Health Technology Assessments

‘DrugAbacus’, a Comparative Cancer Drug Pricing Platform Powered by Real Endpoints’ RxScorecard™, is Launched

Posted on Friday, June 19, 2015

Westport, CT, June 19, 2015 – Real Endpoints (RE) is pleased to announce that its RxScorecard™ is the information technology platform supporting Memorial Sloan Kettering Cancer Center’s DrugAbacus – an interactive tool for considering the basis of cancer drug prices. Conceived by Dr. Peter B. Bach, Director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering (MSK), DrugAbacus was launched at MSK’s DrugAbacus generates a dollar-value for cancer drugs available in the United States (beginning in 2001 with Gleevec) based on a user’s settings for six different domains of potential value including the treatment’s survival benefit, side effects, and the incidence of the condition targeted. Memorial Sloan Kettering licensed the Real Endpoints RxScorecard platform for research purposes so users can generate “Abacus prices” and compare them with actual prices of these drugs at the time of launch in a visual and intuitive format. “We believe RxScorecard is the only tool available that provides a 360 degree comparison of the multiple components of a drug’s value in an independent, objective and systematic approach. We developed the IT platform to make it very easy for users to access our analysis, and are delighted that Dr. Bach selected this platform for DrugAbacus,” said Julie Eskay Eagle, RE’s Vice...

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Wall Street Journal publishes article on new cancer pricing tool from Memorial Sloan Kettering using RE’s RxScorecard technology

Posted on Friday, June 19, 2015

June 19, 2015 – Memorial Sloan Kettering Cancer Center, one of the nation’s top cancer hospitals, has created an interactive calculator that compares the cost of more than 50 cancer drugs with what the prices would be if they were tied to factors such as the side effects the drugs produce, and the amount of extra life they give patients. Please click here to access the article....

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Evidence and Endpoints in Cancer: Can Both Payers and Regulators be Satisfied?

Posted on Wednesday, March 27, 2013

How can oncology drug developers design their trials to satisfy both regulators and payers, and thereby maximize both access and commercial success?  It’s an increasingly urgent question as cancer programs continue to dominate pipelines, and drugs bills. Yet “there’s a fundamental tension” between the clear evidentiary base required to get a drug approved, and the emerging, sometimes inconsistent data sought by payers to justify funding that drug, notes Roy Baynes, SVP Oncology Therapeutics at Gilead Sciences Inc. Above all, he emphasizes the need for close engagement with payers, at least in Europe, from an early stage. Collaborating prospectively with governmental payers may help address the reality that “individual sponsors have little leverage,” he says.  (In the US, it’s not at all clear to us that payers want much to do with pharmas before products get very close to market.  And in oncology specifically, payers still can’t really say “no” to paying for products approved by the FDA; European governments have no such inhibitions.) There are some rules that now beginning to hold across the board, though, notwithstanding often considerable differences in evidentiary standards across treatment-type, positioning, and disease area. Having a “meaningful comparator is obviously important,” point out Baynes, who will be speaking at NextLevel Pharma’s PharmAccess Leaders’ Forum in...

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The Drug Assessment Process: Inadequate and Costly

Posted on Wednesday, January 16, 2013

The more I study it, the more I believe the process of drug assessment by payers and providers needs some serious attention (we’ll pay plenty at the Real Endpoints Symposium, March 11-12). But driving action requires concern — and so, who cares?  Answer is: anyone interested in improving the dismal economics of healthcare.  As we noted here, drug-spend inflation is skyrocketing, thanks largely to the cost of new drugs and, in particular, new specialty drugs.  And the best mechanism we have for controlling those costs is the process, led by Pharmacy & Therapeutics committees, for assessing the value of drugs and establishing utilization guidelines.  But best, in this case, doesn’t mean adequate. Most obviously, the process is redundant.  Several hundred payers and several thousand hospitals all have P&T committees, with associated clinical pharmacy specialists and other research infrastructure, looking at the same materials about the same drugs…and by and large coming up with pretty similar answers. It’s slow and under-productive.  Based on our admittedly unscientific survey, P&T committees at most mid-sized and smaller plans meet quarterly and make decisions on, maybe, 13-15 new drugs per year.  They don’t have the time or bandwidth to re-assess new data on existing drugs that could change their formulary status. It’s oddly limited. ...

