Digital therapeutic (DTx) products have the ability to reach patients and caregivers through a variety of patient access pathways. This results in a diverse landscape of possible DTx market access models. In the past, DTx prescription products have been viewed as the only gated patient access path; however, that is not the case. Nearly all patient access to DTx today—including prescription and non-prescription products—involves vetting by a third- party to ensure the right patients have access to the right products.
Product authorization and patient access pathways may differ based on local or national DTx regulatory, Health Technology Assessment (HTA), or payor requirements.