A successful market access strategy for Europe encounters a variety of factors: the reimbursement situation in individual European countries, the competitive environment, and the preferences of patients and healthcare professionals.

Market access in Europe regularly presents a challenge for pharmaceutical companies, regardless of their country of origin. There are various aspects to be considered:

Central Approval does not Guarantee Market Access to the Individual EU Member States

In terms of market access, European countries are no different from other developed countries like the USA or Japan, where approval does not automatically guarantee economic success: Although a drug is basically marketable throughout the EU once it has obtained EMA approval through the centralized approval process, for example, it is not prescribed by doctors until it has been included in the reimbursement catalog of the respective country. In the case of innovative drugs, a prerequisite for this is usually the successful completion of a formal process for inclusion in a catalogue of reimbursed drugs. This includes a formal assessment by the reimbursement authorities of a country, including health technology assessment. The details are presented here.

Price Levels, Supply Systems & Patient Numbers as Market Access Factors

When developing a market access strategy for Europe, it is important to assess the individual European markets in terms of price levels and patient numbers. In addition, it must be examined whether the drug will be used primarily in the inpatient or outpatient sector. This can vary from country to country in Europe. There are many reasons for these differences, as the level of medical care within the individual European countries varies. The individual EU countries are not financially equal and, for historical reasons, medical care is also very different. In addition, the customs of the medical profession also differ from country to country. For example, an innovative drug may be gladly and often prescribed in Denmark. The same drug though may not be successful in Spain, even though it may be prescribed because the doctors there are not comfortable with it. Similarly, patients differ from country to country, which explains the large variations in the prescription of certain groups of drugs. For example, there are large variations in the prescription of antidepressants or antidiabetic drugs, as lifestyles vary and therefore predispositions are different. It is therefore often advisable to hold discussions with key opinion leaders when the launch of a new drug is planned. This is especially true if the drug is to be used in the hospital sector.

Market Access and Competition

Finally, the competitive situation regarding market access must also be taken into account. This is particularly true for orphan drugs, as some manufacturers get centralized approval for the whole of the EU, but do not market them in every country. In this context, drugs that were placed on the market before the introduction of the centralized approval by EMA are sometimes also relevant for competition. These products are often still on the market in the individual countries, have a national marketing authorization, on the basis of which they may only be marketed in the relevant market. These "old products" can have a large market volume in individual markets, although they are not particularly relevant with regard to the entire EU. Finally, for European market access it must also be examined whether parallel imports are to be expected. This is generally permitted due to the free movement of goods within the EU. Some EU countries promote this by requiring pharmacies to dispense a certain quota of re-imported drugs to patients.

Strategic Issues when launching an Innovative Drug

Another important aspect is the expected price development. Depending on the European country, the procedure for setting prices varies considerably, as does the timing of it: pricing and reimbursement processes may commence before or after the date when a new drug may first be prescribed. In Germany, for example, drugs can be prescribed from the time of approval onwards at the expense of the statutory health insurance fund, and at the price chosen by the manufacturer. Price negotiations only take place later: In the first year after market launch, the manufacturer is free to set prices. This is often a great advantage for a pharmaceutical manufacturer, because the drug can be sold at a reasonable price for at least a year. In addition, the German price is also of direct importance to other European markets, since these refer to the German sales price (together with other European prices). Germany in turn also references the prices of various EU countries. Therefore, a prudent launch strategy must always take into account these price referencing mechanisms, so that the low price negotiated for one European country does not affect the price level of other EU countries. Often Germany is the first country chosen by pharmaceutical companies for product launch, but sometimes other countries are more suitable. It is also important to know that not all prices are published. Therefore, as part of a market access strategy, it is also important to consider which markets can possibly be served despite low prices, since the low prices there cannot influence the price level in other European countries if these are not published.