Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?

Judicious use of real-world data (RWD) is expected to make all steps in the development and use of pharmaceuticals more effective and efficient, including research and development, regulatory decision making, health technology assessment, pricing, and reimbursement decisions and treatment. A "learning healthcare system" based on electronic health records and other routinely collected data will be required to harness the full potential of RWD to complement evidence based on randomized controlled trials. We describe and illustrate with examples the growing demand for a learning healthcare system; we contrast the exigencies of an efficient pharmaceutical ecosystem in the future with current deficiencies highlighted in recently published Organisation for Economic Co-operation and Development (OECD) reports; and we reflect on the steps necessary to enable the transition from healthcare data to actionable information. A coordinated effort from all stakeholders and international cooperation will be required to increase the speed of implementation of the learning healthcare system, to everybody's benefit.

Ensuring access to medicines: how to redesign pricing, reimbursement and procurement?

This policy brief is one of a series on addressing market and policy failures in the pharmaceutical sector that was prepared for the Austrian EU Presidency. It explores the most frequently applied policies for new high-priced medicines as well as some alternative approaches. In each case, the strengths and limitations are assessed and options for improvement are studied. The brief shows that the lack of transparency on ‘real’ prices and development costs for medicines is a key limitation to many policies and argues that improving transparency and cooperation, both within countries and among EU Member States, is the way forward.

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries.

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.

Drivers of poor medical care.

The global ubiquity of overuse and underuse of health-care resources and the gravity of resulting harms necessitate an investigation of drivers to inform potential solutions. We describe the network of influences that contribute to poor care and suggest that it is driven by factors that fall into three domains: money and finance; knowledge, bias, and uncertainty; and power and human relationships. In each domain the drivers operate at the global, national, regional, and individual level, and are modulated by the specific contexts within which they act. We discuss in detail drivers of poor care in each domain.

Pharmaceutical policies in a crisis? Challenges and solutions identified at the PPRI Conference.

In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines. The research presented highlighted that commonly used pharmaceutical pricing and reimbursement policies are not sufficiently effective to address current challenges. Conference participants called for fundamental reforms to ensure access to medicines, particularly to new and potentially more effective and/or safe medicines, while safeguarding the financial sustainability of health systems and working towards universal health coverage.

[The impact of the economic crisis on health systems of OECD countries]. / L'impact de la crise économique sur les systèmes de santé des pays de l'OCDE.

This paper describes measures adopted by OECD countries in the health sector in response to the economic crisis which began in 2008: increase and diversification of revenues collected for health, increases in user charges, reductions in staff, salaries and prices of health goods and services; and policies aiming to increase health systems efficiency. It then reviews the impact of these policies on health spending trends.

Pharmaceutical regulation in France 1980-2003.

This paper provides an overview of French pharmaceutical policy between 1980 and 2003, which was dominated by price control and management of the positive list during the 1980s, with new policy instruments being introduced in the 1990s. The development and diffusion of prescription guidelines has been used to promote more appropriate use of medicines, and some measures aimed at developing the generic market have been implemented. In parallel, attempts have been made to set expenditure caps for physicians' prescriptions and for pharmaceutical companies' turnover. This second option seems to be more durable and effective, although its effectiveness in controlling increases in pharmaceutical expenditure remains limited. Pharmaceutical regulation is now more transparent than it used to be, and the monitoring of prescriptions is steadily improving. However, some areas remain problematic, for example over-prescription of certain classes of medicines such as antibiotics and probably psycholeptics.

The "Health Benefit Basket" in France.

The French "Health Benefit Basket" is defined principally by positive lists of reimbursed goods and services; however, global budget-financed hospital-delivered services are more implicitly defined. The range of reimbursable curative care services is defined by two coexisting positive lists/fee schedules: the Classification Commune des Actes Médicaux (CCAM) and the Nomenclature Générale des Actes Professionnels (NGAP). The National Union of Health Insurance Funds has been updating these positive lists since August 2004, with the main criterion for inclusion being the proposed procedure's effectiveness. This is assessed by the newly created High Health authority (replacing the former ANAES). In addition, complementary health insurers are consulted in the inclusion process due to their important role in French health care financing.

Health care systems in transition: France

The Health Systems in Transition (HiT) series provide detailed descriptions of health systems in the countries of the WHO European Region as well as some additional OECD countries. An individual health system review (HiT) examines the specific approach to the organization, financing and delivery of health services in a particular country and the role of the main actors in the health system. It describes the institutional framework, process, content, and implementation of health and health care policies. HiTs also look at reforms in progress or under development and make an assessment of the health system based on stated objectives and outcomes with respect to various dimensions (health status, equity, quality, efficiency, accountability).