MedTech-related technology assessments and clinical guidelines from NICE in April 2021

In April 2021, NICE published three Interventional Procedures Guidance (IPG):

• Deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults;
• Repetitive short-pulse transscleral cyclophotocoagulation for glaucoma;
• Melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic cancer in the liver

Interventional Procedure Guidance 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 concluded that evidence on the safety and efficacy of deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adults is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research. The procedure should only be done in centers with expertise in deep brain stimulation and experience in managing OCD. Further research should be primarily in the form of randomized controlled trials and should clearly define the area of the brain that should be targeted in this procedure.

NICE recommended repetitive short-pulse transscleral cyclophotocoagulation for glaucoma to be used only in the context of research, concluding that evidence on the safety of shows no major safety concerns but evidence on efficacy is inadequate in quality.

Regarding melphalan chemosaturation with percutaneous hepatic artery perfusion and hepatic vein isolation for primary or metastatic cancer in the liver, NICE made the following conclusions and recommendations:

• Evidence on the safety of the procedure shows there are serious, well-recognized complications;
• There is some evidence of short-term tumor response for patients with metastases in the liver from ocular melanoma. For these patients, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
• For patients with primary liver cancer or metastases in the liver that are not from ocular melanoma, evidence of efficacy is inadequate in quality and quantity. For these patients, this procedure should only be used in the context of research;
• The procedure should only be done in specialist centers by a multidisciplinary melanoma team that includes an interventional radiologist, an anesthetist, an oncologist, and a clinical perfusion scientist trained and experienced in the procedure;
• Further research should be in the form of randomized controlled trials against current best practices, including other liver-directed and systemic therapies. It should report details of patient selection, concurrent therapies and techniques, and adverse events, including those related to chemotherapy.

MedTech Innovation Briefing (MIB) 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.

Two MIBs were published in April:

• RenalSense Clarity RMS for acute kidney injury - a critical care monitoring system that continuously measures urine flow, automatically transmitting to the medical staff real-time data and notifications of fluctuations, on a 24/7 basis;
• microINR for anticoagulation therapy - a hand-held point-of-care coagulometer for measuring international normalized ratio (INR) in people having anticoagulation therapy. The device allows self-monitoring for coagulation with reduced blood sample needs and increased connectivity capabilities.

Also, two clinical guidelines with MedTech-related recommendations were issued in April:

The guideline for chronic pain (primary and secondary) in over 16s covers assessing all chronic pain (chronic primary pain, chronic secondary pain, or both) and managing chronic primary pain.

NICE does not recommend offering transcutaneous electrical nerve stimulation (TENS), ultrasound, and interferential therapy to manage chronic primary pain because there is no evidence of benefit.

Laser therapy and transcranial magnetic stimulation (TMS) both showed a benefit for patient-reported pain. Considering the quality of the evidence, the limited long-term data, and the lack of evidence on cost-effectiveness, the committee decided not to make a practice recommendation for laser therapy or TMS. However, because the limited evidence was promising, NICE made recommendations for clinical- and cost-effectiveness research on laser therapy and TMS for chronic primary pain to inform future guidance.

The guideline for atrial fibrillation (AF) diagnosis and management includes new and updated recommendations on detection and diagnosis of AF, assessment of stroke and bleeding risks in AF, stroke prevention, rate control, left atrial ablation, preventing recurrence after ablation, preventing and managing postoperative AF.

NICE concluded that the evidence did not support changing recommendations on diagnostic tests for AF detection. 12-lead ECG should be used as the test to confirm atrial fibrillation, to prevent the use of less accurate ECG devices, such as mobile and lead-I ECG devices. NICE made a research recommendation on the diagnostic accuracy of key index tests (such as the KardiaMobile, MyDiagnostik, Microlife BP monitors, iPhone plethysmography, and pulse palpation) compared with the gold standard of 12-lead ECG in people with risk factors for or symptoms of atrial fibrillation.

NICE made new recommendations on left atrial ablation:

• Radiofrequency point-by-point ablation should be considered in people with symptomatic paroxysmal or persistent AF if drug treatment is unsuccessful, unsuitable, or not tolerated;
• Cryoballoon ablation or laser balloon ablation can be used if radiofrequency point-by-point ablation is assessed as being unsuitable.

NICE provided the following rationale for these recommendations: based on evidence, the catheter ablation techniques were the most clinically effective ablation options. Thoracoscopy and the hybrid techniques led to lower recurrence, but they also led to more serious adverse effects. There were no clear differences in efficacy between the four catheter ablation techniques: radiofrequency point-by-point, radiofrequency multi-electrode, laser, and cryoballoon ablation. However, the economic model showed that radiofrequency point-by-point ablation was more cost-effective over a lifetime than antiarrhythmic drug treatment and other ablation strategies in people for whom one or more antiarrhythmic drugs have failed. Cryoballoon, radiofrequency multi-electrode, and laser ablation were the second, third and fourth most cost-effective options, accordingly.

See the full details here.

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