Pharma Is Shifting Clinical Trials Out Of The UK
14 CommentsBy Ed Silverman // June 26th, 2008 // 8:10 am
Take Roche. The drugmaker balked at providing the National Institute for Clinical Health and Excellence, or NICE, with cost-effectiveness data for its Avastin cancer med. NICE chairman Michael Rawlins claims Roche “would rather not supply the drug in the UK than risk a negative opinion,” according to The Financial Times. And so NICE has advised the UK National Health Service not to underwrite the med, which is used for first-line lung and breast cancer treatment.
But the stand-off is the most high profile instance of growing tensions over the sharply escalating cost of cancer treatments between UK and pharma, which are cutting back on clinical trials in the UK, the FT writes. And Pfizer, Roche and Merck-Serono have all told the paper they have or will reduce the number of patients enrolled in trials for life-threatening diseases such as cancer.
The drugmakers say they are increasingly frustrated that NICE continues to advise the NHS against using their meds. The result, the drugmakers claim, is that few UK patients are receiving “gold standard” treatment so there is too small a group against which to compare their experimental drugs, according to the FT.
Chris Brinsmead, head of the UK arm of AstraZeneca and newly appointed president of the Association of the British Pharmaceutical Industry, says a sample of just four drugmakers revealed that more than 20 trials had failed to get off the ground since the start of last year because they could not recruit patients.
“Two or three years ago, this would have just been hypothetical,” he tells the FT, stressing that the UK’s relative share of global clinical trials was already in decline although absolute numbers were stable. “It would be a great shame if the trend continued.”
The tension comes after health secretary Alan Johnson last week announced a review that could pave the way for patients to pay more fees for cancer drugs the NHS refuses to buy without losing the right to NHS care for the rest of their treatment, the paper writes. Avastin has been at the center of the dispute, with a price of more than $7,000 a month for most patients.
Nice had already rejected the drug as not cost effective for bowel cancer, where dosage costs about nearly $4,000 a month, prompting patients to buy it privately. The agency also recommended against the use of Merck-Serono’s Erbitux for colorectal cancer, although the drugmaker had not provided data becuse its licence had been modified and it would be resubmitting data for new applications.
A Roche spokesman confirmed the drugmaker will not provide cost-effectiveness data to Nice for Avastin’s new uses for breast and lung cancer because its own calculations showed it would be too expensive to meet the agency’s criteria. When asked if Roche could have simply reduced the price, he tells the FT that “other healthcare systems seem to think it’s fairly priced.”
Matthew Holford
When I was a kid, it was standard that the person whose ball it was, got to play centre forward (I’m talking soccer, here, of course). The reason for this was because if one didn’t get to play centre forward, one took oneself and one’s ball home…
Trouble is, by the look of NICE’s comment, Roche’s ball was flat, anyway.
Matt
Jack2
Matt,
NICE applies a standard of ~$50,000/quality adjusted life year or QALY. This means a drug must cost $50,000 or less per additional year of perfect health it adds to a person’s life. Most 1st world nations*, although they don’t analyze the drugs as systematically as NICE, use a much more generous standard to define cost effectiveness (eg a drug might be cost-effective if it costs $100k/QALY).
IMO, The UK seems ready to bend over backwards and do whatever it can to keep pharma companies in the UK other than pay for new branded meds.
*My gut tells me that Canada might operate under the same standard as NICE, or an even stricter standard, but I don’t have anything to back that up.
Bruce
Jack2
Canada is more third world than first world in its reimbursement of oncology drugs. And it isn’t a national reimbursement; each province determines what drugs are covered.
I am not sure what the standard is for QALY. But I have worked on brands that have been approved with less and more than $50000
Cheers!
Bob Freeman
There’s something of a disconnect between official policy and the real world at the provincial level(s) in Canada. They have guidelines that call of QALY-based cost-effectiveness analyses but the reality is that decisions are based on cost-minimization analyses where the financial impact of the new drug on the drug budget is assessed.
Jack2, did I read somewhere that the UK’s NICE may raise the threshold to $120,000? (Whatever that is in Pounds Sterling).
Jack2
With the way the dollar’s gone, I assume $120k = 12 pounds.
Bob Freeman
You may be right
Chris
There have been numerous reports that highlighted the shift of trials away from the EU, including UK. In 1997 9% of US-initiated trials were led by non-EU principal investigators; this grew to 29% in 2007. The fastest growth in the past five years has come from India, China, Russia and Argentina.
Back in May the European Commission and the pharmaceutical industry unveiled a €2bn (£1.6bn) partnership to try to halt the EU’s declining international role in medical research. About the same the UK govt antagonized the industry by failing to enter into discussions on pricing.
