Sources familiar with the details of Pfizer's new crown drug negotiation failure: the negotiation before the Pfizer executives have left the scene

The work related to the 2022 health insurance negotiations has all been completed, and on January 18, the National Health Insurance Bureau released the results of this round of negotiations. The much-anticipated new crown oral drug Paxlovid produced by Pfizer failed to enter the health insurance catalog through the health insurance negotiations. Recently, sources familiar with the matter briefed a reporter from the New Beijing News on the details of Pfizer's P-drug negotiation failure.

"In the Paxlovid negotiations, the health insurance side did its best to be sincere"

According to the source, there was no so-called offer as low as more than 600 yuan, and the actual offer was much higher than that. Negotiations were ultimately unsuccessful because Pfizer's offer was too high, too far from the reserve price, and basically did not reduce its price during the negotiations.

"On that day, including Paxlovid, Pfizer **** had six drugs in the health insurance negotiations. The first five were negotiated by their vice president, and by the time Paxlovid was negotiated, the vice president and other executives had already left the room." This source said, although by whom to negotiate, how to negotiate, are the strategy of the enterprise, but this fact also to negotiate the health insurance party to send a more clear signal. Combined with the negotiation process of the business side without the intention to reduce prices to see, the willingness expressed by the enterprise has been quite obvious.

The source said again, health insurance drug negotiation, whether the enterprise side has the will to reduce prices, whether the willingness to enter the health insurance, the enterprise in the rules within the scope of the decision-making and the freedom to choose the strategy. Paxlovid negotiation, the health insurance side did the best sincerity, the negotiation failure is not in any way because of the drug is too low price.

Paxlovid temporary payment until the end of March, the State Health Insurance Administration said the new crown treatment drugs within the catalog is guaranteed

Paxlovid, produced by Pfizer, is a drug that was conditionally approved for importation and registration by the State Pharmaceutical Administration in February last year and is used for the treatment of mild-to-moderate new crown infections accompanied by progression of high risk factors for severe disease in adults. The drug was later included in the New Coronavirus Pneumonia Diagnostic and Treatment Program and temporarily included in the scope of health insurance payments.

It is reported that the drug's previous health insurance purchase price was 2,300 yuan. The State Medical Insurance Bureau due to the early approval of the listing of Azulfidine and Paxlovid two drugs, such as price and other issues, has interviewed the two drugs production and management enterprises, the enterprises took the initiative to take measures to reduce the price. the price of Paxlovid from 2,300 yuan to 1,890 yuan.

According to the rules of the health insurance negotiation, the on-site negotiation starts with an offer from the enterprise side, which has two chances to offer and confirm. If the second confirmed price is higher than 115% of the negotiation base price, the negotiation fails and is automatically terminated; on the contrary, the two sides will enter into the negotiation process, the two sides finally agree on the price must not be higher than the negotiation base price of the health insurance.

After the end of the negotiations, the NHPA said three new crown treatment drugs were included in the scope of the negotiations, including Paxlovid, azivudine tablets and lung detoxification particles. Among them, Azulfidine tablets and lung detoxification particles negotiations were successful, Paxlovid did not succeed due to the high price quoted by companies.

Huang Xinyu, deputy director of the Department of Pharmaceutical Services Management of the National Health Insurance Administration, responded to Paxlovid's failure to enter the health insurance catalog through the negotiation of the health insurance program, and whether it will have an impact on the new crown medication guarantee, at a press conference on the State Council's Joint Prevention and Control Mechanism on 11th of this month. The medical insurance payment scope was adjusted in accordance with the update of the medical treatment program. In the annual adjustment of the health insurance drug catalog, the new crown treatment drugs have been the focus of high attention.

"The National Health Insurance Bureau formulated a new crown 'Class B B tube' after the optimization of the treatment cost of medical insurance policy notice, which explicitly continues the diagnosis and treatment program within the directory of drugs outside of the temporary payment policy of health insurance, the first payment to March 31 this year. During this period, the patient's medication will not be affected." Huang Xinyu said, in the health insurance catalog, the treatment of colds, fever, cough and other symptomatic treatment of more than 600 kinds of drugs, the insured person's medication clinical choice is relatively rich. The National Health Insurance Bureau is also highly concerned about the progress of research and development of new crown treatment drugs, there may be some new crown treatment of new drugs in the near future in the successive declaration of listing.

