trofinetide oral soln 200 MG/ML — Blue Cross Blue Shield of Montana

Initial criteria

• The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following:
• 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR
• 3. The prescriber has submitted TWO peer-reviewed journal articles (e.g., JAMA, NEJM, Lancet) supporting the proposed use as generally safe and effective with acceptable study designs (randomized, double blind, placebo controlled clinical trials – case studies not acceptable)
• Allowed compendia (non-oncology): DrugDex level 1, 2A or 2B, AHFS-DI supportive text
• Allowed compendia (oncology): NCCN 1 or 2A, AHFS-DI supportive text, DrugDex level 1, 2A or 2B, Clinical Pharmacology, LexiDrugs evidence level A

Approval duration

12 months