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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the R/R PMBCL pembrolizumab indication only (KEYNOTE-170; refractory or relapsed after >=2 prior lines), DISTINCT from the R/R classical Hodgkin lymphoma Keytruda indication (KEYNOTE-087/-204) and from ALL solid-tumour Keytruda settings (1L NSCLC, melanoma, HCC, etc.). PMBCL is a rare DLBCL subtype, not Hodgkin lymphoma. See all Keytruda indications →
Label 1.6: 'for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.' Approved 2018-06-13 on KEYNOTE-170 as an ACCELERATED approval; clinical benefit was verified and it converted to traditional approval on 2020-10-14, so it should no longer be flagged as accelerated. Two gates for modelling: relapsed patients need 2 or more prior lines, and the label carries an explicit Limitation of Use - 'KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.' Not carried on the Qlex subcutaneous label. No EU extension of indication on the EPAR as of 2026-09-16.
All markets
2026 net revenue · modelled
$24M
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
R/R PMBCL is the rarest kind of good outcome: a young-skewed lymphoma with near-universal 9p24.1 amplification overexpressing PD-L1 and PD-L2, which is why pembrolizumab produced an ORR of ~45% with median duration of response not reached and roughly 80% of responders still in response at 48 months. Those durable young responders are also the economics, realized per-patient exposure runs to the 24-month cap, giving a modelled ~$185k US net. But the pool is squeezed from both ends: PMBCL is ~7% of DLBCL and mostly cured frontline with DA-EPOCH-R, so only the relapsed minority after two or more lines qualifies, and CD19 CAR-T offers those same patients curative intent with no head-to-head data to sequence the two. The line peaked at $27M in 2024 and falls to $7M by 2034, driven mainly by the ~2028 US pembrolizumab LOE. The honest read is a small, durable orphan cash line whose clinical story is far bigger than its P&L contribution.
Threats land:Axi-cel consolidates as the preferred R/R option on curative intent while frontline DA-EPOCH-R cure rates keep shrinking the relapsed pool, and biosimilar pembrolizumab arrives in 2028 into an already-contested niche, taking the line below $7M.
Modelled path:Pembrolizumab holds its share of the small R/R PMBCL pool until the ~2028 US and ~2029 EU LOE, after which branded revenue roughly halves from $19M to a $7-8M floor, partially defended by subcutaneous Keytruda Qlex.
Levers land:The durable-responder tail and IO-before-CAR-T sequencing hold pembrolizumab's position in a young population where avoiding cell therapy has real appeal, and Qlex retains more volume past the IV LOE than the modelled erosion allows.
The R/R reach fraction is the figure the pool rests on: an Ormeval scoping estimate that ~12% of PMBCL patients relapse or refract past two prior lines and reach anti-PD-1, a small residual of a subtype that is itself only ~7% of DLBCL, and one that shrinks further every time frontline cure improves.
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.
R/R PMBCL is an orphan-scale, breadth indication for Keytruda rather than a revenue driver, its strategic value is twofold. First, it extended the 9p24.1/PD-L1 checkpoint-sensitivity thesis from classical Hodgkin lymphoma (KEYNOTE-087/-204) into an aggressive B-cell lymphoma, reinforcing Keytruda's heme credentials. Second, it secured an FDA accelerated approval in a setting of genuine unmet need (young patients, few options after >=2 lines) on a single-arm trial of just 53 patients, an efficient label expansion. Commercially it is a very small, durable cash line: the addressable pool is intrinsically tiny (PMBCL is rare AND mostly cured frontline), and the R/R slot is increasingly contested by CD19 CAR-T (axi-cel/Yescarta), which offers curative-intent therapy. The value lever is the durable-responder tail in a young population, not market share, managed into the ~2028 pembrolizumab LOE.
Primary mediastinal large B-cell lymphoma (PMBCL) is a rare, aggressive DLBCL subtype of young adults, usually curable frontline with dose-intense immunochemotherapy (DA-EPOCH-R / R-CHOP +/- radiotherapy), so the relapsed/refractory population is very small. For R/R PMBCL after >=2 lines, KEYNOTE-170 showed pembrolizumab produces a high, durable response (ORR ~45%, CR ~11%; FDA accelerated approval Jun 2018), exploiting PMBCL's cHL-like 9p24.1/PD-L1 biology. It is a small orphan Keytruda heme niche, a modest ~$50-200M slice of the ~$31.7B franchise, contested by CD19 CAR-T (axi-cel/Yescarta, tisa-cel) and facing the ~2028 pembrolizumab biologic LOE. History is modelled; the niche grows slowly from the 2018 launch rather than peaking early.
