Healthcare security authorities will step in earlier to assess pricing policies for novel medical products, in a bid to speed up their entry into clinical use after market approval, according to a document released by the National Healthcare Security Administration on Tuesday.
Normally, pricing procedures for innovative medical technologies and equipment are initiated only after they have received approval from drug regulators, and it usually takes a long time for a product to be added to the insurance charging catalog and reach patients.
Under the pre-pricing pilot program outlined in the document, provincial-level healthcare security authorities will begin pricing guidance and evaluation at an earlier stage before market authorization, such as when a new technology enters clinical research or a new device enters the special review process.
In this way, once these novel products gain market approval, pricing procedures can be completed more quickly.
"We can achieve seamless alignment between market approval and the establishment of pricing guidelines, which will speed up the application of key innovations and enable them to benefit more people," said the administration.
The guideline clarifies that the pilot program applies to three types of high-level innovation: new technologies with significant clinical value and breakthroughs in diagnosis and treatment methods; new equipment that meets major clinical needs, effectively addresses treatment challenges and improves treatment efficiency and precision; and new consumables that fill gaps in diagnosis and treatment and change surgical plans.
One example is the artificial larynx, which aims to restore the voices of patients who have undergone surgery to remove the entire larynx.
The guideline also stresses that pre-pricing work allows no slacking. Provincial-level authorities should strictly vet eligible candidates and establish scientific and fair assessment procedures and standards.
