NHS Drug Tariff Part IX Chapter Two: Passing the New Test

• Richard Tuson
• /
• 29 Jul 2025

NHS Drug Tariff Part IX – New Barriers to Entry for Devices

In Chapter 1 of this series, we outlined how all devices listed on Part IX of the NHS Drug Tariff will now face time-limited approval and mandatory renewals. That change alone marks a significant shift in the NHS’s approach to medical device reimbursement in primary care.

But the second – and perhaps more profound – reform lies in the new enhanced assessment framework. Every new product application, and most renewals, must now pass a 100-point scoring system covering quality, price, and social value. This is a major departure from the largely procedural process that existed before.

The New Assessment – Evidence, Value, and Price Pressure

The new framework scores product submissions as follows:

• 50 points for quality
• 40 points for price
• 10 points for social criteria

A minimum total score of 55 is required to pass, with at least 20 points in quality and 0 in price. The framework applies to both new listings and renewals, unless exempted.

This means every applicant must present evidence of product performance, alignment with NHS priorities, and competitive pricing. A benchmark pricing method has been introduced – 32% above the lowest eligible price in the cluster will result in zero or negative points.

Quality Criteria – Supporting the Wider NHS Agenda

Suppliers must meet core quality requirements and select up to three “value add” criteria from four themes:

• Supporting system savings
• Enhancing self-care
• Reducing inequalities
• Demonstrating effectiveness

Notably, innovation is no longer a separate category, as it’s considered intrinsic to the others. High-evidence thresholds apply to new product types only. NHS panels assessing applications will include clinicians, commissioners, and patient representatives.

This elevates the review to something much closer to a NICE-style evaluation – in both rigour and expectation.

Social Criteria – From Packaging to Supply Resilience

Social value has been redefined as simply “social”, and now includes:

• Circular economy and recyclability
• Sustainable packaging
• Resilient supply chains

These make up 10% of the total score. While some single-use products may score lower, the framework allows flexibility for suppliers to demonstrate other sustainability commitments.

The social assessment links closely with the Design for Life roadmap, signalling NHS alignment with the broader environmental and manufacturing agenda.

Temporary Listings and Appeals

The framework includes a mechanism for temporary listings – up to two years – for innovative products without sufficient NHS usage data. This provides a route in for early-stage technologies that meet core safety and prescribing criteria. A review process will follow, determining either full listing or removal.

In addition, applicants now have a right of appeal on quality or social scores if they fail the overall threshold, and may contest their product’s categorisation cluster. This will be critical in contested or borderline submissions.

Our Take

This is a significant tightening of the gateway to NHS primary care prescribing. The enhanced assessment framework introduces new expectations, raises the bar on evidence, and puts downward pressure on price.

We’ve already supported clients through early versions of this process – including the Geko device for venous leg ulcers – and can confirm that preparing submissions now requires a structured, evidence-led approach more akin to NICE than historic Tariff forms.

Whether seeking new listing or renewal, suppliers must now compete not just on product availability, but on performance, system value, and social responsibility.

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 2 of our explainer series on NHS Drug Tariff reform Read Chapter 1 on re-listing and renewals & Chapter 3 on categorisation and temporary access routes.