Imagine you are full of ambition and you recently started a new position in market access. Congratulations! After a few weeks of hard work your company identified you the best suited colleague to estimate the launch date of a new product. The choice is yours! You can read and apply legislation by yourself (good luck), or you can learn from colleagues (smart idea).

Some questions need to be asked on beforehand. Which country? Is your product concern a pharmaceutical product, a medical device, a diagnostic test, healthcare related software or a combination of these? Is it a ‘me too’ product or does it provide an answer to an unmet medical need? What is the regulatory background of your product?

By the time you’re being asked to evaluate a potential launch date, many of these will be answered, so you’re ready to start your exercise in estimating the procedural timelines. Unfortunately, legislation has indicated several options can become valid and some hurdles will come up. Would your company be open to negotiate with the authorities? What about reference countries? Fast track procedure? Former procedures? Floor price? Hmmm… much more complex than expected.

This blog has not the intention to learn you all aspects of the procedural timelines (status June 2022). Instead we would like to focus on a hypothetical example, which can help you to define the variables you need to take into account.

Let’s focus on the Belgian pharmaceutical market. As your company targets to bring an innovation to the patients, a ‘Class 3 application’ (administrative procedure) is not valid. If a ‘Class 3 procedure’ would be possible (mainly for generics, hybrid drugs and biosimilars) your company may count 60 to 90 calendar days from day of submission.

Two options are left: a ‘Class 2’ (budget neutrality versus competitors) or a ‘Class 1’ application (clinical benefit). Both procedures can be done in 180 calendar days. But… this is theory. In practice both procedures can take 1 year or even more. How is this possible?

Therefore you need to understand the procedural dynamics in line with Belgian legislation (Royal Decree of Feb. 2018).

A class 2 or class 1 application consists of several steps. During some of these steps, you can  interact with the commission of reimbursement (‘CRM’).

As soon as the reimbursement request is submitted (via an electronic platform) and when all dossier elements are complete: ‘day 0’ is defined and ‘the ‘clock’ will start to count for 180 calendar days. But how to delay the procedure (stop the clock)?

Option 1: during the procedure, at two different moments (at ‘Day 60’ and at ‘Day 120’), a ‘clock stop’ can be used to provide answers or clarifications to the committee’s questions. This ‘clock stop’ can take a maximum of 90 days each. Of note: once per procedure, the company can also ask for a procedural hearing. This hearing can be requested without a formal clock stop. In this case, the procedure will be delayed with a maximum of 25 days. In practice, most companies ask for a formal clock stop during which a hearing can be requested.

Option 2: Some companies will trigger a ‘clock stop’ at ‘Day 90’. At ‘Day 90’, your company should notify the maximum price as received from Economic Affairs to the CRM. If not done in time, the clock will stop for a maximum of 180 days. If no price is notified within this time, the procedure will be closed.

Strategic options and decisions can induce a delay in the procedure. For example, the company will define a new floor price in the upcoming weeks. This new floor price can become an important element to achieve success during the ongoing procedure. Another example is new clinical information, which becomes available during the clock stop(s).

An important strategic decision remains the option between a ‘Class 1’ or ‘Class 2’.

Your company should balance out the risks with the benefits of the potential ‘class 1 procedure’. What are the benefits? Indeed: a premium list price. In addition, the procedure can be initiated at CHMP opinion and thus several weeks before EMA approval. The earlier the submission can be done, the faster the product can become available. In addition, other countries can use the list price for reference. Disadvantages? Although a premium price is requested, there is no absolute guarantee that this high list price will be achieved. A health economic assessment will be needed to balance out the clinical benefit versus the extra costs (unless your product concerns an orphan designation). Depending of the (financial and clinical) uncertainties, the authorities can ask to ‘refund’ a part of your revenue by use of a managed entry agreement (MEA). In addition, the procedural time needed to end up with a MEA will take a few months in addition versus a ‘class 2 procedure’ (budget neutrality versus comparators). Most probably, a new procedure (full application) will be needed to get out of the contract later on.

We recommend you to assess all options in a multidisciplinary team and explore if it is worthwhile to target a premium price as well if your company is open to take the risks.

Assuming that all this information can be estimated on beforehand you will be able to provide your company with a robust answer regarding timelines.

Good news: we have build a calculator which can help you to define the best estimate of launch date. This calculator includes all procedural options which can be used or which can play a role in the procedure (delivery of EMA approved texts, clock stops & hearing moments, MEA procedure, … ). The beauty of this calculator is that you can simulate several scenario’s to present to your company. Interested to receive this calculator? Just call! And bear in mind: we don’t charge every service!

If you would like to benefit from more insights, give us a call as well. We are happy to guide you through all elements needed.

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