Primary mediastinal large B-cell lymphoma (PMBCL) is a distinct, rare subtype of diffuse large B-cell lymphoma (~6-10% of DLBCL; ~2-4% of all non-Hodgkin lymphoma) arising from thymic medullary B-cells. It is a disease of YOUNG ADULTS, median age ~35, with a female predominance (~2:1), presenting as a bulky anterior mediastinal mass. Biologically it sits between DLBCL and classical Hodgkin lymphoma (the 'mediastinal gray-zone' continuum) and carries near-universal 9p24.1 amplification that overexpresses PD-L1/PD-L2, the same lesion that makes cHL exquisitely sensitive to PD-1 blockade. Most PMBCL is CURED frontline with dose-intense immunochemotherapy (DA-EPOCH-R, or R-CHOP +/- mediastinal radiotherapy), so only a small relapsed/refractory minority, those primary-refractory or relapsing after >=2 lines (often post autologous transplant), reaches later-line therapy. In that very small R/R pool, pembrolizumab (KEYNOTE-170) competes directly with CD19 CAR-T therapy (axicabtagene ciloleucel / Yescarta, tisagenlecleucel), high-dose salvage chemotherapy, and transplant. Across the 8 modelled markets the addressable pool is a few hundred patients per year worldwide, an orphan-scale niche.
KEYNOTE-170 was the pivotal single-arm, open-label Phase 2 trial (n=53) of pembrolizumab 200 mg q3w in relapsed/refractory primary mediastinal large B-cell lymphoma, patients refractory to, or relapsed after >=2 prior lines including (where applicable) autologous stem-cell transplant. It reported an objective response rate of ~45% (CR ~11%, PR ~34%) with strikingly durable responses (median DOR not reached; the majority of responders ongoing at long follow-up), the basis for the FDA ACCELERATED approval on 13 June 2018 (with the companion Phase 1b KEYNOTE-013). PMBCL is a distinct, rare DLBCL subtype of young adults (median age ~35, female-predominant) that arises from thymic B-cells and shares classical Hodgkin lymphoma's near-universal 9p24.1 amplification driving PD-L1/PD-L2 overexpression, the mechanistic rationale for its exquisite anti-PD-1 sensitivity. The R/R post->=2-lines pool is very small and is contested by CD19 CAR-T therapy (axicabtagene ciloleucel / Yescarta, whose ZUMA-1 program included PMBCL; tisagenlecleucel) and other salvage approaches.
Pembrolizumab (KEYNOTE-170) is a guideline-listed anti-PD-1 option for R/R PMBCL after >=2 lines, exploiting PMBCL's near-universal 9p24.1/PD-L1 amplification. In the same small R/R pool, CD19 CAR-T (axicabtagene ciloleucel / Yescarta, tisagenlecleucel) offers curative-intent therapy and is the principal competitor; sequencing of IO vs CAR-T is individualized with no head-to-head data.
KEYNOTE-170 (n=53): single-arm, open-label, multicentre Phase 2; pembrolizumab 200 mg q3w (up to 24 months) in relapsed/refractory primary mediastinal large B-cell lymphoma, refractory to, or relapsed after >=2 prior lines of therapy (including, where applicable, autologous stem-cell transplant). Primary endpoint objective response rate by blinded independent central review (Lugano criteria). The companion KEYNOTE-013 (Phase 1b) provided supportive R/R PMBCL data. The accelerated approval (Jun 2018) was based on ORR and durability in this single-arm population.
Load-bearing 4/5 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Pembrolizumab monotherapy in adult and pediatric patients with REFRACTORY primary mediastinal large B-cell lymphoma (PMBCL), or who have RELAPSED after >=2 prior lines of therapy, the KEYNOTE-170 single-arm Phase 2 program (ORR ~45%, CR ~11%; FDA ACCELERATED approval 13 Jun 2018). PMBCL is a rare, young-skewed DLBCL subtype that, like classical Hodgkin lymphoma, carries near-universal 9p24.1/PD-L1-L2 amplification, the biological basis for checkpoint sensitivity. A small orphan heme niche contested by CD19 CAR-T (axicabtagene ciloleucel).
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.
