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Final price determination from the National Association of Statutory Health Insurances Insurance Funds (GKV-SV) paves the way for greater patient access.

San Francisco and Berlin, June 11th, 2024 - Mahana Therapeutics, a leading provider of prescription and wellness digital therapeutics, announced today that it has completed price negotiations with Germany’s National Association of Statutory Health Insurance Funds (GKV-SV). The GKV-SV, assigned by the German health insurance funds, is responsible for establishing the permanent price of digital therapeutics following their permanent listing of on the DiGA-directory, the official BfArM (germ.: Bundesinstitut für Arzneimittel und Medizinprodukte, engl.: Federal Institute for Pharmaceuticals and Medical Devices) register for all approved DiGAs (Digital Health Applications, or “Digitale Gesundheitsanwendungen”). Cara Care for IBS has been permanently reimbursed since November 2023 by all statutory health insurers in Germany making it widely accessible to all irritable bowel syndrome (IBS) patients.

The process of establishing the GKV-SV permanent price was based on a comprehensive, value-based evaluation of Cara Care for IBS. This evaluation included assessing the strength of clinical evidence, clinical efficacy to improve patient outcomes, cost effectiveness and quality of life improvements demonstrated by Cara Care for IBS. The GKV-SV represents all statutory healthcare and long-term care insurance funds in Germany and, thus, the interests of more than 70 million insured persons and contribution payers.

“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,” said Simon Levy, CEO of Mahana Therapeutics. “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 for Mahana’s Digestive and Hearing Health portfolio of digital treatments.”

Mahana’s self-guided, digital chronic condition management programs employ a proprietary cognitive behavioral therapy (CBT) platform that complements consumer health and pharmacological treatments to address high unmet needs associated with digestive, hearing, dermatology, and women’s health chronic conditions.  When used with standard of care treatments, these programs can dramatically improve outcomes, patient treatment satisfaction, quality of care and overall patient quality of life while reducing associated provider workload burden.

Cara Care for IBS can be prescribed and re-prescribed for 90 days and is approved for patients aged 18 to 70. Cara Care for IBS complements medical guidelines and can be used in combination with standard of care therapies or as a stand alone therapeutic option. An algorithm is used to provide a personalized treatment plan that provides  modules utilizing patient education, dietary therapy via the low-FODMAP diet, cognitive behavioral therapy (CBT), and gut-directed hypnosis. Cara Care for IBS is the only holistic therapy for irritable bowel syndrome and the first and only BfArM-approved DiGA to offer four recognized care effects, which were defined by the BfArM as follows: ”improvement in health status", ”improvement in quality of life", ”coping with illness-related difficulties in everyday life" and ”health literacy".

IBS is a common functional gastrointestinal disorder for which no recognizable organic cause can be found. The diagnosis can be made by ruling out other possible diseases related to the symptoms. The estimated 11 million people in Germany who suffer from it can experience repeated cramp-like abdominal pain, constipation and/or diarrhea, a feeling of pressure and fullness after eating and bloating over a long period, which often leads to a considerable impairment of their quality of life.

Clinical Study Demonstrates Efficacy of Cara Care for IBS
‍The GKV-SV permanent price decision was based, in part, on a randomized controlled clinical trial of a total of 378 patients who used the Cara Care digital health application (DiGA) to treat irritable bowel syndrome. Participants in the intervention group showed significant improvements in the areas of symptom severity, quality of life, impairment of work productivity, impairment of activity and health literacy compared to the control group after a period of 12 weeks. Around 70 % of participants were able to reduce their symptoms to an extent that was strongly noticeable. In contrast, there was none to very little improvement in the participants of the control group who only received the standard of care. 

About Mahana Therapeutics
‍Mahana Therapeutics is a leading developer of digital chronic condition management programs that are designed to empower patients with chronic conditions to live fuller lives. The company’s first product, Mahana IBS, was the first digital therapeutic to receive FDA clearance for the treatment of IBS and provides cognitive behavioral therapy (CBT) to adults with IBS. Mahana Therapeutics announced recently that it has acquired Berlin-based HiDoc Technologies GmbH, operating as Cara Care, a leader in digital digestive healthcare. More information is available at www.mahana.com.

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Media Contacts:‍
Justin Zamirowski
press@mahanatx.com

Colin Sanford
colin@bioscribe.com

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1 BARMER Arztreport 2019. Schriftenreihe zur Gesundheitsanalyse. Grobe, Steinmann, Szecsenyi. Band 14

2 Weiβer LM, et al. The effectiveness of an app-based digital therapeutic for irritable bowel syndrome: Results of a randomized controlled trial. Presented at: UEG Week; Oct. 14-17, 2023; Copenhagen, Denmark (hybrid meeting).

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