The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.
In 2023, Japan has faced mounting criticism from the pharma industry for its annual price reductions. Ahead of the G7 summit hosted in Japan in May 2023, a delegation of 24 CEOs from the Biopharmaceutical CEO Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. Meanwhile, in 2023, China agreed to add 126 drugs to its National Reimbursement Drug List, in a negotiation process that has become more transparent and predictable than ever before. South Korea faces drug pricing reform, while Australia’s government has started an overhaul of its health technology assessment process.
Chinese patients will soon have wider access to newly approved cancer drugs following the publication of the 2024 National Reimbursement Drug List (NRDL) that added 126 new drugs to the list. Price cuts to drugs averaged 61.7%. The additions and cuts are in line with the previous year.
Artificial intelligence (AI) has been approved for use in the U.K. National Health Service (NHS) for the first time, after passing an expedited health technology assessment.
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
