Sino-US cancer treatment and medication expenditure doubled double the development rate of new drugs, only 8%

Medical Network June 4th In the five years, the cost of cancer treatment and drugs doubled in China and the United States, ushered in a Great Leap Forward. At the same time, the number of new cancer drugs launched in 2018 has reached a record number of 15, and the global cancer market is developing rapidly. In China, through medical insurance negotiations, many cancer drugs have been included in medical insurance, and a number of innovative drugs have been accelerated. When a new round of medical insurance negotiations is about to usher, many pharmaceutical companies are calling for innovative drugs to enter medical insurance, but in quantity and price. In the game, some experts called for a rational view.

In 2018, the number of new cancer drugs launched worldwide reached a record 15, the global cancer treatment expenditure increased by 12.9%, and the world of oncology drugs ushered in two double-digit growth in 2018.

The above data is disclosed in the "Global Tumor Trend Report 2019" published by IQVIA recently.

1. Leaders in spending and growth: China

The above report pointed out that spending on cancer treatment reached nearly 150 billion US dollars in 2018, an increase of 12.9% over the same period of last year, achieving double-digit growth for five consecutive years.

China is leading the way in spending and growth, and it has grown 24% in 2018 to reach $9 billion in total spending, even though China's supportive care has fallen by 10%. IQVIA expects that the growth rate of treatment spending will reach 11%-14% in the next five years, and the compound annual growth rate will bring the total market to $20-23 billion.

In the past five years, China’s cancer spending has more than doubled, mainly due to increased use of existing branded drugs, while new drugs have contributed less. In terms of per capita spending, China’s per capita spending is only $4.5 per person, compared to $173 per person in the United States.

Globally, the expenditure on anticancer drugs is highly concentrated. The top 38 drugs account for 80% of the total expenditure, and more than half of the anticancer drugs actually have annual sales of less than $143.6 million.

In terms of drug count and indications, 57 new cancer treatments have been approved for a total of 89 indications over the past five years, some of which treat multiple tumor types.

In the past five years, almost one-third of the approved indications were cancers of the blood system, with 28 indications for approval, and the highest number of lung cancers in solid tumors, reaching 12, followed by breast cancer and melanoma, 7 and 6 respectively. Indications, while other solid tumors are mostly 1-3 indications.

In addition, the global market launched a record number of new oncology drugs in 2018, bringing new treatment options to patients and continuing to change the treatment modalities that were introduced less than five years ago. In 2018, larotrectinib was approved for the treatment of solid tumor patients with NTRK gene fusion, which was the first targeted therapy for “unlimited cancer” when approved.

2 , oncology research and development pipelines grow steadily

Due to the increasing number of targeted therapies in the tumor pipeline, the number of drug pipelines in the late stage of research and development increased from 711 in 2017 to 849 in 2018, an increase of 19%, compared with 77% in 2008. . In the late 2018 development pipeline, 91% of the therapies were targeted to small molecules or biologic therapies. Targeted biologics increased by 30% compared to 2017, while targeted small molecule therapy increased by 14%.

In the late oncology research and development, the emerging bio-pharmaceutical company and it became the sole protagonist. At present, there are more than 700 companies in the world engaged in post-oncology research and development, including 29 academic research institutions, 626 emerging biopharmaceutical companies, 28 large pharmaceutical companies with global sales of over $5 billion and 28 medium-sized companies.

At present, there are about 450 cancer immunotherapy in different stages of clinical development, and these therapies have more than 60 mechanisms of action. The in-situ treatment in phase 3 contains nine mechanisms of action, while the in-situ treatment in the early development pipeline contains 62 different mechanisms of action.

Cancer immunotherapy in the 2018 R&D pipeline treats a total of 43 cancer types, of which the treatment of 25 major cancer types includes 52 different mechanisms of action. The PD-1/PD-L1 inhibitor type is used to treat 14 different cancer types, including blood cancer and solid tumors. Nearly half of the top 25 cancer types are blood cancers, and the ongoing treatment for acute myeloid leukemia (AML) contains 12 different types of next-generation mechanisms of action, such as INDO inhibitors, OX40 receptor agonists, and CD33 regulation. Agent.

As new approaches to treatment receive more and more attention and investment, nearly 100 next-generation biotherapies including gene therapy, cell therapy and nucleotide therapy will be available in the late 2018 development pipeline, with 2013 Compared with nearly doubled, it has also increased by 32% compared to 2017.

The report believes that PD-1 / PD-L1 checkpoint inhibitors remain the most successful immunotherapy for cancer, and that formulations (such as oral) or immunotherapy combinations and targeted therapies (such as TKIs) and next-generation biotherapeutics may be improved. Will promote the breakthrough of cancer treatment.

