 Home > Active Ingredient News > Drugs Articles > Biotech and Medicare's "seven-year itch": behind the price negotiations for 13 new drugs to abandon...

Biotech and Medicare's "seven-year itch": behind the price negotiations for 13 new drugs to abandon...

 Last Update: 2023-02-02
 Source: Internet
 Author: User

Tags

dmso pharmaceutical grade

different candies

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

After 7 years of running-in, under the increasingly perfect processes and rules, well-prepared pharmaceutical companies can basically achieve clear expectations
.
No longer mysterious drug price negotiations, from the perspective of the market, it has begun to release the tone
of "moderate" price reduction.
After comprehensive strategy, product differentiation competitiveness, market structure and other factors, enterprises have more ideas in the game of medical insurance access, and 13 innovative drugs have voluntarily given up their qualification for drug price negotiation, which is regarded as a clear signal
.

When the drug price negotiations reached their seventh year, the "seven-year itch" between innovative pharmaceutical companies and medical insurance began to appear
.

According to statistics from China Merchants Securities, in the medical insurance negotiations in 2022, 13 domestic innovative drug products that met the declaration conditions voluntarily gave up participating in the medical insurance drug price negotiations
in 2022.
"After that, there will be more and more," said Wang Yu, an industry insider familiar with the market, adding that the reason for the concentration in 2022 is that with the accumulation of innovation, local innovative pharmaceutical companies have entered the harvest period
of product commercialization.
Many of these Biotechs often develop small indications in order to make innovative drugs go to market as quickly as possible, which are often exclusive to the market and have insufficient motivation to enter medical insurance
.

"After that, there will be more and more," said Wang Yu, an industry insider familiar with the market, adding that the reason for the concentration in 2022 is that with the accumulation of innovation, local innovative pharmaceutical companies have entered the harvest period
of product commercialization.

From the 20-man legion of four Buick GL8s in 2020, all red masks, to the latest commemorative photos, or even giving up participation in negotiations, have the strategies of innovative pharmaceutical companies really changed?

The answer is "no", but innovative pharmaceutical companies have a more mature understanding of payment access
.

Do innovative drugs have to be insured? Which products are suitable for immediate launch? Which ones can wait? In this regard, the chief commercial officer of a leading innovative pharmaceutical company analyzed to the manager of E Pharmaceutical, "It is difficult to have a unified criterion, and what is suitable is the best
.
" She said that it is mainly affected by several factors, first of all, to look at the competitive landscape, secondly to look at their own product line, but also to look at the existing team configuration and so on
.

"For example, the company's product is an exclusive product, and the second and third companies are expected to come late, and they can have a lead period
of several years.
In this case, in fact, the concept of all aspects has not been established, plus supporting testing, pathology, etc.
are not matched, and the benefits of price reduction are actually not large
.
At this time, the most important thing for enterprises is to do the necessary things well
.
For example, if several competitors enter at the same time, and then there are iterative products, different strategies must be adopted
.
”

Also, see if you are well prepared internally
.
"The first is the treatment concept of the product, including detection, pathology stratification, classification, if the disease can not be diagnosed, then the drug in all aspects ready (prepared) is not enough
.
" Moreover, when entering medical insurance, everyone hopes to achieve more patients or a longer medication cycle, and can achieve price for quantity
.
But if your team isn't big enough, you can't do it to hospitals below the head; Or to the bottom, the team has just been established, the team for hospital access is not ready, the channel cannot be reached, and the relationship with the local hospital, department, and clinician has not been established, and it is impossible to do a very effective academic promotion
.
I don't think it's
possible to exchange price for volume.
”

In addition, there is also a consideration for the expected market coverage, "If you want to focus on the domestic market, drug price negotiations must be a fight
.
" However, if companies want their products to expand in overseas markets such as Europe and the United States, in order to maintain the global price system, then they may not be so interested in the medical insurance catalog catalog that is bound to reduce prices to enter.
"
An innovative pharmaceutical company said to the manager of E
Pharmaceutical.

"If you want to dominate the domestic market, drug price negotiations must be a fight
.
" However, if companies want their products to expand in overseas markets such as Europe and the United States, in order to maintain the global price system, then they may not be so interested in the medical insurance catalog catalog that is bound to reduce prices to enter.
"

Therefore, each company should judge the situation and consider its final choice
from multiple dimensions.
Of course, this choice can only be tested
by the performance of the market in the end.

01 Exclusive varieties

From the perspective of the 13 varieties that gave up to participate in the negotiation, there are mainly two types of products, one is PD-(L)1, and the other is mostly exclusive indication/mechanism drugs with a good competitive pattern, whether they are imported from outside or independently developed, and most of the indications are small
.

