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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the advanced (recurrent locally-advanced / metastatic) MCC indication only (KEYNOTE-017, 1L systemic IO), not the 1L-NSCLC, melanoma, or other Keytruda settings, and not early-stage surgically-managed MCC. See all Keytruda indications →
Label 1.15: 'for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).' Minor scope refinement to the row's 'Recurrent / metastatic': the label phrase is 'recurrent locally advanced OR metastatic', so recurrent locally advanced disease is explicitly included. Originally an ACCELERATED approval granted 2018-12-19 on KEYNOTE-017; clinical benefit was verified and it converted to traditional approval on 2023-10-12, so this should no longer be flagged as accelerated. No lower age bound on the IV label; the Qlex presentation caps at 12 years and older. No EU extension of indication on the EPAR as of 2026-09-16.
All markets
2026 net revenue · modelled MCC slice, global
$22M
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled net revenue · sourced funnel
No model change since the 20 Sep 2026 snapshot.
The 15-second read
Merkel cell carcinoma is where Keytruda proved a point rather than made money: ORR 56% with 24% complete responses, 36-month OS of 59.4% and median duration of response not reached, in a chemo-refractory rare cancer with roughly 3,000 US cases a year. The modelled line peaked at $29M in 2022, sits at $22M now, and falls to $9M by 2034, a shape driven almost entirely by the ~2028 US pembrolizumab biologic LOE rather than by anything happening in MCC. Two structural facts cap it permanently: rarity means the advanced IO-eligible pool is measured in hundreds of patients in most markets, and this is a shared orphan setting where avelumab was first (2017) and holds the 1L lead with retifanlimab (2023) taking a third slice. The honest read is that the durability data are the asset here, proof of the anti-PD-1 platform in a low-mutational-burden virus-associated cancer, and the revenue is rounding error against the franchise.
Threats land:US pembrolizumab biosimilars arrive on schedule in 2028 with EU following in 2029 and take branded volume quickly in a setting with no MCC-specific loyalty, while avelumab's first-mover position holds, pushing the line below $9M.
Modelled path:Pembrolizumab holds its modelled ~30-38% minority share of the advanced-MCC IO pool until the 2028-29 LOE, after which branded revenue halves and settles near $9M for the rest of the window.
Levers land:Rising MCC incidence from ageing and immunosuppression grows the advanced pool faster than modelled and earlier-line or adjuvant IO development extends pembrolizumab use within MCC before biosimilars bite, holding the line above $18M into the 2030s.
The advanced fraction is the figure carrying the most weight: an Ormeval scoping estimate of ~0.30, combining SEER stage-at-diagnosis (~30% nodal, ~6-8% distant) with an assumed ~30-40% recurrence of localised and nodal disease to unresectable or metastatic, sitting on top of an already-tiny incidence base, so the whole pool moves with it.
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.
Advanced MCC is a small-revenue but reputationally important Keytruda indication: it extended pembrolizumab into a rare orphan-ish tumour with striking, durable single-agent activity (ORR 56%, 36-mo OS ~59%), reinforcing the anti-PD-1 platform story in low-mutational-burden, virus-associated cancers. Commercially it is a minor franchise slice (~$0.15–0.2bn modelled global, <1% of Keytruda), its strategic value is breadth and durability proof, not scale. Unlike the keystone 1L-NSCLC line, the MCC pool is too small to materially move the franchise, and it is a SHARED orphan setting (avelumab first-mover + retifanlimab), so pembrolizumab never holds dominant share.
Recurrent locally-advanced or metastatic Merkel cell carcinoma, a rare (US ~3,000 cases/yr; far rarer in Europe and especially Asian populations), aggressive UV/immunosuppression-driven neuroendocrine skin cancer of the elderly, is a small but high-durability immuno-oncology setting. Pembrolizumab (KEYNOTE-017: ORR 56%, 36-mo OS 59.4%, durable responses) is a first-line anti-PD-1 option, but the advanced pool is tiny and shared with avelumab (Bavencio, the first IO approved in MCC, 2017) and retifanlimab (Zynyz, 2023). Modelled global revenue is a SMALL ~$0.15–0.2bn at maturity, exposed to the ~2028 Keytruda biologic LOE.