Previously reported

Medicare "national talks" on the day Pfizer China vice president left the field red in the face, did not say a word

"Science and Technology Board Daily" January 7, January 7, a new round of four days of national health insurance negotiations have entered the third day, according to the "Science and Technology Board Daily" reporter on-site incomplete statistics, today's day is expected to have 30 to 30 to 30 days of negotiations, the new round of national health insurance negotiations. statistics, today's day is expected to have 30-40 companies to participate in the negotiations, including nearly 20 in the morning and more than 15 in the afternoon.

Pfizer, the focus of the whole field, appeared in the morning session, and Roche, Bajaj Shenzhou, Hausen Pharmaceuticals, and Allis entered in the afternoon. In addition, according to the judgment of people on the scene, Bojian, Hengrui Medicine, Fosun Pharmaceuticals and other companies are expected to participate in today's negotiations. From the point of view of the analysis of the entering enterprises, the varieties of today's negotiations or cover rare diseases, anti-tumor drugs and so on.

According to the "List of Drugs Passing the Formal Review on the Adjustment of the National Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance Drug Catalog in 2022" published by the National Health Insurance Bureau, the varieties of the above drug companies that have passed the preliminary review are:

_Negotiations are again stuck in a "stalemate"

Today is the coldest day of the past three days. The most coldest day, but unlike yesterday's "rhythm seems to accelerate", today's on-site negotiations seem to have become somewhat stalemated. "I heard that today's negotiation is a little slow", midday, also participated in the afternoon session of the enterprise so said to the "Science and Technology Board Daily" reporter.

According to the reporter's on-site observation, at about 8:28 in the morning, the negotiators of the pharmaceutical companies entered the field one after another, almost 9:30 or so, before the first batch of enterprises out of the field, and after 10:30, leaving the field of the enterprises gradually began to more and more, and focused on coming out of the time period is between 10:40-11:50.

In the afternoon, 15+ enterprises lined up to enter the field at 13:30, but it was not until after 15:00 that they were seen leaving the field one after another, and it was not until the reporter left around 17:40 that several enterprises could be seen waiting outside to participate in the negotiation of the teammates.

It was dark, and people were still waiting outside

But even so, there were still several enterprises in the morning, when faced with the reporter's questioning, said, "the negotiation is quite smooth", "the price reduction is within the expected".

"Talks are going quite well," another business person told Sci-Tech Daily, reportedly referring to their family as "BeiDa." From the Medical Insurance Bureau published through the form of review of the drug list speculation, "BeiDa" or Beida, and Beida Pharmaceuticals through the form of review of only one product Ensatinib hydrochloride capsules.

"The talk was particularly good. The attitude of the officials inside is also very good, and everyone wants to talk about it." In the afternoon, more enterprises so bluntly, and after coming out of the "three" negotiating team also happy to take a group photo.

And for the health insurance side of the "sincerity", Alix chairman and general manager Du Jinhao also said to reporters after the end of the negotiations, "the country's support for enterprises is still quite large.

_P drug talks?

Statistics show that this year, there are nine companies to declare the number of drugs more than five, of which, Novartis Pharmaceuticals with 14 drugs to participate in the health insurance negotiations, becoming the current health insurance negotiations declared the largest number of drugs; ranked second is Pfizer, the **** there are 11 drugs through the form of review, including four varieties have been in the health insurance directory and seven have not yet entered the catalog of the varieties.

It's worth noting that the company's every move today is particularly in the spotlight, following market news that Pfizer's star new crown oral drug Paxlovid could be up for health insurance negotiations on the 7th.

At 8:30 a.m., a reporter also saw Qian Yun, Pfizer's vice president of China and head of market access, outside the National People's Congress (NPC) Convention Center, with a folder containing a calculator and a Pfizer logo.

However, in everyone's anxious waiting, until 13:20 pm, when the afternoon negotiation enterprises have come to the NPC Conference Center outside the door, Qian Yun Fang ended the negotiations, alone out of the field. In the face of reporters, she was red in the face, did not say a word, just call someone to come to pick her up, and along the street all the way to the west.

Pfizer China VP Qian Yun leaves

Pfizer's star anti-neocoronazole oral drug, the Nematrevir tablets/ritonavir tablets combo package, was approved for sale in the country in February 2022, and was initially provisionally included in the health insurance at a price of 2,300 yuan per box, which has been recently lowered to 1,890 yuan per box.

To date, three new crown oral small-molecule drugs have been approved for marketing in China, including Real Bio's azulfidine and Merck Sharp & Dohme's monoravir, in addition to Pfizer Paxlovid. However, because of the late approval, Azivudine's new crown indication and Monoravir are not eligible to participate in the current health insurance negotiations.

