- CVS Health’s Cordavis business seems to want quasi-regulatory oversight of Humira biosimilars
- 340B’s skyrocketing growth continues, but the market is changing
- Plans sponsors' fading interest in alternative funding programs
- A post-Asembia review from DCI’s trip to Las Vegas
P.S. Join my nearly 56,000 LinkedIn followers for daily links to neat stuff.
Register now for The 340B Drug Pricing Program: Trends, Controversies, and Outlook, a new live video webinar with Adam J. Fein, PhD. Click here to learn more and reserve your spot at the June 21 event.
Cordavis: Bringing to Life the Promise of High-Quality Biosimilars, CVS Health
Last September, CVS Health launched Cordavis, a new biosimilar-focused subsidiary. (My $0.02 at the time: What’s Behind CVS Health’s Novel Vertical Integration Strategy for Humira Biosimilars.) Cordavis has played a crucial role in boosting uptake of biosimilars of Humira.
Dr. Sree Chaguturu, Executive Vice President and Chief Medical Officer of CVS Health, wrote the white paper linked above.
Dr. Chaguturu outlines some unusual roles for CVS Health as a “co-manufacturer” of biosimilars. These include “batch-by-batch review of critical quality documents,” approval of “any proposed changes to production specifications or subcontractors described in regulatory filings,” laboratory testing of selected batches, etc.
In my social media post, I mused that CVS seems like it doesn't need or trust the FDA. Brian Henry, Senior Vice President and Chief Communications Officer at CVS Health, jumped into the social media conversation, writing in part:
Dr. Sree Chaguturu, Executive Vice President and Chief Medical Officer of CVS Health, wrote the white paper linked above.
Dr. Chaguturu outlines some unusual roles for CVS Health as a “co-manufacturer” of biosimilars. These include “batch-by-batch review of critical quality documents,” approval of “any proposed changes to production specifications or subcontractors described in regulatory filings,” laboratory testing of selected batches, etc.
In my social media post, I mused that CVS seems like it doesn't need or trust the FDA. Brian Henry, Senior Vice President and Chief Communications Officer at CVS Health, jumped into the social media conversation, writing in part:
“As you would likely expect, we do value, respect, and will continue to work with the FDA. Our focus is on the operational aspects of biosimilars—cost, access, supply, device types, for example—in addition to supporting clinical efficacy and safety.”I appreciate the clarification. Nonetheless, I remain puzzled as to why CVS feels the need take on quasi-regulatory oversight roles for two FDA-approved and currently marketed products: Sandoz' Hyrimoz and AbbVie's Humira.
The 340B Drug Discount Program Grew to $124B in 2023, IQVIA
In some unsurprising news, 2023 was another year of skyrocketing growth for the 340B Drug Pricing Program. IQVIA estimates that 340B purchases at list prices hit $124 billion, up by $17 billion (+16.5%) compared with the 2022 figure. As a reminder, billions more in payments and spreads cannot be considered a cut to the safety net.
As DCI discussed in Sections 11.5. and 12.3.5. of our 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, manufacturers’ contract pharmacy restrictions have shifted purchases to covered entities’ in-house pharmacies and away from the large PBMs and retail chains that dominate the 340B market. For 2023, purchases by hospitals and clinics grew by 18.9%. Meanwhile, purchases by retail and mail pharmacies grew by “only” 10.2%, which was 260 basis points higher than non-340B growth.
DCI estimates that more than 17% of brand-name drug sales occur at 340B discounts, which can be as high as 100%. The Genesis Health Care, Inc. v. Becerra case seems likely to fuel further growth by broadening the definition of a “patient.”
For more on the 340B program, please join me on June 21 for my new live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook.
[Click to Enlarge]
As DCI discussed in Sections 11.5. and 12.3.5. of our 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, manufacturers’ contract pharmacy restrictions have shifted purchases to covered entities’ in-house pharmacies and away from the large PBMs and retail chains that dominate the 340B market. For 2023, purchases by hospitals and clinics grew by 18.9%. Meanwhile, purchases by retail and mail pharmacies grew by “only” 10.2%, which was 260 basis points higher than non-340B growth.
