Curavit’s Post

The Digital Therapeutics (DTx) world is recovering and on its way to being a very legitimate market. Born of the concept that media can be medicine, DTx exploded onto the scene with promises of digital drugs, massive reach and untapped market potential. As is often the case with emerging markets all has not gone to plan. But, there is light at the end of this tunnel. Fueled with greater understanding of what makes media medicinal, new regulatory pathways and viable payment options, it looks like we are finally ready to go. According to Andy Molnar, CEO of the Digital Therapeutics Alliance, “During the last few months, we have seen a lot of DTA's hard work pay off in the form of health policy updates; CMS 2025 Proposed Physician Fee Schedule (PFS) has been released that includes three new codes to cover digital mental health treatment (DMHT) devices and this is a huge step forward. Plus, these changes are tracking internationally, with processes in Germany, France, South Korea, and Japan covering prescription DTx.” This form of therapy, with broad reach and efficient costs structures, appears to be the only viable option to address the ever growing global mental health crisis. It is very good news it is finally ready to come online… (🤞) #digitaltherapeutics #immersivemedicine #reimbursement #mentalhealth https://lnkd.in/gvgUytuQ

📢 In response to the recent Health Affairs article (Vol 42. No. 11), "Studies of Prescription Digital Therapeutics Often Lack Rigor and Inclusivity," DTA has carefully reviewed the content. We've identified several areas that appear to be misleading or false. 💡 DTA remains committed to advancing digital therapeutics, emphasizing evidence-based practices. 📚💻 🌟 Moreover, we firmly believe that Digital Therapeutics (DTx) represents the future of healthcare. 🚀 With the potential to address health disparities and alleviate clinician burnout, DTx stands at the forefront of a transformative healthcare landscape. 🌐 To learn more, you can read the full DTA response here: https://lnkd.in/eBJmNJSW And watch Andy Molnar on the Health Tech Talk Show with Kat McDavitt this Friday, February 9th at 4:30pm ET to talk about the article and the future of digital therapeutics. #DTA #DTxNews #DigitalHealth #DigitalTherapeutics #DTx #medtech

𝗪𝗶𝗹𝗹 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝗙𝗶𝗻𝗮𝗹𝗹𝘆 𝗕𝗿𝗲𝗮𝗸 𝗧𝗵𝗿𝗼𝘂𝗴𝗵? 📲 Digital therapeutics - evidence-based therapeutic interventions driven by software to prevent, manage, or treat medical disorders - have shown promise for years but have struggled to gain widespread adoption. One major hurdle? Lack of reimbursement from Medicare and most commercial payers - even when FDA-approved. That could soon change. This July, the Centers for Medicare & Medicaid Services proposed new payment codes for mental health digital therapeutics in the 2025 Physician Fee Schedule. If finalized, these changes could take effect in January, creating a clear path to payment and pushing digital therapeutics into the mainstream. Though the approval is not yet guaranteed, the potential impact is significant. Industry experts see these new codes as a catalyst for growth, incentivizing companies to innovate, doctors to recommend, and patients to use these technologies. Companies like DeepWell DTx are already making strides, having received FDA clearance for their biofeedback software, which paves the way for future innovations in conditions like stress, high blood pressure, and even epilepsy. 🧠 But challenges remain. Research shows that 𝘄𝗵𝗶𝗹𝗲 𝟴𝟱% 𝗼𝗳 𝗽𝗵𝘆𝘀𝗶𝗰𝗶𝗮𝗻𝘀 𝗯𝗲𝗹𝗶𝗲𝘃𝗲 𝗱𝗶𝗴𝗶𝘁𝗮𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝗰𝗮𝗻 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗰𝗮𝗿𝗲, 𝗼𝗻𝗹𝘆 𝟭𝟭% 𝗳𝗲𝗲𝗹 𝗲𝗾𝘂𝗶𝗽𝗽𝗲𝗱 𝘁𝗼 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗲 𝘁𝗵𝗲𝗺 𝗶𝗻𝘁𝗼 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲. Education and awareness are key to unlocking the full potential of DTx, especially as we face an ongoing mental health crisis and a shortage of providers in the post-pandemic landscape. Some pharma companies are looking to get in on the action: ➡️ Click Therapeutics, Inc. and Boehringer Ingelheim: collaborating to develop digital therapies for schizophrenia. ➡️ Eisai Co., Ltd. and Voluntis: partnering to create a DTx solution for cancer patients using the Theraxium platform. ➡️ Biofourmis and 中外製薬 / Chugai Pharmaceutical Co., Ltd.: targeting endometriosis by combining Biofourmis' DTx with Chugai's pharmaceutical expertise. The FDA's implementation of Prescription Drug Use-Related Software has the potential to enhance collaboration between DTx and pharmaceutical companies. This shift marks a significant step toward integrating technology into healthcare and fostering innovative solutions for patient care. As the industry adapts to this digital landscape, it’s clear that the future of pharma is digital, evolving faster than ever before. #HealthcareInnovation #DigitalTherapeutics #HealthTech #MentalHealth #FDA #Pharma #DigitalPharma

