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:
-
ONE of the following:
-
The requested agent is being used for migraine prophylaxis AND ALL of the following:
-
ONE of the following:
-
The individual has at least 15 headache days per month of migraine-like or tension-like headache for a minimum of three (3) months (chronic migraine) AND BOTH of the following:
-
The individual has at least eight (8) migraine headache days per month for a minimum of three (3) months;
and
-
The requested agent is FDA labeled for chronic migraine prophylaxis;
or
-
The individual has less than 15 headache days per month (episodic migraine) 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
-
The requested agent is FDA labeled for episodic migraine prophylaxis;
and
-
ONE of the following:
-
The individual has ONE of the following to at least two (2) migraine prophylaxis classes (i.e., anticonvulsants [divalproex, valproate, topiramate], beta blockers [atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [amitriptyline, venlafaxine], candesartan):
-
A trial and inadequate response after an adequate trial as defined by BOTH of the following:
-
The trial length was at least eight (8) weeks at generally accepted doses;
and
-
The individual was greater than or equal to 80% adherent to the prophylaxis agent during the trial;
or
-
An intolerance or hypersensitivity to therapy with at least two (2) migraine prophylaxis classes;
or
-
The individual has an FDA labeled contraindication to ALL migraine prophylaxis agents (i.e., anticonvulsants [divalproex, valproate, topiramate], beta blockers [atenolol, metoprolol, nadolol, propranolol, timolol], antidepressants [amitriptyline, venlafaxine], AND candesartan);
and
-
ONE of the following:
-
The individual has ONE of the following to TWO (2) injectable CGRPs for migraine prophylaxis (e.g., Aimovig [erenumab], Ajovy [fremanezumab], Emgality [galcanezumab]):
-
A trial and inadequate response;
or
-
An intolerance or hypersensitivity that is not expected to occur with the requested agent;
or
-
The individual has an FDA labeled contraindication to ALL injectable CGRPs for migraine prophylaxis (e.g., Aimovig [erenumab], Ajovy [fremanezumab], Emgality [galcanezumab]) that is not expected to occur with the requested agent;
and
-
Medication overuse headache has been ruled out;
or
-
The individual has another FDA labeled indication for the requested agent and route of administration;
or
-
The individual has another indication that is supported in compendia for the requested agent and route of administration;
and
-
If the individual has an FDA labeled indication, then ONE (1) of the following:
-
The individual's age is within FDA labeling for the requested indication for the requested agent;
or
-
There is support for using the requested agent for the patient's age for the requested indication;
and
- The individual will NOT be using the requested agent in combination with another prophylactic CGRP agent for the requested indication.
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 Blue Cross Blue Shield's precertification process;
and
-
ONE of the following:
-
ALL of the following:
-
The requested agent is being used for migraine prophylaxis;
and
-
The individual has had 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
-
The requested agent is being used for an indication other than migraine prophylaxis AND 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 Code
