England's NHS waged a tense behind-the-scenes fight against pricey hep C drugs

When England’s cost-effectiveness gatekeepers gave their blessing to Gilead Sciences’ pricey hepatitis C drugs last year, some of the country’s sickest patients were already being treated under a special access program.

But as the National Institute for Health and Care Excellence (NICE) was weighing Gilead’s evidence and pricing on Sovaldi and Harvoni, the country’s National Health Service was maneuvering behind the scenes to delay or block the agency’s approvals, according to a BMJ investigation to be published Thursday.

The NHS inflated the number of patients it expected to treat, the BMJ says, to argue that the pricey drugs were too expensive to be broadly used. And when NICE issued its cost-effectiveness blessing anyway, the NHS resorted to setting treatment quotas to restrict the number of patients receiving the meds.

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“NHS England, unable to budget for broad access to these drugs, tried to alter the outcome of the NICE process and, when it failed, defied NICE’s authority by rationing access to the drugs,” the BMJ article states. The journal worked on its investigation with researchers from the University of Cambridge and the University of Bath.

The BMJ investigation highlights the tension between patient access and drug pricing and illustrates how treatments deemed cost-effective aren’t necessarily affordable. And it shows that single-payer healthcare systems--theoretically able to take a more long-term view of expensive drugs that prevent future healthcare costs--can still be overwhelmed by drugs that promise a cure but impose a heavy up-front cost burden.

That’s all been under debate since Gilead was preparing to roll out its highly effective, yet highly expensive, hepatitis C drugs in 2014. When the drugs hit the market, U.S. payers began a complicated dance: Caught between patients needing treatment and price tags of $84,000 per year for Sovaldi and later, $94,500 for Harvoni, insurers and PBMs raised coverage hurdles to limit their spending.

After a new cocktail from AbbVie hit the scene, U.S. payers quickly struck discounts, and more rebates are expected to follow as Merck negotiates formulary deals on its new entrant Zepatier. Some insurers are still restricting access despite those discounts--and some Medicaid programs are said to be limiting access severely--but top payers, such as the pharmacy benefits manager Express Scripts, promised to open up access once they inked discount deals.

But in England and other single-payer countries, prices have been much lower from the beginning. France, for instance, strongarmed Gilead into a big discount, complete with refunds on patients who didn’t respond. The BMJ quoted prices of €41,000 in France and £35,000 in England.

Even so, the NHS pushed back as NICE was reviewing the meds, arguing that the drugs couldn’t be cost-effective if the health service couldn’t afford them. Some experts took issue with the NHS’s calculations--“The figure they quoted in the NICE submission was something like £2bn, which was clearly fantasy,” a Queen’s Medical Centre hepatologist, Steve Ryder, told the BMJ. “The assumption to come up with that figure was that you had no discounts on any of the drugs at all and that every single person with hepatitis C in England would come forward that year for treatment, so it was a completely ridiculous standpoint to take.”

But it wasn’t all about numbers, or so some say. One set of patient groups saw the hep C battle as a power struggle between the NHS and NICE. And a former NHS clinical advisor, who quit in the midst of the hep C battle, figures that the NHS was using the hep C drugs as part of that fight.

“I think some people in NHS England would love to clip NICE’s wings and turn it into a kind of recommendatory rather than mandatory body,” said Andrew Ustianowski, a consultant in infectious diseases at Pennine Acute Hospitals NHS Trust (as quoted by the BMJ).

“And if you are going to choose a fight then choosing this battlefield is quite a sensible thing to do,” he added, particularly because the NHS had arranged for the sickest hep C patients to be treated already. With fewer truly sick patients needing treatment, dragging its feet would be less of a PR hazard for the NHS. “People don’t have symptoms for years or cirrhosis for decades. So once you’ve treated the obviously sick and those with cirrhosis, who do you treat next?” Ustianowski said. “I think they’ve chosen this fight quite well."

- see the BMJ investigation

Related Articles:
Analysts press for M&A as Gilead’s high-flying hep C franchise comes down to earth
After stalling for months, NHS England pledges £190M for new hep C treatments
Good news, hep C drugmakers: VA stops rationing your pricey treatments
Gilead's hep C combo Harvoni wins NICE blessing at $58K price
U.K. cost watchdog gives thumbs-up to Bristol-Myers' hep C drug
France strikes big hep C treatment deal for Gilead's Sovaldi

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