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E&O: Software as a Medical Device
Here's what's new in FDA-regulated Software as a Medical Device....
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Fwd: New bill asks Medicaid to cover PDTs. More Apple-AliveCor.
Thu, 24 Oct 2024 15:17:54 -0400
exitsandoutcomes.com
Issue 176
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Issue 176 Digital health research from Brian Dolan
E&O Fridays.
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.
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=91036ed97d&e=a10e979d46>
*Here's what's going on in FDA-regulated and pharma-focused digital health
this week...*
- *Click Therapeutics received
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=fb804af1c5&e=a10e979d46>
Breakthrough
Device Designation from the FDA for CT-132, a prescription digital
therapeutic that aims to be an "adjunctive preventive treatment for
episodic migraine in patients aged 18 years and older" once it is fully
developed.*
- *Wise Therapeutics inked
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=b5affaf8a5&e=a10e979d46>
a deal with RxHealth to use its app distribution platform to enable
providers to "prescribe" their digital therapeutic for reducing stress and
anxiety, Personal Zen. Wise tells me the company has made Personal Zen
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=928bde7425&e=a10e979d46>
available under the FDA's public health emergency waiver for digital health
devices targeting psychiatric disorders. The announcement with RxHealth
also suggests that providers can use the new Remote Therapeutic CPT codes
as a way to get payment for monitoring their patients' use and adherence
to Personal Zen. Wise is still eyeing FDA submissions in the future, but
may also launch another mental health-focused digital therapeutic under the
FDA's waiver in early 2023. *
- *Apple-AliveCor: Earlier today the panel of judges at the ITC that is
mulling over whether to ban the importation of Apple Watches because an ITC
judge found the device to infringe on AliveCor's patents, announced that it
would not enforce an import ban (if it decides on one next week) until
after the appeals process is finished over at the US Patent Office's court
system, which recently ruled that Apple did not infringe on AliveCor's
patents. So, the ITC may still announce plans for a ban on imports of Apple
Watches next week, but it won't enforce it unless AliveCor's appeal at PTAB
prevails at some point in the future.*
- *In a letter to the agency, Abbott suggested that the FDA reconsider
its guidance document priorities for next year. Among other things, the
company asked it to add a draft guidance to its priority list that
describes "**a process to evaluate a predetermined change control plan
for digital health devices."*
- *News you know: **Virtual reality behavioral health companies BehaVR
and OxfordVR announced
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=5ce9409405&e=a10e979d46>
plans to merge along with a new $13 million in funding from Optum
Ventures, Oxford Science Enterprises, Confluent Health, Accenture Ventures,
Chrysalis Ventures and Thornton Capital.*
- *Pfizer is building out a new team called "Digital Health & Medicines"
headed up by longtime digital therapeutics entrepreneur Edward Cox, who
spent the past few years at Eversana and previously was CEO of Dthera. Job
descriptions
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=af471c818a&e=a10e979d46>
for new positions on the Pfizer DHM team explain: "Pfizer’s digital health
products are designed to establish Pfizer as an industry leader in this
digital health, addressing unmet needs and improving patient outcomes. Our
initial products will provide benefits around the drug for patients in core
therapeutic areas of interest for Pfizer. Given this intersection, the
Strategy and Assessment Associate will spend extensive time working
directly with peers in TA-aligned business units, including Global
Marketing leaders and regional and country-level leaders focused on
biopharma commercialization, as well as BD team members with relevant
experience. This role will also liaise extensively with Digital Health
Startups and other organizations, with the goal of building industry
relationships and launching partnerships."*
- *Germany did not remove any prescription digital therapeutics from its
national formulary (DiGA program) this week, but it did lower the price of
one. Interestingly, this digital health program already went through a
price reduction, which I noted last month in a round-up of DiGA changes
published in E&O Fridays Issue 172: "Selfapy's course on depression. Price:
Lowered from €540 to €290.94." Now, it is permanently listed at an even
lower price point: €217.18 for 90 days of use.*
- *One more thing... In case you somehow missed it this week: This
investigation
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=5e164839bd&e=a10e979d46>
by STAT News and The Markup is worth reading. It digs into how 50 virtual
care startups use online marketing tools that sometimes send personal
health information to the big tech companies' servers. Much of what they
uncovered falls outside of HIPAA, but it raises important ethical
questions. Lots to consider, but after reading it, one of the many
questions I have: What would it mean for the future of digital health if
companies were not allowed to use digital marketing channels?*
*Did a friend forward this to you? You, too, can win friends and influence
people via newsletter forwards by clicking right here
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=a5a7e32a54&e=a10e979d46>.
