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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the cervical-cancer indication only (KEYNOTE-826 advanced, KEYNOTE-A18 locally-advanced, KEYNOTE-158 2L mono), not the other Keytruda solid-tumour settings (NSCLC, melanoma, endometrial, etc.). See all Keytruda indications →
Both halves on label; since=2018 correct for the earlier of the two, date added. Label 1.12 carries the 2L single-agent indication ('recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >=1)'), first approved as an ACCELERATED approval on 2018-06-12 from KEYNOTE-158 and converted to traditional approval on 2021-10-13; and the 1L combination ('in combination with chemotherapy, with or without bevacizumab... persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS >=1)') from KEYNOTE-826, approved 2021-10-13. Scope point the row omits: BOTH halves require CPS >=1 - there is no PD-L1-unselected cervical indication. Neither is accelerated any longer.
Shared model · 2 pages
2026 net revenue · modelled cervical slice
$932M
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Whole modelled scope (Cervical cancer (advanced + locally-advanced)), not this setting alone
No model change since the 20 Sep 2026 snapshot.
The 15-second read
Pembrolizumab owns the advanced cervical-cancer continuum on the strength of KEYNOTE-826, OS HR 0.63 in PD-L1 CPS≥1, median survival 28.6 versus 16.5 months, with KEYNOTE-158 cohort E covering the smaller previously-treated slice at a modest ORR of 14.6%. Commercially this is a mid-size Keytruda indication, modelled at roughly 3-4% of a $31.68B FY2025 franchise, peaking at $1.02B in 2027 and then falling to $418M by 2034. The reason for the fall is not competitive: it is the molecule's own US composition-of-matter expiry around 2028 (EU ~2029), which hits every Keytruda indication at once. Beneath that, the advanced setting is the contested part of the franchise, atezolizumab plus bevacizumab and chemotherapy has positive Phase 3 data in 1L, tisotumab vedotin competes post-IO, and in China, the largest incidence base at roughly 150,000 cases a year, cheaper NRDL-listed domestic PD-1s take a real slice. The honest read: a strong clinical position in a mid-size, geographically awkward indication with a dated biosimilar clock running on it.
Threats land:Domestic Chinese PD-1s take more than the modelled ~30% of the China pool while the ~50% testing-and-access reach gate proves optimistic, and atezolizumab plus bevacizumab erodes 1L Western share, leaving the indication short of $1.02B even before biosimilars arrive in 2028.
Modelled path:The indication peaks at $1.02B in 2027 as advanced-setting uptake matures, then pembrolizumab biosimilars from ~2028 (US) and ~2029 (EU) drive gradual branded erosion through $786M in 2029 and $594M in 2030 to $418M by 2034.
Levers land:Subcutaneous Keytruda Qlex, approved September 2025, retains enough volume through the biosimilar wave on convenience grounds, and broader NRDL and emerging-market access lifts treated volume in the high-burden geographies faster than the modelled reach gate allows.
The China block: roughly 150,000 cases a year, but reduced by a ~50% testing-fit-and-treated reach gate and then capped at ~42% branded penetration against NRDL-listed domestic PD-1s at a ~$30k/yr net price. The model names China as its biggest judgement call, and every one of those three figures, reach, penetration, net price, is an Ormeval scoping estimate applied to the largest incidence pool in the indication.
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.
Cervical cancer extends Keytruda into a curative-intent gynaecologic-oncology setting and is a template for moving IO from metastatic into locally-advanced disease (KEYNOTE-A18 is the first PD-1 win added to chemoradiotherapy in this tumour). Commercially it is a mid-size franchise slice (~$1.0–1.3bn modelled peak, ~3–4% of Keytruda), but strategically it cements Merck's leadership in HPV-associated and women's cancers and creates a large new earlier-line volume pool (A18) just as later-line metastatic IO matures. It is also globally meaningful for access: cervical cancer's burden is concentrated in China and emerging markets, so the indication is central to Keytruda's ex-US and NRDL strategy.
Cervical cancer, overwhelmingly HPV-driven, a leading cancer of women in low/middle-income settings and the global hotspot in China (~150k cases/yr), is a mid-size but growing Keytruda indication. Pembrolizumab is now standard in 1L advanced disease (KEYNOTE-826 + chemo ± bevacizumab; OS HR 0.63 in CPS≥1) and, from 2024, in newly-diagnosed high-risk locally-advanced disease with chemoradiation (KEYNOTE-A18; PFS HR 0.70). KEYNOTE-158 monotherapy covers the smaller previously-treated PD-L1+ slice. The A18 expansion into the larger, earlier-stage population is the key forward growth driver; ~85–90% of patients are PD-L1 CPS≥1 and so on-label.
