Posts made in July, 2012

Could German Pricing Reform Lead to More US-Style Payer Competition?

Posted on Tuesday, July 31, 2012

It’s an odd, chalk-and-cheese notion: that a typically European, rather socialist form of pricing and reimbursement reform such as AMNOG, Germany’s system of early added-benefit assessment for new drugs, could help drive more free-market-style competition between the country’s statutory health insurance (SHI) funds. There are signs that it’s happening, though — albeit via a roundabout route. That matters to pharma, since more competition among payers means a more aggressive efficacy drive. That may in turn call for direct contracting with individual drug firms, be it to help generate compelling outcomes data, improve adherence or whatever. Unlike most other European payers, Germany’s SHIs are awash with cash. That’s in part thanks to an increase in individuals’ health care contribution rate, as a percentage of gross wage, to 15.5% from January 2011. But AMNOG helped too, causing a drop in drug expenditure of 6.5% in the first half of 2011. This comfortable position means few, if any, SHIs have to charge top-up premiums to their insured in order to cover costs. That means less competition, since, to any individual, all of the 150 or so funds look similar. But less competition is precisely the opposite of what government has been trying to promote since 2009, with reforms designed to increase pricing...

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The Healthcare Round-up: July 20-27

Posted on Friday, July 27, 2012

Might Ultra-Orphans Enjoy An Easier Passage Past NICE? Perhaps. After much back-and-forth, it seems our old friend NICE will, starting in 2013, assess the cost-effectiveness of high-cost drugs for patients suffering from ultra-rare diseases (affecting fewer than 500 patients across England). These kinds of products, increasingly popular with drug firms, generally struggle to meet NICE’s general evidence requirements (given the difficulty of data collection). Thus, in the past, the agency has considered – and approved – very few. Why might things be easier now? Well, because of the road taken to get here: persistent patient (and industry) lobbying earlier this year gave rise to a newly-created Advisory Group For National Specialised Services (AGNSS), a committee set up to advise the government on which specialized services and technologies should be provided via the National Health Service. But just months on, it seems they’ve recognized that NICE is where the HTA expertise lies, so the buck’s passed back. Except that these ultra-orphan drugs won’t go through the standard NICE process; instead, NICE will develop a new “impartial and robust” mechanism for providing independent recommendations on which drugs should be commissioned nationally. Thus, it won’t be all about the £30,000 cost-per-QALY threshold. In a press release, health minister Lord Howe noted NICE...

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Votrient’s European HTA Report Card: Could Do Better

Posted on Tuesday, July 24, 2012

Harmonizing Europe’s patchwork of health technology assessment systems is probably a pharma pipe dream (albeit one that the economic crisis could push closer to reality). But the 28-member EUnetHTA network, created with this lofty goal in mind, has already done something useful for payers and pharma. It has created a European-level relative effectiveness report-card for GSK’s renal cancer drug Votrient. The marks aren’t great. Now ok, they were only mock exams: the drug was part of a pilot scheme, led by the Dutch and French reimbursement authorities. The 60-page document (in its third draft) contains a clear disclaimer that it’s not suitable for decision-making. But the pilot’s aim — to create a rapid comparative effectiveness report for individual medicines at the time of launch, mirroring similar processes already underway in markets like Germany and the UK — reflects real life. As such, the results should provide a wake-up call to pharma, and their publication will only strengthen and legitimize individual payers’ demands. The pilot compared Votrient’s effectiveness to that of Sutent, interferon alfa and best supportive care. The take-home findings (found on pages 7-9 of the report) are dominated by claims of “no comparative data available” and a “very low [grade] hazard ratio”.  Only in one box is the quality of...

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Orphan vs Effectiveness: German Payers Win 11% Discount on Esbriet

Posted on Tuesday, July 24, 2012

InterMune’s orphan drug for idiopathic pulmonary fibrosis (IPF), Esbriet, on July 23 became the second product to be priced within Germany’s new reimbursement system.  The result: an almost 11% discount on the drug’s initial ‘free’ price in Germany (in place since September 2011), on top of the 16% mandatory rebate that for now affects all drugs in Germany. Superficially, that looks like a clear win for payers. But it’s not entirely bad news for pharma either — particularly those developing orphan drugs. Indeed, Intermune management on a same-day conference call declared the net $33,000 per patient, per year price tag for the drug — published clearly for all to see — as “fabulous”. How so? After all, Esbriet’s price in Germany — which used to top the drug price rankings — is now lower than that in at least half of the other six European countries for which prices have been set (in Iceland, Esbriet sells for $43,700 per patient, per year). Yet in fact, Esbriet, as the pioneer orphan within Germany’s hastily-implemented new system, has emerged relatively unscathed after a very rocky ride.  In late 2011, it received the lowest possible ‘added benefit’ score from HTA body IQWiG, which advises the German reimbursement authority, G-BA. These scores, granted to new...

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The RE Healthcare Round-Up

Posted on Friday, July 20, 2012

Real Endpoints’ Weekly Healthcare Round-Up has returned. Cue Carol Anne of the ’86 cult flick Poltergeist II – or, if you prefer, the infamous, avenging nerd Lewis (Revenge of the Nerds II) or the exuberant but dorky Stu Price (The Hangover). Feel free to mock our retro-culture cool, but don’t doubt our enthusiasm…or the importance of synthesis. In the six weeks since our last Round-Up, we’ve seen the approval of Qsymia and Belviq, two new obesity drugs that, thanks to their regulatory delays, now face a much bleaker reimbursement climate; WellPoint’s decision to purchase Amerigroup for a 43% premium to gain dominance in the so-called dual eligible population; and, oh yes, a 5-4 vote by the Supremes to uphold most of Obama’s landmark healthcare plan. As pundits continue to unpack the ramifications associated with the healthcare law, the hot-button issue now is how the constitutionally de-clawed portion of the law, Medicaid expansion, will unfurl. Already several governors, especially Texas’s Perry have spoken out about the downsides of Medicaid expansion, raising the specter of financial ruin.  Maine’s governor Paul LePage plans to go a step further, announcing the recent Supreme Court ruling provides him the power to cut thousands of Mainers from the state Medicaid rolls. Much of the US...

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Could the Euro Crisis Accelerate a Unified HTA Process?

Posted on Thursday, July 19, 2012

As several European economies teeter on the brink of total breakdown, possibly taking the Euro currency with them, what’s the deal for drug pricing & reimbursement? The negatives are easy to spot: acceleration of the already-downward pricing trend in Europe, more blanket price cuts, more patient self-pay (such as in Spain) and more Greek hospitals unable to pay their drugs bills.  Indeed, it’s not even good news from Europe’s engine economy, Germany, where the actual drug prices resulting from negotiations between payers and pharma — based on a drug’s comparative effectiveness score — are published for all to see and reference. Perhaps there’s a silver lining, though. One possible repercussion of Europe’s financial crisis is an acceleration of standards underpinning Europe’s HTA requirements. The economic meltdown means that many of Europe’s countries risk not being able to afford to expand and improve their own health technology assessment agencies, and are thus more likely to look for direction from the likes of NICE (which many — including outside Europe — already do) but also EUnetHTA, a noble, if ambitious, European HTA coordination project. Its aim is to create a series of basic HTA methodological principles and guidance for use across Europe, a single information management system, and to help improve...

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