Author: Guo Jinhui
At the point where the medical insurance drug catalog is adjusted, the three-party game among pharmaceutical companies, patients, and medical insurance departments becomes more subtle. What came to the fore this year was the spinal muscular atrophy (SMA) treatment drug Noxinagen Sodium Injection.
On the same day that the National Medical Insurance Administration issued the "Work Plan for the 2020 National Medical Insurance Drug Catalog Adjustment (Draft for Comment)" (hereinafter referred to as the "Draft for Comment"), the family of children with SMA who sold 700,000 drugs per injection could hardly pay the sky-high price The news of the cost of medicine has also attracted widespread attention on the Internet.
Nosignal sodium injection is known as a "high price" imported drug in the industry. Even among the rare disease drugs known for being expensive, the price of nosignal sodium is also in the forefront. The "China Rare Disease Medical Insurance City Report 2020" shows that among the six rare disease drugs that have an annual treatment cost of more than one million for children, are not covered by medical insurance and have no generic drugs available, the cost of noxinagen sodium for the treatment of children is 2.09 million yuan ranked first.
The appeal of the family members of children with SMA is to reduce the burden of drug costs. First of all, they hope that this drug can be included in medical insurance. Bojian China, the manufacturer of the drug, said in a subsequent statement that the company has always maintained active communication with relevant national and local government departments and called for the establishment of a multi-party co-payment mechanism to further improve the availability of drugs for SMA patients in China.
According to Bojian’s statement and the above-mentioned draft of the National Medical Insurance Administration, Nosinagen Sodium meets the conditions for applying to participate in this year’s medical insurance negotiations. As for whether it can be included in the list of medical insurance negotiations and eventually enter the medical insurance list, it depends on whether it can pass the expert review. And whether the company can offer the "most sincere" price.
It must be concerned that the availability of similar high-priced drugs will not be completely resolved by entering medical insurance, but only the beginning. As Class B drugs, in addition to the differences in outpatient reimbursement policies in different regions, the proportion of high-priced drugs that can be reimbursed in medical insurance is limited. If the price is still very high after negotiation, the proportion of self-payment after medical insurance may not be affordable for all families.
Many experts interviewed by a reporter from China Business News said that my country’s economic development determines that my country’s medical insurance system based on the basic principle of “guarantee basics” cannot independently act as the “medicine god” for patients with rare diseases. To solve the problem of medical expenses for rare diseases, it is necessary to establish a medication guarantee mechanism including basic medical insurance, critical illness relief, financial special funds, and social assistance as soon as possible.
"Sky-price drugs" need to pass several passes to enter medical insurance
On August 10, the one-week consultation for opinions on the adjustment of the national medical insurance drug catalogue ended. According to the draft for comments, the adjustment of the drug catalogue in 2020 has entered the preparatory stage, and the enterprise declaration guidelines will be issued in August. According to the scope of adjustment of the 2020 drug catalog, eligible companies can submit necessary materials to the National Medical Insurance Center as required. Conduct formal review of materials and publicize the drugs that have passed formal review.
The “Scope of New Drugs that Can Be Included in the 2020 Drug Catalogue” listed in the draft for comments includes inclusion in the list of urgently needed overseas new drugs for clinical use, the list of encouraged generic drugs, or the list of children’s drugs that are encouraged to research and develop, and the list shall be approved by the state before December 31, 2019. Drugs approved for marketing by the drug regulatory authority (including new indications approved during this period).
According to Bojian China's statement, SMA, a rare disease, is the first to benefit from the national rare disease-related policies. In May 2018, SMA was included in the National List of the First Batch of Rare Diseases. In November 2018, Noxinassen Sodium Injection was included in the "List of the First Batch of New Drugs Urgently Needed in Clinics". In February 2019, Noxinassen Sodium Injection was approved in China through the priority review process.
According to relevant national regulations, the drugs participating in the 2019 national medical insurance negotiations must be drugs approved before December 31, 2018. Noxinassen Sodium Injection was approved in February 2019, and it does not meet the conditions for participating in the 2019 national medical insurance negotiations.
A pharmaceutical economics expert told a reporter from China Business News that from the situation announced by the pharmaceutical company, nosienagenic sodium is a clinically urgently needed drug, and it meets the conditions for the negotiation of the medical insurance catalog this year, and the company can apply. The National Medical Insurance Bureau also hopes that every disease can be found in the medical insurance catalogue to treat drugs. Since there is no medicine for SMA in the existing medical insurance catalogue, the National Medical Insurance Bureau also pays great attention to Nosinagen sodium.
However, in the end, whether noxinagen sodium can enter the medical insurance list requires at least two key steps.
The first is the expert review stage after the enterprise application. The Medical Insurance Bureau will organize review experts to conduct review and form a list of recommendations for adding drugs in four aspects, including new transfers, direct transfers, possible transfers, and adjustments to the limited payment scope. The second is whether the price quoted by the company during the bidding negotiation is within the evaluation price range of the Medical Insurance Bureau.
