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The trend to bring new medications to market so they reach patients as quickly as possible, ‘market access’ in the jargon of the biotechnology and pharmaceutical sectors, involves “quick innovation and sharing risks”, according to Antoni Gilabert, Managing Director of Pharmacy and Medicines of the Catalan Health Service. “We have to minimize the uncertainties in evaluation, results and financing with collaborative models”, he added.

Gilabert outlined the needs of the public health system in Catalonia at the Lessons Learned: Market Access and Reimbursement workshop held by Biocat and CataloniaBio on the 29th of November at the Parc Científic de Barcelona, where participants were also able to listen to and debate the lessons learned by five sector experts from consultancies and the industry.

The moderator of the workshop, Pepi Hurtado, a partner at Insights in Life Sciences, reminded the participants that we are all aware that this is a long, complex process, but that “if we bear in mind the requirements that financial backers need from the very beginning of development, we can work on early market access". Other important factors are: Is there an unmet clinical need? How many patients am I targeting? What competitive advantage does my product really have? How will the financial backer evaluate the clinical benefits?

Hurtado also warned that we should not confuse regulatory agencies with financial backers: “They do not choose medications; they only evaluate them”.

Oriol Solà-Morales, the General Manager of HITT, recommended defining the regulation strategy at the start of a medicine’s development and ascertaining the client for each one. “Do they need it? Do they want it? Can they pay for it? I always ask these questions”, he said. When purchasing new medications, Catalonia is witnessing a significant change: “the health results are being valued more and more, in addition to just the price”.

 

At the heart of the industry

What is the implementation of a market access strategy in a pharmaceutical or biotech company like? It can be defined in two words: anticipation and tons of preparation. Òscar Pérez, the Director of Regional Access & Business at Celgene, believes that it is essential to educate organizations. “It is a cultural change that every pharma has to make. We are not talking about market access as a function but as a process in which the value proposition must be adapted to fit the different stakeholders while always proving the clinical and economic value”.

The Director of Institutional Relations at the multinational Ferrer, Laura E. Ayzin, commented that they are working “by making consultations around the region in the initial phase”, and in terms of the relationship with those who have to buy the medication, “we always leave with content and having designed the goal according to those whom we are going to see”.

If a medical device is being introduced instead of a drug, the process, the regulations and the financial backer change. In this case, “the financing on hospital level is the key to accessing innovative technology”, says Carme Pinyol, the General Manager of Innova-Strategic Consulting. Once the CE marking of the technology has been earned, it is financed via the hospital’s annual budget. “The hospital negotiates the net price directly with the manufacturers”, she states. Currently there is no national regulation on the price and financing, factors which are so clearly determined for medications.

 

New "Lessons Learned" in 2017

This was the last day in the Lessons Learned series for 2016, with a total of 14 sessions and over 600 participants. We’ll be back next year! If you are interested in us talking about a specific topic, please send us a proposal at sramirez@biocat.cat.

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