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Continuous manufacturing can help drugmakers save on development costs by reducing API waste...The continuous – as opposed to batch – method has been revered for its improved product quality and lower outlays, such as reduced good manufacturing practice areas, transport, and storage...The one thing that continuous manufacturing will definitely save you money on, is development..Commercial benefit?...It may look on paper that a batch method is going to be cheaper…but none of that cost will account for batches failing in commercial development, and then not being able to sell that product... The more complex the process it, the more susceptible you are to doing that...

Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago...Allan Coukell and Sean Dickson...write...that policymakers would be "well served by greater transparency on hospitals' use of 340B revenues," but warn that reductions in 340B eligibility will lead to a transfer from Medicare spending on 340B hospitals to increased revenue for drug manufacturers...In January, a final rule went into effect that cut drug payments to 340B hospitals by almost 30%. The American Hospital Association and other groups are currently suing the U.S. Department of Health and Human Services over the rule. Earlier this month, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments for the case...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The House is set to take up a controversial “right-to-try” bill next week — and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT...right-to-try legislation aims to give terminally ill patients a different pathway to access experimental treatments that are not FDA approved...“In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections, I think the Walden bill gives us less work to do,” Gottlieb said. “With the Johnson bill, we’d have to do a little bit more … in guidance and perhaps in regulation to achieve some of those goals, and I think those are the goals that Congress wants us to achieve.”

Samantha DiGrande, Welcome to This Week in Managed Care from the Managed Markets News Network

Nicole Grassano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Grassano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The House of Representatives...voted....to pass Sen. Ron Johnson’s, R-Wis., Right to Try legislation, sending the bill to President Donald Trump’s desk. The vote is the culmination of a multi-year campaign...which aims to provide access to unapproved drugs under review at the Food and Drug Administration to patients facing life-threatening illnesses with no further options...The bill covers a much broader population than an earlier House-passed version. The president has been a vocal advocate...it may have unintended effects and potentially hinder FDA’s authority without changes...Conservative groups including Freedom Partners and Americans for Prosperity backed the effort, calling attention to the fact that 40 states have passed versions of Right to Try, a strategy employed by Goldwater to drum up momentum for the bill...The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process...The Senate’s bill would allow unproven therapies to be given to patients without FDA notification for up to a full year and would not establish any standards for informed consent...

Analysts are predicting a surge of M&A activity in the biotech space, with large pharma firms looking to pad their pipelines with new acquisitions, US tax reform freeing up cash flow, and rapidly-consolidating US healthcare buyers likely to put more pressure on the price of existing drugs. How is the biotech M&A landscape likely to develop over the course of 2018?

• Key drivers of biotech M&A in 2018 - So what are the major drivers spurring this latest biotech M&A push?...The first factor to consider is one that has plagued big pharma for years, and is as big a problem now as ever: the patent cliff.
• Tax reform spurs M&A - Major tax reforms implemented in the US by the Trump administration could also be fueling a surge in large firms snapping up biotech innovators.
• Waiting for a ‘detonator’ - With President Trump’s tax reform something of a detonator in itself, the market may be waiting for a massive merger or acquisition to kick off an M&A feeding frenzy in the biotech space

Accountable care demands that data crunching these days be agile to enable quick pivots in strategy...With rising drug costs, value-based care, changes in reimbursement rules and more demanding consumers, there's no shortage of things that can change in a year. That means hospital IT departments need to employ quicker, more agile analytics that enable them to pivot in response to fast-changing conditions...And that’s why Dana Darger...director of pharmacy at Rapid City (South Dakota) Regional Hospital...said healthcare organizations need to think more like stores when it comes to issues of dollars and cents..."Hospitals have never behaved with what I'll call a retail mindset,” Darger said. “Retail stores can tell you what they make on everything."...As healthcare moves inexorably toward value-based reimbursement, entities are going to need to analyze data more quickly and make those retail-type business decisions..."If you look traditionally at the way pharmacy works, pharmacists tend to look at the world as expense-driven," said Darger. "They base things on what drugs cost, rather than what the margin is..."A lot of times, people are trying to get the data to say what they want it to say. You have to figure out how to let the data tell the story so you can make changes based on it."