Brentuximab vedotin for treating CD30-positive Hodgkin s lymphoma [ID722] Second appraisal committee C meeting Chair s presentation 9 November 2016

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1 Brentuximab vedotin for treating CD30-positive Hodgkin s lymphoma [ID722] Second appraisal committee C meeting Chair s presentation 9 November 2016

2 Current management No standard of care and no NICE guidance Figure 3-1 of the company s submission 2

3 Brentuximab vedotin (Adcetris, Takeda UK) Antibody drug conjugate targeting cancer cells expressing CD30 protein Dosed at 1.8 mg/kg intravenously over 30 mins every 3 weeks Indicated for 1) Relapsed/refractory CD30+ Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) or 2) Relapsed/refractory CD30+ HL after 2 prior therapies when ASCT or multi-agent chemotherapy not an option 3) CD30+ HL at increased risk of relapse or progression after ASCT Regulator s definition of increased risk narrower than final scope AETHERA trial 2 or more risk factors vs. any 1 risk factor Currently on CDF for populations 1 and 2; 6 cycle stopping rule in place Final scope issued by NICE includes all 3 populations 3

4 NICE scope Pop. 1. Relapsed/refractory CD30+ve Hodgkin s lymphoma (HL) after ASCT 2. CD30+ve HL after 2 previous therapies when ASCT or multi-agent chemotherapy not an option 3. CD30+ve HL at high risk of residual disease 1 after ASCT Int. Com. Out. 1 People who have any of the following: 1. primary refractory disease; 2. disease relapse within 1 year of completing first-line treatment; 3. +ve PET scan prior to ASCT; or 4. extra-nodal involvement at the time of relapse prior to ASCT Brentuximab vedotin 1. Relapsed/refractory post ASCT : established clinical management without brentuximab vedotin including chemotherapy 2. 2-lines ineligible : best supportive care 3. High-risk : best supportive care OS, PFS, objective response rate, complete response rate, adverse effects of treatment, health-related quality of life 4

5 Use of brentuximab vedotin in clinical practice Committee agreed with clinical experts brentuximab vedotin would mainly be used for Relapsed/refractory post ASCT (population 1) ASCT/chemotherapy-ineligible (population 2) The committee heard from clinical experts it was not routine practice to treat people at increased risk of relapse or progression after ASCT (population 3) Brentuximab vedotin thought of as effective bridge to potentially curative transplant Autologous (ASCT) or allogeneic (allosct) depending on stage in therapy and clinical circumstances (e.g. donor availability) Relapsed/refractory post ASCT ASCT Relapse/ Progression Brentuximab vedotin AlloSCT ASCT/chemotherapyineligible Salvage chemo Positive PET scan ASCT Brentuximab vedotin ASCT 5

6 Clinical evidence on Brentuximab considered at first committee meeting Population Evidence Design Primary outcome Relapsed/ refractory post ASCT High-risk ASCT/ chemotherapyineligible SG trial (n=102) AETHERA (n=329) Pooled data from phase I studies, a Japanese-only study, and a NPP (n=59) Open-label, singlearm (phase II) Double-blind, placebo-controlled RCT (phase III) Non-randomised, non-controlled data Objective response Progression-free survival (per independent review facility) Various Abbreviations: ASCT, autologous stem cell transplant; NPP, named patient programme; RCT, randomised controlled trial 6

7 Appraisal committee s ACD conclusions about clinical evidence Mostly retrospective and non-randomised Evidence immature and limited for 2 most relevant populations Outcomes mostly for anti-tumour effect (i.e. response rates rather than survival Company relied on comparisons with historical controls, which may be invalid Need to consider phase IV data that would be available for ASCT/combo-chemotherapy-ineligible population 7

8 1. R/R post ASCT - Considerations: ERG s exploratory analysis (ACM1) Analysis ICER Company s base case 39, Selecting different parametric functions to model PFS 52, People have chemotherapy only if alive and relapse-free 40, Using the scheduled, rather than actual, dose of brentuximab vedotin in , Applying planned 16-cycle doses in the brentuximab vedotin arm 49, Assuming no mortality benefit for brentuximab vedotin 54, Sourcing treatment-related adverse events from clinical study report 39,132 ERG s preferred based case combines analyses 1, 2, 3 and 5 83,771 8

