The European Marketing Authorization process, for new lifescience products, is harmonized through EMA’s centralized procedure (with exclusion of the UK and Switzerland).

However, Market Access processes, timelines, HTA interactions, pricing and reimbursement decisions for medicines remain a national or, in some countries, a regional or hospital by hospital competence. This makes the landscape a very different dynamic to the one in the US.

Understanding the localized opportunities and threats

Unfortunately, there isn’t a one process fits all scenario when exploring your route to Market Access in Europe. You will find many nuances country by country. Some European countries require lifescience companies to submit information on their new asset, 18-36 months prior to launch. This is a process known as Horizon Scanning. Other countries, on the other hand, will obtain information through activity that is planned by the agency, rather than activity initiated through a company submission or through other initiatives such as the BeNeLuxA network.

You must be prepared with lots of insight and knowledge or work with an experienced partner who understands the requirements. It will save you valuable time and resources in what can be a small window of opportunity.

Where’s the value in data?

The value of the type of data will vary from country to country. Each country will place different weight on what they signify as “value”. One country may favor Overall Survival (OS) data while others find more value in Progression Free Survival (PFS).

You’ll need to understand, or work with a partner who understands, what is required and how to weight your findings and data documentation. This will make your path as efficient as possible to support reimbursement and pricing decisions in your favor.

Working out the pricing and reimbursement strategy

Another major Market Access concern relates to pricing and reimbursement. You’ll need to adapt to different regions requiring different types of documented data, HTA Dossiers, and evidence before market access will be granted for your new product.

For example, France and Germany tend to focus more attention on the clinical evidence and additional benefit of your product. The UK and Netherlands will focus their attention on the cost-effectiveness of your product. In Italy, the Budget Impact Analysis is mandatory in addition to Cost-Effectiveness analysis. While in Switzerland, the medicine is examined for safety, efficacy, and quality before being included in the Specialties List (SL).

The where and when

Across Europe, patient access to new medicines will differ dramatically. You’ll find they are strongly connected to the pricing and reimbursement processes and decision making.

Findings show that Germany has the slowest average time to market   after EMA authorization. In France, the time can be slightly longer than 12 months. In Italy and Spain the process can take much longer. This is due to the responsibility for provision of healthcare generally being decentralized by regions.

We also have special considerations to be made for Orphan Drugs, as patient access may be even longer if a well-considered strategy has not been created ahead of time.

Building a more efficient (and less stressful) path into Europe

As you can see, the consideration that must be given to strategy, research, data, and scheduling, as well as the number of processes that must be undertaken by lifesciences companies to launch a product in Europe can be overwhelming.

It’s why so many lifesciences companies partner with regional experts. It can make the path to a successful launch in Europe a less stressful and more efficient one. This is something that I have written about previously and highlighted how it is time for some new thinking, and the fact that you may need to be looking for the right partner for your business and even considering the benefits of outlicencing.

As a first step, Solem can help your plans by providing a tailored Market Access timeline with key activities that your company needs to undertake. This will highlight needs from a general perspective to more specific, country-to-country requirements.

Our timeline gives you a high-level view of what is to come 3 years prior to regulatory approval, and 3 years after. This view is based on the information provided by the company, desk research, and expert experience in Market Access. From a more general view, you’ll understand which activities are necessary from Environmental Assessment to a Preliminary MA Plan, Gap Analysis, Data Generation, and Final MA Plan.

Solem also adds country specific milestones to guide your plans. We’ll also support your organization to prioritize activities according to what is needed in each European country. Such a high-level overview provides you with the necessary information to plan future resources and budget requirements as your asset approaches regulatory approval.

Below are 2 parts of a Solem Market Access timeline example:

Figure 1: Solem Global Illustrative Example

Figure 2: Solem Global Illustrative Example Ireland

To help support these timelines, we provide a report with specific key information on your chosen countries, along with reference for further guidance. Once a company understands the activities that lay ahead when they’re planning to enter European markets, then they should begin to think about their strategy as early as possible.

An experienced expert like Solem will support you from the outset or at any stage of the process.

—

References

Frenoy, E. (2019). From Market Authorization to Patient Access: How Long is Too Long? Retrieved from Global Forum: https://globalforum.diaglobal.org/issue/june-2019/from-market-authorization-to-patient-access-how-long-is-too-long/

WHO. (2018). Medicines Reimbursment Policy in Europe. World Health Organization. Retrieved from https://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf