Toward greater efficiency and equity in healthcare resource allocation: Dr Panos Kanavos to lead consortium in ADVANCE_HTA European Commission FP7 grant

Healthcare policymaking is increasingly driven by the need to reconcile mounting healthcare system demands with constrained resources. This is particularly true for medical technologies such as pharmaceuticals, medical devices and diagnostics, which comprise a sizeable proportion of healthcare budgets. In the health policy sphere, efforts to match resources with demands are often centred on devising and implementing policies that deliver greater value for money. The undertaking of value assessments for medical technologies by way of Health Technology Assessment (HTA) is one such policy lever that can be deployed in achieving this end. Through the rigorous evaluation of clinical and pharmaco-economic evidence, together with relevant stakeholder perspectives, HTA endeavours to inform healthcare resource allocation and decision-making at the micro-, meso-, and macro-levels of the healthcare system

Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States

This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors - including institutional ones - contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market

Medicines in parallel trade in the European Union: a gravity specification

While recent research has explored the phenomenon of drug parallel trade in regulated environments such as the European Union (EU), or the European Economic Area, little is known about the mechanisms that explain its origin or the role of the distribution chain in exporting and importing countries in determining its extent. By building on theoretical literature explaining the role of the distribution chain, this paper draws on an empirical specification of a gravity model to examine the determinants of inter-country flows of parallel-traded drugs. In this context, the paper deals with the effect of differences in the regulation of and competition in the distribution chain in the countries of origin and destination. The paper draws on proprietary data from the Intercontinental Medical Statistics database (for the Netherlands and other EU countries that export to the Netherlands) which identify the country of origin of parallel-imported medicines from 1997-2002 for a therapeutic group (statins) for which there is no generic competition. The study reveals that although parallel trade is a specific form of arbitrage, it is primarily a regulation-induced phenomenon. As a result, although the driving force for parallel trade is price differences across countries, the propagation mechanism lies in (a) the way drug prices are regulated across countries and (b) fragmentation and the underlying incentive structure in the wholesale distribution chain in countries where drug prices are regulated. The implications that flow from our study are that a more flexible and competitive and less fragmented (along national borders) distribution chain, particularly at wholesale level, might reduce the extent of and potential for parallel trade

The pharmaceutical distribution chain in the European Union: structure and impact on pharmaceutical prices

In an environment characterised by fragmentation in the market structure of wholesale and retail entities, significant diversity in terms of remuneration schemes as well as regulations pertaining to operational features of wholesale and retail entities, but also significant developments in policy and practice concerning distribution, the objective of this report, is twofold: First, to map the distribution chain in EU Member States, including the main actors in wholesaling and retailing, discuss the requirements to provide certain services and outline their sources of remuneration, both direct and indirect. Second, to collect and analyse data on distribution margins, fees and service requirements in the originator and generic markets in EU Member States with a view to understanding the impact the distribution chain is having on the prices of reimbursable prescription only medicines (POMs). The report does not address issues relating to over-the-counter (OTC) medications

Acquiring pharmaceutical industry assets in the UK: 1 + 1 = 1?

The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Similarities between the two companies include dropping sales; however, relative to its size, AstraZeneca has a more promising R&D pipeline, especially in therapeutic areas where Pfizer’s strength is currently limited (e.g. oncology). Ensuring a portfolio diversification would make Pfizer’s takeover proposal a knight’s one, but history points towards a knave-like behavior

Value-based assessment of new medical technologies: towards a robust methodological framework for the application of multiple criteria decision analysis in the context of health technology assessment

In recent years, multiple criteria decision analysis (MCDA) has emerged as a likely alternative to address shortcomings in health technology assessment (HTA) by offering a more holistic perspective to value assessment and acting as an alternative priority setting tool. In this paper, we argue that MCDA needs to subscribe to robust methodological processes related to the selection of objectives, criteria and attributes in order to be meaningful in the context of healthcare decision making and fulfil its role in value-based assessment (VBA). We propose a methodological process, based on multi-attribute value theory (MAVT) methods comprising five distinct phases, outline the stages involved in each phase and discuss their relevance in the HTA process. Importantly, criteria and attributes need to satisfy a set of desired properties, otherwise the outcome of the analysis can produce spurious results and misleading recommendations. Assuming the methodological process we propose is adhered to, the application of MCDA presents three very distinct advantages to decision makers in the context of HTA and VBA: first, it acts as an instrument for eliciting preferences on the performance of alternative options across a wider set of explicit criteria, leading to a more complete assessment of value; second, it allows the elicitation of preferences across the criteria themselves to reflect differences in their relative importance; and, third, the entire process of preference elicitation can be informed by direct stakeholder engagement, and can therefore reflect their own preferences. All features are fully transparent and facilitate decision making

Value-based assessment of new medical technologies: towards a robust methodological framework for the application of multiple criteria decision analysis in the context of health technology assessment

In recent years, multiple criteria decision analysis (MCDA) has emerged as a likely alternative to address shortcomings in health technology assessment (HTA) by offering a more holistic perspective to value assessment and acting as an alternative priority setting tool. In this paper, we argue that MCDA needs to subscribe to robust methodological processes related to the selection of objectives, criteria and attributes in order to be meaningful in the context of healthcare decision making and fulfil its role in value-based assessment (VBA). We propose a methodological process, based on multi-attribute value theory (MAVT) methods comprising five distinct phases, outline the stages involved in each phase and discuss their relevance in the HTA process. Importantly, criteria and attributes need to satisfy a set of desired properties, otherwise the outcome of the analysis can produce spurious results and misleading recommendations. Assuming the methodological process we propose is adhered to, the application of MCDA presents three very distinct advantages to decision makers in the context of HTA and VBA: first, it acts as an instrument for eliciting preferences on the performance of alternative options across a wider set of explicit criteria, leading to a more complete assessment of value; second, it allows the elicitation of preferences across the criteria themselves to reflect differences in their relative importance; and, third, the entire process of preference elicitation can be informed by direct stakeholder engagement, and can therefore reflect their own preferences. All features are fully transparent and facilitate decision making

Healthcare payer perspectives on the assessment and pricing of oncology multi-indication products: evidence from nine OECD countries

Background: New pharmaceuticals are increasingly being developed for use across multiple indications. Countries across Europe and North America have adopted a range of different approaches to capture differences in the value of individual indications. Objective: The three aims of this study were (i) to review the price-setting practice over the past 5 years for multi-indication products across England, France, Italy, Spain, Belgium, Switzerland, Turkey, Canada and the USA; (ii) to assess the impact of current practices on launch strategy; and (iii) to identify issues in the implementation of indication-based pricing. Methods: Ten current and former members of health insurance organisations, healthcare payer organisations or health technology assessment agencies with expertise on pharmaceutical purchasing were invited to participate in semi-structured interviews. Interview transcripts were imported into NVivo 12 for thematic analysis. Results: The majority of countries studied require full assessments upon launch of a new indication. Five different approaches to pricing were identified: weighted pricing, differential discounting, mandatory discount, price anchoring and free pricing. Manufacturers show a tendency to launch first in niche indications with high unmet need to achieve a high price. Stakeholders from England, France, Italy, Belgium and Switzerland consider their current system fit for purpose, while other countries expressed concern over the administrative burden of monitoring products at indication level. Conclusions: Given the high administrative burden, it is questionable whether indication-based pricing would provide additional public benefit above and beyond current weighted dynamic single pricing and differential discounting practices for multi-indication products