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Why Payers Don’t Really Control the Drug Benefit — and Why They Need to

Posted on Tuesday, January 8, 2013

It’s certainly the biggest change in healthcare in my business lifetime: the transformation from a fee-for-service economy fueled by abundant dollars to an essentially capitated world of financial tradeoffs.  The transformation will likely take longer than we expect. (What transformation doesn’t?) Still, payers and providers –and the various big and small service providers hoping to serve them — are already trying to improve  swaths business processes as diverse as connectivity, transparency, and consumer communication (see the David Shaywitz/Tony Wolff skeptical take on at least the digital aspect of all this) . But relatively little of this re-engineering aims at the purchase and management of drugs.  (We’ll be talking about the most important innovations at the Real Endpoints Symposium, March 11-12, in Philadelphia). There are a few experiments on the margin.  Some payers are playing with tougher formularies (e.g., UnitedHealth de-preferred major market leaders Januvia and Humira, with significant success in moving the former’s market share to Onglyza and less success with Humira).  “Pathways” in oncology (attempts to standardize physicians on specific drugs) show promise.  And now that Medicare, through its star ratings, is paying plans to improve adherence, there’s an opportunity for new models that predict when patients will adhere to their meds and when they won’t. (For the...

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As Pressure Builds on US Prices, Is Pharma Ready?

Posted on Friday, December 14, 2012

Free drug pricing in the US has fewer than five years to run, thanks to mounting pressure on health care spend and resulting efficiency drives.  That’s the message to pharma investors, be it from fund-managers speaking at Bloomberg Industries Healthcare event in London on Dec. 10, or from analysts such as as Citi’s Andrew Baum. It’s tempting not to believe it. After all, for now, US drug price increases are actually at a five year high in the mass retail market, according to Bloomberg Industries’ healthcare research director Sam Fazeli. And hospital drug price increases, too, have rebounded since 2009. “For now, the game’s the same in the US: you can price at whatever you like,” he concluded.  With Europe on its knees, status quo in the US is what many pharma are relying on. They’d better make sure they have a plan B when the dream ends, though. “There’s a lot of momentum behind evidence-based therapy and paying-for-performance in the US. We have to be ready to hear about how some of that translates into drug pricing,” warned fund manager Dan Mahony of Polar Capital Holdings at the Bloomberg meeting. Zaltrap provided an early example of drug price pressure in the US: Hit hard by Memorial Sloan Kettering’s decision not to use it –...

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Reimbursement “Furies” Real, But Won’t Avenge Pharma Til 2017, Says Citi

Posted on Tuesday, December 4, 2012

“Beware the Three Furies,” warns Citi analyst Andrew Baum.  In a report for pharma investors published Nov. 29., Baum turns to classical mythology to describe shared savings models, drug pathways and ACOs — the forces that will soon dominate US health care plans. He’s chosen an interesting analogy: The Three Furies were goddesses of vengeance, who punished the wicked for their crimes; they’re also described as “tormenting those who have yet to atone for their sins”. So we, and plenty of others, agree that pharma should be nervous. “Reimbursement, not R&D pressure,” is the is the biggest risk facing pharma investors, writes Baum. But although “alarmed” by the drivers, and potential consequences, of US healthcare cost containment (particularly given the dire state of the EU), Baum reckons drug firms’ earnings won’t feel the full brunt of US pricing pressure “until at least 2017.” He argues that for the next five years, the revisions to the US healthcare system will have the greatest impact on medtech, hospitals, and diagnostics, with less focus on pharmacy-related costs.  Even in the case of drug pathways, singled out as the most important long-term structural risk to the biopharma industry “meaningful adoption will remain slow” in Baum’s view. To back that up, he cites research by...

