Mahana’s DTx for IBS gets permanent reimbursement in Germany

Mahana Therapeutics has been granted permanent reimbursement in Germany for its Cara Care for irritable bowel syndrome (IBS), paving the way for greater patient access to the digital therapeutic (DTx).

Cara Care for IBS is a mobile app that uses cognitive behavioural therapy (CBT) to help patients adapt their behaviour and thinking in a way that allows them to reduce the severity of IBS symptoms. A final price of €248 per course has now been agreed with Germany’s National Association of Statutory Health Insurance Funds (GKV-SV).

The DTx has been reimbursable as an ‘app on prescription’ in Germany for patients with IBS since November 2023, after getting a provisional listing in the national reimbursable digital health applications (DiGA) directory with a placeholder price that made it reimbursable through the statutory health insurance (SHI) scheme.

The preliminary approval is easier to obtain, but valid for one year only, and during that time developers can build their case for a permanent listing. If they fail to do so, the listing can be revoked.

After providing additional evidence of Care Care for IBS’ efficacy, a permanent price has now been agreed with the GKV-SV, introducing a binding reimbursement amount that applies retrospectively from the second year of listing and making it officially recognised as a reimbursable digital health application by the German government.

A spokesperson for Mahana told pharmaphorum that SHI patients will not have to pay upfront for the DTx, while those with private health insurance (PHI) might have to pay the amount first and then receive a refund from their insurance company.

Germany was the first country to enable the reimbursement and prescription of DTx on a national level, making it an important market for digital health companies trying to build a sustainable market for their products. US-based Mahana has been seeking opportunities in countries where the reimbursement of DTx is outpacing the situation in its home market.

“The outcome of these pricing negotiations and resulting high price-to-value recognises 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, Mahana’s chief executive.

“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,” he added.

IBS is a common long-term bowel condition, causing symptoms such as abdominal pain, bloating, and diarrhoea or constipation, and CBT is a well-established approach to managing the disorder. Although access to therapists can be tricky, DTx offers a way to sidestep that limitation. It is estimated there are around 11 million people with IBS in Germany.

Mahana acquired Cara Care for IBS as part of its acquisition of Berlin-based HiDoc Technologies in March, which also included DTx products for inflammatory bowel disease (IBD), coeliac disease, and heartburn and a pipeline focused on tinnitus, pruritus, and vulvodynia.