Collecting Real World Evidence: HTA s perspective
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- Hollie Moore
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1 Collecting Real World Evidence: HTA s perspective Dr. Kelvin Chan, MD FRCPC MSc (Clin Epi) MSc (Biostats) Clinical Lead, Provincial Drug Reimbursement Programs, CCO Co-Director, Canadian Centre for Applied Research in Cancer Control Medical Oncologist, Sunnybrook Odette Cancer Centre Advancing Health Economics, Services, Policy and Ethics
2 Contents What types of uncertainty do HTA committees encounter in their deliberations? How often does pcodr Expert Review Committee (perc) request collecting evidence to reduce uncertainty? What types of information can be potentially obtained by collecting real world evidence (RWE)?
3 Disclaimer Member of HTAs pcodr Expert Review Committee Committee to Evaluate Drugs Ontario Steering Committee of Cancer Drugs Personal opinion Does not represent the views of U of Toronto, pcodr, CED, OSCCD, CCO, Ministry etc. Information from publicly available source
4 Ontario Cancer Plan IV ( )
5 Health Technology Assessment (HTA) Committee s Recommendations
6 Recent Example
7 Things that HTA committees consider before making a recommendation to fund (or not to fund) In general, HTA committees (pcodr, CED, OSCCD) consider the following inputs: Clinical benefit (from clinical trial data) Efficacy (survival) data Safety data Quality of Life (QOL) data Patient values Cost-effectiveness and budget impact Adoption feasibility
8 Uncertainty in clinical data Uncertainty in clinical data Survival data Missing or limited Surrogate of overall survival Non-comparative Short term data Safety data Missing data/late data Quality of life data Missing data (numerous examples)
9 Non-Comparative Data Romidepsin in Peripheral T-Cell Lymphoma It was noted that due to the limitations of relying on non-comparative, non-randomized evidence and the heavy reliance on extrapolation of overall survival data, there was substantial uncertainty in the magnitude of the net clinical benefit associated with romidepsin. - pcodr Expert Review Committee Final Recommendation Adapted from Piekarz et al. BLOOD 2011 Adapted from Coiffier et al. JCO 2012
10 Missing Quality of Life Data Vismodegib in Basal Cell Carcinoma quality of life and functional outcomes are very important in this population. Patients with BCC who are inappropriate for surgery may experience severe disfigurement, leading to extreme social isolation and decreased quality of life. - pcodr Expert Review Committee Final Recommendation Survival is main a concern for patients with locally advanced or metastatic disease Disease progression may lead to facial disfigurement, and thus a decreased QoL This study presents no QoL data, however researchers connected a response and decreased tumour size to an improvement in overall QoL Adapted from Sekulic et al. NEJM 2012
11 Economic evidence: Estimation or guess-timation Cost-effectiveness analysis and budget impact analysis Model structure and methods Comparator and long term clinical efficacy Uncertainty in the inputs of the model Number of patients Duration of drug treatments Resource utilization Underestimation of ICER (sometimes 1-2 fold difference) Underestimation of BIA
12 Short Term Survival Data Pembrolizumab in Unresectable Metastatic Melanoma In the absence of longer term data, perc was unable to accept this assumption of prolonged benefit and agreed with the EGP s use of alternative data sources to extrapolate survival in both settings. - pcodr Expert Review Committee Final Recommendation Adapted from Robert et al. NEJM 2015
13 Loss in Translation : Uncertainty about Translating clinical trial evidence to the real world Trial patients are different from real world patients e.g. age, co-morbidities, performance status, diffusion Intensive monitoring on trial Different practice patterns in the real world Duration of treatment (treatment until progression vs. discontinuation before progression) Dose intensity of treatment in the trials vs. in the real world Management of side-effects (e.g. febrile neutropenia are managed mostly as in-patient in Ontario) Sequencing of subsequent lines of available therapy Different from what was available on the trial Changes in drug price over time (e.g. generics) Drop in price in the older drugs will make the new drug less costeffective
14 EXPERIENCE OF pcodr EXPERT REVIEW COMMITTEE (perc)
15 Requesting Real World Evidence pcodr 60 reviews (Up to Feb 2016) Total of 21 pcodr reviews requested Real World Evidence 13 pcodr reviews explicitly requested Real World Evidence 10 pcodr reviews potentially requested Real World Evidence Potential RWE Request: Unclear if perc requested RWE, but it could be beneficial
16 Next Steps for Real World Evidence Collection Inform magnitude of clinical benefit and cost-effectiveness or the true cost-effectiveness Define the potential clinical benefit or magnitude of clinical benefit Define the population or disease Inform duration of treatment Inform duration of treatment and cost-effectiveness Inform sequencing of available therapies 7 23 requests for RWE for 21 studies
17 Breakdown of pcodr Reviews 60 Final Recommendations Positive Recommendation Conditional Recommendation Negative Recommendation (4 requested RWE) (17 requested RWE) 39
18 Number of Recommendations Temporal Trends in RWE Requests 60 perc Final Recommendations Negative Recommendations Without RWE Request With RWE Request Final Recommendation Issue Year
19 Number of Recommendations Breakdown by Tumour Site 60 perc Final Recommendations Negative Recommendations Without RWE Request With RWE Request Heme Melanoma GI GU Lung Breast Other Gyne Tumour Site
20 Number of Studies Breakdown by Study Characteristics: 21 Studies Primary Endpoint of Final Recommendations Requesting RWE DSV (Decrease in Spleen Volume), MCyR (Major Cytogenetic Response), MaHR (Major Haematological Response)
