There is no doubt that "soul bargaining" is one of the key words in 2021, and the logic behind it is that "every group should not be abandoned".
The Health Bureau combed through the public information and found that after the Sodium Norcina injection entered the medical insurance, the out-of-pocket expenses of patients everywhere were not completely consistent. In Ningbo, 6 injections are required in the first year, the cost is 198,000 yuan, and the patient pays about 30,000 yuan a year, which is 5,000 yuan per injection; in Zhengzhou, after two medical insurance reimbursements, the patient pays about 16,000 yuan per injection.
In the future, there will be more sky-high drugs entering medical insurance. Will the today of Nosina sodium become the tomorrow of other "sky-high drugs"?
01 Five logics of medical insurance bargaining
According to Wang Lin, a member of the Expert Committee on Rare Disease Diagnosis and Treatment and Protection of the National Health and Health Commission, "the most hard-core problem in the rare disease drug guarantee mechanism is the payment of value-added orphan drugs."
In 2020, the National Health Insurance Bureau intends to include sodium Northinacine in the negotiations. However, the price thrown by Bojian at that time was 699,700 yuan per needle, which was not negotiable. The competent authorities can only recede.
In the negotiations held on November 11, 2021, the negotiators and the representatives of the enterprise spent 90 minutes and went through 8 rounds of bargaining, from the initial 53680 yuan per needle to about 30,000 yuan.
Understand the logic of this series of "bargaining" to understand how the Medicare Bureau will treat other high-priced drugs.
One
An annual fee of 300,000 is an unwritten threshold.
This is also the reason why Bojian initially offered about 50,000 yuan. Zheng Jie, head of the National Medical Insurance Negotiation Drug Fund Calculation Expert Group, explained that the threshold of 300,000 yuan for annual treatment costs is not artificially set, but is calculated, "Among nearly 3,000 medical insurance drugs, the maximum payment amount of the medical insurance fund is 300,000 yuan. ”
Wang Lin told the Health Bureau that the medical insurance fund should ensure safety and fairness, and if rare disease drugs enter the medical insurance directory at a very high price, it may have an impact on the safety of the basic medical insurance fund.
She also reminded that whether a value-added rare disease drug can be replicated in the way it enters the health insurance list at a "floor price" is also worth studying; in addition, how it enters the hospital, to pharmacies, including the accessibility of drugs for patients, should be tracked and studied in depth.
Second
Accurate measurements.
Medical insurance drugs should comprehensively consider the reasonable drug needs of the insured, the clinical value of the drugs, the degree of innovation, the affordability of the medical insurance fund, etc., rather than bargaining in the sky.
In 2021, the medical insurance negotiations for the first time formulated pharmacoeconomic calculation guidelines and unified measurement standards. At the same time, more than 40 pharmacoeconomics experts participated in the calculation examined innovative drugs from five dimensions, including clinical efficacy, safety, economy, innovation and fairness, and used them as factors for their price adjustment.
The same drug is assigned two experts to conduct "back-to-back measurements" to improve the quality and scientific level of the review.
Third
There are competitors.
In addition to Northinalsan sodium, Novartis Zolgensma and Roche's risperolam are both spinal muscular atrophy drugs.
Novartis' Zolgensma was approved in the United States in May 2019, and on January 7, 2022, the drug's application for clinical trials in China was accepted. In 2022, it is highly likely that Zolgensma will also be eligible for medical insurance; in addition, in June 2021, the State Food and Drug Administration has approved the release of Roche's risprolane oral solution for bulk marketing, and Nocinasine sodium faces strong competition.
Unlike The Nasinasine sodium injection, which requires lumbar puncture administration, risperline is an oral drug with better compliance; in terms of price, risperm is priced at a retail price of 63,800 yuan per bottle in China, and the annual cost after the drug is about 650,000 yuan.
If Nosina Na na does not enter the medical insurance, in case Lispolan goes in, Bo Jian cannot afford such a failure. Therefore, Bojian can make up its mind to accept the "bargaining", which is also one of the underpinnings of the "soul bargaining" of the medical insurance side.
Fourth
Most rare disease drugs are products that have been on the market abroad for many years, and their research and development costs have been partially or fully recovered.
