 Home > Active Ingredient News > Drugs Articles > Behind 95% of "soul bargaining", explain in detail the five major bargaining logics of the National Medical Insurance Bureau

Behind 95% of "soul bargaining", explain in detail the five major bargaining logics of the National Medical Insurance Bureau

 Last Update: 2022-02-22
 Source: Internet
 Author: User

Tags

corporate management

what color sulfur

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

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 given up"
.

The Health Knowledge Bureau combed the public information and found that after Nosinagen Sodium Injection entered the medical insurance, the out-of-pocket costs of patients in various places were not exactly the same
.

In Ningbo, 6 injections are required in the first year, and the cost is 198,000 yuan.

In the future, more high-priced drugs will definitely enter the medical insurance
.

Will the today of Nosinagen Sodium become the tomorrow of other "high-priced drugs"?

01.
Five logics of medical insurance bargaining

According to Wang Lin, a member of the first National Health and Health Commission Rare Disease Diagnosis and Protection Expert Committee, "the hardest problem in the drug protection mechanism for rare diseases is the payment of value-for-money orphan drugs
.

In 2020, the National Medical Insurance Administration intends to include Nosinagen sodium in the negotiation
.

However, the price offered by Bojian at that time was 699,700 yuan per needle, which was not negotiable

In this negotiation on November 11, 2021, the negotiating experts and the company representatives spent 90 minutes, and after 8 rounds of bargaining, from the initial 53,680 yuan per needle to about 30,000 yuan
.

If you understand the logic behind this series of "bargaining", you will understand how the Medical Insurance Bureau will treat other high-priced drugs
.

One: The annual fee of 300,000 yuan is an unwritten threshold
.

This is also the reason why Bojian initially quoted around 50,000
.

Zheng Jie, the leader 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 calculated.

Wang Lin told the Health Knowledge Bureau that the medical insurance fund must ensure safety and fairness.
If rare disease drugs enter the medical insurance catalog at a very high price, it may have an impact on the security of the basic medical insurance fund
.

She also reminded that it is worth studying whether the way in which super-value rare disease drugs enter the medical insurance catalog at a "floor price" is replicable ; in addition, how it enters the hospital and the pharmacy, including the availability of drugs for patients, should be tracked in depth.
and research
.

Whether it is reproducible to enter the medical insurance catalogue of value-for-money rare disease drugs at a "floor price" is also worth studying

Second: accurate measurement
.

Medical insurance drugs should comprehensively consider the insured's rational drug use needs, the clinical value of drugs, the degree of innovation, and the affordability of medical insurance funds, rather than haggling
.

In 2021, the medical insurance negotiation will formulate the pharmacoeconomic calculation guidelines for the first time and unify the calculation standards
.

At the same time, more than 40 experts in pharmacoeconomics who participated in the calculation investigated innovative drugs from five dimensions, including clinical efficacy, safety, economy, innovation and fairness, and used them as factors for price adjustment

2021 Medicare Negotiations Develop Pharmacoeconomic Calculation Guidelines for the First Time

The same drug is equipped with two experts to conduct "back-to-back calculations" to improve the quality and scientific level of the review
.

Third: there are competing products
.

In addition to Nosinagen, Novartis' Zolgensma and Roche's Risprom 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 very likely that Zolgensma will also be eligible for medical insurance ; in addition, in June 2021, the State Food and Drug Administration has approved the launch of Roche's risprom oral solution powder, and Nosinagen sodium faces strong competition

It is very likely that Zolgensma will also be eligible for Medicare , and Nosinagen Sodium faces strong competition

Unlike Nosinagen Sodium Injection, which requires lumbar puncture, risprom is an oral drug with better compliance; in terms of price, the retail price of risprom in China is 63,800 yuan per bottle, with a gift of 63,800 yuan per bottle.
The annual cost after the drug is about 650,000 yuan
.

If Noxinagen Sodium is not included in the medical insurance, in case Lisperan is included, Biogen cannot afford such a failure
.

Therefore, Bojian can make up his mind to accept "bargaining" , which is also one of the strengths of the "soul bargaining" of the medical insurance side

In case Lispo Lan got in, Bojian couldn't afford such a failure

Fourth: Most rare disease drugs are products that have been marketed abroad for many years, and their research and development costs have been partially or fully recovered
.

Xiong Xianjun, the former director of the Medical Service Management Department of the National Medical Insurance Administration, strongly disapproved 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.
To enter the Chinese market, we must consider China's national conditions
.
"

Fifth: The reason why the sky-high price drugs can be negotiated into floor prices is that the biggest confidence of the Medical Insurance Bureau is the larger domestic market
.

