Study Casts Doubt on Cost-Effectiveness of Digital Therapy for Lower Back Pain

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As digital therapeutics companies make the case for their inclusion on payor formularies, a new study suggests the economic case might be difficult for certain health conditions.

Investigators in Germany evaluated a digital therapeutic designed to treat lower back pain. They found the product was unlikely to be cost-effective, at least without a substantial decrease in price. The study was published in the journal JMIR mHealth and uHealth.

Patients with nonspecific back pain are generally urged to receive regular physical therapy, increase physical activity and use medication as needed for temporary relief, noted corresponding author Daniel Lewkowicz, M.Sc., of the University of Potsdam.

Recently, a number of digital therapeutics have been developed to treat chronic pain, and the investigators said they generally include video-based exercise instruction, educational materials, and prompts to remind patients to follow the program. In theory, digital therapeutics can allow patients to receive meaningful care without the need for face-to-face physical therapy. However, digital therapies come with a cost. The therapeutic used in the analysis, called ViViRa, had a three-month cost of €239.96 in Germany (about $256 in US dollars at the time of the study).

In the study, the investigators used published data about the app to run simulations designed to determine the likelihood that the program would be more cost-effective than treatment as usual.

The simulations showed no clear evidence that the digital therapeutic would improve patients’ quality of life. On average, the digital therapeutic conveyed such a small average quality-of-life benefit in the models that the incremental cost per quality-adjusted life year gained would be very high, the authors said.

“The corresponding incremental cost-utility ratio (ICUR) amounts to an additional €34,315.19 per additional QALY,” the authors wrote. In US dollars, that translates to more than $37,000 per QALY.

The likelihood that the digital therapeutic would be more cost-effective than treatment as usual was low, they said.

The authors noted that their findings were highly contingent on the cost of the digital therapeutic. If the price of the product were reduced by about 31%, the authors said, the digital therapeutic would be cost-effective and would likely become the “dominant strategy” for treating patients with lower back pain, even though the data suggest the app led to outcomes that were largely similar to treatment as usual.

However, they warned that the current price tag for the app’s digital therapeutic care (DTC) could be a barrier to payor and patient adoption.

“These high initial fees may backfire for such highly scalable and easily available app programs, especially if patients’ compliance is unobservable, and there is a high risk for early discontinuation of the DTC,” they said.

Lewkowicz and colleagues noted several limitations to their analysis. For one, their study was based on probable outcomes; the real-world outcomes could be different. Moreover, they did not include longer-term impacts the digital therapeutic could have. For instance, if it led to a reduced need for injection therapy or surgery, its cost effectiveness could increase significantly.

The study is also highly specific to both the condition being treated — lower back pain — and the location.

In Germany, the country’s binding medical fee schedule sets the cost of face-to-face physical therapy at €21.11, about $23. The digital therapeutic may be more cost-effective in settings where physical therapy sessions are more expensive.

The investigators said their findings show healthcare decision-makers should be “cautious” when considering the reimbursement of prescription digital therapeutics. But they also said digital therapeutics have the potential to improve.

“However, future developments of DTC apps may involve further decision-support interventions, which may improve compliance, decrease attrition, and eventually yield better healthcare outcomes,” they said.