NATIONAL CANCER DRUG FUND PRIORITISATION SCORES

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1 NATIONAL CANCER DRUG FUND PRIORITISATION SCORES Drug Indication Regimen (where appropriate) BORTEZOMIB In combination with dexamethasone (VD), or with dexamethasone and thalidomide (VTD), is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation Magnitude of Survival Benefit (progression free survival and overall survival) Additional incremental benefit over comparator treatment in pivotal Phase III trial. Phase II data allowable only for: rare cancers or rare subgroups, e.g of common cancers or patients with refractory/relapsed disease when Phase III trial is unlikely because of rarity of condition and small case numbers. Quality trial criteria would be when a valid historical control group is available or there are several preferably large studies with similar patient eligibility or inclusion criteria and specified patient outcomes. half the points for Phase II evidence (PFS only) ie divide PFS score by 2. For phase II trials, do not score for OS. Phase I data is not appropriate. Record exact score to one decimal place if necessary (eg 2.5). Specify where Phase III data may be in progress, where Ph II data have been quoted. NB where the time falls halfway between two scores, use the higher score..a Disease Free Survival, Progression Free Survival, Time to Treatment Progression (Specify) DFS Y/N PFS Y TTP Y/N Other (specify) Of trials which report measures of PFS,DFS and TTP, it is the primary specified outcome measure for the trial which is to be used for scoring purposes Criteria Absolute values for benefit e.g. 2.3 months versus 8. 4 months = 3.9 months (Please quote p value below) Less than 2 months Recorded 2. to 3. months 2 4 to 5 months 3 6 to 7 months 4 8 to 9 months 5 VTD 56.2 mths vs. TD 28.2 mths Diff = 28 mths 7

2 to months 6 > 2 months 7 Precision of PFS/DFS/TTP (Please quote p value) HR (quoted in trial) Absolute values (HR) e.g..82 ; 95%CI.673 to. ; p=.5 Hazard Ratio p=..b Overall Survival If Phase II data, the score for OS benefit will automatically be set at zero, unless there is a very robust comparison possible with a contemporaneous study of equivalent patients who did not receive the treatment under evaluation. Criteria Absolute values for benefit e.g. 2.3 months versus 8. 4 months = 3.9 months (Please quote p value below) Less than 2 months Recorded 2 to 3 months 2 4 to 5 months 3 6 to 7 months 4 8 to 9 months 5 to 2 months 6 > 2 months 7 Median OS not reached in either PETHEMA (median F/U 35.2m) Precision of OS (Please quote p value) HR (quoted in trial) Absolute values (HR) e.g..82 ; 95%CI.673 to. ; p=.5 Hazard Ratio N/A 2 Quality of life Criteria Recorded Published evidence of significant improvement in overall Quality of Life (QOL), using a validated tool. 2 Measurable evidence of significant improvement in relevant aspect(s) of QOL using a validated tool or evidence of lack of deterioration in overall QOL using a validated tool or clear evidence of major improvement in QOL without validated tool (eg clinically significant reduction in blood transfusion) No QOL data collected in the trial or QOL data not analysed

3 Measurable evidence of significant deterioration in relevant aspect(s) of QOL using a validated tool or clear evidence of major deterioration in QOL without a validated tool (eg clinically significant increase in incidence of febrile neutropenia) Published evidence of significant deterioration in overall QOL using a validated tool. Minus Minus 2 3 Toxicity compared to the existing active standard therapy. Criteria Recorded Significant improvement 2 Improved Equal Worsened Minus - Significantly worsened Minus 2 4 Degree of clinical unmet need, i.e. a step change for the clinical setting concerned eg the first ever systemic therapy for a condition. N.B. If there has been no score in section of this tool, then no score can be assigned for this section unless case made for exception Criteria Recorded or N/A No alternative treatment 3 Alternative Active standard treatment exists 5. Strength of Evidence Criteria Grade Recorded Grade Two or more good quality Phase III Randomised Controlled Trials, both published A One good quality Phase III Randomised Controlled Trial, published Comparative Phase II trial, published B C A Non-Comparative Phase II, published Unpublished data (in abstract form only) Unpublished data (in abstract form only) 2 D U U2 Appropriate methodology for the treatment setting, presented at an international meeting 2 Methodology inappropriate for treatment setting and/or not presented at international meeting

