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Analysis: Creative drug pricing flourishes in hard-up Europe

By Ben Hirschler

LONDON (Reuters) - Fifty percent off the first three months of cancer medicine. Buy a course of eye treatment and get extra injections free. A money-back guarantee if your erectile dysfunction pills don't work.

"Special offers" on prescription medicines are all the rage in state-backed healthcare systems across Europe as governments struggle to balance the books.

Such money-off and pay-for-performance schemes are being fuelled by both austerity budgets and competition from cheap generics, which are forcing drugmakers to be more inventive in showing that their expensive new medicines still offer value for money.

The complex schemes do nothing for transparency - something the European Union advocates in medicine pricing - but they often suit both governments and companies, with the latter keen to avoid commercially damaging cuts in list prices.

"Global companies do not want their list prices to drop because that will have a knock-on effect as different countries increasingly reference each other over drug prices," said Brian Godman, a researcher at Sweden's Karolinska Institute.

"The only way round that is for companies to enter into some form of arrangement with the authorities," according to Godman, who works with various health authorities across Europe researching drug pricing and reimbursement options.

Reference pricing is a growing headache for drugmakers because Greece and other indebted EU states are slashing the prices they pay for drugs, in some cases by more than a quarter, triggering a downward spiral internationally as other countries follow suit.

As a result, Europe's already fragmented pharmaceutical market is becoming increasingly opaque, although one thing is clear: the pressure on medicine prices across the continent is not going to end any time soon.

Drug companies are already hurting, with GlaxoSmithKline, for example, cutting its sales outlook for 2012 in July due to lower European prices.

NICE OR NASTY?

Many of today's complicated pricing arrangements have their origins in pioneering work by Britain's National Institute for Health and Clinical Excellence (NICE), which was set up in 1999 to systematically assess the cost-effectiveness of new drugs.

Its refusal to accept some pricey products has angered patients, and the tough line has forced drugmakers to find novel ways to make medicines affordable - either by offering discounts or making payment conditional on measurable benefits.

It is an approach now being adopted from Spain to Poland, resulting in a patchwork of schemes that can cause frustration among doctors struggling to assess the true cost of treatments.

"It is spreading pretty quickly," said Patrick Flochel, global pharmaceuticals leader at Ernst & Young. "There is a big push everywhere with healthcare reforms."

Britain remains the leader, but Italy has emerged as the second biggest market for so-called risk-sharing schemes, which have been embraced enthusiastically by the Italian Medicines Agency. One reason for this is that drug spending in Italy is tied by law to total healthcare expenditure.

Cancer drugs are a major focus, reflecting the dilemma posed by costly new treatments that may help some patients but often only extend life by only a few months.

Cancer accounts for 15 of the 25 special schemes detailed on NICE's website whereby drugs companies can offer patients ways to access high-cost drugs. It also dominates in Italy, where arrangements typically call for provision of cancer drugs at a 50 percent discount for the first two or three months.

For companies, getting the value proposition right in cancer is a delicate balancing act - and it can only get trickier.

Roche, the world's biggest cancer drugmaker, recently pushed into new territory with the U.S. launch of Perjeta, a new breast cancer drug designed to be used with its existing product Herceptin. It is the first example of a costly targeted cancer combination therapy from a single company.

The result is a treatment that is effective but extremely expensive, with a typical 18-month course of Perjeta plus Herceptin costing approximately $188,000.

Despite that price tag, Perjeta is winning sales in the United States. Europe, however, where the drug has yet to be launched, is likely to prove a lot more challenging.

Roche - which already has German and Italian schemes that cap the maximum price per patient of Avastin, another cancer medicine - will have to weigh more novel pricing schemes as such new combinations hit the market.

"The 10,000-foot view is that we just follow the science and do what's right for patients, and then figure out a commercial model that can work," Hal Barron, head of global product development, said in a recent interview.

HEAD-TO-HEAD STUDIES

Others have cut different kinds of deals.

GlaxoSmithKline struck an agreement with NICE in 2010 offering Britain's health service a straight discount plus an additional rebate if its new kidney cancer drug Votrient failed to match Pfizer's Sutent in a head-to-head trial.

To GSK's relief, Votrient was as good as the Pfizer rival when results were finally reported at a conference last month.

Novartis, meanwhile, pays for extra treatment with its eye drug Lucentis if British patients need more than 14 injections, while in Denmark various schemes tie payments to results for several drugs, including erectile dysfunction pills.

Tying payments to clinical results is an enticing idea for payers, though these schemes are complex to administer.

"There are genuine risk-sharing schemes, where there is real payment according to performance, and then there are a whole host of schemes which are essentially price cuts," said Gary Johnson, managing director of consultancy Inpharmation. "It's fair to say the price-cut type scheme is probably dominant."

(Editing by Will Waterman)

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