NHS England looks set to roll out increased standardisation of local prescribing formularies in the community for some key categories of MedTech products. A new project is being launched by the Department of Health and Social Care’s MedTech and Innovation Directorate, linked to its review of the operation of Part IX of the Drug Tariff (which lists medical devices that are approved for NHS prescription to patients).

The aim is to provide guidance, says the project brief, “to improve the consistency of local medical devices formularies reflecting the importance of the patient voice in decision making and wider principles of value-based procurement”.

But, fearing that spending reductions are at least part of the reason behind the project, some in industry aren’t convinced, arguing that local formularies (short lists of products and devices recommended as options for prescribers in the local area) risk compromising the right of clinicians to prescribe, and of patients to receive, whichever product on Part IX they consider best meets the needs of the individual patient.

Such restrictions could adversely impact upon patient experiences and outcomes, proving to be a false economy if the move leads to otherwise avoidable complications and/or episodes of treatment.

The project is being driven forward with an unusual air of urgency, kicking off with a call for evidence in early July, and completing with the publication of the new guidance in April 2026, and production, by all local NHS systems (ICSs) in England, of the new formularies by April 2027.

The range of products set to be caught in this new project is very wide, including continence, stoma and wound care; gastrointestinal and urological care; respiratory and airway management; lymphoedema, support and therapeutics; sexual, reproductive and pelvic health; diabetes, glucose monitoring and insulin delivery; oral, dental, ear, eye and nasal care.

Anticipating concerns about the need to avoid unintended consequences for clinicians and patients, the initial project brief does identify a series of issues that will need to be considered.

Those issues include: clinical effectiveness; availability of/access to “real world” evidence; supporting self-care; supporting system savings; reducing health inequalities; supporting patients in living life to the full; appearance, comfort, fit of medical devices; patient choice; diversity of users (including skin colour, those with physical or mental health restrictions, allergies etc.); quality/accessibility of information to help patients choose a device; impact of patient’s personal circumstances; adherence to use of medical devices by patients; accessibility/availability of medical devices; inclusion of medical devices characteristics [learning curve, incremental innovation, dynamic pricing, and organisational impact]in Health Technology Assessments; influence of sex and gender in clinical trials of medical devices; software as a medical device; medical devices used for patient self-testing; medical devices safety.

Industry must proactively engage with this process, as should clinicians, patients and their advocates, and those with expertise in assessing whole system costs when comparing one product with another in the same category. Real world evidence and case studies must be part of the process if patients are not to be adversely affected by an over-reliance on randomised control trials, which are simply not available or feasible for many product categories. The principle that clinicians may prescribe any device listed on Part IX, that they consider most appropriate for their patient, should be highlighted in every formulary and must not be compromised. Med-Tech Insights