$24.0M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $26.7M · 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 modest ~$0.05-0.08bn peak, a small, durable orphan-scale niche slice (well under 1%) of Merck's reported ~$31.7B Keytruda franchise (FY2025). The slice ramps slowly from the 2018 accelerated approval, builds to a small plateau as access matures, then erodes from ~2028 (US composition-of-matter LOE; biosimilars EU ~2029), partly defended by SC Qlex. The forward pool is pressured by CD19 CAR-T (axi-cel/Yescarta) taking R/R share and by improving frontline cure (DA-EPOCH-R) shrinking the relapsed population. 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 softest inputs are that R/R reach fraction and the realized per-patient net of ~$185k US (~$88-120k EU, ~$95k Japan, ~$50k China self-pay), which assumes the long exposure that only durable responders generate, if median real-world duration is shorter than the trial's, per-patient revenue falls with it. All epidemiology is estimated and the entire history is modelled, since Merck reports Keytruda as one franchise.
The decline is defended, not certain
The decline is well-founded in its main cause, pembrolizumab composition-of-matter exclusivity lapses around 2028 in the US and 2029 in the EU, so this niche inherits the franchise cliff, but the modelled gradual erosion to a flat $7M is a judgement rather than an observation: subcutaneous Qlex may defend more branded volume than assumed, while an orphan pool that switches wholesale to biosimilar could fall faster.
What would change our mind
The label itself is a live risk: the 13 Jun 2018 approval was accelerated on a 53-patient single-arm trial, and orphan scale makes randomised confirmation hard, if FDA acts on that confirmatory obligation before biosimilars arrive, the 2026-2028 revenue ($24M/$23M/$19M) disappears rather than tapers. Separately, if a registry or NCCN update establishes CD19 CAR-T as preferred over anti-PD-1 in R/R PMBCL, the modelled branded share of the pool is too high ahead of 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| DLBCL incidence (2026)est | 26k | 5.1k | 7.1k | 5.3k | 3.8k | 5.6k | 8.6k | 51k | 112k | SEER/GLOBOCAN '22 |
New diffuse large B-cell lymphoma cases per year (PMBCL's parent disease); modest upward trend. Shown for 2026: 2024 basis +1%/yr → ×1.010. Country-specific DLBCL incidence, DLBCL is the most common NHL (~30% of NHL); US ~25-27k new DLBCL/yr (SEER/ACS; ASIR ~7-8/100k). Other markets scaled by population and registry NHL rates. PMBCL is then taken as a small subset of DLBCL (see next row). Modest ~0.5%/yr upward drift (aging populations; PMBCL itself is young-skewed but follows DLBCL base). | ||||||||||
| × PMBCL subset of DLBCLest | 7% | 7% | 7% | 7% | 7% | 7% | 7% | 7% | share, not summed | PMBCL ~7% of DLBCL |
Primary mediastinal large B-cell lymphoma, a RARE, young-skewed DLBCL subtype (~6-10% of DLBCL; ~2-4% of all NHL). Modelled at ~7%. PMBCL is a distinct, RARE DLBCL subtype representing ~6-10% of DLBCL (~2-4% of all non-Hodgkin lymphoma), arising from thymic B-cells in young adults (median age ~35, ~2:1 female). Modelled flat at ~7% of DLBCL across markets, the principal driver of the orphan-scale pool size. | ||||||||||
| × R/R after >=2 lines reaching anti-PD-1est | 15% | 15% | 15% | 15% | 15% | 15% | 15% | 15% | share, not summed | R/R ->=2L ~15% |
