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2022 is a special year
for Merck's PD-1 pembrolizumab (known as "K drug").
In 2022Q1, K drug surpassed Humira, the first blockbuster drug for ten consecutive years, with sales reaching US$4.
809 billion, which is the throne
of the global "medicine king".
Some industry institutions predict that the annual sales of K drugs may reach 25 billion US dollars
in the future.
Unlike Humira after the patent period, K drugs are in the prime of life, and the patent protection period until 2028 may contribute at least more than $100 billion to Merck
.
When K medicine is in full swing around the world, it has a very different landscape in China
.
.
Compared with the market expectation of a market size of 20 billion US dollars for K drugs in 2022, China's market share is likely to be less than 3%.
As early as July 2018, K drug was approved for marketing in China, and it has been four years since its market sales, and in 2019 it once occupied the top of the domestic PD-1 sales list, and then was surpassed by Hengrui, according to 2021 data, K drug domestic sales are about
3 billion.
Although in the first half of 2022, the sales of PD-1 in domestic sample hospitals showed that K drugs ranked first and returned to the city, but the growth has weakened
.
weakness.
Compared with BeiGene's tislelizumab entering the medical insurance price reduction, K drug abandonment into medical insurance has always been a headache for the bosses of Merck China
.
In 2019-2020, Merck China once actively impacted medical insurance, but unfortunately ended in failure, and then began to focus on the "self-pay route"
.
Question: With K medicine pearl jade in front, innovative drugs give up entering medical insurance, can they really replicate their brilliance?
Question: With K medicine pearl jade in front, innovative drugs give up entering medical insurance, can they really replicate their brilliance?1.
The difficulty and confidence of K medicine not entering medical insurance, Baekje is "out of blue" in China
The difficulty and confidence of K medicine not entering medical insurance, Baekje is "out of blue" in China
The abandonment of medical insurance for K drugs is largely due to pricing that is subject to Merck's global price system
.
At first, the annual cost was about 325,000 yuan when it was listed in China, and with the domestic production joining the competition, this year K drugs dropped to 70,000 yuan (Innovent Biologics Sindilimab is only 40,000 yuan), according to the latest price, this cost is already 1/3
of the United States.
As one of the PD-1 products with the best efficacy in the world, Merck also has its own pride, and it is "impolite" to drop it further, and it is also easy to cause the collapse of the price system in other parts of the world
.
In addition, according to the Health Bureau, the sales team of K Drug has been maintained in the range of 600-700 people, which is not large compared to the commercialization team of thousands of people driven by local pharmaceutical companies; When the self-pay route strategy is formed, if the price is continuously reduced to achieve price for volume, without expanding the team, whether the KPI of sales can skyrocket, and whether the performance & profit is better than the original has become a question
to be considered.
It is worth noting that not all innovative drugs can "hard" give up entering medical insurance, PD-1 as a rare broad-spectrum anti-tumor drug, even if pharmaceutical companies are unwilling to reduce prices, as long as the indications are rich, efficacy & safety is good, there are always people willing to pay; The other category may be rare disease drugs and exclusive drug varieties, pharmaceutical companies have strong bargaining power, and market buyers can only passively accept the pricing
of pharmaceutical companies.
Merck, in fact, also showed the world the "explosive strategy" of creating K drug large items, which can be simply summarized as "three axes": "occupancy" of large indications, expansion of clinical indications, and new growth curves
of adjuvant therapy.
.
At present, the approved indications of K drug in the United States have covered nearly 20 cancer types and more than 30 indications, including non-small cell lung cancer, gastric cancer, liver cancer and other large
cancers.
According to the 2022Q3 conference call, the rapid growth of K drugs in the United States this year has mainly benefited from adjuvant/neoadjuvant therapy
for triple-negative breast cancer, kidney cancer, melanoma and other cancers.
Among domestic PD-1 pharmaceutical companies, BeiGene is the best way to borrow this strategy
.
.
So far, BeiGene's tislelizumab has 9 approved indications and 5 indications are included in medical insurance, all of which are the most of the domestic PD-1
.
In addition, in terms of going overseas, Europe, the United Kingdom, Australia and other countries have accepted marketing applications
for different indications of tislelizumab.
BeiGene's tislelizumab achieved sales of RMB1.
036 billion, RMB1.
62 billion in 2021 and RMB2.
179 billion in the first three quarters of 2022, respectively, bucking the trend and achieving rapid growth
.
2.
The reference of sales strategy
The reference of sales strategy
The sales of non-medical insurance drugs will encounter more difficulties in practice than expected, and will first face three major problems: access difficulties, prescription difficulties, and payment difficulties, corresponding to three important groups
: hospitals, doctors and patients.
