Issue 150
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:
- I haven’t had a chance to dig into it yet, but at first blush, this new resource from the Digital Therapeutics Alliance looks to be worthwhile: An “initial framework to assess DTx products, their value, and impact in real-world settings.” Download it here.
- In its latest quarterly filing this week, Pear Therapeutics continues to make progress toward the targets it set for itself last year. The company posted $2.7 million in revenue for the first quarter. (It aims to bring in $22 million in revenue this year after hitting around $4 million in 2021.) It also topped 9,700 prescriptions in the quarter. (Aiming for between 50,000 and 60,000 scripts this year.) More in the release here.
- More: On Pear’s quarterly call with analysts, the first question came from Bank of America and focused on what the evolution of Pear’s marketing spend and strategy looked like. The analyst specifically asked about the company’s mix of marketing channels and named Doximity and Medscape as examples. Pear’s response focused on its investment in building out its physician-facing platform and integrations with EHRs.
- Another interesting moment in the investor call was when Pear said it would no longer update investors on its number of covered lives. Pear described this metric as a proxy and it prefers more direct numbers. When asked about the decision, Pear described a recent incident at an industry event where a consulting firm said that Pear had approximately 80 million covered lives currently. Pear told the firm it thought that number was too high.
- Moving on… The big pharma digital health partnership news this week goes to Sidekick Health, which just raised a big round of funding. Sidekick and Pfizer have worked together for years, and this week they launched their fourth digital health offering together. This one is focused on atopic dermatitis, also known as eczema. The digital health program goes live in the UK first and then Belgium, Norway, the Netherlands, Sweden, France, Ireland, and Japan later this year.
- Rockley Photonics, which went public via a SPAC not too long ago, recently announced a tech licensing deal with Medtronic that will see Rockley’s “Bioptx biomarker sensing platform, which includes the Company’s wearable band, cloud analytics, and AI, [integrated] into Medtronic’s solutions for use across various healthcare settings.” Rockley also teased a big deal with a tier one wearables maker that many assume to be Apple: “The Company achieved an important milestone, shipping the enhanced, higher-performance Pro version of its VitalSpex biosensing technology to one of its early access, tier-1 consumer wearables customers. VitalSpex Pro solution biomarkers include alcohol, glucose and lactate in addition to the biomarkers provided by the Baseline solution.” Apple is known to be a Rockley customer, but it seems unlike Apple to allow one of its suppliers to tease announcements like this, right? I’m leaning toward this being someone else…
- One more thing: This might be a first since I started tracking it weekly three years ago, but the FDA didn’t add any new 510(k)s to its public database this week. Yet another signal that the agency is underfunded?
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UK’s NICE recommends physicians prescribe Big Health’s Sleepio instead of sleeping pills
The news you know:
“NICE has recommended Sleepio as an effective alternative to sleeping pills, which would save the NHS money as well we reducing prescriptions of medicines such as zolpidem and zopiclone that can be dependency forming. Economic analysis found that healthcare costs were lower at one year when using Sleepio, mostly because of fewer GP appointments and sleeping pills prescribed.”
This is a big deal. Who said digital therapeutics aren’t a threat to pharmaceuticals? A key contributor to the positive outcome for Big Health was NICE’s economic analysis, as noted above. I took a look at the organization’s analysis to better understand how NICE came to its conclusion, and it’s likely this recommendation will put some pricing pressure on other digital therapeutics. Before taking a look at the recent NICE report, it’s helpful to revisit some of their older analyses.
In a Big Health study that NICE analyzed a few years ago, the cost of Sleepio was pegged at $400 (£321) per user per year. (That price is the one that appears to be most often cited, especially for the US market.) Another NICE document from 2021 stated that the price for Sleepio was £200 ($249) per user per year in the UK. Let’s assume the typical price for Sleepio is somewhere between those two numbers.
OK, onto some excerpts from NICE’s most recent report on Sleepio. Here’s the summary paragraph on the price at which Sleepio is cost-effective:
“At a price of £45 per person, Sleepio is cost saving compared with usual treatment in primary care. This is based on an analysis of primary care resource use data before and after Sleepio was introduced in 9 GP practices. Healthcare costs were lower at 1 year, mostly because of fewer GP appointments and sleeping pills prescribed.”
