In depth analysis: 17 varieties market changes

On October 10, the State Medical Security Bureau issued the notice on including 17 kinds of anticancer drugs into the category B scope of the national basic medical insurance, work injury insurance and maternity insurance drugs catalogue In this round of negotiation on anticancer drugs led by the National Health Insurance Bureau, 17 products were included in the national health insurance catalogue through negotiation, with an average decrease of 56.7% Among them, the largest decline was the treatment of non-small cell lung cancer products of AstraZeneca tiresar, with a decrease of 71% However, the product of Novartis in the treatment of bone marrow fibrosis, lucotinib phosphate (jiekewei), has become the only one out of this round of negotiations According to the requirements of the notice, 17 kinds of negotiation drugs are included in the category B scope of the national directory of basic medical insurance, industrial injury insurance and maternity insurance drugs (2017 version) (hereinafter referred to as the drug directory), and the payment standard of medical insurance is determined The competent medical insurance departments of each province (district or city) shall not transfer the negotiated drugs out of the catalogue or adjust the limited payment scope At present, in areas where the integration of urban and rural residents' medical insurance has not been realized, these drugs should also be included in the payment scope of the new rural cooperative medical system in time according to the regulations The payment standard stipulated in the "medical insurance payment standard" for negotiated drug varieties includes all the expenses jointly paid by the basic medical insurance fund and the insured, and the sharing proportion of the basic medical insurance fund and the insured shall be determined by each overall planning area The stipulated payment standard shall be valid until November 30, 2020, and shall be adjusted according to the relevant provisions of the medical insurance payment standard after expiration During the validity period, if a generic drug (generic drug) is listed, the state health insurance bureau will adjust the payment standard of the drug according to the price level of generic drug and give a further notice If the actual price in the drug market is obviously lower than the current payment standard, the State Medical Insurance Bureau will negotiate with the enterprise to re formulate the payment standard and notify the enterprise separately According to the notice, the provincial (District, city) drug centralized purchasing agencies shall publicly hang the negotiated drugs on the provincial drug centralized purchasing platform according to the payment standard before the end of October 2018 The medical insurance department shall update the information system in time to ensure the implementation before the end of November In addition, effective measures should be taken to ensure the supply and rational use of negotiated drugs If the actual expenses incurred by medical institutions in 2018 exceed the total amount control index due to policy reasons such as the inclusion of negotiated drugs in the catalogue, reasonable compensation shall be given at the end of the year for liquidation, and the factors of rational use of negotiated drugs shall be taken into consideration when formulating the total amount control index in 2019 At the same time, it is necessary to strictly implement the limited payment scope of negotiated drugs, strengthen the use management, and focus on the monitoring and analysis of drugs with high cost and large dosage, so as to ensure the safety of medical insurance fund Since May 1 this year, the import of anti-cancer drugs has implemented zero tariff and reduced import value-added tax by 3% The two tax reductions have brought a lot of imagination space to the industry After that, relevant policies have come one after another On August 17, the notice on Issuing the scope of drugs for 2018 special negotiation of anti cancer drug medical insurance access was posted on the website of the Chinese government, which announced 18 varieties of 12 enterprises included in this special negotiation of anti cancer drug medical insurance access This is the first time since the establishment of the National Health Insurance Bureau to lead the drug price negotiations As a super payer, the discourse power of the health insurance bureau is obviously much stronger than the leading departments in the first two rounds However, under the clear demand of high-level officials to reduce the price of anticancer drugs, this result is significantly higher than the drug price negotiation in 2017 In addition, in terms of follow-up security, the National Health Insurance Bureau has required to do a good job in the provincial-level anti-cancer drug special centralized procurement, to carry out relevant security in terms of access and quantity In terms of the proportion of drugs, the first two rounds of drug price negotiations are not included in the proportion of drugs and are accounted for separately Obviously, favorable policy guarantee is the necessary condition for the negotiation result to be implemented Note: the picture comes from China Medical Insurance Compared with the market retail prices of 17 negotiated drugs in 2017-2018, it is preliminarily estimated that the maximum drop of drugs in this negotiation is more than 70% All data are for reference only, please refer to official information 1 Novartis became the biggest winner Although one product was out of the game, Novartis was selected as the biggest winner in this round of drug price negotiations with four varieties of anti-cancer drugs Among the four products successfully selected by Novartis, octreotide acetate microspheres and nilotinib capsules for injection are both old products that have been on the market in China for at least ten years, while serenitinib capsules and pezoparine tablets are new products that have been on the market in China in recent two years It is worth noting that there are no competing products of the same kind in the domestic market for the four varieties that Novartis finally negotiated successfully, which will undoubtedly further seize market share for Novartis In terms of old products, the patent of octreotide acetate microspheres for injection has expired in January 2017 Obviously, Novartis hopes that it will continue to maintain vitality before the generic drugs go on the market In 2016, the sales volume of octreotide acetate microspheres for injection in the United States was US $853 million According to evaluatepharma, the sales volume of octreotide acetate microspheres for injection will slightly increase in 2017 and 2018, and will slowly decline to US $820 million a few years later At present, there is no competitive product of octreotide acetate microspheres for injection in China The price reduction of octreotide acetate