Podcast Episode Recommendation: Dear Diabetes Podcast with hostess Reneé Rayles Episode 7

 

The Dear Diabetes Podcast with hostess Reneé Rayles is a relatively new podcast covering the subject of diabetes; it began quite recently on March 29, 2023. However, Reneé Rayles recently interviewed Civica, Inc.'s current CEO Ned McCoy.  Recall that on June 1, 2023, Ned McCoy succeeded Martin VanTrieste as Civica's President and CEO (see the press release at https://www.businesswire.com/news/home/20220524005169/en/Civica-Announces-Leadership-Transition for details). She spoke with Mr. McCoy about the company's affordable insulin biosimilar effort, which is proceeding according to plan. It has been a while since anyone spoke with Mr. McCoy about its biosimilar insulin plan.

Civica has released news about many key steps in its affordable insulin plan along the way, and I am sharing those in this post.

For example, since the original March 3, 2022 Civica biosimilar announcement, the company's consumer-facing CivicaScript operating unit announced a partnership with the drug wholesaler formerly known as AmerisourceBergen (that company subsequently changed its name to Cencora) [see AmerisourceBergen Kicks Off Strategic Relationship with Civica, January 23 2023, BusinessWire, https://www.businesswire.com/news/home/20230123005078/en/AmerisourceBergen-Kicks-Off-Strategic-Relationship-with-Civica AND Drug Wholesaler AmerisourceBergen Announces Intent to Change Name to Cencora, January 24, 2023, BusinessWire, https://www.businesswire.com/news/home/20230124005416/en/AmerisourceBergen-Announces-Intent-to-Change-Name-to-Cencora for news about its name-change] as its drug distribution partner to get its insulins on pharmacy shelves nationwide.

Last June, Civica selected a Germany-based org. known as Profil to undertake necessary clinical trials needed to secure FDA approvals (see Civica Selects Profil as Clinical Trial Partner for Affordable Insulin Initiative, June 2, 2022, BusinessWire, https://www.businesswire.com/news/home/20220602005189/en/Civica-Selects-Profil-as-Clinical-Trial-Partner-for-Affordable-Insulin-Initiative).

In January 2023, Civica signed an agreement with Switzerland-based Ypsomed to license that company's insulin pen designs (see Civica Welcomes Ypsomed as Injection Pen Partner for Its Affordable Insulin Initiative, January 31, 2023, BusinessWire, https://www.businesswire.com/news/home/20230131005294/en/Civica-Welcomes-Ypsomed-as-Injection-Pen-Partner-for-Its-Affordable-Insulin-Initiative). Since then, Ypsomed has revealed to investors that it will supply Civica with the company's disposable UnoPen design.

Civica also signed contracts with a few innovative PBMs (both of which are Public Benefit Corporations which do not engage in "spread pricing" which are known to push prescription drug prices up) to work with insurance companies to gain coverage, including both Navitus and EmsanaRx (also note that on May 16, 2023, EmsanaRx announced it was changing its name to AffirmedRx) to help with insurance company coverage.

For the news releases on Civica's announced PBM partnerships, see: Navitus Health Solutions Joins CivicaScriptTM to Further Availability of Lower-Cost Generic Medications, July 13, 2022, BusinessWire, https://www.businesswire.com/news/home/20220713005349/en/Navitus-Health-Solutions-Joins-CivicaScriptTM-to-Further-Availability-of-Lower-Cost-Generic-Medications, and EmsanaRx Joins CivicaScript to Make Lower-Cost Generic Medicines Available to its Pharmacy Benefit Members, June 14, 2022, GlobeNewswire, https://www.globenewswire.com/news-release/2022/06/14/2462229/0/en/EmsanaRx-Joins-CivicaScript-to-Make-Lower-Cost-Generic-Medicines-Available-to-its-Pharmacy-Benefit-Members.html and the name change  was revealed at EmsanaRx, PBC Announces Corporate Name Change to AffirmedRx PBC, May 16 2023, EIN Presswire, https://www.einpresswire.com/article/633152906/emsanarx-pbc-announces-corporate-name-change-to-affirmedrx-pbc.

Finally, I would be remiss if I failed to acknowledge the fact that Civica's consumer-facing CivicaScript operating unit is already selling at least one prescription drug to patients which resulted in major price-cuts for the drug across the industry. The company makes and sells the generic drug at prices which were much lower than what it sold for before Civica stepped-in (see CivicaScript Announces Launch of its First Product, Creating Significant Patient Savings, August 3, 2022, BusinessWire, https://www.businesswire.com/news/home/20220803005101/en/CivicaScript%E2%84%A2-Announces-Launch-of-its-First-Product-Creating-Significant-Patient-Savings for details on that). 

