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Rare diseases, also known as "orphan diseases", refer to diseases with a very low incidence and are rare
.
In the field of rare diseases, low investment in scientific research, low diagnosis rate, and lack of effective treatments are common, and the vast majority of rare disease patients and families still face "the disease has no cure", "the doctor has no medicine", and "the medicine has no guarantee".
Dilemma
.
In order to cope with these problems, drugs used by patients with rare diseases have gradually become the focus of attention during the adjustment of the national medical insurance drug catalogue.
Since the normalization of the national medical insurance drug catalogue in 2019, rare disease drugs have entered the medical insurance through negotiation every year.
The total number of catalogues has reached 45
.
On December 3, the National Medical Security Administration held a press conference to announce the adjustment results of the 2021 National Medical Insurance Drug List.
A total of 74 new drugs were added to the list
.
Among them, 7 drugs for rare diseases were shortlisted, even including drugs for rare diseases with a price tag of one million yuan
.
Specifically, the rare disease drugs that have entered the medical insurance list through negotiations this time are human coagulation factor IX, icatibant acetate injection, noxinazan sodium injection, fampiridine sustained-release tablets, and agalsidase alpha.
Concentrated solution for injection, eloyuumab injection, and clofenac soft capsules are used to treat hemophilia, hereditary angioedema, spinal muscular atrophy, multiple sclerosis, Fabry disease, hypolipidemic, and thyroid gland.
Prime protein amyloidosis cardiomyopathy
.
Among them, Noxinassen Sodium Injection and Agalase Alpha Injection Concentrated Solution are both famous for high-priced rare disease drugs, and their manufacturers are Bojian and Takeda respectively
.
It is reported that before medical insurance negotiations, the price of Bojian’s Nosinagen Sodium Injection was as high as 700,000 yuan per injection, and the annual cost of Takeda’s concentrated agarase alpha injection solution was generally at the level of one million yuan
.
Up to now, although the specific price of new drugs entering the medical insurance catalog has not been announced
.
But generally speaking, in order to enter the medical insurance catalog, pharmaceutical companies usually cut prices to "trade price for quantity
.
" Therefore, the industry expects that the rare disease drugs entering the current path, including the million-dollar rare disease drugs, will be reduced in price.
As for the price reduction, it depends on the announcement in 2022.
.
In general, China has successively issued a series of policies in recent years to continuously promote the development of rare disease prevention and protection
.
With the reform and development of the national medical and health system, and the continuous optimization of the drug review and approval process, a variety of high-value drugs have been approved in China in 2019 and 2020 respectively
.
In this context, the industry predicts that the continued optimization and reform of the drug review and approval process in the future will accelerate the launch of rare disease drugs, and the pace of inclusion in the national medical insurance catalog will increase year by year
.
Affected by this, more and more patients with rare diseases and their families will see new hope
.
However, it is worth noting that in the process of development in the field of rare diseases, relevant companies also need to find ways to reasonably reduce the cost of medication for patients in order to increase the availability of drugs in rare disease patients and continue to increase independent research and development of rare disease drugs
.
.
In the field of rare diseases, low investment in scientific research, low diagnosis rate, and lack of effective treatments are common, and the vast majority of rare disease patients and families still face "the disease has no cure", "the doctor has no medicine", and "the medicine has no guarantee".
Dilemma
.
In order to cope with these problems, drugs used by patients with rare diseases have gradually become the focus of attention during the adjustment of the national medical insurance drug catalogue.
Since the normalization of the national medical insurance drug catalogue in 2019, rare disease drugs have entered the medical insurance through negotiation every year.
The total number of catalogues has reached 45
.
On December 3, the National Medical Security Administration held a press conference to announce the adjustment results of the 2021 National Medical Insurance Drug List.
A total of 74 new drugs were added to the list
.
Among them, 7 drugs for rare diseases were shortlisted, even including drugs for rare diseases with a price tag of one million yuan
.
Specifically, the rare disease drugs that have entered the medical insurance list through negotiations this time are human coagulation factor IX, icatibant acetate injection, noxinazan sodium injection, fampiridine sustained-release tablets, and agalsidase alpha.
Concentrated solution for injection, eloyuumab injection, and clofenac soft capsules are used to treat hemophilia, hereditary angioedema, spinal muscular atrophy, multiple sclerosis, Fabry disease, hypolipidemic, and thyroid gland.
Prime protein amyloidosis cardiomyopathy
.
Among them, Noxinassen Sodium Injection and Agalase Alpha Injection Concentrated Solution are both famous for high-priced rare disease drugs, and their manufacturers are Bojian and Takeda respectively
.
It is reported that before medical insurance negotiations, the price of Bojian’s Nosinagen Sodium Injection was as high as 700,000 yuan per injection, and the annual cost of Takeda’s concentrated agarase alpha injection solution was generally at the level of one million yuan
.
Up to now, although the specific price of new drugs entering the medical insurance catalog has not been announced
.
But generally speaking, in order to enter the medical insurance catalog, pharmaceutical companies usually cut prices to "trade price for quantity
.
" Therefore, the industry expects that the rare disease drugs entering the current path, including the million-dollar rare disease drugs, will be reduced in price.
As for the price reduction, it depends on the announcement in 2022.
.
In general, China has successively issued a series of policies in recent years to continuously promote the development of rare disease prevention and protection
.
With the reform and development of the national medical and health system, and the continuous optimization of the drug review and approval process, a variety of high-value drugs have been approved in China in 2019 and 2020 respectively
.
In this context, the industry predicts that the continued optimization and reform of the drug review and approval process in the future will accelerate the launch of rare disease drugs, and the pace of inclusion in the national medical insurance catalog will increase year by year
.
Affected by this, more and more patients with rare diseases and their families will see new hope
.
However, it is worth noting that in the process of development in the field of rare diseases, relevant companies also need to find ways to reasonably reduce the cost of medication for patients in order to increase the availability of drugs in rare disease patients and continue to increase independent research and development of rare disease drugs
.
