Tuesday, July 19, 2022

CivicaScript Signs Navitus as Partner; Costco Pharmacies Will Sell Civica Insulin Biosims

$30/vial Could Become The New Normal in 2024

My readers may recall that on March 3, 2022, I blogged about concurrent press releases from both Civica, Inc. and the JDRF (see my coverage HERE for original news, followed by more detailed analysis on how it was poised to disrupt the PBM kickback scheme HERE) that its CivicaScripts operating unit plans to enter the U.S. market for insulin biosimilars starting first with the basal insulin analogue insulin glargine, followed by biosimilars of lispro and aspart, which is expected to happen in 2024 assuming it encounters no regulatory delays.

The original aim of starting with glargine first was to try and disrupt the severe underlying market dysfunction that has resulted in basal insulin analogues being priced at nearly three-times as much money as prandial insulin analogues are now (in part because the unbranded Lilly and Novo Nordisk products introduced in 2020 had successfully brought prices of prandial insulins down while Sanofi had not done the same with Lantus). However, on June 28, 2022, Sanofi announced (see my coverage of that HERE) announced a two-pronged approach to not only slash prices of branded-Lantus to a price of $35/vial with a ValYOU coupon, but will also introduce an unbranded glargine product aimed at bypassing the entire PBM rebate mess which has worked fairly well for rivals Lilly and Novo Nordisk on selected prandial insulins.

Lilly has since revealed to investors during the company's most recent quarterly earnings presentation to investors that its unbranded Lilly Insulin Lispro now accounts for about one-third of the company's total U.S. Humalog sales, while rival Novo Nordisk revealed to investors in the company's 2021 Annual Report that in 2021, Novo Nordisk's U.S. affordability offerings (the biggest one being Novo Nordisk Pharma Inc.'s "unbranded biologic" version of Novolog called simply Novo Nordisk Insulin Aspart U-100) had "reached more than 1 million Americans" since the unbranded prandial insulin analogue product was introduced the previous year.

That said, while the price-cuts have been very welcome relief for patients who have been unfairly victimized by PBM rebate aggregation which has largely left patients without of the benefit of the deep discounting from manufacturers, Civica's model will rely on offshore manufacturing of the Active Pharmaceutical Ingredients ("API's") with a collaborative partner named GeneSys Biologics Pvt. Ltd. based in Hyderabad, India who will make the bulk insulin there, and then ship it to a new "fill & finish" facility in Petersburg, Virginia near the state capital of Richmond, where it will be packaged into vials and insulin pens, and put into boxes with relevant package inserts required by FDA and shipped to pharmacies nationwide. Still, there was still some skepticism that Civica could commercialize insulin in U.S. retail pharmacies. PBM's are notorious for using contracts to punish retail pharmacies that attempt to bypass the PBM rebate complex. 



However, on July 13, 2022, we saw the first concrete evidence that Civica's retail commercialization plan will actually happen. Navitus Health Solutions describes itself as "an industry-disrupting pharmacy benefit manager (PBM) committed to bringing humanity to pharmacy benefits management through greater transparency and affordability".

A joint press release from CivicaScript and Navitus Health Solutions (Navitus is smaller-sized PBM which claims about 7 million covered lives, of which 2.5 million are commercial lives; it is a PBM owned by the nonprofit hospital chain SSM Health and Costco Wholesale Corporation) announced (see the press release at https://www.businesswire.com/news/home/20220713005349/en/Navitus-Health-Solutions-Joins-CivicaScriptTM-to-Further-Availability-of-Lower-Cost-Generic-Medications/) that Navitus had joined CivicaScript as a "founding member", although the most practical impact of this particular announcement is that it guarantees that Civica's biosimilar insulins will be available for purchase from Costco pharmacies nationwide once they're FDA approved. Costco also operates its own mail order pharmacy (to be licensed as a pharmacy in the U.S., no membership can be required, therefore you don't need to be a Costco member to purchase Costco Pharmacy prescriptions online or at its warehouses) which can be found HERE. Users can search prescription drug prices for the Costco Member Prescription Program (which is a cash-pay program which does not accept insurance) option by visiting https://www.costco.com/cmpp. This is believed to be the first of similar deals CivicaScript is now working to arrange to ensure its biosimilar insulins will be available for patients to buy. Costco tries to offer low cash-prices on many generic  prescriptions so that members might consider bypassing their insurance.



