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Category Archives: Diagnostics

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

“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”. … Continue reading

Clinical Utility: An Ever Higher Bar To Clear For Molecular Diagnostics

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 … Continue reading

Managing Molecular Diagnostics: The View from Aetna’s Ira Klein

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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). … Continue reading

The Healthcare Round-Up: August 3 -19

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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 … Continue reading

Are Choppy Reimbursement Waters in the Forecast for Oncotype Dx?

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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 … Continue reading

The Healthcare Round-Up: May 19-26

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 … Continue reading

The Healthcare Round-Up: May 11-18

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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 … Continue reading

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

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 … Continue reading

The Healthcare Round-Up: 3/7 – 3/13

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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 … Continue reading

Drug Targeting & Reimbursability: It Ain’t Easy

All things being equal, insurers prefer a drug that’s designed to work for a person with a specific genotype than one targeting a more general group of patients. The notion makes sense medically. It should make sense economically too — less drug gets wasted on people who won’t benefit and who might incur expensive side-effects in the bargain. That’s the promise of personalized medicine,  and it’s why new drugs focusing on more specific populations than … Continue reading

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