The European market access environment is increasingly challenging for industry. Countries struggle to maintain sustainable healthcare systems amidst stringent healthcare budgets, which consequently escalates their demands and requests to the pharmaceutical industry. The World Pharma Pricing & Market Access Congress and Evidence EU 2016 events took place in London last month, where EU healthcare leaders and the pharmaceutical industry delved into the trends affecting this evolving market access environment.
Planning ahead is essential to provide relevant evidence to both European regulators and payers. The Multi-HTA Early Dialogues, through EUnetHTA (European Network for Health Technology Assessment) and SEED (Shaping European Early Dialogues), are a collaborative approach fostering early planning and aiming at harmonizing evidence requirements across Europe. However, differences still remain in standards and methodologies between countries. This challenge multiplies in those countries with regional healthcare competencies like Spain, with a highly decentralized system; there, despite the introduction of the national therapeutic positioning reports, successful access and uptake requires meeting regional needs.
Early access to medicines and RWE are priorities for the EU member states – yet this requires the completion of many levels in the market access game. These priorities are conflicting with the requirements to obtain marketing authorization, a favorable HTA and P&R outcome and securing uptake. These processes demand a complex approach that calls for the integration of the R&D with the market access strategies, to design clinical trials whose results will meet the different stages’ requirements.
Countries are increasing their demands on clinically meaningful endpoints, and those with a conservative approach on evidence, such as Germany, consider surrogate endpoints are not enough and ask for harder evidence to assess a drug’s additional benefit, also demanding direct comparisons that allow identify clinical improvements. Not meeting these stringent requirements leads to a “no additional benefit” label and a lower price than standard RP therapy, since manufacturers would have to provide larger discounts than the mandatory state rebate to foster uptake. Given that Germany is reference for 80 countries and publishes the reimbursable price (what is now being reconsidered by the G-BA); to diminish the international drawbacks this can bring, some companies prefer to leave the German market after the first year of free pricing (several market exits in diabetes and one in oncology – 9 up to now).
Demonstration of cost-effectiveness is vital for inclusion of a new therapy in healthcare systems with a tight healthcare budget. Health economic (HE) assessments are essential to identify the efficiency of a new technology and they are increasingly complemented with a budget impact analysis to determine affordability.
Economic evaluation has been introduced to inform on price and uptake decisions. In France the Healthcare Products Pricing Committee (CEPS) has started conducting the HE assessment in parallel with classical HTA to those new products with major or important improvement in actual clinical benefit or which are likely to have a significant impact on the national healthcare expenditure.
Proving and communicating value – to all stakeholders involved – is a harsh task in the complex and changing environment for health technology adoption. Payers are troubled with limited budgets for the short-term political cycle, which many times keeps out innovation from the healthcare system. Market access delays due to all the bodies involved in the process are a constant problem for patients, manufacturers and politicians.
We are in a fast-changing world and patients require faster access to effective treatments. To achieve this and turn around the slow uptake in the UK, the NICE has set up the Office for Market Access (OMA) and has approved new arrangements for the Cancer Drug Fund.
Clinical outcomes and RWE are imperative to demonstrate the value and societal impact of innovations. Towards fostering healthcare systems, the focus has to switch from drug cost to securing the best outcomes also in the long-term. Value is the combination of benefits and resources utilization. Although companies have adapted their operations to develop processes and strategies to collect real world evidence (RWE) for their products, many countries haven’t yet adapted their systems for this. Only some countries have well stablished registries like Italy, which allow the collection and analysis of data in order to make and adjust decisions, and to allocate healthcare resources more efficiently.
What is then key to uptake? Nowadays, the most consistent key element across Europe is affordability. Countries need to have good and sustainable healthcare systems. Innovation must not break up with sustainability – it should be part of it. And it is also linked to improvement, so by all means has to be included. This urges countries to adapt their pricing systems to go “beyond the pill” with new approaches that will improve affordability.
Despite the European common goals and movements towards harmonization, each country still wants to handle processes in their own way. And it will continue this way. There won't be coordinated pricing despite the constant use of ERP, because each country has its own GDP and high hopes to achieve better discounts than the rest.
Countries must focus on tailoring their processes and healthcare systems to this demanding environment to achieve the best value for money. Though overlooking into this, EU stakeholders lack initiative to address new pricing methodologies - yet innovation shouldn’t wait. That is why manufacturers prefer to engage or even kick off (if necessary) state-of-the-art pricing agreements and provide affordable innovation to patients.
Now seems the right moment for the biopharmaceutical industry to get further involved in the process and become the trusted partner of European healthcare payers.
It’s time to change the game. What are you waiting for?