Hepatitis C And PrEP Bring More Funding Headaches For NHS England

Drugs for hepatitis C and HIV prevention are causing funding problems for the NHS in England as court battles loom and innovation continues to bring more cost pressures.

A number of recent developments in the UK have again thrown the spotlight on the pressure being placed on the National Health Service by the arrival of effective but expensive new therapies, and also raised questions over the relationships between the NHS, local authorities and the National Institute for Health and Care Excellence (NICE).

A prominent charity is seeking judicial review of NHS England's decision to limit the number of patients who will be able to access the new hepatitis C drugs despite a green light for their use from NICE.

Meanwhile, NHS England has said it will appeal against a High Court ruling that it is legally able to fund Gilead's HIV drug Truvada for pre-exposure prophylaxis (PrEP), as NICE prepares to look at the evidence base for PrEP in high-risk groups.

The moves come amid controversy over the recent launch of the revamped Cancer Drugs Fund, which is now controlled by NICE but which critics say will still not guarantee UK patients access to oncology drugs that are available elsewhere.

All these developments serve to intensify the debate over how the NHS is expected to handle funding issues in future as more high-cost drugs come through company pipelines in areas of unmet need.

The hepatitis C drugs – Gilead's Sovaldi (sofosbuvir) and Harvoni (sofosbuvir plus ledipasvir), Bristol-Myers Squibb's Daklinza (daclatasvir), and Abbvie's Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir) – have already generated considerable controversy because while they are highly effective, they are also very expensive.

The latest row was sparked by NHS England's decision in March 2016 to impose a cap on the number of people that hospital trusts are allowed to treat with the products each month, even though NICE issued guidance in 2015 recommending their use through NHS England's specialized commissioning program. In April the charity, the Hepatitis C Trust, published data showing how many people NHS England intended to treat in each of the 22 new "operational delivery networks" (ODNs) in 2006-17 (the so-called "run rates").

The decision to limit access was greeted with concern by the trust, which said this was "the first time NHS England have imposed a cap on drugs that NICE have said are cost effective and must be made available." It added that this approach was in marked contrast to that of many other countries like Australia, Germany and Scotland, which see these drugs "as an opportunity to treat as many as possible and eliminate hepatitis C in their countries."

Should NHS England be allowed to go ahead with rationing the hepatitis C drugs, it might set a precedent for any other NICE-approved treatments, cautioned Rachel Halford, deputy CEO of the Hepatitis C Trust.

The matter was also investigated by the British Medical Journal, which together with the universities of Bath and Cambridge reported that NHS England was unable to budget for broad access to the hepatitis C drugs and so tried to alter the outcome of the NICE process "and, when that failed, defied NICE's authority by rationing access to the drugs."

In an article published on July 27, 2016, the BMJ said that NHS England had failed to plan ahead for expensive drugs it knew were in the pipeline, exaggerated the likely number of patients and the consequent financial burden, and claimed thousands of other NHS patients with other diseases would die if it had to fund the hepatitis C drugs.

The article alleged that NHS England delayed acting on NICE's recommendation on Sovaldi by requesting a three-month extension to implement the NICE guidance, questioned the evidence level on Harvoni and two other drugs, and then restricted the products' use by imposing quotas on clinical teams around the country.

On a broader level, the article said NHS England was "also accused of pursuing the broader agenda of trying to hamper NICE's ability to impose budget busting drugs on the health service", and of "having cynically chosen this battleground because most people with hepatitis C are from marginalized groups without a voice, such as people who inject drugs."

NICE Takes Issue With BMJ Claims

NICE, though, took issue with the BMJ's claims. Its chief executive, Sir Andrew Dillon, said that NHS England "did not try to change our recommendations on whether the NHS should make recently licensed treatments for Hepatitis C available to NHS patients."

NHS England, he said, put forward its views on NICE's draft guidance as they were entitled to do, and NICE took their comments into account, along with those from patient and professional groups and from the drug manufacturers.

"Our final guidance on Harvoni recommends that treatment and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need. It is a matter for them to decide how best to do this," Sir Andrew added.

But the Hepatitis C Trust agreed that hepatitis C was a soft target. Rachel Halford, its deputy CEO, said that hepatitis C is "not attractive, so it could be seen as an easy win." By contrast, she pointed out, other countries such as Australia and France have negotiated deals on the hepatitis C drugs.

As of March this year Australia is investing A$1bn ($765m) over five years to make Sovaldi, Harvoni and Daklinza available to all patients with chronic hepatitis C infection under the Pharmaceutical Benefits Scheme, while France has implemented an access scheme involving a company rebate mechanism (Also see " French parliament OKs hep C drug rebate scheme " - Scrip, 4 Dec, 2014.).

The trust has now begun proceedings for a judicial review of NHS England's decision on the grounds that when NICE approves drugs for use on the NHS, the NHS has a legal responsibility to deliver those drugs in accordance with NICE's recommendations, and "we believe it is illegal to cap the number of patients who can be treated," Halford told the Pink Sheet. If the judge allows the review to go ahead, it could take place in late 2016 or early 2017, she noted.