The CBN reporter learned that at this stage, experts will discuss what kind of clinical needs and effects the medicines can meet, and that medicines like Noxinagen Sodium can treat diseases that were previously incurable. Experts will be very concerned. However, “in the expert review stage, whether the drug can be included in the negotiation list depends on its price, because it is too expensive. Experts must consider the affordability of medical insurance funds in various regions,” said the aforementioned pharmaceutical economist.
Zhu Minglai, director of the Research Center for Health Economics and Medical Security of Nankai University, said that in terms of the universality of social security, rare diseases and people should be included in the scope of medical insurance, but the beneficiaries of this disease are relatively small, and the basic The principle is "wide coverage and basic guarantee", rare disease drugs are expensive, and many require lifelong medication, the treatment cost is very high, and it is obviously unaffordable to rely on medical insurance funds alone.
Professor Wu Jing of the School of Pharmacy of Tianjin University told China Business News that it is the goal of my country's universal medical insurance to ensure that the insured has medicine for any disease, but this also needs to be adapted to the level of national economic development. People with common diseases have medicines, but people with rare diseases have no medicines. This is an unfairness, but it is very complicated to solve this problem.
“We must consider not only the horizontal fairness of the policy, but also the vertical fairness. For example, for patients with diabetes, the treatment cost may be 10,000 yuan a year, but if they have muscular dystrophy and similar diseases, it may cost 100 yuan a year. More than ten thousand yuan. Then there must be doubts from the insured. Since the same premium is paid, why the protection level of the latter can be more than 100 times that of the former? Does this also mean a kind of unfairness? So our basic Medical insurance must constantly weigh between these two fairness." Wu Jing said.
The biggest obstacle to rare disease drugs entering medical insurance
A highlight of the adjustment of the medical insurance catalog last year was the priority given to the treatment of major diseases such as cancer and rare diseases. The negotiation of drugs for seven rare diseases including bosentan and magnastat was successful and entered the scope of the medical insurance catalog B, which freed patients with rare diseases such as pulmonary hypertension and type C Niemann Pick's disease from the predicament of no cure in the catalog.
The "China Rare Disease Medical Insurance City Report 2020" shows that after the National Medical Insurance Catalogue was updated in 2019, a total of 38 rare disease drugs are currently included in the national medical insurance, involving 21 rare diseases, of which 9 are eligible for Category A reimbursement.
According to the report, there are still 25 rare disease drugs on the market that have not been included in the national medical insurance list, involving a total of 21 rare diseases. Among them, there are 12 kinds of drugs, involving 14 kinds of rare disease indications. Among these 12 kinds of drugs, the annual treatment cost of 6 kinds of drugs exceeds one million yuan, and there are no generic drugs available, and patients face a very large burden of medication.
Nosinagen sodium is one of the six most expensive rare disease drugs in China, ranking sixth in adult treatment costs and first in children's treatment costs.
Zhu Minglai said that China’s negotiation of rare diseases into medical insurance has just started. Last year, it started with some slightly cheaper drugs. However, it must be noted that entering the medical insurance catalog does not mean that patients can be free of charge. Reimbursement of Class B drugs The ratio is limited.
A reporter from China Business News also learned from people familiar with the matter that the affordability of patients is also an important consideration for the medical insurance bureau and expert review in evaluating sky-high prices for medical insurance. If overpriced drugs enter the catalog, the patient’s out-of-pocket costs will not be affordable for every family. If these medicines are not included in the catalog, the doctor may not prescribe them; once in, if the doctor prescribes them, the self-paid part may also cause the patient to return to poverty due to illness. This situation is not uncommon in recent years.
The high price has become the biggest obstacle preventing the entry of Nocinagen sodium into medical insurance. Even if it can enter the list of negotiated drugs in the expert review in September, then during the negotiation and bidding stage in October, pharmaceutical companies must come up with a price within the acceptable range of the medical insurance fund to enter the 2021 medical insurance list. .
In the negotiation and bidding stage, the National Medical Insurance Administration will organize calculation experts to conduct evaluations through fund calculations, pharmacoeconomics and other methods, and provide evaluation opinions. Negotiation experts carry out negotiations or bidding with companies based on the evaluation opinions, determine a unified national medical insurance payment standard, and simultaneously clarify management policies.
In Professor Wu Jing's view, to solve the payment problem of rare diseases, it is necessary to establish a multi-level medical security payment system. Basic medical insurance only covers the basic parts that it should provide. Others can be jointly solved through multiple channels such as special funds and social assistance. , To establish and link up this complete system, and control the expenses paid by individuals to 50,000 to 60,000 per person, and the problem of rare diseases can be solved.
The establishment of a multi-channel payment mechanism for rare disease medical insurance has become a consensus in the industry, and local medical insurance departments have also conducted many useful explorations.
Zhejiang Province has set up the nation’s only special fund for rare diseases. Each basic medical insurance participant pays 2 yuan per year, which forms a special fund of about 100 million yuan. The stipulation that “over 700,000 yuan will be reimbursed in full” Greatly reduce the patient's personal burden. Taking Gaucher's disease as an example, pediatric patients who use the special drug imiglucerase in Hangzhou can get 96% government reimbursement, and the individual's annual self-finance is less than 30,000 yuan.