Cervical cancer is a near-uniformly HPV-driven malignancy of the cervix, stratified at diagnosis by FIGO stage. Early-stage disease (FIGO I–II) is treated surgically or with chemoradiation with curative intent and largely sits OUTSIDE the IO pool. The IO-relevant populations are: (1) newly-diagnosed high-risk LOCALLY-ADVANCED disease (FIGO III–IVA, node-positive IB2–IIB) treated with definitive chemoradiotherapy, the KEYNOTE-A18 setting added in 2024; and (2) PERSISTENT, RECURRENT or METASTATIC disease, the KEYNOTE-826 1L-advanced (chemo ± bevacizumab) and KEYNOTE-158 previously-treated (PD-L1 CPS≥1 monotherapy) settings. Incidence is heavily skewed to China (~150k/yr) and is far lower in HPV-vaccinated, well-screened Western markets (US ~13.8k/yr); the addressable IO pool is the locally-advanced + advanced/recurrent subset, ~85–90% of whom are PD-L1 CPS≥1.
The KEYNOTE-826/-A18/-158 program established pembrolizumab across the cervical-cancer continuum. KEYNOTE-158 cohort E first showed single-agent activity in previously-treated PD-L1+ disease (ORR ~14.6%), the basis for the 2018 US accelerated approval. KEYNOTE-826 (2021) then added pembrolizumab to chemotherapy ± bevacizumab in persistent/recurrent/metastatic disease and cut the risk of death by ~37% in CPS≥1 patients (OS HR 0.63), making chemo-IO the 1L advanced standard. KEYNOTE-A18 (2024) moved pembrolizumab earlier, into newly-diagnosed high-risk locally-advanced disease with chemoradiotherapy (PFS HR 0.70; OS HR 0.67), the first IO win in curative-intent cervical cancer and the larger pool that grows the indication from 2024.
PD-L1 (CPS by IHC 22C3) selects the 826/158 advanced-disease populations (~85–90% CPS≥1); FIGO stage selects the A18 locally-advanced curative-intent population. Early-stage surgical disease is outside the IO pool. Screening/testing completeness, lowest in China's lower tiers, is the main pre-treatment funnel leak.
Three pivotal trials across the cervical continuum. KEYNOTE-826 (n=617; persistent/recurrent/metastatic; pembrolizumab vs placebo added to paclitaxel + cisplatin/carboplatin ± bevacizumab; dual primary OS/PFS in CPS≥1, CPS≥10 and all-comers). KEYNOTE-A18 / ENGOT-cx11 (n=1060; newly-diagnosed high-risk FIGO 2014 III–IVA, or IB2–IIB node-positive; pembrolizumab vs placebo added to cisplatin-based chemoradiotherapy; primary PFS then OS). KEYNOTE-158 cohort E (previously-treated advanced cervical cancer, PD-L1 CPS≥1; pembrolizumab 200 mg q3w monotherapy; ORR primary), basis for the 2018 accelerated approval.
Load-bearing 5/6 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Pembrolizumab across the recurrent/advanced and locally-advanced cervical-cancer settings, KEYNOTE-826 (pembrolizumab + paclitaxel/platinum ± bevacizumab in persistent, recurrent or metastatic disease, 1L advanced), KEYNOTE-A18 (pembrolizumab + cisplatin-based chemoradiotherapy in newly-diagnosed, high-risk FIGO III–IVA locally-advanced disease), and KEYNOTE-158 cohort E (pembrolizumab monotherapy in previously-treated PD-L1 CPS≥1 advanced disease). 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.
$932M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $1.02B · launch 2021 → 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 the indication's growth SHAPE: the modelled cervical slice rises from the 2021 KN-826 launch, small in 2021-22, then STEPPING UP from 2024 as KEYNOTE-A18 adds the larger locally-advanced population, to a ~$1.1-1.2bn plateau by the late 2020s ≈ ~3-4% of the FY2025 franchise. This is a mid-size, GROWING indication (it does NOT peak in 2022 and decline, it grows as A18 enlarges the pool). 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. The 'today' marker splits modelled history from forecast. Forward revenue is MODEL-BASED, not reported or consensus.