3 , the success rate of new drugs decreased

The number of oncology clinical trials initiated in 2018 reached 1,170, an increase of 27% compared to 2017. The number of Phase 1 clinical trials has increased significantly over the past three years, with a 46% increase compared to 2015. The number of Phase 2 and Phase 3 clinical trials has steadily increased since 2013. Compared with 2013, the number of Phase 2 clinical trials has increased by 100%, and Phase 3 clinical trials have reached 83%.

However, it is worth noting that the success rate of new oncology development is still limited. Although there are 15 oncology NASs listed in 2018, the success rate of new drug development is reduced due to the decline in the success rate of Phase 1 clinical trials and Phase 3 clinical trials. Only 8%, down from 2017.

Developing innovative new anticancer drugs is still a slow process. The new drug in 2018 was approved from the initial patent application to the new drug, and the research and development process took an average of 10.5 years. This number has been reduced by four years compared to 2017 and has been reduced by one year compared to the average from 2007 to the present. At all stages of the trial, the average duration of the 2018 oncology trial was 3.2 years, compared with 1.8 years for all other treatment areas, a difference of more than 40%.

Oncology therapy benefits from the special qualifications provided by regulatory agencies. For example, an effective drug that is approved for breakthrough therapy can be approved after completing Phase 1 or Phase 2 clinical trials. In 2018, the development time for drugs approved for breakthrough therapy was 10.1 years.

In terms of access to anti-cancer therapies, IQVIA's research found that only patients from nine countries including the United States, Germany, Britain, France, Italy, and Canada are able to obtain recently listed global anticancer drugs.

4 , into the medical insurance may be a double-edged sword

The report shows that the average annual expenditure of new drugs continues to rise. In 2018, the expenditure of each drug is between US$90,000 and US$300,000, and the average new drug expenditure is US$176,000, which is lower than the US$209,000 in 2017. However, it is higher than the average expenditure of $143,000 in 2012-2018.

US cancer drug spending has doubled since 2013, spending more than $56 billion in 2018, with $9 billion in growth coming from PD-1/PD-L1 inhibitors. In the past five years, China’s cancer treatment spending has also doubled. However, this large amount of expenditure and corporate advocacy for innovative medicines have caused concern.

"Excessive advocacy of oncology drugs is not good for pharmaceutical companies." At a medical policy seminar held in Beijing in April, an expert from the Development Research Center of the State Council warned the representatives of pharmaceutical companies present.

The expert believes that after too many high-priced oncology drugs enter the medical insurance, the pharmaceutical companies may face a stronger price reduction. If the medical insurance eventually moves toward drugs and the proportion of reimbursement declines, "(the parties) may not achieve anything."

According to the E-drug manager, the current domestic innovative drugs are positive for the inclusion of medical insurance. Many of the PD-1s that have been listed are striving to enter the medical insurance catalogue. Even some insiders have stated that the domestic PD-1 will be able to borrow 2019. The year's medical insurance negotiations entered the catalogue. Some foreign companies also indicated that more than five products will be considered for medical insurance or ready to participate in the negotiations this year.

This kind of positive attitude is more obvious in local medical insurance. At the end of 2018, Merck's Investor PD-1 monoclonal antibody can be incorporated into the Shenzhen great sickness supplement health insurance directory. And just last month, the king is Biological Terry Plymouth monoclonal antibody (melanoma indications) and Merck may Investor (non-small cell lung cancer indications) be included in Zhuhai city supplementary medical insurance at their own expense malignant tumor drug project Drug List ( The third batch), eligible insured persons can enjoy the treatment of malignant tumors at their own expense.

Last year, 17 anti-cancer drugs were negotiated for medical insurance, and 10 of them were listed after 2017.

However, some commentators believe that the pharmaceutical companies involved in the negotiations seem to have unspeakable “grievances”. The 17 kinds of new anti-cancer drugs newly included in medical insurance have reached the lowest decline rate of 31%, the largest drop of 80%, although representatives of pharmaceutical companies in the negotiations have expressed that "to maximize the social benefits of the negotiations, so that the majority of the insured are actually Enjoy the dividend of health care reform." However, whether the "price-for-value" will certainly lead to the increase in sales, for some drugs that are relatively short in the Chinese market, and still in the patent period, pharmaceutical companies still face different possibilities. The pressure of pharmaceutical companies is reflected in the game of R&D investment costs and “returning to the present”. In addition, the willingness to pay for medical insurance has already appeared on generic drugs, and if pharmaceutical companies excessively call for high-priced innovative drugs to be included in medical insurance, whether innovative drugs are also Will face the pressure of control fees, causing conjecture.