4 6 References and Search Strategy: References: Morgan G. et al. Cyclophosphamide, thalidomide, and dexamethasone as induction therapy for newly diagnosed multiple myeloma patients destined for autologous stemcell transplantation: MRC Myeloma IX randomized trial results. Haematologica. 22 Mar;97(3): Harousseau J. et al. Bortezomib Plus Dexamethasone Is Superior to Vincristine Plus Doxorubicin Plus Dexamethasone As Induction Treatment Prior to Autologous Stem- Cell Transplantation in Newly Diagnosed Multiple Myeloma: Results of the IFM 25- Phase III Trial. J Clin Oncol 28: Rosinol L., et al. Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study. Blood. 22 Aug 23;2(8): Cavo, M. et al. Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study. Lancet 2; 376:

5 Decision summary Total Additional Notes 6A The request was for the use of the combination of bortezomib and dexamethasone (VD) or bortezomib, thalidomide and dexamethasone (VTD) as induction chemotherapy in previously untreated patients with myeloma eligible for high dose chemotherapy and stem cell transplant. Standard induction chemotherapy in the UK is currently cyclophosphamide, thalidomide and dexamethasone (CTD). Data from a number of trials of VD or VTD were submitted but none had been compared with the CTD combination. The studies of VD were not considered further as the comparators in these studies were combinations which in the UK have been superceded by CTD. The National Cancer Drug Fund (NCDF) panel thus examined two trials which compared VTD vs TD. It concentrated on the Pethema study as this had a treatment pathway which was considered to be closest to UK practice (mainly because the study design used a single stem cell transplant though the panel noted maintenance treatment as part of the study design [the latter not considered to be standard treatment in the UK]). The panel noted the superior complete remission rates post induction (35 vs 4%) and post stem cell transplant (46 vs 24%), the superior progression free survival (PFS) (56 vs 28 mo) but the absence of any survival benefit. The superior complete remission rates came at the expense of increased toxicity. The applicant informed the panel that they (and some other myeloma experts) considered CTD to be equivalent to TD (ie that the contribution of the cyclophosphamide was insignificant) though there was no direct evidence to support this assertion. The applicant also considered that the complete remission rates after induction treatment and high dose chemotherapy were suitable proxies for survival and that the superior complete remission rates observed in the Pethema trial would lead to a benefit in overall survival (OS) with longer follow-up. In terms of the CDF scoring tool, bortezomib in this application scored 7 for PFS, + for OS, + for QOL, for toxicity and + for unmet need = 6 B. The NCDF panel debated three main issues. The first was whether CTD and TD were equivalent and this was concluded to be unknown (given that new agents such as thalidomide have brought greater efficacy to the treatment of myeloma yet cyclophosphamide has contributed significantly over the years). The second issue was that there is, as yet, no survival difference in the Pethema trial. Despite the big difference in PFS, it is clear that 2nd and further lines of therapy are having a significant effect on the disease and therefore on OS. It was considered to be unknown, as yet, whether bortezomib is better used in induction therapy or kept in reserve for 2nd line treatment. The panel was also unsure as to whether the relationship between complete remission rate post stem cell transplant and survival was a robust one, particularly with the active 2nd and further line therapies currently available. The final issue was that the NCDF panel was wary of changing a myeloma treatment pathway on this early evidence without evidence of OS benefit, particularly in view of the clear OS benefits of bortezomib in the 2nd line setting where it should be freely available in NHS England. The CDF panel concluded that bortezomib was not to be added to the NCDF cohort policy list in view of the above issues although would be happy to reconsider if there was a robust OS difference with VTD on further follow-up.

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