The AMS Blog

When a new drug is approved, the developer usually trumpets its ability to fill an unmet medical need. But a German agency that evaluates the quality of medical treatments disagrees is calling for an international reform of drug development and approval. In a recent analysis published in The BMJ, the Institute for Quality and Efficiency in Health Care (IQWiG), Germany’s health technology assessment agency, found that the majority of newly approved drugs were actually not much different from standard care. Among 216 new approvals—152…

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More than 3.2 million Americans live with chronic hepatitis C, according to the FDA. Of those, around 700,000 to 1 million are Medicaid patients. While HCV is curable, treatment presents a substantial cost burden to patients and payers. This has led to radical new payment model innovations—for example, Louisiana’s Netflix-style subscription model will allow the state to contract on a monthly basis for unlimited access to an HCV drug. The subscription-based models are not the only new payment models. WellCare, through Care1st Health Plan Arizona, along…

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Dive Brief: One month since the landmark approval of Novartis’ gene therapy Zolgensma, a handful of top U.S. insurers have set out coverage policies more restrictive than the label granted by the Food and Drug Administration, suggesting some payers may be balking at the therapy’s record-setting price tag.  So far, 11 of 30 major insurers tracked by Bernstein, an investment firm, have published policies for Zolgensma, with all opting to cover the gene therapy. But some, like Anthem and several…

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After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time. The newfound transparency follows a Kaiser Health News investigation that revealed device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database, bypassing the public FDA database that’s pored over by doctors, researchers and patients….

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Novartis’ multiple sclerosis med Gilenya is facing U.S. generic challengers on all sides to its blockbuster sales, and the company hoped a court order could stave them off. The Swiss drugmaker got what it asked for—and it might just keep the med at the top of Novartis’ bestseller list, at least for now. A suite of Gilenya competitors, including Mylan, Dr. Reddy’s Laboratories and Aurobindo Pharma, have been barred from immediately launching generic versions of the drug after a U.S. district judge in Delaware…

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The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019. FDA said it initially indended the ASR program to be for “specific well-known and well-characterized events associated with specific devices,” and that exempted submissions excluded events where the device may have caused or contributed to a patient death,…

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Take a look at most global drugmakers’ income statements, and it’s obvious the U.S. is all-important for pharma. Sales in the country typically outshine those in other regions. And it’s no wonder: The U.S. is a $485 billion market, according to IQVIA’s latest report on the global drug industry. That size opportunity is one reason the U.S. is the first place most drugs launch. But the U.S. is also where drugmakers have the most pricing power, and where regulators, for all the criticism…

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Three drug companies sued the Trump administration over its mandate that they start disclosing their list prices in their ads. The lawsuit, filed Friday in U.S. District Court in the District of Columbia, picks a fight with the top health officials even as the pharmaceutical industry is actively campaigning for the administration’s proposed ban on rebates for pharmacy benefit managers in Medicare Part D. Merck & Co., Eli Lilly and Co. and Amgen sued along with the Association of National Advertisers, claiming that HHS…

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We like to view modern medicine as based on rigorous science, and while it certainly beats the various dangerous alternatives out there, sometimes physicians still end up adopting practices based on little evidence. When a medical treatment, device or procedure is no better than previous or lesser alternatives, it’s deemed a ‘medical reversal’. These discredited practices are a major barrier to better and cheaper healthcare, but actually identifying them is surprisingly difficult and rarely done. A recent study, designed to create a more comprehensive list, has…

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Insys Therapeutics, an opioid manufacturer, has agreed to pay $225 million to settle the federal government’s criminal and civil investigations into the company’s marketing practices. As part of the settlement, Insys Therapeutics admitted to bribing doctors to prescribe their opioid painkiller. Last month, a federal jury in Boston found five top Insys Therapeutics executives guilty of racketeering conspiracy for these same practices. Now, the federal government is holding the company accountable.  In the agreement, the drug maker admitted to orchestrating…

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