9 R/R post ASCT Considerations ACM1 Company and ERG base case results Company s base case ERG s modified base case Total cost ( ) Total QALYs ICER ( /QALY) Total cost ( ) Total QALYs ICER ( /QALY) Chemotherapy 27, , Brentuximab vedotin 88, ,327 92, ,771 Committee preferred ERG modified base case; however disagreed with ERG s assumption of no mortality benefit for brentuximab vedotin Requested scenario analyses varying the mortality benefit of brentuximab vedotin within a plausible range Using number of treatment cycles from SG (average 9.7 cycles) as higher than clinical practice Requested applying stopping rule after 4 5 treatment cycles if no response seen Brentuximab vedotin NOT recommended for this population 9

10 Results and ACD committee conclusions Other populations (2) High-risk population Company s ICER: 56,342/QALY, ERG ICER: 590,407/QALY ERG s ICER mirrored committee s preferred analysis more closely than company s Noted that results based on broader definition of high risk than marketing authorisation As ICER too high, and population not relevant to clinical practice, committee concluded that no further analyses need be considered Brentuximab vedotin NOT recommended (3) ASCT/chemotherapy-ineligible population No economic model Brentuximab vedotin NOT recommended until new economic model provided 10

11 Consultation comments Professional groups Royal College of Physicians Royal College of Pathologists Clinical expert The Christie NHS Foundation trust Division of molecular and clinical cancer sciences, the University of Manchester Web comments Company Takeda 11

12 Consultation comments Professional groups Brentuximab vedotin revolutionized treatment, and ground breaking innovation Clinically most useful in (1) Patients relapsing after ASCT (i.e. as a bridge to allosct); and (2) Patients not achieving PET-ve complete metabolic remission after 2 lines of chemotherapy For relapsed/refractory disease post ASCT, average number of cycles is 5 6 when used as a bridge to allosct For both indications, maximum 4 cycles could initially be recommended, with at least PR required to continue treatment Disagree that brentuximab vedotin not an end-of-life treatment for ASCT/chemotherapy-ineligible population Criteria sometimes fulfilled e.g. when PET scan +ve prior to transplant 12

13 Consultation comments Clinical experts Treatment post ASCT in high-risk individuals not reflective of UK practice Treatment offers substantial survival benefits, and an effective bridge to transplant Provided updated results from single-centre named patient programme (the Christie in Manchester) N=33, of whom 24 had Hodgkin lymphoma, which was refractory to 2 lines of chemotherapy, or ASCT Among patients with Hodgkin lymphoma, objective response rate = 63%, and complete response rate = 17% Of 25 patients eligible for allosct, 8 proceeded to transplant after brentuximab vedotin 5 (20%) alive and disease-free after median follow-up of 25.3 months 13

14 Consultation comments Web comments Low toxicity and minimal side-effects Higher patient functioning on brentuximab vedotin Increased patient confidence Great improvement over chemotherapy Enables bridging to transplant in young fit HL patients 4-8 cycles better reflects UK clinical practice Dismal patient outlook in terms of quality and quantity of life without brentuximab vedotin Cost savings from reduced supportive care and hospital stays Equality issues 14

15 Consultation comments Company New PAS (simple discount all populations) (new evidence) New analyses (1) Relapsed/refractory post ASCT population Modified base case in response to ACD Further model modifications (2) ASCT/chemotherapy-ineligible population New phase IV clinical study C25007 (requested in ACD) Real-world observational data (not requested in ACD) New economic model (created for the requested new data) (3) High-risk population: modified base case in response to ACD New evidence submitted by company was rejected by NICE, as it is not routine practice to treat people at increased risk of disease relapse or progression, therefore new evidence will not change the committee decision (as per section of process guide) 15

16 Patient access scheme (PAS) Since the last committee meeting the company has submitted a simple discount PAS of 10% which applies to the whole licensed population No administrative process will be required to claim the discount offered by the PAS Course costs r/r HL post-asct 55,005 ASCT/chemotherapy-ineligible 35,767 All base case and scenario analysis ICERs incorporate the savings generated from the PAS Economic models have been updated to account for the saving 16

