The National Healthcare Security Administration (NHSA) has released the updated rules that will govern this year’s National Reimbursement Drug List (NRDL) update. The revisions focus on “Negotiation Drug Renewals” and “Non-exclusive Drug Bidding,” with significant changes to the negotiation drug renewals process, indicating reduced pressure on innovative drugs undergoing renewals.
Agreement Renewal: Regular List and Simplified Renewal
Scope and Payment Standards:
The NHSA’s updated rules outline the scope for regular list agreement renewals, which includes non-exclusive drugs approved by the NMPA by June 30, 2023, exclusive drugs from the 2019 catalog, and negotiated drugs in the catalog for over eight years. Payment standards vary from government pricing for certain drugs to volume-based procurement (VBP) policies for others. Provincial healthcare security departments are encouraged to establish their own payment standards based on generic drug prices.
Procedure:
Expert discussions will determine whether drugs should be included in the regular list management during the review process.
Simplified Renewal Conditions:
Drugs with agreements expiring on December 31, 2023, may qualify for a simplified renewal with a two-year validity period, provided they meet specific conditions related to exclusivity, budget expenditure, and market environment stability.
Rule for Payment Standards:
Payment standards for drugs not adjusting payment standards will be based on the ratio of actual fund expenditure to fund expenditure budget. For drugs requiring payment standard adjustments, the ratio will be determined within the next two years based on the increase in fund expenditure budget due to payment scope adjustments.
Negotiated Drugs and Payment Deduction Ratios:
For negotiated drugs unchanged for ≤ 4 years, pricing changes will follow a specified table. For those continuously included as negotiated drugs for over 4 years, payment deduction ratios will be halved. Category 1 drugs may apply for a reduction through renegotiation if certain conditions are met.
Renegotiation and Price Bidding:
Exclusive drugs and those not meeting simplified renewal criteria may be subject to renegotiation. Non-exclusive drugs recommended for inclusion after expert evaluation will undergo price bidding, with the enterprise’s quote compared against the medical insurance’s willingness to pay. Successful bids will be included in the reimbursement drug list, with the lowest quotes determining payment standards.
Payment Standards and Supply:
Drugs included through bidding will have their enterprise quotes as payment standards, unless lower than 70% of the medical insurance’s willingness to pay. Participating enterprises must commit to supply the drugs at the quoted price during the bidding validity period and report any significant supply changes to the NHSA within one month.-Fineline Info & Tech
