DECISION AND SUMMARY OF RATIONALE

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1 DECISION AND SUMMARY OF RATIONALE Indication under consideration Clinical evidence Clofarabine in the treatment of relapsed acute myeloid leukaemia (AML) The application was for clofarabine to remain in the CDF as treatment for patients with relapsed acute myeloid leukaemia (AML). The CDF panel was aware that clofarabine was unlicensed in this indication and had never been appraised by NICE for this indication. There are no randomised trials to inform the evidence base related to this indication. PFS = 0 OS = 0 QoL= 0 Tox = -2 Unmet need = 0 The evidence base is limited to various phase 2 studies, all of which are of small patient numbers. Becker (2011) reported 50 patients with relapsed AML treated with clofarabine in combination with high dose cytarabine and filgrastim priming (GLAC). The complete remission (CR) rate was 46% and the median overall survival (OS) was 9 months (mo). The median duration of follow-up was 1.9 years. There were 17 patients still alive at the time of reporting, 13 of which had been treated with high dose chemotherapy (HDCT) and stem cell transplantation (SCT). Toxicity was very significant especially infective and pulmonary in nature and less so affecting the skin, liver, gastrointestinal tract and kidneys. The CDF panel observed a persistent tail on the OS curve over time. The CDF noted the retrospective study performed to compare the efficacy of a clofarabine plus high dose cytarabine based combination in one institution vs a fludarabine plus high dose cytarabine based treatment in another treatment centre in adult relapsed refractory AML. The median OS duration for GCLAC was 8.8 mo. The progression free survival duration was not reported for GCLAC. After accounting for duration of 1st complete remission, salvage number of regimens, age and cytogenetics, GCLAC was associated with a higher CR rate (odds ratio of 9.6, p<0.0001) and longer OS (hazard ratio 0.43, 95% confidence interval not stated, p=0.0002). The CDF panel noted the modest but significant tail on the OS curve over time in the GCLAC series. The CDF panel was aware that the use of clofarabine in relapsed/refractory AML is an unlicensed indication. It knew that the standard treatment for patients with relapsed/refractory AML as first choice salvage chemotherapy was the combination of fludarabine, idarubicin, cytarabine and filgrastim. The panel considered that it was biologically plausible for clofarabine-based treatment to still be potentially successful salvage treatment but would seek an opinion from the NHS England Bone Marrow Transplantation Clinical Reference Group for the data and role of clofarabine-based therapy in relapsed/refractory AML as potential salvage treatment. It noted the continued low but persistent number of applications to the CDF for the

2 use of clofarabine in relapsed/refractory AML (56 applications for use of clofarabine for AML in 2014/15). The CDF panel noted that the use of clofarabine is still present in some international treatment guidelines. The CDF panel understood that its decision making could affect the opportunity for patients and clinicians in England to participate in international trials of the systemic therapy of AML. The CDF panel recognised that there was a tail on the clofarabine OS curve over time in view of the patients that responded to initial treatment with a clofarabine-based combination and then went onto HDCT and SCT. It was satisfied that a proportion of such treated patients would be cured of relapsed AML and this outcome would not be possible without such clofarabine-based treatment. The panel s scores for clofarabine-based combination chemotherapy in relapsed/refractory AML were as follows: - 0 for PFS (no data) - 0 for OS (phase 2 study) - 0 for QOL (phase 2 study, no data) - minus 2 for toxicity - 0 for unmet need. This resulted in a total of -2D. The CDF panel recognised that if clofarabine-based chemotherapy did not result in any significant chance of HDCT and SCT (and thus cure), then the panel s scoring would reflect an accurate measure of the impact of the drug. However, the panel was clear that there was a modest but definite chance of longer term survival and cure and thus there would be a tail on the OS curve over time. The CDF scoring of clofarabine therefore greatly underestimated the potential value of the treatment. It did not regard clofarabine-based treatment as a step change in the management of relapsed/refractory paediatric AML nor was it the only active systemic therapy in AML. Nevertheless clofarabine-based treatment did provide a modest chance of successful rescue which in any population would provide a long term return on the investment. The panel concluded that this was a case in which it should use its clinical judgement alongside the scores from the National Cancer Drugs Fund Prioritisation Tool and should depart from the result that would be suggested by that tool. Cost Conclusion CDF criteria for use Total clinical score -2D The cost of clofarabine per cycle at the list price (including VAT) is 23,871. Despite the high drug cost of clofarabine (albeit measured within the rare CDF drug scoring system), the CDF panel decided that in view of the above considerations as to the potentially curative benefit provided by treatment with clofarabine, the CDF should retain the use of clofarabine-based chemotherapy in relapsed /refractory AML provided that this regimen continues to be relevant in everyday practice and used as a bridge to transplant. As per current criteria Key for strength of evidence:

