Denkbeeldige Wereld: The New Dutch Guidelines for Economic Evaluations in Healthcare

2017

On January 26, 2017, the Institute for Clinical and Economic Review (ICER) posted its final report on treatments for multiple sclerosis (MS) with disease modifying therapies (DMTs). The objective was to provide a modeled assessment of the effectiveness and value of the various DMTs against each other and supportive care. The model considered both relapsing-remitting and primary-progressive MS with hypothetical patient cohorts tracked from therapy initiation to death in a lifetime cost-utility framework. Recommendations were made for possible DMT package price discounts given benchmark willingness-to-pay cost per QALY thresholds. The purpose of this commentary is to assess this modeled analysis from the criteria of normal science: are the claims presented for the competing DMTs credible, evaluable and replicable? The review concludes that the ICER model does not meet required standards. The claims made for comparative effectiveness and value are non-evaluable. They are immune to failure. The review concludes that if models are to contribute to improving our understanding of the effectiveness and costs of DMTs then they should be evaluable in the short-term to allow feedback to formulary committees in a meaningful timeframe. Type: Commentary

Multiple Sclerosis and the Comparative Value Disease Modifying Therapy Report of the Institute for Clinical and Economic Review (ICER)

2017

Imaginary Worlds and Efficiency Frontiers: Should We Abandon the IQWiG Health Technology Assessment Model?

2017

The contribution of cost-effectiveness analysis to the pricing of pharmaceuticals in Germany is at best marginal and in many, if not most cases, absent. While this may reflect a reasonable belief that cost-effectiveness analysis adds little if anything to pricing and formulary placement decisions, its marginalization reflects considerable dissatisfaction, if not frustration, with modeling efforts by the Institut für Qualität und Wirtschaftlichkeit im Gesundheitseesen (IQWiG). In part, this reflects the rejection of quality adjusted life years (QALYs) as the common outcome standard, together with the adoption of the efficiency frontier as the default framework for modeled claims. The purpose of this commentary is to consider the merits, in the German context, of an efficiency frontier framework for cost-effectiveness and pricing decisions. The commentary concludes that the efficiency frontier framework for health technology assessment, in supporting the creation of non-evaluable claims from models or simulations, fails of to meet the standards of normal science: it fails to support claims that are credible, evaluable and replicable. It should be abandoned. If cost-effectiveness modeling is to play a constructive role in pricing negotiations in Germany then manufacturers should be required to submit evaluable claims. The most effective way of ensuring this is to require manufacturers to accompany any submission for a new product with a protocol detailing how their claims, to include those for clinical outcomes, cost-effectiveness and budget impact, are to be evaluated and reported to decision makers in a meaningful time frame. Type: Commentary

Intelligent Design and Imaginary Worlds in Cost-Effectiveness Claims: An Overview of Commentaries in INNOVATIONS in Pharmacy from July 2016 to February 2017

2017

Over the past 30 years, thousands of modeled cost-effectiveness studies have been published. Whether this effort has been worthwhile is debatable. For supporters of modeled cost-effectiveness studies, this effort has been worthwhile because the modeled claims are intended to inform health care decision makes. To opponents, the effort is seen as largely a waste of time because the claims are typically non-evaluable. Rather than subscribing to the standards of normal science in its focus on hypothesis testing through experimentation and replication, opponents have viewed practitioners in health technology assessment as being content to develop imaginary worlds with no thought to their role in practical decision-making. Given this ongoing commitment to constructing imaginary worlds, the purpose of this commentary is bring together the various commentaries, together with supporting publications that have appeared in INNOVATIONS in Pharmacy since mid-2016. This is in response to requests from faculty and graduate students at the College of Pharmacy, University of Minnesota for an overview of the arguments presented to date in support of a new research program that rejects imaginary constructs in favor of credible, evaluable and replicable claims to support formulary decision making. Type: Commentary