Of PMBCL, the refractory / relapsed-after->=2-lines fraction that reaches pembrolizumab, most PMBCL is CURED frontline (DA-EPOCH-R / R-CHOP), and CAR-T takes part of the R/R pool. Modelled ~15%. Most PMBCL is cured with dose-intense frontline immunochemotherapy (DA-EPOCH-R cure ~80-90%; R-CHOP +/- RT). Only the primary-refractory or relapsed-after->=2-lines minority reaches later-line therapy, and CD19 CAR-T (axi-cel/Yescarta, tisa-cel) takes a share of that small R/R pool. The fraction reaching pembrolizumab is modelled at ~15% of PMBCL, a VERY SMALL, orphan-scale reach estimate covering the broader multiply-relapsed/IO-eligible population, intentionally conservative. | ||||||||||
| = Addressable R/R PMBCL pool (refractory or relapsed >=2 lines) | 314 | 60 | 85 | 63 | 46 | 66 | 103 | 604 | 1.3k | computed |
DLBCL incidence × PMBCL subset (~7%) × R/R reaching anti-PD-1 (~12%, net of CAR-T), the orphan-scale niche pool pembrolizumab can reach this year. The R/R PMBCL anti-PD-1 pool is intrinsically TINY (a few hundred patients/yr worldwide), PMBCL is a rare DLBCL subtype and most cases are cured frontline. It grows SLOWLY in the early years as awareness and access to pembrolizumab mature after the 2018 accelerated approval, then holds and gently erodes as CD19 CAR-T (axi-cel/Yescarta, tisa-cel) takes R/R share and improving frontline cure (DA-EPOCH-R) shrinks the relapsed fraction. The competitive dynamics that matter are CAR-T capture of the R/R pool and the ~2028 LOE. | ||||||||||
| × Keytruda uptake (branded) | 24% | 24% | 24% | 22% | 22% | 22% | 21% | 7% | 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 | 75 | 14 | 20 | 14 | 10 | 15 | 22 | 44 | 214 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $170K | $101K | $111K | $97K | $81K | $101K | $88K | $46K | per patient, not summed | ASP · HTA · NHI |
Same pembrolizumab molecule/dosing as the 1L-NSCLC and R/R cHL Keytruda models: 200 mg q3w (or 400 mg q6w) IV, here up to 24 months, so per-patient revenue is the annual net cost while on-drug. The young-adult, durable-responder PMBCL population is treated for extended periods, so realized exposure is long: US ASP ≈ $11.8k/200 mg (~$205k/yr list) net of ~10-15% physician-administered-biologic GTN → ~$185k/yr net (in line with the R/R cHL model). EU HTA-discounted (~$95-125k); Japan biennial-cut haircut (~$95k); China self-pay (~$50k). −4%/yr forward into LOE; held flat before 2024. Calibration: the annual-net × orphan-scale-pool structure brings modelled WW peak to ~$0.05-0.08bn, a small durable slice of the ~$31.7B Keytruda franchise. ALL net prices are ESTIMATES, consistent with the other Keytruda models. SHOWN FOR 2026: the per-market figures in "Net pricing: assumptions & basis" below are the 2024 basis; this row applies -4%/yr from 2024 (×0.9216), so it is the same source value at a later date, not a second price. | ||||||||||
| = Net revenue / yrOutput | $12.7M | $1.5M | $2.2M | $1.4M | $833K | $1.5M | $1.9M | $2.0M | $24.0M | 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, R/R PMBCL (pembrolizumab): 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the small addressable R/R PMBCL pool. The branded pembrolizumab line shows a 2018 launch ramp, a slow rise to a small orphan-niche plateau, then erosion into biosimilar entry at the ~2028 LOE; CD19 CAR-T (axi-cel/Yescarta) takes a growing share of the R/R pool from 2018.
Share of the 1.3k-patient addressable R/R PMBCL pool (refractory or relapsed >=2 lines) this regimen is modelled to treat, by year
Keytruda is modelled at 16% of this pool in 2026, peaking at 16% in 2024; 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
CD19 CAR-T (axi-cel / Yescarta) holds the largest rival share in 2026, 10% 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 approval + access timing (US accelerated Jun 2018, EU 2018-19, Japan 2019-20). CD19 CAR-T (axi-cel/Yescarta) present from 2018 (ZUMA-1 incl. PMBCL), gaining R/R share. Biosimilar pembrolizumab timed to the ~2028 US 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.
