Location, location, location – European access to new medicines is a national postcode lottery [Advocacy Lab Content]

Europe has vast differences in the stages of a medicine’s journey, from approval to pricing, and reimbursement, leading to significant delays and unequal patient access – often depending on a patient’s residence.

Euractiv’s cross-country report highlighted inequalities between member states regarding access to novel medicines, however, the fragmented picture goes wider as indicated by the W.A.I.T. (Waiting to Access Innovative Therapies) indicator – a European study into the availability of innovative medicines, conducted by IQVIA on behalf of the European Pharmaceutical Association (EFPIA).

“The average time it takes for a new medicine to become available ranges from 126 days in Germany compared to 804 days in neighbouring Poland. The EU has not managed to move the dial on this in a number of years, despite multiple proposals,” Nathalie Moll, EFPIA director general, told Euractiv.

“It’s not acceptable that a cancer patient in one country must wait for care while others are treated,” Mall added, claiming that tackling health inequalities between countries, as well as in the same country and between regions, is an industry priority.

In 2023, barely half of the newly approved pharmaceuticals reached patients in Greece; surprisingly, Belgium was one point better; while the percentage in Poland was even lower. At the same time, the board leader Germany was at 88%, with 147 out of 167 new therapies available.

 Just 47% of medicines reached Greece.

One in two new therapies approved by the EMA between 2019 and 2022 hadn’t reached patients in Greece. Out of those that made it, 52% were fully publicly available, while access to the rest was limited. What has improved is the time from central approval to availability, from 674 days, according to last year’s WAIT Indicator, to 587.

“The reduction of the number of days [it takes for] a medicine approved by the EMA to reach patients in Greece is a positive sign,” said Mihalis Himonas, General Director of SFEE, the Greek association of pharmaceutical companies. He told Euractiv: “Nevertheless, we believe that the number of medicines that reach patients must increase.”

According to Himonas, interventions to improve access should focus on mandatory returns (clawbacks and rebates). “It should be a combination of funding the pharmaceutical budget and controlling demand. Those two can close the gap that high mandatory returns have caused and consequently lift barriers that impede access,” he explained.

“From a European perspective, the EU Regulation on Health Technology Assessment will also help. From the Greek point of view, repealing the ‘5-11’ criterion for reimbursement is also going to contribute,” he added.

For a medicine to be reimbursed in Greece, it must be already reimbursed in five out of 11 EU countries with established HTA systems.

“New medicines reach patients in Greece, but not always on time. We should focus on removing barriers that delay access and find ways to streamline the patient’s road to innovative treatments through viable strategies,” George Kapetanakis, President of the Hellenic Cancer Federation, commented to Euractiv.

He also underlines the importance of an EU-designed framework focused on unmet needs, promoting innovation and access to affordable treatments, supporting early access programmes and enhancing cooperation between countries to pricing and reimbursement.

Poland’s slow road to improvement

Poland has advanced by one place to rank 20th among the 36 surveyed European countries in the W.A.I.T. study, with a score of 41% of available therapies.

Today, 69 out of 167 novel therapies are reimbursed in Poland, but as many as 83% of them are reimbursed only for a limited group of patients. This result is 5% worse than last year.

The time from registration to reimbursement has decreased from 827 days last year to 804 days in the current study, but it is still one of the worst in the ranking. Only four countries are behind Poland: Serbia, Bosnia, Turkey, and Malta.

“The good result is evidence that we are moving in the right direction, and thanks to positive reimbursement decisions, we are catching up on the delays in Polish patients’ access to innovative therapies,” Michał Byliniak, General Director of the Association of Innovative Pharmaceutical Companies INFARMA told Euractiv.

However, a detailed analysis of the W.A.I.T. results shows that older drugs are still more often reimbursed in Poland.

“Among those 69 drugs reimbursed in Poland, only eight were registered in 2022, while the rest were from previous years. This means that we are not fully utilising the potential of innovation, and Polish patients benefit from new drugs only when they are no longer new,” Byliniak added.