microspheres for injection is 39.89% Obviously, a large price reduction can benefit more patients, and at the same time, it can continue to consolidate the market position of the product in the way of price for quantity Another old product, nilotinib capsule, was launched in China in 2009 As an improved product of imatinib, the leader of Novartis, its approved indication is second-line treatment, i.e adult patients with chronic or accelerated stage of chronic myeloid leukemia (Ph + CML) with fecheng chromosome positive resistance or intolerance to previous treatment (including imatinib) Similarly, nilotinib capsule currently has no similar competitive products in the domestic market, and the price reduction of nilotinib capsule is 68.45% Previously, nilotinib capsule has been included in the catalogue of serious illness medical insurance in Hunan Province and Zhejiang Province, and has been supported by local medical insurance payment In terms of new products, seretinib capsule is the second generation of ALK inhibitor for the treatment of non-small cell lung cancer, which was launched in China in 2018, and pezopanil tablet was also launched in China in 2017 After this round of drug price negotiation, the price reduction was 65.22% This is not the first time Novartis has participated in the drug price negotiation In 2017, Novartis' ophthalmic drug, rezumab, was successfully selected into the second round of drug price negotiation led by the Ministry of human resources and social security, with a reduction rate of 20% But this round of negotiation is not the same In the last round of negotiation, two varieties of leizhumab and conbercept, which have direct competitive relationship, were selected through price reduction, and in terms of price reduction, the latter is even lower than leizhumab, which makes the price difference between domestic drugs and imported drugs rapidly narrow, directly affecting the competition pattern in the market In this round of negotiation, the four products selected by Novartis are all exclusive products in the current market In order to respond to the call of the national anti-cancer drug price reduction, the first part of the negotiation is to cover more markets and further increase the volume of products on the premise of price for volume 2 In the negotiation list of the coming non-small cell lung cancer war, there are 5 products for the treatment of non-small cell lung cancer, namely, clozatinib capsule, oxitinib mesylate, serenetinib capsule, alfatinib maleate and enrotinib hydrochloride capsule, which are also the most selected products in the treatment field In the final negotiation results, all the five products were selected, with the highest price reduction rate of tirissa reaching 70% According to data statistics, the eight major non-small cell lung cancer countries in the world in 2015 are the United States, France, Germany, Italy, Spain, the United Kingdom, Japan and China, accounting for 52.4%, 6.0%, 8.5%, 3.4%, 3.1%, 3.5%, 15.8% and 7.2% of the non-small cell lung cancer market, respectively The US market accounts for half of NSCLC, followed by Japan, Germany and China It is predicted that by 2025, these eight countries will account for 27.1%, 7.8%, 7.6%, 5.4%, 6.3%, 7.5%, 22.4% and 16.0% of the market share, respectively China and Japan will become the main growth points of non-small cell lung cancer market in the future In the Chinese market, according to data statistics, the market scale of small molecule targeted drugs for lung cancer market in China was 3.23 billion yuan in 2015, with a compound growth rate of 22.6% from 2010 to 2015 At present, the three main products, exetane, gefitinib and erlotinib, are suitable for the treatment of locally advanced or metastatic non-small cell lung cancer that has received chemotherapy and is not suitable for chemotherapy Oxytinib mesylate (tiresar) is the first third generation oral targeted drug in the world, which can solve the drug resistance problem caused by T790M mutation At present, there is no similar product in China In 2017, it took only seven months for Teresa to go public in China, from entering the green channel to being officially approved The speed of listing set a new record in China According to the data of 2018 half year report, the sales volume of AstraZeneca in China in the first half of 2018 was US $1.893 billion, up 24% year on year, with strong growth Among them, tumor business increased by 37% year-on-year, and Teresa has made great contributions In 2015, Iressa, the first generation of non-small cell lung cancer product under AstraZeneca, passed the first round of drug price negotiation, with a decrease rate of 55%, and has achieved large market volume It is clear that Teresa is also looking for the same way to expand access to drugs Prior to that, Pascal soriot, Global CEO of AstraZeneca, said in an interview with e-drug managers that before, through negotiations, the price of Eliza had decreased so as to expand the access of drugs, and Teresa also hoped to enter more medical insurance directories through negotiations Since its launch in China in 2005, eresa has been the drug with the highest market share of EGFR-TKI in China According to the data of China Financial Research Report, the sales volume of gefitinib in China in 2015 was 1.243 billion yuan, accounting for 38.5% of China's EGFR-TKI market share However, with the strong involvement of local enterprises and other multinational pharmaceutical companies, it will be increasingly difficult for AstraZeneca to move forward in the domestic non-small cell lung cancer market only by relying on IRESSA Therefore, the approval of Teresa has given AstraZeneca an important weapon in the increasingly fierce competition The successful inclusion in the medical insurance catalogue adds an important weight to its market competition While safeguarding its market share, it continues to attack Beida and Roche Bifetinib maleate (giterry) is considered as a "late good drug", which was launched in China in 2017 after nearly five years in the United States This is the first and only second generation irreversible TKI (tyrosine kinase inhibitor) targeted drug in the world It has been approved to treat EGFR mutation positive NSCLC patients in more than 70 countries, and has become the first choice of EGFR targeted drugs in many countries However, the competition pattern of giterry in the domestic market is not optimistic Similar products have basically entered the national medical insurance catalog, and generic drugs of competing products have begun to appear on the market, which has to face a lot of pressure on the price, and the time point for giterry to appear on the market just missed the national drug price negotiation of that year In addition, the listing of Teresa, which has not been listed for a long time in China, also has a great impact on the former Therefore, the successful selection of giterry is a long-awaited one for bi