2024 BioPharma Trends (Part 2): Five more topics we’re tracking
Jennifer Hinkel MSc CHW FRSA
Oncology & Biotech Leader - Access/GTM/HEOR | Tech Founder (Data, Econ, Game Theory, AI) & Board Member | Oxford PhD Evidence Based Medicine | NASA Scientist | Creative
Earlier this week, we served up five industry trends that we’re keeping an eye on, and we have five more dynamics that are shaping the landscape. Here are more thoughts as 2024 unfolds, with a look at policy priorities and a few thoughts on new technologies:
??Will the changes for co-pay accumulators stick? Back to the PBM and payer front, we previously mentioned DOJ scrutiny into PBM practices, but what about co-pay accumulators? Patient advocacy groups have been hammering PBMs and making noise in Washington about these for years, and 2024 might be when we see some major changes based on a district court ruling that all forms of patient assistance must count towards deductibles and out-of-pocket maximums. If you didn’t know about them, co-pay “accumulators” or “maximizers” are mechanisms used by insurers and PBMs to prevent manufacturer co-pay assistance from counting towards a patient’s deductible and out-of-pocket maximum. HHS has dropped an appeal of the ruling; will it remain?
??What’s next for PDABs? Prescription Drug Affordability Boards (PDABs) are a thorn in the side of pharma and have created a lot of extra work for any team member working on state Government Affairs these days. Amgen has brought a lawsuit against the Colorado PDAB over Enbrel, Maryland’s PDAB is making waves, and Virginia may follow in their footsteps. Patient advocacy groups are up in arms around maintaining access, especially for rare disease therapies with high list prices (that also tend to have pretty decent payer coverage). Do PDABs interfere with interstate commerce and due process? Expect a complex legal battle ahead that will send strong signals to other states.
?? Election Year Dynamics — what to watch for? 2024 is an election year not only in the US, but also in the UK, Brazil, India, and Mexico. In the US, expect a lot of rhetoric around drug pricing and healthcare access, but probably little change. Remember that IRA MFP announcements will emerge prior to November. Across the pond, the UK might be facing higher taxes amidst imperatives to increase funding for a struggling National Health Service (NHS); will this pressure extend to drug pricing, NICE, and the Cancer Drugs Fund??
??New, Remote Clinical Trial Models Enabled by Telehealth and Remote Patient Monitoring — The pandemic accelerated the adoption of telehealth, and this trend is expected to continue growing in 2024. Most interesting for industry, though, is the expansion of telehealth and remote patient monitoring into clinical trials, enabling real-time data collection and broader, more diverse participant recruitment. Enabled by a mix of new technologies and services—from mobile phlebotomy and wearable capillary blood collection devices to just-in-time clinical trial networks and blood-based NGS for tumor analysis—clinical trials that reach more into the community and even the home are here to stay, which is a great thing for trial access and recruitment, and an exciting thing for innovators in this space.?
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??What are manufacturers doing with AI? This one is a wildcard; on one hand, we have soaring valuations for AI-enabled companies and a race among manufacturers to declare that they are using the latest AI technologies in drug development, biomarker discovery, and more… all while a number of large biopharmas simultaneously stated that they don’t allow their employees to use ChatGPT on network devices because they are afraid that confidential information will be leaked to the robots (or the general public). We believe that the speed of AI adoption will create clear winners and losers, with those who figure out how to harness and deploy the tech across key areas of the business quickly outpacing those who lag behind. Of course, there are risks. We’ll be watching to see which companies prepared well, and which were content to be left behind.
??These trends are just a handful of what we, and our clients, have been talking about this year, and where we’re helping navigate a changing landscape.?
Are there other trends that have been on your mind?
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I am really curious to hear thoughts from others on this and whether there are other industry trends you think we should examine at Sigla Sciences