The first domestic CAR-T is about to go on sale Who will pay for the high price?

Recently, Fosun Pharma's Fosun CAR-T product FKC876 (Aquilon injection) market application entered the administrative approval stage, is expected to be approved in the near future.
approved, it will be the first CAR-T therapy product in China.
car-T is definitely on the list if you want to say the hottest immunotherapy in recent years.
CAR-T, as a cellular immunotherapy treatment, transforms T cells from patients in vitro so that their expression can specifically identify the subject of the tumor cell surface target - chime antigens, and then return to the patient to play an anti-tumor role.
As a rising star since "birth," Novartis's star drug, Tisagenlecleucel, was launched in August 2017 to treat patients with relapsed/difficult-to-treat B-cell acute lymphoblastic leukemia (B-ALL) under the age of 25.
the launch of Kymriah is a milestone for global cancer immunotherapy.
, two more CAR-T drugs have been approved for the market.
Kymriah went on sale in October 2017, Gilead's Kite Pharmaceuticals targeted CD19 autocytocytotherapy product Axicabtageneciloleucel (trade name: Yescarta) and was approved by the FDA in October 2017 to become the world's first CAR-T cell drug for the treatment of recurring/refractic large B-cell lymphoma.
approval of two CAR-T products has also successfully demonstrated the promising future of cell immunotherapy in the treatment of tumors. after nearly three years of silence in the
CAR-T market, the FDA has accelerated approval of Brexucabtagene autoleucel, another CAR-T treatment by Gilead's Kite Pharmaceuticals, for the treatment of adult patients diagnosed with heterocytic lymphoma (MCL), who have not responded to other therapies or have relapsed.
is the first FDA-approved product to treat MCL based on cell gene therapy and the second CAR-T product approved by Kite Pharmaceuticals after Yescarta.
With Fosun Kate CAR-T drug approved nearly, the industry expects that in 2021 there will be several CAR-T products approved for market, domestic CAR-T commercialization brought about by the rationality of drug pricing and the corresponding payment methods of concern.
pricing in the first year of domestic commercialization? Cell therapy is still in a very early stage of development compared to small molecules of oral medicine or injectable antibodies.
CAR-T as a highly personalized treatment, each patient has received a variety of treatments before receiving CAR-T treatment, such as bone marrow transplant surgery, chemotherapy, targeted therapy, etc., the preparation and programming of T-cells will vary.
so from research and development, preparation to production have a highly specialized requirements, high production costs, long production process, can not form a standardized process and other issues determine the cost of cell therapy expensive treatment.
From a pricing point of view, Kymriah's one-time fee is $475,000, which can be refunded if it doesn't work after a month, and $373,000 for Kymriah's treatment of non-Hodgkin's lymphoma (NHL) without refund.
yescarta is priced at $373,000 for treatment in the NHL and is non-refundable.
of $3.4 million for treatment is undoubtedly a more costly and costly expense for the average patient, which also limits the access of patients with CAR-T therapy.
car-T therapy is so cheap? The head of a cell therapy-related enterprise in China admitted that the fundamental reason is that CAR-T therapy is a personalized therapy, the individualized differences of each patient lead to different preparation cycles of T-cells, 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.
"CAR-T involves the construction of genetic engineering vectors and CAR-T cell preparation and other issues," the aforementioned person in charge of the E drug manager, which includes the collection of patients' immune cells, in-body cell culture, transtotype, amplification and return and other preparation and treatment processes.
CAR-T drug pricing is highly cost-influenced, "in the process of machinery and equipment, consumables costs, process packaging, quality control testing costs, cell products GMP plant operating costs and so on are expensive."
" costs are hard to come by in the short term, and it's hard for companies to pay for them.
"the initial price of domestic CAR-T commercialization may not be much different from overseas pricing."
"China's pricing should be more in line with national conditions", domestic experts in the field of related cell therapy pointed out that CAR-T treatment pricing can not be referred to abroad, domestic pricing needs to be clinical needs as the core, patient-centered, in full consideration of social benefits on the basis of the realization of China's national conditions suitable 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.
generally believes that the commercialization of domestic CAR-T will require consideration of how to reduce the cost of treatment so that more patients benefit from the treatment.
a huge proposition before us is, how to make enterprises have a certain return at the same time, but also to make Chinese patients affordable? How much room for decline in the pricing of CAR-T therapies in China in the future? How can businesses reduce costs? "Perhaps lower than overseas, the cost of domestic CAR-T depends in part on the cost of the industry upstream and downstream.
" an industry insider, who did not want to be named, believes that the current to ensure the effectiveness and safety of local production of CAR-T equivalent to overseas products, the use of accessories reagents are the same as abroad.
if the future upstream and downstream related enterprises can pass scientific certification, after replacing domestic accessories reagents still achieve the same effectiveness and safety, the cost can be reduced, pricing naturally has room for reduction.
innovations that make it more critical to reduce costs. Li Yiping, CEO of
Pharmaceuticals Mingjuno, said at the 6th BiG IMPACT Annual Meeting that as a company that needs to continue to innovate technology, in the long run, our goal is to reduce production costs, which is certain, but cost reduction is not only dependent on simply reducing the cost of labor and raw materials, must be driven by technological innovation.
