It's been a while since I did a post on recent news in pharmacy-related digital heath, so I'm thinking of changing it up and doing small blurbs on recent news that I think may be of interest to the pharmacy community. I welcome your thoughts on this style or recommendations! So let's jump into it.

Civica Rx Insulin, will it be cheaper?

Insulin. The bane of price debates in pharmaceuticals up there with EpiPens years back. We heard people think Mark Cuban might start making it, and then comes CivicaRx back from 2018 with an announcement that got all the attention back on them. They are looking to bring generic insulins to the market by 2024, which really sounds exciting.

Now, looking at it, they are working with GeneSys Biologics, which currently has 6 insulin biosimilars in the pipeline. Based on the CivicaRx announcement, it's likely that GeneSys has a biosimilar for Lantus ready in the next year to go under review, and then CivicaRx can start manufacturing it. No idea on the Novolog or Humalog biosimilars, though, could be soon, could be the end of the decade.

Two questions I have. 

1. Will these be interchangeable biosimilars, like Semglee and Lantus, or will providers have to write for these biosimilars? I feel like that's gonna cause some ruckus on the pharmacy side if not.

2. Insulin pens are combination products. Vials are easy. Pens, not so much. I'd be keen to see which company CivicaRx is going to court to make the pens and the legal side of that. Again, if the pens are really different, pharmacists will need to be prepared to educate patients on that (similar to what happened with brand vs. generic Advair Diskus if you want a comparison). In addition, this will likely throw a wrench in digital health companies focused on adherence with pens using an add-on. Now they got another pen to deal with. Wheeee...

DarioHealth + Sanofi Form a Partnership 

DarioHealth has been around for a while. I knew them more like something akin to iBGStar back in the day with a device that attaches to your smartphone to help with blood glucose testing. But things change. The strategic agreement involves $30M to leverage Darios push into the DTx space. Interestingly, seems a market they are targetting is employer benefit programs, but wouldn't be surprised to see Medicare Advantage plans as well based on other chronic condition management (with an emphasis on diabetes) adopting said strategy.

I find it interesting, given that Sanofi had said pre-pandemic they would focus on other therapeutic areas away from cardiometabolic, and that their flagship diabetes product, Lantus, has its first interchangeable biosimilar coming to market this year from competitors. I'm quite interested to see what comes of this, given some of the recent issues around the DTx space (think Anthem almost rejection of coverage comes to mind), but other developments I'll mention below may also be a positive angle. 

In any event, Dario + Sanofi is an interesting development. Given that other companies are battling in this space for chronic condition management and diabetes (like Virta, Omada), I can see perhaps Sanofi is trying to keep up with other DTx partnerships that Eli Lilly and Novo Nordisk may also be pursuing as well. Pharma and DTx aren't dead yet, but I think the prescription digital therapeutics market will be the next battleground.

For the pharmacy space, I am really waiting to see perhaps joint DTx/PDTs being pushed out with either something along the line of Walgreens/CVS/Walmart or maybe even some of the newer digital pharmacies (Ro, Capsule, Alto) to give an edge in combatting in the primary provider space. I can't imagine that this angle isn't being targeted in some manner.

Mobvoi's Smartwatch and Arterial Health

I never heard of Mobvoi before today. Probably because I tend to stick with Apple Watches. But in an increasingly crowded space in the health and wellness market, having any differentiator is key. It seems their new TikWatch has the feature to track arterial health, which is interesting compared to a heart rate/rhythm monitor. It reminds me of Withings smart scales that give a cardiovascular health score. 

Now theirs no FDA clearance, I saw, and probably because they are flying under the wellness market coverage. So given that, unsure if it plays a role in the digital medicine/biomarker field. I feel that will be an issue against other companies who seem to be going that route, but who knows, maybe that's their pivot in the future. Given the risk of cardiovascular disease, this may be something some people consider, or it'll stick more in the general athletic health and wellness crowd. Waiting to see if this means people will come asking if they need to take an aspirin a day, though if the score is bad.

