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Medical News, February 26, the clinical urgent need for overseas new drug catalogs, is generally considered to be an important channel for speeding up the launch of imported new drugs
.
Starting from the release of the first batch of clinically needed overseas new drugs in 2018, three batches have been released so far
.
So, how many of these three batches of clinically urgently needed overseas new drugs have been successfully marketed? How many have entered the medical insurance catalog?
Three batches track list directory the wind: Who is and who is out?
The first batch: products that have been approved for marketing have been removed
.
A total of 48 products were included in the consultation draft of the first batch of clinically urgently needed overseas new drugs released in August 2018
.
In the first batch of the official draft of the list of urgently needed overseas new drugs announced in November 2018, a total of 40 products were finally included in the catalog
.
The products excluded from the first batch of official drafts are aletinib, eculizumab, emtricitabine/tenofovir dipivoxil, alafenamide/avirevir/combistat, iloyudan 8 products including anti-, olaparib, piperacillil, pembrolizumab and teriflunomide
.
These products have been approved for listing before the official draft is released
.
The second batch: newly included products with additional indications
.
A total of 30 products were included in the second batch of drafts of the list of urgently needed overseas new drugs released in March 2019
.
In the official draft of the second batch of clinically needed overseas new drugs announced in May 2019, 5 products in the draft for comments were removed and 1 product was added.
.
The newly added product is NORDITROPIN (somatropin) injection, which treats the endocrine and metabolic diseases Noonan syndrome and Prader-Willi syndrome; however, Levi has the same indications Levemir Insulin Detemir [rDNA origin] Injection was excluded
.
The other four excluded products are: Inavir (laninamivir octanoate hydrate) and Xofluza (Baloxavir marboxil) for the treatment and prevention of influenza A and B infections, Praluent Alirocumab for the treatment of hypercholesterolemia, and the treatment of children over 4 years old And Verkazia (ciclosporin) for severe vernal keratoconjunctivitis (VKC) in adolescents
.
The second batch of catalogue products that have been on the market before the official draft is announced are recombinant human growth hormone injection, beraprost sodium tablets, adalimumab, gorcarivir pirentavir tablets and sildenafil tablets, which are expected to enter The reason for the catalog is to increase indications
.
Recombinant human growth hormone injection and beraprost sodium tablets were originally in the medical insurance catalogue, but the medical insurance limit of recombinant human growth hormone injection can only be reimbursed for primary growth hormone deficiency in children.
The clinical indication that needs to be urgently declared is Noonan syndrome And Prader-Willi syndrome; the medical insurance of beraprost sodium tablets is limited to "patients with a diagnosis of chronic arterial occlusion and clear signs of ulcers, intermittent claudication, and severe pain".
The clinical indications that need to be reported urgently are "Pulmonary Hypertension"
.
The scope of reimbursement allowed for the two products of medical insurance does not include indications that are urgently needed clinically, which means that in fact the indications declared for these two products in urgent clinical needs have not been included in the medical insurance
.
Adalimumab 2019 to negotiate access to health insurance directory, Medicare is limited to: 1.
a clear diagnosis of rheumatoid arthritis by traditional DMARDs treatment for 3 to 6 months of diseaseThose with a decrease in activity of less than 50%; a well-diagnosed ankylosing spondylitis (excluding pre-radiological axial spondyloarthritis) NSAIDs who have been fully treated for 3 months with a decrease in disease activity of less than 50%; and a rheumatology specialist Physician's prescription
.
2.
Patients with severe plaque psoriasis who are ineffective, contraindicated or intolerant to systemic treatments need to follow the instructions for medication
.
3.
Second-line treatment of patients with Crohn's disease
.
4.
The second-line treatment for patients with moderate to severe ulcerative colitis, but the clinical indications urgently needed to be applied for are ophthalmic diseases "interuveitis, posterior uveitis and panuveitis"
.
Sildenafil citrate tablets have been on the market in China in 2002.
The clinical urgently needed application is for the indication of "pulmonary hypertension".
In 2020, it entered the centralized drug procurement and passed the 2020 medical insurance form review, but it still failed to enter.
Medical insurance catalog
.
Third batch: Consultation draft and official draft list are consistent.
In October 2020, the third batch of clinically urgently needed overseas new drugs list was released, and a total of 7 products entered the catalog
.
In November of the same year, the third batch of the official draft of the list of urgently needed overseas new drugs was released, and the products in the draft and the official draft were exactly the same
.
Two of the seven products are the second batch of products that have not been included in the official list for the second batch of clinically urgently needed overseas new drug list consultation drafts, which are Xofluza (Baloxavir marboxil) and Verkazia (ciclosporin)
.
IL-17 , Hepatitis C NS5A : Two popular targets
combined with three batches of catalogs, one target with 3 drugs that can enter the clinically urgently needed overseas new drug catalog can be considered as a popular target category
.
Therefore, IL-17 family and hepatitis C NS5A-related drugs are two popular target categories
.
