The last week or so has seen significant debate about the impact of the UK’s decision to withdraw from the European Union. We all recognise that this decision will impact the way Pharma gains access to both the UK and European markets. However, access to new and innovative medicines has been subject to significant changes at national level for the last ten years, particularly as the role of health technology assessment (HTA) broadens. Being able to make a robust economic case for new interventions is critical in most European markets. This year we have witnessed France begin the transition from a pricing model mainly based on clinical benefit towards a more economically-focused system, initially for high-cost medicines. Manufacturers will now be required to submit budget impact models (BIMs) to HAS (French National Authority for Health) in support of the drug pricing process. HAS’s recently published draft guidance on how to develop a budget impact analysis (BIA) was based on recommendations from the ISPOR task force report II (2014), and national guidelines from various countries in Europe, Canada and Australia. Prior to these guidelines manufacturers were relatively free to perform their own methodology for BIA. The final guidance will be published in October 2016.

Budget impact analysis became mandatory in France in January 2016 with the signing of a new three-year pricing framework. Under the agreement signed by both the pricing committee and the industry, BIAs are required for innovative medicines anticipated to exceed drug sales of €50 million.

As part of the reimbursement listing in France the BIA will be required in addition to a cost‑effectiveness assessment, with both analyses forming part of the pharmacoeconomic analysis, often referred to as the efficiency assessment. This shift in focus to an economic justification was first introduced over three years ago, with 2013 marking a turning point in the way France evaluates medicines for pricing and reimbursement. HAS have made it clear that the BIA will be primarily used to inform pricing decisions. This new mandatory tool may help France develop innovative reimbursement mechanisms.

France is not alone, over a dozen European countries currently require the submission of a BIA to support reimbursement and formulary listings. Many countries adopt the recommendations of the ISPOR task force, while others have developed their own guidelines based on existing practices. What we learn from France is that things do not stand still; for a country that has historically based its reimbursement decisions around clinical benefit, this shift to include economic assessment is quite fundamental. As payers struggle to provide access to new and innovative treatments whilst still controlling their budget, many countries in Europe will certainly choose to implement BIA. Regardless of Brexit we understand that international referencing, both in the pricing and HTA fields, means that such developments cannot be considered in isolation or purely at a national level.

If you would like to know more about how to build an effective BIM please talk to us. We know what works when developing a convincing payer communication tool; we focus on the flow of the information within the tools, making sure we tell a valid story which decisions-makers can follow from beginning to end. For further information or to request a demonstration of our Budget Impact tools please click on the link below.

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