Switzerland, rightly regarded as one of the world’s most innovative nations, risks damaging its reputation if innovative new medicines continue to face significant delays and roadblocks in their introduction to the domestic Swiss market. Key stakeholders from pharma industry associations Interpharma and scienceindustries and local affiliate heads for multinationals Bayer and Biogen recently spoke to PharmaBoardroom about the market access and pricing challenges for innovative products in Switzerland and the solutions being proposed to overcome them.
Beating the Backlog
While the Swiss pharma market grew by 2.8 percent in 2019, the market access situation for innovative specialty drugs is “a particular pain point” and risks restricting the market’s further growth, as well as patients’ ability to get treatment according to CEO of innovative pharma industry association Interpharma, René P Buholzer.
He explains, “last year only 24 percent of new products were given a price within 60 days as stipulated in the regulation, meaning that our members had a large backlog of products not being reimbursed. 11 of the 46 applications were admitted within 60 days, over half took longer than 120 days and there is a backlog of 136 new active substances not yet listed on the specialty list.”
Unfortunately, regulatory processes and timelines are not matched by reimbursement processes
Katharina Gasser, managing director for Switzerland of US-headquartered neuroscience-focused biotech Biogen, adds “Since 2015, there has been a huge increase in those that are not being taken care of in the usual 60 days, which leads to massive delays for Swiss patients. Patients elsewhere in Europe are getting earlier access to treatments than those in Switzerland, which is unjust.”
For Axel Steiger, CEO of German firm Bayer’s Swiss operations, these delays in the reimbursement process are also a cause for concern. “Unfortunately, regulatory processes and timelines are not matched by reimbursement processes,” he states. “The value of innovation needs to be reflected adequately and in a timely manner. We therefore hope to see early and broad access for patients to innovation to maintain the high quality of the Swiss healthcare system for patients.”
Several of our interviewees were keen to single out Switzerland’s drug regulator, Swissmedic, for praise in terms of its adaptation to new technologies and its fast speed of approval, but identified the Federal Office of Public Health (FOPH), which determines pricing and reimbursement, as the major source of these delays.
Stephan Mumenthaler, director of scienceindustries, a broad business association for the chemical, pharmaceutical and life sciences industries in Switzerland, proclaims that “from a scienceindustries perspective, [Swissmedic has] made a lot of progress. Although there is still a way to go to achieve the final goal of positioning Swissmedic as a first-wave-agency, we are confident in seeing further progress here. The more virulent problem is getting an adequate price for the therapies from the FOPH in a reasonable timeframe. These dialogues take much longer than they previously did and represent a significant headache for our members.”
The products and active substances most affected are the new and complex ones that require advanced procedures not yet developed by the FOPH
Buholzer adds “the FOPH would tell you that the prices the industry is asking for are too high, but that is too simple of an answer. The products and active substances most affected are the new and complex ones that require advanced procedures not yet developed by the FOPH. Of course, there may be products missing long term data or for which the efficacy is questionable, but this insecurity is inherent in new therapeutic products and breakthrough ideas.”
He laments that “The situation, worsening since 2016, is that at the end of the day the patients cannot access these drugs, apart from through the exemption rule which comes with a lot of bureaucracy on the insurance doctor and pharma side. This is unproductive and often unequal, with access depending on which canton a patient lives in or which company they are insured by. That is not the promise we gave in law to the Swiss population – the basic insurance should ensure that patients get the same kind of treatments, regardless of their wealth, location, or insurance company.”
Starting the Conversation (Earlier)
In terms of solutions to these delays, Biogen’s Gasser highlights the importance of communication between the industry and the pricing body to increase understanding, especially for advanced and complex new treatments. “Earlier dialogue with the FOPH about the molecules we have in late-stage development would not necessarily lead to marketing authorisation but would lead to better understanding,” she notes. “The FOPH, like all stakeholders, needs to quickly get up to speed with new treatments, therapies, and approaches.”
She continues, “We are also strongly suggesting that experts look into these application dossiers and that the FOPH reaches out to these experts even more. Then we stick to timelines that will help everyone involved and build a good legal framework with clarity on how to manoeuvre and ensure earlier access.”
Buholzer also plays up the importance of inter-stakeholder communication and education, but between swissmedic and the FOPH. “Another key issue is ensuring that the FOPH and Swissmedic work more closely together so that the technical elements of a new drug are well understood. Because these are complex questions, we need stronger early dialogue between the FOPH and the industry so that the day after Swissmedic approves a drug, the reimbursement process can begin.”
He goes on, “From a patient perspective, it is not sufficient if the regulatory agency is relatively quick but then the reimbursement process is not properly handled. For reimbursement we need more early dialogue, the right experts, and procedures that allow the FOPH to begin handing out scientific advice earlier in the process, thereby potentially decreasing insecurity. We are working towards minimising conflict and finding a compromise between our need to honour innovation and the concern that society should not pay high prices for drugs that may not deliver what they promise.”
More Value-Based Pricing: A Way Out?
The Swiss pharma industry seems to be increasingly open to the adoption of new, value-based pricing models to break this impasse and ensure that patients in Switzerland can access the latest treatments. As Gasser admits, “Interpharma and its member companies are open to discussing new price schemes and price models. There is not one way to approach this issue.”
There is an urgent need for introducing new pricing models which take the full value of innovative therapies into consideration to maintain access for patients in Switzerland
Mumenthaler proclaims, “What we miss in Switzerland is real value-based pricing. The FOPH needs to remember that the products under discussion are often lifesaving medications, these in therapeutic areas where we had no cure at all, so far. They often make treatments much more effective and leads not only to higher quality of life for patients but also relieve the general public, for example by reducing or even preventing lost work. There is an urgent need for introducing new pricing models which take the full value of innovative therapies into consideration to maintain access for patients in Switzerland.”
Interpharma’s Buholzer agrees, noting that Switzerland has already made some progress in value-based pricing and has the potential for greater uptake. “In the European context, Switzerland is often cited as being very advanced for this type of price modelling, and we are now going even further down this route. We are curious to look around to learn what is happening in the US and other parts of Europe and to adapt this to a Swiss context.
He adds, “A new law proposal now in consultation would provide a legal basis for this type of price model and, while the government may perceive it as a vehicle to get lower prices, we see it as a model mitigating the insecurities and concerns that exist around new therapies.”