Yang Yue's team at Tsinghua University evaluated the price, efficacy and safety of similar onco-targeted drugs produced and imported

Recently, Yang Yue's research group at the School of Pharmacy of Tsinghua University published a title: The Price, Efficacy, and Safety of Within-Class Targeted Anticancer Medicines between Domestic and Imported Drugs in China: A Comparative Analysis
.
According to data from the World Health Organization (WHO) in 2020, there are nearly 4.
57 million newly diagnosed cancer patients and 3 million deaths in China, and its cancer incidence and mortality rate have ranked first
in the world.
The annual cost of oncology medical treatment exceeds 220 billion yuan, and China's anti-cancer drug expenditure has more than doubled in the past five years, and the affordability of anti-tumor drugs has become a major problem
facing China's public health field.
Since 2015, China has initiated a series of reform measures, including drug review and approval reform and access to the national medical insurance drug list, aiming to improve the affordability of anti-tumor drugs in China and benefit more patients (Figure 1).

According to the annual drug report issued by the Center for Drug Evaluation of the State Medical Products Administration, breakthroughs
have been made in the quantity and variety of anti-tumor targeted drugs developed by local pharmaceutical companies in China.
At the same time, multiple rounds of national drug price negotiations carried out by the National Medical Security Administration have reduced the price of anti-tumor targeted drugs by more than 50% on average, which is of great significance for improving the affordability of
patients.
However, there is very limited
evidence on whether there is a difference in monthly treatment costs between domestic and imported anti-tumor targeted drugs (defined as anti-tumor drugs with the same target for the treatment of the same indication).
More importantly, it is unclear whether domestic similar anti-tumor drugs can provide sufficient efficacy and safety for patients compared with imports
.

Figure 1: China's drug approval and review reform and the development process of national medical insurance negotiation

In order to solve the above problems, Asia has systematically evaluated the price (initial launch and latest monthly treatment cost), efficacy and safety
of similar anti-tumor targeted drugs produced and imported in China.
The study included 12 groups of domestic and imported anti-tumor targeted drugs with the same target and indications approved for marketing from 2010 to 2022 (at least 1 domestic and imported anti-tumor targeted drug in each group).

The results of the study show that the monthly treatment cost of domestic and imported similar anti-tumor targeted drugs has decreased by 71% and 62% respectively since their launch, mainly due to the important role
of national medical insurance drug price negotiation.
Compared with imported anti-tumor targeted drugs, the median monthly treatment cost of domestic similar anti-tumor targeted drugs is significantly lower than that of imported anti-tumor
drugs.
At the same time, there is no significant difference
in efficacy and safety between domestic and imported similar anti-tumor targeted drugs.
These evidences support that in recent years, the reform of drug approval and review (the listing of domestic similar anti-tumor targeted drugs) and national medical insurance negotiations have played an irreplaceable role in improving the affordability of cancer patients in China, and at the same time provide Chinese solutions
to solve the problem of drug affordability of cancer patients worldwide.
This study also provides strong evidence
for more domestic similar anti-tumor targeted drugs to go global.

1) Domestic anti-tumor targeted drugs have a price advantage over imported similar drugs

Compared with the monthly treatment cost at the time of initial launch, the monthly treatment cost of the latest (2022) domestic and imported anti-tumor targeted drugs showed a significant price reduction trend (Figure 2).

The median monthly cost of treatment for domestically produced and imported drugs decreased by 71% (P<0.
001) and 62% (P<0.
001),
respectively.
In addition, the median monthly treatment cost of domestic anti-tumor targeted drugs (3786$ vs.
5393$, P=0.
007) and the latest (1222$ vs.
2077$, P=0.
01) were significantly lower than those of similar imported antitumor drugs (Figure 3).

。 Taking PD1/PDL1-targeted drugs for the treatment of non-small cell lung cancer as an example, the median monthly treatment cost of domestic PD1/PD-L1-targeted drugs is only 878$, which is far lower than imported similar anti-tumor targeted drugs (7667$), which also makes Chinese patients expect to enjoy the world's lowest PD1/PDL1-targeted drug treatment price
.
Figure 2: Comparison of imported and domestic similar anti-tumor targeted drugs in the initial launch and the latest (2022) monthly treatment cost changes

Figure 3: Comparing the difference between imported and domestic similar anti-tumor targeted drugs in the initial launch and the latest (2022) monthly treatment costs

2) There is no significant difference in the effectiveness of domestic and imported similar anti-tumor targeted drugs

After proving that domestic anti-tumor targeted drugs have more price advantages than imported similar drugs, the research group evaluated the main effectiveness indicators of domestic and imported anti-tumor targeted drugs, including overall survival (OS), progression-free survival (PFS) and objective response rate (ORR).

。 The results showed that there was no significant difference in OS indexes between domestic and imported anti-tumor targeted drugs (HR: 0.
71 vs.
0.
66, P=0.
38) (Figure 4).
There was no significant difference in PFS (HR: 0.
51 vs.
0.
48, P=0.
60) (Figure 5); There was also no significant difference in median ORR (ORR: 37% vs.
48%; P=0.
51) (Figure 5).

Figure 4: Differences in overall survival (OS) between domestic and imported similar anti-tumor targeted drugs Figure 5: Differences in progression-free survival (PFS) between domestic and imported similar anti-tumor targeted drugs Figure 6: Differences in objective response rate (ORR) between domestic and imported similar anti-tumor targeted drugs 3) There is no significant difference in the safety of domestic and imported anti-tumor targeted drugs After proving that there is no significant difference in the effectiveness of domestic anti-tumor targeted drugs and imported similar drugs, The research group further evaluated the safety indicators of domestic and imported anti-tumor targeted drugs, including the incidence of serious adverse reactions (SAEs) and the incidence
of GRADE ≥≥3 AEs.
The results showed that there was no significant difference between domestic and imported anti-tumor targeted drugs in the incidence of SAE (RR: 1.
40 vs 1.
18, P=0.
23) (Figure 7) and GRADE≥3 adverse events (RR: 1.
57 vs 1.
61, P=0.
92) (Fig.
8).

Figure 7: Differences in serious adverse reactions (SAEs) between domestic and imported similar anti-tumor targeted drugs

Figure 8: Differences in GRADE≥3 adverse reactions of similar domestic and imported anti-tumor targeted drugs

In summary, China's domestic similar anti-tumor targeted drugs are not only significantly better than imports in terms of price, but also reach a considerable level
in terms of efficacy and safety.
The research supports that China should further encourage the research and development of innovative drugs, include more anti-tumor targeted drugs in the negotiation of the national medical insurance catalog, and make tumor targeted drugs benefit more patients in China and around the world
.