The Hepatitis C Trust is pursuing legal action against NHS England for its decision to limit the number of patients who can receive new hepatitis C drugs.
In March 2016, NHS England announced that treatment with several new drugs would be limited to 10,000 of the most in-need patients in 2016–2017, in order to manage costs. There are an estimated 160,000 patients living with hepatitis C in England.
The Hepatitis C Trust, a UK charity, says it wrote to NHS England and requested that the organisation reconsider its decision. “NHS England replied with a response that The Hepatitis C Trust did not find satisfactory. With great regret it now has to consider seeking a judicial review of the decision,” the charity says.
NHS England has defended its approach, describing the trust’s decision to pursue legal action as “strange”. “Over the past year the NHS has actually made hepatitis C treatment its biggest single [new] investment — making available £200m,” it says. Only 7,000–10,000 patients are expected to come forward for treatment, NHS England adds, although a previous estimate from the organisation put the figure at 10,000–20,000 people.
In 2015, several new hepatitis C drugs were approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body that provides evidence-based guidance to the NHS. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals.
“This is the first time NHS England has imposed a cap on drugs that NICE has said are cost effective and must be made available,” says The Hepatitis C Trust.
However, NHS England maintains that the decision to treat patients based on greatest clinical need is in line with NICE guidance. “The right approach is to do what NICE and the NHS recommended, namely treat urgent hepatitis C patients first — as we have done — and then work through the backlog of chronic but non-urgent cases over time, while taking advantage of downward pressure on drug prices,” says an NHS England spokesperson. “By contrast, attempting to do what some of the drug companies and their partners would prefer would create a bill for British taxpayers running into the billions, meaning dramatic offsetting cuts in other critical NHS services.”
The public list prices of the new drug regimens range from £60,000 to £120,000 per person, depending on whether a 12-week or 24-week course of treatment is used. However, the actual cost of these drugs to the NHS is expected to be far lower, after discounts agreed with the pharmaceutical companies. For example, the NHS’s budget of £200m for 10,000 patients is a cost of £20,000 per person.
The new generation of hepatitis C drugs are highly effective, offering cure rates of more than 90% and a far more tolerable side effect profile compared with older, interferon-containing drug regimens.
“It is truly ironic that NHS England should choose to start rationing drugs that are so effective they cure almost everyone who is treated,” says Charles Gore, chief executive of The Hepatitis C Trust. “It feels like people with hepatitis C are being picked on. We are having to look to the courts to protect them.”
In comparison, the NHS is estimated to spend more than £500m a year on treating HIV and more than £500m a year on rheumatoid arthritis treatments.
The Hepatitis C Trust also points out that NHS England’s approach to tackling hepatitis C is in “marked contrast” to countries such as Australia, Germany and Scotland, which “see the introduction of these new drugs as an opportunity to treat as many as possible and eliminate hepatitis C in their countries”.
In the past few months, NHS England has also come under fire for backing out of funding drugs for pre-exposure prophylaxis (PrEP) for men at high risk of contracting HIV, a strategy that can prevent 92% of infections. After the National AIDs Trust began legal proceedings, NHS England said it would reconsider its decision.