Medical insurance negotiation prospect: sky-high drugs, Paxlovid waiting for 'turning positive', PD-(L)1 once again chasing the deer...

According to various sources, a new round of adjustment of the national medical insurance catalogue will start on January 5, 2023, for three days. The exact address was not officially announced, but there was information that the negotiations were at the site or at the center of the National People's Congress.

On September 17, 2022, the National Health Insurance Administration announced the list of drugs that passed the formal review, and this round of declarations involved 490 drugs (generic names, the same below). After review, 344 drugs passed the preliminary form review, with a pass rate of 70%.

On October 16, the National Health Insurance Administration announced the results of the expert review of the adjustment of the national medical insurance catalogue in 2022.

On December 6, the National Health Insurance Administration reported that in order to ensure a smooth and orderly on-site negotiation, comprehensively considering the impact of the new crown epidemic and the needs of negotiation work, the on-site negotiation of the 2022 national medical insurance drug catalogue was postponed, and the specific time is to be determined.

Since the first launch of national drug negotiations in November 2015, a total of six batches have been launched at the national level, covering many major disease areas such as cancer, rare diseases, and chronic diseases.

Nowadays, the annual medical insurance negotiation has attracted much attention from the industry, and whether a batch of high-priced, popular targets and other drugs can enter the medical insurance catalog has become the biggest attraction. For example, the new crown oral drug, PD-1, HER2, the third generation of EGFR, AR and CDK4/6 and other heavy targets, the negotiation results are worth looking forward to.

The new crown oral medicine is hot, can Paxlovid "turn positive"

With the liberalization of the epidemic, the new crown oral medicine was rushed for a while, and on the eve of medical insurance negotiations, the topic and popularity only increased. Whether the price of the new crown oral medicine that has been snatched out can be reduced, and how much it will be reduced, has become the focus of attention of the people.

In the previously announced preliminary review list, two new coronavirus treatment drugs appeared - Pfizer's nematevir tablets/ritonavir tablets combination package (Paxlovid), and real biological azvudine tablets.

On February 12, 2022, the State Food and Drug Administration conditionally approved the import registration of Pfizer's new coronavirus treatment drug nematevir tablets/ritonavir tablets combination packaging (PAXLOVID) for the treatment of adult patients with mild to moderate novel coronavirus pneumonia with risk factors for progression to severe disease, such as patients with advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease and other high-risk factors for severe disease.

Real Bio's Azvudine tablets were first conditionally approved for marketing to treat AIDS. On July 25, 2022, Azvudine tablets of Real Bio were conditionally approved to add an indication application for the treatment of new coronavirus pneumonia for the treatment of adult patients with common novel coronavirus pneumonia. On August 9, 2022, Azvudine tablets were included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (9th Edition)".

On September 6, 2022, Azvudine tablets were included in the preliminary review list of the medical insurance catalog. The condition for passing the declaration is "off-list condition 1", that is, a new generic drug approved for marketing by the national drug administration between January 1, 2017 and June 30, 2022. Industry insiders believe that the indications for the treatment of the new crown with azvudine were only approved in July this year, so this medical insurance negotiation may only involve the indications for the treatment of AIDS.

On August 11, 2022, according to the official website of Fosun Pharma, according to the price of medical insurance in various places, the price of azvudine tablets is 270 yuan per bottle, 35 tablets per bottle, and 1mg per tablet. Pfizer's new crown oral drug Paxlovid was soon exposed to a price of 2,300 yuan / box on the domestic market, and has been temporarily included in China's medical insurance payment scope.

In December 2022, after the epidemic was released, the new crown oral medicine was sold out. Paxlovid is priced at 2980 yuan / box online, and the reservation price of many platforms is close to 4000 yuan, and even scalpers have fried the drug to tens of thousands of yuan... The Indian version of generic drugs has also been robbed, and it is difficult to distinguish between true and false.