Xiong Xianjun, former director of the Department of Pharmaceutical Service Management of the National Medical Insurance Bureau, is extremely disapproving of pharmaceutical companies maintaining the so-called "global pricing strategy", according to his public statement: those drugs have been sold in the US market for many years, and the research and development costs have already been recovered, and then entering the Chinese market must consider China's national conditions."
Fifth
The reason why sky-high drugs can negotiate floor prices, the biggest confidence of the medical insurance bureau is the larger domestic market.
Some analysts said that in view of the market of nearly 30,000 patients with spinal muscular atrophy in China, the reason why Bojian accepted a sharp price reduction was more of a consideration to seize the Chinese market.
02 Price reduction is only the first step
Ordinary consumer goods can be divided into low, medium and high-end, life-saving drugs do not distinguish between expensive and low, only to cure the disease as the ultimate purpose. Many patients with rare diseases are impoverished due to illness, and "sky-high drugs" far exceed the purchasing power of ordinary families.
The global pharmaceutical industry has developed a basic understanding of rare disease products: the number of patients is small, and the cost of research and development is high.
On the one hand, high pricing prevents most patients from benefiting from the latest scientific and technological achievements; on the other hand, there is no sufficient commercial return to discourage pharmaceutical companies and even withdraw from the market. Novartis' Zolgensma was priced at $2.12 million in the United States, which immediately attracted global public opinion.
Even if it has been included in the medical insurance reimbursement, the annual treatment cost is at least tens of thousands of yuan, in the final analysis: there are too few patients.
For enterprises, R & D and production costs are one aspect, clinical trial costs are another part, due to the small number of rare disease patients, the cost of clinical enrollment of patients is huge.
Wang Lin believes that after these "sky-high drugs" enter the medical insurance directory at low prices, the payment end has stabilized, but what impact will it have on the future research and development of new drugs and scientific and technological innovation? What will be the impact on the introduction of innovative drugs from abroad? These are all worth pondering.
"Compassionate medicine" in clinical research can also be used as an adjunct to help patients who can't afford to pay and get more real-world data.
But this is not the main solution to the problem, and it comes with huge ethical questions.
Price reduction is only the first step in the protection of drugs for rare diseases. How to truly reduce the financial burden on the majority of patients? After the birth of the First Catalogue of Rare Diseases in 2018, different forms of exploration have been carried out across the country.
03 Exploration of local medical insurance
In March 2018, Henan Province updated the Catalogue of Outpatient Diseases for Medical Security for Serious and Exceptionally Serious Diseases, including 16 diseases such as multiple sclerosis, amyotrophic lateral sclerosis, primary immunoglobulin deficiency, and idiopathic pulmonary fibrosis into the scope of outpatient reimbursement.
What is particularly special is that the reimbursement limit for these 16 new diseases does not set a threshold as long as it meets the regulations.
The payment ratio of the basic medical insurance pooling fund for urban and rural residents in Henan is 80%, and the inclusion of rare disease drugs in the scope of outpatient reimbursement is undoubtedly a big step in the exploration of the protection model.
Also advancing is Chengdu. In March 2021, the Chengdu Medical Insurance Bureau announced the "Scope and Identification Standards for Drugs Guaranteed for Rare Disease Drugs", which clarifies that all disease indications specified in the national "First Rare Disease Catalogue" can be continuously standardized under the condition that medical insurance pays less than 400,000 yuan per year and the personal burden is less than 60,000 per year.
In August 2021, when Nocina sodium had not yet entered the national medical insurance, it had entered the "Chengdu Rare Disease Drug Guarantee Drug Scope", and with the assistance of relevant foundations, the cost of the first injection per patient was 59,000 yuan, which was significantly closer to the current medical insurance price.
The inclusion of health insurance at the local level also laid a solid foundation for subsequent national negotiations. Huang Rufang, founder of The Corde Rare Disease Center, said that the Chengdu model is very grounded, and only by answering the question of how much money patients need to pay can we judge whether the rare disease reimbursement model can continue to operate.
The Zhejiang model, on the other hand, starts with diseases, uses unified financing standards, unified treatment levels, and unified drug management to form a special fund for rare diseases. Specifically, the reimbursement ratio of less than 300,000 yuan is 80%; the reimbursement ratio of 300,000 yuan to 700,000 yuan is 90%; and the expenses of more than 700,000 yuan are fully reimbursed. According to the principle of capping personal burdens, the personal burden of rare disease patients in Zhejiang is not more than 100,000 yuan per year.
