EU Needs More Teamwork On Drug Pricing & Access

EU member states are being urged by the European Commission to cooperate more closely on pricing and reimbursement, managed access deals and policies to promote generics and biosimilars.

The EU wants member states to work more cooperatively on medicines access

The European Commission is stepping up its efforts to improve access to medicines by calling on EU member states to cooperate more strategically in areas like pricing and reimbursement and health technology assessments, and to maximize the potential savings from generics and biosimilars.

In the “State of Health in the EU – Companion Report 2019,” the commission says that the product life cycle of medicines “reveals ample scope for member state cooperation in ensuring safe, effective and affordable therapies, including everything from rational spending to responsible prescribing.”

The report, which was produced in association with the Organization for Economic Cooperation and Development (OECD), looks at five areas: medicines access, vaccine hesitancy, gaps in health system accessibility, digital transformation of health promotion and disease prevention, and the skills mix.

It draws a number of conclusions and recommendations based on the 2019 country health profiles that were drafted for the latest version of the “State of Health in the EU” cycle, which was initiated by the outgoing health commissioner, Vytenis Andriukaitis.

In his introduction to the report, Andriukaitis, who will be succeeded as health commissioner on 1 December by Stella Kyriakides,  says: “It is the ultimate aim of the State of Health in the EU cycle to support member states in constantly improving the effectiveness, accessibility and resilience of their health systems. This robust country-specific and cross-EU knowledge now feeds into both national policymaking and EU level cooperation.”

"Payers find it difficult to devise affordable and equitable access schemes for medicines with increasingly high prices" – European Commission report

 

In the section on medicines access, the report says that while selective funding of cost-effective, affordable medicines is “key to safeguarding sustainable access to medicines in the EU,” national health policymakers have “struggled to strike a balance between ensuring accessibility to medicines, providing incentives for pharmaceutical innovation and ensuring the fiscal sustainability of health spending.”

While it acknowledges the importance of the pharmaceutical sector in encouraging innovation and economic growth in the EU, it says that most countries have “challenges related to the affordability of pharmaceuticals,” as payers find it difficult to devise affordable and equitable access schemes for medicines with increasingly high prices.

This, it declares, has “further exacerbated existing concerns from member states about the appropriateness of the current R&D model, as well as the future fiscal sustainability of current levels of pharmaceutical expenditure.”

Price Discussions, Managed Access Deals

The commission believes there is plenty of mileage in cross-border cooperation initiatives. It notes that “some member states have taken up cross-country collaborative approaches in recent years. These may result in joint procurement and joint pricing (and reimbursement) negotiations for specific medicines, in addition to collaboration in other areas such as information sharing, HTA or horizon scanning.”

Among ongoing initiatives are the BeNeLuxA coalition, the Valletta Declaration and the Nordic FINOSE collaboration. Under these projects, pricing and reimbursement continue to be a competence of the participant countries, “but there is a keen interest in continuing the communication and exchange of information at EU level, for instance via a future platform for mutual exchange and learning,” the report says.

Noting the commission’s proposal for a regulation that would strengthen HTA cooperation on health technology assessments in Europe, which is currently going through the EU legislative process, the report says this would help member states make “timely, evidence-based decisions related to patient access to new medicines and other health technologies while at the same time reducing the administrative burden borne by the industry.”

Another idea for closer cooperation explored in the report is addressing what the commission sees as an imbalance in the relationship between pharmaceutical companies and national authorities when it comes to pricing and reimbursement discussions on new medicines.

“The inclusion of new products in the basket of covered services usually requires both parties to negotiate on the conditions for a product to enter a market,” the report says. “A first step towards balancing the bargaining power of stakeholders consists of bridging information gaps that may put payers at a disadvantage in the pricing and reimbursement negotiations with manufacturers.”

It suggests that fostering more cooperation among EU countries in this regard “could offer promising opportunities to improve the affordability of medicines through more transparent pricing and greater competition among manufacturers.”

A cooperative approach could also prove beneficial in the area of managed access deals. The report says that the arrival of new, high-cost medicines for smaller populations requires a “critical reflection on the need to redesign existing payment models, in particular with a focus on instalment plans to smoothen out upfront purchasing costs and pay-for-performance approaches to ensure high-value care is provided.” Expertise “can be pooled at EU level in this regard,” it adds.

Generics And Biosimilars

The potential cost savings from generic and biosimilar medicines, which of course are another key lever in containing drug costs, are addressed, albeit briefly, in the report.

It says that biologicals “already make up around a quarter of pharmaceutical expenditure,” but the uptake of biosimilars shows a mixed picture, with the uptake of biosimilars across member states varying wildly within the same interchangeable product class. “This high variance hints at a large untapped potential for efficiency gains for several countries,” it declares.