3 Criteria Two or more good quality Phase III Randomised Controlled Trials, both published One good quality Phase III Randomised Controlled Trial, published Comparative Phase II trial, published Non-Comparative Phase II, published Unpublished data (in abstract form only) 1 Unpublished data (in abstract form only) 2 Grade A B C D U1 U2

4 NATIONAL CANCER DRUG FUND PRIORITISATION SCORES Drug Indication Regimen (where appropriate) Clofarabine In the treatment of relapsed acute myeloid leukaemia (AML) As above 1 Magnitude of Survival Benefit (progression free survival and overall survival) Additional incremental benefit over comparator treatment in pivotal Phase III trial. Abstracts will be accepted if they are updates of published and peer-reviewed papers 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 pre-specified patient outcomes. half the points for Phase II evidence (PFS only) i.e. 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 (e.g. 2.5). Specify where Phase III data may be in progress, where Phase II data have been quoted. If the main evidence base is a randomized phase II study, then score as for phase III study if comparator(s) appropriate; indicate clearly in this situation that this is data from a randomized phase II study NB where the time falls halfway between two scores, use the higher score. 1.A Disease Free Survival, Progression Free Survival, Time to Treatment Progression (Specify) DFS Y/N PFS Y/N 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 months versus 8. 4 months = 3.9 months (Please quote p value below) Less than 2 months 0 Recorded 2.0 to 3.0 months 2 4 to 5 months 3 6 to 7 months 4 8 to 9 months 5 10 to 11 months 6 No data 0 12 to 13 months 7 14 to 15 months 8 16 to 17 months 9

5 18 to 19 months to 21 months to 23 months months 13 Precision of PFS/DFS/TTP (Please quote p value) HR (quoted in trial) Absolute values (HR) e.g ; 95%CI to ; p= Hazard Ratio N/A 1.B Overall Survival If Phase II data, the score for OS benefit will automatically be set at zero, unless it is a randomized phase II study (with appropriate comparators and marked clearly as a randomized phase II study) or 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 months versus 8. 4 months = 3.9 months (Please quote p value below) Less than 2 months 0 Recorded 2 to 3 months 2 4 to 5 months 3 6 to 7 months 4 8 to 9 months 5 10 to 11 months 6 12 to 13 months 7 14 to 15 months 8 Not scored phase II trial to 17 months 9 18 to 19 months to 21 months to 23 months months 13 Precision of OS (Please quote p value) HR (quoted in trial) Absolute values (HR) e.g ; 95%CI to ; p= Hazard Ratio N/A

