Posts made in June, 2012

First ‘Added Benefit’ Net Price In Germany Pulls Brilique Down 17%

Posted on Tuesday, June 26, 2012

It could have been a lot worse. Earlier this month, after five negotiation rounds, AstraZeneca and Germany’s statutory health insurance fund association, the GKV, agreed a price for clot-buster Brilique (Brilinta in the US).  The price came in at about 17% below AZ’s original ‘free’ price — including the country’s mandatory 16% rebate. As the first drug to go through — and emerge from — Germany’s no-nonsense new reimbursement system (AMNOG), Brilique’s price sends some important signals to the rest of the industry. The first (and most important) is that the actual prices of new drugs in Germany — negotiated on the basis of an added-benefit score given to products based on their effectiveness relative to a chosen treatment standard — will indeed be published, at least for the foreseeable future. That was a subject for debate (and still is, in political circles), but the law as it stands promotes price transparency. It’s industry’s loss, given Germany’s position as a reference state for over two dozen other countries. Secondly: Brilique’s price — E905.20 annually ($1,127), compared to a E1092 list price — suggests that German authorities aren’t out there to deliver an immediately fatal blow to pharma. Considering the mandatory 16% rebate, the cut was only about 4% (from E2.08 per day,...

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Time to Knock RCTs Off Their Perch, Says NICE’s Rawlins

Posted on Friday, June 22, 2012

It’s about time randomized controlled trials (RCTs), the bread-and-butter of clinical drug development, were knocked off their perch at the top of the evidence hierarchy. That’s the view of NICE Chairman Michael Rawlins, delivering the annual Office of Health Economics lecture at the Royal Society of Physicians in London on June 18. It’s a view worth noting – and exploring – given that Rawlins helms what’s arguably the most influential Health Technology Assessment body in the world. His conclusion – that decision-makers including NICE should consider a far broader evidence base, including observational studies – may comfort pharma, but regulators have a long way to go. Most drugs are approved on the basis of RCTs – trials that randomize patients to either a treatment arm, or a control arm, assume no difference between them, and then assess the probability that observed differences in outcomes between the two groups are significant or occur by chance. RCTs have well-known advantages, Rawlins conceded. They include minimal bias (each patient has the same chance of getting the treatment, or not), minimized chance of random error, and simple, widely accepted statistical methodology and criteria for significance. But Rawlins outlined how RCTs are only poorly generalizable to the wider population, in terms of patient numbers,...

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The Ugly Truth: Pharma’s Poorly Placed to Address Payor Pressures

Posted on Tuesday, June 19, 2012

That was the message from Citi’s healthcare conference held in New York back in February. It’s not a new message, but as with any information that’s vital to a sector’s future, it has to be told again and again. So just  how ugly is this ugly truth: well, really ugly if you’re GSK with a payor-unfriendly portfolio including the likes of primary care drug Advair (class competition from Symbicort) and late-stage pipeline candidates like diabetes me-too  Syncria.  No wonder GSK’s comments on the EU reimbursement environment in particular were “more negative than peers'”, writes Citi analyst Andrew Baum. Some of this was playing safe to avoid missing expectations, as GSK did in its last quarter results; most of it is just reality. Things aren’t, apparently, so ugly if you’re Roche: Baum claims the cancer specialist suggested there have even been signs of improvement on the European pricing front since last year. But it’s all relative: that optimism just reflects a slower rate of price decrease. By and large, writes Baum, “company momentum to build the value proposition for their products is poor.” And that will matter increasingly as pricing and access pressures in the EU worsen, and as the US enters a “deflationary pricing environment” in the second half of this...

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ASCO Highlights New Drugs, ISPOR How They’ll Be Paid For

Posted on Monday, June 11, 2012

  It was perhaps a sign of the changing — but not changed — times that last week’s ASCO meeting, highlighting the next-generation of promising new cancer drugs, overlapped almost perfectly with a gathering designed to help figure out how these new treatments will be paid for. ISPOR (the International Society for Pharmacoeconomics and Outcomes Research) held its annual jamboree in Washington DC June 2-6, making it very tricky for any single person to understand both the clinical strengths of the latest cancer treatments, and how well those might sit with cost-pressured payers making tough coverage choices. The Real Endpoints team took a stab at it, though. Find out what we learned by joining our June 14 webinar, “Reimbursement Insights From ASCO: More Drugs Means More Cost Pressure”. As it happened (by design, we wonder?) the third plenary session at ISPOR on June 6 – a full 24 hours after the crowds had left ASCO – focused on performance-based risk sharing arrangements. These schemes – aiming to link the price of a treatment to the outcome it generates – are arguably most pertinent to expensive cancer drugs that don’t, sadly, work for all patients. Now sure, we know many pharma remain resistant to risk-sharing deals (why share risk unless...

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The Healthcare Round-Up: May 27 – June 1

Posted on Saturday, June 2, 2012

Pick up your jumbo pack of toilet paper –and health insurance too. What started as a quiet partnership between club warehouse wholesaler Costco and insurance giant Aetna has now expanded to include relationships in nine states with two more pending approval.  Two years ago, the two joined forces to provide Costco Personal Health Insurance, a health insurance program that offers consumers five options in terms of medical and dental coverage.  Costco sees the tie-up as a means of both diversifying into new product areas and providing “value” to customers via access to a provider network of more than 500,000 primary care and specialty physicians, discounted pharmacy drugs, and online wellness tools and programs. (The other big box store making serious noise about moving into healthcare is Walmart.) For Aetna, the expansion of the partnership shows its commitment to the so-called retail insurance market. One of the underpinnings of the Affordable Care Act is the individual mandate and creation of health insurance exchanges to provide consumers with medical benefits outside the confines of traditional employer-sponsored insurance. Many insurers believe that their future growth depends on enrollment in these exchanges; Aetna has been among the most aggressive in inking alliances or mergers that allow improved benefit designs for exchange users. And...

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