Collectively, these Civica insulin (and a few related) press releases prove without doubt that Civica knows what it's doing, and that its announced introduction dates are very likely to be true. I fully expect we shall see Civica insulin biosimilars in 2024, but more importantly, they will re-introduce the concept of therapeutic choice in insulin therapy to doctors and their patients, rather than the routine non-medical switching of non-interchangeable (according to FDA) insulins based on whoever is paying the PBM the biggest rebate kickbacks. That's how things used to work until PBMs decided it was better to help themselves than it was to save everyone else money.

For its part, Civica has said all along that the company aimed for "market impact" rather than market share with its affordable insulin initiative. The company forecast that it anticipated making enough insulin to supply about 30% of the U.S. insulin market, although it could expand capacity if necessary. But Civica never aimed to unseat Novo Nordisk or Lilly, but force them to opt out of the PBM kickback scheme and lower their prices. That finally happened in March 2023.

Big three branded insulin makers (Lilly, Novo Nordisk and Sanofi) each announced in March 2023 (catch my coverage at https://blog.sstrumello.com/2023/03/the-insulin-pbm-rebate-kickback-scheme.html AND https://blog.sstrumello.com/2023/03/bursting-bubble-of-over-inflated-us.html) of their intention to slash insulin list prices, in order for big insulin to cut their insulin prices, they will effectively opt-out of the PBM commercialization channel which requires huge legally-exempted cash rebate kickbacks paid to PBM formulary managers which amounted to an estimated total (across all drug classes) $236 billion annually as of 2022 according to estimates from Pembroke Consulting. We also know thanks to USC research that about half of all that cash was lining the PBMs' pockets (see https://healthpolicy.usc.edu/article/more-than-half-of-insulin-expenditures-going-to-middlemen-new-usc-schaeffer-study-finds/ for more).

Since 2019, the big three branded insulin-makers have seen the evidence they needed that it was safe for them to "opt out" of the PBM commercialization channel for (at least for patent-expired) insulins. In effect, PBMs threatened them that insulin price reductions would result in the insulins being dropped from formularies. But last spring, Lilly told investors that nearly one-third of domestic Humalog sales were the unrebated, unbranded version rather than the heavily-rebated (to PBMs) branded version. In the company's 2021 Annual Report, rival Novo Nordisk also revealed that more than 1 million Americans had taken advantage of the company's "affordability options" and the biggest component of that are the company's two unbranded "authorized generic" versions of Novolog and Tresiba (Novolog/aspart being the much bigger seller of the two). Collectively, this information provided sufficient proof that big insulin really did not need PBMs to sell their insulin (at least patent-expired varieties). PBMs then tried to say they would dump other drugs made by the same manufacturers from their formularies, but that never happened, which proved the PBM were bluffing on that.

One thing Civica's President Ned McCoy did not really acknowledge in this podcast was the reality that the Civica biosimilar insulins will actually be cultured in GeneSys Biologics laboratories located offshore 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 details on that). The insulin Active Pharmaceutical Ingredient ("API") will then be shipped to a Civica "fill & finish" facility in Petersburg (in Chesterfield County), Virginia near the state capital of Richmond in the Meadowville Technology Park where the insulin APIs made in India will be packaged into vials and insulin pens and distributed nationwide. All biosimilars plan to make the insulin APIs offshore (so far, all of the publicly-held companies have announced they will make the insulin APIs in Malaysia, India and China). Originally, the biosimilar plan was to use the margins derived from that to pay PBMs legally-exempted rebate kickbacks, but now it looks as if that won't be necessary. But they may have to slash their prices, instead, so it looks like a wash from a business perspective.

While the Dear Diabetes Podcast does not appear to break any new ground which hadn't already been addressed after the March 3, 2022 announcement (I covered several podcasts including HERE and HERE), the interview was with the new company CEO, hence we can get his unique perspective on the company's biosimilar insulin plan, and he does talk a bit more about how the company is implementing its commercialization plan for the company's biosimilars of Lantus, Novolog and Humalog.

The link to Dear Diabetes Podcast with hostess Reneé Rayles Episode 7 can be listened to below, or by visiting https://dd.buzzsprout.com/2162967/12746747-ep-7-30-insulin-with-the-non-profit-pharmaceutical-company-civica-rx-an-interview-with-ceo-ned-mccoy