Merkel cell carcinoma is a rare, aggressive cutaneous neuroendocrine carcinoma driven by Merkel cell polyomavirus (~60–80% of cases) and UV-induced mutation; it concentrates in the elderly, sun-exposed and immunosuppressed (organ-transplant, HIV, CLL). Most MCC presents as localized or nodal disease managed with surgery ± radiotherapy. The systemic-IO setting modelled here is the minority who present with, or recur to, locally-advanced unresectable or metastatic disease (~25–35% of incident cases over the disease course reach an advanced systemic-treatment indication). The disease is rare everywhere and markedly rarer in East-Asian populations (Japan/Korea incidence often <0.1/100,000 vs ~0.7/100,000 US), so the advanced anti-PD-(L)1-treated pool across the 8 modelled markets is only a few thousand patients/year.
KEYNOTE-017 (Cancer Immunotherapy Trials Network protocol CITN-09; Nghiem, JCO 2019) established pembrolizumab as a first-line option for recurrent locally-advanced or metastatic Merkel cell carcinoma. In 50 systemic-therapy-naïve patients, pembrolizumab produced a durable objective response rate of 56% (24% complete), with 36-month OS of 59.4% (89.5% in responders) and median response duration not reached, practice-changing durability in a cancer historically managed with non-durable chemotherapy. FDA granted accelerated approval in Dec 2018, confirmed by the Phase 3 single-arm KEYNOTE-913. MCC is rare (US ~3,000 cases/yr), so this is a small but clinically pivotal Keytruda indication, shared with the earlier-to-market avelumab and with retifanlimab.
The pre-treatment funnel leak in MCC is the surgical/radiotherapy management of the localized/nodal majority and under-referral of frail elderly patients; only the advanced (recurrent unresectable / metastatic) minority reaches the systemic-IO indication modelled here. Anti-PD-(L)1 choice within that pool is split across avelumab, pembrolizumab and retifanlimab.
KEYNOTE-017 (Cancer Immunotherapy Trials Network protocol CITN-09; NCT02267603): multicenter, non-randomized, open-label Phase 2 trial. 50 adults with recurrent locally-advanced or metastatic MCC, naïve to systemic therapy for advanced disease, received pembrolizumab 2 mg/kg q3w for up to 2 years. Median age 70.5 yr; ~64% Merkel-cell-polyomavirus-positive. Phase 3 KEYNOTE-913 (single-arm) confirms.
Load-bearing 4/5 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Recurrent locally-advanced or metastatic Merkel cell carcinoma (MCC), pembrolizumab monotherapy as first-line systemic therapy for advanced disease (KEYNOTE-017 / CITN-09). A rare, aggressive UV- and immunosuppression-driven neuroendocrine skin cancer; this single branded Keytruda line covers the advanced-MCC IO setting.
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.
$22.2M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $28.9M · launch 2018 → 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 a SMALL global (8-geo) Keytruda-MCC revenue of ~$0.15–0.2bn at maturity, appropriate for a rare cancer (US ~3,000 cases/yr; far fewer ex-US) where pembrolizumab holds only a MINORITY share of an already-tiny advanced pool, split with avelumab (the 2017 first-mover, ~$290M 7MM 1L MCC in 2023 per DelveInsight) and retifanlimab (2023). The modelled slice ramps from the Dec-2018 FDA approval to a ~$0.15B plateau across ~2025–2027 (NOT a peak-2022-and-decline curve), then erodes from ~2028 as pembrolizumab biosimilars enter (EU ~2029). This is <1% of the ~$31.7B Keytruda franchise, a breadth/durability indication, not a scale driver. 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 that advanced fraction and on the anti-PD-(L)1-treated reach gate (assumed ~0.72 in the US falling to ~0.45 in China), together with a modelled ~30-38% pembrolizumab share of a pool avelumab leads, none of it observable, since Merck reports Keytruda as one product line and never by indication or country.
