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NHS England's Sovaldi fund: opening the floodgates?

Published on 26/07/14 at 06:37pm

Whilst seemingly more and more barriers are being erected to slow down the adoption of new medicines, there is a new phenomenon in England that is actually trying to speed up market access.

Enter the advent of the silo fund which is designed to allow taxpayers’ money to fund new medicines that have not yet been appraised by NICE, in order to get them to patients as quickly as possible.

The latest funding stream has been enacted by NHS England, which approved an £18.7 million investment to pay for Gilead’s new hepatitis C pill Sovaldi (sofosbuvir) in combination with the antiviral ledipasvir, in April.

The recommendation of the body’s Clinical Priorities Advisory Group (CPAG) means that whilst the drug goes through the NICE process, Sovaldi will be funded for those hep C patients at significant risk of mortality – or who require transplantation.

This means that around 500 patients in England with acute liver failure, and/or awaiting liver transplantation could gain early access to Sovaldi, whereas before they were required to wait for a NICE decision prior to national funding being granted.

This is the second time the NHS has intervened to fund a particular disease and follows the Cancer Drugs Fund (CDF) that came into being four years ago, but this is the first time a single drug has been given its own unique cash stream.

This could well open the floodgates for more pharma firms desperate to gain a silo fund foothold for their new and expensive drugs; but it could also mean pharma will be less willing to lower the price of its medicines.

Sovaldi: an exception to the rule?

This new silo fund is due to a set of unique circumstances, meaning that a duplicate fund for another drug or disease would have to rely on a similar set of conditions, but that does not mean it could not be repeated.

For Sovaldi it has been clear throughout clinical testing that it is a highly efficacious medicine – in fact, it is the most effective hepatitis C treatment currently available.

Recent clinical trial data show Sovaldi can effectively cure the disease in over 90% of patients in just 12 weeks. This is compared to other treatments such as Vertex’ Incivek (telaprevir) and Merck’s Victrelis (boceprevir), which take double the amount of time to treat and have cure rates of around 75 per cent.

The efficacy of Sovaldi has also translated into astonishing sales – hitting over $2 billion in its first quarter for 2014 and $3.2 billion in its second – making it the fastest-selling medicine in the world and on course to break the $10 billion barrier by next year, should this trajectory hold.

This could, theoretically, almost cure the disease in an entire patient population, and would also negate the need for chronic hep C patients to require liver transplants and life-long care, which is a high cost to the NHS.

So it has an impressive efficacy profile but it also benefited from a strong communications drive, notably from the patient group the Hepatitis C Trust that is partially funded by pharma firms, who became a highly vocal advocate for the fund along with use of the drug.

In fact the Trust criticised the NICE process for being too slow for these patients, and welcomed the silo fund in April when it was announced.

On top of this, Gilead was recently voted as the second most respected pharma company in the ‘Corporate Reputation of Pharma’ report for 2014 behind ViiV – the collaborative group of companies that includes GSK and Pfizer, which like Gilead also focusses on infectious diseases.

It has been this three-pronged combination: reputation, efficacy and strong patient group lobbying that led to the creation of the fund. Any other pharma firm would need an equally strong combination if wanted to gain the same treatment, which would not be easy.  

High cure rate, high cost  

But its price tag has proven controversial, and Gilead has certainly not had a comfortable ride in the US where the treatment costs $1,000 (£600) a day – or $84,000 for a full course of treatment.

In fact it was picketed by members of the public last year after it was approved, with some saying it was simply too costly for American hep C patients who have no access to national health services.

US health insurers, who are becoming increasingly vocal over the rising costs of new medicines, also lashed out earlier this year with the leading US health insurer AHIP (America’s Health Insurance Plans) – accusing pharma of ‘taking advantage’ of the insurance system by pricing products at ‘unsustainable levels’.

Writing on the firm’s ‘Coverage’ blog, it said recently: “Sovaldi has shown tremendous results, and it’s the kind of medical innovation we need to sustain. Unfortunately, the drug’s maker has priced it at an astronomical level that is not sustainable for consumers, innovation, or society.”

The cost is much less in the UK, with the NHS estimating it at around £11,661 for a pack of 28 x 400mg tablets. The NHS list price for Sovaldi is £34,983 per patient for a 12-week course, with an additional £2,400 for Roche’s ageing injectable treatment Copegus (ribavirin), which is required for the full course of treatment.

A 24-week dose is expected to cost £69,965 (but this does not include the cost for Roche’s hep C medicines, which will also be a factor).

Although less than in the US, the price tag for Sovaldi is still much higher than almost any other medicine on the NHS, and costs even more than most oncology biologics.

