You are Lena Fischer, Head of Market Access at Aurelis Digital Therapeutics. Reimbursement approval determines whether the product reaches patients or stalls.
Aurelis has built a prescription app that treats chronic insomnia with cognitive behavioral therapy. Regulators cleared it as a medical device, and one national system now lets certified digital health apps qualify for reimbursement if they demonstrate a positive care effect. Payers are skeptical: they lack familiar frameworks for pricing software, question durability of benefit, and fear open-ended costs if prescribing scales. The clinical evidence is a single trial showing improved sleep at twelve weeks, with limited long-term or cost-offset data.
You decide how to price and prove value for a digital therapeutic seeking public reimbursement.