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 the tested-fit-and-treated reach gate (~0.48 in China to ~0.80 in Japan) applied to cervical incidence, on branded penetration of the IO-relevant pool in each market, and on per-market net prices off a ~$11.8k per-200mg-dose US ASP, with no indication-level actuals anywhere, since Merck reports Keytruda as a single ~$31.68B franchise and this slice is a modelled 3-4% of it.
The decline is defended, not certain
The post-2027 decline is the pembrolizumab biosimilar wave rather than anything specific to cervical cancer, and as a biologic it is modelled as gradual share loss rather than an overnight cliff, a reasonable treatment, since biologic erosion is slower and more price-led than small-molecule genericisation. The uncertainty is depth: subcutaneous Qlex is a genuine administration-based defence that has no small-molecule analogue, and in chemoradiation and chemo-IO regimens where the PD-1 is one component of a complex protocol, switching may be slower than the modelled 59% fall from peak implies.
What would change our mind
The base case is wrong if pembrolizumab biosimilars do not reach the US market by end-2029, the entire descent from $1.02B to $418M is that one clock, and a delay would leave the branded curve years above the model. A separate falsifier that bites earlier and in the other direction: if atezolizumab plus bevacizumab and chemotherapy secures NCCN Category 1 preferred status alongside pembrolizumab in 1L advanced disease before 2028, the modelled branded share of the addressable cervical-IO pool is too high in exactly the years the curve is meant to be peaking.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cervical cancer incidence | 14k | 3.2k | 4.6k | 2.4k | 1.9k | 3.2k | 11k | 151k | 191k | GLOBOCAN 2022 / SEER |
New cervical-cancer cases per year; slow long-run decline (HPV vaccination + screening) folded into the pool trajectory rather than this base. Country-specific GLOBOCAN 2022 cervical-cancer incidence, cross-checked to national registries. China is the world's largest single incidence base (~150k/yr); Western markets are far lower (US ~13.8k/yr) thanks to screening and HPV vaccination. Long-run incidence decline is captured in the pool trajectory, so the base incidence is held flat (cagr 0). | ||||||||||
| × IO-relevant stage (locally-advanced + advanced/recurrent)est | 42% | 42% | 42% | 42% | 42% | 42% | 46% | 48% | share, not summed | SEER · FIGO · registries |
FIGO III–IVA locally-advanced (KEYNOTE-A18 + chemoradiation) PLUS persistent/recurrent/metastatic disease (KEYNOTE-826 1L advanced + KEYNOTE-158 2L). Excludes early-stage surgical disease, which is outside the IO pool. Combines the locally-advanced curative-intent pool (FIGO III–IVA newly diagnosed, KN-A18) with the advanced/recurrent/metastatic pool (KN-826 + KN-158, including recurrences of earlier-stage disease). Roughly half of incident cases ultimately enter an IO-relevant setting in well-resourced markets. China/Japan present at later stage (more locally-advanced/advanced at diagnosis), modestly raising the share; the A18 expansion (2024) is what activates the locally-advanced portion of this rate. | ||||||||||
| × PD-L1 CPS≥1 (on-label)est | 88% | 88% | 88% | 88% | 88% | 88% | 88% | 88% | share, not summed | KEYNOTE-826 / -158 CPS |
PD-L1 combined positive score ≥1 by IHC 22C3, the label criterion for the KEYNOTE-826 and KEYNOTE-158 advanced-disease regimens (~85–90% of cervical patients). KEYNOTE-A18 (locally-advanced + CRT) is all-comers, but the blended pool rate is held at the CPS≥1 prevalence. ~85–90% of cervical cancers are PD-L1 CPS≥1, the on-label population for the advanced-disease pembrolizumab regimens (826/158). The locally-advanced A18 label is all-comers, so this gate is mildly conservative for that slice, but the ~0.88 blended rate is applied across the pool for consistency. Roughly uniform across markets. | ||||||||||
