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:||04/15/2014|
|Status:||Reviewed||Last Review Date:||02/13/2014|
This document addresses the use of intravenous or subcutaneous administration of dihydroergotamine (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 adults meeting the following International Headache Society consensus criteria (Cephalalgia, 2005):
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary for the acute treatment of migraine attacks without aura in adults meeting the following International Headache Society consensus criteria (Cephalalgia, 2005):
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary for the acute treatment of cluster headache episodes in adults meeting the following International Headache Society consensus criteria (Cephalalgia, 2005):
Intravenous or subcutaneous dihydroergotamine therapy is considered medically necessary in adults for any of the following conditions:
Not Medically Necessary:
Intravenous or subcutaneous dihydroergotamine therapy is considered not medically necessary when the criteria listed above are not met.
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|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2014]|
|339.3||Drug induced headache, not elsewhere classified (rebound headache)|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2014]|
|G44.40-G44.41||Drug-induced headache not elsewhere classified|
The International Headache Society acknowledged in a 2004 Cephalalgia report that a migraine is a common disabling primary headache disorder ranked by the World Health Organization (WHO) as number 19 among all diseases worldwide causing disability.
Migraine can be divided into two major sub-types:
Note: Aura is an early symptom of an attack of migraine with aura, being the manifestation of focal cerebral dysfunction. Aura typically lasts 20-30 minutes and precedes the headache.
Acute Migraine Treatment
Despite recent advances in the science and treatment of migraine over the past decade, many clinicians have not significantly changed their approach to managing migraine. Nearly 60% of migraine sufferers continue to use over-the-counter (OTC) remedies exclusively to manage their headaches, despite a rise in the number of physician-diagnosed migraines (Bahra, 2002). Many of these diagnosed individuals still report significant suffering, highlighting the need for appropriate treatment in the management of migraine headache.
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, bearing in mind that both prescription and 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.
Cluster Headache Treatment
The International Headache Society (2004) has published criteria for diagnosing cluster headache. Criteria for diagnosis specify an individual must have had at least five attacks occurring from one every other day to eight per day, attributable to no other disorder. In addition, headaches must cause severe or very severe unilateral orbital, supraorbital, or temporal pain lasting 15 to 180 minutes if untreated and be accompanied by one or more of the following: ipsilateral conjunctival injection or lacrimation, ipsilateral nasal congestion or rhinorrhea, ipsilateral eyelid edema, ipsilateral forehead and facial sweating, ipsilateral miosis or ptosis, or a sense of restlessness or agitation.
Episodic cluster headache is defined as at least two cluster periods lasting seven to 365 days and separated by pain-free remission periods of one month or longer. Chronic attacks recur over more than one year without remission or with remission lasting less than one month.
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 three 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, Product Insert Information, 2009):
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Reviewed||02/13/2014||Medical Policy & Technology Assessment Committee (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
|Anthem Mid West|
|MA-001||IV DHE (Intravenous Dihydroergotamine) for the Treatment of Headache|
|WellPoint Health Networks, Inc.|