Wednesday, August 09, 2023

Podcast Episode Recommendation: Healthy Dose of Dialogue Episode 31 "A Dose of Prescription Drug Disruption"

Today, I am recommending a podcast episode worth listening to. Specifically, it is an episode from June 15, 2022 of the podcast known as "Healthy Dose of Dialogue" which describes its mission to "gather the brightest minds in healthcare to share their unique perspectives on transformative marketplace trends, industry insights, and their vision for the future".













This particular episode (EP31: "A Dose of Prescription Drug Disruption") is an interview with the President of CivicaScript PBC, which in case you weren't aware of it, is an affiliated business unit of the nonprofit drug company Civica, Inc. and CivicaScript is its operating unit dedicated to lowering the cost of select high-cost generic medicines. The president of CivicaScript is a woman named Gina Guinasso. 

 

 

 

 

 

 

 

 



What makes CivicaScript PBC unique from the corporation known as Civica, Inc. is that CivicaScript was established as a public benefit corporation to reach consumers directly through retail and home delivery pharmacies rather than from a hospital setting which is where most of Civica's other drug business serves. CivicaScript is unique in that the company deploys what it calls a Retail Unilateral Pricing Policy ("UPP"). The CivicaScript Unilateral Pricing Policy sets a Maximum Retail Price (MaxRP) for all CivicaScript Products. This UPP is designed to fulfill its mission to offer low cost pharmaceuticals to patients. In order to remain in good standing, CivicaScript Resellers must advertise and sell all CivicaScript Products at or below the MaxRP. Violations or refusal to participate in CivicaScript's UPP could result in loss of ability to purchase CivicaScript Products.





Recall that on March 3, 2022, CivicaScript announced the company's intention to sell biosimilar versions of the three bestselling insulins https://www.civicainsulin.org/ currently on the U.S. market: glargine (Lantus), aspart (Novolog) and lispro (Humalog). 

While Civica will follow an identical business model to other biosimilar insulin companies (Sandoz/Gan & Lee, Lannett/HEC, Amphastar/ANP) by procuring the insulin Active Pharmaceutical Ingredients ("API") from an offshore biotech partner known as GeneSys Biologics in Hyderabad, India (see the company press release at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ for information on the GeneSys Biologics collaboration), because of CivicaScript's unique UPP, the maximum patient out-of-pocket price patients will be charged will be $30/vial or $55/box of 5 prefilled insulin pens which was disclosed in the concurrent JDRF press release (see https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html for pricing info) on the same news.

Also of note is that Civica signed a licensing agreement with Switzerland-based Ypsomed AG to use that company's disposable insulin pen (see https://www.businesswire.com/news/home/20230131005294/en/Civica-Welcomes-Ypsomed-as-Injection-Pen-Partner-for-Its-Affordable-Insulin-Initiative/ for a bit more on the pen licensing agreement), and we later learned from Ypsomed's investor presentations that will be the company's UnoPen design (download the presentation at https://www.ypsomed.com/en/media-investors/presentations.html?file=files/media/03_Documents/04_Presentations/2022_23/Ypsomed%20Full-Year%20Results%202023.pdf and visit slide #13 for more).

CivicaScript President Gina Guinasso originally started on the drug company side of the pharmaceutical business, and then later moved to the PBM side of the business with the OptumRx business of United Healthcare, where she was a senior executive. She admits that she never would even have been considered for or gotten the job with Civica had it not been for her prior experience on the OptumRx PBM side of the prescription drug business. But as it turned out, that particular PBM experience made her especially well-suited to lead the CivicaScript business because she really understands what the business practices of both pharma and PBM's are.

In the interview, Gina Guinasso is interviewed by host Andy Chasin, who is Blue Shield of California's Vice President of Federal Policy and Advocacy. The podcast episode itself can be accessed at at https://www.doseofdialogue.com/episodes/31. However, I am embedding the podcast episode here for convenience. Just beware that the website also includes a transcript for the episode, so you can refer back to it if you want to read the episode transcript itself. Even though this episode is a year old, its one definitely worth a listen!

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