MedTech-related technology assessments and clinical guidelines from NICE in May 2022

IPG is developed for most of the 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 May 2022, NICE published three new Interventional Procedures Guidance (IPG) and provided the following conclusions:

• Evidence on the safety and efficacy of supercapsular percutaneously assisted total hip arthroplasty for osteoarthritis is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
• Evidence is adequate on the short-term safety and efficacy of personalized external aortic root support (PEARS) using mesh to prevent aortic root expansion and aortic dissection in people with Marfan syndrome. Evidence on long-term outcomes is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
• Recommendations on endoanchoring systems in endovascular aortic aneurysm repair (EVAR) differ depending on the patient's clinical characteristics:

• For people with unfavorable aneurysm morphology needing an EVAR as a primary procedure, or for people with an existing EVAR who need a secondary procedure, evidence on the safety of using endoanchoring systems is adequate, but evidence on efficacy is limited in quantity and quality. Therefore, it should only be used with special arrangements for clinical governance, consent, and audit or research;
• For people with favorable aneurysm morphology needing an EVAR as a primary procedure, evidence on the safety of using endoanchoring systems is adequate. However, evidence on efficacy is inadequate in quantity and quality. Therefore, for these people, this procedure should only be used in the context of research.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, give greater independence to patients, or detect or monitor medical conditions.

In May 2022, NICE issued one new MTGs on Sleepio to treat insomnia and insomnia symptoms, which provided the following recommendations:

• Sleepio is recommended as a cost-saving option for treating insomnia and insomnia symptoms in primary care for people who would otherwise be offered sleep hygiene or sleeping pills;
• For people who may be at higher risk of other sleep disorder conditions, such as in pregnancy or in people with comorbidities, a medical assessment should be done before referral to Sleepio;
• More research or data collection is recommended on Sleepio for people who are eligible for face-to-face cognitive behavioral therapy for insomnia (CBT‑I) in primary care. This is because there is limited clinical evidence to show how effective Sleepio is compared with face-to-face CBT‑I.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations. The six new MIBs published in May 2022 are:

• ViewSite Brain Access System (VBAS) for the surgical management of deep brain lesions, a transparent tubular brain retractor system designed to access and visualize the surgical field during microneurosurgical techniques;
• Granulox for managing chronic non-healing wounds, a topical sterile hemoglobin spray for treating chronic non-healing wounds, such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers;
• AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas, a prognostic risk stratification test for identifying low-risk non-ulcerated early-stage cutaneous melanoma in children and adults;
• Bladder EpiCheck for detecting bladder cancer recurrence, in-vitro diagnostic test that analyses 15 DNA methylation biomarkers associated with bladder cancer and determines whether the methylation patterns indicate the presence of cancer;
• Kurin Lock for blood culture collection that isolates the first flash of blood from the sample. This first flash may contain contaminants (for example, microorganisms from the skin surface) that could cause false-positive results during blood culture;
• TriageHF Plus for remotely monitoring people with cardiac implantable electronic devices at risk of heart failure or worsening heart failure is a care pathway that uses a heart failure risk score, an online data management platform, and telephone assessment. It can only be used for people who have a Medtronic cardiac implantable electronic device (CIED) and needs the CareLink network service.

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