Cognizant and Microsoft target RPM

Ahhh. Remote patient monitoring (RPM). I feel this is going to be the big thing this decade. Expanding the power of telehealth and going towards the 'hospital at home model. But, RPM isn't exactly an easy process. What tech do you use, where do you put the data, how to integrate it into the workflow, data interoperability, etc.

So now we see Cognizant enter and say they are going to work with Microsoft, or more specifically, their cloud, to help power their RPM strategy. It sounds like the generic mish-mash of tech-driven RPM with Bluetooth empowered devices. Nonetheless, it's on my radar and something I'll watch eagerly. I feel that there's still a big territory to carve out in the tele+RPM space. Again, waiting to see what level of scale pharmacy is going to get into RPM. I look at some systems, like Oschner, who have pharmacists using their own internal system for CCM+RPM, and I think eventually home-brewed could be replaced by other systems to get a larger population scale.

Apple PCOS Research

Women's health is a huge sector that is getting a lot of funding and attention as of late, and for good reasons. So it's no surprise to see that Apple Women's Health Study is seeking to tap into the role of mobile health as a possible viable tool. In this case, tying together data inputted into the Apple Health platform and related sensor data (e.g., smartwatch) seem to be helpful in finding some connections between cardiovascular health, menstruation, and PCOS. This aligns, I think, from a public health standpoint of early detection and, who knows, maybe a tool that could spot PCOS earlier than later for young women. It's probably years away from a practical model being released, but I like to keep my eye on these types of studies that really show the scale of digital biomarkers that are coming to fruition. Maybe from a pharmacy perspective, it could be an early marker for the intervention of certain therapeutics that some populations are missing out on, for example.

Amazon + Teledoc, say hello to Alexa for Me!

Voice is probably something we'll see further advance in time. I throw it up there in the realm of metaverse integration. I think voice biomarkers and utilization in care have large potential, and given Amazon's past forays into exploring the premise of Alexa in healthcare capabilities, I find it as no surprise to see them teaming up with Teladoc.

Now, for years I have been presenting a hypothetical scenario where one day you walk into your home start coughing, Alexa asks if you want a teleconsult and then a test delivered, whereupon a positive result means they send you a medication immediately. I think there are tremendous logistical barriers to this model, but that will be an end game.

So now the Teladoc now has a voice-communication tool in the customer home through Amazon, with just asking 'Alexa I want to talk to a doctor,' for instance. I think with video coming along, it'll open some possibilities. I think my core issue with just another means of engaging telehealth is:

• Does this increase access to a provider quicker than normal operations?

• Even with video offered later, does it expand access to possible services?

• What else is being roled into this platform?

I mean, it's a nice partnership and may be convenient to Amazon members then, but I'm not sure how 'groundbreaking' this is; rather, I think it opens up the conversation about whether Teladoc or another telehealth company just gets acquired by Amazon. My stance currently is that telehealth is nice but limited with current abilities unless bundled with other services or platforms, and when Amazon starts steering things alongside Teladoc, then things will really get interesting. Otherwise, even with my theoretical model, the logistics will favor some hybrid care models still heavily reliant on brick-and-mortar businesses.

Test to Treat and the State of the Union Implications

I'm sure you've seen it by now, but I think it's worth commenting upon. So the state of the union saw President Biden put forward the concept that people can go to the pharmacy, get tested for covid, and if positive, then treat. Sounds really good, right? I mean, lots of drug interactions, pharmacists know what meds the patient is on, a great way to address everything in one go.

Except... the AMA put out a statement they feel pharmacists can't do this because... of multiple drug interactions. Many providers and the pharmacy community are voicing their disapproval of this AMA position, but let's be frank. This is par for the course of the pandemic, where earlier we saw pushback on pharmacists providing pediatric covid vaccination before, issues around pharmacy testing sites, and now this. And, when it comes down to it, its cost and profits. The pharmacy is a prime locale that may make some profit off this model, but it's going to cut into the other providers who can't bill for testing, interpretation, and prescribing care. I mean, what are pharmacists going to bill for? Just the test and the medications. Way different margins here, where payers probably will like one over the other, and the AMA sees another area chipped away in profits.

