NHS England is poised to implement increased standardization of local prescribing formularies for specific categories of MedTech products in community settings. The Department of Health and Social Care’s MedTech and Innovation Directorate is spearheading this initiative, which is linked to its review of Part IX of the Drug Tariff. This review lists medical devices approved for NHS prescription to patients.
The project’s primary objective is to enhance the consistency of local medical devices formularies. It emphasizes the importance of patient voice in decision-making and broader principles of value-based procurement. However, some industry stakeholders are skeptical, fearing that cost-cutting measures are a significant driver behind the project. They argue that local formularies could limit clinicians’ ability to prescribe and patients’ access to the most suitable products listed on Part IX.
Such restrictions might negatively impact patient experiences and outcomes, potentially leading to avoidable complications and additional treatment episodes. The project is progressing rapidly, with a call for evidence issued in early July and plans to publish new guidance by April 2026. All local NHS systems in England are expected to develop new formularies by April 2027.
The range of products affected by this project is extensive, encompassing continence, stoma, and wound care; gastrointestinal and urological care; respiratory and airway management; lymphoedema, support, and therapeutics; sexual, reproductive, and pelvic health; diabetes management, glucose monitoring, and insulin delivery; and oral, dental, ear, eye, and nasal care.
The initial project brief acknowledges potential concerns and outlines several key issues to be considered, including clinical effectiveness, real-world evidence, patient choice, diversity of users, and the quality of information available to patients. Industry stakeholders, clinicians, patients, and experts in assessing whole system costs must engage proactively with this process. The inclusion of real-world evidence and case studies is crucial to prevent over-reliance on randomized control trials, which are often not feasible for many product categories.
It is essential that the principle of clinicians being able to prescribe any device listed on Part IX, deemed most appropriate for their patient, is upheld in every formulary. This principle must not be compromised to ensure that patient care is not adversely affected.
