Issues in payer protection of digital therapeutics – Healthcare Economist

April 3, 2024

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The Digital Therapeutics Alliance defines a digital therapeutic (DTx) as “evidence-based therapeutic interventions which are pushed by high-quality software program applications to forestall, handle, or deal with a medical dysfunction or illness.” One key query is what elements do US payers bear in mind when evaluating DTx and the way does that differ from normal prescription drugs. A paper by Gomez Lumbreras et al. (2024) held digital focus teams with 21 US payers to search out the reply. Key concerns embrace:

Want for Proof. Nearly all survey respondents (n = 19/21 90%) indicated they’d require a medical trial to think about protection of the product. This proof consists of information on efficacy, effectiveness and worth (together with cost-effectiveness perspective)
DTx Protection: Medical, Pharmacy or Different? Many respondents have been unsure if reimbursement ought to undergo medical or pharmacy advantages. The bulk thought it will in all probability be the pharmacy and therapeutics committee (n = 15/21 71%), however , a number of members answered “different” (n = 6/21, 29%) [see Figure below]
FDA Regulation and Pending Laws. Total, 14/21 (66.7%) respondents would require an FDA analysis of the DTx product for it to be thought of for protection (particularly if coated underneath the pharmacy profit). Different respondents indicated that FDA analysis was helpful however not all the time required for protection. A number of payers cited the necessity for proof past the necessities of the FDA to think about a DTx product for protection (e.g., effeciveness, worth).
Reimbursement: NDC vs. CPT. A prescription can be mandatory for a lot of well being plans to reimburse a DTx product provided that many insurance policies exclude reimbursement for over-the-counter merchandise. Contributors broadly agreed {that a} coding system can be required, and {that a} Present Procedural Terminology (CPT) code or Nationwide Drug Code (NDC) can be probably the most environment friendly methods to make sure reimbursement.
Obstacles. Obstacles talked about embrace sturdiness of remedy impact, price of merchandise, and mechanisms for reimbursement/fee. Different points included the function of DTx merchandise on affected person engagement and remedy adherence. Many perceived that DTx weren’t “bona fide” therapies partly as a result of some thought of them simply “apps” and comparable variations may very well be downloaded on-line without cost.
Payer Administration. Some claimed that utilization administration insurance policies (e..g, prior authorization, step edits, amount limits) may very well be used for DTx simply as they’re for prescribed drugs. Others instructed {that a} DTx product may very well be a part of a care administration program moderately than protecting it individually. A number of members defined that their organizations have been at the moment protecting DTx merchandise as a part of medical applications.