Product Launch

A tale of two new hepatitis C drugs

Posted on Thursday, March 10, 2016

Despite discount, Merck’s just approved Zepatier unlikely to win share with most US payers, except in Medicaid, according to RxScorecard™.  New combo from Gilead could ensure company’s dominant position among US payers. Westport, CT, March 10, 2016 It can take more than a big discount to get payers to buy into a new drug. Although Merck is launching its new hepatitis C virus (HCV) medicine, Zepatier, at an approximate 30% discount to the “list” price of the overwhelming market leader, Gilead’s Harvoni, RxScorecard™ analysis shows that it is unlikely to make significant headway in most commercial and Medicare plans. Meanwhile, RxScorecard™ shows that Gilead’s sofosbuvir/velpatasvir (SOF/VEL) combination, likely to be approved this summer, could be a big winner, obsoleting Gilead’s own Harvoni, as Harvoni sidelined Gilead’s first entry, Sovaldi. But SOF/VEL will succeed only if it matches the discounting Gilead is providing with Harvoni. Real Endpoints LLC (RE) came to these conclusions based on its proprietary tool RxScorecard™, which assesses the relative value of marketed and pipeline drugs from a 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. The HCV market has been enormously attractive to drug companies. According...

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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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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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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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Risk-Shares Pop Up Again As Payers, Pharma Circle New Payment Models

Posted on Wednesday, October 3, 2012

Say you’re GSK, and a head-to-head trial pitting your drug against the market leader showed non-inferiority. Say, too, that even though you assembled some trial evidence that patients preferred your drug vs. the leader, this hadn’t convinced everyone. So, with 70% of prescriptions still favoring your competitor, what to do? Blunt rebating is one option – but hardly commercially attractive. So how about taking the risk of testing your tolerability claim in the real world? That won’t eliminate the need to rebate (that’s a permanent fixture with me-too drugs) But it may limit it – and, potentially, allow a reduction in the rebate going forward. Here’s how such a contract might work. In exchange for covering drug A, the payer gets discount X. If the drug meets a certain tolerability threshold (defined, of course, relative to the competitor) that discount remains. If it doesn’t, the discount deepens. In the future, if that tolerability data can be turned into reduced overall cost (side-effects, treatment switching costs) the discount may shrink. Impracticable and unlikely to pass muster with payers, you say. Generally speaking, you’d be right. Exhibit number one supporting your conclusion: the paucity of risk-sharing in the US to date. Exhibit number 2: payers’ publicly disclosed reasons for this scarcity,...

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Orphan vs Effectiveness: German Payers Win 11% Discount on Esbriet

Posted on Tuesday, July 24, 2012

InterMune’s orphan drug for idiopathic pulmonary fibrosis (IPF), Esbriet, on July 23 became the second product to be priced within Germany’s new reimbursement system.  The result: an almost 11% discount on the drug’s initial ‘free’ price in Germany (in place since September 2011), on top of the 16% mandatory rebate that for now affects all drugs in Germany. Superficially, that looks like a clear win for payers. But it’s not entirely bad news for pharma either — particularly those developing orphan drugs. Indeed, Intermune management on a same-day conference call declared the net $33,000 per patient, per year price tag for the drug — published clearly for all to see — as “fabulous”. How so? After all, Esbriet’s price in Germany — which used to top the drug price rankings — is now lower than that in at least half of the other six European countries for which prices have been set (in Iceland, Esbriet sells for $43,700 per patient, per year). Yet in fact, Esbriet, as the pioneer orphan within Germany’s hastily-implemented new system, has emerged relatively unscathed after a very rocky ride.  In late 2011, it received the lowest possible ‘added benefit’ score from HTA body IQWiG, which advises the German reimbursement authority, G-BA. These scores, granted to new...

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