Should NHS England be allowed to go ahead with rationing the hepatitis C drugs, it might set a precedent for any other NICE-approved treatments, Halford cautioned. "If NHS England wants to act outside NICE guidance and cap patient numbers, a change in legislation is needed which should be done in a transparent manner."

Gilead told the Pink Sheet that according to the NICE mandate and the NHS Constitution, "Gilead’s hepatitis C treatments and other NICE recommended direct-acting antivirals should be available on the NHS for all eligible patients with hepatitis C in England (and Wales), if deemed appropriate by their treating physician."

The company said it understood the challenges facing the NHS in terms of budgetary constraints, and that in other countries it had been supporting alternative approaches to procurement. It welcomed "recent indications" by the NHS "that they will now work with the industry to look into ways of implementing such alternative models in England in the near future."

It added that it had "always been and remains ready to engage with NHS England to support increased access, clinical freedom, budget certainty and better outcomes for hepatitis C patients, many of whom who can’t currently access treatment due to run rates and other processes currently in place."

PrEP Funding Headache

Another Gilead drug, the HIV treatment Truvada (emtricitabine plus tenofovir disoproxil fumarate), is proving something of a funding headache for the NHS, this time regarding its use for pre-exposure HIV prophylaxis (PrEP).

Although this use is not yet officially authorized in the UK or the rest of the EU – the company filed a centralized approval application with the European Medicines Agency in January – it has been made available through a research trial and special programs, and can now be accessed through various private schemes.

The only European country where PrEP is currently reimbursed is France, which in January implemented a temporary use recommendation (RTU) for the treatment as part of a diversified HIV prevention strategy (Also see "France Leads Europe In Reimbursing Truvada For HIV Prophylaxis" - Scrip, 5 Jan, 2016.).

Although Truvada has been shown to be highly effective in preventing transmission of the HIV virus in high-risk men, NHS England, which estimates the cost of funding PrEP at up to £20m per year, had argued that under the National Health Service Act 2006 it did not have the power to commission PrEP, and that this was a matter for the local authorities because it was a preventative public health measure. The local authorities disagreed, saying they did not have the money to pay for PrEP.

The decision was challenged in the High Court by the National Aids Trust (NAT), and after a hearing on July 13, Mr Justice Green ruled that NHS England had "erred in deciding that it has no power or duty to commission the preventative drugs in issue." He said that in his judgment NHS England's powers included "commissioning for preventative purposes, and this includes for HIV-related drugs."

In an Aug. 2 statement, NHS England said it had been advised that the court's ruling interpreted the legislation on NHS England's role and functions "in a way that is inconsistent with Parliament's intention," and that it had been granted permission to appeal the judgment at the Court of Appeal.

NAT said the ruling showed that NHS England had acted unlawfully in withdrawing PrEP from its decision-making process, and that it was perfectly lawful for NHS England to commission PrEP. But it said it was "enormously disappointing" that NHS England had decided to appeal the ruling, "especially given the wide ranging and well reasoned arguments it contains."

There will now be a 30-day public consultation on PrEP, and an NHS England committee will consider the case for commissioning it, NAT added.

Cut Price To Secure Funding?

NHS England confirmed that it would publish a draft policy proposition for the potential commissioning of PrEP for consultation as soon as possible. However, PrEP will still have to compete for funding with a range of other products that are also covered by the various levels of specialized commissioning.

NHS England said that considering the drug for commissioning "does not imply that PrEP – at what could be a cost of £10-20 million a year – would actually succeed as a candidate for funding when ranked against other interventions." And it suggested that Gilead might want to offer a lower price to boost its chances of success.

NHS England's director of specialized commissioning, Dr Jonathan Fielden, said that "in those circumstances, Gilead – the pharmaceutical company marketing the PrEP drug Truvada – will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned.”

NICE Looking At PrEP Evidence

In the meantime, NICE said it has been asked to conduct an evidence review of PrEP in high-risk groups, noting that as with any new intervention, PrEP must be properly assessed in relation to clinical and cost effectiveness. "This evidence review signifies the next step forward and will inform any subsequent decisions about commissioning," the institute said in an emailed statement. "It will look at the evidence for effectiveness, safety, patient factors and resource implications."

The NICE evidence summary, which will be published in the autumn, will run alongside a pilot scheme looking at the effectiveness of the product that is set to start this summer with funding of around £2m.

The high prices of new innovative drugs are a recurrent theme at present, and hit the UK headlines again when the revamped Cancer Drugs Fund (CDF) was formally launched at the end of July (Also see "New UK Cancer Drugs Fund Dismays Pharma, Charities" - Scrip, 1 Aug, 2016.).

Under a new approach, all new cancer drugs will be referred to NICE, which can recommend them for routine commissioning. If they appear promising but the evidence is not strong enough for routine use, they will be given a conditional recommendation by NICE and made available to NHS patients with interim funding from the CDF.

NHS England said the new approach meant patients would be able to access promising new drugs much earlier, although industry complained that the NHS had not listened to its concerns about the expenditure control mechanisms, and that companies were expected to underwrite the risks of managing the CDF budget.

From the editors of Scrip Regulatory Affairs.