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Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.

Objectives: To assess the effectiveness of a proactive provider intervention in prompting prior authorization (PA) submissions or provider response prior to PA expiration for medically complex Medicaid patients., Study Design: Pre-post outreach study with data from pharmacy claims and provider outreach., Methods: The intervention and historical comparison (control) groups included expired PAs from December 2019 to February 2020 and from December 2018 to February 2019, respectively. Provider outreach, including telephonic and fax attempts, was conducted over a 2-week period prior to PA expiration. Outcomes were classified as positive or negative based on provider conversation coupled with the result (eg, PA submission) for the intervention group and based solely on pharmacy claims for the control group. The primary end point was the percentage of positive outcomes between the groups, analyzed via χ2 test. The time from PA expiration to the new PA submission was evaluated via t test., Results: A total of 342 outreach attempts were conducted for 270 PAs representing 193 unique patients. Outreach was more likely to result in positive outcomes in the intervention group vs no outreach in the control group (87% vs 25%; P < .00001). On average, PAs were submitted 3.5 days prior to expiration in the intervention group vs 13.0 days after expiration in the control group (t = -7.50; P < .00001)., Conclusions: Proactive outreach resulted in a greater percentage of PA submissions and a significantly reduced time to PA submission. These findings provide important information for payers in guiding clinical programs to enhance continuity of care among at-risk populations.

Background: Breakthrough direct-acting antivirals set a new standard in the management of hepatitis C virus (HCV) with regard to cure rates and improved tolerability; however, the health care system is challenged by the cost of these medications., Objective: To describe the effect of a comprehensive HCV medication management program on optimized regimen use, prior authorization (PA) modifications, and medication cost avoidance in a state Medicaid program., Methods: This program consists of a 2-tiered prescriber outreach: (1) regimen outreach to promote optimized regimen selection and (2) refill outreach to support medication adherence. PA criteria were developed to identify optimized regimens, taking into account member- and virus-specific factors as well as cost. Prescriber outreach was conducted to recommend the use of an optimized regimen as applicable. Successful regimen outreach was defined as the number of members for whom a recommendation was accepted. A refill report identified members without a subsequent paid HCV medication claim within 25 days of the previous claim and outreach to the prescriber's office was performed. The outcome measure for refill outreach was the number and type of PA modifications made secondary to outreach (closure or extension). Cost avoidance was calculated for members who completed treatment with an optimized regimen. Return on investment (ROI) was calculated for the program., Results: Between December 18, 2013, and January 31, 2015, 911 members had PA requests approved for simeprevir, sofosbuvir, or ledipasvir/ sofosbuvir. Of these members, 223 (24.5%) met the criteria for regimen outreach. Pharmacist interventions to treat with an optimized regimen were accepted for 135 members (60.5%). Following implementation of prescriber outreach to promote refills, between March 10, 2014, and January 31, 2015, offices were informed of an upcoming refill for 515 members. As a result of outreach, 19.6% of members had a subsequent PA modification. Sixty-nine approved PAs (for 68 members) were closed after correspondence with the prescriber, and 33 approved PAs (for 33 members) were extended. The total projected cost avoidance was $3,770,097. The comprehensive HCV medication management program demonstrated an ROI of $10.28 for every $1 spent., Conclusions: A comprehensive HCV medication management program can help contain costs while ensuring that members have access to most clinically appropriate regimens., Disclosures: No outside funding supported this study. Lavitas reports personal fees and nonfinancial support from University of Tennessee, Advanced Studies in Medicine and grant funding from Bristol-Myers Squibb, outside the submitted work. All other authors report no conflicts of interest. The poster "Overview of a Hepatitis C Medication Monitoring Program in a State Medicaid Program" was presented October 8, 2014, by Lavitas at the AMCP Nexus 2014 meeting in Boston, Massachusetts. A program update was presented at the 2015 American Drug Utilization Review Society Meeting on February 27, 2015. Study concept and design were contributed by Price, Lenz, and Jeffrey, with assistance from Lavitas, Tesell, and Hydery. Lavitas, Tesell, and Hydery collected the data, assisted by Price, Lenz, and Jeffrey, and data interpretation was performed by all authors. The manuscript was written by Greenwood, Lavitas, Tesell, and Hydery, with assistance from the other authors, and was revised by all authors.