Place of Service Dihydroergotamine mesylate injection Office Administration (D.H.E. 45®) Home Infusion Administration Outpatient Facility Administration Infusion Center Administration Self-Administration– May be covered under the pharmacy benefit
HCPCS: J1110 per 1 mg
Conditions listed in policy (see criteria for details) • Cluster headaches • Migraine headaches
AHFS therapeutic class: Antimigraine agent; Ergot Derivative Mechanism of action: Dihydroergotamine is a semisynthetic ergot alkaloid that is structurally and pharmacologically related to ergotamine.
(1) Special Instructions and Pertinent Information If member has a Prescription Benefit, please refer cases to Pharmacy Services for prior authorization.
If covered under the Medical Benefit, please submit clinical information for prior authorization review via fax. Please include medical rationale why medication cannot be home self- administered.
(2) Prior Authorization/Medical Review is required for the following condition(s) All requests for D.H.E. 45® (dihydroergotamine mesylate injection) must be sent for clinical review and receive authorization prior to drug administration or claim payment.
Cluster headaches 1. Recommended by a neurologist or a headache specialist, AND 2. Patient is currently on a prophylactic medication from the following list: prednisone, dexamethasone, verapamil, lithium or topiramate, OR contraindication to all agents above recognized as being efficacious for cluster headache prophylaxis, AND 3. Inadequate response, intolerable side effect, or contraindication to sumatriptan and zolmitriptan, AND 4. Number of injections requested per month does not exceed the amount needed to treat the number of headache days experienced per month, AND 5. Not taking D.H.E injection along with any triptan, or an ergot-type drug
Covered Doses Up to 3 mg per 24 hours, and up to 6 mg/week, given IM or SQ
Coverage Period Cover for 3 months
ICD-10: G44.001, G44.009
Dihydroergotamine mesylate injection (D.H.E. 45®)
Effective: 05/06/2020 Page 1 of 4 Migraine headaches for patients LESS than or equal to 8 headaches days per month 1. Treatment failure or intolerable side effect with at least 2 different triptans, AND 2. The total number of injections requested per month does not exceed the amount needed to treat the number of headache days experienced per month, AND 3. Not taking D.H.E injection along with any triptan, or an ergot-type drug
Covered Doses Up to 3 mg per 24 hours, and up to 6 mg/week, given IM or SQ
Coverage Period Cover indefinitely
ICD-10: G43.001- G43.819, G43.A01-G43.D19
Migraine headaches for patients GREATER than 8 headaches days per month 1. Patient is currently being followed by a neurologist or at a headache clinic, AND 2. One of the following: a. Currently on a prophylactic medication (beta-blocker, calcium channel blocker, antidepressant, anticonvulsant) OR b. Inadequate response, intolerance, or contraindication to all of the following migraine prophylactic drugs: divalproex, valproate, topiramate, amitriptyline, venlafaxine, atenolol, and nadolol, AND 3. Treatment failure or intolerable side effect with at least 2 different triptans, AND 4. Not taking D.H.E injection along with any triptan, or an ergot-type drug AND 5. The total number of injections requested per month does not exceed the amount needed to treat the number of headache days experienced per month
Covered Doses Up to 3 mg per 24 hours, and up to 6 mg/week, IM or SQ
Coverage Period Cover indefinitely
ICD-10: G43.001- G43.819, G43.A01-G43.D19
(3) The following condition(s) DO NOT require Prior Authorization/Preservice All requests for D.H.E. 45® (dihydroergotamine mesylate injection) must be sent for clinical review and receive authorization prior to drug administration or claim payment.
(4) This Medication is NOT medically necessary for the following condition(s) Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367.21, including objective evidence of efficacy and safety are met for the proposed indication.
Please refer to the Provider Manual and User Guide for more information.
(5) Additional Information How supplied: 1 mg/ml solution supplied in sterile ampules for I.V., I.M., or subcutaneous administration
Table 1. AAN 2012 Classification of Migraine Preventative Therapies (Silberstein, 2012)
Dihydroergotamine mesylate injection (D.H.E. 45®)
Effective: 05/06/2020 Page 2 of 4 Level A Level B Level C Level U Other Established efficacy Probably effective Possibly effective Inadequate or Possibly or probably conflicting data to ineffective support or refute use
Antiepileptics: Antidepressants: ACE Inhibitors: Antidepressants: Antiepileptics: • Divalproex sod • Amitriptyline • Lisinopril • Fluvoxamine • Lamotrigine • Valproate • Venlafaxine • Fluoxetine • Oxcarbazepine3 • Topiramate Alfa-agonists: Beta blockers: • Clonidine Antiepileptics: ARBs: Beta blockers: • Atenolol • Guanfacine • Gabapentin • Telmisartan • Metoprolol • Nadolol • Propranolol Antiepileptics: Antithrombotics: Beta blockers: • Timolol • Carbamazepine • Acenocoumarol • Acebutolol • Coumadin Antihistamines: Benzodiazepine: • Cyproheptadine Beta Blockers: • Clonazepam • Bisoprolol ARBs: NSAID: • Candesartan Ca Channel Blockers: • Nabumetone • Nicardipine Beta blockers: • Nifedipine TCA/Other: • Nebivolol • Nimodipine • Clomipramine • Pindolol • Verapamil
Carbonic anhydrase inhibitor: • Acetazolamide
Muscle relaxants: • Cyclandelate
TCA: • Protriptyline ACE = ace inhibitor; ARB = angiotensin receptor blocker; TCA = tricyclic antidepressant
(6) References • AHFS®. Available by subscription at http://www.lexi.com • Beithon J, Gallenberg M, Johnson K, et al. Diagnosis and Treatment of Headache. Institute for Clinical Systems Improvement. Updated January 2013. Available at: https://www.icsi.org/_asset/qwrznq/Headache.pdf • Dihydroergotamine mesylate injection [package insert], Novartis, distributed by Valeant Pharmaceuticals North America, revised 09/2009 • DrugDex®. Available by subscription at http://www.micromedexsolutions.com/home/dispatch • Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology. 2010; 75: 463-473. • Landy S, Smith. Treatment of primary headache: acute migraine treatment. In: Standards of care for headache diagnosis and treatment. Chicago (IL): National Headache Foundation; 2004, p.24-39. Available at: www.headaches.org • May A, Leone M, Afra J, et al. EFNS Task Force EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol. 2006;13:1066-1077 • Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of cluster headache: The American Headache Society evidence-based guidelines. Headache 2016; 56: 1093-1106. • Silberstein SD, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012;78(17):1337- 1345. • Snow V, et al. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med 2000; 137:840-849. • Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013 Jul 15;88(2):122-8. Review.
Dihydroergotamine mesylate injection (D.H.E. 45®)
Effective: 05/06/2020 Page 3 of 4 (7) Policy Update Dates of last review: 2Q2020 Date of next review: 2Q2021 Changes from previous policy version: • No clinical change to policy following routine annual review.
Dihydroergotamine mesylate injection (D.H.E. 45®)
Effective: 05/06/2020 Page 4 of 4