17 Population/ Parameter Relapsed/ refractory post ASCT (same as ACM1) ASCT/ chemotherapy-ineligible (New evidence and economic model) Design 0003 phase II (single-arm) C25007 phase IV (single arm) & UK observation study N (56 C UK obs study) Intervention Brentuximab vedotin Brentuximab vedotin Comparator Source of PFS data Source of OS data Source of utility values Number of cycles Economic model evidence "Blended comparator" of single/combination chemotherapy +/- radiotherapy 0003 (study follow-up); Robinson et al (extrapolation) 0003 (study follow-up); Martinez et al (extrapolation) Swinburn et al (Investigator assessed) Single agent chemotherapy (same efficacy assumed regardless of agent) Pooled dataset (study follow-up); Little et al.; Mead et al. 1982; Haim et al. 1995; Zinzani et al (extrapolation) Pooled dataset (study follow-up); Little et al.; Mead et al. 1982; Haim et al. 1995; Zinzani et al (extrapolation) Pooled data (estimated from relative response rates) (pre-transplant) Agthoven et al. (post-transplant) 5.7 (Pooled dataset) (7.4 C25007 & 4.1 UK obs study) 17

18 PFS PFS 1. Relapsed/refractory post ASCT Parameter Company s modifications to the model (1) Company s base case analysis ERG s base case Company s revised analysis Extrapolation of PFS from allosct Robinson et al Lognormal distribution fitted to tail of the data Generalised F function fitted to the whole curve Gamma function fitted to tail of the data Within trial" period (up to 6.08 years) Brentuximab vedotin: 0003 study (n=102), observed KM curve, investigator-assessed Chemotherapy +/- radiotherapy: 0003 study self-control group (n=56), investigatorassessed ERG approach (accepted by committee) Brentuximab vedotin Chemo +/- radio Brentuximab vedotin (original base case) Chemo+/- radio (original base case) Years in model Company s modified approach Brentuximab vedotin Chemo +/- radio Brentuximab vedotin (original base case) Chemo+/- radio (original base case) Years in model 18

19 Relapsed/refractory post ASCT Company s modifications to the model (1) PFS Parameter Company Rationale ERG main critique Extrapolation of PFS for brentuximab vedotin and chemotherapy ERG used mean hazard includes patients who progressed soon after allosct for whom hazard is high Preferred using timespecific hazard, and couldn t implement generalised F function in Excel Risk of progression is underestimated Not extrapolating from the full curve Co assume risk of progression is equal to risk of progression of patients who received allosct 6.08 years before (arbitrary portion of the curve) Only impacts brentuximab vedotin, as almost all chemo patients had progressed by 6 yrs 19

20 OS OS Relapsed/refractory post ASCT Company s modifications to the model (2) OS Parameter Company s base case analysis ERG base case analysis In trial OS As trial curves No proven trial gain Extrapolation of OS beyond trial follow-up Exponential model (mortality rate based on time interval to months from Martinez) Weibull function (entire dataset from Martinez et al.) ERG extrapolation approach (accepted by committee) Brentuximab 0.80 Chemo +/- radio 0.70 Brentuximab (original base case) 0.60 Chemo +/- radio (original base case) Years in model Company s modified approach Brentuximab Chemo +/- radio Brentuximab (original base case) Chemo +/- radio (original base case) Years in model 20

21 Parameter Relapsed/refractory post ASCT Company s modifications to the model (2) Company s revised analysis Rationale ERG main critique Within trial duration Assumed mortality benefit of brentuximab over chemotherapy (LY gained: 6.97yr BV; 5.32 yr chemo) Based on naïve indirect comparison between 0003 trail and observational data reported in Martinez et al. No evidence was presented by the company to support the survival benefit associated to brentuximab vedotin Extrapolation of OS beyond trial follow-up Lognormal function Weibull function overpredicts hazard between 3 6 years Concerns about the face validity of the survival estimates (i.e. 6 years), which were in contrast with the opinions of the clinical expert at the committee meeting 21

