The Medical Products Administration and Health Commission of Guangdong province have released the sixth batch of urgently needed imported drugs and medical devices for clinical use in the Guangdong-Hong Kong-Macao Greater Bay Area. This latest list includes two new drugs and ten medical devices, while also adding indications to one drug and removing three drugs and one device that have since received approvals from the National Medical Products Administration (NMPA).
The newly included drugs are ethyl eicosapentaenoate and varenicline tartrate. The three drugs removed from the list are entrectinib, polatuzumab vedotin, and erenumab, all of which have received NMPA approval in the past year. Additionally, brolucizumab has been granted a new indication for treating visual impairment caused by diabetic macular edema (DME).
In conjunction with this release, Guangdong’s healthcare security bureau announced a new pricing notification for medical services related to the listed products, adopting a “filing management” approach. Designated medical institutions, excluding non-profit entities, can utilize the listed medical devices to provide services, with pricing to be filed and managed at the provincial level. These prices must be independently determined by institutions based on established practices from overseas.
The registered service price items are exclusive to designated institutions and are not included in Guangdong’s basic medical service pricing list. Both medical institutions and patients will be responsible for self-payment. If there is a desire to expand the application of any registered project to non-designated institutions, the corresponding device must first secure market approval from the NMPA.
Designated institutions are encouraged to procure drugs and medical consumables from the list through procurement platforms, leveraging group purchasing power and volume-based procurement strategies. A market-oriented pricing mechanism will be implemented, with designated institutions responsible for applying initial online listing prices and managing product information. Institutions must also register and manage service items and report service volumes to local medical insurance bureaus biannually. This notice takes effect on March 1, 2024, and remains valid for five years.- Flcube.com
