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I caught a report from OptumRx of “Five Drugs Set to Have the Biggest Impact on Payers and Patients.” It’s a glimpse into late-stage pipeline products likely to be high-impact launches. You can find it here: https://www.fiercehealthcare.com/payer/optum-5-drugs-set-to-have-biggest-impact-payers-and-patients   It’s always worth looking at the pipeline of pharmaceuticals in development. It’s probably even more worthwhile looking…

There’s a lot of attention going to Acthar Gel and how Medicaid has stripped it of its favorable rebate status, retroactively. Folks ask me, who really cares about a Medicaid rebate case – is this different? And I’ll now say… YES, this case is different.   This Acthar Gel situation can inspire a lot of…

Both the general press and the trade press have delighted in predicting great injury (if not even death) to Mallinckrodt (MNK), maker of a drug called Acthar Gel. The concern relates to Medicaid drug rebates, and a CMS action to impose retroactive drug rebates on the drugmaker that could reach $600M. (The company has many…

The world of launching a new healthtech product is outrageously complicated in our era. Even large and sophisticated devicemakers can turn a blind eye to small regulatory details that destroy any chance for profitable reimbursement. That can send a promising healthcare innovation straight to the landfill.   How can such smart companies make such expensive…

There’s more brewing in US health reform than ever. Is this good or bad for the world of pharma?   When Obamacare passed, big pharma privately smiled  –  anticipating bigger US markets (as “everyone” got insurance) and bigger profits (as drugmakers stayed a step ahead of pricing reforms). This glee turned out to be… all…

Several clients have asked what Commissioner Gottlieb’s departure will mean – to their own industries and other FDA constituencies. To ponder the question, I replaced my private consultant hat with my old “bureaucrat’s hat” from my days with CMS and FDA.   As I considered the question, and digested the trade press, I realized the…

The drug pipeline is filled with high-priced, high-impact cures. Drug price reforms might kill them – is there any cure for the cure? Anyone who’s read a US newspaper in the last year knows the politicians are trying to tackle the very real problem of very expensive drugs. Branded drugs are quite expensive for a…

I recently posted some thoughts on the dilemma drugmakers face in balancing their reporting obligations to FDA against their general business model of selling their product. I received feedback that reporting obligations are the least of the drugmakers’ woes.   I’ll stand my ground that drugmakers face a huge task in both policing the drug…

It’s clear the opioid crisis is real. It’s not as clear, though, what kind of obligation this crisis might trigger for anyone to report their own failings to government enforcers. Let’s take a look.   WE’RE DYING, WHO’S REPORTING? Let’s recall that the catch-phrase “opioid crisis” isn’t a single crisis, but a collection of different…

Ultimately, controlling drug pricing is a shell game. Fixing national drug spend promotes a stronger economy (GDP). Negotiating lower Medicare costs helps the Medicare Trust Fund (or the national debt). Lower OOP spares a patient’s pocketbook (and maybe helps re-elect incumbents). No proposal really helps with all three. In fact, many plans serve one goal…