22 Relapsed/refractory post ASCT Company s modifications to the model (3) Parameter ERG s modified base case Company s revised analysis Rationale Treatment in the chemotherapy arm Only if patient alive and relapsefree As per ERG s modified base case, but costs capped at the maximum number of cycles for each regimen To avoid accruing costs beyond the maximum number of cycles Treatment dose Scheduled dose applied in both treatment arms Actual dose applied in both treatment arms (assumed relative dose intensity [RDI] of 94% from clinical trial in both treatment arms) Reflects trial, clinical practice, and committee s preference 22

23 Relapsed/refractory post ASCT Company results Scenario Treatment Total cost Company s modified base case Stopping rule: 4 cycles if no PR/CR 1 Total QALYs Chemotherapy 27,26 XXXX Brentuximab ICER ( /QALY) Total cost Total QALYs ICER (w/ PAS) ( /QALY) vedotin 8 7,81 XXXX 33,151 Chemotherapy 2 7,29 XXXX 27,29 XXXX Brentuximab vedotin 7 9,15 XXXX 28,337 73,04 XXXX 24, cycles used as response was only assessed at cycles 4 and 7 in SG Scenario analyses (including stopping rule) on the mortality benefit of brentuximab vedotin (chosen range based on opinion of 3 clinical experts) ) 40% 35% 31% (base case) ICER ( /QALY) 30% 25% 20% 15% 10% 23,938 24,481 24,998 25,111 25,844 26,710 27,745 29,007 23

24 Relapsed/refractory post ASCT ERG critique (1) Progression free survival modelling Company used a different parametric function to that used in their original analysis and not the ERG s and committee s preferred parametric PFS function Progression rate is set at equal to the rate of patients who received allosct 6.08 years before from Robinson et al, a patient group who would be considered cured from HL Extrapolation is still based on an arbitrary portion of the curve reported by Robinson et al Overall survival modelling Company inappropriately assume survival benefit for brentuximab in the short term (within trial period) This feeds into long term OS extrapolation, further compounding the issue 24

25 Relapsed/refractory post ASCT ERG critique (2) Stopping rule Stopping rule of 4 cycles if at least a partial response is not observed Company state that a small proportion didn t achieve complete (CR) or partial response (PR). But this figure is 30% (31/102) The company assumption of a dose cap not requiring an efficacy adjustment is implausible Cost of chemotherapy Previous calculations overestimated the acquisition cost of chemotherapy The impact of this modification was not substantial on the ICER Non-harmonisation of the data sources from which chemotherapy treatment duration was extracted remains an issue Dose intensity Given data limitations, the company approach of equal relative dose intensities is reasonable 25

26 Relapsed/refractory post ASCT ERG preferred base case (including PAS) Scenario Treatment Total cost Total QALYs ICER ( /QALY) ERG s modified base case 4 cycle stopping rule Chemotherapy 31,832 XXXX Brentuximab vedotin 85,121 XXXX 67,368 Chemotherapy 31,832 XXXX Brentuximab vedotin 77,279 XXXX 57,170 No in trial mortality benefit Extrapolation of whole curves No stopping rule 26

27 Relapsed/refractory post ASCT ERG exploratory analysis (including PAS) OS HR scenario analysis, no stopping rule Hazard ratio ICER ( /QALY) ,368 57,342 49,388 42,960 37,703 33,393 OS HR scenario analysis, 4-cycle stopping rule Hazard ratio ICER ( /QALY) ,170 48,860 42,259 36,919 32,550 28,965 ERG base case HR is 1.00 (no survival benefit for brentuximab over chemotherapy) 27

28 Relapsed/refractory post ASCT Issues for consideration Brentuximab and chemotherapy data comparability Survival gain PFS extrapolation (arbitrary portion of the curve) Stopping rule (4 cycles if no CR or PR) 28

29 2. ASCT/combo-chemotherapy-ineligible C25007 study new evidence Design Population Results (n=60) Phase IV, single-arm, open-label, multicentre (no UK patients) study (ongoing) post-marketing authorisation commitment to regulator Adults with CD30+ relapsed/refractory Hodgkin lymphoma; no prior SCT; SCT or multi-agent chemotherapy not an option at time of enrolment Median number of cycles 7 (mean 7.5 cycles) 1 ry outcome: objective response rate (complete + partial response) 1 29 (48%) Complete response 9 (15%) Partial response 20 (33%) Patients proceeding to stem cell transplant 1 Assessed by independent review facility 28 (47%); ASCT: 28/28, allosct: 1/28 29

