When Dr Andrew Hill, a senior visiting research fellow in the Department of Pharmacology and Therapeutics at the University of Liverpool, discovered that Gilead Sciences had declined to work with the National Institute for Health and Care Excellence (NICE) on cost-effectiveness evaluations for its breast cancer drug sacituzumab govitecan (Trodelvy), he was aghast. 

Five hundred women in England with HR-positive, HER2-negative breast cancer would be denied access to the treatment because, in his view, the company had put profit before patients.

According to NICE, Gilead declined to submit evidence for an appraisal because the firm “considers that the technology is unlikely to be a cost-effective use of NHS resources.”

Gilead has not issued an official press statement on NICE’s decision. However, in an interview with The Timesin August, Peter Wickersham, Gilead’s general manager for the UK and Ireland, blamed the UK’s “underinvestment in medicines,” which he said was “decades in the making.”

Hill agrees with NICE’s decision, arguing that it would simply cost too much per life-year saved to declare it as cost-effective.

“It’s off the scale to want to charge £45,000 to extend life by 5 months. It’s just not worth it at this price,” Hill told Medscape News UK. “It’s the responsibility of the drug company to not just make a drug that’s useful, but affordable. Gilead could offer an affordable price for their drugs and still make large profits but they’re refusing to do this.”

A Growing Rift Over NHS Drug Pricing

For months, the government has been in dispute with pharmaceutical companies over how much the NHS pays for new branded medicines. The issue has reached boiling point, with major firms warning they may scale back launches or investments in the UK if the NHS does not increase the prices it pays for new drugs. 

At the same time, the US administration under President Donald Trump has applied pressure on drugmakers to lower prices domestically and offset the difference by seeking higher returns in other markets, including the UK. 

NICE typically evaluates the cost of each additional quality-adjusted life year (QALY) gained from a new treatment. The standard threshold allows a maximum of £20,000-£30,000 per QALY. Higher thresholds — up to about £50,000 per QALY — may be applied for treatments targeting the most severe conditions or those used at the end of life.

However, ministers have reportedly discussed plans to raise the cost-effectiveness threshold by 25%, potentially increasing how much the NHS in England pays for new medicines. 

Dan Howdon, associate professor in health economics at the University of Leeds, believes such a move would be driven by the wrong motivations – notably pressure from both the US administration and the pharmaceutical industry. He warned that increasing the threshold would mean the NHS pays more for patented drugs and that population health could fall as money is diverted from other services. 

Research published in The Lancetlast year found that between 2000 and 2020, new drugs delivered 3.75 million additional QALYs at a cost of £75 billion. Redirecting that money to existing NHS services could have potentially added 5 million additional QALYs.

For lead author Huseyin Naci, associate professor of health policy at the London School of Economics and Political Science, the findings were striking.

“Every pound spent on a new drug is a pound not spent elsewhere,” he told Medscape News UK. “We found that while new medicines delivered real health gains, the same investment in existing NHS services could have delivered even more.”

Naci added that new drug prices often show little relationship to their actual clinical benefit. “If the goal is to maximise health with the NHS’s limited budget, then paying less for new drugs would help ensure we get as much value from medicines as we do from other NHS services,” he said.

‘Cheaper Interventions Deliver More Value’

For Hill, inflated drug prices mean fewer resources for prevention, diagnostics, and essential care.

“There are a lot of interventions that are a lot cheaper than the threshold — think blood pressure and cholesterol checks and vaccines. There’s an argument we could do way more prevention and focus on that instead. There’s only so much money for new branded drugs — they’re a big burden on the budget. Pharmaceutical companies damage the NHS by overcharging for their new drugs.”

He pointed to recent examples in which NICE had made the decision to reject other new drugs because it didn’t consider them cost-effective, including the Alzheimer’s drugs lecanemab and donanemab. 

“All of the rhetoric has been ‘shame on the NHS,’ but nothing about the greed of drug companies,” Hill said.

James Lomas, lecturer in the Department of Economics and Related Studies at the University of York, said that other countries often use NICE’s assessments as an international benchmark for what is acceptable in pricing.

“All of this means that it may make a product more profitable if at a higher price, but with fewer patients having access to it,” he told Medscape News UK.

He added that schemes such as the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) — which asks companies to rebate a share of revenue back to the NHS — attempt to reconcile high list prices with affordability.

Under VPAG, companies pay a percentage of revenue back to the NHS, capping the annual growth of branded medicine spending. According to the government, the scheme is expected to save £14 billion over 5 years. However, it has provoked a backlash from the pharmaceutical industry as sales growth has exceeded the cap in recent years, meaning the industry has had to pay back more than anticipated.

“If there must be a double aim of making drugs more affordable while allowing higher list prices, this may be the least worst solution,” Lomas said. “But it can't be overlooked that not only is this process much less transparent than NICE simply having a lower threshold, but it also treats all new pharmaceuticals as if they offer the same value relative to their cost and fails to anchor that value assessment to what value is achieved by existing NHS spending.”

Could Raising the Threshold Harm Patients?

Howdon warned that increasing the threshold could have paradoxical effects.

“Increasing the threshold means the pharmaceutical company increases their prices as baseline for all new drugs, meaning we pay more for something we would have bought anyway,” he told Medscape News UK. “And some new treatments that the NHS would have previously not have purchased — because companies wanted too much — will now be purchased.”

He added: “I believe that if we want to improve and maximise population health, the NHS already pays too much for new drugs as the threshold is set too high.”

For patients, the implications are deeply personal. NICE decisions on cost-effectiveness can determine whether lives are extended or cut short.

Melanie Sturtevant, associate director of policy, evidence and influencing at Breast Cancer Now, said the current system is failing patients with incurable disease. She wants NICE to lower the bar for what it defines as a “severe condition,” adding that the introduction of the severity modifier had made it more challenging to get end-of-life medicines, such as Trodelvy, approved.

“The decision by Gilead confirms our fears that a deeply unfair system is deterring drug companies from putting new life-extending treatments through a NICE appraisal. And the heartbreaking human impact is that people with incurable secondary breast cancer will have their lives cut short,” she said.

Sophie Cousins, MIPH, is a global health journalist who has reported from more than 20 countries.