Ruth Lopert

Disinvestment and value-based purchasing strategies for pharmaceuticals : an international review

Pharmaceutical expenditure has increased rapidly across many Organisation for Economic Cooperation and Development (OECD) countries over the past three decades. This growth is an increasing concern for governments and other third-party payers seeking to provide equitable and comprehensive healthcare within sustainable budgets. In order to create headroom for increasing utilisation, and to fund new high-cost therapies, there is an active push to ‘disinvest’ from low-value drugs. The aim of this article is to review how reimbursement policy decision makers have sought to partially or completely disinvest from drugs in a range of OECD countries (UK, France, Canada, Australia and New Zealand) where they are publicly funded or subsidised. We employed a systematic literature search strategy and the incorporation of grey literature known to the authorship team. We canvass key policy instruments from each country to outline key approaches to the identification of candidate drugs for disinvestment assessment (passive approaches vs. more active approaches); methods of disinvestment and value-based purchasing (de-listing, restricting treatment, price or reimbursement rate reductions, encouraging generic prescribing); lessons learnt from the various approaches; the potential role of coverage with evidence development; and the need for careful stakeholder management. Dedicated sections are provided with detailed coverage of policy approaches (with drug examples) from each country. Historically, countries have relied on ‘passive disinvestment’; however, due to (1) the availability of new cost-effectiveness evidence, or (2) ‘leakage’ in drug utilisation, or (3) market failure in terms of price competition, there is an increasing focus towards ‘active disinvestment’. Isolating low-value drugs that would create headroom for innovative new products to enter the market is also motivating disinvestment efforts by multiple parties, including industry. Historically, disinvestment has mainly taken the form of price reductions, especially when market failures are perceived to exist, and restricting treatment to subpopulations, particularly when a drug is no longer considered value for money. There is considerable experimentation internationally in mechanisms for disinvestment and the opportunity for countries to learn from each other. Ongoing evaluation of disinvestment strategies is essential, and ought to be reported in the peer-reviewed literature.

Applying rapid 'de-facto' HTA in resource-limited settings: experience from Romania.

BACKGROUND In attempting to constrain healthcare expenditure growth, health technology assessment (HTA) can enable policy-makers to look beyond budget impact and facilitate more rational decision-making. However lack of technical capacity and poor governance can limit use in some countries. Undertaking de facto HTA by adapting decisions taken in countries with established processes is a method that may be applied while building domestic HTA capacity. We explored the potential for applying this approach in Romania. METHODS As part of a review of the basic health benefits available to insured Romanians we examined the listing process and content of the Romanian drug reimbursement formulary. We assessed value for money indirectly by drawing on appraisals by UKs NICE, and for products considered cost effective in the UK, adjusting prices by the ratio of Romanian per capita GDP to UK per capita GDP. FINDINGS We found more than 30 of the top 50 medicines on the Romanian formulary unlikely to be cost-effective, suggesting that existing external reference pricing mechanisms may not be delivering good value for money. CONCLUSIONS While not taking into account local costs or treatment patterns, absent local considerations of value for money, this method offers a guide for both drug selection and pricing. Until robust local HTA processes are established this approach could support further analysis of existing prices and pricing mechanisms. Applied more generally, it is arguably preferable to external reference pricing, product delisting or arbitrary price cuts, and may support the future development of more rigorous, evidence-based decision-making.

The Regional Comprehensive Economic Partnership, Intellectual Property Protection, and Access to Medicines

The inclusion of elevated standards of intellectual property (IP) protection in the recently negotiated Trans-Pacific Partnership (TPP) agreement has raised serious public health concerns regarding access to medicines. A lesser-known trade agreement under negotiation in the Asia-Pacific region is the Regional Comprehensive Economic Partnership (RCEP). Framed as an attempt to reassert ASEAN’s position in response to the United States–led TPP, RCEP includes key players China and India as well as several low- and middle-income countries (LMICs). Leaked drafts of IP provisions proposed by Japan and South Korea raise similar concerns in the Asia-Pacific region. This article identifies TRIPS (Trade Related Aspects of Intellectual Property Rights agreement)-Plus provisions in leaked negotiating texts and examines their implications for LMICs that are not also parties to the TPP: Cambodia, Indonesia, Laos, Myanmar, the Philippines, Thailand, China, and India. We find that higher levels of IP protection delay the market entry of generic medicines, giving rise to increased costs to governments and reduced access to essential medicines. The article concludes that the public health community should recognize risks inherent in trade agreements that promote expansions of IP rights and engage with governments to ensure that public health is adequately and explicitly protected in trade and investment negotiations.