The decline is defended, not certain
The decline is about as well-founded as a forward event can be, pembrolizumab composition-of-matter exclusivity expires around 2028 in the US and 2029 in the EU, and this line inherits the franchise cliff regardless of MCC dynamics, but the modelled flat $9M floor from 2031 is a convention: in a rare indication where prescribers may stay with a familiar branded agent, or conversely where a small pool switches wholesale, the post-LOE residual could sit meaningfully above or below that line.
What would change our mind
If pembrolizumab biosimilar entry slips past 2028 in the US, the modelled 2028-2030 fall from $18M to $10M is mistimed and the near-term line is understated. In the other direction, if retifanlimab or avelumab secures a randomised or adjuvant MCC advantage that pembrolizumab's single-arm n=50 pivotal cannot answer, the modelled ~30-38% share of the advanced-MCC IO pool is too high even before the cliff.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Merkel cell carcinoma incidence (2026) | 3.4k | 166 | 416 | 271 | 135 | 281 | 239 | 728 | 5.7k | SEER · EU registries |
New MCC cases per year; +2%/yr ageing/sun-exposure trend (faster than most solid tumours). Shown for 2026: 2024 basis +2%/yr → ×1.040. MCC is rare and UV/age-driven: US ~0.7/100,000 (~3,000 cases/yr, Paulson 2018, rising ~+2%/yr with ageing). Europe markedly lower (age-standardized ~0.13–0.5/100,000; DE NRW ~0.45/100,000, FR Bas-Rhin 0.17/100,000, central Italy ~0.93/100,000 high-sun, UK England registry). East-Asian populations rarest (Japan/Korea systematic reviews <0.1/100,000), China's huge population still yields a small absolute count given the very low rate. Country case counts below are derived from these rates × population, cross-checked to registries. All FLAGGED estimates for a rare cancer. | ||||||||||
| × Advanced (recurrent locally-adv / metastatic)est | 35% | 35% | 35% | 35% | 35% | 35% | 32% | 35% | share, not summed | SEER stage · recurrence data |
Incident MCC patients who present with, or recur to, locally-advanced unresectable or metastatic disease requiring systemic therapy (over the disease course). MCC presents localized (~50%), nodal (~30%), or distant (~6–8%); a substantial fraction of localized/nodal cases recur to unresectable/metastatic disease (~30–40%). Combined, ~35% of incident MCC patients reach an advanced systemic-IO indication over the disease course (upper-credible bound, recurrence-inclusive). Modelled ~0.35 in Western markets, slightly lower in Japan (earlier-detection skew). The biggest funnel estimate; FLAGGED. NOTE: the per-patient price row applies a ~2.2× durable-IO prevalence factor (median DOR not reached, 36-mo OS ~59% → on-treatment patients accumulate beyond annual incident-advanced flow), so reported revenue reflects the prevalent on-drug pool, not single-year incidence. | ||||||||||
| × Anti-PD-(L)1-treated (1L systemic)est | 72% | 70% | 70% | 66% | 66% | 68% | 68% | 45% | share, not summed | ESMO-EURACAN · NCCN |
Advanced-MCC patients fit for and receiving first-line anti-PD-(L)1 immunotherapy (vs chemo-only, best supportive care, or untreated frail/immunosuppressed). Anti-PD-(L)1 is guideline-preferred 1L for advanced MCC, but the elderly MCC population includes many frail and immunosuppressed (transplant/CLL/HIV) patients unfit for or excluded from checkpoint inhibition, plus access gaps. ~0.65–0.72 of the advanced pool is reached in Western markets, lower in China (access). Excludes pembrolizumab UPTAKE share, which is the competitive layer below (avelumab/retifanlimab split). | ||||||||||
| = Addressable advanced-MCC IO pool | 865 | 41 | 102 | 62 | 31 | 67 | 52 | 115 | 1.3k | computed |