Some analysts said that given the market of nearly 30,000 patients with spinal muscular atrophy in China, the reason why Bojian accepted the sharp price reduction was more 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, and life- saving medicines are not divided into high and low, only the ultimate purpose of curing diseases
.
Many rare disease patients are impoverished because of their illnesses, and the "high-priced medicines" far exceed the purchasing power of ordinary families
.

Life-saving medicine does not distinguish between high and low, only to cure the disease as the ultimate goal

The global pharmaceutical industry has formed a set of basic understandings about rare disease products: the number of patients is small, and the research and development costs are high
.

On the one hand, high pricing prevents most patients from benefiting from the latest scientific and technological achievements; on the other hand, insufficient commercial returns will discourage pharmaceutical companies and even withdraw from the market
.
The price of Novartis' Zolgensma in the United States was set at $2.
12 million, which immediately attracted criticism from global public opinion
.

Even if it has been included in 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, and clinical trial costs are another major part.
Due to the small number of rare disease patients, it costs a lot to gather clinically enrolled patients
.

Wang Lin believes that after these "high-priced drugs" entered the medical insurance catalog at low prices, the payment side has stabilized, but what impact will it have on new drug research and development and technological innovation in the future? What impact will it have on the introduction of foreign innovative drugs? These are worth thinking about
.

What impact will it have on new drug R&D and technological innovation in the future? What impact will it have on the introduction of foreign innovative drugs? These are worth thinking about
.

"Compassionate medication" in clinical research can also be used as an adjunct, which can not only help patients who cannot afford to pay, but also obtain more real-world data
.

But this is not the main problem-solving method, and it is accompanied by huge ethical problems
.

Price reduction is only the first step in the protection of rare disease drugs
.
How to really reduce the financial burden of the majority of patients? After the birth of the "First List of Rare Diseases" in 2018, various forms of exploration have been carried out across the country
.

After the birth of the "First List of Rare Diseases" in 2018, various 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 Insurance for Major and Extraordinary Diseases", which included 16 diseases such as multiple sclerosis, amyotrophic lateral sclerosis, primary immunoglobulin deficiency, and idiopathic pulmonary fibrosis.
Included in outpatient reimbursement
.

What is particularly special is that as long as the reimbursement limits for these 16 new diseases meet the regulations, there is no threshold
.

As long as the reimbursement limits for these 16 new diseases meet the regulations, no threshold will be set

Henan's urban and rural residents' basic medical insurance pooling fund payment ratio is 80%, and the inclusion of rare disease drugs into the scope of outpatient reimbursement is undoubtedly a big step in the exploration of the protection model
.

There is also Chengdu that continues to advance
.
In March 2021, the Chengdu Medical Insurance Bureau announced the "Scope and Certification Criteria of Drugs for Rare Diseases", which clarifies that for the disease indications specified in the National "First Batch of Rare Diseases List", the medical insurance pays less than 400,000 yuan per year, and the personal burden is 6 Under the condition of less than 10,000 years per year, patients can obtain continuous standardized medication
.

For the disease indications specified in the National "First Batch of Rare Diseases List", under the conditions of medical insurance payment of less than 400,000 per year and personal burden of less than 60,000 per year, patients can obtain continuous and standardized medication

In August 2021, before Nosinagen Sodium has entered the national medical insurance, it has already entered the "Chengdu Rare Disease Drug Protection Drug Scope".
With the assistance of relevant foundations, the first injection fee for each patient is 59,000 yuan.
, this amount has been significantly close to the current medical insurance price
.

Being included in medical insurance at the local level also laid a solid foundation for subsequent national negotiations
.
Huang Rufang, founder of the Kode Rare Disease Center, said that the Chengdu model is very grounded.
Only by answering the question of how much patients need to pay can we judge whether the rare disease reimbursement model can continue to operate
.

Being included in medical insurance also lays a solid foundation for subsequent national negotiations

The Zhejiang model starts from the disease, uses unified financing standards, unified treatment levels, and unified drug management to form a special fund for rare diseases
.
Specifically, the reimbursement rate is 80% for expenses below 300,000 yuan; 90% for expenses ranging from 300,000 to 700,000 yuan; and full reimbursement for expenses above 700,000 yuan
.
According to the principle of capping the personal burden, the personal burden of rare disease patients in Zhejiang should not exceed 100,000 yuan per year at most
.

The Health Knowledge Bureau has noticed that in addition to the above-mentioned regions, Qingdao, Shanghai and other places have explored the reform of the payment method of rare disease medical insurance in different ways
.
At the same time, the same problem is also displayed everywhere:

If financing only depends on medical insurance and critical illness insurance funds, it will be limited by the fact that the development of medical insurance in various regions is extremely uneven
.

