Prescription Digital Therapeutics – Enhanced & Net Results

Restricted Products:

• AspyreRxTM digital therapeutic application
• EndeavorRx® digital therapeutic application
• Leva® Pelvic Health System digital therapeutic application
• LuminopiaTM One digital therapeutic application
• MahanaTM IBS digital therapeutic application
• reSET-O® digital therapeutic application
• reSET® digital therapeutic application
• Somryst® digital therapeutic application

FDA Approved Use:

• AspyreRx
  • Intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes.
• EndeavorRx
  • Indicated to improve attention function as measured by computer-based testing in children ages 8 to 17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
• Leva Pelvic Health System
  • Intended for: 1) strengthening of the pelvic floor muscles; 2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women, and 3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women.
• Luminopia One
  • Indicated for improvement in visual acuity in amblyopia patients ages 4 to 7 years old, associated with anisometropia and/or with mild strabismus.
• Mahana IBS
  • Intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS).
• reSET-O
  • Intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician.
• reSET
  • Intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician, who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program.
• Somryst
  • Intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia — CBT-I) to patients 22 years of age and older with chronic insomnia.

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The patient completed the previous course of therapy with the requested agent; OR
   1. BOTH of the following:
      1. The patient has NOT completed the previous course of therapy with the requested agent; AND
      2. The prescriber has provided information indicating the patient is now capable of completing a full course of therapy; AND
2. The prescriber has provided information indicating that the patient would benefit from additional time with the requested agent.

Duration of Approval:

EndeavorRx: one additional course per 180 days

All other products: one additional course per 365 days

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

July 2024: Criteria change: Added AspyreRx, EndeavorRx, Leva Pelvic Health System, Luminopia, Mahana IBS, and Somryst. Changed policy name.

October 2022: Original utilization management policy issued.