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First, the difficulty of access to high-value innovative drugs continues To increase the value of innovative drugs usually refers to innovative drugs with high innovative value, can significantly extend survival time or improve the quality of life, but the treatment costs are high.
The population targeted by such drugs tends to have a large base and suffer from malignant tumors, autoimmune deficiencies and other serious diseases, with "heavy disease, good efficacy, high cost, large population" four characteristics.
in China, high-value innovative drug medical insurance access is facing the problem of sustainable development.
1. The urgent need for access Is very urgent for patients to incorporate high-value innovative drugs into basic medical insurance.
patients suffering from malignant tumors, autoimmune diseases and other serious diseases due to the lack of effective treatment methods, short life span, poor quality of life, and high-value innovative drugs can significantly improve the quality of life of patients, extend the life of patients.
take advanced non-small cell lung cancer as an example, the five-year survival rate of patients is less than 5%, while the first-line treatment of Paboliju monotherapy can improve the five-year survival rate to 23.2%.
but high-value innovative drugs are often expensive to treat each year and are unaffordable for patients themselves.
Taking autoimmune disease treatment drugs as an example, according to the author, the eight immunologic preparations negotiated in 2020 (injection with Bellevu monoanti, sinimod tablets, hydrochloric acid fingomod capsules, injection with Vidley pearl monoanti, Ben Vimod The average annual treatment cost before admission is 106,000 yuan, which is 3.4 times the per capita disposable income (30733 yuan) in China in 2019.
2. The difficulty of access increases As the health care negotiations continue to advance, the difficulty of access to high-value innovative drugs negotiations continues to increase, showing the overall trend of "continuous decline in success rate" and "continuous decline".
is that the success rate of negotiations is getting lower and lower.
according to official statistics, the overall success rate of negotiations on pharmaceuticals has fallen from 82% in 2017 to 73.46% in 2020, compared with less than 50% for only three of the seven PD-1/PD-L1 monodes shortlisted for negotiations in 2020.
is a further increase in the decline in negotiations.
according to the author's statistics, the decline in negotiations on two types of high-value innovative drugs, anti-tumor drugs and immunologic agents, increased year by year from 46.76 percent and 30.59 percent in 2017 to 63.88 percent and 50.25 percent in 2019, respectively.
reason analysis High-value innovative drug access is difficult, first of all because of its high cost, large population base, the basic health insurance fund structure has a major impact.
to the treatment of non-small cell lung cancer, for example, before the 2018 health care negotiations, the drug sales in the first three quarters of the year has reached 1.85 billion yuan, the impact on health insurance funds.
More importantly, such products usually have a greater risk of expenditure, that is, high-value innovative drugs into the health insurance after the demand-inducing effect (demand-inducing effect refers to the high-value innovative drugs into the health insurance, due to medical insurance reimbursement and price decline, further stimulate the demand for treatment, induce clinicians and patients to choose to use, resulting in the expansion of the treatment population.)
), resulting in a significant increase in the number of treatments and a rapid increase in sales, and an increase in fund spending that is likely to exceed the expectations of health-care regulators.
For example, the sales of the eight anti-tumor drugs negotiated successfully in 2019 increased by an average of 209% compared to the second quarters of 2019 (data source milnet key city public hospitals chemicals - Chinese medicine terminal competition pattern).
8 anti-tumor drugs are: hydrochloric acid alethini capsules, pyrithione capsules, injectable retiquine, olapali tablets, Malay acid pyrithione tablets, patoju monoanti-injections, cyndili monoanti injections and reedcotini tablets.
)。
Thever, in the absence of effective means of controlling the risk of the fund, the most concise way to reduce risk is to negotiate a reduction, as far as possible to reduce the unit price, to achieve the goal of controlling the risk of the fund.
short-term effects, negotiating a sharp price cut not only effectively controls fund spending, but also increases the affordability of innovative drugs, providing good news for patients at large.
But from the perspective of long-term sustainable development, low prices make it difficult for enterprises to recover high research and development costs in the short term, and are not conducive to enterprises to maintain global market pricing strategies, thereby affecting the sustainability of innovation, resulting in the slow listing of high-value innovative drugs in China, and ultimately affecting the access of patients.
To PD-1 single resistance as an example, from the global price level, PD-1 single anti-health insurance pricing is higher, Navuliyu single resistance and Pabli pearl single resistance in the United Kingdom, Germany, Canada, Japan, South Korea five countries annual treatment costs of about 650,000 yuan (price data sources in the United Kingdom, Germany, Canada, Japan and South Korea official website, and consider the exchange rate, tax rate factors into Chinese prices).
), while China's health care pricing is much lower than the international level, in 2019 the negotiation access to the letter Dili single anti-annual treatment costs 986,000 yuan, in 2020 negotiated access to the Karelli pearl monoanti, for the reilly pearl single anti-terracytic treatment costs are lower.