AstraZeneca practice pricing system in Germany



AstraZeneca with the German regulatory authorities around the development of new blood thinner Brilique pricing issues a year-long debate. Major pharmaceutical companies are closely watching the dynamic AstraZeneca in Germany, to develop new strategies to adapt to the German market.

European countries to control health care costs make a new attempt to prove than the old and new compounds with greater therapeutic benefits of drugs will only be high priced
Recently, AstraZeneca developed in the German market for its new blood thinner Brilique set each and 1.69 euros ($ 2.38 together) the sales price, the company expects the drug to be the next one "blockbuster" drugs. However, AstraZeneca can do so in Germany, Europe's largest pharmaceutical market to maintain the high prices remains to be seen.
The British pharmaceutical company with insurance agencies and regulatory authorities in Germany issues surrounding the drug pricing debate for over a year, and this is the price of the new law for the first time the German practice.

Better clinical

New price method, large pharmaceutical companies with new challenges. Previously, pharmaceutical companies developing new drugs just to prove safe and effective, but now, but also to prove that new drugs than the drug treatment clinic has been worth more. If a pharmaceutical company can demonstrate to the German drug regulatory authorities of new compounds with greater therapeutic benefits, the pricing of the drug can not be higher than competitive products.

This is a European country to make health care expenditures for the control of a new attempt. This year in January, according to AstraZeneca became the first German revised procedure for new drugs approved pharmaceutical companies. AstraZeneca is responsible for health care services in Germany Klaus Runge, vice president (Claus Runge), said: "We help the government design a new drug pricing system."

Last year, AstraZeneca realized sales of 33.3 billion, of which more than half of sales are about to lose their patent in 2014, the drug. According to data compiled by Bloomberg projected to 2016, Brilique will achieve annual sales of 2.4 billion. Brilique AstraZeneca can become a rising star, will depend on whether the drug approved for sale in the United States. United States Government does not Medicare (Medicare) program beneficiaries to use the drug price negotiations with pharmaceutical companies. While in other countries and regions, AstraZeneca will be priced on the Brilique 2.25 ~ 3.50 euros.

Analysts said Germany's ongoing reform of the AstraZeneca drug prices (especially Brilique) is very important to France and other relevant decisions of the European mainstream market will have a ripple effect.

The German government estimates that the price of the new law will save the country each year about 20 billion euros of expenditure. Opposition from the pharmaceutical industry that the new reforms will undermine innovation. Patrick Lee, CEO of Eli Lilly (John C. Lechleiter), said Europe pricing pressures exerted on pharmaceutical concern, in the past year, Li Li has to fly over Berlin, Madrid and London, with local health officials to discuss matters relating to regulatory reform . He said the British Ministry of Health, based on the clinical value of price negotiations to be delayed time to market of new drugs.

New German Law of drug prices

Currently, Eli Lilly and other pharmaceutical companies are closely watching the dynamic AstraZeneca in Germany, hoping to develop a new strategy to adapt to the German market.

The new drug price law in Germany last November passed, it is Chancellor Angela Merkel plans to eliminate the German public insurance system this year, the core of the deficit measure. German Health Minister Philippe general Chrysler (Philipp Rosler) drug price negotiations, this time with the patient to pay premiums of 22 billion euros of temporary discounts and price freeze on the implementation of an old drug combination.

Pharmaceutical companies, this process has six steps. First of all, after 6 months of internal assessment, pharmaceutical companies set the price for the drug, the price will be the starting point for negotiations with the regulators.

Next, the pharmaceutical companies have to "Federal Joint Committee" (FJC) to submit dossiers to prove superior to market existing drugs similar drugs. FJC is the German standard of compensation for the development of a pharmaceutical organization. If the efficacy of new drugs through the testing, the pricing will be same as existing drugs on the market. For example, Brilique current price higher than clopidogrel about 22%. If the drug can clear away obstacles to the characterization, pharmaceutical companies and public insurance institutions (covering approximately 90% of the population in Germany) can negotiate a price in the original negotiations on the basis of a discount given the magnitude of the insurance company.

FJC Master 席莱纳赫斯 (Rainer Hess) said that in 2013, after price negotiations, cost savings equivalent to 22 billion euros of temporary discounts. Supporters said the move aims to strictly control spending on health care and to ensure that only truly innovative drugs to become profitable. Association of the German statutory health insurance fund, a spokesman said: "If a breakthrough drug, we are willing to pay."

Thinking the same as the regulatory authorities

Regulatory authorities in France asked AstraZeneca to provide more information about Brilique side effects after the drug AstraZeneca has withdrawn an application to market in France. AstraZeneca said it intends to submit a new application. Anticoagulant drug market in Europe, France occupies 1 / 3 of market share. In the United States, FDA initially rejected the drug in the market in December last year. Second review is scheduled for July this year.

Lee Lai-tat said that if too much emphasis on the pharmaceutical companies must prove that a drug has better efficacy, will enable pharmaceutical companies to start thinking like that as regulators. For example, in addition to that carried out a better than clopidogrel Brilique medical research, AstraZeneca also used quality-adjusted life year (QALY) of this ratio, commissioned a review of the research data for the economy. This measure is estimated that medical interventions should not only increase the life of the patient, but also based on the patient's health level (perfect health 1 point, death had 0 points), to assess their quality of life. QALY results indicators traditionally used by government agencies, such as the UK's National Health and Clinical Excellence, which the British National Health Service system to submit cost-effectiveness of drugs with the recommendation.

AstraZeneca internal review found that, in accordance with the measured 0 ~ 1 (1 point is the best health outcomes), Brilique provided QALY is 0.13. Company reported that for some patients Brilique (rather than the current standard drugs) will increase each year from 2500 to 5700 euros in costs. AstraZeneca spokesman explained: "We are looking for ways to prove that our drugs have value."

Just last month, AstraZeneca issued a result, this is the first pharmaceutical company claims that its drugs have QALY results. If the German model in other places "flourish", there will be more and more pharmaceutical companies begin to emulate a variety of AstraZeneca to market research to support. (Di-compiled)



2011-06-13