Program pilots pre-pricing for medical tech

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 recently released National Healthcare Security Administration document.

Normally, pricing procedures for innovative medical technologies and equipment take place only after drug regulators approve a product, and it often takes time for a product to be added to the insurance charging catalog and reach patients.

Under the nationwide 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 catalogs, which will speed up the application of key innovations and enable them to benefit more people," the administration said.

The document clarifies that the pilot program applies to three types of high-level innovation.

They encompass high-value technologies that drive breakthroughs in diagnosis and therapy, advanced equipment that meets critical needs while enhancing precision and efficiency, and innovative medical consumables that bridge care gaps and transform surgical protocols.

One example is the artificial larynx device, which is designed to restoring the voices of patients who have undergone surgery to remove the entire larynx.

According to the document, pre-pricing applications should be submitted by tertiary hospitals — those at the top of the nation's three-tier system that undertake a large number of highly innovative medical research — to provincial-level healthcare security authorities.

When a new product eventually obtains market authorization, provincial authorities can officially add a new pricing item through an accelerated green channel, add new items with conditions or merge them with existing pricing items. If the novel product fails to obtain approval, pre-pricing procedures will be terminated.

The guideline also stresses that pre-pricing work permits no shortcuts. Provincial-level authorities are to strictly evaluate eligible candidates and establish scientific and fair assessment procedures and standards.

So far, the administration has formulated 40 batches of unified pricing catalogs, covering more than 200 medical service items including emerging technologies such as proton radiotherapy, surgical robots, remote surgery and brain-computer interface implantation.

While most existing technologies and products have corresponding charging guidelines, the pilot program aims to establish pricing rules for those that are still in the pipeline.

Pan Xiangbin, vice-president of Fuwai Hospital under the Chinese Academy of Medical Sciences, said it often takes a lengthy process for new technologies or products to go from initiation to final approval.

"The pre-pricing initiative can help reduce duplicate applications, duplicate certifications and regional differences that tend to drag out the process, and enhance hospitals' enthusiasm for applying, making them more willing to adopt new technologies," said Pan during a seminar held by the administration recently.