Medication Information for Patients with Limited English Proficiency: Lessons from the European Union

Misuse or misunderstanding of medication information is a common and costly problem in the U.S. The risks of misunderstanding medication information are compounded for the large and growing population of individuals with limited English proficiency that often lacks access to this information in their own language. This paper examines practices related to translation of medication information in the European Union that may serve as a model for future U.S. policy efforts to improve the quality and availability of medication information for individuals with limited English proficiency.

The Trans Pacific Partnership Agreement, intellectual property and medicines: differential outcomes for developed and developing countries.

The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delaying the introduction of low-cost generics. While developing nations negotiated transition periods for implementing some obligations, all parties would have eventually been expected to meet the same standards had the TPP come into force. While the TPP has stalled following US withdrawal, there are moves by some of the remaining countries to reinvigorate the agreement without the United States. The proponents may seek to retain as much as possible of the original text in the hope that the United States will re-join the accord in future. This article presents a comparative analysis of the impact the final 2016 TPP intellectual property chapter could be expected to have (if implemented in its current form) on the intellectual property laws and regulatory regimes for medicines in the TPP countries. Drawing on the published literature, it traces the likely impact on access to medicines. It focuses particularly on the differential impact on regulatory frameworks for developed and developing nations (in terms of whether or not legislative action would have been required to implement the agreement). The article also explores the political and economic dynamics that contributed to these differential outcomes.

Financial costs associated with monopolies on biologic medicines in Australia

Objectives The aim of the study was to estimate the potential savings to the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) in 2015-16 if biosimilar versions of selected biologic medicines (biologics) had been available and listed on the PBS. Methods The research involved retrospective analysis of Australian Medicare expenditure data and PBS price data from 2015-16 for biologics, for which biosimilar competition may be available in future, listed on the PBS. Results Australian Government expenditure on biologics on the PBS and RPBS was estimated at A

Pharma's Next Frontier? New Threats to Public Health in the Regional Comprehensive Economic Partnership Agreement

2.29 billion dollars in 2015-16. If biosimilar versions of these medicines had been listed on the PBS in 2015-16, at least A

The Trans Pacific Partnership Agreement and access to HIV treatment in Vietnam

367million dollars would have been saved in PBS and RPBS subsidies. Modelling based on price decreases following listing of biosimilars on the PBS suggests that annual PBS outlays on biologics could be reduced by as much as 24% through the timely introduction of biosimilars. Conclusions Biologic medicines represent a large proportion of government expenditure on pharmaceuticals. Reducing the length of monopoly protections on these medicines could generate savings of hundreds of millions of dollars per year. What is known about the topic? Biologics take up an increasing share of pharmaceutical expenditure, but no previous published studies have examined Australian Government expenditure on biologics or the potential savings from reducing the duration of monopoly protection. What does this paper add? This paper provides new evidence about Australian Government expenditure on biologics and potential savings for selected medicines that are still subject to monopoly protection and thus are not yet subject to biosimilar competition. In 2015-16 Australian Government expenditure on biologics through the PBS and RPBS was estimated at A

Willingness To Pay For Cancer Therapy

2.29 billion dollars. If biosimilar versions of these medicines had been listed on the PBS at that time, at least A

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States

367million dollars would have been saved. What are the implications for practitioners? Reducing the duration of monopoly protection on biologic medicines could save hundreds of millions of dollars annually that could be redirected to other areas of the healthcare system.