A Tale of Two Patients: Who Will the Proposed Safe Harbor Regulation Most Benefit?

Posted by Pranava Goundan on Fri, Apr 12, 2019

Howard Deutsch and Kyle Harpole co-wrote this blog post, which previously published on The Active Ingredient.

The U.S. Department of Health and Human Services has proposed a new rule for safe harbor protection of drug discounts, effective Jan. 1, 2020. While the rule hasn’t been finalized, it has received more than 25,000 public comments, indicating that the current rebate model likely will be swept out to sea in favor of a model that aims to more directly address beneficiaries’ concerns about rising out-of-pocket costs. The percentage of patients whose out-of-pocket spending exceeds $2,000 nearly doubled between 2011 and 2015. The proposed regulation focuses on curtailing these costs by establishing, among other things, point-of-sale discounts for beneficiaries. We recently wrote about how pharma can prepare for the shifting seas of a new access and reimbursement landscape. In this post, we’ll compare two common Medicare Part D, non-LIS patient populations, diabetes and rheumatoid arthritis, to demonstrate how individual patients’ payment contributions would change under the proposed regulation.


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Pharma in Interesting Times

Posted by Ed Schoonveld on Tue, Jan 08, 2019

“May you live in interesting times” is an intriguing Chinese expression that’s seemingly a blessing, but it’s really a curse. The pharmaceutical industry is facing a very tough year as an erratic U.S. president and a public that’s frustrated about drug prices provide motivation for bad solutions. It’s interesting that the Health and Human Services Secretary from the industry, Alex Azar, is now seeking to initiate price controls, albeit as a five year “experiment” rather than properly vetted legislation. Equally interesting is that the public frustration was mainly triggered by a combination of insurance funding concerns for a Hepatitis C cure and exotic price increases for off-patent drugs. This is not to say that the industry goes without blame. Pharma is better known for its lobbying power and erectile dysfunction ads than for its public communications. The pharma business model can’t easily be explained in 140 characters, but we certainly need to try a lot harder.


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