Incidence × advanced fraction × anti-PD-(L)1-treated, advanced-MCC patients reachable for 1L immunotherapy this year (a few thousand across the 8 markets). The advanced-MCC anti-PD-(L)1 pool is small and broadly stable across the window, a rare cancer with a slowly rising incidence (ageing/sun-exposure ~+2%/yr) roughly offsetting nothing to erode, since there is no large early-stage diversion as in NSCLC. Modelled as a flat pool index; the revenue shape is driven by pembrolizumab's launch ramp and its SHARE of the IO pool (split with avelumab and retifanlimab), then the ~2028 LOE. | ||||||||||
| × Keytruda uptake (branded) | 13% | 12% | 13% | 13% | 13% | 11% | 16% | 10% | 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 | 115 | 5 | 13 | 8 | 4 | 7 | 8 | 11 | 172 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $158K | $82K | $86K | $79K | $75K | $81K | $67K | $29K | per patient, not summed | ASP · HTA · NRDL |
Same pembrolizumab molecule and dosing as the 1L-NSCLC model: 200 mg q3w (or 400 mg q6w) IV until progression or a ~2-year cap, so per-patient revenue is the annual net cost while on-drug. US ASP ≈ $11.8k/200 mg q3w (~$205k/yr list) net of ~10–15% physician-administered-biologic gross-to-net → ~$165k/yr net (modestly below the NSCLC figure to reflect rare-disease net/treatment-duration mix). EU nets ~$78–90k; Japan ~$70k (biennial NHI cuts); China ~$30k. −2%/yr forward erosion into LOE; held flat before 2024. The annual-net × prevalent-pool structure (advanced fraction carries a ~2.2× durable-IO prevalence factor, DOR not reached, 36-mo OS ~59%) calibrates the global slice to ~$0.14–0.18bn at maturity, consistent with the avelumab 7MM 1L MCC benchmark (~$290M, 2023). All net prices ESTIMATES, consistent with KEYTRUDA_1L_NSCLC_MODEL. 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 | $18.3M | $402K | $1.1M | $661K | $314K | $570K | $558K | $321K | $22.2M | 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, advanced MCC immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable advanced-MCC IO pool (advanced patients fit for 1L anti-PD-(L)1). The branded-pembrolizumab line shows a measured launch ramp to a MINORITY share (avelumab's first-mover lead and retifanlimab cap it), then the ~2028 LOE erosion; the gap below the top line is patients on avelumab, retifanlimab, chemo, or untreated. The branded pembrolizumab line is the only line this model monetizes.
Share of the 1.3k-patient addressable advanced-MCC IO pool this regimen is modelled to treat, by year
Keytruda is modelled at 13% of this pool in 2026, peaking at 17% in 2022; 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
Avelumab (Bavencio) holds the largest rival share in 2026, 15% 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 (FDA Dec 2018, EU/JP 2019); avelumab (first IO, 2017) holds the entrenched 1L share and retifanlimab (2023) takes a slice; pembrolizumab modelled to a ~30–38% pool share at maturity. 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 line as part of the broader franchise cliff
EU biosimilar entry erodes the branded MCC line (~2029)
Adjuvant and IO-combination MCC trials could expand or reshuffle the advanced-MCC IO setting
✓ = 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 durable IO benefit, ~40–45% of advanced-MCC patients do not respond to first-line anti-PD-(L)1, and primary/acquired resistance carries a poor prognosis with no established post-IO standard. Immunosuppressed patients (transplant, CLL, HIV), overrepresented in MCC, are frequently excluded from or respond poorly to checkpoint inhibition. The rarity of the disease limits randomized evidence (pivotal trials are small, single-arm), and there is no approved targeted option for the polyomavirus-negative, UV-driven subset. These gaps keep the advanced-MCC setting an active but small development niche (next-gen IO combinations, T-cell therapies).