Become the newsletter-forwarder we both know you were meant to be. Act
fast! This offer won't last forever (I am not immortal). *
New Senate bill aims to clarify how state Medicaid plans can pay for
prescription digital therapeutics
The Digital Therapeutics Alliance is backing a new bill on Capitol Hill
this week that asks CMS to clarify for state Medicaid plans how they can
provide assistance to help beneficiaries pay for prescription digital
therapeutics. The same Senator that introduced the DTA's last bill is the
lead sponsor on this one: Sen. Shelley Capito (R-WV). Sen. Jeanne
Shaheen (D-NH) is once again the first to co-sponsor.
The group hopes to tuck the bill into the big year-end omnibus spending
bill for the fiscal year 2023.
Unlike the Access to Prescription Digital Therapeutics bill that E&O has
been tracking for years, this one is not focused on creating a new Medicare
benefit category for PDTs. It just aims to make it clear to state Medicaid
leaders around the country that they have the authority to pay for PDTs via
medical assistance programs.
Massachusetts' Medicaid plan MassHealth was the first in the country to
step up and pay for prescription digital therapeutics when it signed a deal
with Pear Therapeutics to give its members access to reSET-O and reSET.
Pear has since used this win to try to convince other states to do the same
-- with mixed results.
For example, here's a recent lobbyist effort from Pear in the state of
Connecticut:
"Currently reSET and reSET-O are preferred on the MassHealth non-drug
formulary with no [prior authorization]. We have requested CT Medicaid to
mirror coverage like MassHealth given the high need in CT for more
evidence-based treatments for Substance and Opioid Use Disorders.
Currently, some employers in the CT private sector (The Hartford, Prime
Therapeutics) offer commercial coverage for reSET and reSET-O but citizens
in the Medicaid program are not able to access these treatments. CMS has
recently designated unique HCPCS code A9291 Prescription digital behavioral
therapy, FDA cleared, per course of treatment. This allows Payors,
including Medicaid, to cover PDTs via the pharmacy (NDC Code) or DME
(medical/HCPCS Code A9291) benefit.
The state of Michigan recently appropriated $1.5 Million of federal state
opioid response grant funding to develop a pilot program integrating
innovative prescription digital therapeutics to assist individuals with
opioid use disorder with recovery. The pilot program integrating innovative
prescription digital therapeutics will use evidence-based technologies
modeled on a specific form of cognitive behavioral therapy combined with
fluency training in conjunction with contingency management for opioid use
disorders, known as community reinforcement approach.
We are asking this committee to: Request coverage under Medicaid for PDTs
for OUD and SUD and, or Grant a budget line item to be used by CT Medicaid
to develop a pilot program integrating innovative prescription digital
therapeutics to help people in CT with substance use disorder or opioid use
disorder on their recovery journey."
I suspect that if this new bill passes, then Pear wouldn't have to make its
case this way. Here's what the new bill's text shows that it aims to do.
Three things:
- The bill directs CMS to provide guidance to states on methods for
paying for prescription digital therapeutics
- It directs CMS to provide technical assistance to states that "seek to
incur an expenditure" for providing medical assistance to cover PDTs;
- And it provides a definition for "prescription digital therapeutics".
The other older PDT Access bill will have to come back in the new
Congress. The need for a Medicare benefit category isn't solved by the
Medicaid clarification bill introduced this week.
Clinical trials: Blue Note Therapeutics, Pear Therapeutics, Wise
Therapeutics
This is a recurring feature of E&O Fridays that digs into new digital
health-related clinical trials as well as updates to others that E&O
mentioned in previous issues.
