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Medical News, February 24, "In the future, there will be no more'blockbuster' drugs, but a'cluster bomb' type and a'categorized directed' type
.
" Xu Wei, Professor, China Pharmaceutical University, Vice Dean of the School of International Medicine and Business This is said in the 2021 China Pharmaceutical Industry New Year Outlook
.
This article attempts to answer three questions: What changes will happen to the innovative drug market? Is it necessary for innovative drugs to enter medical insurance through the National Talks? How to solve the last mile of medical insurance?
01What changes will happen to the innovative drug market?
Innovation is leading changes in the competitive landscape of the pharmaceutical industry
.
On the one hand, the pattern of original research drugs and generic drugs is being reshaped
.
Meinenet data shows that from 2017 to 2020, the sales share of original research drugs has increased from 25% to 30%
.
It is predicted that the global prescription drug growth rate will remain at 7.
4% in the next five years, of which original research drugs will occupy more and more market shares, and the proportion of generic drugs will become smaller and smaller, gradually evolving from 72% to 65%
.
On the other hand, the global drug structure has also undergone drastic changes
.
From the perspective of TOP10 global prescription drug sales, the global prescription drug market is undergoing a shift from chemical drugs to biological drugs.
This change is also demonstrated in the upstream services of the pharmaceutical industry.
More and more chemical drug CDMOs are turning to biological drug CDMOs.
Ming Bio's performance in Hong Kong stocks is the best example
.
It is worth noting that this change will lead to the birth of a new business model
.
why? Xu Wei explained that chemical drugs are usually effective for many patients, but only 30% to 40% of these patients may be considered "effective treatment
.
" In this context, the sales strategy of pharmaceutical companies usually considers the patient base
.
In the biological drug market, the market is subdivided due to factors such as genotyping and target specificity.
In this market segment, 80% to 90% of these biological drugs have miraculous effects.
If the price is right, then It is possible to monopolize a certain market segment
.
Therefore, he believes that based on this change, the sales model and competitive landscape of pharmaceutical companies will also change accordingly
.
For example, an important way for the commercialization of innovative drugs-medical insurance negotiations, is it necessary to enter the medical insurance catalog through medical insurance negotiations? This is placed in front of all pharmaceutical companies problems, especially for those just one or two new drugs start-up companies is more critical
.
02Is it necessary for innovative drugs to enter medical insurance through the national talks?
"In fact, for clinical therapeutic drugs, we all think that medical insurance is always helpful for sales
.
" Xu Wei affirmed, "Medicine insurance is like giving medicines a discount
.
" Multinational pharmaceutical companies were the first to get medical insurance.
Bonus
.
Data from sample hospitals in 2019 show that among the 17 medicines that were successfully negotiated by the national medical insurance in 2018, 13 varieties have doubled after they landed in 2019
.
Among them, Celgene's azacitidine and Novartis' ceritinib both entered the medical insurance with a 60% decrease, and achieved a year-on-year growth rate of about 24 times and 23 times respectively
.
BI's afatinib, Bayer's regorafenib, Takeda's ixazomib, and Roche's vemurafenib decreased by about 45%, and the year-on-year increase was 15 to 19 times
.
The three products with the largest price reduction (71%), Osimertinib (AZ), Axitinib (Pfizer), and Crizotinib (Pfizer), also achieved growth rates of 11 times, 6 times and 3 times, respectively
.
It is worth noting that AZ’s Osimertinib medical insurance has become one of the top 10 varieties in the national hundred-bed compound.
.
Image data source: Mi Nei.
com Advanced Database.
This effect makes all pharmaceutical companies salivate
.
In this negotiation, there were only two local pharmaceutical companies, namely Chia Tai Tianqing and Hengrui Pharmaceuticals.
In particular, Anlotinib achieved an approximately 19-fold increase
.
From the perspective of drugs that have never been covered by medical insurance, the first batch of drug negotiations organized by the Health and Family Planning Commission in 2015 included three drugs for the treatment of non-small cell lung cancer: erlotinib, gefitinib (Iressa), and icotinib After Iressa entered the medical insurance, there was a significant increase from 2016 to 2018, while erlotinib was gradually declining during the same period
.