For example, Nosinagen Sodium Injection is a class B drug of medical insurance.
Due to the slight differences in medical insurance policies in different places, the reimbursement range of class B drugs of medical insurance is between 70% and 80%.
The out-of-pocket part is about a few thousand yuan to 15,000 yuan
.

Nosinagen Sodium Injection is a class B drug of medical insurance.
Due to the slight differences in medical insurance policies in different places, the reimbursement range of class B drugs of medical insurance is between 70% and 80%.
The superimposed local benefit policy, the self-pay part of patients in most areas About a few thousand 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 to a certain extent alleviate the pressure that the national medical insurance must "haggle" in one step
.

Shi Luwen, director of the Department of Pharmacy Management and Clinical Pharmacy, School of Pharmacy, Peking University, believes that in the future, drug protection for rare diseases should be appropriately expanded and the level of protection should be appropriately expanded based on the actual situation in each region and the results of relevant calculations
.

In the future, the drug protection for rare diseases should be appropriately expanded and the level of protection should be appropriately expanded according to the actual situation in various places 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 Beijing Medical Association, suggested that the Ministry of Human Resources and Social Security, the Ministry of Civil Affairs, the Ministry of Finance and the Health and Health Commission and other departments can jointly formulate normative documents.
Based on the current level of economic and social development, the balance of medical insurance funds, the incidence, diagnosis and treatment of rare diseases, and certified by the organization's experts, the scope of medical insurance for rare diseases can be gradually determined in stages and in batches
.

After the organization's expert certification, the range of rare diseases medical insurance can be gradually determined in stages and in batches

04.
Multi-level guarantee

Enrolling in medical insurance is not the only solution for "high-priced drugs" to fly into the homes of ordinary patients
.
Looking at global experience, it is clearly unrealistic to rely on governments alone
.

As early as the 1980s, the United States took the first step to identify the definition of orphan drugs, that is, the number of sick people per year was less than 200,000
.
After nearly 30 years of development, the public medical policies, access to drugs, and reimbursement methods for rare diseases in the United States are relatively complete, and even the annual treatment cost of $100,000 can be affordable
.

The high return directly drives 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 and Health Commission and five ministries and commissions announced the "First Batch of Rare Disease List" in 2018, related fields entered the fast lane
.

After the National Health and Health Commission and five ministries and commissions announced the "First Batch of Rare Disease List" in 2018, related fields entered the fast lane

"The money always has to be paid by someone
.
" Several experts in pharmacoeconomics told the Health Knowledge Bureau that finding other payment methods for rare disease drugs in addition to basic medical insurance has become a common choice for 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, mutual medical assistance, charitable choices, and personal efforts can all enable rare disease patients to enjoy better quality diagnosis and treatment services
.
"

The diagnosis and treatment of rare diseases must rely on a multi-level guarantee mechanism

In fact, inclusive commercial insurance and 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 welfare insurances that have been launched across the country involve the protection of drugs for rare diseases
.

Among the 120 welfare insurances that have been launched nationwide, 51 involve the protection of drugs for rare diseases

Among them, 19 Huimin Baos clearly proposed to protect rare diseases, covering multiple sclerosis, Fabry disease, spinal muscular atrophy, idiopathic pulmonary fibrosis, mucopolysaccharidosis and other diseases
.

Although Huiminbao cannot fundamentally solve the problem of payment for rare disease drugs, the reimbursement amount is guaranteed to be at least 60% or hundreds of thousands or even millions of reimbursement amounts can be enjoyed , giving the public the hope of more treatments
.

The reimbursement amount is guaranteed to be at least 60% or you can enjoy a reimbursement amount of hundreds of thousands or even millions

However, due to the different economic conditions in different places, there are still many rare disease patients who cannot be guaranteed
.
Obviously, the construction of the rare disease prevention and control system should be promoted from top to bottom
.

In March 2020, Article 8 of the "Opinions on Deepening the Reform of the Medical Security System" issued by the State Council clarifies that: to promote the development of a multi-level medical security system, including exploring the mechanism of drug security for rare diseases
.

Impact assessment of the first national rare disease list (2018-2021)

It has been three years since the first national rare disease catalogue was launched.
What is the progress of clinical diagnosis and treatment, drug progress and policy support in the field of rare diseases in China?

From now on, the Health Knowledge Bureau and the Kod Rare Disease Center will release the "Influence Evaluation of the First National Rare Disease Catalogue (2018-2021)" from six major directions: policy, industry, scientific research, clinical practice, society, and patient organization
.

Health Knowledge Bureau and Kod Rare Disease Center "Influence Evaluation of the First National Rare Disease List (2018-2021)"

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.