Pharma criticises 'heavy handed' NICE affordability test


Plans to cut the cost of expensive new medicines could mean delays getting them to patients in England, according to the UK pharma industry.

NICE and NHS England have been consulting on changes to processes that will fast-track medicines with low budgetary impact to patients.

But also included is a proposal for a budget impact assessment - a kind of 'affordability' check.  This would mean any drug set to cost the NHS £20 million or more a year would trigger affordability discussions between a pharma company, NICE and NHS England.

Above that threshold, NHS organisations will begin talks with drug companies to try to get the price down.

NHS England has pushed for the new budget impact assessment to prevent problems similar to those caused by hepatitis C drugs such as Gilead’s Sovaldi (sofosbuvir). NICE ruled Sovaldi to be cost effective - but this didn't reflect the overall, upfront cost - the affordability of the drug.

NHS England has resorted to rationing to keep its budget impact down, something which has proven controversial with pharma companies and patient organisations.

In 2015/16 NHS spending on Gilead’s Harvoni (sofosbuvir+ledipasvir) and Sovaldi for hepatitis C was £154 million, although AbbVie’s Humira (adalimumab) inflammatory diseases drug had the largest budget impact, costing the NHS almost £417 million.

The industry says that the new affordability check is unfair - as NICE already screens new medicines for cost effectiveness, and the PPRS pricing system limits overall NHS drug spending.

[caption id="attachment_21182" align="alignnone" width="120"]The ABPI's Mike Thompson The ABPI's Mike Thompson[/caption]

ABPI chief executive, Mike Thompson, said: “The ABPI agrees with the NHS England’s objective of developing a workable solution for managing the introduction of new medicines which are likely to create significantly high costs to the NHS.”

“However, given that all new drugs approved by NICE have already gone through a process to ensure they are cost-effective and clinically beneficial, the proposal to impose a £20million budget cap on these medicines is both heavy-handed and unrealistic and will mean more patients face delays in accessing appropriate NHS care.

"Better long term planning by the health service would ensure that major breakthroughs are managed into the NHS in an appropriate and affordable way and with less disruption.”

The ABPI said it supports plans to fast-track medicines with an estimated budget impact of less than £10,000 per Quality Adjusted Life Year.

But it and UK biotech industry association the BIA both warned that NICE’s proposals could delay or prevent access to drugs for ultra-rare diseases.

The consultation also proposes a £100,000 cost per QALY threshold for rare and ultra-rare disease drugs would receive automatic funding.

Above this threshold, ultra-rare disease drugs would receive cost-effectiveness assessments and the BIA and ABPI are concerned this could lead to many such drugs being rejected or delayed.

“We believe that this will have a detrimental impact on the development of new products for those who desperately need them and that this this proposal should be paused while a better solution is identified,” said Thompson.

These new checks on affordability send out a message is in clear contradiction to the government's proposed life sciences industrial strategy.  Theresa May's government is promising to help make the UK a world leading life sciences market, but pharma and biotech says this can't be fully achieved if the NHS doesn't use its new medicines.

This argument is one that will be clearly played out behind the scenes, but as the government is currently refusing to give the NHS extra money to cope with growing demand, it is also unlikely to give way on the new proposals for NICE.

There is some hope that the ABPI and the government could negotiate a new 'value-based' pricing system, but this is  unlikely to emerge until 2019, after the existing PPRS pricing system expires.