30 ASCT/combo-chemotherapy-ineligible C25007 study survival results OS PFS (investigator) PFS (independent review) Progression-free survival (median) Investigator: 5.0 mts (95% CI ) IRF: 4.8 mts (95% CI ) Overall survival (rate) 12 mts: 86%, 24 mts: 74% Median not reached 30

31 ASCT/combo-chemotherapy-ineligible Real-world UK observational data new evidence Data collected retrospectively from patients treated with brentuximab vedotin in major centres in England N=78 across 10 centres, but analysis set includes only 75 patients due to missing data Mainly funded by Cancer Drugs Fund Based on investigator assessment as not protocol driven Best response (n=75) Objective response rate (complete + partial response) 40 (51%) OS PFS Complete response 19 (24%) Partial response 21 (27%) Patients proceeding to stem cell transplant 45/78 (58%) Median PFS Median OS 5.68 mts 37.2 mts 31

32 ASCT/combo-chemotherapy-ineligible Economic model (4-state Markov model) new evidence Adults with relapsed/refractory disease after 2 previous therapies when ASCT or multi-agent chemotherapy not an option Brentuximab vedotin Standard of care (SoC) Single-agent chemotherapy (such as gemcitabine or vinblastine) Agents assumed equally efficacious but cost differed Weekly cycle length; 70-year time horizon; 3.5% discount rate (costs and benefits) 32

33 ASCT/combo-chemotherapy-ineligible Summary of key model inputs (1) new evidence Clinical outcomes Brentuximab vedotin: pooled data, phase IV + observational SoC: adjusted curves for brentuximab vedotin based on response rates reported in literature for SoC, thereby using response rates as surrogate for clinical outcomes Also the following scenario analyses Above approach combined with expert opinion on PFS and OS hazard ratios for SoC Naïve comparison with published observational data for SoC (Little et al. 1998) Other clinical parameters Value Source Number of brentuximab vedotin cycles (mean) Transplant rate Brentuximab vedotin Standard of care 5.7 Pooled data 53% Pooled data 5.3% Literature Health state Utility value (literature + assumptions) EFS: Brentuximab vedotin 0.81 EFS: SoC 0.77 PPS: Brentuximab vedotin 0.38 PPS: SoC 0.38 Post-transplant (1-14 days) 0.42 Post-transplant (15 days-3 mts) 0.60 Post-transplant (after 3 mts)

34 ASCT/combo-chemotherapy-ineligible Summary of key model inputs (2) new evidence The company provided multiple sources for their estimates of transitional probabilities The source of EFS/SCT & PPS/SCT was unclear according to the ERG From/To EFS/PPS EFS/SCT EFS/Death PPS/SCT PPS/Death Source Pooled dataset, company s elicitation of PFS HR through surrogate approach (as indicated in the updated economic model) Descriptive statistics * National Life Tables (ONS) Descriptive statistics * Unknown, company s elicitation of OS HR through surrogate approach (as indicated in the updated economic model) Table adapted from table 4 ERG appendix 2 critique *ERG could not find time-to-event data or KM curves 34

35 ASCT/combo-chemotherapy-ineligible Company s modified base-case results (inc PAS) Total cost Total QALYs ICER ( /QALY) Standard of care 15,074 XXXX Brentuximab vedotin 70,767 XXXX 29,826 Disaggregated QALYs Brentuximab vedotin Standard of care Incremental EFS XXXX XXXX XXXX PPS XXXX XXXX XXXX allosct XXXX XXXX XXXX ASCT XXXX XXXX XXXX Total XXXX XXXX XXXX All QALY gains from transplant 35

