Monday, July 15, 2024

Reimbursement Secured for Mahana Therapeutics’ IBS Digital Therapeutic in Germany

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Reimbursement approval for Mahana Therapeutics’ digital therapeutics (DTx) app, Cara Care for irritable bowel syndrome (IBS), has been permanently secured in Germany, marking a significant milestone for the company. This development paves the way for broader patient access to this innovative treatment. Cara Care for IBS is a mobile application that leverages cognitive behavioral therapy (CBT) to assist patients in managing and reducing the severity of IBS symptoms by modifying their behavior and thinking patterns. The German National Association of Statutory Health Insurance Funds (GKV-SV) has agreed on a final reimbursement price of €248 per course.

Initially, Cara Care for IBS was made available to IBS patients in Germany in November 2023 as an ‘app on prescription’ under a provisional listing in the national reimbursable digital health applications (DiGA) directory. This provisional approval, which allowed reimbursement through the statutory health insurance (SHI) scheme, was set with a placeholder price and was valid for one year. During this period, Mahana had to provide additional evidence of the app’s efficacy to secure a permanent listing.

Mahana successfully demonstrated the effectiveness of Cara Care for IBS, leading to an agreement on a binding reimbursement price with the GKV-SV. This price applies retrospectively from the second year of listing, officially recognizing Cara Care for IBS as a reimbursable digital health application by the German government. According to a spokesperson for Mahana, SHI patients will not have to pay upfront for the DTx, while those with private health insurance (PHI) may need to pay initially and then seek reimbursement from their insurance providers.

Germany’s Leadership in Digital Therapeutic Reimbursement Paves Way for Mahana’s IBS Treatment

Germany has been a pioneer in enabling the national reimbursement and prescription of digital therapeutics, making it a critical market for digital health companies aiming to establish a sustainable presence. U.S.-based Mahana has been actively exploring opportunities in countries where the reimbursement landscape for digital therapeutics is more advanced compared to the U.S. market.

Simon Levy, Mahana’s chief executive, highlighted the significance of the reimbursement approval: “The outcome of these pricing negotiations and resulting high price-to-value recognizes that the GKV-SV values the proven benefits Cara Care for IBS can provide to the millions of patients suffering from IBS in Germany. The positive outcome of this negotiation with one of the most important stakeholders in the German healthcare system solidifies a clear pathway for establishing long-term access and reimbursement.”

IBS is a prevalent long-term bowel condition characterized by symptoms such as abdominal pain, bloating, and diarrhea or constipation. Cognitive behavioral therapy is a well-established treatment approach for IBS, but access to therapists can often be challenging. Digital therapeutics like Cara Care for IBS offer a viable alternative, bypassing the limitations associated with traditional therapy access. It is estimated that around 11 million people in Germany suffer from IBS.


Mahana’s Acquisition and German Reimbursement Approval Mark Milestones in Digital Therapeutics

Mahana’s acquisition of Berlin-based HiDoc Technologies in March significantly expanded its product portfolio. The acquisition included Cara Care for IBS and other DTx products targeting inflammatory bowel disease (IBD), coeliac disease, and heartburn, as well as a pipeline focusing on conditions such as tinnitus, pruritus, and vulvodynia.

The permanent reimbursement approval for Cara Care for IBS not only enhances patient access to this effective treatment but also underscores the growing acceptance and integration of digital therapeutics within mainstream healthcare systems. Mahana’s success in Germany sets a precedent and provides a robust model for other countries to follow, potentially accelerating the adoption of digital health solutions worldwide.

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In conclusion, the permanent reimbursement approval for Cara Care for IBS in Germany is a landmark achievement for Mahana Therapeutics, reflecting the value of digital therapeutics in addressing chronic conditions like IBS. This approval ensures that millions of IBS patients in Germany will have better access to an effective, innovative treatment, contributing to improved health outcomes and quality of life. The move also highlights Germany’s leading role in integrating digital health solutions into its healthcare system, setting a benchmark for other nations to emulate.


Resource: Mahana Therapeutics, June 11, 2024

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