trofinetide oral solution 200 MG/ML — Blue Cross Blue Shield of New Mexico
other FDA labeled or compendia-supported indications
Initial criteria
- 1. Member resides in Ohio AND
- 2. Plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
- A. Patient does NOT have any FDA labeled contraindications to the requested agent AND
- B. ONE of the following:
- 1. Patient has another FDA labeled indication for the requested agent and route of administration OR
- 2. Patient has another indication that is supported in compendia for the requested agent and route of administration OR
- 3. Prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective. Accepted study designs may include randomized, double blind, placebo controlled clinical trials (case studies not acceptable)
Approval duration
12 months