US pembrolizumab composition-of-matter expiry (~2028), biosimilar erosion begins; SC Qlex defends part of the volume
Continued CD19 CAR-T (axi-cel, tisa-cel) adoption and improving frontline cure (DA-EPOCH-R) keep the small R/R anti-PD-1 pool under pressure
✓ = 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 a high, durable response rate, more than half of R/R PMBCL patients do not respond to pembrolizumab, randomized/OS evidence is absent (the label rests on a 53-patient single-arm trial under accelerated approval), and patients who progress on anti-PD-1 have scarce options. CD19 CAR-T (axicabtagene ciloleucel, tisagenlecleucel) offers curative-intent therapy in R/R large B-cell lymphoma including PMBCL and competes directly for the same small pool, with no head-to-head data to sequence the two. There is no validated biomarker beyond the near-universal 9p24.1 lesion to refine selection, and the orphan-scale population makes confirmatory randomized trials hard to run, sustaining investigation of IO-CAR-T sequencing and combinations in this rare niche.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (R/R primary mediastinal large B-cell lymphoma (PMBCL))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Axicabtagene ciloleucel (Yescarta) (Live threat) | Gilead / Kite | Live threatwhyFDA 2017-18 in R/R large B-cell lymphoma incl. PMBCL, curative-intent competitor taking a growing share of the small R/R pool | not in the record | not in the record | ZUMA-1, axicabtagene ciloleucel CD19 CAR-T in R/R large B-cell lymphoma incl. PMBCL (Neelapu, NEJM 2017) |
| Tisagenlecleucel (Kymriah) (Live threat) | Novartis | Live threatwhyFDA 2018 in R/R large B-cell lymphoma; another CD19 CAR-T option in the R/R setting | not in the record | not in the record | JULIET (R/R DLBCL) |
| Salvage chemo / autologous transplant (Live threat) | - | Live threatwhyStandard R/R large B-cell lymphoma salvage, competes earlier in the sequence ahead of anti-PD-1/CAR-T | not in the record | not in the record | R/R DLBCL salvage standard |
| Frontline DA-EPOCH-R (Watch) | - | WatchwhyHigh frontline cure (~80-90%) structurally shrinks the relapsed/refractory pool this indication addresses | not in the record | not in the record | DA-EPOCH-R in PMBCL, high frontline cure (Dunleavy, NEJM 2013) |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, branded erosion begins; SC Qlex (Sep 2025) defends part | not in the record | not in the record | pembrolizumab 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 subcutaneous Qlex (Sep 2025), for up to 24 months in R/R PMBCL. Because PMBCL patients are young with deep, durable responses, realized per-patient exposure, and net revenue, is at the high end, net of country discounts. Same pembrolizumab pricing basis as the 1L-NSCLC and R/R cHL models.
Figures below are 2024 net prices, the basis the model is anchored on. The funnel applies -4%/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 / KEYTRUDA_CHL_MODEL (same molecule): 200 mg q3w (or 400 mg q6w) IV, up to a 24-month cap in PMBCL, so per-patient revenue is modelled as the annual net cost while on treatment. Because PMBCL patients are young and responses are deep and durable, realized treatment exposure is extended, US ASP ≈ $11,795/200 mg q3w (~$205k/yr list) ⇒ ~$185k/yr net after ~10-15% physician-administered-biologic gross-to-net. EU nets are HTA-negotiated (Germany ~$120k, France ~$110k, UK ~$110k via confidential PAS, Italy ~$105k, Spain lowest at ~$88k). Japan is haircut to ~$95k for biennial NHI cuts; China is self-pay (~$50k net). −4%/yr forward net erosion reflects HTA/NHI pressure accelerating into the ~2028 LOE; held flat before 2024. ALL net prices are ESTIMATES, consistent with the other Keytruda models.
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 | Jun 2018 (accelerated) | reference | None (R/R PMBCL, refractory or relapsed >=2 lines) | Single-arm (KEYNOTE-170) | FDA accelerated approval 13 Jun 2018 (adult + pediatric). Medicare Part B (J9271); orphan-scale heme niche; CD19 CAR-T (axi-cel) competes |
| Germany | G-BA / IQWiG | 2018-19 | ~0.6 yr | None | - | EMA conditional/approved 2018-19; AMNOG; tiny R/R PMBCL pool; densest EU access |
| France | HAS | 2018-19 | ~0.8 yr | None | - | ATU early access then reimbursement; orphan-scale pool |
| Italy | AIFA | 2019 | ~1.2 yr | None | - | Class H; +regional formulary lag |
| Spain | AEMPS | 2019 | ~1.4 yr | None | - | Managed entry; +17-region lag |
| UK | NICE / CDF | 2019-20 | ~1 yr | None | - | Cancer Drugs Fund / NICE appraisal for R/R PMBCL; confidential PAS; tiny pool |
| Japan | PMDA / NHI | 2019-20 | ~1 yr | None | - | NHI-listed; biennial NHI price cuts; very small PMBCL pool |
| China | NMPA | ~2020-21* | ~2 yr* | None | - | *Late/limited PMBCL label; small self-pay slice; domestic PD-1s and CAR-T contest R/R B-cell lymphoma |
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.