| × Tested, fit & systemically/CRT-treatedest | 78% | 78% | 78% | 74% | 74% | 76% | 80% | 48% | share, not summed | testing audits · access |
Biomarker-tested (PD-L1), fit for and receiving a pembrolizumab-eligible regimen (chemo ± bev, or chemoradiation). Branded pembrolizumab UPTAKE of this reachable pool is the share row below (excluded here to avoid double-counting). Captures PD-L1-testing completeness and fitness for an IO-eligible regimen (excludes untested, unfit, best-supportive-care and access-gapped patients). High in Western academic systems and Japan (~0.74–0.80); markedly lower in China (~0.48, testing and gynaecologic-oncology access concentrated in tier-1/2 cities, large rural under-treatment). Excludes pembrolizumab UPTAKE, the competitive share layer below. | ||||||||||
| = Addressable cervical-IO pool | 4.4k | 1.0k | 1.5k | 725 | 587 | 988 | 3.9k | 37k | 50k | computed |
Incidence × the rates above, IO-relevant (locally-advanced + advanced/recurrent), PD-L1 CPS≥1, tested-and-treated cervical-cancer patients reachable for a pembrolizumab-based regimen this year. The addressable cervical-IO pool STEPS UP from 2024 as KEYNOTE-A18 (FDA Jan 2024) adds the larger newly-diagnosed locally-advanced (FIGO III–IVA + chemoradiation) population on top of the KEYNOTE-826 advanced/recurrent and KEYNOTE-158 2L base. Western incidence drifts slowly down with HPV vaccination + screening, but the A18 expansion more than offsets that into the late 2020s before the pool plateaus. China's huge incidence base and broadening NRDL/oncology access ramp the pool more steeply. Indexed to base year 2024 = 1.0. | ||||||||||
| × Keytruda uptake (branded) | 53% | 46% | 46% | 37% | 37% | 45% | 46% | 21% | 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 | 2.3k | 457 | 672 | 266 | 215 | 444 | 1.8k | 7.8k | 14k | 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 · NRDL |
Same molecule and per-patient economics as the rest of Keytruda: per-patient revenue is the annual net cost while on-drug (a treated patient generates ~a year of revenue per forecast year, matching the incident-pool × annual-net structure used in the NSCLC/PACIFIC models). US ASP ≈ $11.8k/200mg q3w (~$205k/yr list) net of ~10-15% physician-administered-biologic gross-to-net → ~$180k/yr. EU nets ~$80-95k. Japan ~$75k (cumulative biennial NHI cuts). China NRDL-negotiated → ~$30k/yr net. −2%/yr forward erosion (price compression 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 | $401M | $39.5M | $61.3M | $21.7M | $16.5M | $37.5M | $130M | $224M | $932M | 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, cervical-cancer immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable cervical-IO pool (IO-relevant, PD-L1 CPS≥1, treated cervical-cancer patients). The branded-pembrolizumab line shows the launch ramp from 2021, the A18 step-up from 2024, then the ~2028 LOE biosimilar erosion; the gap below the top line is patients on competing IO/ADC regimens, chemo-only, or untreated. The branded pembrolizumab line, 826 chemo-IO, A18 chemoradiation-IO and 158 monotherapy, IV and SC Qlex, is the only line this model monetizes.
Share of the 50k-patient addressable cervical-IO pool this regimen is modelled to treat, by year
Keytruda is modelled at 28% of this pool in 2026, peaking at 31% in 2027; 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 (domestic PD-1 / cemiplimab) holds the largest rival share in 2026, 8% 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 (KN-158 mono 2018, KN-826 advanced 2021, KN-A18 locally-advanced 2024, China 2022/NRDL). Atezolizumab+bev (BEATcc), tisotumab vedotin (Tivdak), and domestic Chinese PD-1s take in-class/post-IO share; pembrolizumab biosimilars timed to the ~2028 US / ~2029 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.
