Hepatitis C Sangui drugs encountered high price or resistance in the EU market

The business club reported on May 3 that the price of the new Hepatitis C therapeutic drugs jointly produced by Merck and Johnson & Johnson in the French market has reached or exceeded 22,000 euros (31,271 U.S. dollars). Some doctors said that this kind of price set a precedent and it may restrict the use of new hepatitis C drugs in the European market.

High price boycott

According to the French Patient Association SOS Hepatites, according to a government health care plan for seriously ill patients, the price of Telaprevir, a hepatitis C drug, produced by Johnson & Johnson and Vertex Pharmaceuticals, is 22,000 euros. Under the same plan, the price of Boceprevir, a hepatitis C drug produced by Merck, is as high as 30,000 euros. For these seriously ill patients, there are no other effective therapeutic drugs on the market.

MSD and Johnson executives stated that once these drugs are approved for use in a wider market, their prices may decline. However, Antonio Craxi, director of gastroenterology and internal medicine at the University of Palermo, Italy, said that this model of pricing in France suggests that the new drug may increase the cost of hepatitis C treatment by a factor of 2, and it will also make it possible for the UK, Russia and Eastern European countries to postpone or limit The patient uses these drugs.

MarkThursz, a professor of hepatology at Imperial College London, said in an interview at the European Association for the Study of the Liver Disease in Berlin: “We may not be able to use them until the price falls and it is not the best economic environment to introduce expensive new drugs.” .

Thursz said that the National Institute of Health and Clinical Excellence (NICE) in the United Kingdom may restrict patients to use new hepatitis C drugs even if these patients have already tried existing drugs without treatment effect; in addition, NICE may also require genetic testing. To confirm if the patient is likely to respond to new drugs.

Italy and Spain may also postpone or limit the use of new hepatitis C drugs. At present, Italy spends approximately 350 million euros per year on existing hepatitis C therapeutic drugs. If this cost increases twice, it will exceed 1 billion euros.

Telaprevir and Boceprevir are being reviewed by regulators of the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) is scheduled to hold hearings on these two new drugs at the end of April.

The French Agency for Health, Safety and Health Products (AFSSAPS) stated that in France, Telaprevir and Boceprevir received temporary special approval in December last year according to a plan for medical care for seriously ill patients. This allows the two new drugs to bypass General approval process.

At present, about 500 patients in France are receiving new treatment for hepatitis C. SOS Hepatites spokesperson Michel Bonjour said in an interview that the new drug was given to patients together with the current standard therapeutic drug interferon and the generic name Ribavirin, and that the total treatment cost per patient for up to 1 year may reach 45,000. ~ 70,000 euros. All these costs were paid by the French National Health Insurance Plan.

Will improve patient cure rate

Patrick Bergstedt, senior vice president of vaccines and infectious diseases at Merck, said in an interview that the price of this treatment is not a good sign. He said that seriously ill patients who participated in the French medical care program used Boceprevir for 44 weeks, while the more typical one was 24 to 32 weeks. Therefore, it is highly probable that the patient's treatment cost for one course of treatment will be lower than the 30,000 euro that Meshad currently obtains from this medical plan in France. Bergstedt said that the cost-effectiveness of these drugs is undoubted. The real question is how you will manage these drugs in stages and how you will use them responsibly to ensure that the patients most in need are treated first. Vertex, based in Cambridge, Mass., transferred the issue to its partner Johnson & Johnson, which will sell Telaprevir in the European market. Isabelle Lonjon-Domanec, the head of Johnson & Johnson’s global medical affairs responsible for Telaprevir, said that Johnson & Johnson has not yet determined the final price of Telaprevir.

The patient took Telaprevir in combination with standard treatment medication for 12 weeks and continued treatment with the old standard drug. The entire treatment period was between 6 months and 1 year.

Both of these new hepatitis C drugs are protease inhibitors, and they use the same technology that humans have achieved in the field of HIV research. Studies have shown that when used in combination with existing drugs, they can increase the patient's cure rate from half to 1/3 to 3/4.

Howard Liang, an analyst at Boston Leeink Swann & Co., estimates that in the United States, the prices of the two new drugs may reach $35,000 to $40,000.

Liang said in an interview that the cure of the disease saved a lot of follow-up costs. "This is a shock to doctors, but I think this is reasonable because it cures the disease."

New drug development continues

Hepatitis C spreads through contact with infected blood. As a virus, it tends to develop into a chronic disease. It can cause nausea and fatigue during the devastating effects on the liver for years or decades. According to WHO, there are approximately 170 million people worldwide infected with hepatitis C.

At the same time, the next generation of drugs with higher cure rates and fewer side effects may be available in the next three years.

The Swedish pharmaceutical company Medivir AB has stated that it expects to begin marketing a competitive drug that is used in conjunction with interferon in 2013. More than a dozen pharmaceutical companies, including Boehringer Ingelheim, Gilead Science, and Bristol-Myers Squibb, are seeking to develop cocktail drugs to replace existing compound interferon.

Charles Gore, president of the World Hepatitis Alliance (WHA), a patient rights group in Geneva, said that the imminent competitive situation has made MSD, Vertex and Johnson & Johnson not have much time to recover their investments. In an interview, he said: “This is a difficult question to answer. On the one hand, we must find ways to get people to get new drugs and receive treatment; on the other hand, we must encourage pharmaceutical companies to develop long-term in this therapeutic field. research work."