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

Posted by Pranava Goundan on Thu, Apr 11, 2019

Howard Deutsch and Kyle Harpole co-wrote this blog post with Pranava Goundan.

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.


>
Read More

The Rebate Rules Are Changing. Here’s What Pharma Needs to Do to Prepare

Posted by Howard Deutsch on Wed, Mar 20, 2019

Pranava Goundan co-wrote this blog post with Howard Deutsch.

In the classic political film, “The Candidate,” Robert Redford’s character, fresh off his victory, turns to his election strategist and asks, “What do we do now?” And the movie ends right there. The pharmaceutical industry now is facing a similar moment. After years of advocating for more transparent pricing and criticizing the rebate-for-access model for its perverse pricing incentives, pharma is on the cusp of partly getting its wish. But our movie doesn’t end there, so we must answer that question: What do we do now?


>
Read More

Our Drug Rebate Prediction Is Coming True: Now Can We Turn Our Attention to the Value of Drugs?

Posted by Pratap Khedkar on Tue, Feb 12, 2019

We predicted last year that prescription drug rebates’ days could be numbered as more healthcare stakeholders clamor for price transparency. Judging by the new rule proposed by Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson, this has now come to pass. The proposal aims to wipe out the behind-the-scenes negotiation tool—which has been linked to a growing discrepancy between a drug’s list and net prices—and instead share the savings directly with Medicare patients. 


>
Read More

Collaboration Sparks a New ‘Value of Drugs’ Discussion, and Pharma Needs to Speak Up

Posted by Joe Stevens on Wed, Feb 06, 2019

The industry’s current value and payment system is being scrutinized as pharma companies continue to expand their traditional, treatment-based drug discovery models to include potential cures. The Institute for Clinical and Economic Review (ICER) is collaborating with the U.K.’s National Institute for Health and Care Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health to address some of the perceived challenges in pharmaceutical valuation methodologies, namely how the industry should be evaluating high-cost, but potentially curative, treatments.


>
Read More

Even in a Favorable Regulatory Environment, Will Biosimilars Gain Traction in the US This Year?

Posted by Pratap Khedkar on Fri, Jan 25, 2019

Christina Corridon co-wrote this blog post with Pratap Khedkar.

Despite 16 approvals in the last four years, just six biosimilars currently are being marketed stateside. The U.S. biosimilars market hasn’t progressed as anticipated, yet some experts are wondering whether the biologic follow-ons can redeem themselves with a breakout year in 2019.

The U.S. biosimilars market has a tough road ahead. The WAC list price differential between biosimilars and the originator drugs is hovering around 30%, on average, which likely isn’t speeding biosimilars’ adoption in the U.S. Rather than playing the long game and waiting for the U.S. landscape to become more attractive, some biosimilar manufacturers like Momenta are choosing to exit the market. And others like Pfizer have shuttered their preclinical biosimilar programs to focus their efforts elsewhere. On the flip side, the Trump administration has zeroed in on drug pricing and biosimilars as priorities—and, of course, the two are intertwined.


>
Read More