Market Access Europe at eyeforpharma Barcelona

Mar 12, 2019 - Mar 14, 2019, Barcelona

Catalyse market access innovation with real-world, patient value

American Healthcare System 1 - 0 Europe

When it comes to pricing and access, the European healthcare system is losing.

The criticisms levelled against the US healthcare system are well rehearsed: It has too many players, it is dizzyingly complex, inefficient and expensive. On the surface, Europe’s healthcare systems look positively harmonious by comparison, more so given the moves underway to facilitate future cross-collaboration.

American healthcare 0, European healthcare 1, then? It depends where you’re looking. Europe’s shortcomings when it comes to pricing and access are scarcely being discussed let alone addressed. The effect on drug launches is chilling, driving business towards other markets and potentially leading to poorer patient outcomes since European doctors often have less choice when prescribing an appropriate treatment to patients than their US counterparts.

This is the concern of Martin Strandberg-Larsen, VP of Pricing & Market Access, Nordics & Baltics Region, AstraZeneca, who believes it is Europe that could learn a trick or two from the US system, where there is more flexibility, more room to negotiate and more opportunities to develop products for a diverse market.

“US patients with healthcare insurance are getting the newest innovations first; Europe as a whole is falling behind,” he says.

The list of drugs that are simply no longer marketed in Europe is growing, he observes. If a recent panel he attended is anything to go by, where an unexpectedly large show of hands indicated the extent of companies admitting that had decided not to launch a treatment on the European market.

Regulatory demands involved in European drug approval are high - as they rightly should be - but it comes as a surprise to many people that the requirements often are higher even compared to the US, says Strandberg-Larsen. “The European requirements for additional studies and more long-term trials are different from US requirements, so a decision to go for European approval often makes the drug development program much costlier and more complicated.”

But regulatory approval is only the first hurdle when it comes to bringing novel medicines to market in Europe. “In Europe the marketing authorization for a drug is just the start. There then follows a range of national and regional hurdles with the various payers that can prolong timelines before doctors can prescribe new medicines to patients in need. So, we have this cocktail of high regulatory standards, high requirements for market access and then the reward in Europe is comparatively low, says Strandberg-Larsen.”

The resulting impact on the choice of treatments is becoming increasingly stark. “In Germany, for example, due to the payer process put in place in 2011, we have seen more than 30 products withdrawn across a range of treatment areas, including diabetes, oncology and psychiatry, all known for high medical unmet need and a cause of significant mortality and morbidity in the population.

“My concern is that the balance is no longer there, and it is why a lot of products are no longer launched even in the biggest European markets. This means that in many European countries, patients will not have access to all the treatments approved by the European Medicines Agency, as it is often not even possible to pay privately,” says Strandberg-Larsen. “This issue is not well understood by the general public in European countries due to the lack of transparency and benchmarking between countries on the disparity in the availability of treatments," he says.

The rewards in the US are more attractive leading many companies to devote the bulk of their efforts to the US market. However, this means that drugs are not developed to meet the needs of Europe’s patient populations, in favor of the US, Chinese and Japanese population requirements.

“No one will ask the critical question in Europe of why we are not getting access to the best medication given the high prices we pay for healthcare? Do we really want societies in which drugs are not being developed because there are no rewards for doing so?”

There is evidence of the impact of less choice on patients. According to a 2013 study, which looked into US healthcare plans where doctors had more prescribing freedom versus those that were more restrictive with less choice treatments, the former were associated with better patient outcomes, he says.

“This is a complex field, but doctors tend to know their patients and their history and will prescribe the most appropriate treatments if they have the freedom to do so. The risk is that this is not possible when administrators make the decisions based on rules and requirements and with a static view of what it is to treat a disease or to be a patient.”

However, Strandberg-Larsen remains positive about the future outlook for Europe. “It is too important an area for patients not to be solved. My personal view is that the solution is greater collaboration between pharmaceutical companies and healthcare systems, where the goal is to increase transparency and benchmarking between countries on the availability of treatments. We need to get away from one-size-fits-all payment solutions and come together to identify new, more flexible payment models that carefully link patient outcomes to payments within indications. Such models also need to be adaptable as the medical field advances and as we collect real-world evidence on how new innovations are being used most effectively”, says Strandberg-Larsen.

“That would be valuable for everyone, not least patients, who will have access to more treatments. It might also show which prices are justified and which are not. We are still learning how to use statins, for example, even though they were introduced as far back as in 1987. We are learning because they are out in the market being used. This is the right way of looking at it, rather than treating scientific innovation as a commodity like a bottle of water. It is more complex than that,” says Strandberg-Larsen.

The time is right to collaboratively explore new pricing and reimbursement models, because Europe’s healthcare budgets may not be as constrained as assumed and there is room to allocate spending in ways that reward innovation, he says.

“In primary healthcare, many high-volume treatments for common illnesses (such as diabetes or heart disease) are now generic - we are saving money and making treatments more widely available to Europeans. Take Denmark as an example, where medicine expenditure as a share of total healthcare expenditure has decreased over the last decade. In theory we can reinvest that money for newer, more innovative treatments to benefit the patients most in need, then, over time, they will also become generic and so available more cheaply."

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Market Access Europe at eyeforpharma Barcelona

Mar 12, 2019 - Mar 14, 2019, Barcelona

Catalyse market access innovation with real-world, patient value