2021-11-23-世界卫生组织-ATC_50th_Executive_Summary_5页_276kb

50th WHO Drug Statistics Methodology Working Group Meeting Summary

Geneva, October 14-15, 2021 (Virtual)

Executive Summary

• Opening & Agenda: The meeting was presided over by Dr. Vera Vlahović-Palčevski and introduced plans for public pre-meeting consultations on ATC/DDD matters. Dr. Kerry Atkins is the rapporteur.
• ATC Classification Updates: 63 new temporary ATC codes were established.
  • Sparsentan: Recommended classification under V03AX (Other therapeutic products) for treating focal segmental glomerulosclerosis and Immunoglobulin A nephropathy. Aligned future classifications with pipeline substances; recommended postponing reconsideration pending market authorization approval.
  • Irinotecan Sucrofate/Liposomal Irinotecan: Recommended maintaining liposomal irinotecan under code L01CE02, reasoning formulations with identical active ingredients should share codes.
  • Vitamin B12 Preparations: Proposed reclassification for B12 combinations with ≥0.5 mg content into B03BA51 (cyanocobalamin, combinations). Suggested a guideline comment directing symptomatic treatment preparations here.
  • Nivolumab & Relatlimab: Recommended classifying the fixed combination under a new L01XY08 code within broader antineoplastic combinations.
  • Difelikefalin: Recommended maintaining the previous classification in V03AX (Other therapeutic products), advising guideline cross-references with D04AX.
  • Gefapixant: Recommended keeping it in R05DB (Other cough suppressants) despite reclassification options, due to its role as a cough suppressant; confirmed new codes for irinotecan related substances.
  • Monoclonal Antibodies (L01XC/L01F): Decision to create a 4th level classification under L01XC(new) for monoclonal antibodies was aligned with the upcoming 2022 ATC/DDD index. Other pipeline needs were deferred.
• COVID-19 Vaccines: Proposed decomposing J07BX levels for various COVID-19 vaccines. Recommended restructuring to include specific ATC levels based on technology platforms and indications (J07BN).
• Iron Preparations (B03AC/B03AD): Discussed re-integrating separate 5th-level codes for parenteral iron, but agreed current grouping (mixed old/new) is less confusing; confirmed alignment of B03AD details with specific combination partners.
• Defined Daily Doses (DDD): The Meeting accepted 15 new temporary DDD recommendations. Public objections deadline was January 2022.

Key takeaways: Focus on maintaining classification consistency based on active ingredients/formulations; careful handling of new compounds (Sparsentan); separate grouping of parenteral magnesium solutions; planned revision of COVID-19 vaccine ATC classification; ongoing assessment of complex therapeutic classes like monoclonal antibodies.