Impact of withdrawal of NICE approval for 'old' medicines

The National Institute for Health and Care Excellence (NICE) will re-evaluate its approval for a number of older medicines. This action marks a significant change in its approach, shifting from solely appraising new technologies to actively managing the lifecycle of all approved treatments. The policy, which stems from the NHS 10-Year Plan, will have direct consequences for the NHS and the life sciences industry.

A new strategy for medicines lifecycle management

For the first time, NICE is removing the policy that guaranteed continued commissioning for previously approved drugs. It is systematically reviewing existing guidance to remove support for treatments that no longer represent value. This move is part of a wider strategy to maximise health outcomes for the population within the existing NHS budget.

The goal is a multi-faceted approach to smarter spending:

• Making space for innovation: The policy aims to create efficiencies and make room for new, innovative technologies.
• Optimising value: Continued market access will increasingly rely on a company's ability to demonstrate that its drug is sustainable and cost-effective in the real world.
• Strategic discontinuation: Actively identifying and retiring older medicines and interventions that are less effective or no longer cost-effective will free up resources.

This new, lifecycle-based approach means that NICE will be much more accepting of real-world evidence (RWE) to demonstrate a product's ongoing value after its initial launch. This is a critical shift from relying almost exclusively on trial-based outcomes for approval.

The context of NHS funding pressures

The change in NICE's strategy occurs alongside specific financial pressures. The NHS is resource-constrained and wants better value for money. A key driver is also the desire to reduce variation in care across the country, often referred to as the "postcode lottery," by introducing a Single National Formulary to standardise prescribing.

From the government’s perspective, this is a logical policy. If a more effective or cost-effective alternative has become available since a drug was first approved, re-evaluating it makes sense. This approach could push the pharma and tech industries to continuously demonstrate the value of their products compared to newer entrants.

Unanswered questions for the sector

While the strategic direction from NICE is clear, its practical implementation has created a "fear factor" in the industry due to insufficient detail. The debate now centres on the operational specifics and the potential impact on investment, innovation, and patient care.

Key areas of uncertainty include:

• Commercial viability and innovation: For industry, a primary concern is how long a technology appraisal will remain valid. If the period is too short, it may not be sufficient to justify the significant investment required for a NICE submission, which can amount to hundreds of thousands of pounds. This creates another barrier that could lead global head offices to de-prioritise the UK market.
• The reassessment process: The process itself is largely undefined. Key questions remain over what criteria will trigger a reassessment, how frequently it will occur, and who will pay for the work. While new evaluation criteria will be used as the benchmark, the specifics have not been confirmed.
• Patient access and protection: There is significant concern about the direct impact on patients. While NICE has offered reassurance that the process will be gradual and protective of those already on a treatment, questions remain. It is also notoriously difficult to withdraw a treatment once it is embedded in clinical practice.

Implications and the path forward

NICE's policy evolution creates a new operating environment. For the NHS, it is a mechanism to manage its medicines budget and redirect funds towards newer, more effective treatments. The standardisation intended through a future Single National Formulary will support this.

For pharmaceutical and medtech companies, the environment presents distinct challenges and opportunities. The active review of older products will affect revenue from established portfolios. Conversely, the commitment to accelerate access for new, high-value innovations creates a clear incentive for continued research and development.

Ultimately, how the pharmaceutical industry navigates these changes may depend on its approach to the debate. To negotiate effectively, the industry must frame its position around the impact on patients, demonstrating value through real-world evidence and a commitment to patient care. Ultimately, decisions should help to create a more sustainable healthcare system, improve patient outcomes and secure a bright future for the life sciences industry in the UK.

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