21 WHAT REAL WORLD EVIDENCE CAN WE COLLECT?
22 Potential Deliverables (effectiveness, safety, quality of life, cost-effectiveness)
23 Potential Deliverables (verify economic models)
24 Discussions HTA committees commonly make best possible recommendations based on substantial uncertainties pcodr ERC commonly requests for the collection for further evidence to reduce uncertainties How can further evidence be collected? Routinely collected data (population-based admin data) Evidence building program (prospective collection of data) Real world experiments (real world pragmatic randomized trials) Who will use this evidence once collected? Practitioners and patients informed treatment decisions Policy decision-makers and payers Re-HTA (recommendation-makers)
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that the best available evidence has not demonstrated that pcr can predict long-term outcomes in the neoadjuvant setting.
pcr in one arm of a randomized clinical trial comparing two neoadjuvant chemotherapies predicts for improved event-free or overall survival in that arm of the clinical trial. perc noted that the NeoALTTO
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large impact on cost-effectiveness. perc discussed that one of the main factors affecting the costeffectiveness estimates was the survival estimates used in the economic model. In reviewing the clinical
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well structured and organized, provided perc with a much deeper understanding of patients experiences with relapse or refractory CLL/SLL and its treatment. perc deliberated upon the cost effectiveness
The pcodr review also provided contextual information on ALK mutation testing.
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differ and that they each has a unique mechanism of action. As such perc considered that it would be important for clinicians and patients to be able to choose either drug as a first-line treatment option.
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Overall, perc considered that everolimus aligned with patient values. Patient advocacy group input on everolimus indicated that patients with pnets value the outcome of progression-free survival as a measure
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noted that there are case reports of a rebound effect upon discontinuation of ruxolitinib (Tefferi 2012), although this was not observed in either the COMFORT I or COMFORT II studies. Therefore, perc considered
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at least one dose interruption. perc noted the manufacturer of ponatinib issued a dose reduction recommendation in the PACE study; however, there are currently no data on the optimal starting dose for
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information aligned with the expected toxicity profile of panitumumab, which is well-known as panitumumab is already used as a third-line therapy for patients with mcrc. perc also noted QoL did not deteriorate
Clinician input indicated that avelumab in second-line treatment would be used following chemotherapy and should be strongly considered as first-line. However, perc noted that avelumab in the first-line
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perc discussed the feasibility of adoption of intralesional therapy with aldesleukin and noted that aldesleukin had been in use in this way for this patient population for a number of years as it was previously
patients who have received multiple lines of prior chemotherapy including a platinum-containing regimen patients without formal measurable disease
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ipilimumab aligned with patient values. Although few patients had direct experience using this combination agent, patients indicated that side effects associated with nivolumab plus ipilimumab were few
midostaurin should be extended to patients who are deemed fit to receive intensive induction and consolidation, regardless of age.
midostaurin should be extended to patients who are deemed fit to receive intensive induction and consolidation, regardless of age. perc deliberated on the toxicity profile of midostaurin and noted that
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brentuximab. Given that the median survival of Hodgkin lymphoma patients who relapse after ASCT is approximately two years, perc considered that the manufacturer had substantially overestimated the incremental
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cetuximab plus FOLFIRI to convert unresectable liver metastatses to resectable, perc confirmed that neither the FIRE-3 study nor the CRYSTAL study were designed to assess resectability and, in the absence
for patients with ECOG PS 0-1 as indicated in the CheckMate-067 trial. Upon reconsideration of the Initial Recommendation, perc noted PAG s feedback requesting guidance on extrapolating eligibility to
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CheckMate 025, as patients may derive a benefit, based on the opinion of the CGP and the mechanism of action of nivolumab.
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risks. Therefore, perc agreed that the reimbursement criteria should match the eligibility criteria of the SELECT trial.
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to be meaningful. Considering the impact of cough on patients QoL, perc noted that improvement in cough within the FLAURA trial was meaningful to patients. perc, however, noted that fatigue was the most
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require close monitoring. perc noted that induction therapy is generally administered in-hospital while consolidation therapy is administered on an out-patient basis. Because of the potential for serious
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into consideration the concerns of the patient. Upon reconsideration of the perc Initial Recommendation,the Committee discussed feedback from the patient advocacy group reporting concerns that the definition
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