The first is on the market, how is the domestic CAR-T therapy priced?

There has been a joke abroad that the biggest side effect of drugs is price, especially for new drugs.
days ago, Fosun Kate CAR-T therapy Yikililun race injection application in China has entered the "in the approval" stage, which is currently the fastest CAR-T products, if approved, it will become the first domestic, the world's fourth approved car-T therapy approved for listing.
so far, there has not been any CAR-T products approved, the product approved after the commercialization of how to price? Has become a difficult problem in front of enterprises.
's CAR-T product therapy Kymriah was approved by the U.S. FDA in August 2017 for the treatment of relapsed or refractic (R/R) B cell acute Lymphocytic leukemia (ALL), the world's first approved CAR-T treatment at the time, was initially priced at $475,000, or about $3.08 million, in the United States and generated sales of $278 million in 2019.
In October 2017, Gilead Kite Pharmaceuticals' CAR-T therapy Yescarta was approved by the FDA to treat adult patients with certain types of large B-cell lymphoma, making it the second car-T therapy approved in the world, priced at $373,000, or about $2.42 million, with sales of $456 million for the full year of 2019.
health insurance has become an important way for Kymriah and Yescarta to improve accessibility and affordability because of high pricing.
In 2018, the NHS announced coverage of Kymriah for clinical treatment, and patients under the age of 25 with relapsed or refractic B-cell acute lymphoblastic leukemia (ALL) applied to Novarma for Kymriah treatment through the Cancer Drugs Foundation (CDF), which estimates that only a small number of leukaemia patients in the UK are eligible for treatment each year, with the number of eligible patients estimated at around 30 at the time.
But for commercial reasons, Novartic did not disclose the price of Kymriah under the NHS agreement, which originally cost 282,000 pounds, or about $373,000 per patient, about $373,000 per patient, about $100,000 less than the price in the U.S., so why are prices different from country to country? Novartic's explanation at the time was: "Different pricing methods are needed to help support access to patients, and because the health care systems and infrastructure for quality inspections vary widely between the US and eucess, and even in EU countries, it is not possible to price in a one-size-fits-all way, and pricing models need to be tailored to the unique circumstances of each market."
" followed by Kymriah's entry into U.S. and Japanese health insurance, and in February 2019, the U.S. approved the formal inclusion of CAR-T cell therapy, and in August of that year, the Centers for Medicare and Medicaid Services (CMS) announced that it would pay not only for CAR-T cell therapy, but also for all related services and treatments, including drug administration, cell collection and treatment, cell return, and outpatient or inpatient care.
May 2019, Japan's Central Social Security Medical Agreement approved Kymriah's inclusion in health insurance, priced at about 33.5 million yen (about 2.1 million yuan), according to Japan's Ministry of Health, Labour and Human Rights. The highest-priced drugs, calculated under Japan's "high health care system" of public health insurance, will cover most of the cost of using Kymriah from Japan's public insurance, with patients paying a minimum of 410,000 yen (about 257,000 yuan) for the drug.
But Kymriah's application to Japanese health insurance is subject to three conditions: the drug is treated only in certain groups of leukemia and lymphoma, and is under 25 years of age, and is not effective with other anticancer drugs.
estimates at the time by Japan's Ministry of Health, Labour and Industry that the number of patients in Japan who met all three conditions at the same time was up to 216 a year, with a market demand of about 7.2 billion yen (about 450 million yuan).
yescarta only went to the U.S. and not to the U.K.
However, due to the large population base and large number of patient groups, the inclusion of foreign health insurance does not seem to be realized in China, at least not in the short term after the product is approved for market.
domestic pricing factors need to consider which generally speaking, the price of products need to take into account the direct production costs, supply chain overall costs, market sales scale, policy environment and other factors, CAR-T therapy as a sexual therapy is particularly true.
, citing E drug managers, reported that the price of car-T therapy approved abroad is so high, the fundamental reason is that CAR-T therapy is a highly personalized therapy, each patient's individual differences lead to different T-cell preparation cycle, in which case it is extremely difficult to form a standardized workflow, and standardized workflow is an extremely important part of the commercialization of medical products to control costs.
At the same time, CAR-T preparation process, involving machinery and equipment, consumables costs, process packaging, quality control testing costs, cell products GMP plant operating costs are expensive, high costs lead to enterprises from the beginning it is difficult to implement low-cost sales of products, some industry insiders believe that the domestic CAR-T commercialization of the initial price may not be much different from overseas pricing.
Take Fosun Kate's Ikili Lunsai injection, for example, it has been revealed that as of January 2020, Fosun Kate's cumulative research and development investment in it was about RMB474 million (including patent and technology licensing fees, unaudited).
But there are experts pointed out that: China's pricing is more in line with the national conditions CAR-T treatment pricing can not refer to foreign countries, domestic pricing needs to clinical needs as the core, patient-centered, in full consideration of social benefits on the basis of the realization of China's national conditions of the pricing program.
to link efficacy to drug pricing and introduce value pricing mechanisms, many countries or regions have established health technology assessment organizations and conducted assessment of complementary health care decisions to guide drug pricing.
At a large forum attended by medical reporters, some entrepreneurs also said: "If CAR-T therapy is priced at $475,000 in China, it will not work, it would be better to send it directly to the United States for treatment, but if it is priced at 300,000 to 500,000 yuan, this price is likely to be accepted." Because of a bone marrow transplant, if no other complications occur, about half a million is almost, if CAR-T treatment can be set in such a price range, and the therapeutic effect can be alleviated for more than a year, or after the relief to give patients a bone marrow transplant opportunity, after more than five years of relief, can have such expectations, I believe there is still a market.
" there are enterprises said that in order to ensure product quality under the premise, can replace imported supplies through domestic supplies, the production costs directly down, the cost of falling, the final product prices will have a certain amount of room for decline.
China and the United States CAR-T clinical volume profile data (as of June 30, 2020) also learned that domestic CAR-T therapy research and development has entered a very hot state, according to relevant statistics show that by the end of June 2020, a total of 557 CAR-T clinical trials are under way, of which China ranked first accounted for 306, followed by the United States, including 209, China and the United States accounted for more than 90% of the global CAR-T clinical trials.
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