Drugs

HHS Head Dismisses Industry Resistance to Drug Prices Plan

Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Azar said 10/26 that HHS is steadfast with the Trump Administration’s plans to change the way Medicare pays for costly physician-administered drugs. Currently, these drugs are reimbursed at the average sales price in the U.S. market plus a price-based add-on fee. The proposed new model would allow Medicare to set a target price based on the discounts drug companies give other countries.

During an address at Brookings Institute, Azar acknowledged industry insistence that the U.S. currently “has a competitive marketplace that controls costs,” including in its “market-based Medicare Part B program” but he asserted that it is time for change. “The only thing standing in the way is the one special interest that has benefited from this program far out of proportion to any other actor, for the last 15 years: the pharmaceutical industry,” he said. “Finally seeing this system reformed, in fact, is one of the pharmaceutical industry’s ultimate nightmares. I can tell you that because it used to be my job to have pharmaceutical nightmares.”

Azar said the new model will fit into a larger effort to “spark real price competition and negotiation in drug markets. A number of these physician-administered drugs are biologics, and we haven’t yet succeeded in building a robust market for biosimilars. Earlier this year, we did approve the first biosimilar for one of these high-cost drugs. But there isn’t nearly enough competition, in part because the current system actually penalizes doctors for seeking out more affordable alternatives.”

He said that the model will aim to ensure physicians make the same whether they’re prescribing a more expensive branded biologic or its biosimilar. “This gives manufacturers a meaningful new opportunity to start bringing down prices through biosimilar competition,” he said.

The Administration is projecting $17 billion in Medicare drug spending savings over the next five years under the model.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome