Market Access Mexico

Oct 3, 2016 - Oct 4, 2016, Mexico City

Create innovative access strategies to cover the needs of patients and the government

Breaking Down Barriers for Greater Access to Diabetes Medication

We spoke to Oliver Stahl about access to new diabetes medications in Germany and key European markets.



For the longest time, countries have been fighting the battle of getting medicines to the people that need them most. This requires governments to balance two competing interests: those of companies who work tirelessly to develop innovative drugs and those of consumers who need these medicines to live more comfortable lives. This balancing act is particularly prevalent within diabetes, where access to medicines is crucial in enabling patients to manage symptoms and live otherwise normal lives.

While the pharmaceutical industry has been pushing forward with new drugs to fight diseases like diabetes, these drugs don’t go directly to patients. Governments have regulatory structures in place to make sure that the drugs are safe and reasonably priced. While the intention is good, this can leave many vital medications in regulatory limbo. Some medications that actually pass regulations can also become too expensive for patients to purchase. In the European market, there are variations in the regulatory guidelines across the different countries, and looking into this market provides insight into the challenges in regulating drugs and how certain regulatory standards can impede access to medications.

Navigating the European regulatory maze

Among the European countries, Germany’s regulatory structure is touted to be the most complex. At the 2nd Annual Pharma Pricing, Reimbursement, and Market Access conference, held in London, Oliver Stahl, Senior Director for Corporate Affairs of Eli Lilly Germany, presented a report highlighting the differences in the dossier sizes submitted for each country. While the range for one particular company might be around 100 to 250 pages, those in Germany can run up to an average of 3,500 pages.

The passing of the Act on the Reform of the Market for Medicinal Products (Arzneimittelmarkt-Neuordnungsgesetz – AMNOG) changed the way in which Germany approved and gave benefits to drugs. One of the highlights of the AMNOG was the establishment of the Federal Joint Committee (Gemeinsamer Bundesausschuss – G-BA), which subjects new drugs to an early assessment of benefit - where it is compared with the current drug that is recommended by the committee. It is also here that the drug’s price reference is established by looking into its active ingredients.

The goal of this entire process is to reduce the price of drugs. However, in an interview with Stahl, he notes that this creates complications, especially in the case of diabetes medications. He says, “In Germany, most of the new medications for diabetes failed to get an additional benefit in the G-BA assessment. In comparison with other European markets, the G-BA looks at different comparators and study endpoints for the assessment. For example, they do not look at blood sugar control but rather at hypoglycemic events or cardiovascular events.”

This makes a positive benefit assessment especially difficult to get in Germany because many study programs were designed before the implementation of AMNOG, so at the time the G-BA requirements were not set. “Also study programs are typically developed in a global context. In such cases, it can be very difficult to align the different needs of the various regulatory and HTA authorities,” says Stahl. “In the end, you might end up with a negative assessment.” In Germany, failing the assessment can have staggering consequences in terms of pricing, with higher prices resulting in market withdrawal being more likely to occur.

Even if you have a positive assessment and negotiated a price at national level, it is not ensured that patients get access to the product.

There are also some differences in the way price and volume is controlled in European countries, although almost all abide by the general process of a health technology assessment followed by price negotiations. France, for example, includes some degree of economic regulation throughout the lifecycle of the new medicine. Where it becomes more complex is when considering the various regions of these countries. Even if national assessments are already being carried out, regions can still negotiate prices and adjust quotas further. In Spain, they can even argue for more restrictions. According to Stahl, this means that, “Even if you have a positive assessment and negotiated a price at national level, it is not ensured that patients get access to the product.”

Healthcare economics across Europe

For a certain drug, its viability for consumers at a given price depends on how well the country is doing economically. There will be countries for which the price can be too high, while the citizens of another country may consider the price to be sufficient. Considering economics, therefore, is important in price negotiations, especially in Europe where there are large differences in GDP. In Stahl’s presentation, he highlights how Luxembourg’s GDP per capita in 2013 is roughly 17 times higher than that of Serbia. On the ground, this implies gaps in purchasing capacity and monthly income.

I firmly believe that we should allow more for differential pricing. That means we do not determine the price by a formula, but rather negotiate prices based on the needs of a specific healthcare system.

There are numerous ways to do this, but it essentially means that the price of a drug in a certain country is based on how much the drug costs in other countries close to it. According to Stahl, “IPR creates an economic incentive to charge the same price in all countries, regardless of the economic situation, the differences in healthcare priorities, treatment paths or patient needs.” In other words, it makes it very difficult to set prices according to the needs of a particular health care system and can lead to delayed or restricted access for patients.

In light of the inherent issues of IPR, the alternative that Stahl argues for is differential pricing. “I firmly believe that we should allow more for differential pricing,” asserts Stahl. “That means we do not determine the price by a formula, but rather negotiate prices based on the needs of a specific healthcare system.” This approach has garnered more attention in recent years because low- and middle-income countries have grown significantly in terms of both population and GDP, meaning that they now present a market that the pharmaceutical industry can tap. It will be impossible to breakthrough, however, if prices are too high and are blind to the circumstances of the country, hence the need to consider differential pricing as an alternative. Through this method, the price barrier to access can be broken down.

Call for openness and collaboration

At the end of the day, Stahl hopes that regulatory bodies adopt more open policies that are sensitive to the needs of diabetes patients around the world. He notes that both the government and the pharmaceutical industry need to come together to make sure that those who need the drugs get them. He says, “Jointly, we can achieve sustainability for healthcare systems and innovation for patients.”


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Market Access Mexico

Oct 3, 2016 - Oct 4, 2016, Mexico City

Create innovative access strategies to cover the needs of patients and the government

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