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 –...

Learn More

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...

Learn More

Patient-Based Pricing: An Answer To The Soaring Cost of Innovation?

Posted on Friday, September 21, 2012

Roche’s investor day on Sept. 5 provided heartening news for breast cancer patients. Executives outlined an array of increasingly targeted therapeutic permutations to combat the tumor, building on its leadership with Herceptin. But payers will have come away worried. The slew of new drugs, combinations and conjugates points to rapidly-multiplying per-patient costs, as (likely) premium-priced individual treatments are teamed up. Roche seems to be aware of the tension. Even as it promoted more effective versions of existing blockbusters like Herceptin, it also discussed a new model for how such drugs ought to be paid for: patient-based pricing. Marketing chief David Loew talked about moving “from pack-based to patient-based pricing”, borrowing from a concept that is gaining traction scientifically –personalized medicine—and applying it to the commercial marketplace. “Different prices will be applied…depending on indication, setting, and combination,” he told investors. How this works without causing administrative chaos is unclear — but the alternative, sum-of-the-parts pricing, is equally nightmarish. Those holding their breath for the era of cheaper Herceptin (whose patents are due to expire in 2014 in Europe and five years later in the US will likely have to wait far longer. That’s because Roche has redefined the boundaries on  its Her-2 breast cancer franchise, conveniently expanding Herceptin’s commercial life cycle with...

Learn More

German Scoreboard: Payers 1, Pharma 1

Posted on Thursday, March 29, 2012

AstraZeneca and other biopharmas wait with bated breath for the first drug price tags to emerge from Germany’s new early added-benefit assessment process. So who’s winning as this hastily-introduced system undergoes its final tweaks? For now, we think it’s 1-1,  payers and pharma. But that score could soon change. Industry has lost out on reference pricing: if negotiations between sponsors and the sick funds association hit the wall (as several are expected to do, especially in the early days), then an arbitration committee will refer to a European reference price made up of prices from a list of 15 European countries, including beleaguered and bankrupted Greece.  Calls for the basket to include a far shorter list of wealthier and healthier economies — as is applied, for instance, to vaccines prices — were ignored. But orphan drug sponsors will be reassured that Germany’s reimbursement authority the G-BA has declared that these niche drugs will only undergo benefit assessments only if and when they hit the E50 million sales threshold. That follows the snafu around InterMune’s IPF treatment Esbriet — the system’s guinea-pig orphan — which HTA body IQWiG declared to be of little or no added-benefit once side-effects were taken into consideration.  G-BA had to paper over this high-profile decision...

Learn More

Is France Creating Its Own NICE?

Posted on Monday, March 26, 2012

Sort of. It seems that the French are getting more comfortable with the idea of calling health-economics by its real name, and of carrying out explicit cost-effectiveness evaluations a la NICE in the UK. Equally worrying for pharma is that France — with its top-ranking pharma-per-capita spend — is also looking to its other neighbour, Germany, for ideas on how to further tighten entry hurdles for new pharmaceuticals. The new HTA acronym to note: CEESP, the Commission d’Evaluation Economique et de Sante Publique (the commission for economic evaluation an public health). This body, until recently buried in an advisory capacity within the corridors of the country’s overarching drug reimbursement body, HAS, has had its teeth sharpened. Thanks to the latest iteration of France’s finance and social security law, CEESP now has the same legal status as HAS’ powerful Transparency Commission (which basically determines reimbursability). It will analyse just how watertight companies’ economic models are for their new drugs, and that will inform decisions by the country’s drug pricing agency. Furthermore, the pricing agency may soon empower CEESP to carry out cost-effectiveness analyses of new drugs prior to reimbursement decisions. To date, CEESP has only rarely commented on the cost-benefits of individual drugs. As such, its bumped-up role (with legal underpinning) marks “a...

Learn More

Medco Enters Europe: One Company’s Hurdle Is Another’s Opportunity

Posted on Tuesday, February 21, 2012

With falling prices and growing reimbursement hurdles, Europe is the last place most pharma want to be right now. One man’s hurdle is another’s opportunity, though. So it is for Medco, the US-based pharmacy benefit manager, which has recently launched a Europe-focused international operation, underpinned by various legacy collaborations including in Germany, the UK and the Netherlands. The idea: to apply its US expertise and experience in the European context, where different systems and different stakeholders face nonetheless similar challenges. And yes, they’re mostly around cost. Europe spends $1.7 trillion annually on health care, the vast majority in chronic diseases. Most if not all of the EU 27 are seeking to rein in health spend, and realizing (after plenty of attempts) that simply cutting drug prices won’t work. Enter Medco. It’s essentially trying to export to the EU its US patient adherence programs (or “advanced clinical solutions”) and mail-order/specialty pharmacy experience to help European payers improve the efficacy and outcomes of the drugs they do pay for. Much of the focus thus far has been in Germany, Europe’s largest market, where Medco in October 2011 bought out a joint venture with wholesaler and service provider Celesio AG. As a result of this, Medco already provides medication to patients on behalf...

