Arrangements need to be put in place to ensure that the National Institute for Health and Care Excellence (NICE) can access all the evidence underlying product licensing decisions taken by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), says the National Audit Office (NAO).Because NICE has no automatic access rights to manufacturer information submitted to either EMA or the MHRA, the Institute’s legal position is not as strong as the regulators, and this leads to duplication of effort by NICE and also the possibility of gaps in the evidence available to it, says the NAO, in a memorandum sent to the House of Commons Committee of Public Accounts (CPA).
NICE should also require manufacturers to give assurances that that they have confirmed at a global level that the evidence submitted is complete, says the memorandum, which examines the availability of clinical trial information when medicines are licensed and appraised for use in the NHS, and also the decision to stockpile Roche’s antiviral Tamiflu (oseltamivir) for the treatment of pandemic influenza.
Between 2006-07 and 2012-13, the Department of Health purchased nearly 40 million units of Tamiflu, at a cost of £424 million at 2011-12 prices, the NAO reports. It says it has received correspondence from a number of Members of Parliament (MPs) raising questions about access to all clinical trials information for UK regulators when licensing and appraising new drugs, and about the decision to stockpile Tamiflu.
"A key concern was that, without full clinical trial information, public money could be spent on ineffective medicines," it says.
The NAO’s investigation has found general consensus that Tamiflu reduces the duration of flu symptoms and in certain circumstances prevents flu, when administered promptly, but that there is less consensus about the extent to which Tamiflu reduces complications, and hence hospitalisation and death rates. Published evidence analysing the extent to which complications are reduced has not been accepted in some of the assessments and has been the focus of critiques by the Cochrane Collaboration of the evidence base for the drug's efficacy, it notes.Turning to the stockpile, the NAO reports that between 2009-10 and 2012-13, 2.4 million units of Tamiflu were consumed in the UK, primarily during the influenza pandemic of 2009-10 and that, over the same period, 10 million units were written off. Some write-offs are inevitable, as the likely long periods between pandemics means stock will reach the end of their shelf life without being used.
However, of these 10 million units, 6.5 million were written off before reaching the end of their shelf life in 2009-10, at a cost of £74 million, due to the Department being unable to verify that Tamiflu stock distributed to the NHS during the 2009-10 pandemic had been stored correctly. This was because of poor record-keeping by the NHS, says the Office.To reduce the risk of such unnecessary write-offs, the Office calls on NHS England and Public Health England to ensure that all providers of antivirals in a pandemic have robust storage and quality control in place during a pandemic, in line with the Department's Antiviral Distribution Framework Guidance, and that the Department should seek assurances from these agencies that this is the case.
Also, when making decisions about stockpiling pandemic medicines, the Department and its agencies should concentrate on building up knowledge about the added value of stockpiling through reducing complications and deaths - if necessary by commissioning additional independent research, it says.And the Department needs to review its guidance and methods for ensuring that those in need of Tamiflu receive it quickly enough for it to be of use, the Office adds.
Commenting on the NAO's findings, CPA chair Margaret Hodge MP said it was "extremely worrying" that the government had spent $242 million stockpiling 40 million units of Tamiflu between 2006-07 and 2012-13 "despite there being question marks over the effectiveness of the drug."
"Although Tamiflu speeds up recovery times, experts do not agree over its ability to reduce complications and hospitalisations," she said.
And it was "a shocking example of incompetence" that £74 million of taxpayers’ money was squandered when 6.5 million units of Tamiflu were written off because of poor record-keeping by the NHS. "There is simply no excuse for this waste," she said.
It is important that NICE and the MHRA assure themselves that they have all clinical trials information, and it is essential - not only for the public purse but for public safety - that the Department of Health carefully examines how it stockpiles medicines in the future, said Lady Hodge, who is Labour MP for Barking.