Quantifying public and private investment in European biopharmaceutical research and development.

Robust biopharmaceutical research and development (R&D) ecosystems require investment from both the public and private sectors. In Europe, there is an interest in growing biopharmaceutical R&D given its contribution to public health and the economy, which requires an understanding of current public and private investment. In addition, recent European draft legislation has focused on the public sector's contributions to biopharmaceutical R&D to inform pharmaceutical prices. However, there is little empirical evidence on the specifics of public and private funding for medicine R&D in Europe. This paper performs aggregative data collection to quantify 2019 investment in biopharmaceutical R&D by the public and private sectors in 6 countries: Belgium, France, Germany, Norway, Poland, and the United Kingdom. We find that, across these countries, the private sector accounts for just under two-thirds of investment. We contrast results to those obtained using high-level R&D indicators from the Organization for Economic Co-operation and Development (OECD) and contextualize differences. We then provide 2013-2019 estimates for Belgium, France, Germany, and the United Kingdom (countries with data to support such analysis), and show that total spending grew over those years, although proportions attributable to each sector remained stable. These findings should provide further evidence for debates on policies to effectively grow the biopharmaceutical R&D sector.

Assessing the Cost-Effectiveness of Next-Generation Sequencing as a Biomarker Testing Approach in Oncology and Policy Implications: A Literature Review.

OBJECTIVE: A key hurdle in broader next-generation sequencing (NGS) biomarker testing access in oncology is the ongoing debate on NGS's cost-effectiveness. We conducted a systematic review of existing evidence of the costs of NGS as a biomarker testing strategy in oncology and developed policy suggestions. METHODS: We searched multiple databases for studies reporting cost comparisons and cost-effectiveness of NGS across oncology indications and geographies between 2017 and 2022, inclusive. Inclusion criteria were established based on indication and type of cost-effectiveness analysis provided. We validated analyses and policy recommendations with 5 payer/policy maker interviews in the United States, Europe, and United Kingdom. RESULTS: Of the 634 identified studies, 29 met inclusion criteria, spanning 12 countries and 6 indications. Cost comparisons of NGS were evaluated using 3 methodologies: (1) comparison of direct testing costs, (2) comparison of holistic testing costs, and (3) comparison of long-term patient outcomes and costs. Targeted panel testing (2-52 genes) was considered cost-effective when 4+ genes were assessed, and larger panels (hundreds of genes) were generally not cost-effective. Holistic analysis demonstrated that NGS reduces turnaround time, healthcare staff requirements, number of hospital visits, and hospital costs. Finally, studies evaluating NGS testing including the cost of targeted therapies generally found the incremental cost-effectiveness ratio to be above common thresholds but highlighted valuable patient benefits. CONCLUSIONS: Current literature supports NGS's cost-effectiveness as an oncology biomarker testing strategy under specific conditions. These findings underscore the need to develop policies to support holistic assessment of NGS to ensure appropriate reimbursement and access.

Why is the screening rate in lung cancer still low? A seven-country analysis of the factors affecting adoption.

Strong evidence of lung cancer screening's effectiveness in mortality reduction, as demonstrated in the National Lung Screening Trial (NLST) in the US and the Dutch-Belgian Randomized Lung Cancer Screening Trial (NELSON), has prompted countries to implement formal lung cancer screening programs. However, adoption rates remain largely low. This study aims to understand how lung cancer screening programs are currently performing. It also identifies the barriers and enablers contributing to adoption of lung cancer screening across 10 case study countries: Canada, China, Croatia, Japan, Poland, South Korea and the United States. Adoption rates vary significantly across studied countries. We find five main factors impacting adoption: (1) political prioritization of lung cancer (2) financial incentives/cost sharing and hidden ancillary costs (3) infrastructure to support provision of screening services (4) awareness around lung cancer screening and risk factors and (5) cultural views and stigma around lung cancer. Although these factors have application across the countries, the weighting of each factor on driving or hindering adoption varies by country. The five areas set out by this research should be factored into policy making and implementation to maximize effectiveness and outreach of lung cancer screening programs.

An international comparative analysis and roadmap to sustainable biosimilar markets.

Background: Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. Methods: The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council. Biosimilar policies were identified and their sustainability was assessed based on country-specific reviews of the scientific and grey literature, validation by industry experts and 23 international and local non-industry experts, and two advisory board meetings with these non-industry experts. Results: Given that European countries tend to have more experience with biosimilars and more developed policy frameworks, they generally have higher sustainability scores than the other selected countries. Existing approaches to biosimilar manufacturing and R&D, policies guaranteeing safe and high-quality biosimilars, exemption from the requirement to apply health technology assessment to biosimilars, and initiatives counteracting biosimilar misconceptions are considered sustainable. However, biosimilar contracting approaches, biosimilar education and understanding can be ameliorated in all selected countries. Also, similar policies are sometimes perceived to be sustainable in some markets, but not in others. More generally, the sustainability of the biosimilar landscape depends on the nature of the healthcare system and existing pharmaceutical market access policies, the experience with biosimilar use and policies. This suggests that a general biosimilar policy toolkit that ensures sustainability does not exist, but varies from country to country. Conclusion: This study proposes a set of elements that should underpin sustainable biosimilar policy development over time in a country. At first, biosimilar policies should guarantee the safety and quality of biosimilars, healthy levels of supply and a level of cost savings. As a country gains experience with biosimilars, policies need to optimise uptake and combat any misconceptions about biosimilars. Finally, a country should implement biosimilar policies that foster competition, expand treatment options and ensure a sustainable market environment.

