Joint MHRA/NICE pathway 'benefits industry over patients'
Parallel reviews of new medicines by the UK's MHRA drug regulator and reimbursement authority NICE benefit industry more than patients and the NHS.
That is the contention voiced by Huseyin Naci at the London School of Economics and Political Science in the British Medical Journal, who argues that the recently introduced joint regulatory and health technology assessment (HTA) approval pathway fails to align the independent standards of evidence required by the two agencies in a meaningful way.
The pathway runs two independent processes in parallel with the aim of synchronising their conclusions, he contends, offering companies earlier revenue and a longer rebate-free window, but the benefits for patients and the NHS are less clear.
"Earlier access to effective new drugs can matter for patients with substantial unmet needs, and months of delay can carry clinical consequences," writes Naci, an associate professor in the Department of Health Policy at the LSE and founder and director of the Pharmaceutical Policy Lab, in the editorial.
"But the pathway does not target this population; it will expedite NHS availability of new medicines irrespective of evidence of added therapeutic benefit," he adds, pointing to a similar scheme in Canada that "resulted in no difference in time to availability between drugs with and without added therapeutic benefit."
Naci also notes that fixed deadlines on drug evaluations have historically been associated with higher rates of adverse events and post-marketing safety events, such as the addition of boxed warnings or tightened safety labelling, than those approved through standard pathways.
A further problem is that NICE committees may be asked to assess products on evidence not yet fully vetted by the MHRA, compounding the uncertainty under which they already operate, according to Naci.
He is also concerned that early adoption of "expensive, potentially low-value medicines" could extend the period during which they divert NHS resources from more cost-effective interventions, a factor that is "exacerbated" by the 2025 US-UK trade agreement, which commits NICE to a 25% higher cost-effectiveness threshold.
He is calling for transparency on the "assumptions underpinning the pathway and assessment of its anticipated benefits and harms for all stakeholders, not just industry."
The aligned pathway – which is due to start delivering guidance next month – has been trumpeted by the government as a way to bring new medicines to patients three to six months earlier and make the UK a more attractive location for pharma industry investment.
The Association of the British Pharmaceutical Industry (ABPI), which called the pathway "one of many necessary improvements in the UK health and life sciences ecosystem," has identified poor patient access to medicines as one of the key weaknesses undermining the UK's global position in life sciences.
Photo by jana bemol on Unsplash
