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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The Benefits and Misconceptions of Indication-Based Pricing

Posted by Ed Schoonveld on Fri, Jul 21, 2017

A recent Wall Street Journal article raised the challenge related to Novartis’ high-cost orphan drug Ilaris, which may have clinical potential in a broader use as a cardiovascular drug. For the cardiovascular use, the company would have to charge a significantly lower price to gain adoption in the market. It’s a fairly extreme example of a common situation where drugs with potential uses in different indications, different population sizes and different competitive price levels are posing a tough dilemma for the drug company. Indication-based pricing, allowing for a different price across diseases treated, would provide a solution to this problem and would, in some cases, allow for earlier and broader patient availability of new prescription drug treatments.


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