Hainan provincial bureaus, including the Healthcare Security Administration (HSA), Healthcare Commission, and Medical Products Administration, along with five other bureaus, have jointly issued a set of Measures to “Support the Development of Innovative Drugs and Medical Devices in Hainan Province.” The initiative aims to ensure seamless integration between the market approval of innovative drugs and devices and medical security/insurance systems. The document outlines requirements for innovative payments, real-world data utilization, clinical management of innovative drugs and devices, digital medicines, and hospital access processes.
The Measures call for the establishment of a pricing mechanism for newly approved innovative drugs and devices, with an emphasis on independent enterprise pricing, reasonable price setting, and enhanced price management and supervision. Medical institutions are encouraged to negotiate prices independently with pharmaceutical and equipment enterprises on the procurement platform, excluding drugs involved in national negotiations and volume-based procurement (VBP). The Measures also propose the expansion of medical insurance payment channels, inclusion of innovative drugs in “dual channel” management, and the promotion of electronic prescription circulation platforms.
Real-world data is encouraged as a reference for purchasing medical insurance value, with the aim of establishing a policy system and technical standards for its application in medical insurance. The use of real-world data in value evaluation of innovative drugs and devices is proposed, exploring its potential as a reference for reimbursement drug list adjustments and national drug evaluations.
Clinical management of innovative drugs and devices is to be optimized, with direct online procurement for those meeting conditions and priority support for innovative applications through compatibility with existing price items. The development of digital medicine is supported to leverage its role in medical cost control and accelerate health management application. The integration of “Internet plus” medical service prices into the current medical service price policy system is also promoted.
Hospital access procedures are to be reformed, with innovative drugs and devices not subject to assessment restrictions and an urging for medical institutions to streamline access procedures. Online applications for eligible innovative drugs and devices are to be completed within five working days, with a green channel for major innovative projects. An early intervention mechanism for key products, including innovative drugs and medical devices, is to be established, along with platforms for the development of innovative drug and device enterprises, commercial insurance companies, and medical institutions.- Flcube.com