The IL-17 family includes Secukinumab, Ixekizumab and Brodalumab, and hepatitis C NS5A related to Maviret (Glecaprevir/Pibrentasvir), Sofosbuvir+Velpatasvir+Voxilaprevir and Ledipasvir+Sofosbuvir
.
Medicare insurance case what success rate?
As of November 2020, a total of 28 generic names of drugs on the clinically urgently needed overseas new drug list have been listed in the country for the first time, and 21 of them have entered the formal review of the 2020 medical insurance catalog adjustment
.
As an exclusive imported product, it will face medical insurance negotiations after entering the medical insurance form review.
If the medical insurance negotiations are successful, related products are expected to become a new growth point for imported pharmaceutical companies
.
In 2018, the two products that were approved in the clinically urgently needed overseas new drug catalog, Ledi Pavesofosbuvir tablets and Selepag tablets, were included in the 2019 medical insurance negotiation catalog
.
In 2019, there were 16 products in the clinical urgently needed overseas new drug catalog that were first listed in China.
A total of 12 products have passed the medical insurance form review and finally entered the medical insurance negotiation list.
They are the lowest clinically needed overseas new drugs in the medical insurance catalog in the past three years.
One year
.
A total of 9 products in the clinically urgently needed overseas new drug catalogue for the first time on the domestic market in 2020, all passed the medical insurance form review, and finally entered the medical insurance negotiation catalogue
.
In other words, of the 28 products whose generic names were first launched in China after the release of the list of clinically urgently needed overseas new drugs, only 8 eventually entered the medical insurance catalog, so the proportion of products entering the medical insurance accounted for about 29%
.
In the past two years, only one product that urgently needs new overseas drugs to enter medical insurance is oncology drugs, and the possibility of immune system drugs and skin drugs entering medical insurance is relatively higher
.
summary
The catalogue of urgently needed overseas new drugs has always been regarded as a channel for the accelerated review and approval of imported new drugs
.
However, there are still 24 products in the first batch of 40 products that have not yet been approved for listing, accounting for 60%; 21 of the second batch of catalogs have not been listed before the publication of the catalog, and a total of 10 products have not been approved for marketing, close to 50% ; 100% of the third batch of catalogs have not been approved for listing
.
It can be seen that the clinical urgent need for new overseas drugs may not necessarily be able to get all of them on the market quickly
.
Even if they are on the market, the number of clinically urgently needed overseas new drugs on the market after 2019 may not be able to enter the medical insurance catalog, and many of the products are drugs for rare diseases with high prices, not the basic insurance of the medical insurance fund.
Medicines that will be considered
.
According to the actual situation, domestic generic drug manufacturers can choose products with a wide range of indications for imitation
.
.
Starting from the release of the first batch of clinically needed overseas new drugs in 2018, three batches have been released so far
.
So, how many of these three batches of clinically urgently needed overseas new drugs have been successfully marketed? How many have entered the medical insurance catalog?
Three batches track list directory the wind: Who is and who is out?
The first batch: products that have been approved for marketing have been removed
.
A total of 48 products were included in the consultation draft of the first batch of clinically urgently needed overseas new drugs released in August 2018
.
In the first batch of the official draft of the list of urgently needed overseas new drugs announced in November 2018, a total of 40 products were finally included in the catalog
.
The products excluded from the first batch of official drafts are aletinib, eculizumab, emtricitabine/tenofovir dipivoxil, alafenamide/avirevir/combistat, iloyudan 8 products including anti-, olaparib, piperacillil, pembrolizumab and teriflunomide
.
These products have been approved for listing before the official draft is released
.
The second batch: newly included products with additional indications
.
A total of 30 products were included in the second batch of drafts of the list of urgently needed overseas new drugs released in March 2019
.
In the official draft of the second batch of clinically needed overseas new drugs announced in May 2019, 5 products in the draft for comments were removed and 1 product was added.
.
The newly added product is NORDITROPIN (somatropin) injection, which treats the endocrine and metabolic diseases Noonan syndrome and Prader-Willi syndrome; however, Levi has the same indications Levemir Insulin Detemir [rDNA origin] Injection was excluded
.
The other four excluded products are: Inavir (laninamivir octanoate hydrate) and Xofluza (Baloxavir marboxil) for the treatment and prevention of influenza A and B infections, Praluent Alirocumab for the treatment of hypercholesterolemia, and the treatment of children over 4 years old And Verkazia (ciclosporin) for severe vernal keratoconjunctivitis (VKC) in adolescents
.
The second batch of catalogue products that have been on the market before the official draft is announced are recombinant human growth hormone injection, beraprost sodium tablets, adalimumab, gorcarivir pirentavir tablets and sildenafil tablets, which are expected to enter The reason for the catalog is to increase indications
.
Recombinant human growth hormone injection and beraprost sodium tablets were originally in the medical insurance catalogue, but the medical insurance limit of recombinant human growth hormone injection can only be reimbursed for primary growth hormone deficiency in children.
The clinical indication that needs to be urgently declared is Noonan syndrome And Prader-Willi syndrome; the medical insurance of beraprost sodium tablets is limited to "patients with a diagnosis of chronic arterial occlusion and clear signs of ulcers, intermittent claudication, and severe pain".