A review of the sustainability of vaccine funding across Europe and implications for post-COVID policymaking.

BACKGROUND: Approaches to routine vaccine funding and the underlying budget-setting process vary greatly across European countries. The ongoing COVID-19 pandemic has put enormous pressure on healthcare systems, affecting resilience of the overall vaccine ecosystem. METHODS: This article reviews how vaccine budgets are structured across 8 European countries (England, Finland, France, Germany, Italy, Norway, Romania, and Spain). First a literature review of the landscape was undertaken, followed by expert interviews to review the findings and consider policy principles to secure prioritisation and sustainability of routine vaccination budgets post-COVID. RESULTS: The organisation of budgets and vaccine spending varies greatly across Europe. In 2/8 countries (France and Germany) vaccine spending is subsumed into a wider healthcare budget. In 2/8 countries (Italy and Romania) the budget differentiates public health and prevention spending from other areas of healthcare, though there is no standalone vaccine budget. In 4/8 countries (England, Finland, Norway and Spain) there is a standalone vaccine budget, however this may not cover all elements needed for immunisation delivery and is not always transparent. CONCLUSION: Ensuring adequate and dynamic country vaccine budgets, with horizon scanning approaches like in England and Finland, or flexible vaccines expenditures like Germany, would greatly help the timely availability of public funding for new vaccines and strengthen vaccines supply security in Europe through a more virtuous European vaccine ecosystem.

The impact of vaccine procurement methods on public health in selected European countries.

Introduction: Across Europe, immunization programs have brought immense benefits to the prevention of infectious diseases. The vaccines used are procured through a variety of models such as tenders and Pricing & Reimbursement. However, to date, the impact of the procurement method on the performance and sustainability of vaccination programs and on public health has received little attention.Areas covered: Drawing on a review of the academic and policy literature, complemented by an interview program with stakeholders involved in the procurement of vaccines, the authors have documented the relationship between procurement method dynamics and the level of protection against vaccine-preventable diseases in Germany, Italy, Spain and Romania for, measles-containing vaccines, hexavalent and influenza vaccines.Expert opinion: Price-based tenders can contribute to vaccine supply issues, discourage the provision of value-added services supporting vaccination coverage and disincentives future R&D. Although it is observed that price-based tenders can intensify competition in the short term, there can be unintended consequences such as damage to long-term competition. As European countries are committed to strengthen their immunization programs, they should consider the implications of current vaccine procurement models on the vaccine ecosystem and on public health.

Competition between on-patent medicines in Europe.

There is widespread concern regarding the high price of innovative medicines and their impact on the sustainability of healthcare systems. However, the debate rarely accounts for the evolution of prices over the lifetime of the medicine and the impact of competitive forces. This article uses the experience of hepatitis C (HCV), during the years 2010-2017 to examine the impact of in-class competition and implications for policies that enable competition. To study the HCV market, we focused on European countries and applied a two-step approach involving a comprehensive literature review and an analysis of monthly sales data in US$ across seven European countries from July 2011 until July 2017. We find that competition to address the unmet medical need has led to significant treatment improvements to the benefit of patients, payers and the wider healthcare system and society. Competitive launches have led to innovative agreements, lowering the cost per treatment and improving patient access to treatment. For innovators, intense competition does not only impact the price set and their market share but in many cases shortens the economic life of the product to only a fraction of the patented period. This has an impact on future research decisions, focusing efforts on areas where unmet need is greatest. Sustainable innovation requires a well-balanced policy framework that provides the appropriate incentives and encourages competition.

Challenging Perceptions About Oncology Product Pricing in Breast and Colorectal Cancer.

Although significant progress has been made in the past decade in the treatment of both common and rare cancers, there has been significant concerns about the cost, and especially the value, of certain new oncology drugs. These concerns touch upon a number of issues regarding the price of these medicines, the value they deliver and the ability of healthcare systems to fund them. This paper looks at these perceptions and the extent to which they apply across different oncology products. Whilst it is acknowledged there is evidence that the launch price of pharmaceutical treatments for some forms of cancer has been rising in recent years, this is not uniformly the case; we find evidence to the contrary for some forms of cancer. This is illustrated by the cases of breast and colorectal cancer. We find cancer medicine prices depend on a number of factors, including pre-existing treatment options within a therapeutic class. Indeed, a number of studies have focused on the cost of treatment per month of overall survival gained as a simple (although partial) metric to judge value for money. Given the importance of oncology products being used in combination, developing similar approaches to capturing the overall cost of treatment will be crucial.