The Health Bureau noted that in addition to the above-mentioned areas, Qingdao, Shanghai and other places have explored the reform of rare disease medical insurance payment methods in different ways, and the average reimbursement ratio in various places is more than 60%. At the same time, the same problem is also shown everywhere:
If the financing relies only on medical insurance and major illness insurance funds, it will be limited by the extremely uneven development of medical insurance levels in various places.
For example, Nosinasin sodium injection is a medical insurance class B drug, due to the slight difference in medical insurance policies in various places, the reimbursement range of medical insurance class B drugs is between 70% and 80%, and the superimposed policy of benefiting the people, the self-payment part of patients in most areas is about thousands of yuan to 15,000 yuan.
The more flexible protection methods of local medical insurance are actually a situation that enterprises are happy to see. Trying to popularize this place can alleviate the pressure that national medical insurance must "bargain" in one step to a certain extent.
Shi Luwen, director of the Department of Pharmaceutical Affairs Management and Clinical Pharmacy of peking university school of pharmacy, believes that in the future, the drug guarantee for rare diseases should be appropriately expanded and the level of protection should be appropriately expanded according to the actual situation of various localities and combined with relevant calculation results.
Ding Jie, member of the National Committee of the Chinese People's Political Consultative Conference, former vice president of peking university first hospital, and chairman of the rare disease branch of the Beijing Medical Association, suggested that the Ministry of Human Resources and Social Security, the Ministry of Civil Affairs, the Ministry of Finance, the Health and Family Planning Commission and other departments can jointly formulate normative documents to comprehensively integrate the current level of economic and social development, the balance of medical insurance funds, the incidence and diagnosis and treatment of rare diseases, and be certified by organizational experts to gradually determine the scope of rare disease medical security diseases in stages and batches.
04 Multi-level guarantee
Entering medical insurance is not the only solution for "sky-high drugs" to fly into the homes of ordinary patients. Looking at the global experience, it is clearly unrealistic to rely solely on governments.
As early as the 80s of the last century, the first step in the United States was to identify the definition of orphan drugs, that is, the number of people who suffer from illness each year is less than 200,000. After nearly 30 years of development, the public medical policy, access to drugs and reimbursement methods for rare diseases in the United States are relatively perfect, and even the treatment cost of 100,000 US dollars per year can be afforded.
High returns directly drive the enthusiasm of multinational giants for research and development.
The diagnosis and treatment of rare diseases in China is still in its infancy. However, after the National Health Commission and five ministries and commissions announced the "First Catalogue of Rare Diseases" in 2018, related fields have entered the fast lane.
"The money always has to come out." A number of pharmacoeconomics experts told the Health Bureau that finding other payment paths for rare disease drugs in addition to basic medical insurance has become a common choice between the industry and governments.
Zhu Kun, an associate researcher at the Chinese Academy of Fiscal Sciences, said that the diagnosis and treatment of rare diseases must rely on a multi-level guarantee mechanism. "This is inseparable from the full coverage of basic medical insurance and medical assistance, and commercial insurance, medical mutual assistance, charitable choices and personal efforts can enable rare disease patients to enjoy better diagnosis and treatment services."
In fact, inclusive commercial insurance, working with local governments, may be able to explore a successful model. Taking the first batch of rare disease catalogues as the benchmark, 51 of the 120 Huimin Insurance companies that have been launched so far in the country involve the protection of drugs for rare diseases.
Among them, 19 Huimin Bao clearly proposed to protect rare diseases, covering multiple sclerosis, Fabre disease, spinal muscular dystrophy, idiopathic pulmonary fibrosis, mucopolysaccharide storage disease and other diseases.
Although Huimin Bao cannot fundamentally solve the problem of paying for rare disease drugs, the reimbursement amount is at least guaranteed at 60% or can enjoy hundreds of thousands or even millions of reimbursements, so that the public can see more hope for treatment.
However, due to the different economic conditions in different places, there are still many rare disease patients who cannot be protected. Obviously, the construction of the prevention and control system for rare diseases should be promoted from the top down.
In March 2020, the State Council issued Article 8 of the Opinions on Deepening the Reform of the Medical Security System, which clearly states: Promote the development of a multi-level medical security system, including exploring a guarantee mechanism for the use of drugs for rare diseases.
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