36 ASCT/combo-chemotherapy-ineligible Sensitivity and scenario analyses (including PAS) Sensitivity analysis (only those that changed the ICER by > 1000/QALY either way) ICER ( /QALY) Base case 29,826 - Number of cycles of brentuximab vedotin: study 35,955 Transplant rate for brentuximab vedotin: 53% 19% (EMA data) 35,066 Survival during allosct: Sureda 2012 (sensitive patients) 24,989 Number of cycles of brentuximab vedotin: observational study 25,502 TT to SCT curve: Weibull 26,327 Dataset used: study only 32,847 Dataset used: observational study only 27,725 Relative dose intensity for brentuximab vedotin: 90% 27,932 Cost of allosct: ± 20% 28,570 31,082 SoC response rates: equal to brentuximab vedotin 30,981 Scenario analyses around the modelling of clinical outcomes for SoC ICER ( /QALY) Base case 29,826 - Surrogate outcomes approach combined with expert opinion 27,675 Naïve comparison with Little et al. 28,449 36

37 ASCT/combo-chemotherapy-ineligible ERG critique of new company evidence (1) Due to undocumented changes in the updated model, the ERG decided to work with the first of the company s two submitted economic models The ERG made a number of model alterations such as; Using updated model inputs in the with the original economic model structure (Replacing HR for TTP and PPS with the value of 1 (correcting for flawed surrogate outcome approach) ; Changing N (C not 68) and trial outcomes to reflect results; SCT rate corrected to 5.3%from 3.5% Structure of the model limits its validity Substantial uncertainty around any comparison between brentuximab vedotin and standard care based on Little et al. (Although still likely to be more informative than clinical expert opinion) Other Issues identified by the ERG No literature review for parameter selections No justifications for choice of survival curves No probabilistic sensitivity analysis (PSA) 37

38 ASCT/combo-chemotherapy-ineligible ERG critique of new company evidence (2) Differences in patient characteristics and prognostic factors makes pooling the available data inappropriate. C25007 study non-comparable patient population. 18% had fewer than 2 prior therapies. Very different ASCT vs allosct rates. UK observational study provides more relevant data Inappropriate comparator for the study populations. Both studies reflect a population eligible for more than monotherapy (even if the sub-group specification does not) 5.3 % could be a serious underestimation of SCT rate after chemotherapy : Zinzani et al. reports a rate of 14%; Clinical expert estimated probabilities of 15% and (30%-40%) Model fails to capture benefit of reduced toxicity and infection related with the use of brentuximab vedotin 38

39 ASCT/combo-chemotherapy-ineligible ERG critique of new company evidence (3) The model structure does not capture disease progression or duration of response after SCT Model does not allow movement from SCT to post progression survival or event free survival Majority of post-sct patients will relapse within 2 years; having a considerable impact on quality-of-life which is not captured in the model Health state Company model utility values EFS: Brentuximab 0.81 EFS: Chemotherapy 0.77 PPS: Brentuximab 0.38 PPS: Chemotherapy 0.38 Post-SCT (1-14 days) 0.42 Post-SCT (15d-3mths) 0.60 Post-SCT (3months +) 0.77 ERG calculate average utility as 0.50 after year 1 post-sct Health state Utility value Time period % patients Weighted values EFS years PPS years EFS years PPS years Weighted average Total n/a 69 years n/a

40 ASCT/combo-chemotherapy-ineligible ERG scenario analysis (with PAS) ERG scenario analysis ICER ( /QALY) Base case (updated model) 29,826 Base case (original model with updated data) ERG preferred 28,144 - Using the UK observational dataset 26,952 Zinzani et al probability of receiving SCT after chemotherapy (14% not 5.3%) 32,532 Clinical expert opinion of post-chemotherapy SCT probability (35% not 5.3%) 59,645 Using regulator post-brentuximab SCT probability (19% not 53%) 53,106 OS curves showing decreased survival benefit of 20% after SCT 33,999 OS curves showing decreased survival benefit of 30% after SCT 37,302 Using different utility value (0.50) after SCT 51,126 Using HRs of for TTP and for PPS 26,076 40

41 ASCT/combo-chemotherapy-ineligible ERG s alternative base case (with PAS) ERG s alternative base case ICER ( /QALY) Base case (original model with updated data) ERG preferred 28,144 - Using the UK observational dataset 26,952 Clinical expert opinion of post-chemotherapy SCT probability (35%) 45,877 Using 0.5 utility value after SCT 79,814 OS curves showing decreased survival benefit of 20% after SCT 96,239 41