_Third-generation EFGR inhibitor first-line indications of the "fierce battle"

Notably, Hausen Pharmaceuticals and Allergan are both participating in today's negotiations.

According to the reporter from the Science and Technology Board Daily, in this negotiation, only one product, the third-generation EFGR inhibitor vorametinib mesylate tablets, has passed the formal review by Allis, while the similar product of Haosen Pharmaceuticals, ametinib mesylate tablets, has also passed the formal review. As a result, today's health insurance negotiations between the two companies may center on the first-line indications for third-generation EGFR inhibitors.

Hauser Pharmaceuticals' ametinib has now been approved for two indications in China since it was first approved in 2020:

a. Adult patients with locally advanced or metastatic non-small-cell lung cancer who have experienced disease progression on or after prior treatment with an epidermal growth factor receptor tyrosine kinase inhibitor, and who have been tested and confirmed to have a positive EGFRT790M mutation.

b. For the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor exon 19 deletion or exon 21L858R substitution mutation.

The second-line indications were successfully negotiated for Medicare in 2021, with the price dropping from RMB 9,800/box, with a monthly fee of nearly $30,000, to RMB 3,520/box, with a monthly cost of RMB 10,560, and with only RMB 3,168/month out-of-pocket after reimbursement of up to 70% of the Medicare rate.

From the point of view of the scale of sales, amitinib was approved for listing in March 2020, sales reached 700 million yuan in the first year after the listing, and more than 1.5 billion yuan in 2021. 2022 is expected to see a release of growth in 2021, after the second-line therapeutic indications into the health insurance. Previously in Henson Pharmaceuticals 2020 annual results investors meeting, management has also expressed confidence in amitriptyline in the three years after the inclusion of health insurance to achieve 5 billion yuan in sales.

Alex's vomitinib, approved for marketing in 2021, is also currently approved for two indications:

a. For the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer who have experienced disease progression on or after prior treatment with an epidermal growth factor receptor tyrosine kinase inhibitor and who have been tested and confirmed to have EGFRT790M mutation-positive disease.

b. For the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer who have an EGFR exon 19 deletion mutation or an exon 21 substitution mutation.

Vomitinib is the 2nd third-generation EGFR inhibitor approved and marketed domestically, and its second-line indication entered the health insurance catalog at the end of the same year it was approved in 2021, with a rapid negotiated price reduction of 79%, from 16,000 yuan per box to 3,304 yuan per box, with a monthly cost of treatment of about 7,080 yuan, and only 2,124 yuan/month for the patient after reimbursement of up to 70% of the rate by health insurance.

After approval in March 2021, vomitinib's sales revenue in 2021 was $236 million. In addition, in April 2022 Allis granted Fosun Pharma the exclusive promotion rights in the broad market to accelerate the omni-channel commercial layout and market coverage of vomitinib.

Now that a new round of health insurance negotiations has begun, the industry believes that, because the first-line indications into the health insurance will apply to a wider range of people, so it is expected that amitriptyline and vomitinib or will be all-out impact on this negotiation.

The reporter of "Science and Technology Board Daily" also noticed that AstraZeneca's third-generation EGFR inhibitor ositinib mesylate tablets also passed the preliminary examination of the current round of health insurance negotiation, and at present, ositinib has three indications approved, and its latest health insurance payment price is RMB 5,580/box, and if calculated with 70% of the reimbursement rate of the health insurance, the patient is only responsible for RMB 1,700/box/month.

"This year, if both amitinib and vorametinib first-line indications are going to hit the health insurance, the price may fight with ositinib." Some analysts judged this way.

_Off-site highlights

While the negotiations have reached the third day, the tension and importance of enterprises to this "national examination" has only increased. "Did you bring N95 masks?" "Antigen with it?"

More enterprises are early to the site to step on the spot to learn from the experience. In today's day alone, a reporter from Sci-Tech Board Daily coincidentally encountered three such enterprises:

"We talked in the afternoon, and the notice was to enter the site at 13:30 pm, but I came over to take a look first." It's not even 12:00 noon and there are businesses already arriving at the negotiation site.

"We are talking tomorrow." There were also companies that came to step on the spot, told Sci-Tech Daily. Interestingly, although refused to disclose the name of their own enterprises and the variety of negotiations, but when someone on the scene to discuss this negotiation, the other party is a careful attention to listen.