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Real Endpoints’ RxScorecard™ predicted launch failure of major new anti-cholesterol drugs

Posted on Thursday, February 11, 2016

Analysis from 2015 showed that because PCSK9 inhibitors had not proved more than incremental value for most patients, payers would dramatically restrict their usage. Poor Q4 sales show that’s exactly what happened. Westport, CT, February 11, 2016 In a press release issued July 7, 2015,  Real Endpoints LLC (RE) predicted that the two soon-to-be-launched PCSK9 inhibitors from Amgen and Regeneron/Sanofi would not get substantial market uptake. RE based this conclusion on its proprietary tool RxScorecard™, which assesses the relative value of marketed and pipeline drugs from a patient’s and payer’s point of view. RE defines value as a full assessment of a drug’s efficacy, safety, convenience, adherence and economic attributes in comparison to other therapies in the indication. RxScorecard indicated that while both products offered potential efficacy benefits, they demonstrated little incremental value for most patients because of their lack of meaningful outcomes data at launch and their expected high pricing. As a result RE said last July that “Payers will have an extraordinary opportunity to control costs in this class.” That’s exactly what they did. Now that Q4 sales are in for both Praluent and Repatha, the magnitude of their launch failure is clear. Praluent sold only $7 million in Q4; Amgen has not released data on Repatha,...

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‘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 www.drugabacus.org. 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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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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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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Sanofi Blinks First: Zaltrap Price Cut Proves HTA Has Reached The US

Posted on Monday, November 12, 2012

Sanofi’s decision last week to cut the price of its colon cancer drug Zaltrap by up to 50% showed that the US market is no longer immune to European-style drug price pressure. Never mind that the move was partly a result of a messed-up calculation on Sanofi’s part: this was a defining moment in the evolution of America’s troubled health care system. That the price of a drug was cut at all, and voluntarily (albeit under pressure), is notable enough: prices usually go up, especially in the US. But the size of the cut (deeper than almost all of the discounts squeezed out of pharma by European cost-watchdogs’ rule-dominated systems), and the fact that we’re talking about a drug for cancer (until recently among the most price-protected TAs) that’s, technically at least, an NME, is even more remarkable. Zaltrap’s high price of $9-11,000 per month, its questionable efficacy (extending overall survival by just 1.5 months) and safety concerns such as a boxed warnings over fatal GI bleeding were what prompted leading cancer specialists at Memorial Sloan-Kettering Cancer Center to boycott the treatment. The MSKCC scientists were behaving just like an EU-style health technology assessment agency: they were in effect importing the spirit, if not the institution, of a NICE-like hurdle to the US. (There’s no way, incidentally, that Zaltrap...

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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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Discounting For Access: The QALY Math Is Spreading

Posted on Tuesday, November 6, 2012

Last week, England & Wales’ cost-watchdog  NICE approved reimbursement for two drugs for advanced melanoma, Roche’s Zelboraf and Bristol’s Yervoy. As is so often the case at NICE, both drugs had initially been rejected, and both in the end came through with confidential discounts to the list-price. But this isn’t just a story about discounting, nor is it just about the UK. Everyone knows that winning reimbursement in England & Wales boils down to math –  math that culminates in a controversial cost-per-quality-adjusted life year (QALY) figure that has to be below a threshold of £30,000 usually or £50,000 for ‘end-of-life’ treatments such as Yervoy and Zelboraf. What’s less well known is that the oft-criticized QALY is gaining traction among cost-pressured US payers too (as well as in other markets such as France). According to a 2012 oncology survey by Reimbursement Intelligence, almost half (45%) of US payers, (mostly large ones) view assessment of QALY as a viable model for the US health care system. Given this could soon be relevant in the world’s largest market, too, what were the most important variables playing into the reimbursement arithmetic for Yervoy and Zelboraf? Several UK headlines suggested that for both drugs, it was discounting that made the numbers work. That’s true of Yervoy, but not...

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Actelion’s Opsumit Will Test Whether Outcomes Data Can Replace Head-to-Head

Posted on Friday, November 2, 2012

Actelion pulled out all the stops in designing the Phase III trial of its pulmonary arterial hypertension drug Opsumit (macitentan), filed at FDA on Oct 22.  And no wonder: the biotech’s future depends on it, as its own top-selling PAH treatment Tracleer faces patent expiry in 2015. But Opsumit’s regulatory and reimbursement path should also interest any other drug developer seeking to test what kinds of data payers require in order to prioritize a next-in-class therapy that’s likely to be somewhat –but not necessarily hugely — better and safer than existing, soon-to-be-much-cheaper treatments. Opsumit treats a rare, but not ultra-niche condition. It has orphan status, but is a follow-on drug (albeit a highly optimized one) in an increasingly competitive, and genericizing, segment. Phase III data strongly suggest this dual endothelin receptor antagonist has dosing, safety and efficacy advantages over existing PAH treatments. Can Longer-Term Outcomes Data Replace Head-to-Head? But Actelion didn’t pit Opsumit directly against Tracleer or Gilead’s Letairis, the one-two of PAH, for familiar reasons – not least because to adequately power the research, it would have required conducting a large (e.g 5000-patient) and expensive trial.  Instead, it designed a trial that was much longer, and with more outcomes-focused endpoints, than any other PAH study. The placebo-controlled SERAPHIN trial,...

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