Post EMA approval: how soon can products be sold?

Question: After EMA approval, are sales of a pharmaceutical allowed in EU5, before pricing is approved? What is the soonest a company can sell a pharmaceutical agent in Europe after approval?

Answer: There is no consistency across Europe on this; in synopsis, the picture is as follows (accurate as of 1st November 2016):

Germany: Sales are allowed as soon as the product is listed in Lauertaxe (approx. 1 month after EMA approval) provided that the price application dossier has been filed with the GBA (assessment and negotiation take 1 year and during the 1 year there is free pricing). The product can be promoted during this year.

France: The ATU (Temporary Authorization for Use) allows sales prior to approval. After approval, the product can be sold but not promoted until price is granted.

Italy: L648 regulations allow sales prior to approval and after approval until price is granted. No sales or promotion is permitted apart from under L648 unless reimbursement granted. L648 is a commonly-used mechanism for obtaining early sales in Italy. The application must be made by a medical professional and not by the company. The criteria for granting early access under law 648 are outlined below:

  • Law 648/1996 provides that a medicinal product not authorized in Italy can be supplied for the treatment of patients and reimbursed by the Italian national healthcare system, following a prior opinion of the AIFA techno-scientific committee (i.e. CTS), in a case where there is no therapeutic alternative and: (i) the medicinal product is an innovative medicinal product that is authorized in other EU member states but not in Italy; (ii) the medicinal product is currently under evaluation (i.e. clinical investigation); and (iii) the medicinal product will be used for an unauthorized indication.

United Kingdom: Price listing (free pricing under the PPRS), promotion and sales are allowed providing materials have been cleared for promotional use (a one- off approval on launch and then self-regulation along ABPI guidelines). The issue is that it is difficult to get someone to pay for it – the product usually needs to be listed within NHS Trust formularies, recommended by NICE or covered by a separate fund (e.g., Cancer Drug Fund). There is no paid early access program.

Spain: There is no paid early access program, no price listing and no promotion until reimbursement granted. Reimbursement negotiations take place first on national and then on a regional level. Both National and Regional governments have to approve the price of a pharmaceutical product before sales can be generated in Spain. In reality, the two processes can be run in parallel with the company contacting both the National HTA Agency (ISCIII) and the Regional HTA agencies at the beginning and keeping the regional authorities abreast of the discussions on a national level to shepherd the regional negotiations through. If this is done well, both the national and regional approvals come at the same time and the regional authorities accept the national ruling.

In both Italy and Spain, there are often general managers on the ground about a year before reimbursement in order to manage the L648 and pricing/reimbursement discussions.

Variations: there are additional procedures available for hospital-only products (those that administered to in-patients, and not ambulatory day patients). E.g. in Germany a company can elect not to have a GBA assessment (only obligatory if the drug will be sold through the retail channel) and negotiate a hospital price with sick funds if they believe additional funds will be required beyond the applicable DRG category. In the UK, hospital trusts work on the basis of formularies which are approved by a formulary committee. This is also true in France. Similar systems are applicable in Italy and Spain at the regional level.

Caution: These early sales are effectively ‘conditional’: sales cannot be booked until the official price is recognised in each market. Germany, France and Italy have clawback mechanisms to account for any price differential between the pre-price phase and the official price.

Alacrita’s team of European pharmaceutical commercialization consultants are regularly engaged to help clients plan for and execute European product launches. Please contact us if you are looking for help.”

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