Krebsforschung in der Schweiz - SAKK – Swiss Group for Clinical ...

SAKKHow to get involved in ahealth economic analysis:an introduction for clinicalresearchersKlazien Matter-Walstra, Matthias Schw enkglenks,Thomas Szucs, Bernhard PestalozziIn the current oncology climate, reimbursement authoritiesand care providers are in need of evidence demonstratingnot only the clinical effi cacy and safety of newtreatments but their economic value as well. Recentpolicy initiatives in Switzerland express an interest in«real-world» data and request to show favorable healtheconomic characteristics in combination with clinicalbenefi t. One obvious and accepted way to collect datafor a health economic analysis (HEA) is to «piggy-bag»the analysis onto a clinical trial. The only main caveataround this approach is that the effects observed in effi -cacy-oriented clinical trials may not be fully retained inroutine practice settings. The methodology to performpiggy-bag health economic evaluations has been welldescribed (2, 6, 8). However, clinical researchers mayfeel uncomfortable about performing a HEA alongsidetheir study. A recent paper by Marshall et al. (6) providesanswers to many of the questions raised – a highly recommendedreading. In this contribution we will addressthese concerns and advocate for understanding and supportfor HEA alongside oncology trials.Why should a study have a HEAA clinical trial is primarily set up to show clinical benefit. Health economists interfere with this neat plan andintend to show that a new treatment is also cost-effective.What if in the end, the new treatment shows some clinicalbenefi t but does not meet criteria for cost-effectiveness? Isthis important for the clinician to know? Yes, it is. Evidenceof value for money is increasingly being requested,along with clinical safety and effi cacy data, by formularycommittees, reimbursement authorities, and nationalhealth-care systems. An accompanying HEA considerablyincreases the overall value of a clinical trial and counterbalancesthe additional effort. If you avoid to perform aHEA now, someone else will run it later, and will need torely, more than necessary, on assumptions instead of informationprovided by the clinical trialist.The health economic hypothesisThere is a fundamental difference in the questions askedby a health economic study as opposed to a clinical study.The traditional randomized controlled clinical trial isconsidered the gold standard for demonstrating clinicaleffi cacy, while HEA seeks to estimate effi ciency by comparingeffectiveness and cost. In addition, the audienceand readership differ. Clinicians are most interested ineffi cacy, safety, and treatment choices. In contrast, HEAaims at informing the decision making of health care policymakers and payers, by estimating value for money. Itis understandable when a clinical researcher asks a healtheconomist: «What is your hypothesis?», but this questionis misdirected to a certain extent. At a very general level,the hypothesis of an HEA will always be that a treatmentof interest is cost-effective versus an appropriate comparatortreatment. Similarly, an effi cacy trial will always hypothesizethat a treatment of interest is effi cacious versusan appropriate comparator treatment. When it comes tothe specifi cs, the clinician may be in the best position toprovide the required information, due to his/her superiorknowledge of clinical aspects. Because of this, a more specific health economic hypothesis needs to be developed byclinicians and health economists together. It cannot beprovided «ready-made» by the latter professional group.Defining a specific objectiveSo far there is no institution in Switzerland similar to theNational Institute of Clinical Excellence (NICE) in theUK, which decides whether a treatment will be reimbursedby the National Health Service or not. In the UK, HEAaims at estimating the cost per quality-adjusted-life year(QALY) gained. The British threshold for reimbursement isin the range of £20’000-30’000 per QALY. In Switzerland,there is no such an official threshold. Most reimbursementdecisions are still made without a formal consideration ofcost-effectiveness. Therefore, the primary objective of aHEA in Switzerland is to provide neutral information oncost-effectiveness. Such information is likely to become increasinglyimportant and requested. If we are able to provideinformation on treatment costs and value for moneynow, we may be able to inform and shape future approachesto decision making for the Swiss health care system at thenational level, which are most likely to emerge.HEA endpoints and its time frameThe primary endpoints chosen for clinical trials are oftenearly clinical events such as disease progression, while144 Schweizer Krebsbulletin • Nr. 2/2011