Learn More

The Healthcare Round-up: 2/7 -2/13

Posted on Tuesday, February 14, 2012

What’s better than a box of chocolates or a dozen fair trade, organic red roses? A #healthpolicyvalentine. It’s cheaper too. Wonks and journos quickly embraced the nerdy Twitter hash tag created last week by Health and Human Services staffer Emma Sandoe. Notable gems included: Let’s grow Medicare-eligible together I know I am being inpatient, but how about a private exchange? I want to put the oh! in your ACO. Roses are red, violets are blue. I could never ration my love for you. Meantime, here are the notable gems in Real Endpoints’s healthcare round-up for the week of February 7-13: Pfizer’s Lipitor Tactic Isn’t Working: At least in the coverage department at WellPoint. On February 9th the insurer said that as of April 1, it will stop covering Pfizer’s Lipitor in preference for generic atorvastatin. The “no coverage” decision is one of the most visible signs yet of what payers will do to blunt the impact of discount or co-pay cards. (WellPoint had already decided in early December to make branded Lipitor a “tier 3”, non-preferred drug with generics sold by Watson and Ranbaxy given “tier 1” coverage.) Last fall as Lipitor lost its patent exclusivity, Pfizer announced a controversial program that provides the cholesterol-lowering medicine for $4, effectively diminishing...

Learn More

Building The Greater Real Endpoints Community

Posted on Tuesday, January 17, 2012

  You know that old saw “it takes a village”? Before you roll your eyes, consider this: the same underlying premise embodied by this oft-uttered phrase is what’s driving the new openness called “externalization” at drug and device makers. Simply put, in the past few years, product makers have realized that they don’t have a lock on innovation and need to find ways to access new ideas as they reshape their pipelines. So what are they doing? Partnering. We want to partner too. At Real Endpoints, we are well aware that the rapidly changing world of reimbursement makes it impossible to cover the news flow to the degree — and with the rigor– to which we aspire all the time. And we’re also well aware that while we may offer one take on an event, there may be other opinions and analysis that are valuable, both to the readership and to us. We want Real Endpoints to be a forum where ideas about reimbursement are exchanged and debated. That means opening RE to the wider community, not just in the comments section, but in terms of the actual content provided. As such, one of our goals is to bring you a steady stream of thoughtful guest posts on topics...

Learn More

A Biosimilar Deal Making Bonanza

Posted on Thursday, January 5, 2012

Affordability matters to the branded drug industry just as much — if not more — than scientific innovation. Skeptical? Look no further than the trio of biosimilar deals in December 2011. On Dec. 6, Biogen Idec announced a $300m development and manufacturing joint venture with Korea’s Samsung. A couple of weeks later, Momenta, an expert in product characterization, signed a  biosimilars development deal with Baxter that may include up to six products. But most significant in our minds was the deal in the middle: Amgen’s Dec. 19 announcement that it, too, was jumping on board the biosimilars bandwagon, via a long-term, cancer-focused biosimilars tie-up with generics firm Watson. Even this innovative biotech sector pioneer, whose past position was often interpreted as vehement opposition to biosimilars, is acknowledging that cheap copies have their place. And not just a place; Amgen thinks doing biosimilars create shareholder value.  It thinks they’re a win-win, offering ‘’affordable” medicines to the health care system. (Though not, we assume, implying that other biologics aren’t affordable). So “I’m happy about it [the deal] as an Amgen shareholder, and as a citizen,” declared Scott Foraker, VP and general manager, biosimilars, at Amgen. So is this, then, the new kind of innovation – value-based innovation– that’s needed in our payer-driven...

Learn More

Happy Holidays From Real Endpoints

Posted on Friday, December 23, 2011

Real Endpoints will be on holiday until January 2, 2012. Wishing you and yours the very best this holiday season. Peace and joy in the New Year. Thanks for...

Learn More