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Prices of imported drugs are falling, leaving local innovators in an awkward position
Recently, a paper titled "why is it that a major innovative drug that makes imported drugs significantly cheaper still cannot be included in medical insurance after 9 years on the market?" The report caused a strong reaction in the industry.
With the reform of new drug approval and the promotion of generic drug consistency evaluation, Chinese pharmaceutical enterprises are more and more enthusiastic about innovative drug research and development. However, as the local research and development of innovative drugs, its market performance is a few happy few sorrow. China's first class 1.1 fluoroquinolones antibacterial drugs with independent intellectual property rights, which have been on the market for 9 years, have not been included in the national list of medical insurance and the list of basic medicines of public medical institutions in most places. As a class of new drugs, China's first small-molecule anticancer targeted drug "ectinib", which has completely independent intellectual property rights, has entered the 2017 national directory of medical insurance, but is limited by the bidding and procurement cycle and requirements of some provinces, making it difficult to enter the procurement catalogue of many hospitals. But in the market, some domestic innovative drugs have achieved double-digit or even five-digit growth through the inclusion of medical insurance.
It is not surprising that there are such bipolar phenomena. From the experience of mature pharmaceutical markets in Europe and the United States, there are not only super blockbuster drugs that sell for more than 10 billion dollars in one year after being released, but also innovative new compounds that disappear after a few years on the market.
It is up to the market to decide whether innovation can be turned into commercial value. What's more, doctors' clinical needs also determine whether new drugs will stay or not. The health insurance department will also evaluate the inclusion of an innovative drug based on HTA research and medical insurance affordability.
Therefore, for local innovative drug companies, listing does not mean success, and failure to realize market value is common. As a new round of health care negotiations approaches, let's take this opportunity to review what happened to the indigenous innovative drugs that entered the health care inventory through health care negotiations.
Prices of imported drugs are falling, leaving local innovators in an awkward position
Domestic innovative drugs are compared with imported innovative drugs. In March 2016, the state food and drug administration formulated the reform plan for the registration and classification of chemical drugs, which included category 1 (domestic and overseas unlisted innovative drugs). A drug that contains a new compound with definite structure and pharmacological action and is of clinical value. However, most of the domestic innovative drugs on the market before this time are not absolutely original new drugs, which are still developed by Me too or Me better to some extent, or more appropriately, "combination of innovation and imitation".
That is to say, the patent is obtained by modifying the structure of compounds with active target. Most of the time, the biggest advantage is the price of indigenous innovation medicine enterprises in China, the development way of thinking of the walking can make up for the medicine enterprises in our country to the greatest extent on the research and development capabilities, so as to decrease the risk of failure of the research, also avoided because completely innovative drug has certain uncertainty and cannot bring to determine the risk of return.
Although the commercial success of a new drug is caused by internal and external factors, access to health insurance and the exchange of price for volume after access to health insurance is one of the important reasons for its success. Since the implementation of national health insurance negotiations, when the gap between local innovative drugs and imported innovative drugs is narrowed due to reimbursement, it is the key to test whether local innovative drugs can be widely accepted by doctors and patients. After the negotiation, the imported innovative drugs will be significantly reduced, and the price advantage of domestic innovative drugs will be significantly reduced.
The most obvious example of this is bayda's chemena and astrazeneca's iressa. After the two are included in the medical insurance reimbursement, the cost of patients using imported drugs is not too much higher than that of domestic drugs. Patients use imported drugs at their own expense of 10,000 yuan per year, and use domestic drugs at their own expense of about 6,000 yuan per year. The price advantage is not as obvious as that of pure self-payment.
In July 2018, bayda pharmaceutical further lowered the network price of 21 boxes of kemena, from 1399 yuan per box to 1345.05 yuan per box. Policy support, hospital access, market environment and other reasons have created the embarrassing situation of local innovative drugs.
Me too has no advantage
We take two domestic innovative drugs with high sales volume as examples. Microchip biological's eposamine and hengrui's atan (apatinib) are not "global new" or absolutely original in their disease fields, but they are typical examples of Me better.
Epsa is the world's first subtype selective histone deacetylase inhibitor, and because of this, epsa has a very unique anti-tumor mechanism, such as activating the immune function of anti-tumor cells in patients. Only three companies in the world make similar drugs, two of them in the us, which cost rmb280,000 and rmb140,000 a month to treat. By comparison, epsa costs more than 20,000 yuan a month. The drug is administered orally, rather than intravenously, which is used abroad.
Etam developed by hengrui is the world's first small-molecule targeted drug for the treatment of gastric cancer, and the world's first oral anti-angiogenesis drug for advanced gastric cancer, and also the only standard drug for third-line advanced gastric cancer. Its oral drug reflects the advantages of drug delivery mode. Some studies have pointed out that from the perspective of healthcare payers, etan has a higher economic advantage than other competitive products.
Some experts believe that with the acceleration of new drug approval, the life cycle of many innovative drugs, new special drugs and targeted drugs will become shorter and the competition will become more fierce. The first generation of products may not have been admitted to hospital for three or four years, the second generation will be on the market, and the third generation is approaching the successful development. Patients and health care workers are becoming more selective, and the field of innovative medicine where the best drugs are available is likely to be less likely to require the second-best drugs.
From the perspective of enterprises, due to numerous barriers to enter the medical market, innovative drugs developed by r&d enterprises with great pains may be difficult to meet clinical needs in time, and even new drugs quickly become old drugs. At the same time, the difficulty of market access also seriously hinders the innovation enthusiasm of r&d enterprises. The patent protection period of innovative drugs is only 20 years, but the r&d and approval process takes 12-15 years. In addition, the market access takes a long time, and the patent protection will soon expire when enterprises make profits. All these situations seriously restrict the ability and enthusiasm of enterprises to continue innovation. After the research and development of products and the launch of products, pharmaceutical companies should fully consider how to make doctors accept an innovative drug, which is a new issue for local pharmaceutical companies engaged in the sales of generic drugs for a long time.
Marketing also needs innovation
In the pharmaceutical industry, most pharmaceutical companies, even multinational giants, have only a few new drugs become blockbuster, recycling research and development investment and making profits. For local pharmaceutical companies, if they want to achieve the excellent listing of innovative drugs after entering into innovative drugs, it is likely to be difficult for them to adopt the agent method to promote innovative drugs, following the experience of selling generic drugs. No matter from actual combat or theory, agents are mainly driven by interests. They pay more attention to the price difference and promotion difficulty, and consider local gains and losses. All agents will foindicate failure in the promotion of innovative drugs.
In the limited life cycle, "good product does not mean can sell well" has become a major problem faced by many local pharmaceutical companies. Access and academic research are the most important cores in the marketing of innovative drugs. Innovative drug enterprises must find a new way to occupy the academic highland from the perspective of academic promotion and academic exposure. But at the same time, there is also a challenge in front of drug innovation: innovation medicine promoted the initial cost will be very high, and the innovation medicine sales climbing may not so fast, so drug firms in this process is bound to experience a long time, the losses of enterprises must be prepared to build its own sales team, promotion and the losses of a long-term strategic layout.