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HTA Has To Harmonize. It’s A Money Thing.

Posted on Thursday, November 29, 2012

There was bad news and some less bad news for drug firms at the recent NextLevel Pharma Pharmaccess Leaders’ Forum in Berlin, Germany.  The bad news: added-benefit hurdles, in the form of Health Technology Assessments, continue to spread fast as a (mostly) scientific tool for politicians to control access to new drugs. The less bad news: efforts to drive convergence between different countries’ HTA methods are showing signs of success. That may at least help pharma get a grip on how to navigate HTA. And get a grip they must. HTA bodies, like England’s NICE or Germany’s IQWiG, aren’t themselves payers, but they strongly influence payers. Some countries have had HTA for a decade or more, yet pharma still has room for improvement when it comes to dealing with them. “They get about 6 out of 10,” opined Olivier Wong, former senior advisor to France’s health ministry and Haute Autorite de Sante, having come from a state of “not caring.” Pharma should by now be expert in dealing with those who evaluate their products’ benefits. Meeting those evaluation criteria is, after all, probably the single most important factor influencing the size of industry’s commercial return, at least in Europe and several other major markets.  HTA should be up there with...

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Want Better Access? Then Take Some More Risk

Posted on Tuesday, November 20, 2012

Biopharma is an industry seeped in an above-average concentration of risk. Scientific, clinical and regulatory uncertainties add to more typical commercial and market-driven risks. Given that, you’d think pharma execs would be a little more willing to stick their necks out and embrace (or at least explore) change. Some are. They get that payer cost-pressures and pipeline productivity challenges are forcing new, make-or-break approaches to clinical development, payer interactions, and commercial positioning. Yet toward the by-now-rather-less-radical idea of more closely integrating regulatory and HTA requirements, the pharma sector’s attitude is “somewhat capricious,” notes Mel Walker, recently appointed VP Market Access at Otsuka Pharmaceuticals Europe, after six years at GSK. That even a few companies still resist this idea seems odd, since it’s pharma (along with patients) that has most to benefit from a more harmonized regulatory-HTA process. Some drug industry execs are worried that putting regulators in the same room as HTAs — an idea that has been piloted in Europe, in the context of scientific advice, since 2010 — “may lead to HTA somehow influencing regulators to say ‘no’ to more products”, illustrates Walker, who will chair a discussion on HTA/regulatory convergence at the PharmAccess Leaders’ Forum in Berlin later this month. Alasdair Breckenridge, chairman of the UK regulator...

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Drug Approvals Need Shades Of Grey

Posted on Monday, November 12, 2012

FDA’s Endocrinologic and Metabolic drugs advisory committee on Nov. 8 voted 8-4 in favor of recommending Novo’s latest insulin degludec (Tresiba) for approval. The detailed debate and deliberation underscored how unsuitably black-and-white the drug approval process is.  In the end, FDA (just like the European Medicines Agency), will say either ‘yes’ or ‘no’.  Yet the difference between acceptable risk and unacceptable risk among drug treatments isn’t a well-defined one. Nor is the threshold or criteria separating insufficient data from sufficient data. Now, as it happens, in Tresiba’s case the committee also unanimously voted in favor of a post-approval CV outcomes trial, reflecting lingering uncertainties about the drug’s risks.  But that’s unusual — and the conditions, timelines and the potential impact of the results remain unclear. What’s needed is a drug approval system in shades of grey — incremental steps on the way to full approval, for drugs that aren’t definite rejects, nor dead-cert approvals (e.g. most drugs). Programs including FDA’s accelerated approval and EU’s conditional approval go some way towards that, but only rarely. (Just 6 drugs were approved conditionally by EMA between 2009-2011, less than 10% of the total) A handful of projects run by regulators and academics around the world have been seeking, for several years now, to define and progress new, adaptive approaches to...

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