The same is true for infliximab afterwards.
In 2017, due to various factors, it did not enter the medical insurance.
In 2018, there was a significant decline in sales
.
Xu Wei analysis believes that competitors in the same treatment field use medical insurance to expand their market share in a similar way of discounting
.
For the squeezed company, it is not easy to regain the lost market share when it re-enters the medical insurance
.
"Innovative drugs are almost the only way to enter the medical insurance catalog through medical insurance negotiations
.
" So how to do it? Xu Wei believes that we can proceed from four directions: First, consider the clinical value, that is, prepare to negotiate whether the drug has better safety than the existing treatment methods? Is it more effective and clinically valuable? Secondly, is it worthwhile to analyze from pharmacoeconomics? Analyze again from the budgetary impact whether medical insurance is affordable? Finally, from the perspective of price/expense, how can medical insurance pay more value? The clinical value must first distinguish between which type of innovative drug is the negotiated drug, whether it is a breakthrough innovative drug or an improved new drug
.
For example, after imatinib mesylate came out, it replaced the original standard therapy of interferon, and the data can almost make the 5-year survival rate of leukemia patients reach more than 90%, and the survival rate is no different from ordinary people
.
This is the clinical value and patient benefit, which needs to be highlighted
.
For improved new drugs, for example, risperidone has been invented by modifying the dosage form, then by modifying the structure, and then obtaining a longer life cycle, and in this cycle, it has significantly met the clinical needs of the clinical trial by modifying the dosage form and structure.
Meet the needs
.
For example, the predecessor of lenalidomide was thalidomide.
There was a "seal fetus" incident in Europe before, and the side effects were very serious.
Later, the structure was changed into lenalidomide and became the world's TOP10 prescription drug
.
03 health insurance the last kilometer how to solve?
In the 2020 medical insurance negotiations, many companies are facing landing problems
.
This is what the industry calls "how to solve the last mile of medical insurance"? "After the state talks, hospitals did not purchase at all ", "There is a medicine that we have been insured for 2 years, but in some places we have not been admitted to the hospital".
.
.
Many pharmaceutical companies have encountered similar problems
.
Hospitals will not purchase medical insurance drugs due to multiple obstacles such as the proportion of drugs and total control, making it difficult for pharmaceutical companies to enter medical insurance for innovative drugs
.
According to Xu Wei, after years of hard work in the industry, a dual-channel approach has been created in the industry to supply patients with medicines.
Some of the national medicines will be placed in hospitals and the other part will be placed in DTP pharmacies
.
In addition, the National Medical Insurance Administration also issued relevant policies to stipulate that the negotiated drugs are not included in the medical institution's drug proportion and total cost control assessment
.
When there are more and more negotiated drugs and more and more types, many drugs are not necessarily used in hospitalization but in outpatient clinics, such as Chinese patent medicines, psychiatric drugs, anti-cancer drugs, and ophthalmological drugs
.
These national outpatient drugs are facing the dilemma of high prices and shortage of medical insurance costs.
How to solve them? Xu Wei pointed out that in order to land, it is necessary to add local gates and gates, so that these "expensive" medicines can break through the quotas of ordinary outpatient clinics and realize the landing.
.
There is another way, that is, whether it is outpatient or hospitalization, after the completion of the national drug talks, a model similar to the previous special drug management will be carried out.
For example, the one-line payment in Sichuan Province does not distinguish between outpatient and hospitalization and no deductible line.
The medical insurance pool is directly based on Proportional payment, but the medical insurance pooling fund for a single natural year capped the cost of medicines for a single insured person of 150,000 yuan
.
There are also plans for Tianjin's DAA program, etc.
, and various places have different landing paths
.
And for products that have not entered the medical insurance catalogue, it is not without a way out.
Xu Wei believes that these products can be considered in three aspects: one is to enter local supplementary medical insurance; Minbao, Suhuibao, etc.
; the third is pure commercial insurance
.
The data shows that from 2012 to 2019, the proportion of pure commercial insurance in social health expenditure increased from 3% to 11%, which shows that the market share of commercial insurance is increasing year by year, and it will become a very important force in pharmaceutical insurance in the future.