The clinical indications that need to be reported urgently are "Pulmonary Hypertension"
.
The scope of reimbursement allowed for the two products of medical insurance does not include indications that are urgently needed clinically, which means that in fact the indications declared for these two products in urgent clinical needs have not been included in the medical insurance
.
Adalimumab 2019 to negotiate access to health insurance directory, Medicare is limited to: 1.
a clear diagnosis of rheumatoid arthritis by traditional DMARDs treatment for 3 to 6 months of diseaseThose with a decrease in activity of less than 50%; a well-diagnosed ankylosing spondylitis (excluding pre-radiological axial spondyloarthritis) NSAIDs who have been fully treated for 3 months with a decrease in disease activity of less than 50%; and a rheumatology specialist Physician's prescription
.
2.
Patients with severe plaque psoriasis who are ineffective, contraindicated or intolerant to systemic treatments need to follow the instructions for medication
.
3.
Second-line treatment of patients with Crohn's disease
.
4.
The second-line treatment for patients with moderate to severe ulcerative colitis, but the clinical indications urgently needed to be applied for are ophthalmic diseases "interuveitis, posterior uveitis and panuveitis"
.
Sildenafil citrate tablets have been on the market in China in 2002.
The clinical urgently needed application is for the indication of "pulmonary hypertension".
In 2020, it entered the centralized drug procurement and passed the 2020 medical insurance form review, but it still failed to enter.
Medical insurance catalog
.
Third batch: Consultation draft and official draft list are consistent.
In October 2020, the third batch of clinically urgently needed overseas new drugs list was released, and a total of 7 products entered the catalog
.
In November of the same year, the third batch of the official draft of the list of urgently needed overseas new drugs was released, and the products in the draft and the official draft were exactly the same
.
Two of the seven products are the second batch of products that have not been included in the official list for the second batch of clinically urgently needed overseas new drug list consultation drafts, which are Xofluza (Baloxavir marboxil) and Verkazia (ciclosporin)
.
IL-17 , Hepatitis C NS5A : Two popular targets
combined with three batches of catalogs, one target with 3 drugs that can enter the clinically urgently needed overseas new drug catalog can be considered as a popular target category
.
Therefore, IL-17 family and hepatitis C NS5A-related drugs are two popular target categories
.
The IL-17 family includes Secukinumab, Ixekizumab and Brodalumab, and hepatitis C NS5A related to Maviret (Glecaprevir/Pibrentasvir), Sofosbuvir+Velpatasvir+Voxilaprevir and Ledipasvir+Sofosbuvir
.
Medicare insurance case what success rate?
As of November 2020, a total of 28 generic names of drugs on the clinically urgently needed overseas new drug list have been listed in the country for the first time, and 21 of them have entered the formal review of the 2020 medical insurance catalog adjustment
.
As an exclusive imported product, it will face medical insurance negotiations after entering the medical insurance form review.
If the medical insurance negotiations are successful, related products are expected to become a new growth point for imported pharmaceutical companies
.
In 2018, the two products that were approved in the clinically urgently needed overseas new drug catalog, Ledi Pavesofosbuvir tablets and Selepag tablets, were included in the 2019 medical insurance negotiation catalog
.
In 2019, there were 16 products in the clinical urgently needed overseas new drug catalog that were first listed in China.
A total of 12 products have passed the medical insurance form review and finally entered the medical insurance negotiation list.
They are the lowest clinically needed overseas new drugs in the medical insurance catalog in the past three years.
One year
.
A total of 9 products in the clinically urgently needed overseas new drug catalogue for the first time on the domestic market in 2020, all passed the medical insurance form review, and finally entered the medical insurance negotiation catalogue
.
In other words, of the 28 products whose generic names were first launched in China after the release of the list of clinically urgently needed overseas new drugs, only 8 eventually entered the medical insurance catalog, so the proportion of products entering the medical insurance accounted for about 29%
.
In the past two years, only one product that urgently needs new overseas drugs to enter medical insurance is oncology drugs, and the possibility of immune system drugs and skin drugs entering medical insurance is relatively higher
.
summary
The catalogue of urgently needed overseas new drugs has always been regarded as a channel for the accelerated review and approval of imported new drugs
.
However, there are still 24 products in the first batch of 40 products that have not yet been approved for listing, accounting for 60%; 21 of the second batch of catalogs have not been listed before the publication of the catalog, and a total of 10 products have not been approved for marketing, close to 50% ; 100% of the third batch of catalogs have not been approved for listing
.
It can be seen that the clinical urgent need for new overseas drugs may not necessarily be able to get all of them on the market quickly
.
Even if they are on the market, the number of clinically urgently needed overseas new drugs on the market after 2019 may not be able to enter the medical insurance catalog, and many of the products are drugs for rare diseases with high prices, not the basic insurance of the medical insurance fund.
Medicines that will be considered
.
According to the actual situation, domestic generic drug manufacturers can choose products with a wide range of indications for imitation
.
