Otsuka, Click's depression DTx launches in the US
An FDA-approved digital therapeutic (DTx) that can be used to help people living with major depressive disorder (MDD) has been launched in the US and is available in mobile app stores.
Otsuka Pharma and Click Therapeutics' Rejoyn (formerly CT-152) app – which is used to help people with MDD manage their emotions more effectively – can be unlocked with a prescription from a healthcare provider.
Patients seeking a prescription for the app can ask their current provider or arrange a virtual consultation from online health specialist Wheel Health, a remote healthcare specialist that has partnered with Otsuka and Click to improve access.
Rejoyn became the first prescription DTx to be approved for MDD by the FDA in March, getting the go-ahead for use as an add-on to clinician-managed outpatient care for adults aged 22 and over with MDD who require antidepressant medicines.
Delivered over six weeks, the DTx is designed to help alleviate MDD symptoms using a combination of cognitive emotional training exercises and brief therapeutic lessons.
"In an effort to facilitate broad access, the six-week Rejoyn treatment program is available for a limited time at a discounted price of $50 for patients," said Click and Otsuka Precision Health (OPH) in a joint statement on the launch.
They also said that the launch price of Rejoyn for payors will be $200, adding: "Coverage from health insurers is expected to be forthcoming."
All eyes will be on the commercial success of Rejoyn, given the challenges faced by other companies in building a sustainable business for prescription DTx – mainly due to difficulties in getting reimbursement and encouraging doctors to consider a digital health option for their patients.
Those difficulties resulted in the demise of Pear Therapeutics – a pioneer of the DTx sector – and a change in strategy by another early entrant, Akili Interactive, to focus most of its efforts on direct-to-consumer sales and put its prescription business on the back burner.
Last year, US lawmakers reintroduced the Access to Prescription Digital Therapeutics Act, which would create a dedicated benefit category for these products in Medicare and Medicaid, but that has not yet made it onto the statute, although it was referred to committee.
Notably, OPH has set pricing for Rejoyn that is a lot lower than has been seen with other prescription DTx products, and is more in line with what Akili is charging for its DTC offering. In the meantime, a lot will depend on OPH and Click convincing doctors that the data for its app is robust.
In the pivotal Mirai study of Rejoyn in 286 people with MDD, patients using the app achieved an average 8.78-point reduction change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score – versus 6.66 points for a sham group – meeting the primary endpoint for efficacy. The full or partial response rate to the app was 48.3%, compared to 37.5% for the sham.
Rejoyn is the first DTx to emerge from a collaboration set up in 2019 between Click and Otsuka, worth $300 million, focusing on the development of DTx software.
"We are proud to bring Rejoyn, the first and only FDA-cleared digital treatment for MDD symptoms, to the market," said Sanket Shah, president of OPH.
The launch is an "important milestone in [OPH's] journey to improving the patient experience through data-backed and digital products and services that meet patients where they are," he added.
Click is also working on DTx candidates for schizophrenia with Boehringer Ingelheim and with Indivior on software to support people with substance use disorders. Its in-house pipeline is led by a DTx candidate for migraine.
