Diclegis — Blue Cross Blue Shield of Montana

Initial criteria

• 1. ONE of the following: A. The requested agent is being used to treat pregnancy related nausea or vomiting (not including hyperemesis gravidarum) OR B. The patient has another FDA labeled indication for the requested agent and route of administration AND
• 2. ONE of the following: A. The prescriber states the patient is currently being treated with a requested agent AND the patient is currently stable on the requested agent [chart notes required] OR B. The patient has tried and had an inadequate response to the use of the individual ingredients within the target combination agent as separate dosage forms [chart notes required] OR C. The use of the individual ingredients within the target combination agent as separate dosage forms was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR D. The patient has an intolerance or hypersensitivity to the use of the individual ingredients within the target combination agent as separate dosage forms (that is not expected to happen with the requested agent) [chart notes required] OR E. The patient has an FDA labeled contraindication to the use of the individual ingredients within the target combination agent as separate dosage forms (that is not expected to happen with the requested agent) [chart notes required] OR F. The use of the individual ingredients within the target combination agent as separate dosage forms is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes required] OR G. The use of the individual ingredients within the target combination agent as separate dosage forms is not in the best interest of the patient based on medical necessity [chart notes required] OR H. The patient has tried another drug in the same pharmacologic class or with the same mechanism of action as the individual ingredients in the requested agent and that drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR I. There is support that the use of the individual ingredients within the target combination agent as separate dosage forms is not clinically appropriate for the patient AND
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

up to due date of pregnancy or 6 months (whichever is longer)