NHS Drug Tariff Part IX Chapter Three: Reform, Not Revolution

• Richard Tuson
• /
• 30 Jul 2025

NHS Drug Tariff Part IX – Adapting for Innovation Without Opening the Door

The NHS Drug Tariff Part IX policy update, published in July 2025, introduces structured renewal, formal assessment criteria, and for the first time – a nationally applied product categorisation model. Alongside this, a mechanism for temporary access has been added to support earlier entry for innovative technologies.

This blog – the third in our series – focuses on these two elements: how new categories and clusters will shape listing decisions, and how the NHS is cautiously opening a route for new products without sufficient real-world use data.

New National Categorisation – Grouped, Not Just Listed

Historically, products in Part IX were often listed by brand or manufacturer. The new policy now mandates structured categorisation, developed through expert reference groups and shared with industry.

All future listings – and renewals – will be grouped into Level 1 categories and clusters, with suppliers required to propose their placement at the time of application.

These categories are intended to allow for price benchmarking and evidence comparison. Critically, prescribing professionals will still see the full list of devices, but reimbursement and approval will be driven by how well a product fits its category.

Feedback loops have been built in, allowing industry to suggest new clusters. However, this is now a formally curated list, with categorisation expected to evolve in future waves.

Linked Fees Stay – For Now

Despite the structural change, existing reimbursement fees will not change in this wave. NHS England has explicitly stated that fee review was out of scope, though future phases may revisit this.

Some devices – including continuous glucose monitors, insulin pen needles, and chemical reagent strips – will continue to be subject to defined minimum requirements. Others will not have formal “minimum attribute” definitions, in part due to clinical feedback that flexibility in prescribing is key.

Nonetheless, categorisation will increase transparency – and bring products into direct comparison with similar devices.

Temporary Listing – A Carefully Controlled Innovation Route

To support entry of newer products without NHS prescribing history, the policy introduces a temporary listing mechanism, valid for up to two years.

A product may be granted temporary status if it:

• Meets essential safety and prescribing criteria
• Is significantly different from listed alternatives
• Lacks NHS usage data but has clinical evidence and a defined evidence generation plan

This route is particularly important for SMEs and novel technologies, where full evidence may be emerging but not yet established in NHS practice. The listing is conditional, and a full review will follow after two years – potentially leading to removal or full approval.

Clarity on What’s Exempt – But Innovation Will Be Tested

Part IXA technical specifications and paediatric stoma products remain exempt from these reforms. But most others – particularly in wound care, monitoring, and delivery – will now need to align with their category and demonstrate value.

The innovation route is not a shortcut. Temporary listings must still demonstrate a defined value proposition and pathway to long-term approval. There is no fast track without evidence – only a structured allowance for adoption and learning.

Our Take

The new categorisation framework is a quiet but powerful change. It moves Part IX away from an open listing and toward actively managed groups. This supports better benchmarking – and potentially tighter pricing – without a public price review (yet).

The temporary listing route is welcome, especially for SMEs. But it is no guarantee of success. In our experience, NHS systems are cautious – and evidence expectations remain high.

We’ve supported early use of this route and can help teams shape credible applications with clear value stories, robust plans and the right positioning in their category.

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 3 of our explainer series on NHS Drug Tariff reform. Read Chapter 1 (renewals) and Chapter 2 (assessment scoring) on our LinkedIn page.