By Fineline Cube The National Healthcare Security Administration (NHSA) has formulated and released draft proposals for rules covering the National Reimbursement Drug List (NRDL) annual renewal and adjustment process. These proposals include several documents that address various aspects of NRDL updates, including new rules for renewing contracts for drugs already included in the NRDL through price negotiations. The documents are open to public feedback until June 19, 2022.
Key Changes to the Work Plan The 2022 NRDL adjustment work plan introduces several significant changes compared to the previous year’s approach:
- Adjustment Scope: The 2022 proposal includes drugs with new generic names approved for marketing from January 1, 2017, to June 30, 2022, and drugs approved for major new indications or functional changes during the same period. This represents an expansion from the 2021 scope, which covered drugs approved from January 1, 2016, to June 30, 2021.
- Non-NRDL Drugs: The 2022 proposal specifies four categories of non-NRDL drugs that may be considered for inclusion, compared to three categories in 2021.
- Drug Removal Criteria: The 2022 proposal outlines specific circumstances under which drugs may be removed from the NRDL, including situations where the drug’s risk is considered greater than its benefit, the drug has been removed from the national drug procurement platform, or the drug’s price is significantly higher than comparable alternatives.
- Work Procedures: The 2022 timeline for the adjustment process is May-August 2022 for preparation, filing, expert review, negotiation, and public results, compared to June-November 2021 in the previous year’s plan.
Public Feedback Period The NHSA has invited public feedback on the draft proposals until June 19, 2022. Stakeholders, including pharmaceutical companies, healthcare providers, and patient advocacy groups, are encouraged to submit their comments and suggestions during this period.
Fineline Info & Tech Analysis Fineline Info & Tech will produce a comprehensive report on the proposed changes to the NRDL adjustment process in the near term. This report will provide detailed analysis of the implications for pharmaceutical companies, healthcare providers, and patients.-Fineline Info & Tech