6 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 (e.g. clinically significant reduction in blood transfusion) No QOL data collected in the trial or QOL data not analysed 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 (e.g. clinically significant increase in incidence of febrile neutropenia) Published evidence of significant deterioration in overall QOL using a validated tool. Minus 1 Minus 2 3 Toxicity compared to the existing active standard therapy (best supportive care is considered an active standard therapy for the purposes of scoring toxicity). Criteria Recorded Significant improvement 2 Improved 1 Equal 0 Worsened Minus 1-2 Significantly worsened Minus 2 4 Degree of clinical unmet need, i.e. either the first demonstration of efficacy of a systemic therapy for the disease concerned or a step change for the clinical setting concerned. N.B. If there has been no score in section 1 of this tool, then no score can be assigned for this section unless case made for exception Criteria Recorded or N/A This drug is the first demonstration of efficacy of a systemic therapy for the disease concerned or a step change for the clinical setting concerned 3 0 Neither of the above applies 0 5 Cost per QALY if available. The Costs per QALY calculated by NICE in the course of an appraisal are the most accurate costs per QALY for use in England and Wales. NB Cost per QALY scores will only be used as a tie-breaker for prioritisation in the event of the overall scores incorporating evaluation of clinical efficacy and median drug cost being equal and cost per QALY data is available for compared options at the same drug prices offered to the CDF. The NICE TA number must also be identified below. Cost per QALY, NICE TA identification number and confirmation that this cost/qaly has incorporated the same price as offered to the CDF must be set out here.

7 N/A 6 Cost A further score will be given depending on the median cost of the drug under evaluation. This score will depend on the cost bands used by the NCDF Panel. This scoring system and the score for a drug in this scoring system remains commercially confidential as it would provide an indication of the cost at which the drug was offered to the CDF. 7 Treatment pathway and other key clinical issues Describe the place in the treatment pathway that this application refers to. Set out what the standard comparators are to this application in terms of everyday practice in England State the treatments that this drug will replace and thus be potentially eligible for de-commissioning State whether introduction of this drug/indication into the treatment pathway will increase, decrease or not change the other treatment options in the pathway Set out the eligibility criteria for treatment with this drug/indication State what the rules should be for continuation and discontinuation of the drug/indication Set out the evidence of national support for this application Manufacturer stated: Sanofi has not been able to identify any guidelines in the UK for the treatment of AML. The NCCN describes 3 lines of therapy each attempting to induce CR in order to enable a curative allogenic stem cell transplant. The first regimen is typically cytarabine with either idarubicin or daunorubicin. The second regimen would be the alternative to that first used (i.e. idarubicin if daunorubicin had been previously used) or high dose cytarabine. Clofarabine would be utilised within the GCLAC regimen as a third or later line of aggressive treatment to induce CR prior to transplant (Becker et al. 2015, Am J Hematol, 90: ). 8 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 D Non-Comparative Phase II, published Unpublished data (in abstract form only) 1 Unpublished data (in abstract form only) 2 D U1 U2 1 Appropriate methodology for the treatment setting, presented at an international meeting 2 Methodology inappropriate for treatment setting and/or not presented at international meeting

8 9 Overall score The overall score will take into account the score of clinical benefit in conjunction with the assessment of median drug cost. This score is subject to interpretation and modification by the NCDF Panel if the scoring tool does not adequately reflect the assessed clinical benefit. This overall score is commercial in confidence as it includes the price at which the drug is made available to the CDF. 10 References and Search Strategy: PubMed Search Strategy: Indicate below e.g.: Search terms (MeSH Terms) used in PubMed searches and dates of access for websites viewed. No formal literature search was undertaken References: Please provide Word, pdf or hard copy references with the application 1. Clofarabine EMA Summary of Product Characteristics SMC Guidance No. 327/06, December Becker et al. 2011, BJH 155: Becker et al. 2013, Haematologica, 98: Becker et al. 2015, Am J Hematol, 90: Additional Information: For example: Definitive benefits of new treatment not captured above Trial data planned to prove non-inferiority with existing standard treatment. No unpublished/ In-House/Data on File Pharma contributions to be submitted Manufacturer stated: Please note the limitations of the available data and that the drug was originally licensed by the EMEA under exceptional circumstances for a rare paediatric ALL (acute lymphoblastic leukemia). As such, while limited data is available recent studies have shown significant activity in leukaemia as a slavage therapy. For NCDF Panel use only Total Additional Notes -2D and a confidential cost score

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