It is reported that the current Pfizer Paxlovid medical insurance payment price has been reduced from 2300 yuan / box to 1890 yuan / box, or pave the way for entering the medical insurance catalog... However, according to the average reduction rate of more than 50% in previous medical insurance negotiations, if this price wants to enter the new round of medical insurance catalog, there is still room for price reduction.

On the other hand, domestic new crown treatment drugs are also emerging. On December 29, 2022, the State Food and Drug Administration conditionally approved the import registration of Merck's new coronavirus treatment drug monoravir capsules for the treatment of adult patients with mild to moderate novel coronavirus infection with risk factors for progression to severe disease, such as patients with advanced age, obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, active cancer and other high risk factors for severe disease. In addition, domestic companies such as Simcere Pharmaceutical, Junshi Biologics and other new crown treatment drugs are accelerating their entry into the market, and the competition in this therapeutic field is full of variables.

The old and new PD-(L)1 compete on the same stage, and the domestic competition is fierce

The star anti-cancer drug PD-(L)1 is one of the most talked about drugs in the annual medical insurance negotiations. At present, 14 PD-(L)1 monoclonal antibodies have been approved in China, and 6 domestic drugs are expected to participate in this negotiation, namely 4 PD-1 monoclonal antibodies (new indication negotiation) from Hengrui Pharmaceutical, BeiGene, Innovent Biologics, and Junshi Biologics; Henlius PD-1 monoclonal antibody and Corning Jerry/Sidi / Simcere Pharmaceutical's PD-L1 monoclonal antibody are the first to participate in medical insurance negotiations.

Among them, teripulimab: 2 new indications this time, namely first-line treatment for nasopharyngeal carcinoma and first-line treatment for esophageal squamous cell carcinoma; Cindilimab: 2 new indications this time, namely the first line of esophageal squamous cell carcinoma and the first line of adenocarcinoma at the junction of the stomach and gastroesophagus.

Carrelizumab: 4 new indications this time, nasopharyngeal carcinoma second-line and above, nasopharyngeal carcinoma first-line, esophageal cancer first-line and squamous non-small cell lung cancer first-line; Tislelizumab: The scope of payment adjustment in this declaration involves four new indications, namely second/third line advanced non-small cell lung cancer, second line esophageal squamous cell carcinoma, first line nasopharyngeal carcinoma, and MSI-H/dMMR solid tumor.

Henlius' serplulimab is the first time it has participated in medical insurance negotiations for MSI-H solid tumors. Corning Jerry/Sidi/Simcere PD-L1 monoclonal antibody is also the first to participate in medical insurance negotiations for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite hyperinstability (MSI-H) or mismatch repair gene deficiency (dMMR).

After combing, PD-1 under Hengrui Pharmaceutical, Innovent Biologics, Junshi Biologics and others will compete for first-line treatment indications for advanced esophageal squamous cell carcinoma; BeiGene, Hengrui and Junshi will also compete on the same stage for first-line nasopharyngeal cancer indications; BeiGene, Henlius, Corning Jerry/Sidi/Simcere Pharmaceutical, etc. PD-(L)1 compete on the same stage for MSI-H solid tumors; Innovent Biologics' Cindilimab is the only PD-1 product approved for first-line gastric cancer indications and is expected to be included in medical insurance this year.

On the other hand, Akeso's PD-1/CTLA4 biantibody cardunilib was approved in June 2022 and is eligible to participate in the negotiations. The drug is used in patients with relapsed or metastatic cervical cancer who have previously failed platinum-containing chemotherapy, and its marketing makes up for the unmet need for second- and third-line targeted therapy for cervical cancer. It is understood that the price of the drug is 13220 yuan / 125 mg / bottle.

At present, the price of domestic PD-1 is low, and the overall price is in the range of 30,000-50,000. Domestic PD-1 monoclonal antibody currently occupies most of the domestic market share. Deppon Securities expects that with the subsequent inclusion of major indications in medical insurance and product price reductions, domestic PD-1 will further expand its domestic market share.

