Why Pfizer's new crown drug did not enter the medical insurance catalog, the impact on domestic research in the new crown oral drug geometry

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The much-anticipated Pfizer’s new crown oral drug Paxlovid has failed in the medical insurance negotiations after all, and will not be able to enter the national medical insurance drug catalog in 2022.

For the reason of failure, on January 8, the explanation given by the National Health Insurance Bureau was that the high price quoted by the manufacturer Pfizer Investment Co.

The day before, January 7, a media report said that at 8:30 a.m. that day, Pfizer Global Biopharmaceutical Commercial Group China Vice President, Head of Market Access Qian Yun entered the negotiation infield and did not come out of the negotiation infield until 1:20 p.m. The morning field officially began at 9:00 that day, according to this calculation, Pfizer talked for more than 4 hours that day, while the Medical Insurance Bureau regulations for each drug negotiation time of half an hour. However, it is not clear whether the four hours were spent on the Paxlovid negotiations.

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There are rumors in the market that Pfizer has a total of seven products participating in the current round of health insurance negotiations.

At this point how to view Pfizer Paxlovid this health insurance negotiation failure?

Since recently, many parts of the country are entering the peak of the new crown of serious illness, many medical institutions ICU beds one after another emergency. The use of new coronary small molecule drugs can play a role in reducing the incidence of severe illness. Because of this, Paxlovid is sought after by the market, and “one drug is hard to find”.

On January 6, 2023, the National Health Commission released the “New Coronavirus Infection Treatment Plan (Trial Version 10)”, which listed antiviral treatment drugs including nematovir tablets/ritonavir tablets combination package (i.e. Pfizer Paxlovid). The drug is indicated for adult patients with mild to moderate disease within 5 days of onset and with high risk factors for progression to severe disease, according to the drug.

In medical institutions, the drug is also favored by clinicians. Some clinicians told the first financial reporter that the reason for favoring the drug is mainly twofold: first, the efficacy observed in the clinic is still acceptable; second, the drug has detailed research data, which can provide some medication guidelines more clearly. At the beginning of the epidemic prevention and control policy liberalization, the problem of how to apply the new crown antiviral drug for clinical treatment after the emergence of a large number of infected people had also troubled clinicians.

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Before the launch of this national health insurance negotiation, Pfizer Paxlovid has been temporarily included in some local health insurance payment scope, and the health insurance payment price has been lowered from 2300 yuan per box to 1890 yuan per box, but this health insurance temporary payment period is only until March 31 of this year. In other words, from April onwards, patients will need to pay for the drug entirely out of pocket if they want to use it. For a drug that costs nearly $2,000 a box, it is still on the expensive side for most people.

Why is Pfizer Paxlovid unwilling to “lower its profile” to enter the Chinese health insurance list?

The first is that the drug is in short supply and drug companies are not worried about selling it; the second is that Pfizer is not willing to destroy its own global price system; the third is that the drug has shown certain advantages in terms of efficacy and has become the drug of choice for the treatment of new crowns, and even if the price is not reduced, it is expected that there is still a lot of demand for the drug in the segmented population.

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The company sources said that this time Pfizer Paxlovid abandoned to enter China’s Chinese medical insurance directory, for the same target in the research of China’s domestic drugs, but will usher in a large market replacement space.

Pfizer Paxlovid belongs to the 3CL protease inhibitor, which can inhibit the action of 3CL protease, thus preventing the subsequent series of replication activities of the virus. Currently, there are several Chinese pharmaceutical companies that are developing similar new crown oral drugs. The one that is currently making the fastest progress is SIM0417, a 3CL-targeted neo-crown therapeutic oral drug jointly developed by Centrum Pharmaceuticals (02096.HK), the Shanghai Institute of Pharmaceutical Sciences of the Chinese Academy of Sciences, and the Wuhan Institute of Virus Research.

On December 26, 2022, Jiangsu Provincial Drug Administration released a news release in its public number that SIM0417, is expected to be marketed in February 2023 at the earliest. Jiangsu Provincial Drug Administration introduced that SIM0417 obtained the clinical approval from the State Drug Administration through special approval procedure on March 28, 2022, and was included in the key directory of scientific research and development of the joint prevention and control mechanism of the State Council. on December 16, the phase III clinical of the project has completed all 1208 patients enrolled, and the progress is in the first place of domestic 3CL target drugs.

The above-mentioned business people believe that the domestic 3CL target new crown treatment oral drug will have a great competitive price advantage.

It is worth mentioning that on January 6 this year, the National Health Insurance Bureau released the “New crown treatment drug price formation guidelines (for trial implementation)” (hereinafter referred to as “guidelines”) to the public, based on adhering to the market to determine prices and respect the independent pricing of enterprises, better play the role of the government, the introduction of medical institutions and industry associations to participate in social governance, to guide enterprises to openly and transparently set reasonable prices for new crown treatment drugs.

“The introduction of this Guideline is neutral and negative news for enterprises that are developing new crown oral drugs, which means that the subsequent listing of new crown oral drugs will not be too profitable and drug pricing will be transparent.” The above-mentioned business people also think so.