Shoutout to Jolanda Groenhuijzen, MD  for her tireless dedication to patient-led innovation. Your work is an inspiration to us all! It's not enough to simply understand patients. We must actively involve them in the development of solutions that meet their needs.  Why this matters? Because when we co-create with patients, we unlock a powerful competitive advantage that sets us apart in the market. Here's what I've seen some of the most innovative teams do: Instead of relying on existing, sometimes outdated Patient-Reported Outcomes (PROs), they partner with patients to update and create new PROs that capture the nuances of the modern , patient experience. Here's how to do it: Engage a diverse mini-community of patients • Aim for a representative sample across geographies, ages, genders, and ethnicities   • Keep the group small enough to foster deep, authentic conversations  Empower patients as research partners. Yes, patients can be more than research respondents. • Train patient experts to conduct peer-to-peer interviews   • Leverage the mini-community for agile, iterative research   • Dive deeper into emerging topics and uncover rich insights  Collaborate with patients to refine PRO measures • Identify gaps in existing PROs and co-design solutions   • Ensure comprehensive assessments that inform personalized care  Even though this approach may be new to some, the impact is undeniable. By elevating the patient voice, we can create solutions that truly resonate and differentiate our pipelines. Curious to learn more? Check out the incredible work of our Partnering Lead, Dr Jolanda Groenhuijzen, MD, who led a groundbreaking project co-designing PROs with a mini-community of Multiple Sclerosis patients. Her insights are a game-changer! https://lnkd.in/gqV6DDBs

How to Beat the Competition with Patient Outcomes 🔗 https://lnkd.in/ejJEAWqy Partnering Lead, Jolanda, shares how patient-reported outcome measures can potentially equip pharma partners with an evidence-base to enhance #ClinicalTrials and #ProductDevelopment. #MiniCommunities #PatientInsights #HealthcareInnovation #PatientVoice #PatientReportedOutcomes

Q&A: Creating digital therapeutics for patient impact and profitability - MobiHealthNews #DigitalTherapeutics In a recent Q&A session, industry experts discussed the creation of digital therapeutics for patient impact and profitability. They highlighted the importance of leveraging technology to improve patient outcomes and generate revenue in the healthcare sector. #Collaboration Collaboration between healthcare providers, technology companies, and regulatory bodies is crucial for the successful development and implementation of digital therapeutics. By working together, stakeholders can ensure that these innovative solutions meet regulatory standards and address the needs of patients effectively. #RegulatoryCompliance Ensuring regulatory compliance is a key challenge in the development of digital therapeutics. Companies must navigate complex regulatory frameworks to bring their products to market while maintaining patient safety and data security. Compliance with regulations such as HIPAA and ai.mediformatica.com #digital #health #digitaltherapeutics #digitalhealth #finland #ireland #research #tools #clinical #college #dublin #effectivene #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3VeZdgo)

Exciting times in the world of point-of-care diagnostics! 🌍 As the global market is set to almost double to $80.75 billion in the next decade, the innovations we're seeing are truly transformative. At Europlaz Technologies Ltd, we're at the forefront, supporting groundbreaking technologies like PocDoc's Healthy Heart Check. This app-based platform is revolutionizing access to rapid, accurate diagnostics, offering hope for better, faster healthcare globally. Check out the latest trends and insights in my latest article. #HealthcareInnovation #PointOfCare #Diagnostics #Europlaz #PocDoc

https://lnkd.in/e_MFfBxH How to foster market adaption of digital therapeutics by means of trust? New alliance announced by DirectTrust and Digital Therapeutics Alliance to set up criteria and involve all relevant stakeholder groups aiming to give guidance and improve orientation in the rapidly evolving market of digtal health solutions. Hurdles that will coming later: How to get this trusted solutions visible and well-known by patients, customers and HCPs - label, seal, app directory? Maybe worth to look at experience and achievements of initiatives here in Europe Label2Enable, ORCHA, HealthOn - and #DiGAFastTrack application items required by Federal Institute for drugs and medical devices to get reimbursement for #DTx https://lnkd.in/eWDBVFy5

We were just featured in ONdrugDelivery Issue 166! Don’t miss our roundtable discussion, https://lnkd.in/e4Hrth-n, on the transformative potential of GLP-1 therapies with Kymanox CEO Stephen M. Perry, Mathias Romacker (Kymanox Executive Advisor), and Andreas Schneider (Ypsomed).  GLP-1s are changing the entire healthcare landscape, and staying informed on this topic is critical for anyone in the drug development and delivery space. In this conversation, they cover everything from the growing market potential of GLP-1s to the challenges and opportunities in creating connected, patient-centric delivery systems. Read the full article here: https://lnkd.in/e4Hrth-n #drugdelivery #glp1s

End the week by discovering the practical implications of integrating digital therapeutics into healthcare in this insightful article: https://bit.ly/3tKzti8 Explore how digital therapeutics transform patient care, enhance treatment plans, and reshape the healthcare landscape. Please read, share, and let's discuss in the comments below. How do you see digital therapeutics influencing the future of healthcare practices? 💬💡 #DigitalTherapeutics #HealthcareInnovation #FutureOfMedicine #HealthTech #PharmaceuticalJournal