.
.
" Xu Wei, Professor, China Pharmaceutical University, Vice Dean of the School of International Medicine and Business This is said in the 2021 China Pharmaceutical Industry New Year Outlook
.
This article attempts to answer three questions: What changes will happen to the innovative drug market? Is it necessary for innovative drugs to enter medical insurance through the National Talks? How to solve the last mile of medical insurance?
01What changes will happen to the innovative drug market?
Innovation is leading changes in the competitive landscape of the pharmaceutical industry
.
On the one hand, the pattern of original research drugs and generic drugs is being reshaped
.
Meinenet data shows that from 2017 to 2020, the sales share of original research drugs has increased from 25% to 30%
.
It is predicted that the global prescription drug growth rate will remain at 7.
4% in the next five years, of which original research drugs will occupy more and more market shares, and the proportion of generic drugs will become smaller and smaller, gradually evolving from 72% to 65%
.
On the other hand, the global drug structure has also undergone drastic changes
.
From the perspective of TOP10 global prescription drug sales, the global prescription drug market is undergoing a shift from chemical drugs to biological drugs.
This change is also demonstrated in the upstream services of the pharmaceutical industry.
More and more chemical drug CDMOs are turning to biological drug CDMOs.
Ming Bio's performance in Hong Kong stocks is the best example
.
It is worth noting that this change will lead to the birth of a new business model
.
why? Xu Wei explained that chemical drugs are usually effective for many patients, but only 30% to 40% of these patients may be considered "effective treatment
.
" In this context, the sales strategy of pharmaceutical companies usually considers the patient base
.
In the biological drug market, the market is subdivided due to factors such as genotyping and target specificity.
In this market segment, 80% to 90% of these biological drugs have miraculous effects.
If the price is right, then It is possible to monopolize a certain market segment
.
Therefore, he believes that based on this change, the sales model and competitive landscape of pharmaceutical companies will also change accordingly
.
For example, an important way for the commercialization of innovative drugs-medical insurance negotiations, is it necessary to enter the medical insurance catalog through medical insurance negotiations? This is placed in front of all pharmaceutical companies problems, especially for those just one or two new drugs start-up companies is more critical
.
02Is it necessary for innovative drugs to enter medical insurance through the national talks?
"In fact, for clinical therapeutic drugs, we all think that medical insurance is always helpful for sales
.
" Xu Wei affirmed, "Medicine insurance is like giving medicines a discount
.
" Multinational pharmaceutical companies were the first to get medical insurance.
Bonus
.
Data from sample hospitals in 2019 show that among the 17 medicines that were successfully negotiated by the national medical insurance in 2018, 13 varieties have doubled after they landed in 2019
.
Among them, Celgene's azacitidine and Novartis' ceritinib both entered the medical insurance with a 60% decrease, and achieved a year-on-year growth rate of about 24 times and 23 times respectively
.
BI's afatinib, Bayer's regorafenib, Takeda's ixazomib, and Roche's vemurafenib decreased by about 45%, and the year-on-year increase was 15 to 19 times
.
The three products with the largest price reduction (71%), Osimertinib (AZ), Axitinib (Pfizer), and Crizotinib (Pfizer), also achieved growth rates of 11 times, 6 times and 3 times, respectively
.
It is worth noting that AZ’s Osimertinib medical insurance has become one of the top 10 varieties in the national hundred-bed compound.
.
Image data source: Mi Nei.
com Advanced Database.
This effect makes all pharmaceutical companies salivate
.
In this negotiation, there were only two local pharmaceutical companies, namely Chia Tai Tianqing and Hengrui Pharmaceuticals.
In particular, Anlotinib achieved an approximately 19-fold increase
.
From the perspective of drugs that have never been covered by medical insurance, the first batch of drug negotiations organized by the Health and Family Planning Commission in 2015 included three drugs for the treatment of non-small cell lung cancer: erlotinib, gefitinib (Iressa), and icotinib After Iressa entered the medical insurance, there was a significant increase from 2016 to 2018, while erlotinib was gradually declining during the same period
.
The same is true for infliximab afterwards.
