Clinical UM Guideline
|Subject:||Dihydroergotamine Mesylate (DHE) Injection for the Treatment of Migraine or Cluster Headaches in Adults|
|Guideline #:||CG-DRUG-14||Current Effective Date:||04/05/2016|
|Status:||Reviewed||Last Review Date:||02/04/2016|
This document addresses the use of intravenous or subcutaneous administration of dihydroergotamine (DHE) (Dihydroergotamine mesylate injection USP, Bedford Laboratories™, Bedford, OH) for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes in adults.
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary for the acute treatment of migraine attacks with aura in an adult meeting the following International Headache Society (IHS) diagnostic criteria:
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary for the acute treatment of migraine attacks without aura in an adult meeting the following IHS diagnostic criteria:
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary for the acute treatment of cluster headache episodes in an adult meeting the following IHS diagnostic criteria:
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary in an adult for any of the following conditions:
Not Medically Necessary:
Intravenous or subcutaneous dihydroergotamine therapy is considered not medically necessary when the criteria are not met and for all other indications.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|J1110||Injection, dihydroergotamine mesylate, per 1 mg|
|G44.40-G44.41||Drug-induced headache not elsewhere classified|
Migraine is a common disabling primary headache disorder with 2 major subtypes:
Aura is an early symptom of an attack of migraine with aura, defined by the IHS (2013) as "…the complex of neurological symptoms that occurs usually before the headache…but it may begin after the pain phase has commenced, or continue into the headache phase." Most aura symptoms typically last for 1 hour unless the aura includes motor symptoms, which may last for a longer time.
Acute Migraine Treatment
Effective migraine treatment begins with an accurate diagnosis and a thorough understanding of the impact a primary headache has on the individual's daily life. Clinicians should be aware of the use and the effectiveness of previous and current treatments, keeping in mind that both prescription and over-the-counter (OTC) products have the potential for exacerbating underlying headache patterns. Once a diagnosis is established, it is essential to explain the condition to the individual. Reassuring an individual that their headaches are not caused by something life-threatening, such as a brain tumor or an aneurysm, is an important part of the treatment process.
Kelley and Tepper (2012) analyzed published reports on the acute treatment of migraine headache with triptans, DHE, and magnesium in emergency department, urgent care, and headache clinic settings. Effectiveness varied widely, even when the pain-free and pain-relief statistics were evaluated separately. When paired comparisons were performed, DHE was equivalent to sumatriptan. Although there are relatively few studies involving health-care provider-administered triptans or DHE for acute rescue, they appear to be equivalent to the dopamine antagonists for migraine pain relief. The relatively rare inclusion of a placebo arm and the frequent use of combination medications in active treatment arms complicate the comparison of single agents with each other.
A California Technology Assessment Forum (CTAF, 2014) report, Controversies in Migraine Management, states that individuals who present to the emergency department "…usually have severe headaches and have already tried their usual abortive therapy." In this setting, a number of parenteral therapies are effective, including DHE.
The American Headache Society (AHS) (Marmura, 2015) performed an updated assessment of the evidence for use of medications in the acute treatment of adult migraine headache. The review, conducted by members of the AHS Guidelines Section, identified no new Class I or II studies evaluating the use of DHE (including nasal spray, intramuscular, or intravenous) for acute migraine headache since the American Academy of Neurology (AAN) published guidelines (Silberstein, 2000); therefore, the AHS assigned a level of evidence B for use of DHE ("Level B: Probably effective [or ineffective] for acute migraine, supported by 1 Class I study or 2 Class II studies").
Cluster Headache Treatment
The IHS (2013) has published criteria for diagnosing cluster headache. Diagnostic criteria specify an individual must have had at least 5 attacks occurring from 1 every other day to 8 per day, attributable to no other disorder. In addition, headaches must cause severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes if untreated, and be accompanied by a sense of restlessness or agitation and/or 1 or more of the following symptoms or signs, ipsilateral to the headache: conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, eyelid edema, forehead and facial sweating, forehead and facial flushing, sensation of fullness in the ear, or miosis and/or ptosis.
Episodic cluster headache is defined as at least 2 cluster periods lasting 7 to 365 days (when untreated) and separated by pain-free remission periods of 1 month or longer. Chronic attacks recur over more than 1 year without remission or with remission lasting less than 1 month (IHS, 2013).
The absence of aura, nausea, or vomiting has helped distinguish cluster from migraine headaches, but studies indicate that 14% of individuals with cluster headache experience aura, 51% have a personal or family history of migraine, 56% report photophobia, 43% report phonophobia, and 23% report osmophobia (Van Vliet, 2003). Therefore, the presence of aura, nausea, vomiting, or photophobia should not rule out a diagnosis of cluster headache. A characteristic feature of cluster headache, noted by 93% of individuals in one study, is restlessness, with behaviors such as pacing and rocking the head and trunk with head in hands (Bahra, 2002). Most of these headaches last 15 minutes to 3 hours and recur at the same time of day, often at night. Many attacks begin during the first rapid-eye-movement sleep phase. Individuals may report a seasonal pattern of cluster headache with spring and autumn peaks.
U.S. Headache Consortium
The U.S. Headache Consortium (Matchar, 2003) identified the following goals for successful treatment of acute attacks of migraine:
U.S. Food and Drug Administration (FDA) Boxed Warning and Product Information
Intravenous or subcutaneous dihydroergotamine therapy is contraindicated for use in individuals in any of the following situations (Dihydroergotamine mesylate injection USP, PI, 2009):
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Reviewed||02/04/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information and References sections. Removed ICD-9 codes from Coding section.|
|Revised||02/05/2015||MPTAC review. Format changes and clarifications to the Medically Necessary diagnostic criteria for use of DHE injection for acute treatment of: 1) migraine attacks with aura, 2) migraine attacks without aura, and 3) cluster headache episodes. Clarified the Not Medically Necessary statement. Updated Discussion and References sections.|
|Reviewed||02/13/2014||MPTAC review. Updated Discussion and References sections.|
|Reviewed||02/14/2013||MPTAC review. Updated Discussion and References. Removed Index.|
|Reviewed||02/16/2012||MPTAC review. Updated Coding, Discussion and References.|
|Reviewed||02/17/2011||MPTAC review. Updated Discussion, References, and Index.|
|Reviewed||02/25/2010||MPTAC review. Clarified Medically Necessary criteria for DHE injection in specific situations. Updated Discussion section, moving Contraindications from Clinical Indications. Added statement addressing lack of safety and efficacy in pediatric individuals. Removed Place of Service section. Removed Dosing information from Discussion section. Updated and reformatted References.|
|Reviewed||02/26/2009||MPTAC review. Addition of "in Adults" to the subject title. Clarified Medically Necessary criteria for the acute treatment of migraine attacks with aura. Removed Discharge Plans section. Updated Discussion and References.|
|10/01/2008||Updated Coding section with 10/01/2008 ICD-9 changes.|
|Reviewed||02/21/2008||MPTAC review. Title change from IV DHE (Intravenous Dihydroergotamine) for the Treatment of Headaches to Dihydroergotamine Mesylate (DHE) Injection for the Treatment of Migraine or Cluster Headaches. Reformatted Contraindication section and added Pertinent Medical Management information. Updated and reformatted References.|
|Reviewed||03/08/2007||MPTAC review. Discussion/General Information and References updated.|
|New||03/23/2006||MPTAC initial document development.|
Last Review Date
|MA-001||IV DHE (Intravenous Dihydroergotamine) for the Treatment of Headache|
|WellPoint Health Networks, Inc.|