In December 2021, NICE published two Interventional Procedures Guidance (IPG):
- Endobronchial nerve ablation for chronic obstructive pulmonary disease;
- Transanal total mesorectal excision for rectal cancer.
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.
NICE made the following conclusions:
- Evidence on the safety and efficacy of endobronchial nerve ablation for chronic obstructive pulmonary disease (COPD) is inadequate in quantity. Therefore, this procedure should only be used in the context of research;
- Evidence on the efficacy of transanal total mesorectal excision for rectal cancer is adequate. Evidence on its safety is inconsistent. It also shows the potential for major safety concerns, including damage to adjacent structures and seeding of malignancy. Therefore, 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 December 2021, NICE issued two new MTGs.
- NICE recommended ClearGuard HD antimicrobial barrier caps for preventing catheter-related bloodstream infections in people with central venous catheters having hemodialysis. Data should be collected on any long-term effect of chlorhexidine exposure, particularly in children. Cost modeling shows that ClearGuard HD caps are likely to be cost-saving over one year compared with standard treatments due to the lower incidence rate and associated cost of treating catheter-related bloodstream infections. The estimated savings per person are £351- £1,096, depending on the comparator;
- NICE concluded that Endo-SPONGE shows promise for treating low rectal anastomotic leakage. However, there is not enough good-quality evidence to support the case for routine adoption in the NHS. Further research is recommended to address uncertainties about the benefits of Endo-SPONGE.
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.
One new MIBs published in December 2021 on FreeO2 automatic oxygen titration tool that automatically adjusts the oxygen flow rate required to maintain target oxygenation set by the clinician. FreeO2 operates on a closed-loop and continuously adjusts the flow rate administered between 0 and 20 l/min (with or without humidification) based on blood oxygen saturation (SpO2). That reduces the risks of complications relating to hypoxia and hyperoxia.
One new clinical guideline was published in December 2021 on pelvic floor dysfunction prevention and non-surgical management.
Five clinical guidelines were updated in December 2021:
- Colorectal cancer - minor changes;
- Prostate cancer: diagnosis and management - NICE reviewed the evidence and updated the recommendations on risk stratification to refer to a 5-tier model;
- Suspected cancer: recognition and referral - NICE reviewed the evidence on fixed and age-adjusted thresholds for prostate-specific antigen testing and updated the recommendations on referral for suspected prostate cancer;
- COVID-19 rapid guideline: managing COVID-19 - new recommendations were added on COVID-19-associated pulmonary aspergillosis (CAPA);
- Headaches in over 12s: diagnosis and management - only minor updates were made regarding pharmacotherapy.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues of both newsletters are available for download free-of-charge.
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).