Why is bedaquiline so expensive? Will the price decrease after it is included in medical insurance?

Bedaquiline (Bedaquiline) is a new anti-tuberculosis drug mainly used to treat multidrug-resistant Mycobacterium tuberculosis infection (MDR-TB). This drug was approved by the U.S. Food and Drug Administration (FDA) in 2012 and is the first drug with a new mechanism of action to target drug-resistant tuberculosis. Bedaquiline achieves antibacterial effects by inhibiting the ATP synthase of Mycobacterium tuberculosis, thus preventing the production of cellular energy.

There are several reasons why bedaquiline is expensive. As a new drug, its research and development process includes a large number of clinical trials and safety assessments, all of which require huge financial investments. In addition, because the incidence of tuberculosis, especially drug-resistant tuberculosis, is relatively low globally, pharmaceutical companies have limited expectations in terms of market size, further driving up pricing. Bedaquiline is still subject to patent protection globally, which means that other pharmaceutical companies cannot easily enter the market to compete, resulting in a relatively tight supply and a natural rise in prices.

In the domestic market, bedaquiline fumarate tablets are already on the market as the name of this drug and are included in the scope of medical insurance. Its common specifications are 100 mg 24 tablets/box, and the price is about 10,000 yuan, which is relatively high. With medical insurance coverage, the burden on patients will be reduced, which will also help improve the accessibility of medicines.

Overseas, the specifications of the Russian version of bedaquiline are100 mg, 188 tablets/box, and the price may be around 15,000 yuan (the price will fluctuate due to the exchange rate). However, the pharmaceutical ingredients of bedaquiline sold domestically and overseas are similar, and there are currently no generic bedaquiline drugs on the overseas market.