NHS Drug Tariff Submission Support
Our NHS Drug Tariff Submission Service offers specialised expertise in…
Our NHS Drug Tariff Submission Service offers specialised expertise in…
Leading in market access, Strategy Development from Health Analytical Solutions…
The NHS Drug Tariff Part IX, covering medical devices prescribed in primary care, is undergoing its most significant reform in decades. A new policy issued quietly in July 2025 introduces structured re-listing requirements, temporary access routes, and a detailed categorisation model. This will directly affect MedTech companies supplying everything from glucose monitors to dressings and inhalers.
For suppliers, this marks a transition from one-time approval to a regulated cycle of renewal, underpinned by evidence of clinical value and NHS utilisation. The new framework is designed to tighten product standards, maintain value-for-money, and introduce patient and clinician voices into the listing process.
Until now, most devices listed on Part IX remained on the Tariff indefinitely. From 2025 onwards, products will be subject to time-bound renewals – typically every 4–5 years – with all listings reviewed in ‘waves’ by NHS Business Services Authority.
Suppliers will be given six months’ notice ahead of renewal for their category. Devices that have not been prescribed in the last 24 months may be removed, and a new application will be required to re-enter. The aim is to keep the Tariff aligned with real-world usage, product quality and clinical relevance.
Renewal applications will be evaluated using new national templates. Assessment panels will include clinicians and patient representatives. Where category-level prescribing data shows zero activity across England, Wales or Northern Ireland, products may be flagged for removal.
An indicative renewal schedule is now available on the NHSBSA site, and suppliers should monitor their category timeline. For most, this marks the beginning of a more formal relationship with the Drug Tariff team.
Importantly, reimbursement fees currently linked to Part IX products are not changing under this reform. The new categorisation structure does not revise tariffs. However, NHS England has signalled this could be revisited in future phases.
Additionally, products listed under Part IXA technical specs – such as stoma appliances – are exempt, as are paediatric and neonatal stoma products. These will not be subject to renewal or the enhanced assessment framework for now.
This shift marks a clear pivot from passive listing to active curation of the NHS device formulary. It introduces more transparency and oversight, but also new barriers for companies not actively managing their portfolio and NHS engagement.
We’ve already helped a number of MedTech companies navigate Part IX applications – including being among the first to support a product (Geko for VLUs) through the new review framework, which now shares features with NICE-style submissions.
For MedTech suppliers, success will increasingly rely on demonstrating device use in practice and preparing renewal-ready submissions. This presents both a compliance challenge and a strategic opportunity.
Health Analytical Solutions provides tailored support at every stage – from strategic positioning to submission drafting. If you're preparing for renewal or exploring a new listing, we’re here to guide and support.
Get in touch: enquiry@healthanalyticalsolutions.co.uk or visit https://www.healthanalyticalsolutions.co.uk/services to explore how we can support you.
This is Chapter 1 of our explainer series on NHS Drug Tariff reform
More to follow as guidance on assessment, categorisation, and fee policy develops.
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