Background

• The NRDL listing has 4 steps: manufacturer application submission, preliminary review of application, expert assessment, negotiation, and bidding.
• Preliminary review is an evaluation process to determine whether the manufacturer’s applications meet the conditions for NRDL adjustment, negotiation, or re-negotiation.
• New treatments that have gained regulatory National Medical Products Administration (NMPA) approval before June 30, 2022, are eligible for NRDL negotiation.

Key takeaways

• Improved pass rate: the number of applications and the pass rate have increased in 2022 compared with previous years.
• A total of 490 applications were submitted, of which 344 applications passed the preliminary review. The pass rate was 70% compared with 57% in 2021 (271 of 474 drugs passed).
• Of the 344 applications that passed the preliminary review, 199 are currently not on the NRDL, and 145 are already on NRDL and are currently up for re-negotiation. The pass rates were 60% and 91%, respectively.
• Of the 344 applications that passed the preliminary review, 281 are originators (including drugs from both western and Chinese manufacturers) and 63 drugs are generics.
• Re-negotiation for indication expansion: 58 applications that have passed the preliminary review and are also currently in the NRDL have applied for indication expansion.
• Improved review methodology: this year the manufacturers are required to submit information including efficacy, safety, economic value, innovation, and equity. This gives the manufacturers the opportunity to better demonstrate the value of the treatments.

Avalere Health insights

Rare diseases a continuing priority

Based on the drugs that have passed the preliminary review, prioritization of rare disease is still high up on the radar for NRDL in 2022. Nineteen drugs for rare diseases have passed the preliminary review, the highest number since 2020. This follows the positive inclusion decision received by rare disease drugs nusinersen (Biogen’s spinal muscular atrophy therapy) and tafamidis (Pfizer’s heart drug) for coverage in NRDL 2021 last year.

Tumor agnostic indication in focus

Adding to the innovative rare disease focus, tumor-agnostic treatments seem to be getting a fair amount of representation as well this year. Multiple tumor agnostic treatments such as (also targeting MSI-H or dMMR tumors) are all up for negotiation this year, reinforcing China’s recent commitment towards bringing innovative treatments to market.

The broader perspective

Although China’s approach to improved funding of innovative originator products has been largely seen as a step in the right direction, global pharmaceutical companies are wary of the low success rate and the increasing pricing pressures (which is likely to be further compounded by the increase in healthcare expenditure due to the COVID-19 pandemic). A quick look at the NRDL 2022 shortlist of drugs that have passed preliminary review will make it clear that reimbursement of domestic products is still the main focus of the NRDL with the majority of the drugs on the shortlist coming from local manufacturers.

The jury is still out on how big an impact, if any, the ability to demonstrate innovation and economic value will have on reimbursement decisions.

References

• http://www.gov.cn/
• http://www.nhsa.gov.cn/

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