£45 per person is about $56. Initially, NICE considered higher price points for Sleepio. Big Health apparently originally suggested a sliding scale based on update. Higher uptake meant a lower price per person. So, £90 per person price point assuming 1 percent adoption across the potential patient population:
“At the initial proposed prices, the technology was unlikely to be cost saving compared with treatment as usual When the population-based price proposed in the company submission was used in the EAC base case, Sleepio was cost incurring compared with treatment as usual after 1 year and 3 years. The main driver of the results was the uptake rate of the technology across the population. The EAC reduced the uptake rate to 0.58% from the company’s estimate of 1%, and this increased the cost of Sleepio from £90 to £155.17 per user. The committee agreed with the EAC estimates and noted that any cost savings depended on the uptake rate. NICE then considered a new model: The tiered license-based cost model was proposed after the first committee discussion and the price per user was updated to £66.11. When this cost was applied in the EAC base case, Sleepio was cost incurring by £16.59 per user at the end of year 1 but cost saving by £68.97 per user at 3 years. The committee did not agree that there was enough evidence to extrapolate the data to 3 years and concluded that the cost savings were uncertain.”
So, to add a little more detail on how the final price came to be:
“At the new proposed price, Sleepio is cost saving at 1 year compared with treatment as usual At consultation, the company proposed a price of £45 per user. When the EAC applied this new cost in its base case, Sleepio was cost saving compared with treatment as usual after 1 year, and the cost savings increased if benefits were extrapolated beyond 1 year. The committee noted that there were limitations in the economic modelling because of its dependence on the Sampson et al. (2021) study and the lack of remission outcomes. However, the committee decided on balance that at this price the technology was likely to be at least cost neutral and very likely cost saving, and decided to recommend it as an option for people with insomnia and insomnia symptoms who would otherwise receive treatment as usual.”
For reference: Pear’s prescription digital therapeutic Somryst is priced between $300 and $899 for a couple of months of usage.
Clinical trial updates from Biogen, Takeda, Boehringer Ingelheim, Sidekick, Karuna
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.
Now recruiting: Sidekick Health is now recruiting 174 participants for a study focused on a digital health program for heart failure patients. No pharma partner is listed on this one:
“The study aim is to determine whether a 12-month digitally delivered behaviour change solution for patients with heart failure improves symptom frequency, mental health, quality of life, medication adherence, and self-care behaviour. The primary and secondary endpoints will be captured at 6- and 12-months follow-up visits to assess longer term effect on outcomes.”
Completed: Boehringer Ingelheim and Medullan finished up a digital health efficacy study focused on congestive heart failure patients. They have yet to post results. This one compared Noom vs BodyPort vs Conversa:
“The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.”
Completed: Biogen and Takeda also finished up a digital health study this week that aimed to “evaluate disease progression in persons with early Parkinson disease, as assessed by digital and electronic sensor data collection to be correlated with typical clinical assessments.” No results yet for this one either:
“Subjects will be evaluated via both in-clinic and at-home assessments. The in-clinic assessments are designed to compare the ability of current Parkinson disease clinical trial measures with the ability of mobile and wearable devices to detect disease progression in the early stage of disease. The at-home assessments are designed to determine the feasibility of motor and non-motor assessments of disease progression using a commercially available wearable device/mobile application platform and to determine how this data compares with traditional clinical measures.”
Karuna Labs study on VR-delivered rehab for chronic shoulder pain
Here’s a small VR MSK study that Karuna posted for the first time this week but is already complete. No results yet:
“Chronic shoulder pain is a common musculoskeletal pain condition that can have a profound impact on a sufferer’s life and a large socioeconomic healthcare burden to society. The aim of this study was to determine the feasibility of delivering telemedicine enabled functional shoulder rehabilitation for chronic shoulder pain patients using immersive virtual reality. Ten chronic shoulder pain patients were recruited from local pain clinics. Patients engaged in three sessions of virtual embodiment training per week over the course of eight weeks. Rehabilitation sessions were delivered on an Oculus Quest head-mounted display and hand controllers. Rehabilitation exercises (virtual embodiment training) leverage techniques from graded motor imagery, such as visual mirror feedback and augmentation of the virtual avatar’s movements. Eight pain assessments were administered prior to the first session, and at weeks four and eight to get an indication of the effect that telemedicine delivered virtual embodiment training has on symptoms of chronic shoulder pain.”
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