“The particularly concerning factor is the percentage of drugs reimbursed for specific groups of patients, which for Poland is extremely high and significantly deviates from European standards,” Agnieszka Grzybowska-Zalewska, President of the Board of the Employers’ Association of Innovative Pharmaceutical Companies INFARMA told Euractiv.

She added: “This means that only a portion of patients who could benefit from a particular therapy have access to it. The therapy is thus registered in Poland, almost within reach, but in practice, it remains inaccessible to many patients. The right direction for change should, therefore, be to ensure that Polish patients have fuller access to medical innovations, thereby equalising their chances for longer and better-quality lives.”

Belgium’s call to action

Following the WAIT Indicator results, pharma.be, the Belgian pharmaceutical industry association, is urging for a more ambitious policy to enhance access to innovative drugs within the country through the continuation of a constructive dialogue with all stakeholders.

Belgium faces a significant challenge when it comes to reimbursing innovative medicines. Of the 167 new drugs approved between 2019 and 2022, less than half are covered by the healthcare system. Only 46% of the innovative therapies that received EMA approval are reimbursed in Belgium, a figure that has been declining from 51% last year and 54% the year before.

Patients in Belgium experience increasingly long waiting times for drug reimbursement, averaging 565 days in 2023. The Commission for Reimbursement of Medicines (CTG) advises the government on whether a new drug should be reimbursed and under what conditions.

“Belgium is among the innovation leaders in Europe and ranks sixth in terms of GDP per capita in the European Union. But in terms of our ambition, as a prosperous country, to also let citizens and patients reap the benefits of innovation, often even created here, we are among the laggards in Europe,” said Caroline Ven, CEO of pharma.be.

She has stated that the industry is committed to ensuring the broadest and fastest possible access to innovative drugs and vaccines for Belgian patients.

However, improving access to medicines is a joint responsibility of industry and government, explained Ven, adding: “Today, important reforms are being worked out at both European and Belgian level to improve access to medicines on the one hand and to stimulate research and development towards innovation on the other.”

Multifactoral delays

Barriers to access are often due to a combination of factors. “We know that delays in patients’ access to new medicines can occur even before a medicine has approval due to Europe’s relatively slow regulatory processes,” Nathalie Moll explained, adding that improving the European Medicines Agency’s (EMA) approval speed is a key ambition of the revision of the pharmaceutical legislation, as it is currently slower than the US and other parts of the world.

According to Moll, there are several differences between European regions. “Delays in filing in Western Europe were largely due to the value assessment process and evidence requirements, while delays in Eastern and Southern Europe were mostly due to health system constraints and the corresponding impact this has on the economic viability for manufacturers to launch innovative medicines”, she pointed out.

She further explained there are different reimbursement processes or additional layers of regional and local decision-making. Duplicative or inconsistent evidence prerequisites can also cause delay or a lack of availability. “For example, different countries, HTA bodies and payers may require different endpoints, or some accept real-world evidence where others do not,” she added.

Another cause is the use of external reference pricing (ERP), as many countries don’t start their national pricing and reimbursement (P&R) processes until they have access to reimbursement decisions from several other European countries. Greece is one of them.

“The European Access Hurdles Portal generates even more detailed insights into the reasons behind the delays to patients getting access to medicines. The data shows that the majority (71%) of the time between EMA approval and reimbursement occurs after a product has been filed for P&R. The remaining 29% happens prior to filing,” Mall said.

“As an industry, we have been working on the issues for a number of years, with concrete solutions on the table for discussion,” she remarked. These include a commitment from companies to file for a price in all Member States within two years of EU approval, as well as tailored measures targeted to different countries.

“For example, allowing countries who can afford less for medicines to pay less or through creative payment and reimbursement schemes,” she added.

[By Vasiliki Angouridi, Paulina Mazolewska, Nicole Verbeeck, Edited by Brian Maguire | Euractiv’s Advocacy Lab]

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