I took part in a workshop recently organized by the UK govt to try to explain the measure they are taking to attract clinical trials back to the UK. Some improvements for sure but a lot of lost ground needs to be made up – getting NICE on track would be very helpful I think.
Jack2
My understanding is that the UK government, which periodically renogotiates (and lowers) drug prices, renogotiated earlier than they said they would - even though drug expenditures were below forecast.
harry harrinordiquy
The NICE threshold is not the main issue with access to new cancer meds in the UK- the fact that about 14 major markets worldwide reference their prices to the UK is what is keeping new biologics from the NHS market.
Everyone knows where the goalposts are with NICE - less than £20k per QALY gained, it’s a definite yes, between £20k-30k and its a probable yes.
Companies can submit a price that will pass that cost-effectiveness hurdle if they want to - but they don’t because a low price in the UK means a low price in all those other markets.
Matthew Holford
Jack2 wrote:
“…IMO, The UK seems ready to bend over backwards and do whatever it can to keep pharma companies in the UK other than pay for new branded meds…”
Yes, it’s interesting, isn’t it? Blair, for one, was certainly very keen to promote the UK as the kind of place that clinical trials could (should?) be carried out. The MHRA, of course, was touted as a blue chip world leader in pharmaceutical regulation, and this kind of rubber-stamping would obviously be massively beneficial to the Worshipful Company’s marketing effort. However, it seems questionable as to just how world-leading the MHRA actually is.
Leaving that aside, there is a duty to the public purse. If the cost of a drug is the only impediment to it not being passed for use on the NHS, then that seems fair enough - a hurdle is a hurdle, as long as it’s consistent. Moreover, the fact that the UK has a tougher standard than (most) others, is presumably well known. As such, I don’t see that a refusal to issue permission for use on the NHS really impacts upon the perception of a drug.
I’ve kind of lost track of where I’m going with this, so I’ll just tell you what my perception of the thing is, as much to refocus myself, as anything else: it seems to me that the issue of staging trials in the UK has been linked to NHS use of new drugs. I don’t see that they are in any way connected, which leaves me with only one conclusion: the Worshipful Company is attempting to use the trials issue as a bargaining chip, in order to pressure NICE into granting permissions. Given what I know about the way that the Worshipful Company does business, it’s my perception that that kind of action is certainly seedy enough for it.
Matt
Chris
As I understand it the UK lost ground to other countries largely because of the time to initiate studies. Bureaucracy and loose coordination of site approval made it a nightmare to plan and conduct studies to a timetable and budget. Some of the new moves are intended to strip out a site’s local authority to hold up a study’s progress by undue review etc and to expedite approvals. NICE is a part of the system in terms of protocol review etc. Of course costs will still be higher than other, non-EU centers, and patients will also be more readily available - depending on what’s being studied - in other countries. No doubt the quality of research is high but many companies have been discouraged and it will take time to win back their confidence I suspect.
anon
Good for NICE. They are protecting patients first before the mighty buck. The NHS have recently partnered with Pfizer Health Solutions -very dangerous mix, as politicians in the UK are trying to court drug companies. It will end the same way as the VA fiasco in the US. Just give them a few years.
Former pharma Marketing Exec
Jack2 - you’ve got it right, the trials are a bargaining chip. NICE has been asking for years for this information and they have been very consistent with their demands. Pharma knows up front what it must comply with.
The problem is that the Pharma companies turn around and instigate the patient groups to make NICE the bad person (good cop - bad cop). When it comes to cancer drugs, I know first hand, having worked in the area that some have profit margins of close to and sometimes better than 90%. Since the government is trying to cover these costs, it is only fair they be allowed to negotiate - let’s face it there is plenty of room to do so.
Companies should make a profit, otherwise why would they bother. Governments can’t tell you how much you can make or should be allowed to make. However, I have to wonder when the high profits actually cross over the line of fraud or racketeering.
So, yes the clinical trials are the bargaining chip, but really it is the patients lives who are being played with. They are essentially holding the government hostage and with holding treatment to patients who would not be able to access treatment in some cases were it not for a trial.
Pharma better think about this strategy - this is going to backfire.
Jack2
I wouldn’t call it holding the government hostage.
Roche stated they won’t even try because NICE won’t support it as cost-effective (and they’d rather not have to deal with NICE’s rejection when they negotiate with other governments/US insurers).
I don’t know where you’re getting the profit margin data, FPME, does it just account for the manufacturing costs?
If the profit margin is so high, why are pharma companies simultaneously laying off employees and returning below average stock appreciation to share holders? Are they just throwing all of this money from their giant profit margin in the garbage?