Issue 095

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:

• Thanks to an updated post on ClinicalTrials[DOT]gov, there’s a little more information out this week about Click Therapeutics and Otsuka’s Mirai trial, which Verily is facilitating. The 540-participant study is “a phase 3, 12-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.” While Click wouldn’t give me any explanations when I asked, I think we can assume one of the two digital therapeutics in the study is a sham? (The study is quadruple masked.)
• This job posting from Novartis caught my eye because it claims the pharma company has 1,295 digital health startups in its proprietary network. “We’re establishing 10 Innovations Hubs across the world by 2021, and we aspire to be the #1 partner for the digital health and tech ecosystems.” That’s a lot of startup relationships to manage!
• I was on a call this week with an executive at a digital therapeutics company and mentioned What If Ventures‘ handy spreadsheet of more than 1,000 mental health-focused digital health startups. The person I was talking to hadn’t heard of it. In case you haven’t either, here’s the link.
• Last week I added a new digital health product to the “Digital health reimbursed in Germany via DiGa” tracker on the E&O site but forgot to mention it in the newsletter. Mika, an app that uses CBT, ACT and other interventions to reduce stress resulting from cancer diagnosis and therapy, is now temporarily reimbursed by the German government at $493 (€419) for three months of treatment. Germany’s own Fosanis developed Mika, which is the 12th digital health product to secure reimbursement via DiGa.
• Pear Therapeutics announced that reSET and reSET-O will be added to blockchain-based PBM startup Prescryptive’s formulary.
• One more thing… Ed Cox, the former CEO of early Alzheimer’s-focused digital therapeutics startup Dthera Sciences, is the feature of a recent interview with MobiHealthNews. He talks a bit about Dthera’s struggles. If you’d rather listen to that story, Cox also discussed this on a recent Digital Therapeutics podcast episode.

Was this forwarded to you? Well, scroll on. Definitely don’t click this link. It’s not for you: Don’t click here.

Digital therapeutics lobbying dollars in 2020: $800K

As I noted in Issue 022 back in October 2019, Pear Therapeutics was the only company or organization at that point that had lobbied the federal government about issues related to digital therapeutics. The company spent $40,000 in 2018 and went on to spend another $70,000 in 2019. In 2020, Pear stepped it up and spent $340,000 on lobbying Congress and various federal agencies. Pear’s lobbyists focused on the issues and legislative bills below:

• “Increase awareness of clinical use of FDA cleared prescription digital therapeutics and Medicare coverage.”
• “Issues related to prescription digital therapeutics including S. 3552 – Prescription Digital Therapeutics to Support Recovery Act.”
• “H.R. 5333, Ensuring Patient Access to Critical Breakthrough Products Act of 2019, as it relates to Medicare coverage. S. 3532, Prescription Digital Therapeutics to Support Recovery Act, as it relates to Medicare coverage.”

While Pear went it along in 2018 and 2019, last year Pear’s lobbyists got some reinforcements. The Digital Therapeutics Alliance disclosed its lobbyist activity in 2020 topped $90,000 by the end of the year. The DTA’s lobbyists focused on general DTx awareness but also:

Orexo, which has spent lobbying dollars in past years, started lobbying about digital therapeutics reimbursement for the first time in 2020 too. Here’s a sample of what Orexo’s lobbyist efforts focused on:

Big Health, makers of Sleepio and Daylight, also filed its first lobbyist report in 2020. It spent $40,000. Big Health’s efforts had a singular focus:

Finally, the American Medical Association went to bat for digital therapeutics as part of its massive annual lobbying efforts. Unfortunately, it’s impossible to break out exactly how much the AMA spent on this one issue since it lists out dozens of others in its filings. It is notable, however, that a powerful group like the AMA took up the cause of DTx last year. (All told, the AMA spent about $19.6 million on lobbying the federal government in 2020.)

Cigna and AmeriHealth Caritas: No coverage for Akili’s ADHD digital therapeutic, EndeavorRx

Back in Issue 092 I rounded up a handful of medical coverage policy documents from health plans around the country that had weighed in on Pear Therapeutics’ prescription digital therapeutic for opioid use disorder, reSET-O.

(I’m still a little fuzzy on why health plans post coverage policy explanations for treatments they have deemed investigational, unproven and, therefore, not medically necessary. That seems likely to be a large category. How do they decide which ones to call out and which ones to simply ignore? Hit reply if you can explain that to me — much appreciated. UPDATE: Thanks to everyone who wrote in with explanations and other resources on this.)

This week I found two that came to similar conclusions about Akili Interactive’s EndeavorRx, a digital therapeutic for ADHD that is indicated to improve attention function.

(It’s worth pointing out up top that Akili has not approached the launch of EndeavorRx like a pharma would with a big salesforce attempting to secure coverage at scale right out of the gate. For more on Akili’s go-to-market 180 re-read Issue 088.)

Cigna posted a medical coverage policy for ADHD dated January 15, 2021, but its mentions of Akili seem to indicate its research is out of date:

The FDA granted Akili’s EndeavorRx a De Novo clearance in mid-June 2020. Prior to that date, Akili referred to its therapeutic as “Project Evo.” So, based on the name alone, Cigna’s January 2021 coverage policy is at least seven months out-of-date.

A recent journal article co-authored by Digital Therapeutics Alliance executive director Megan Coder pointed to the Cigna coverage policy document and noted that it ignored Akili’s recent clinical trials:

Managed care organization AmeriHealth Caritas, which has 4.5 million beneficiaries across 13 states, posted a coverage policy for ADHD that appeared much more up-to-date than Cigna’s even though it was published months beforehand. While it acknowledged Akili’s STARS and STARS-Adjunct studies (and discussed some of the results that were available at the time) along with three other studies Akili conducted, the policy still concludes:

The policy’s “findings” sections starts out with:

And it seems like that’s enough for this payer to punt.

Like Cigna, it also pointed to meta-analysis studies that looked at dozens of past brain training intervention studies and concluded the evidence base for this category is still immature.

Clearly, if Akili wants to secure reimbursement from health plans, first the company needs to convince payers to stop pigeon-holing it as just another brain-training game. Both Cigna and AmeriHealth Caritas plan to review the coverage policy in January 2022.

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