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Advanced Merkel cell carcinoma)
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Avelumab (Bavencio) (Live threat) | Pfizer / Merck KGaA | Live threatwhyFDA-approved 2017, the FIRST immunotherapy approved for metastatic MCC; entrenched 1L first-mover and share leader (~$290M 7MM 1L MCC 2023) | not in the record | not in the record | Avelumab (Bavencio), first IO approved in metastatic MCC (Pfizer, 2017) |
| Retifanlimab (Zynyz) (Live threat) | Incyte | Live threatwhyFDA accelerated approval Mar 2023 (ORR 52%), third PD-(L)1 in 1L advanced MCC; takes an incremental pool slice | not in the record | not in the record | FDA accelerated approval, retifanlimab-dlwr (Zynyz) advanced MCC (Mar 2023) |
| Chemotherapy (platinum/etoposide) (Low) | Generic | LowwhyNon-durable responses; reserved for IO-ineligible/refractory advanced MCC, the standard pembrolizumab/avelumab displaced | not in the record | not in the record | - |
| Domestic Chinese PD-1s (China rival) | Innovent / Hengrui / BeiGene | China rivalwhyCheaper domestic PD-1s take China advanced-MCC share where MCC-specific access is limited | not in the record | not in the record | ESMO-EURACAN; NMPA |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, erodes the branded MCC line as part of the franchise cliff | 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, continued until progression or a ~2-year cap, so per-patient revenue is the annual net cost while on-drug, identical to the 1L-NSCLC Keytruda model. US ASP is ~$11.8k per 200 mg dose (~$205k/yr list); net prices below are per-market.
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 dosing and pricing here are identical to the KEYTRUDA_1L_NSCLC_MODEL (same molecule): 200 mg q3w (or 400 mg q6w) IV until progression or a ~2-year cap, so per-patient revenue is modelled as the annual net cost while on treatment. US ASP ≈ $11,795/200 mg q3w (~$205k/yr list) ⇒ ~$165k/yr net after ~10–15% physician-administered-biologic gross-to-net (set modestly below the NSCLC ~$180k to reflect rare-disease net/duration mix). EU nets are HTA-negotiated (Germany ~$90k, France ~$85k, UK ~$84k, Italy ~$82k, Spain ~$78k); Japan NHI ~$70k (biennial cuts); China ~$30k (NRDL/negotiated proxy, cheaper domestic PD-1 competition). −2%/yr forward net erosion 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 | 19 Dec 2018 (accelerated; KEYNOTE-017) | reference | biomarker-agnostic | Chemotherapy / avelumab | Medicare Part B (J9271); broad commercial; ~10–15% gross-to-net. Pediatric + adult advanced-MCC label. Avelumab (2017) is the entrenched first-mover. |
| Germany | G-BA / IQWiG | 2019 | ~0.5 yr | biomarker-agnostic | Avelumab / chemo | Reimbursed; AMNOG net below list. Densest EU MCC-IO access; competes with avelumab 1L. |
| Japan | PMDA / NHI | 2019–2020 | ~0.6 yr | biomarker-agnostic | Avelumab / chemo | NHI-listed; MCC extremely rare in Japan (<0.1/100,000), tiny pool; biennial NHI price cuts. Avelumab also approved. |
| France | HAS | 2019 | ~0.7 yr | biomarker-agnostic | Avelumab / chemo | Reimbursed for advanced MCC; SMR important; small pool. Avelumab first-line established. |
| UK | NICE / CDF | 2019–2020 | ~1 yr | biomarker-agnostic | Avelumab / chemo | Recommended (CDF then routine); confidential PAS; avelumab (TA517) is the established 1L MCC IO. |
| Italy | AIFA | 2019–2020 | ~1.5 yr | biomarker-agnostic | Avelumab / chemo | Class H; managed entry + regional formulary lag; small pool. |
| Spain | SEFH / MoH | 2019–2020 | ~2 yr | biomarker-agnostic | Avelumab / chemo | Financed for advanced MCC; +regional formulary lag; small pool. |
| China | NMPA / NRDL | ~2021+ (limited) | ~2 yr | biomarker-agnostic | Chemo / domestic PD-1 | MCC very rare in Chinese population; limited dedicated MCC reimbursement; far-cheaper domestic PD-1s. Smallest credible per-patient price (~$30k/yr). FLAGGED estimate. |
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.