42 ASCT/combo-chemotherapy-ineligible End of life ACD new evidence Criterion Data available ERG comments Short life expectancy (<24 months) Company report standard care life years of 2.5 (undiscounted)* The ERG base case chemotherapy LY is 7.5, which is reduced to 6.39 when assuming SCT benefit is overestimated by 20% Extension to life of at least an additional 3 months 4.43 LY gained (surrogate approach) (undiscounted)* 4.71 LY gained (surrogate and expert opinion) (undiscounted)* The model has fundamental flaws which could potentially affect the verification (or not) of the EoL criteria. *Data taken from company ACD appendix 2 table 13 If a new model was to be built accounting for all the issues raised by the ERG any (or both) of the criterion verification for EoL could change. 42

43 ASCT/combo-chemotherapy-ineligible Issues for consideration (1) Trial data or UK observational data (or neither?) (2) SCT rate after Brentuximab. (Is 53% right for this initially SCT ineligible population?) (3) SCT rate after chemotherapy (Is 5.3% right?) (4) Are the benefits of SCT in this population exaggerated because of the restrictive model structure? (5) Are the non-sct benefits of brentuximab captured in the model? Reduced toxicity and infection (6) EOL 43

44 3. High-risk population New company analyses post-acd Population deemed irrelevant at ACM1 Not relevant to UK clinical practice New evidence submitted by company was rejected by NICE, as it is not routine practice to treat people at increased risk of disease relapse or progression, therefore new evidence will not change the committee decision (as per section of process guide) 44

45 Key Issues for Consideration Population 1. RR post ASCT Brentuximab and chemotherapy data comparability Survival gain PFS extrapolation (arbitrary portion of the curve) Stopping rule Population 2. Ineligible for ASCT Trial data or UK observational data (or neither?) SCT rate after Brentuximab. (53% for an initially SCT ineligible popn.) SCT rate after chemotherapy (Is 5.3% right?) Are the benefits of SCT in this population exaggerated because of the restrictive model structure? Are the non-sct benefits of brentuximab captured in the model? EOL

46 Other issues for consideration Equalities Geographical inequity in access as brentuximab vedotin is available through NHS Scotland If brentuximab vedotin is available post-asct, ethnic minority groups could be disadvantaged due to smaller numbers of potential donors being available CDF considerations Company did not intend to submit a case because the population was small, and it was unsure what information further data collection could provide 46

47 Available evidence on number of brentuximab vedotin cycles Clinical trials NPPs Population Median number of cycles 0003 (phase II) Relapsed/refractory HL post ASCT 9 C25007 (phase IV) UK (10 centres); (n=78) UK (single centre the Christie in Manchester); (n=33, HL patients: 24) Italy (n=45) Non-US/Canadian countries (n=245, HL patients: 207/245) Relapsed/refractory HL after 2 prior therapies and ASCT/multiagent chemotherapy not an option Lymphoma refractory to 2 lines of chemotherapy, or ASCT (9 patients [27%] had prior ASCT) Relapsed/refractory HL after 2 prior therapies and ASCT not an option, or after ASCT (mean) 5 (best response achieved after 4 cy Relapsed/refractory HL or ALCL

48 1. R/R post ASCT - End of life Received at company submission Criterion Data available ERG comments Short life expectancy (<24 months) Median OS 2.4 years Decreases to 1.2 years for relapses within 1 year after ASCT Recently published and largest, study for this indication (Arai et al.) show 71% of the relapses occur within 1 year of ASCT Company s base case and the ERG s modified base case predict average life expectancy >4 years for chemotherapy (Life years of chemo in company scenario analyses = ) Extension to life of at least an additional 3 months "Real-world" data show 2-year survival of 60% in this population In 0003, median OS = 40.5 months, and 5-year survival = 41% suggesting benefit of brentuximab vedotin will exceed 3 months Survival benefit proposed by the company based on a naïve indirect comparison between 0003 and external observational data No sufficient or robust evidence for brentuximab vedotin to meet this criterion 48

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