02 overseas payment methods, can I learn from them? To be sure, the millions of yuan in "sky-high" treatment costs may be a potential obstacle to the future development of CAR-T therapy in China.
so that countries' payment systems and innovative payment methods can provide reference for domestic use? And how to build a diversified payment system in line with the national conditions? Let's start by looking at how other countries around the world that have approved CAR-T therapies work.
The United States, the world's first approved CAR-T therapy, approved the formal inclusion of CAR-T cell therapy in February 2019, and in August of that year, the Centers for Medicare and Medicaid Services (CMS) announced that it would not only pay for CAR-T cell therapy, but also cover drug management, cell collection and treatment, cell return, and all related services and treatments for outpatient or inpatient care.
the requirements, when these therapies are available at a medical facility registered with the FDA's risk assessment and mitigation strategy, and adaptation is approved by the FDA, the cost of treatment will be covered by health insurance.
addition, Medicare will cover FDA-approved treatments for adaptive disorders other than the instructions, but these treatments are recommended by CMS-approved guidelines.
move faster than the US.
within days of EMA's approval of Kymriah's listing in September 2018, NHS England reached an insurance coverage agreement with Novarma for Kymriah, and two months later, the National Institute for Health and Clinical Optimization, the UK's cost-effectiveness regulator, decided to recommend Kymriah to young patients with relapsed or incurable B-ALL, who applied to Novartic for treatment through the Cancer Drugs Foundation.
As the first Asian country to approve CAR-T therapy, japan's Central Social Security Medical Agreement approved the inclusion of CAR-T cell therapy product Kymriah in may 2019, with a price of approximately 33.5 million yen (about 2.1 million yuan) from May 22.
, Kymriah is currently the most expensive drug in Japan, according to Japan's Ministry of Health, Labour and Human Rights.
the inclusion of health insurance, according to japan's public health insurance "high health care fee system" calculated, the use of Kymriah will be covered by Japan's public insurance, patients only need to cover a minimum of 410,000 yen (257,000 yuan) of drug costs.
for foreigners who are covered by health insurance and pay their dues as long as they are on a legal visa.
"domestic health insurance for CAR-T is not realistic" this is the current industry's general view and consensus.
can you increase patient access without being able to count on Medicare to pay for it? Like CAR-T therapies, a growing number of innovative drugs show great potential in terms of efficacy and even cure, but high prices also have a huge impact on government health care budgets.
how buyers use payment methods, building a social security system that is as affordable and efficient as possible is the focus of attention.
" enterprises to find complementary commercial insurance as an important partners as a way.
" Xuan Jianwei, director of the Institute of Pharmaceutical Economics at Sun Yat-sen University School of Pharmacy, pointed out at the 6th BiG IMPACT Annual Meeting that the current situation of Commercial Insurance in China has set up a lot of payment barriers, and people almost bought serious illness insurance and can not use these drugs.
pharmaceutical companies can be targeted with insurance companies to do pilot.
" innovative drug companies and insurance companies, social, health insurance cooperation, so that health insurance out of a part of the money, insurance companies out of a part of the money, enterprises out of a part of the money, patients out of a part of the money, the real serious illness insurance to do, this is the future of expensive innovative drugs a good way out.
" Xuan Jianwei suggested.
03 track hot to catch up with the United States? Since the first CAR-T therapy was approved, there has been a worldwide research boom in CAR-T cell therapy.
, as of the end of June 2020, there were 670 CAR-T clinical trials under way worldwide, with China and the United States accounting for about 91.3% of the world's total.
, the number of CAR-T clinical trials in China has shown a "blowout" since 2016, and 357 CAR-T clinical trials have been conducted, ranking first in the world, accounting for 53.3%.
CAR-T is also considered to be one of the most promising areas for domestic enterprises to keep up with the pace of global research and development, although there are no domestic products on the market, but the layout of domestic enterprises is still in full swing.
is about to take off China's first approved CAR-T title, the FKC876 (Akramsai Injection), which Fosun Kate introduced from Kite in early 2017 to obtain its technical and commercial rights in Chinese mainland, the Hong Kong Special Administrative Region and the Macao Special Administrative Region, and is scheduled to be localized in China;
only took a year and a half, and in February 2020, Fosun Kate submitted an application for the listing of the Aquilonsai injection, which was accepted by the NMPA.
The listing application is based on a one-arm, open, multi-center bridging clinical trial (FKC876-2018-001) conducted in China, which assessed the safety and efficacy of the product in chinese patients with refratic invasive NHL (Large B cell lymphoma);
has been approved since its declaration and is now about to be approved, and the Aquilonsai injection took less than a year.
with the commercialization of domestic CAR-T products, the national regulatory level has also shown a positive attitude.
the CDE Breakthrough Therapeutics section was first updated last August, 26 drugs have been included in breakthrough drugs so far, four of which are CAR-T therapies.
LCAR-B38M, a legendary creature, became the first variety to be included in the breakthrough treatment, followed by CAR-T products from Meso-Juno, Koji Bio and Heyuan Bio.
the emergence of CAR-T therapy, allowing more patients to see the possibility of some diseases being cured.
CAR-T therapy is also gradually explored from blood tumors to solid tumors.
For the Chinese market, the road exploration of cell gene therapy from technological innovation to industrialization and commercialization has just begun, and the problems of process development, regulatory policy, declaration experience, high cost and commercial development of CAR-T technology need to be solved.
with China's encouragement of innovation, and more open policy support, the pace of domestic CAR-T market will also accelerate, especially those that can achieve standardized production processes, standardization, safety and effective products will stand out.