NHS England says it did not take the creation of the silo fund lightly, and has “considered the place of these treatments in current clinical practice”, and found that it “represents the best use of NHS resources”.

It goes on to say that the drug is in fact ‘highly cost-effective’ adding that as it can potentially help stop the need for liver transplants, it is ‘extremely good value for money’ as a liver transplant can cost around £50,000 per patient.

NHS England adds that NICE “will consider its use cost-effective” based on these calculations.

But there has been a mixed response from health technology assessors. The Scottish Medicines Consortium passed the drug for NHS Scotland funding in June for patients with genotypes of the disease from one to six.

But there are some restrictions, as use in patients who have not yet been treated with genotype 2 is limited to those who are ineligible for – or are unable to tolerate – the older injectable drug made by Roche known as Pegasys (peginterferon alfa).

Use of the 24-week interferon-free regimen of the drug, in combination with Copegus in patients with genotype 3, also has the same restrictions.

NICE however, has not read NHS England’s script, having not yet found it cost-effective. In its first round of draft guidance published in June, the watchdog said it was not minded to recommend the treatment.

Explaining the interim decision Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “The available evidence shows that sofosbuvir [Sovaldi] is an effective treatment for chronic hepatitis C in certain patients. However, evidence is lacking for some sub-groups of patients with chronic hepatitis C, and there are also substantial uncertainties in the evidence base presented by the manufacturer.”

The body has asked for more information: specifically it wants further analyses from Gilead for its drug in combination with Copegus, with or without Pegasys, compared with the two treatments in people with genotype 1 and genotype 3 chronic hepatitis C.

It also wants revised cost-effectiveness analyses presented separately for people with and without cirrhosis, with and without HIV-co-infection, and by treatment history. The watchdog is set to make a final recommendation towards the end of 2014.

NHS England says its policy position on funding the drug will ‘be reviewed’ once NICE has published its guidance on the drug, but as yet it is unclear as to how long the fund will be in place if NICE does not recommend the treatment.

The new CDF?

The Sovaldi fund is reminiscent of the government’s CDF that injects £200 million a year until 2016 to fund new oncology products rejected by NICE, or under appraisal by the watchdog.

There have been complaints over such a fund focussing solely on cancer and directed by Whitehall, not least from NICE’s chairman Professor David Haslam, who in a recent interview with Pharmafocus said: “I understand the political drives [around the CDF] – but it’s a pity they’re necessary.”

This Fund will be ongoing until 2016, having begun in 2010 and costing nearly £1 billion – it has certainly increased access to new oncology medicines, but at a high price to taxpayers.

There is little public evidence to suggest it has increased clinical outcomes in cancer, but politically it has sat well with the public, and the media. It has also of course, benefitted UK pharma subsidiaries who are having their new cancer drugs paid for regardless of NICE’s process or decision.

This is especially true for oncology specialists such as Roche, Celgene and Merck KGaA who have had their cancer medicines blocked from funding for years.

Speeding up access

In February this year the UK drugs regulator the MHRA said that Sovaldi and the antiviral ledipasvir should be given as part of a ‘compassionate-use programme’ for chronic hepatitis C virus’. The investment from England’s taxpayers goes one step further than the original recommendation.

A drug typically takes six to nine months from launch in the UK to a decision being made by NICE, as to whether it is a cost-effective use of NHS resources. If the decision is positive, it is then put onto the formularies of local NHS bodies and must be made available within three months.

In all the process could be up to a year – something that late-stage hep C patients may not always have. When looked at in this light, it becomes obvious from both a political and clinical point of view that speeding up access is simply necessary and NICE, being an arm’s length body of the government, cannot take this decision by itself.

But could other firms developing drugs in this area, which may also produce the same elements Gilead has with Sovaldi, also gain a ‘NICE pass’?

Currently Janssen, AbbVie, Merck and Bristol-Myers Squibb – which gained CHMP backing for its hep C drug Daklinza (daclatasvir) in June – all have treatments in late-stage development which could match or better Sovaldi.

It remains to be seen whether these drugs, should they gain European approval, will benefit from a similar fund during their NICE appraisals.

Does the silo fund mean the floodgates will be opened for all new medicines to gain similar exceptions? In reality, the NHS could never afford to do this, and the situation for Sovaldi required a unique set of circumstances that would most likely not be met by others so readily, but that does not mean there is not the possibility for future funds.

The CDF was meant to be a unique response to the challenges of oncology drug access that would not be repeated, and yet Sovaldi has exactly the same national investment. But as with all market access issues, it will come down to strong clinical evidence, reputation and public backing to work.

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