CSL Behring’s expensive hemophilia B gene therapy is to be reimbursed by the U.K. National Health Service, after the company agreed to an outcomes-based payment scheme. The therapy, Hemgenix (etranacogene dezaparvovec), which has a U.K. list price of £2.6 million (US$3.3 million), was approved under a managed access scheme, in which data will be collected over five years to enable both the long-term effectiveness, and any adverse liver toxicity caused by the transgene, to be monitored.
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.
The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.
The U.K. National Institute for Health and Care Excellence (NICE) has released a preliminary health technology assessment for three modules of the Proknow series of software systems by Stockholm-based Elekta AB, which may improve the delivery of radiotherapy services across the U.K. However, NICE indicated it wants to see more evidence regarding the impact of these software modules on radiotherapy treatment plans.
Chief executives of U.K. medical research charities have issued a call for speedier uptake and more equitable access to new drugs that have received a cost-effectiveness seal of approval from the National Institute for Health and Care Excellence. In a joint report with the Association of the British Pharmaceutical Industry, the heads of eight charities examined a number of cases where access has been limited and set out recommendations to address the challenges of equity, uptake and health inequalities.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS).
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
Transcatheter aortic valve replacement (TAVR) devices are all the rage for treatment of aortic valve disease, but that doesn’t mean valve reconstruction via the so-called Ozaki procedure has been consigned to the pages of medical history. The U.K.’s National Institute for Health and Care Excellence has recommended that trusts in the U.K. health system use this procedure only in clinical trials at least for the time being, although the agency noted that the Ozaki procedure allows the patient to sidestep the need for long-term antithrombotic therapy, a big selling point for patients and clinicians alike.
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