Pembrolizumab composition-of-matter expiry (~2028); biosimilars erode the branded molecule across all indications including cervical
EU biosimilar entry; SC Qlex conversion partly defends IV-biosimilar share loss
Tisotumab vedotin (Tivdak) and atezolizumab-based regimens (BEATcc) compete in advanced cervical cancer post- or alongside pembrolizumab
✓ = 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, advanced/recurrent cervical cancer remains largely incurable, KEYNOTE-826 median OS is ~28.6 months in CPS≥1 and most patients ultimately progress. PD-L1-low/negative patients (~10–15%) derive little benefit and have no IO option; previously-treated monotherapy response is modest (ORR ~15%). In locally-advanced disease, KEYNOTE-A18 improves PFS/OS but a substantial minority still relapse. Antibody–drug conjugates (tisotumab vedotin) and next-generation combinations are pursued precisely because this residual mortality, concentrated in under-screened, under-vaccinated populations, keeps the setting an area of high unmet need.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Cervical cancer (advanced + locally-advanced))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Atezolizumab + bevacizumab/chemo (Live threat) | Roche / Genentech | Live threatwhyPositive Phase 3 (OS/PFS benefit, Lancet 2024), the principal differentiated IO alternative to pembrolizumab in 1L advanced cervical cancer | not in the record | not in the record | BEATcc, atezolizumab + bev/chemo, 1L advanced cervical (Oaknin, Lancet 2024) |
| Tisotumab vedotin (Tivdak) (Live threat) | Pfizer / Genmab | Live threatwhyApproved recurrent/metastatic cervical cancer after prior systemic therapy, the principal post-IO competitor (different mechanism) | not in the record | not in the record | innovaTV-301 |
| Cemiplimab (Libtayo) (Watch) | Regeneron / Sanofi | WatchwhyPositive Phase 3 in previously-treated cervical cancer, a smaller direct PD-1 competitor in later lines | not in the record | not in the record | EMPOWER-Cervical-1 / NMPA |
| Domestic Chinese PD-1s (sintilimab/camrelizumab/tislelizumab) (China rival) | Innovent / Hengrui / BeiGene | China rivalwhyNRDL-listed, far cheaper, structural China cervical share loss for branded Keytruda | not in the record | not in the record | EMPOWER-Cervical-1 / 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, - | -87 (after) | - |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, steep erosion of the branded molecule across all indications including cervical | 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 chemo ± bevacizumab (KN-826), with chemoradiation (KN-A18), or as monotherapy (KN-158). Per-patient revenue is the annual net cost while on-drug. US ASP is ~$11.8k per 200 mg dose (~$205k/yr list); net prices below are per-market, net of country discounts. The same per-patient net price applies as in the other Keytruda indications (same molecule).
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). In cervical cancer it is given with paclitaxel + platinum ± bevacizumab (KN-826) or with cisplatin-based chemoradiotherapy (KN-A18), the A18 regimen is a fixed ~2-year course, while the 826/158 advanced regimens continue until progression or a 35-cycle (~2-year) cap. 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 the NSCLC/PACIFIC models). US ASP ≈ $11,795/200 mg q3w (~$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 confidential PAS ~$88k, Italy AIFA ~$85k, Spain ~$80k (lowest Western). Japan: NHI-listed with biennial price cuts → ~$75k/yr. China is the standout, the NRDL-negotiated price is far below Western levels (~$30k/yr net) and competes 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 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 | 13 Oct 2021 (KN-826, CPS≥1); 12 Jan 2024 (KN-A18, locally-advanced); Jun 2018 (KN-158 mono, accelerated) | reference | CPS≥1 (826/158); all (A18 + CRT) | Chemo ± bevacizumab / CRT | Medicare Part B (J9271); broad commercial; ~10-15% gross-to-net on a physician-administered biologic. List ~$200k/yr; ~$180k/yr net. |
| Germany | G-BA / IQWiG | 2022 (826) → 2024 (A18) | ~0.4 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | Reimbursed shortly after EC approval; AMNOG net below list (~$95k/yr); densest EU access |
| Japan | PMDA / NHI | 2022 (826) → 2024 (A18) | ~0.5 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | NHI-listed; biennial NHI price cuts → ~$75k/yr net; cervical incidence higher than the West (lower historical vaccination) |
| France | HAS | 2022 → 2024 | ~0.6 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | Early access then reimbursement; SMR important; net ~$90k/yr |
| UK | NICE TA779 (826) + locally-advanced appraisal | 2022 → 2024-25 | ~1.2 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | Recommended (CDF then routine); confidential PAS; net ~$88k/yr |
| Italy | AIFA | 2022-23 → 2024-25 | ~1.5 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | Class H; managed entry + regional formulary lag; net ~$85k/yr |
| Spain | SEFH / MoH | 2022-23 → 2025 | ~2 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT | Financed advanced/locally-advanced; +17-region formulary lag; net ~$80k/yr (lowest Western) |
| China | NMPA / NRDL | 2022 (826 advanced); NRDL listing thereafter | ~1.5 yr | CPS≥1 / all (A18) | Chemo ± bev / CRT / domestic PD-1 | NRDL-reimbursed but competes with far-cheaper NRDL-listed domestic PD-1s; the world's largest cervical-cancer incidence base (~150k/yr). Net ~$30k/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.