Dávid Dankó, PhD, MSc Corvinus University of Budapest Institute of Management david.danko at uni-corvinus.hu How can value be measured and assessed? ISPOR 5 th Asia-Pacific Conference, Taipei, 2 September 2012
Pharmaceutical innovation: underlying dilemmas in the early 21st century Innovation content of new active substances introduced between 1975 and 2002 Therapeutic value Provides progress in treatment Does not provide progress in treatment Chemical structure New 143 (10%) 201 (14%) SOURCE: BARRAL, P.E. [2004]: 28 ans de résultats de la recherche pharmaceutique dans le monde 1975-2002. IRDES, Párizs Already known 295 (18%) 821 (56%) Real therapeutic breakthrough has become extremely rare Innovation seems to be biased towards sellable therapy areas, while other areas are largely neglected BUT policy backlashes against some forms of innovation More and more new substances cause disappointment in real-life settings The business model of the pharma industry is undergoing a slow but thorough transformation Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (2)
Health technology assessment as a tool to assess value Health technology assessment (HTA) covers all methods for the systematic evaluation of the comparative value of pharmaceutical products and other health technologies linked to pricing & reimbursement decisions by public and private payers preceding to admission to the reimbursement formulary and during formulary management. Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (3)
A definition from practice: HTA is much more than QALY s and ICER s! Health Technology Assessment (HTA) is the scientific evaluation of medical technologies regarding their effectiveness, appropriateness, efficiency as well as social and ethical aspects and implications. HTA is bridging the gap between the worlds of Science and Politics. In times of general health budget restrictions, HTA becomes more and more important by providing political decisionsmakers with timely, accurate and sound information on medical technologies. Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (4)
Three main paradigms for HTA 1 ECONOMIC EVALUATION 2 QUALITATIVE ASSESSMENT 3 BALANCED ASSESSMENT Based on pharmacoeconomics Strict quantitative methods applied by dedicated HTA agency Attempt to arrive at two economic indicators: ICER, budget impact Cost-effectiveness linked to explicit or implicit threshold Supported by structured review Similarity with regulatory approaches Mainly qualitative methodologies based on collective decision-making No attempt to arrive at ICER: scoring is often used, classification is a priority Consideration of non-financial aspects & broader societal impact Synergies between economic evaluation and qualitative assessment Mainly collective decision-making, which is retraceable and publicly accessible Cost-effectiveness is one input to a classification /scoring algorithm Wide consideration of non-financial aspects & broader societal impact PL HU UK KS F I J TW CH S CAN AUS Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (5)
Criticism towards economic evaluation is it really able to capture value? Debate around acceptable ICER cutoff point or range Too much technicism, hard-tounderstand Pseudo-objectivity Legitimation role and business Pricing effect and perverted incentives Costliness and capabilities PUBLIC BACKLASH & SHIFT AWAY FROM ONE-SIDED ECONOMIC EVALUATION Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (6)
Overview of qualitative value assessment criteria used in current international practice Australia France Italy Japan Spain (implicit) Sweden Better pharmacokinetics Budget impact Clinical efficacy Clinical trial Cost-effectiveness () Currently untreated disease Depth of action Industrial policy Logistics costs Market size New mechanism Orphan disease Patient equality Place in therapy landscape Public health significance Relative price Second-line therapy Severity of disease Side effect profile Technological innovation Therapeutic value SOURCE: OWN COMPILATION Different systems weigh elements differently, and no system covers all elements. Focus is sometimes missing. Assessment criteria used in different countries may cover similar concepts under different terminology. Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (7)
Straightening it out: possible framework for a redundancy-free, balanced system Unmet need Cost- effectiveness Therapeutic value added More favourable side effect profile Therapeutic Szöveg value added Ease-of-use (convencience) Budget impact SOURCE: OWN COMPILATION Explicit local policy priorities Higher effectiveness (degree of response) Cost-effectiveness is necessary but not sufficient for drug reimbursement Therapeutic value added is measured along 4 factors Health policy priorities help decide between therapy areas Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (8)
Institutional background in middle-income countries Several payers, complex decisionmaking processes Intuitive, rather than analytical, decision-makers at political levels Budget impact focus, emphasis on financial aspects Questions around the practical applicability of economic evaluation CAPABILITY GAP, institutional cost-effiency Rational free-riding: Peering on selected international assessment Simplified local evaluation: Very focused, pragmatic local assessment Regional shared service centres for value assessment? Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (9)
Some preliminary suggestions There is considerable variation in HTA systems all around the world, with tendencies toward balanced assessment frameworks. Economic evaluation has challenges in middle-income countries. Blindly following the track which Central Europe followed in the past few years is not helpful. When developing a system, both the logic and process are crucial. Dávid Dankó How can innovation be measured and valued? Taipei, 2 September 2012 (10)