In-depth observation丨The life-saving medicine of "700,000 per shot", what else do you have to do besides getting medical insurance?

  The Paper Special Commentator Li Guowei

  Recently, a piece of news on the Internet stated that “the special drug for the treatment of spinal muscular atrophy, Nocinasheng Sodium Injection, can sell for 700,000 yuan per injection in the Chinese market, but it only sells for 41 Australian dollars in Australia. 205 yuan).” Later, some media published a comment on "How ruthless it is to sell imported medicines for more than 200 yuan per injection for 700,000 yuan", which became the focus of public opinion for a while.

  After that, the National Medical Insurance Bureau also responded that Noxinat Sodium Injection was originally priced by the market, so the price of the drug in each country may vary. Since its listing in China in 2019, it has been included in the medical insurance negotiation schedule. The country hopes to negotiate with relevant pharmaceutical companies, but "because the drug price cannot come down, there is always no way to enter the medical insurance catalog."

  The National Medical Insurance Bureau gave hope, but after the sky-high life-saving drugs are included in the medical insurance, is everything going well? In other words, is being included in medical insurance the only way to make life-saving drugs affordable? This still has to be considered in the long term.

  Spinal muscular atrophy (SMA) is a rare autosomal recessive genetic disease, with an incidence of one in 6000 to one in 10,000 in newborns. Generally speaking, in the treatment of patients with more serious SMA, 6 injections of Nosinagen Sodium Injection are required in the first year, and 3 injections per year starting from the second year. Because of the high cost of treatment, many family members of patients are pinning their hopes on the medical security system.

  So, is it feasible to include Noxinagen Sodium Injection in medical insurance? We might as well evaluate the feasibility based on the current health insurance fund revenue and expenditure, the incidence of SMA and treatment-related costs.

  According to estimates, there are currently 30,000 to 50,000 SMA patients in China, of which type 1 SMA patients with more serious conditions account for about 45%. Assuming that the number of SMA patients in my country is 40,000, the number of patients with severe illness is 18,000. 18,000 people inject 3 injections of Nosinagen Sodium Injection each year, and 90% of the cost is covered by the medical insurance. Therefore, the medical insurance fund is required to bear the cost of 34.02 billion yuan, accounting for the total expenditure of the national basic medical insurance fund in 2019 (20854 billion yuan) 1.63% of the total. Observed from international experience, generally speaking, the total medical expenses for rare diseases account for no more than 1.5% of the national medical security fund.

  According to the National Health Commission, there are more than 20 million patients with rare diseases in my country (in fact, it may far exceed 20 million). The Rare Disease Development Center "Report on the Availability of Drugs for Rare Diseases in China (2019)" pointed out that the upper limit of annual out-of-pocket treatment costs for patients with rare diseases should not exceed 80,000 yuan. If it is assumed that the number of rare disease patients is 20 million and the per capita medical expenses of rare disease patients is 80,000 yuan (in fact, it may far exceed this figure), and the medical insurance covers 90%, the cost of the medical insurance fund is 1.440 billion. In 2019, the total balance of the national basic medical insurance fund was 2,679.7 billion yuan. In other words, the cumulative balance of the National Basic Medical Insurance Fund can only support 1.92 years.

  The above analysis results remind us that the inclusion of rare disease drugs into medical insurance requires careful weighing and acting within our capacity. The impact on the medical insurance fund should not be underestimated, and we should not seek to complete the effort.

  So, in the face of sky-high prices for rare disease drugs, do we have any countermeasures? Considering the experience of all parties and various influencing factors, we can also focus on the following aspects:

  First, take advantage of my country's large population and large market, and reduce drug prices through negotiations with pharmaceutical manufacturers and centralized procurement.

  Second, integrate resources from the government, society, and individuals, coordinate social medical insurance, government medical assistance, social mutual assistance, and commercial insurance, and build a diversified drug security model.

  Third, the state must adopt reasonable policies to reduce drug R&D costs and encourage independent innovation. Observed from international experience, the main reasons for the expensive drugs for rare diseases are high R&D costs, small market scale, and high risks. In order to solve the above-mentioned problems, developed countries in Europe and the United States often encourage pharmaceutical manufacturers by designating rare drug systems. Take the United States as an example. In 1983, the United States enacted the "Orphan Drug Act" (orphan drugs are also called "orphan drugs"), which stipulated the rules for designating a drug as a drug for rare diseases and the "incentives" for stimulating pharmaceutical manufacturers. This includes applying for financial assistance and tax relief for research and development funds, simplifying the approval procedures to speed up the introduction of drugs to the market, reducing or waiving approval fees, and enjoying market monopoly rights for a certain number of years after the drugs are approved to be marketed.

  According to statistics, since 1983 in 2017, the United States has successfully developed and been approved to market more than 600 drugs and biological products for the treatment of rare diseases. From 1973 to 1983, there were fewer than 10 related drugs on the US market.

  In addition to including rare disease drugs in medical insurance, all of the above measures are what we can do now.

  (This article is from The Paper. For more original information, please download the "The Paper" APP)