On the other hand, if pharmacies go big on this, I hope they have the staff on board to handle it. Otherwise, it'll just be a mess with sick patients waiting around to get a test result and prescription while all other operations put on hold.

Ro wants your Sperm and then some

Well, for a company that started off focused on ED and expanded to other low-acuity conditions, it really feels Ro has come full circle. After a recent $150M raise, Ro is acquiring Dadi, a sperm collection start-up. Now Ro has been doing a lot in this space, recently with a fertility start-up as well. I think it's not hard to say that Ro is really focused on sexual health more than ever before. I think that makes sense, given some increasing concern amongst Millenials now planning on creating their own families.

Now there are other male fertility kits out there like Legacy, but I think seeing a full-stack approach across multiple areas in sexual health just makes sense at this point. I'm curious to see if the uptake is higher due to the Ro brand going forward. To be honest, based on how the kit looks, I could see some presence on pharmacy shelves in the future as well.

CVS + Metaverse, what?

The Metaverse is all the rage, and Web3 is going great. Or so I'm told. In any event, CVS came out and said they are going to make sure their content and material are ready for the Metaverse, and to be frank, I really can't blame them.

I still remember playing Left 4 Dead and seeing the pills, which were just Target brand ibuprofen. What a wasted potential for advertising, right? So, the next time we get a metaverse-focused zombie post-apocalyptic survival MMO now, we can all reach for the OTCs sponsored by CVS! 

Plus, you know, if they start offering care through the metaverse in the next decade or so...

What about Digital Therapeutics?

Ok, ok, ok. Yeah, I feel we need to address some interesting DTx/PDT announcements this month. Kinda all over the place, it seems, with some big news and some caveats being thrown in as this field maturates. I'll do that in a different article this month as I feel we'll see more news coming out mid-month.

Studies of Interest:

• Propeller had an interesting one, and I do enjoy their studies; a big fan of the Louisville one, for example. Titled "Impact of a Digital Asthma Intervention on Short-acting Beta-agonist (SABA) Medication Use Among Medicaid-enrolled Children in Southwest Detroit," it looked at the pediatric population with 50 participants in an underserved population and saw some positive clinical outcomes. Now, this is only an abstract presented at a conference, but I'll be interested to read more if a formal pub comes out later.

• Bevens W, Weiland T, Gray K, Jelinek G, Neate S, Simpson-Yap S. Attrition Within Digital Health Interventions for People With Multiple Sclerosis: Systematic Review and Meta-analysis. J Med Internet Res. 2022 Feb 9;24(2):e27735. -- Interesting review paper looking at the churn amongst digital health interventions in the MS population. It might be useful for those that need a baseline.

• Akilii has another publication on their EndeavoRx platform focused on neural and cognitive behavior amongst the pediatric population.

• An interesting economic modeling study based in the EU was conducted on DTx for back pain (which is basically Kaia) which found some positive monetary value in comparison to usual treatment it seems. I suspect we'll see more of these studies in the US to get payers on board.

• Siren Care put out a usability study on their smart socks that seems positive. I'll wait on their clinical study before I make my mind up on the value in this market for diabetes neuropathy complications with smart socks.

• Stern AD, Brönneke J, Debatin JF, Hagen J, Matthies H, Patel S, Clay I, Eskofier B, Herr A, Hoeller K, Jaksa A, Kramer DB, Kyhlstedt M, Lofgren KT, Mahendraratnam N, Muehlan H, Reif S, Riedemann L, Goldsack JC. Advancing digital health applications: priorities for innovation in real-world evidence generation. Lancet Digit Health. 2022 Mar;4(3):e200-e206.

• Lam KH, Bucur I, Van Oirschot P, De Graaf F, Weda H, Strijbis E, Uitdehaag B, Heskes T, Killestein J, De Groot V. Towards individualized monitoring of cognition in multiple sclerosis in the digital era: A one-year cohort study. Mult Scler Relat Disord. 2022 Feb 19;60:103692.