CivicaScript President Gina Guinass said of the Navitus partnership "We are thrilled to have Navitus as a founding member and partner in our commitment to putting people first by lowering the cost of high-priced generic medicines. We partner with organizations that share our commitment to transparency and lowering costs – because everyone deserves access to the medicines they need to stay healthy."

Back on April 2, 2019 (see the FDA statement HERE), the U.S. FDA promised that its new regulatory transition of insulin from the drug to the biologics approval pathway would supposedly help to open up these products to more biosimilar competition, saying at the time "We believe the biosimilar pathway will enable a more robust route for developing lower cost copies of insulin, including products that are fully interchangeable with branded insulins."

FDA added: "While the regulatory transition of insulin products nears, we're cognizant of the fact that it won't be soon enough for the millions of Americans who struggle to pay for their insulin today. Helping to ensure patients have access to the critical drugs is a responsibility shared by all stakeholders, including manufacturers and health plans. We all need to do our part. A drug that's nearly a century old should not have a list price that increases between 15-17% annually. American patients who rely on insulin to live deserve to have high-quality, affordable options. The FDA is dedicated to facilitating access to insulin. We hope our industry partners will join us in doing all we can to help people who need access to the live saving medicines, now."

Indeed, CivicaScript insulins will put the new FDA approval process for biosimilar insulin to the test with applications for three biosimilar insulins at the same time. Civica has already announced that it hired Germany-based Profil to conduct necessary FDA trials, and it's been extraordinarily well-disciplined in the manner it's approaching commercialization. While the process mirrors what rivals including Viatris/Biocon are already doing, being quick isn't exactly something FDA is known for (especially on generic products). Already, there are biosimilar versions of insulin aspart injection U-100 (biosimilar Novolog) from Viatris/Biocon and Lannett/HEC now pending FDA approval, although we have yet to see any concrete evidence of the status of those products which will rely on a very similar FDA approval process. We may wish to watch for forthcoming biosimilar aspart announcements from Viatris/Biocon and Lannett/HEC for clues on what we can expect to see with the forthcoming Civica insulin biosimilars.

However, the most exciting aspect remains the fact that Civica will likely be disruptive to the PBM Kickback scheme, and now we know for certain that Costco will be one of the places where we'll be able to buy these products.

Author P.S.: When I originally wrote this post, I neglected to acknowledge the fact that in addition to Navitus, the CivicaScript unit had previously signed a similar deal with the PBM known as EmsamaRx on June 14, 2022 (the deal was made within days of the Navitus announcement). Catch the press release for that at https://www.globenewswire.com/en/news-release/2022/06/14/2462229/0/en/EmsanaRx-Joins-CivicaScript-to-Make-Lower-Cost-Generic-Medicines-Available-to-its-Pharmacy-Benefit-Members.html for details). EmsanaRx is the PBM unit of the coalition Purchaser Business Group on Health (PBGH), a nonprofit coalition of nearly 40 companies (including both Walmart and Costco as retailers, as well as Boeing Co. and Microsoft Corp. among its members), announced it had launched a new firm that would offer pharmacy benefit management (PBM) services for employers. EmsanaRx is legally organized as a public benefit corporation, similar to the Mark Cuban CostPlus Drug Company. It is a startup which aims to disrupt the corrupt PBM model, but it is a rather tiny-sized PBM in terms of covered member lives; in fact, I think that Costco's own PBM operating unit (which it calls Costco Health Solutions and is legally separate from the Navitus PBM which it co-owns with SSM Health) might actually be larger than EmsanaRx. Still, the fact that CivicaScript is partnering with a growing cadre of smaller PBM startups speaks volumes. It would be a real coup if it manages to land a deal with the rapidly-growing PBM startup known as CapitalRx, but that hasn't happened ... yet. Still, both the Navitus and EmsanaRx are important developments towards commercializing a product which hasn't even been approved yet by the FDA.

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