Mals Musings: Are HTAs about excellence or economics?
As health technology assessment organizations try to meet sometimes conflicting goalssaving money and promoting excellencepharma needs to find new routes to get innovation to the market
The fallout from the economic tsunami continues to ripple around the globe.
The impact on taxes, GDP, jobs, and crime have been extensively assessed and discussed; the conclusions are generally bleak.
Healthcare, in most cases, has been handled with kid gloves, given the emotive and politically toxic nature of the topic.
Yet after Ireland's acceptance of a bailout, governments' ability to protect spending areas is significantly reduced.
Over the coming years, balancing the books will mean few if any expenditures will be spared.
Before the latest economic downturn, the healthcare sector already faced a challenge of its own.
The quality and affordability of healthcare was already high on the agendas of many governments.
Health technology assessment (HTAs) organizations like the UK's National Institute for Health and Clinical Excellence (NICE) were presented as part of the answer to the challenge. (For more on HTAs, see HTAs go global: What it means for market access'.)
Can NICE help navigate a path through the current challenges?
Not so nice
NICE started out trying to ensure the public received an appropriate return on healthcare spend.
The diametrically opposing forces of demographic change and slowing GDP already presented a sizeable challenge.
Given the current financial situation, it is right to ask if NICE can still stand for excellence.
I am not so sure... If NICE can still stand for excellence, then it has moved from the business of clinical assessment into the realm of pure magic.
Recent rejections for Novartis (Afinitor and Glivec) and Roche (Tarceva) are examples of the growing tension between NICE and the industry.
Is NICE adapting a position based on the economic outlook or does it have the mandate to pursue excellence?
The answer may not be totally clear yet, but the question is becoming urgent.
Although evidence suggests that Glivec can delay the recurrence of chronic myeloid leukaemia (CML) in certain people who have had a tumor removed, "it is not clear that it increases survival or that it improves patients' quality of life," the NICE's chief executive Andrew Dillon has explained.
Given the likely funding issues going forward, this trend is likely to continue-unless the industry rethinks its approach.
Can quality-adjusted life years' answer the intricate questions posed by modern ailments? Maybe not!
For the industry, it is time to go back to drawing board and find a different route to getting innovation to the market.
We are all talking about value but ultimately speaking about different things.
There is nothing nice about NICE, but I guess that does not come as a surprise to most of us in the industry.
The question is, How do we manage it?
We have to accept that resources are limited and we have to engage in dialogue about how to meet patients' needs effectively.
The current model is heading towards a standoff.
We should proactively begin the tough discussions.