In 2017, due to various factors, it did not enter the medical insurance.
In 2018, there was a significant decline in sales
.
Xu Wei analysis believes that competitors in the same treatment field use medical insurance to expand their market share in a similar way of discounting
.
For the squeezed company, it is not easy to regain the lost market share when it re-enters the medical insurance
.
"Innovative drugs are almost the only way to enter the medical insurance catalog through medical insurance negotiations
.
" So how to do it? Xu Wei believes that we can proceed from four directions: First, consider the clinical value, that is, prepare to negotiate whether the drug has better safety than the existing treatment methods? Is it more effective and clinically valuable? Secondly, is it worthwhile to analyze from pharmacoeconomics? Analyze again from the budgetary impact whether medical insurance is affordable? Finally, from the perspective of price/expense, how can medical insurance pay more value? The clinical value must first distinguish between which type of innovative drug is the negotiated drug, whether it is a breakthrough innovative drug or an improved new drug
.
For example, after imatinib mesylate came out, it replaced the original standard therapy of interferon, and the data can almost make the 5-year survival rate of leukemia patients reach more than 90%, and the survival rate is no different from ordinary people
.
This is the clinical value and patient benefit, which needs to be highlighted
.
For improved new drugs, for example, risperidone has been invented by modifying the dosage form, then by modifying the structure, and then obtaining a longer life cycle, and in this cycle, it has significantly met the clinical needs of the clinical trial by modifying the dosage form and structure.
Meet the needs
.
For example, the predecessor of lenalidomide was thalidomide.
There was a "seal fetus" incident in Europe before, and the side effects were very serious.
Later, the structure was changed into lenalidomide and became the world's TOP10 prescription drug
.
03 health insurance the last kilometer how to solve?
In the 2020 medical insurance negotiations, many companies are facing landing problems
.
This is what the industry calls "how to solve the last mile of medical insurance"? "After the state talks, hospitals did not purchase at all ", "There is a medicine that we have been insured for 2 years, but in some places we have not been admitted to the hospital".
.
.
Many pharmaceutical companies have encountered similar problems
.
Hospitals will not purchase medical insurance drugs due to multiple obstacles such as the proportion of drugs and total control, making it difficult for pharmaceutical companies to enter medical insurance for innovative drugs
.
According to Xu Wei, after years of hard work in the industry, a dual-channel approach has been created in the industry to supply patients with medicines.
Some of the national medicines will be placed in hospitals and the other part will be placed in DTP pharmacies
.
In addition, the National Medical Insurance Administration also issued relevant policies to stipulate that the negotiated drugs are not included in the medical institution's drug proportion and total cost control assessment
.
When there are more and more negotiated drugs and more and more types, many drugs are not necessarily used in hospitalization but in outpatient clinics, such as Chinese patent medicines, psychiatric drugs, anti-cancer drugs, and ophthalmological drugs
.
These national outpatient drugs are facing the dilemma of high prices and shortage of medical insurance costs.
How to solve them? Xu Wei pointed out that in order to land, it is necessary to add local gates and gates, so that these "expensive" medicines can break through the quotas of ordinary outpatient clinics and realize the landing.
.
There is another way, that is, whether it is outpatient or hospitalization, after the completion of the national drug talks, a model similar to the previous special drug management will be carried out.
For example, the one-line payment in Sichuan Province does not distinguish between outpatient and hospitalization and no deductible line.
The medical insurance pool is directly based on Proportional payment, but the medical insurance pooling fund for a single natural year capped the cost of medicines for a single insured person of 150,000 yuan
.
There are also plans for Tianjin's DAA program, etc.
, and various places have different landing paths
.
And for products that have not entered the medical insurance catalogue, it is not without a way out.
Xu Wei believes that these products can be considered in three aspects: one is to enter local supplementary medical insurance; Minbao, Suhuibao, etc.
; the third is pure commercial insurance
.
The data shows that from 2012 to 2019, the proportion of pure commercial insurance in social health expenditure increased from 3% to 11%, which shows that the market share of commercial insurance is increasing year by year, and it will become a very important force in pharmaceutical insurance in the future.
.
