Prior Authorization : Preferred Drug List

Headache Agents, Acute Treatment

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in the headache agents, acute treatment drug class.

Clinical PA is required for non-preferred headache agents, acute treatment drugs.

PA requests for non-preferred headache agents, acute treatment drugs must be completed, signed, and dated by the prescriber. PA requests for non-preferred headache agents, acute treatment drugs must be submitted on the Prior Authorization Drug Attachment for Headache Agents, Acute Treatment form. Clinical documentation supporting the use of the non-preferred headache agents, acute treatment drug must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed Prior Authorization Drug Attachment for Headache Agents, Acute Treatment form and a completed PA/RF to ForwardHealth.

PA requests for non-preferred headache agents, acute treatment drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Note: Emgality 100 mg has separate PA submission requirements.

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugstopic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for the drug.

Clinical Criteria for Non-Preferred Headache Agents, Acute Treatment Drugs

Clinical criteria for approval of a PA request for non-preferred headache agents, acute treatment drugs (excluding Emgality 100 mg) are all of the following:

• The member's age is consistent with the FDA-approved product labeling for the drug requested.
• The prescriber has evaluated and diagnosed the member as having a history of migraines, with or without aura, according to ICHD-3 diagnostic criteria.
• One of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with at least two preferred drugs from the headache agents, triptans non-injectable drug class.
  • The member has a clinically significant drug interaction with triptans and another medication the member is taking, or the member has a medical condition(s) that prevents the use of triptans.
• The member has taken two preferred headache agents, acute treatment drugs and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for non-preferred headache agents, acute treatment drugs. The supporting clinical information and medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

The medical records must demonstrate that the member meets the clinical criteria and document the member's medical work-up for migraines including complete problem and medication lists.

If the clinical criteria for non-preferred headache agents, acute treatment drugs are met, PA requests may be approved for up to 365 days.

Submitting PA Requests for Emgality 100 mg

PA requests for Emgality 100 mg must be completed, signed, and dated by the prescriber. PA requests for Emgality 100 mg must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form and the PA/RF. Clinical documentation supporting the use of Emgality 100 mg must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

PA requests for Emgality 100 mg may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Emgality 100 mg

Clinical criteria that must be documented for approval of an initial PA request for Emgality 100 mg are all of the following:

• The member is 18 years of age or older.
• The prescriber has evaluated and diagnosed the member as having episodic cluster headaches, according to the ICHD-3, diagnostic criteria.
• The following information has been documented:
  • The number or frequency of cluster headache attacks the member experiences during a cluster period
  • The member's cluster period duration
  • The member's pain-free, remission period duration
• The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
• The member must be compliant with the prescribed episodic cluster headache treatment regimen.
• The member and prescriber have agreed to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] at the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests (initial, initial renewal, and subsequent renewal) for Emgality 100 mg. The supporting clinical information and medical records must document:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

Medical records must document the member's medical work-up for episodic cluster headaches including complete problem and medication lists.

Starting a member on a medication by using manufacturer-provided samples or manufacturer patient assistance programs will not be considered as previous medication history for PA review.

If clinical criteria for Emgality 100 mg are met, initial PA requests may be approved for up to 183 days.

Initial Renewal PA Requests for Emgality 100 mg

Clinical criteria that must be documented for approval of initial renewal PA requests for Emgality 100 mg are all of the following:

• The member's current frequency of cluster headache attacks during an episode has been documented.
• The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
• The member must be compliant with the prescribed episodic cluster headache treatment regimen.
• The member experienced a clinically significant decrease in the frequency of cluster headache attacks during an episode compared to their baseline prior to initiation of treatment with Emgality 100 mg.
• The member and prescriber will continue to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] as the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Initial renewal PA requests for Emgality 100 mg may be approved for up to 183 days.

Subsequent Renewal PA Requests for Emgality 100 mg

Clinical criteria that must be documented for approval of subsequent renewal PA requests for Emgality 100 mg are all of the following:

• The member's current frequency of cluster headache attacks during an episode has been documented.
• The prescriber is required to indicate the member's current episodic cluster headache medications (including drug name[s], dose, and dosing frequency).
• The member must be compliant with the prescribed episodic cluster headache treatment regimen.
• The member has sustained a clinically significant decrease in the frequency of cluster headache attacks during an episode compared to their baseline prior to initiation of treatment with Emgality 100 mg.
• The member and prescriber will continue to follow the established Emgality episodic cluster headache dosing recommendations (300 mg [administered as three consecutive injections of 100 mg each] at the onset of the cluster period, and then monthly until the end of the cluster period) as outlined in the FDA-approved patient labeling.

Subsequent renewal PA requests for Emgality 100 mg may be approved for up to 183 days.