With the higher pricing strategy of K drugs, the target group is basically targeted at people with higher payment ability such as first- and second-tier cities, and at present, K drugs are all over the country in various medium and large cities and provincial capitals
.
Merck China is also using as many sales strategies as possible to increase the coverage of K drugs, which mainly include:
The first is to reduce the price of charitable drug donation, which used to cost nearly 300,000 yuan per year after charitable assistance, and from the beginning of 2021, patients only need to pay 140,000 yuan for 4 courses of self-payment, and they can get the whole process of assistance medication for K drug (the annual cost is as low as 70,000).
The second is the introduction of commercial insurance, Merck has explored as many payment models as possible in order for K drugs to be sold better in China, and currently covers more than 100 cities of Huimin Insurance
.
The third is the new special drug DTP sales model, at the 2021 Health Industry West Lake Forum, the forecast data on the PPT of the director of the Southern Institute showed that Merck's K drug has ranked among the top 10 DTP retail pharmacies in the country, ranking 9th
.
Although the sales strategies of common non-medical insurance products also include the Guangdong Drug Exchange model and the retail pharmacy sales model, the strategic cases of K drugs still have great reference value
for innovative drug products that fail medical insurance negotiations in the future or are ready to abandon medical insurance.
3.
Think: Innovative drugs that have abandoned health care negotiations
Think: Innovative drugs that have abandoned health care negotiations
In this year's medical insurance negotiations, 13 domestic innovative drug products were eligible to participate in this year's medical insurance negotiations, but ultimately did not participate
.
What considerations may pharmaceutical companies be for this part of innovative drugs that do not participate in medical insurance negotiations? What are the potential big items?
PD-1 competition has entered a white heat, late-mover manufacturers have not eaten the first-mover dividend price to fall to the bottom, and cost and commercialization investment have become the core considerations
for enterprises to abandon medical insurance.
The domestic PD-1 "fifth" Akeso's paipelimab sold 212 million yuan in 2021 (more than 3 months on the market), and the sales amount of 2022H1 paiamplimab was about 300 million yuan, although the growth was considerable, but the volume rate decreased
significantly.
Anteniso XPO1 inhibitor celinisol currently has no competition with the same target in China, SINE drug development is not lacking in imagination, celinisol is currently under clinical research including several large hematological tumors, solid tumors, follow-up commercial volume still has a lot of space, do not enter medical insurance may be due to the cost of drugs are not yet controlled, next year to fight
.
CSPC's PI3K doensib has not been expected too much by the market, and PI3K drugs are frequently plagued
by side effects and safety overseas.
In terms of two near-commercialization competitors, Bayer withdrew its NDA application, and Yingli Pharmaceutical's PI3K inhibitor was approved
in November this year.
As the first rabies monoclonal antibody in China, North China Pharmaceutical's olamateivimab effectively fills the market gap, such as the rabies vaccine is mainly self-expense, and it is reasonable to focus on the self-pay market
.
Tengsheng Bo Pharma's ambavirumab/romisivimab is the first new crown neutralizing antibody in China, and there are inherent cost barriers for biological macromolecule drugs, and the price is difficult to drop to the ankle
like small molecule drugs.
In addition, the management mentioned that the reason for abandoning the national talks is: "At present, China's new crown treatment is still covered by the government, and it is not paid for by personal medical insurance
.
" ”
Grand Pharma's tumor interventional product yttrium [90Y] can realize the downward treatment or potential radical cure for patients with intermediate and advanced liver cancer, and with the unique high barrier of drug release and the temporary exclusivity of the product, it has great confidence and medical insurance to say "No"
.
The remaining Innovent Pharma's pemitinib (the first cholangiocarcinoma targeted drug in China, introduced in Incyte), CStone Pharma's ivonib (the world's first IDH1, introduced to Servier), Jimin's credible Solidji phosphate (treatment of basal cell carcinoma, introduced to Novartis), Subi Pharma's emanimumab (rare disease drug, introduced to Suppy).
Medicine) and other drugs, in fact, have common characteristics, including: exclusive & rare disease products, License
On the one hand, domestic pharmaceutical companies need to consider the cost recovery cycle of imported drugs, and on the other hand, they need to take into account the global pricing system of original pharmaceutical companies, which have become important constraints
for them not to enter medical insurance.
Conclusion: Abandoning medical insurance negotiations for innovative drugs is a choice, and it requires pharmaceutical companies to have courage and ability
.
After all, there is only one
K drug.
