Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
The use of eptinezumab (Vyepti) may be considered medically necessary when ALL of the following criteria are met:
-
The individual has an FDA labeled indication or compendia supported indication for eptinezumab (Vyepti) and route of administration AND ONE of the following:
-
Eptinezumab (Vyepti) is being used for migraine prophylaxis AND ALL of the following:
-
ONE of the following:
-
The individual has a diagnosis of chronic migraine (defined as greater than or equal to 15 headache days per month) AND ALL of the following:
-
Greater than or equal to 15 headache days per month of migraine-like or tension-like headache for a minimum of three (3) months
AND
-
Greater than or equal to eight (8) migraine headache days per month for a minimum of three (3) months
AND
-
Eptinezumab (Vyepti) is FDA approved for chronic migraine prophylaxis
OR
-
The individual has a diagnosis of episodic migraine (defined as less than 15 headache days per month) AND BOTH of the following:
-
ONE of the following:
-
The individual has greater than four (4) migraine headache days per month
OR
-
The individual's migraine headaches last greater than 12 hours
OR
-
The individual's migraine attacks cause significant disability or diminished quality of life despite appropriate therapy with acute agents only
OR
-
The individual has contraindications to acute therapies
OR
-
The individual has tried and received inadequate response to acute therapies
OR
-
The individual has serious side effects to acute therapies
OR
-
The individual is at risk of medication overuse headache without preventative therapy
AND
-
Eptinezumab (Vyepti) is FDA approved for episodic migraine prophylaxis
AND
-
ONE of the following:
-
The individual has tried and had an inadequate response to at least two migraine prophylaxis classes [i.e., anticonvulsants (divalproex, valproate, topiramate), beta blockers (atenolol, metoprolol, nadolol, propranolol, timolol), antidepressants (amitriptyline, venlafaxine), candesartan] after an adequate trial as defined by BOTH of the following:
-
The trial length was at least six (6) weeks at generally accepted doses
AND
-
The individual was greater than or equal to 80 percent adherent to the prophylaxis agent during the trial
OR
-
The individual has an intolerance or hypersensitivity to therapy with at least two migraine prophylaxis classes listed above
OR
-
The individual has an FDA labeled contraindication to ALL migraine prophylaxis agents listed above
AND
-
Medication overuse headache has been ruled out
AND
-
ONE of the following:
-
The individual has tried and had an inadequate response to TWO (2) injectable CGRPs for migraine prophylaxis [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)]
OR
-
The individual has an intolerance or hypersensitivity to TWO (2) injectable CGRPs for migraine prophylaxis [e.g., Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab)] that is not expected to occur with eptinezumab (Vyepti)
OR
-
The individual has an FDA labeled contraindication to ALL injectable CGRPs for migraine prophylaxis [i.e., Aimovig (erenumab), Ajovy (fremanezumab), AND Emgality (galcanezumab)] that is not expected to occur with eptinezumab (Vyepti)
OR
-
Eptinezumab (Vyepti) is NOT being used for migraine prophylaxis
AND
-
If the individual has an FDA labeled indication, ONE (1) of the following:
-
The individual's age is within FDA labeling for the requested indication for eptinezumab (Vyepti)
OR
-
The prescriber has provided information in support of using eptinezumab (Vyepti) for the individual's age for the requested indication
AND
- The individual will NOT be using eptinezumab (Vyepti) in combination with another prophylactic CGRP agent.
Reauthorization Criteria
Continuation of therapy with eptinezumab (Vyepti) may be considered medically necessary when
ALL
of the following are met:
-
The individual has been approved for the requested agent previously through the plan's Medical Drug Review process
AND
-
The individual has an FDA labeled indication or compendia supported indication for the requested agent and route of administration AND ONE (1) of the following:
-
ALL of the following:
-
The requested agent is being used for migraine prophylaxis
AND
-
The prescriber has provided information indicating improvement in migraine prevention (e.g., reduced migraine headache days, reduced migraine frequency, reduced use of acute abortive migraine medication) with the requested agent
AND
-
Medication overuse headache has been ruled out
OR
-
BOTH of the following:
-
The requested agent is NOT being used for migraine prophylaxis
AND
-
The individual has had clinical benefit with the requested agent
AND
- The individual will NOT be using the requested agent in combination with another prophylactic CGRP agent.
The use of eptinezumab (Vyepti) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
Procedure Codes