Taking CSPC's Dornsib as an example, price protection may be the first consideration
.
It is understood that doensib targets PI3Kγ and PI3Kδ dual targets, PI3K is a broad-spectrum target, and the indications cover a wide range of tumors and immunity
.
At present, there are 5 approved PI3Kδ inhibitors in the world, and dornsib belongs to the first generation
.
In addition, the PI3Kδ inhibitor Linplisac, independently developed by Yingli Pharmaceutical, was also approved for marketing in 2022, and was commercialized by Hengrui Pharmaceutical, with the same indication as 3L follicular lymphoma
.
At the same time, there are more than ten PI3Kδ inhibitors in the clinic, and the competitive pressure is not small
.
"Follicular lymphoma itself is a very small indication, and the consideration of stone medicine may be to ensure the price, and there is more market space
after the large indication is listed.
" Wang Yu said
.

In addition to North China Pharmaceutical's olmutivimab and Tengsheng Bo Pharmaceutical's ambavirumab/romisivimab, exclusive products, ambavirumab/romisivimab is a new crown neutralizing antibody, which itself is subject to some restrictions, and its management has also mentioned the reason for abandoning the national talk: "At present, China's new crown treatment is still covered by the government, and it is not paid for by personal medical insurance
.
" ”

Omutivimab is the first rabies monoclonal antibody in China, combined with human rabies vaccine, itself rabies vaccine is a self-funded product, and it is a combination product, and the promotion idea is naturally different
.

Jimin's credible Solidji phosphate capsules also do not participate in drug price negotiations, and industry insiders analyze that as an exclusive product, even if it does not enter the medical insurance catalog, the product can also obtain good commercial sales results
.
It is understood that Solidji phosphate capsules were launched in China in July 2021 and are the first approved for the treatment of locally advanced basal cell carcinoma (Basal) in China Cell Carcinoma, BCC).

In January 2020, Jimin Trust Group cooperated with Sun Pharmaceutical to obtain the development and commercialization rights
of Solidji phosphate capsules in Greater China.
Previously, the drug was included in the list of the first batch of overseas new drugs urgently needed for clinical use by CDE
.

Others, such as Antengene's Celiniso, the world's first and only FDA-approved oral XPO1 inhibitor, are approved as a five-line therapy (in combination with dexamethasone) for multiple myeloma (MM) and monotherapy
for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL).
Affected by the indications, the global sales of Celiniso, which has been on the market for more than three years, were only $98.
4 million in 2021.

Grand Pharma's interventional tumor product Yttrium [90Y] is mainly used in conversion therapy (stage reduction, bridging) and palliative care (inoperable, TACE failure, etc.
) in patients with intermediate and advanced liver cancer, palliative care (single use, combination) and conversion therapy (stage reduction, increase residual liver volume)
for patients with colorectal cancer liver metastasis.
This selective radiotherapy product has extremely high barriers and strong exclusivity
.

Subi Medicine's emarimumab is a rare blood disease treatment for adults and children (newborns and older) with primary hemophagocytic lymphohistiocytosis (HLH
).
Similarly, BeiGene's datoximab is the first immunotherapy drug
for neuroblastoma (NB) in China.
However, the market space is relatively small, it is understood that NB mainly occurs in infants and young children, accounting for 8%-10% of childhood malignant tumors, and data speculate that about 3,000 children in China are diagnosed with NB
every year.
These products are imported products that also need to take into account the impact of
the global pricing system.

There is also CStone's ivoranib tablets, which were approved in January 2022 and are one of
its three precision therapeutic drugs approved for marketing in 2022.
CStone has the clinical development and commercialization rights
of ivoranib tablets in Greater China and Singapore.
Evosnib is the first approved IDH1 inhibitor in China for the treatment of relapsed or refractory acute myeloid leukemia (R/R) in adults with IDH1 susceptible mutations AML) patients
.
In February 2022, the product was approved for clinical urgent use in Boao Super Hospital, a specific medical institution in Hainan Lecheng International Medical Tourism Pilot Zone, for the treatment of previously treated adult patients with locally advanced or metastatic cholangiocarcinoma with isocitrate dehydrogenase-1 (IDH1) mutation, bringing new treatment options
to domestic cholangiocarcinoma patients in urgent need of treatment.

For the commercialization of the product, CStone Pharmaceuticals uses its own commercial team to promote it, and in terms of channels, CStone seems to prefer cooperation with commercial insurance
.
CStone Pharmaceuticals recently revealed that the product has been included in more than 80 urban insurances, including Hunan Province, Hainan Province, Suzhou City, etc
.