DCI estimates that more than 17% of brand-name drug sales occur at 340B discounts, which can be as high as 100%. The Genesis Health Care, Inc. v. Becerra case seems likely to fuel further growth by broadening the definition of a “patient.”
For more on the 340B program, please join me on June 21 for my new live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook.
2024 Trends in Specialty Benefit Design, PSG
Are alternative funding programs (AFPs) losing their shine?
As you may recall, AFPs are shady schemes by which commercial plan sponsors drop drug coverage in order to grab charity support intended for uninsured and indigent patients. For background, see Employers Expand Use of Alternative Funding Programs—But Sustainability in Doubt as Loopholes Close. (You can also watch The Economics of Copay Accumulators, Maximizers, and Alternative Funding Programs, a free video in which I compare AFPs to copay accumulators and maximizers.)
PSG’s new 2024 Trends in Specialty Benefit Design surveyed 106 employers and 46 health plans about their use of AFPs. As you can see below, overall use has been somewhat steady over the past three years. However, the number of plan sponsors that are exploring the use of an AFP has been dropping steadily.
Figure 14 (on the report’s page 25) shows that a majority of employers and health plans believe that AFPs are either not at all or only slightly sustainable. Perhaps the tide is turning on plan sponsors’ view that the ends (free drugs) justify the means (bending or breaking the rules to loot a charity).
P.S. PSG’s new report is filled with loads of cool data. Highly recommended!
As you may recall, AFPs are shady schemes by which commercial plan sponsors drop drug coverage in order to grab charity support intended for uninsured and indigent patients. For background, see Employers Expand Use of Alternative Funding Programs—But Sustainability in Doubt as Loopholes Close. (You can also watch The Economics of Copay Accumulators, Maximizers, and Alternative Funding Programs, a free video in which I compare AFPs to copay accumulators and maximizers.)
PSG’s new 2024 Trends in Specialty Benefit Design surveyed 106 employers and 46 health plans about their use of AFPs. As you can see below, overall use has been somewhat steady over the past three years. However, the number of plan sponsors that are exploring the use of an AFP has been dropping steadily.
[Click to Enlarge]
Figure 14 (on the report’s page 25) shows that a majority of employers and health plans believe that AFPs are either not at all or only slightly sustainable. Perhaps the tide is turning on plan sponsors’ view that the ends (free drugs) justify the means (bending or breaking the rules to loot a charity).
P.S. PSG’s new report is filled with loads of cool data. Highly recommended!
Booth #1801 at the AXS24 Summit, Drug Channels Institute
Earlier this month, the Drug Channels Institute team had the pleasure of attending Asembia’s 2024 AXS24 Summit at the wonderful Wynn Las Vegas.
Thanks to the many Drug Channels fans who introduced themselves in Las Vegas. I remain gratified by your compliments and words of encouragement. I was especially flattered by the many people who asked to take pictures with me. Click here to see a small sample of these photos. We’re glad that DCI remains useful and valuable to people throughout the industry.
And thanks to our new friends at HMP Global, DCI also had its very own booth. See below for a great photo with me, Paula Fein, and Bar Stern. Many people stopped by to spin the Drug Channels Wheel O’ Fun (pictured below).
See you there again in 2025!
Thanks to the many Drug Channels fans who introduced themselves in Las Vegas. I remain gratified by your compliments and words of encouragement. I was especially flattered by the many people who asked to take pictures with me. Click here to see a small sample of these photos. We’re glad that DCI remains useful and valuable to people throughout the industry.
And thanks to our new friends at HMP Global, DCI also had its very own booth. See below for a great photo with me, Paula Fein, and Bar Stern. Many people stopped by to spin the Drug Channels Wheel O’ Fun (pictured below).
[Click to Enlarge]
See you there again in 2025!
Navigating The American Healthcare System, South Park: The End Of Obesity
Even after all these years, South Park still does satire better than almost anybody else. For discussion: Is this video clip a satire or a documentary? Click here if you can't see the video below.
The excerpt above comes from The End of Obesity, a darkly comic look at the GLP-1 craze. The full episode is hilariously unhinged, highly offensive, and definitely NSFW.
The excerpt above comes from The End of Obesity, a darkly comic look at the GLP-1 craze. The full episode is hilariously unhinged, highly offensive, and definitely NSFW.
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