Issue 146
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.
Here’s what’s going on in FDA-regulated and pharma-focused digital health:
- Wish I had thought of this one first: STAT has a must-read report (sub. req.) out this week that digs into the FDA’s Breakthrough Device Program: “After months of questions from STAT about the program, the FDA published a list of breakthrough devices on its website on Friday, ahead of this story’s publication. The agency had previously provided STAT with a list of authorized devices that did not include several products whose breakthrough status was revealed by STAT’s reporting. Only after reporters shared that information with FDA officials did the agency publish it for the first time.” So, thanks to STAT, you can now check out the FDA’s begrudgingly disclosed database of 44 authorized breakthrough devices over here on the agency’s site.
- Belgium has finally decided to reimburse one of the prescription digital health programs in its version of Germany’s DiGA formulary. An MSK program named moveUP is the first app in the country to progress to reimbursement. As it is still proving its health economics model out, moveUP is actually at level M3-, which entitles it to preliminary funding. If it proves its economic value, then it can be reimbursed on a structural basis. More here (in Dutch). MoveUP’s site.
- Meanwhile, Germany’s DiGA program added another reimbursed digital health program: Vitadio, a Type II diabetes management app. The first 90-days cost €420. Site
- Maybe nothing new here: The AMA posted a blog about the relatively new Remote Therapeutics Monitoring Services CPT codes. David Kanter, MD, a member of the CPT Editorial Panel and the AMA-convened Digital Medicine Payment Advisory Group, stated the obvious (perhaps, but still nice to see this from an official): “The future intention is that the CPT code set may be expanded to account for other body systems in monitoring devices beyond just respiratory and musculoskeletal.”
- One more thing… The FDA posted another 510(k) clearance for Coala Life’s heart monitor device, which can now be used for auscultation and monitoring of patients’ lungs remotely. Coala’s founding team includes some longtime St. Jude alums. “Coala Heart Monitor received its first 510k FDA clearance in 2019. The indication included, among other things, the ability to perform remote smartphone-based ECG with automatic detection of atrial fibrillation and of ability to remotely auscultate the heart.”
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White House calls for reimbursement of digital therapeutics for substance use disorder in National Drug Control Strategy plan for 2022
The White House put out its plan for curbing overdose deaths from opioids: The National Drug Control Strategy. In what appears to be a first to this reader, the White House explicitly called for reimbursement of digital therapeutics in this year’s strategy document. Maybe more interestingly, the document suggests that HHS, VHA, and DOD should ask Congress for the authority to pay for digital therapeutics. Here’s the relevant section of the 182-page document:
“Explore reimbursement for evidence-based motivational incentives such as contingency management, and explore emerging evidence for digital screening, assessment, and treatment (digital therapeutics). (Agencies Involved: HHS/ASPE, CMS; VA/VHA, DOD)”
“Coverage for the provision of motivational incentives could be considered within health plans. This will require considering billing codes and setting reimbursement parameters. Coverage should be explored for the incentives themselves, as well as for the provider costs for administering them and the digital tools that help enable the treatment (including FDA-cleared and evidence-based approaches). Revisions to existing payment bundles could be assessed by the Department of Health and Human Services (HHS) payers to include these programs alongside MOUD and psychotherapy, as patients with OUD and other SUDs may need concurrent treatment. If needed, HHS, VHA, and DOD should request authority from Congress to cover the costs of motivational incentives and reimburse providers who work with patients using incentives and digital services for contingency management.”
Earlier in the document, the White House spells out what a prescription digital therapeutic is and also references Pear Therapeutics without naming the company:
“In addition, prescription digital therapeutics are software-based disease treatments intended to prevent or treat a disease that are regulated by the US Food and Drug Administration. For example, one prescription digital therapeutic authorized in 2018 delivers cognitive behavioral therapy for individuals receiving buprenorphine for opioid use disorder. Further exploration of such digital therapeutics and other health technology in the form of digital screening, assessment and treatment could help increase services for a wide array of patients.”
More signs of progress that CMS reimbursement for PDTs is lurching forward on Capitol Hill…
Clinical trial updates from Biogen, Mahana Therapeutics, Vicore, and Mayo Clinic
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Mahana Therapeutics’ new 100-participant trial for its flagship IBS DTx
This study has a tight age bracket of 18 to 21-year-olds and it will monitor participants using Mahana’s digital therapeutic for 12 weeks. Mahana is using IBS-SSS as its primary outcomes measure and SGA as its secondary (more here):
“The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana IBS together with care as usual in approximately 100 young adults with Irritable Bowel Syndrome.”
Mayo Clinic pits image recognition algorithm vs humans for skin allergy reaction grading
This is an interesting human vs machine learning study from the Mayo Clinic:
“The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers. Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.”
First patient enrolled: Pharmaceutical company Vicore has enrolled its first patient in its “a fully digitalized, randomized, controlled parallel-group clinical study to evaluate the impact of the digital therapy Almee on the psychological symptom burden in adults diagnosed with IPF.”
Now recruiting: Biogen is now recruiting participants for its Konectom study focused on patients with neuromuscular disorders:
“The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments.”
“The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs [self-administered at home and in-clinic] between person with spinal muscular atrophy (PwSMA) or person with amyotrophic lateral sclerosis (PwALS) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA or PwALS; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA and PwALS groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA or PwALS and to evaluate the clinical safety of Konectom in PwSMA and PwALS.”
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