Washington. Healthcare. Translated.


High-Impact Drugs: Is “Impact” on patients or payers?

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…

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Acthar Gel: from 10,000 Feet

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…

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Devices: Start with Coverage, or Reimbursement?

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…

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Opioids: PS on drugmaker liability

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…

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Opioid Crisis and drugmaker reporting

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…

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Rx Price Reforms: PART III: Pricing Formulas, Consistent with Reform

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…

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