Posts by viellen

Zaltrap: Now the Price is Right

Posted on Friday, November 9, 2012

Power to the payer. Just weeks after a team of Memorial Sloan Kettering Cancer Center physicians criticized the high price tag of Sanofi/Regeneron’s new angiogenesis inhibitor Zaltrap in a New York Times editorial, the manufacturers responded by cutting the drug’s price in half. In a statement sent to media outlets, Sanofi emphasized its decision to reduce Zaltrap’s price tag was rooted in a desire to ensure patient access to the medicine, and cited “market resistance” as the reason for the dramatic turn of events. “We believe that Zaltrap is priced competitively as used in real-world situations. However, we recognize that there was some market resistance to the perceived relative price of Zaltrap in the US,” Sanofi told The Cancer Letter, which was first to break the news about the French pharma’s pricing decision. For now it’s unclear how quickly this price reduction will filter down to the population to whom it matters most: the patients. Peter Bach, one of the Memorial Sloan Kettering physicians who authored the New York Times op-ed noted: “They came and told us yesterday that they are lowering the price. It’s too soon to know if this will alter the reimbursement rate, which is what affects our patients and is our focus.” So how did...

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Hurricane Sandy Disrupts “The Disruptors”

Posted on Monday, October 29, 2012

At Real Endpoints, we know the importance of showing mothers respect – especially Mother Nature. It took a storm the magnitude of Sandy to disrupt “The Healthcare Disruptors”. But with a hurricane wrapped in a Nor’easter bearing down on the East Coast – and continued uncertainty about what the coming days may bring – the wisest course of action was to postpone the Real Endpoints Symposium until 2013. We had a committed audience attending – and a stellar line-up of speakers who are steadfast in their promise to speak at a date TBD. We hope the few months delay means an even bigger audience will be able to tune in. If you’re at a drug or diagnostic company, it can often seem as if innovation is under siege.   And if you’re at a payer, it can just as often seem you’re fighting a battle against needless, expensive new products. At Real Endpoints, we believe new reforms that prioritize quality of care above volume of care create fresh opportunities for payers, providers, and manufacturers to collaborate – to contain costs and produce breakthrough medical technologies. In the coming weeks we’ll have more to say about the 2013 event with insights directly from our disruptors. For now, stay in touch –...

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Clinical Utility: An Ever Higher Bar To Clear For Molecular Diagnostics

Posted on Monday, October 15, 2012

Before covering a pricey molecular diagnostic, payers want proof that the test in question is both efficacious and adds new therapeutic value. As Dr. Ira Klein, Chief of Staff to Aetna’s Chief Medical Officer, told Real Endpoints in this recent podcast “we have to understand that the test gives the member or doctor actionable information.” What Klein and execs at other payers want are data concretely linking a particular test to improved outcomes and health benefits, essentially its so-called “clinical utility.” And “that is where we [payers and diagnostic companies] need to talk”, says Ted Snelgrove, chief commercial officer for Crescendo Biosciences, a Bay Area biotech developing a multi-biomarker blood test for rheumatoid arthritis disease activity, and formerly the commercial guru behind Genomic Health’s Oncotype Dx assay. Snelgrove, who will be speaking alongside Aetna’s Klein at our inaugural Real Endpoints Symposium (Nov 1-2, in Philadelphia – sign up here), takes issue with changing evidentiary standards that are growing ever harder for diagnostic makers to clear. To win reimbursement these days, it’s not enough to show via prospective-retrospective trials that a particular test changes a treatment decision. You’ve also got to publish the data in peer-reviewed journals and win the blessing of either influential technology assessment bodies (e.g. BlueCross Blue...

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Sliding Away From Fee-For-Service: How CareFirst Does It

Posted on Monday, October 8, 2012

There’s been a lot of talk about the pros and cons of the standardization that comes from “Cheesecake Factory” style medicine since Atul Gawande published his thought provoking New Yorker piece. Like it or not, forward-thinking physician practices and payers are already embracing the concept. In oncology, look no further than John Sprandio, president of Consultants in Medical Oncology and Hematology and a pioneer in the oncology patient centered medical home movement, and Winston Wong, AVP and pharmacist at CareFirst BlueCross Blue Shield and one of the earliest payer adopters of cancer clinical pathways. Both gentlemen are vocal about the important role evidence-based guidelines play in ensuring both high quality patient care and better outcomes. But there is another equally important reason why individuals like Sprandio and Wong have embraced clinical pathways. They understand these guidelines are an important first step in moving away from traditional fee-for-service mechanisms that reward docs for prescribing ever more expensive products. It’s a subject they’ll both be speaking about in a few weeks at our annual Real Endpoints Symposium in Philadelphia as part of a panel discussion “Radicalizing Healthcare Payment: Why Fee For Service Will Disappear”. In the case of Wong, he’d be the first to emphasize that fee-for-service reimbursement isn’t going away...

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The Prostate Cancer Battle: Can Xtandi’s Convenience Support a Premium Over Zytiga?

Posted on Friday, September 28, 2012

It may be Orion/Endo’s ODM-201, a potentially first-in-class anti-androgen to treat metastatic castration-resistant prostate cancer, that’s generating the most buzz ahead of this weekend’s European Society of Medical Oncology (ESMO) meeting in Vienna. But payers and physicians have a much more pressing concern: how to objectively evaluate two competing anti-androgens, Janssen’s Zytiga and Medivation/Astellas’s newly approved Xtandi, already on the market to treat advanced prostate cancer in the post-chemotherapy setting. A review of peer-reviewed published data suggests both drugs provide essentially the same overall survival benefit relative to placebo, and have similar quality-of-life data. Thus, the battle boils down to this: whether Xtandi’s superior convenience and its freedom from required co-administration with corticosteroids can support its 28% price premium. That could prove an uphill battle. Medivation and Astellas don’t yet have data linking its benefits to either improved outcomes or cost-savings, data points that are increasingly important in the post-reform era of accountable care. Indeed, there are signs that payers may finally be ready to say no to certain oncology drugs, albeit initially by targeting the low-hanging fruit: next generation, chemical improvements of existing molecules (think Abraxane) rather than first-in-class treatments. In a world where clinical pathways that rank medicines based on efficacy, toxicity, and cost are used to...

