ObjectivesPharmacoeconomics and cost-effectiveness assessments are increasingly taken into account in pricing and/or reimbursement decisions. In an attempt to measure the impact those assessments have on time to pricing and price levels of innovative drugs, we surveyed market availability and drug prices for a basket of 125 innovative medicinal products in the top-five European pharmaceutical markets.

MethodsThe price availability of 125 innovative medicinal products—approved between July 2009 and April 2012 by the EMA—in France, Germany, Italy, Spain, and the United-Kingdom was analysed.

Manufacturer prices of 10 innovative drugs available in each of the markets studied were then compared. In order to do so, VAT, pharmacists’ margins, and wholesalers’ margins were removed from retail prices provided by sources.

ResultsTable 1: Market availability of drugs in the top-five European pharmaceutical markets

out of the 125 innovative drugs approved by EMA between July 2009 and April 2012

Source: IHS PharmOnline International

A limited number of the innovative drugs (17) included in the sample analysed are available in each of the top-five European pharmaceutical markets, although most of them were approved by EMA at least year years ago.

Table 2: Listing of the innovative medicinal products approved by EMA between

July 2009 and April 2012 available in each of the top-five European pharmaceutical markets

Source: European Medicines Agency (EMA) and IHS PharmOnline International

Among the innovative medicinal products available in each of the top-five European pharmaceutical markets, manufacturer prices of 10 drugs were compared. For each drug, the ranking of the markets studied from the highest manufacture price (1) to the lowest (5) is summarised in the following table.

Table 3: Ranking of the top-five European pharmaceutical markets

according to manufacturer price levels

Source: IHS PharmOnline International; exchange rate UK: 1 GBP = 1.25367 EUR

Data indicate that prices of drugs are usually the highest in Germany (they were the highest in 6 out of the 10 case studies). It comes as no surprise considering that most drugs for which prices were compared had been approved before the AMNOG pricing reform, and none of them belongs to the 27 drugs that completed the early benefit assessment.

Prices of innovative drugs tend to be the lowest in France. This result is unexpected given the fact that French legislation specifies that prices of drugs deemed innovative (ASMR ratings from I to III) cannot be lower than the lowest price in Germany, Italy, Spain, and the UK. However, the French National Authority for Health (HAS) is increasingly stringent when granting ASMR ratings, as demonstrated by the annual activity reports: 18 ASMR from I to III were granted in 2009. This figure dropped to 13 in 2010 and only 1 in 2011.

Conclusions As summarised in the following chart, Germany is where the most innovative drugs are available and prices are the highest. Conversely, France has fewer innovative drugs available—due to longer pricing procedures—and the lowest prices—due to the increasingly stringent assessment of drug innovation provided by the HAS. In Italy, Spain, and the UK, price levels differ on a case-by-case basis. In the UK, more drugs are available, while in Italy, prices of orphan drugs tend to be higher.

Number of drugs available out of the 125 innovative drugs approved by EMA between July 2009 and April 2012

Percentage

Germany 74 59%UK 67 54%Spain 49 39%France 41 33%Italy 40 32%

Brand name Marketing approval date

Gilenya 17/03/2011Jevtana 17/03/2011Vpriv 26/08/2010Ozurdex 27/07/2010Votrient 14/06/2010Nivestim 08/06/2010Menveo 15/03/2010Revolade 11/03/2010Prevenar 13 09/12/2009Onbrez Breezhaler 30/11/2009Multaq 26/11/2009Eporatio 29/10/2009Ilaris 23/10/2009Resolor 15/10/2009Cimzia 01/10/2009Onglyza 01/10/2009Mozobil 31/07/2009

Brand name Germany Italy Spain UK France

Gilenya 1 3 5 2 4Vpriv 1 5 3 2 5Ozurdex 1 5 4 2 3Revolade 2 1 3 5 4Onbrez Breezhaler 1 5 2 3 4Ilaris 4 5 3 1 2Cimzia 1 3 2 4 5Onglyza 1 2 3 5 4Mozobil 3 1 4 5 2Eporatio 2 1 3 5 4Ranking Average 1.7 3.1 3.2 3.4 3.7

Availability and Pricing of New Pharmaceuticals in the Top 5 European Pharmaceutical MarketsReinaud F, Ando G (IHS, London, United Kingdom)

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