*Completed: Pear's trial of a new gamified version of reSET-O for opioid
use disorder*
At the end of November, Pear's study on a new gamified version of its
flagship prescription digital therapeutic, reSET-O, finished up. No results
yet. Here's the brief on the study
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=7a4d3bde04&e=a10e979d46>
:
"This is a randomized, controlled, open-label, decentralized study to
evaluate patient engagement with PEAR-008, a game-based digital therapeutic
for the treatment of opioid use disorder. PEAR-008 is a new version of
reSET-O, an FDA-authorized mobile application treatment (available by
prescription only) for opioid use disorder. The study will examine if
changing the application's delivery format and enhancing clinical content
affects how patients use and interact with the intervention."
*Now recruiting: Wise Therapeutics study on a gamified digital therapeutic
for social anxiety disorder*
Wise also changed up the study design for this trial
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=3eb1852d98&e=a10e979d46>
by reducing the arms from three to two. While the company had two
experimental groups before it now only has one and a placebo group:
"This study aims to assess the feasibility and efficacy of the digital
therapeutic ABM-01 in adults ages 22-65 with SAD. Participants access
ABM-01 on their mobile smart phone and complete treatment over a period of
30 days. Enrolled participants will be randomly assigned to one of two
groups (Experimental Group and Placebo Control) and be assessed over five
periods of time (Baseline Session, 30-Day Treatment Phase, Post-Treatment
Session, 6-Month Follow Up Session, 12-Month Follow Up Session)."
*New: Blue Note Therapeutics re-launches a study observing longterm
follow-up on its two prescription digital therapeutics for cancer care,
attune and cerena*
More on the study
<https://exitsandoutcomes.us19.list-manage.com/track/click?u=cb777ca790addd96d38989aa9&id=00c5ac2e25&e=a10e979d46>
here:
"The RESTORE extension study is a non-interventional, long-term follow-up
study with people who participated in the study referred to as RESTORE
(NCT05227898). The purpose of this extension study is to understand the
durability of the effects of two digital software devices on anxiety and
other indicators of psychological and physical health in participants of
the RESTORE study in the 6-months after study completion. Subjects who were
enrolled and not withdrawn from the original RESTORE study are eligible to
participate. People who consent to participate will be asked to
electronically complete a set of questionnaires at 3 months and 6 months
following the scheduled date of their RESTORE end-of-study visit."
Links to E&O's reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form
research reports, databases, and past newsletter editions. Click below for
dedicated pages for each of those categories:
- Read through the long-form E&O research reports here
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.
- Search and sort the E&O databases here
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.
- Skim more than 200 past issues of E&O newsletters here
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.
So ends *Issue 176 *of E&O Fridays.
*Help me E&O subscribers, you're my only hope*: If you learned something
from today's issue, would you forward this newsletter to someone you think
might be interested?
[image: Exits & Outcomes]
Digital health research, news, and analysis from Brian Dolan.
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Exits & Outcomes · 32 Independence Rd · Bedford, MA 01730-2434 · USA
**Relevance to Digital Therapeutic Companies:**
The email provides updates on regulatory and industry developments relevant to companies developing prescription digital therapeutics (PDTs):
* **Breakthrough Device Designation:** Click Therapeutics received FDA designation for its CT-132 PDT for episodic migraine.
* **PDT Distribution Partnership:** Wise Therapeutics partnered with RxHealth to distribute its Personal Zen PDT for stress and anxiety.
* **Medicaid Reimbursement:** A new Senate bill aims to clarify how state Medicaid plans can provide assistance for PDTs.
* **Abbott's Guidance Request:** Abbott suggested that the FDA consider a draft guidance on evaluating change control plans for digital health devices.
* **Clinical Trials:** Updates on clinical trials for PDTs from Blue Note Therapeutics, Pear Therapeutics, and Wise Therapeutics.
These developments indicate a growing interest from regulatory agencies, healthcare providers, and patients in the potential of PDTs. They also highlight the challenges faced by companies in navigating the regulatory and reimbursement landscape.
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