Med Tech-related technology assessments from NICE in December 2024

The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

In December 2024, NICE published three new IPGs and made the following conclusions:

• Direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant can be used with special arrangements for clinical governance, consent, and audit while more evidence is generated. The evidence is limited in quality and provided mainly from observational studies. Short-term evidence suggests that people who have skeletal fixation after an amputation above the knee have improved quality of life and are better able to carry out normal daily activities. However, there is evidence of serious complications, such as fractures and infections, which can lead to additional treatments and surgery and significantly impact a person's mental health;
• MRI-guided focused ultrasound subthalamotomy for treating Parkinson’s should only be done as part of a formal research study. There is little evidence of the efficacy and safety of this procedure, which suggests the procedure may reduce Parkinson's symptoms, including tremors. However, the evidence is short-term and comes mainly from only one center. So, the procedure's benefits and the patient group that might benefit from this procedure are also unclear. This procedure also has the potential for serious complications;
• MRI-guided focused ultrasound thalamotomy for treating moderate to severe tremor in Parkinson’s should only be done as part of a formal research study. There is little good-quality evidence for this procedure, mainly from observational studies, which suggests that people who have had the procedure have fewer and less severe tremors. A potential benefit is that the tremor reduction can be seen and controlled during the procedure. Some people who cannot have deep brain stimulation may particularly benefit from this procedure. Also, there are reports of complications, and long-term research with more people is needed to understand the longer-term outcomes of the procedure. 

NICE Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

In December 2024, NICE issued one new DG on Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome (OSAHS), with the following conclusions:

• Four technologies received positive recommendations (AcuPebble SA100, Sunrise, WatchPAT 300, and WatchPAT ONE) to diagnose and assess the severity of OSAHS in people 16 years and over. When considering whether to use these devices in place of home respiratory polygraphy or home oximetry, the specific considerations described in the DG should be taken into account;
• In the following cases, technologies were only recommended in the context of research:
• For people 16 years and over, more research is needed on the Brizzy home-testing device to diagnose and assess the severity of OSAHS before it can be used in the NHS;
• For people under 16 years, more research is needed on the following home-testing devices to diagnose and assess the severity of OSAHS before they can be used in the NHS: Brizzy, Sunrise, WatchPAT 300, WatchPAT ONE.

Health Technology Evaluations (HTE) using the Early Value Assessment (EVA) approach are the new type of NICE guidance to provide rapid conditional recommendations on promising health technologies that have the potential to address unmet national needs. NICE evaluates the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.

In December 2024, NICE published one EVA on Digital technologies to support self-management of chronic obstructive pulmonary disease (COPD): early value assessment  and made the following recommendations:

• Seven digital technologies (Active+me REMOTE, Clinitouch, COPDhub, COPDPredict, Lenus COPD Support Service, Luscii, myCOPD) to support self-management of COPD in adults can be used in the NHS during the evidence-generation period;
• More research is needed on the stand-alone Doccla WellGuide patient app to support self-management of COPD before it can be used in the NHS.

See the full details here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.