PharmExec Blog

HTA Concerns From European Drug Agency

EU-flag2The EMA’s Thomas Lönngren has gone public with his disquiet over organizations such as NICE. But pharma still needs more allies in fighting what it sees as the failings of the health technology assessment bodies, says Pharm Exec Europe‘s Brussels correspondent, Reflector.

Europe’s pharmaceutical firms were never very keen on Britain’s influential National Institute for Health and Clinical Excellence (NICE). Industry has long feared that NICE’s judge-and-jury character confers an unacceptable level of unchallenged authority on the guidance it issues about what constitutes value for money. And in an area as contentious as health technology assessment, such power can be a dangerous threat to drug industry fortunes.

But now a new concern has emerged — not just from anxious pharmaceutical industry executives, but from an altogether more surprising source. Thomas Lönngren, executive director of the European Medicines Agency (EMA), has gone public with his disquiet over the role of bodies such as NICE.

His strictures extend further than the UK market, to embrace the entire EU ideal of a single market for pharmaceuticals. He says the single market has been ‘broken’ by the sort of health technology assessments typified by NICE.

Industry has long feared that NICE’s judge-and-jury character confers an unacceptable level of unchallenged authority on the guidance it issues about what constitutes value for money.

In his view, patient access is being impeded by what he sees as new product approval mechanisms based on cost-effectiveness. He insisted on the role of his agency in assessing products in terms of the criteria laid down by EU medicines legislation — of quality, safety and efficacy. Price, he made clear, does not come into the equation at the medicines agency.
Lönngren’s words are music to the ears of a pharmaceutical industry increasingly nervous about the impact of health technology assessment, and above all about its potential abuse as a fourth criterion for product approval.

Industry executives have latched even more energetically onto suggestions that Lönngren made about these value-for-money assessments undermining the work of his agency.

The agency boss has highlighted what he sees as risky moves to assess the cost-effectiveness of products in off-label use. He cited recent steps by UK health authorities to urge NICE to conduct an evaluation of off-label use of Avastin in age-related macular degeneration.

Lönngren indicated that he was unhappy with this development. How could his agency assure its responsibilities for patient safety if other authorities were encouraging use of a product in areas where no risk-benefit evaluation had been made, he asked.

The industry is repeating Lönngren’s words as widely and as often as it can — doubtless out of the same concerns for patient safety, but also conscious that assessments by NICE are already used to beat down prices for products in their authorized indications, and extending this practice into product comparisons for off-label use opens up a Pandora’s box of threats to reasonable evaluation.

An ally in Dalli?
Getting the head of EMA on the right side of the argument, however, is only part of the battle. European pharmaceutical executives face a tougher job in persuading national health and social affairs ministries of the merits of their case. They could do worse in seeking allies within the other major European Union player — the European Commission. But will the new Commissioner for Health, John Dalli, come down on the safety side of the argument, or defend the need for ever harsher scrutiny of drug bills?

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