L chemo-IO option; modest share of the setting | not in the record | not in the record | EMPOWER-Lung-1 / POSEIDON / NMPA |
| Ivonescimab (Live threat) | Summit Therapeutics / Akeso | Live threatwhyHARMONi-2 (China, NMPA-approved) beat pembrolizumab monotherapy on PFS (HR 0.51, Lancet 2024) and, per a late-breaking analysis at WCLC 2026, on overall survival (30.8 vs 22.6 mo, HR 0.73, P=0.009). HARMONi-3, Summit's global trial vs pembrolizumab + chemo (NCT05899608), is Recruiting per CT.gov with an estimated primary completion of Dec 2028 and no readout yet. Ivonescimab carries no FDA approval. | not in the record | not in the record | HARMONi-2, ivonescimab vs pembrolizumab, 1L PD-L1+ NSCLC (Zhou, Lancet 2024) |
| Domestic Chinese PD-1s (sintilimab/camrelizumab/tislelizumab) (China rival) | Innovent / Hengrui / BeiGene | China rivalwhyNRDL-listed, far cheaper, structural China 1L share loss for branded Keytruda | not in the record | not in the record | EMPOWER-Lung-1 / POSEIDON / NMPA |
| 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, - | -107 (after) | - |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2031 (Merck FY2025 Form 10-K patent table), steep erosion of the largest line (mAb precedent 40-60% volume loss in 12 months) | 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), continued until progression or 35 cycles (~2-year cap), so per-patient revenue is the annual net cost while on-drug, not a fixed course. US ASP (CMS J9271) is ~$11.8k per 200 mg dose (~$205k/yr at ASP); net prices below are per-market, net of country discounts.
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.
These markets do not erode smoothly. On the dates below the modelled net price steps to a new level, and the funnel uses that level from that year forward.
Pembrolizumab is dosed 200 mg every 3 weeks (or 400 mg q6w) IV, or as subcutaneous Qlex (FDA Sep 2025), continued until progression or a 35-cycle (~2-year) cap, so per-patient revenue is modelled as the annual net cost while on treatment (the incident-pool × annual-net structure captures ~one patient-year of revenue per forecast year, as in PACIFIC/FLAURA). US ASP (CMS J9271) ≈ $11,795/200 mg q3w (~$205k/yr at ASP) ⇒ ~$180k/yr net after ~10-15% physician-administered-biologic gross-to-net (lighter than oral-oncology GTN). EU nets are HTA-negotiated: Germany AMNOG ~$95k, France ~$90k, UK NICE confidential PAS ~$88k, Italy AIFA ~$85k, Spain ~$80k (lowest Western). Japan: NHI-listed with biennial price cuts → ~$75k/yr. China is the standout: Keytruda is NOT NRDL-listed (it failed the 2020 negotiation round and has stayed out since), so the ~$30k/yr net is an Ormeval estimate of the self-pay price net of Merck's patient-assistance-program support, far below Western levels, and competes with even cheaper NRDL-listed 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 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 | 24 Oct 2016 (KN-024); Aug/Oct 2018 (KN-189/-407) | reference | ≥50% mono; all-PD-L1 + chemo | Platinum chemo | Medicare Part B (J9271); broad commercial; ~10-15% gross-to-net on a physician-administered biologic |
| Germany | G-BA / IQWiG | 2017 (mono) → 2019 (combo) | ~0.5 yr | ≥50% mono; all + chemo | Platinum chemo | Reimbursed at launch; AMNOG net below list; densest EU access |
| Japan | PMDA / NHI | Feb 2017 (mono) → Dec 2018 (combo) | ~0.4 yr | ≥50% mono; all + chemo | Platinum chemo | NHI-listed; large driver carve-out (~45% EGFR/ALK+) shrinks the pool; biennial NHI price cuts |
| France | HAS | 2017 → 2019 | ~0.7 yr | ≥50% mono; all + chemo | Platinum chemo | ATU early access then reimbursement; SMR important |
| UK | NICE TA531/TA557/TA683 | 2018-2020 | ~1.5 yr | ≥50% mono; all + chemo | Platinum chemo | Recommended via CDF then routine commissioning; confidential PAS |
| Italy | AIFA | 2018-2020 | ~1.5 yr | ≥50% mono; all + chemo | Platinum chemo | Class H; managed entry; +regional formulary lag |
| Spain | SEFH / MoH | 2018-2020 | ~2 yr | ≥50% mono; all + chemo | Platinum chemo | Financed 1L; +17-region formulary lag |
| China | NMPA | 2019 (combo 1L) | n/a (self-pay) | all + chemo | Platinum chemo / domestic PD-1 | NOT NRDL-listed: Keytruda failed the 2020 NRDL negotiation round and has stayed out of the list since, so patients self-pay (list price cut via Merck’s patient assistance program), while NRDL-listed domestic PD-1s (sintilimab, camrelizumab, tislelizumab) are far cheaper and reimbursed |
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.
Every material move on this page, newest first, the public fact, and what our model made of it.
What recently moved · last 90 days
Keytruda's 12-year BPCIA reference-product exclusivity expires (first licensure 4 Sep 2014)
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.