A batch of high-priced drugs and domestic innovative drugs to be "qualified"

The new round of medical insurance negotiations also includes many high-priced drugs, such as JW Therapeutics' relmacel injection, Roche's SMA drug rispramine, Takeda's injectable veraside A and Sanofi's imigresidase.

WuXi Juno's CAR-T new drug relmacel injection was approved in China in September 2021, with a retail price of 1.29 million yuan per injection, and a revenue of 31 million yuan in only three months after its listing in 2021.

It is worth referring to the fact that in the 2021 medical insurance negotiations, Fosun Kate's 1.2 million yuan per injection of CAR-T Aquilen passed the qualification review, but did not participate in the negotiation in the end. In this round of medical insurance negotiations, Fosun Kite did not appear with Aquilencel injection, and I wonder whether JW Therapeutics' CAR-T new drug can be successfully negotiated this time.

In order to enter the medical insurance catalog, Roche's SMA drug rispram is also actively reducing prices. On June 9 this year, the Shandong Pharmaceutical and Equipment Centralized Procurement Platform issued a notice on the voluntary price reduction of risprand, and Roche took the initiative to reduce the price of the rare disease drug rispram for spinal muscular atrophy (SMA), and adjusted the price of the bidding platform to 14,500 yuan per bottle according to relevant policies.

In addition, many domestic innovative drugs are expected to be included in this round of negotiations, involving companies such as Hengrui Pharmaceutical, Remegen Biologics, and Betta Pharmaceutical.

Among HER2-targeted drugs, a total of 5 products were involved in this medical insurance negotiation: Hengrui Pharmaceutical's pyrotinib added the indication of HER2-positive breast cancer neoadjuvant therapy, Remegen Biologics' HER2-ADC vedicitumab added the indication of urothelial cancer, and Roche's enmetrastuzumab participated in medical insurance negotiations for the first time; Ternitumab's enitumab will be negotiated for a contract extension.

Public data shows that HER2 monoclonal antibody occupies the vast majority of the market share in the current domestic market, of which trastuzumab accounts for the highest proportion; Hengrui's HER2 inhibitor pyrotinib has considerable sales; HER2ADC has a low market share due to its high price.

The three third-generation EGFR inhibitors in China have all added NSCLC-related indications, and Alice's vometinib and Hausen Pharmaceutical's ametinib have added NSCLC first-line treatments to participate in this medical insurance negotiation; AstraZeneca's osimertinib is negotiating for this renewal, and its NSCLC adjuvant therapy after tumor resection is participating in the medical insurance negotiations for this new indication. The annual treatment costs of vometinib, ametinib and osimertinib are 86,000 yuan, 128,000 yuan and 68,000 yuan, respectively.

From the perspective of enterprises, Hengrui has 3 innovative drugs approved for the first time, all of which participated in this year's medical insurance negotiations, namely AR inhibitor revilumide tablets, CDK4/6 inhibitor dalcili tablets, and SGLT2 inhibitor hengliflozin tablets; Zai Lab's two new products participated in medical insurance negotiations, namely Qingle, a product for the treatment of gastrointestinal stromal tumors, and Neozaile, an anti-infective drug; Betta Pharma's ALK inhibitor ensartinib added first-line ALK-positive NSCLC...

It is understood that a total of 199 Chinese medicines and Western medicines outside the list and 145 Chinese medicines and Western medicines in the list participated in the negotiations in this round of medical insurance negotiations. One of the highlights is that for the products in the catalog, a simple renewal rule has been introduced this time, and the reduction rate is linked to the previous occupation of medical insurance expenses, which is controllable and predictable compared with the previous negotiation model.

Industry insiders believe that with the normalization of medical insurance negotiations and the continuous maturity of negotiation rules, the negotiation rules and procedures of innovative drugs have become clearer and more systematic, and the negotiation rate of renewal and new indications has decreased moderately.