‘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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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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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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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: May 19-26

Posted on Sunday, May 27, 2012

Real Endpoints would like to congratulate our intern, Halleh Balch, on her graduation from Swarthmore College. We expect great things from Halleh in the years to come; she is one to watch! PSA: To test – or not to test. The big news this week was the United States Preventative Services Task Force’s decision to downgrade the necessity prostate-specific antigen test. After reviewing two large studies, the task force’s working group decided the PSA test, which is designed to flag prostate cancers early, does more harm than good, leading to overdiagnosis and increased treatment risks rather than improved outcomes. According to the USPSTF’s findings, between 1986 and 2005 an estimated one million men received surgery, radiation therapy or both thanks to findings of the PSA test. Of these, at least 5000 died soon after surgery and between 10,000 and 70,000 had serious complications, while another 200,000 to 300,000 suffered impotence. And while the task force is officially recommending against the test, the group seems to have learned something from the mammogram debacle. If patients and doctors feel the test is necessary, it should be performed, as long as there is an “informed “ discussion about the possible benefits and harms. Many, including Matt Farber, the director of the economics and...

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The Healthcare Round-Up: May 11-18

Posted on Friday, May 18, 2012

Boom time for HCV testing: US health officials released proposed guidelines Friday recommending that all baby boomers should be tested at least once for the hepatitis C virus, which is transmitted through contaminated blood and is often undiagnosed. Infection rates of the silent epidemic have dropped since the 1990s thanks to better blood and organ screening technology, but according to the CDC one in 30 baby boomers (defined as born between 1945 and 1965) are infected with HCV and don’t know it. John Ward, director of the CDC’s viral hepatitis division predict a blood test would identify hundreds of thousands of infections. The proposed guidelines will only fuel the already rampant desires of many biopharmas to become HCV powerhouses. Gilead and Bristol-Myers Squibb are currently duking it out to become the first to offer a non-interferon based regimen, but with new screening guidelines dramatically increasing the treatment pool, expect other companies to look at the space with interest. For payers, meantime, the CDC recs mean more hard choices. With two new hep C drugs on the market – Incivek and Victrelis – payers are already scrutinizing costs in this specialty arena. According to the 2011 Express Scripts Drug report, hep C isn’t in the top 5 costliest specialty trend...

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The Healthcare Round-Up: 3/21 -3/28

Posted on Wednesday, March 28, 2012

All eyes are on Capitol Hill this week as the Supremes hear oral arguments in one of the most important –and politicized—cases in decades: the constitutionality of the Affordable Care Act, the signature piece of legislation passed thus far in Barack Obama’s presidency. It’s anybody’s guess how the Court will vote –questions on day 2 tied to the constitutionality of the individual mandate were pointed and seemed to fluster the administration’s lawyer Donald Verrilli. One thing seems clear: Justice Anthony Kennedy’s view of the mandate will play a crucial role in whether that provision stands. As Scotusblog reports, if Kennedy can find a limiting principle in the federal government’s defense of the insurance mandate or think of one of his own, it could survive—and his arguments just might convince Chief Justice John Roberts to side with the four liberal justices who are already signaling they will support it. But if Kennedy, who expressed skepticism about the mandate, rules against it, the one piece of health reform that insurers really liked will go by the wayside. Whether that scuttles payment reforms already at work by major insurers is another question. Indeed, as CIGNA CEO David Cordani told Bloomberg recently, “With or without the healthcare law, the economic forces are driving...

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The Healthcare Round-Up: 3/7 – 3/13

Posted on Wednesday, March 14, 2012

The Legality of Co-pay cards: It’s no secret co-pay cards are a contentious issue; now, they’ve been taken to the courts. Last week, the consumer advocacy group, Community Catalyst, filed suit against 8 drug companies seeking to ban the use of co-pay cards on behalf of unions that provide drug benefits for civilian and uniformed municipal workers in New York City, carpenters in New England, and plumbers in various states. Among the drug companies specifically named in the lawsuit: Pfizer, which set off the most recent conflagration when it launched its $4 co-pay card for branded Lipitor after the drug’s patent expired this past November.  In its suit, Community Catalyst argues that co-pay cards are an illegal inducement “designed to undermine cost-sharing arrangements.”  In effect, the existence of co-pay cards provides patients with a financial disincentive to use cheaper medicines, while the majority of the bill is still paid for by insurers or pharmacy benefit managers. Community Catalyst’s arguments echo those made by the Pharmaceutical Care Management Agency in a November report estimating that co-pay cards will increase prescription drug costs by $32 billion over the next decade.  Meanwhile, proponents of the practice note that co-pay cards don’t just make things economically feasible for patients; often spending less out-of-pocket...

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