02 PD-(L)1 latecomer

Enterprises with the same target and indication, namely Chia Tai Tianqing/Akeso's PEMPLIMAB and Yuheng Biologics' Cyberbolimab, have chosen to give up
.

For this result, an obvious logic is that in the indication of Hodgkin lymphoma, this is a "not profitable" product, which is the "reasonable" choice
of the enterprise.

First of all, from the indications of the two products, it is clear that these two products are already proper latecomers
.
December 2018 In January, Innovent's Cindilimab was the first to receive NMPA approval for the treatment of relapsed or refractory classical Hodgkin lymphoma
.
In 2019, the indications of Cindilimab were included in the medical insurance
with 98,800 yuan per year.

It also means that if latecomers negotiate health care, it means that they must be on par
with the first mover in terms of price.
In addition, Hodgkin lymphoma is actually an indication for a small patient population, and in 2020, there were 6829 new cases of Hodgkin lymphoma in China, and the market space was limited
.

Based on these two premises, these two products, in the case that the forerunner Cindilimab has entered the hospital, the possibility of achieving price for volume by entering medical insurance is relatively low
.

At the same time, these two products approved in 2021, the company has carried out commercial exploration, and also achieved certain results
.
Since the beginning of the market, the price of the drug has been directly targeted at the price after medical insurance negotiations that year, and the cost of the drug is capped at 39,000 yuan in two years, and the annual cost is less than 20,000 yuan
.
According to the sales data of peamplimab disclosed in the current market, the sales of the product in the 3 months of listing in 2021 will be 212 million yuan, and the sales amount in the first half of 2022 will be about 300 million yuan, and the data forecast that the revenue of the changed product is expected to exceed 500 million yuan
in 2022.
According to the data disclosed in the 2021 annual report of Yuheng Pharmaceutical, by the end of 2021, Yuheng Biotech has preliminarily completed the establishment of the commercialization team, and the marketing center has
185 employees.
Sepalimab injection has covered patients in more than 260 hospitals, and the cumulative shipment has exceeded 10,000 units
.

From the perspective of the overall strategy of the company, Akeso, although abandoning the peamplimab for medical insurance negotiations, has put a lot of effort
into its new product biclonalimab product cardunilimab injection (PD-1/CTLA-4 bi-antibody).
In June 2022, cardunilimab passed the priority review and approval process with conditional approval for marketing, which is suitable for the treatment of patients with relapsed or metastatic cervical cancer who have previously failed platinum-containing chemotherapy, and is the first domestic bispecific antibody approved for marketing and the world's first PD-1/CTLA-4 dual antibody, which involves PD-1 and is its own pianpulimab
.

Different from the commercialization strategy selection cooperation of PEAMPLIMAB, for bispecific antibody products, Akeso personally formed a team to lead the commercialization of the product, and the size of the sales team increased from 196 to 630 people
.
The management of Akeso has revealed that in the absence of competitors, the sales of cardunilimab may reach 3 billion yuan in the next 2 to 3 years
.

Unfortunately, Yuheng Biologics' sepalimab, which was included in the breakthrough therapy drug review program in March 2021, indicated for cervical cancer
with relapse or metastasis and positive PDS1 expression (CPS≥1) that has progressed after receiving one or more lines of platinum-containing standard chemotherapy.
Moreover, the listing application for this indication was accepted in March 2022 and has not yet been officially listed
.
However, Akeso's bispecific antibody has been approved in the indication of cervical cancer, and if the product successfully passes the national talks, then the commercialization of PD-1 of Yuheng Biologics will be in a more passive situation
.

The more controversial point is the cornerstone's strategy
for PD-L1 sugemalimab.
Although there are already PD-1 product related indications included in medical insurance, and this year's negotiations have also negotiated a number of PD-1 new non-small cell lung cancer indications, as a larger indication, industry insiders believe that "the cornerstone can still be fought for"
.

It is understood that sugemalimab was approved for the indication of stage IV non-small cell lung cancer at the end of 2021, and in May 2022, it was approved for the treatment of unresectable disease progression after concurrent or sequential chemoradiotherapy Patients
with stage III non-small cell lung cancer.
This product became the first PD-L1 antibody approved for the treatment of patients with stage III non-small cell lung cancer with concurrent or sequential chemoradiotherapy, and the only PD-L1 antibody
that covers both stage III and IV non-small cell lung cancer indications.

It is reported that the commercialization of sugemalimab in the mainland is the responsibility of partner Pfizer, which means that whether to participate in medical insurance negotiations is decided by Pfizer
.

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.