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Abraxane: The Canary in the Oncology Reimbursement Coal Mine

Posted on Tuesday, September 18, 2012

When it comes to oncology drugs, payers are lousy at saying no. There are good reasons for this, including state mandates and fear of public/political backlash. But none will help curb costs. So if payers know they can’t realistically say yes to everything anymore, in which instances can they say no — and not be pilloried? Abraxane is a reasonable place to start. It’s basically a patient-friendlier version of one of oncology’s old-standbys, the chemotherapy paclitaxel. Abraxane takes one-sixth the time to infuse as paclitaxel and there’s a reduced risk of allergic reactions because of the medicine’s formulation. But based on Real Endpoints’ calculations, all that comes at a price tag that’s forty-three times higher than paclitaxel. And it’s not as if the drug is more efficacious or safer than the generic, according to a controversial Phase III study in metastatic and locally advanced breast cancer patients published at this year’s ASCO. Indeed, in that head-to-head trial, paclitaxel provided substantially better progression free survival and fewer side effects than Abraxane. Celgene and certain oncologists have questioned these findings in light of the non-standard Abraxane dose used in the study. But payers seem to have spotted an opportunity: In a July 2012 survey conducted by Real Endpoints affiliate Reimbursement Intelligence,...

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Managing Molecular Diagnostics: The View from Aetna’s Ira Klein

Posted on Friday, September 7, 2012

What could be more intuitive than providing the right medicine to the right patient at the right time? Alas, the actual implementation of personalized medicine is frustratingly imprecise—and, increasingly, expensive. And that’s a big concern for payers who wrestle with questions of cost, and what constitutes clinical validation and utility when making diagnostic coverage decisions. Not only is it a topic of discussion at our inaugural Real Endpoints Symposium (taking place November 1-2 in Philadelphia). It’s also the subject of this podcast with Symposium speaker Ira Klein, MD, Chief of Staff to Aetna’s Chief Medical Officer and an innovator in oncology reimbursement. A recent white paper published by UnitedHealth Group shows why payers are so concerned about the costs of new genetic tests. Based on their data, UnitedHealth estimates national spending for molecular diagnostics could grow from $5 billion in 2010 to $15 – $25 billion by 2021. And all too often these tests lack a clear clinical rationale;  per United’s data, only about 400 of the estimated 1300 genetic tests on the market are actually evidence based. As Aetna’s Klein notes, tests — like therapeutics — get used in populations where the evidence is shaky. For payers with limited budgets, the concern is such pricey diagnostics won’t lead...

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The Healthcare Round-Up: August 3 -19

Posted on Monday, August 20, 2012

The Olympics (and shark week) are over, the dog days have officially arrived, and here at the West Coast branch of Real Endpoints, it’s back to work as the little people head back to school. (Already!) Given Mitt Romney’s choice of Paul Ryan as his running mate, it’s a sure bet healthcare (especially Medicaid and Medicare) will remain a subject of debate in the run-up to the presidential election. So will the subject of “big medicine” and standardization. Atul Gawande’s New Yorker piece on the topic continues to generate discussion in the blogo- and twitter-spheres as well as #longread recommendations. And it’s no wonder. If you’re like me you’ve probably taken for granted (or refused to believe) that a chain like the Cheesecake Factory can provide high quality food and service for a reasonable price. What Gawande does so well is show you the non-obvious steps that CF uses to manage the process and highlight where—and how—such standardization would make a difference in healthcare delivery. Even better are the specific examples he cites, whether it’s Steward Hospital’s tele-ICU service or Brigham and Women’s Hospital’s attempt to standardize joint-replacement surgery. In the latter case, it’s interesting to see how the creation of a dedicated process –for instance, one that requires...

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Are Choppy Reimbursement Waters in the Forecast for Oncotype Dx?

Posted on Thursday, August 16, 2012

Genomic Health’s Oncotype Dx, a 21-gene assay to predict breast cancer recurrence and chemotherapy response, is one of the market leaders in the brave and expensive new world of molecular diagnostics. Influential payers like Medicare and Blue Cross Blue Shield have endorsed the test, which lists for more than $4000; powerful societies like the National Comprehensive Cancer Network and the American Society of Clinical Oncology have also given the diagnostic their blessing. Meantime Oncotype Dx’s position as standard-of-care has been further codified by clinical pathway providers such as Cardinal’s P4 Healthcare, McKesson’s US Oncology, and Via Oncology. The upshot:  competitors such as Agendia’s MammaPrint and Clarient’s Mammostrat have thus far failed to challenge Oncotype Dx’s primacy. But that doesn’t mean Oncotype Dx’s reimbursement case remains a slam dunk, especially in Europe where payers are demanding more proof of the test’s cost-effectiveness. In provisional guidance released earlier this year, the UK’s health technology assessment agency NICE noted it “could not recommend” Oncotype Dx “because of uncertainty in the evidence of clinical effectiveness leading to uncertainty about the cost-effectiveness.” Final guidance has been delayed until a subsequent September committee meeting. As outlined in this recent Real Endpoints’ Insight, NICE’s stance on Oncotype Dx should be a cautionary reminder to developers of...

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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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