Issue 203
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 are a few quick happenings in FDA-regulated and pharma-focused digital health…
- The FDA granted Apple a new 510(k) clearance for its Irregular Rhythm Notification Feature algorithm, which runs on Apple Watches. No details yet on what changed as the agency hasn’t posted the summary document yet.
- The FDA also granted Welldoc a new 510(k) clearance for its “BlueStar and BlueStarRx” devices — similarly no summary document from the agency yet.
- The FDA and DEA published a joint open letter about the ongoing shortage of ADHD medications that included a plug for Akili’s EndeavorRx: “FDA has already taken steps to support the development of alternative treatment options. In 2020, for instance, FDA permitted marketing of a game-based digital therapeutic to improve attention function in children with ADHD. This device offers a non-drug option for improving symptoms associated with ADHD in children.”
- Germany’s national formulary of reimbursed digital health programs (DiGA) permanently listed a binge eating program from Selfapy this week — just three months after the program was provisionally listed in the formulary. The online course costs €540.00.
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Akili and AppliedVR make their cases to the CMS HCPCS committee
CMS posted the recordings from the HCPCS Committee’s three-day meeting with code applicants back in late May and early June. A week before the meeting took place, I wrote about applications from Akili, AppliedVR, and Luminopia in Issue 195 here.
Luminopia: As I noted back in May, Luminopia received a preliminary decision from CMS that its application for a new HCPCS code was accepted. So, unsurprisingly, the company didn’t show up for the meeting since they agree with the prelim decision.
Akili makes the case that EndeavorRx is not CBT and is not related to CBT
Akili has been trying to convince CMS to create a new HCPCS code that better describes EndeavorRx for a while now. It previously convinced the committee that the HCPCS code Pear Therapeutics helped create for digital prescription cognitive behavioral therapy (A9291) was not inclusive of EndeavorRx. In response to that application, CMS tweaked the code so it read “cognitive and/or behavioral therapy,” which seemed to solve the issue since EndeavorRx certainly is “cognitive” related and “therapy.” But Akili applied again in this latest round because it believes its therapy is unrelated to CBT and shouldn’t be lumped together with it. (Having a unique code would be ideal.)
Here’s the concluding slide from Akili’s presentation to CMS at the May-June meeting:
Most of Akili’s presentation focused on differentiating EndeavorRx’s mechanism of action vs. cognitive behavioral therapy (CBT). Following the presentation, CMS asked Akili a few follow-up questions, but I can’t tell from the questions which direction the group is leaning as to whether or not Akili’s presentation convinced them of the need for a unique code. Maybe you can? The questions were:
- Are there any studies published or planned on the effect of EndeavorRx in an adult population? (Short version of the answer from Akili: Yes.)
- Do the benefits of EndeavorRx relative to the improvement in attention persist when the gaming is discontinued both in the short term and long term? (Short version of the answer from Akili: Yes.)
- Is this part of CPT code 98978 for remote therapeutic monitoring for cognitive behavioral therapy? (Short version of the answer from Akili: No, this is not a remote monitoring device.)
- Can the treating practitioner generate a report about program adherence? (Short version of the answer from Akili: Not really. Parent version of app has that now and they could share with HCP.)
- Obviously, there has evolved a large difference between the product we found in the 2017 medical blog and the RelieVRx that the VA pays for. Help us understand the evolution — the changes in the product — that led to that cost increase. (No short answer here but AppliedVR makes clear that earlier device is not comparable.)
- The content for the earlier device was licensed from third parties and the content for the current device is mostly created in-house? (Short answer: yes.)
- Is the headset the same for both the earlier and current device — just a change in software? (Short answer here is: No. Hardware and software have changed.)
- in-house vs third-party content,
- servicing the devices between patients,
- ensuring the content was accessible to people with disabilities,
- and turnaround time for getting a patient a new device if theirs is broken.
Apple is looking to hire a healthcare market access and reimbursement expert with AR/VR experience
While the launch presentation for Apple’s new augmented reality headset, Vision Pro, didn’t focus on the device’s potential healthcare applications, a new job opening at Apple suggests that Apple has ambitions to secure payer coverage for the device.
The job post shows the company is looking to hire an expert in reimbursement and market access for “innovative products.” The job description also notes that experience with augmented reality or virtual reality products is a plus. Last hint: The job is listed as a position within the company’s health and hardware teams.
Here are a few excerpts from the JD:
“Our team is seeking an experienced expert in Reimbursement, Market Access, and Commercialization to join our innovative, cross-functional team! This role requires a deep knowledge of global healthcare systems and reimbursement mechanisms and exceptional business acumen – balancing understanding and the ability to simplify complex concepts for all audiences. Our ideal candidate has demonstrated success in securing novel payment models for innovative products.”
“Knowledge of virtual reality and augmented reality technology and its applications in healthcare is a plus.”
“In this role, the candidate will:
- Develop novel Reimbursement and commercialization strategies in collaboration with other teams at Apple
- Payer Engagement: Establish and maintain relationships with key payers, reimbursement authorities, and relevant stakeholders to influence reimbursement policies and secure optimal coverage and reimbursement for Apple products
- Health Economic Analysis, Reimbursement Submissions: Generate evidence-based value propositions and support reimbursement negotiations. Develop and submit any documentation needed for coverage
- Monitor the reimbursement landscape, reimbursement regulations, guidelines and competitor activities, providing insights and recommendations to inform strategic decision-making
- Training and Education: Provide training and education to internal teams on reimbursement strategies and processes to maximize market penetration and adoption.”
Trials: Big Health, Swing, Limbix, Blue Note
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Now recruiting: Study from Big Health and Oxford University on treating fibromyalgia with Sleepio
This marks the first time that Big Health’s Sleepio has been used to treat symptoms in a population of patients with fibromyalgia. The study hopes to enroll 80 participants and its randomized, parallel assignment. More:
“The goal of this clinical trial is to investigate the potential benefits of a digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) platform, Sleepio, in individuals suffering from fibromyalgia, a condition commonly associated with cognitive issues and sleep disorders.”
Meanwhile: Swing Therapeutics takes STANZA to Spain in study on a Spanish language version of its fibromyalgia digital therapeutic
“Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM.”
Terminated: Limbix Health, recently acquired by Big Health, terminates trial due to low enrollment
“The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children’s Health System of Texas (CHST).”
Terminated: Blue Note Therapeutics terminates a trial as it re-evaluates digital therapeutic for depression in cancer — Attune
Blue Note Therapeutics has made its prescription digital therapeutics available thanks to the FDA’s pandemic-era enforcement policy for psychiatric digital health devices. Blue Note recently updated this clinical trial to show that it had terminated it because it is “reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)”. More on the now-terminated study:
“This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.”
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