title: Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.
abstract: BACKGROUND
  Few patients with migraine syndrome receive treatment with preventive medication regimens, and some of these patients fail to gain adequate migraine relief. Botulinum toxin has been suggested to be effective in the treatment of migraine for a select population. An integrated health system created a medical policy and a supporting preauthorization form that permits coverage of botulinum toxin for the off-label treatment of migraine for patients who (1) fail at least 3 drug classes for acute treatment, (2) fail at least 4 different preventive medication classes, and (3) receive consultation from a neurologist.
  
  
  OBJECTIVE
  To (1) evaluate the impact of botulinum toxin therapy on quality-of-life (QOL) measures evaluated by direct member survey results, and (2) assess the use and cost of migraine-related medications and overall medical and pharmacy services pre- and post-botulinum toxin therapy.
  
  
  METHODS
  The study was a retrospective analysis of administrative claims data from a 500,000-member integrated health system for the time period January 1, 2003, to October 31, 2007. Administrative claims data were used to identify members with a billing code (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]) for migraine (346.xx), tension headache (307.81), or headache (784.0) diagnosed by a neurologist. Administrative claims data for these patients were then queried for the use of botulinum toxin for dates of service from January 1, 2003, through October 31, 2006. A survey was sent to the identified patients (N=54) to assess 6 QOL measures associated with the use of botulinum toxin. Self-reported symptomatic improvement was assessed using a 5-point Likert scale for 6 questions regarding headache severity, headache frequency, use of rescue medications, productivity/absenteeism, recreational activities, and life enjoyment. For the subset of patients (n = 32) who maintained health plan eligibility from 18 months before through 18 months after the first botulinum toxin therapy claim (index date), medical and pharmacy claims data were used to assess the utilization and cost of specific medications and overall pharmacy and medical costs for the 18-month pre-index and post-index periods. Cost was defined as allowed charge, which is the sum of plan cost and member cost.
  
  
  RESULTS
  Of 54 surveys sent to all patients identified as having used botulinum toxin for the treatment of migraine from January 1, 2003, to October 31, 2006, 34 surveys were returned (63%). Almost 3 of 4 respondents (73%) reported moderate or better improvement in overall migraine or headache QOL measures, and 27% reported little or no improvement. For the 32 patients with continuous eligibility for the total observation period of 36 months, the average migraine-related pharmacy utilization, excluding botulinum toxin, increased by 50.5%, from 1.84 claims per patient per month (PPPM) in the 18-month pre-index period to 2.77 claims PPPM in the 18-month post-index period (P = 0.011) and by 59.5% by mean days supply (42.58 days to 67.93, P=0.008). Total migraine-related pharmacy cost increased by 80.9%, from $142.08 PPPM to $256.97 PPPM (P=0.013). Acute-treatment migraine-related pharmacy utilization increased from 1.23 claims PPPM to 1.92 claims PPPM (P=0.004). There was no significant change in either the number of claims for migraine prophylaxis medications (0.61 PPPM to 0.85 PPPM, P=0.121) or the use of hospital emergency room services related to migraine or headache (0.07 PPPM vs. 0.10 PPPM, P=0.449). The mean migraine-related and nonmigraine-related (i.e., all-cause) combined medical/hospital and pharmacy expense, including botulinum toxin, increased by 111.3%, from $651.13 PPPM in the pre-index period to $1,376.05 PPPM in the post-index period (P<0.001).
  
  
  CONCLUSIONS
  The majority of patients who received botulinum toxin for refractory migraine reported improvement in disease-specific symptoms and overall QOL, but total medical and pharmacy costs were higher in the period after treatment, and there was no reduction in the use of other migraine-related medications.
authors.affiliation: Pharmacy Services, SelectHealth, 4646 West Lake Park, Suite N3, Salt Lake City, UT 84107, USA. Matt.Mitchell@selecthealth.org
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Mitchell
authors.forename: Kenneth
authors.initials: K
authors.lastname: Schaecher
authors.forename: H Eric
authors.initials: HE
authors.lastname: Cannon
authors.forename: Matt
authors.initials: M
authors.lastname: Speckman
mesh_terms: D000328:Adult; D001905:Botulinum Toxins / Q000191:economics / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A / Q000191:economics / Q000627:therapeutic use*; D003625:Data Collection; D016208:Databases, Factual; D016527:Drug Costs; D005260:Female; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000191:economics; D009465:Neuromuscular Agents / Q000191:economics / Q000627:therapeutic use*; D010148:Intractable Pain / Q000188:drug therapy / Q000191:economics; D010593:Pharmaceutical Services / Q000191:economics; D011788:Quality of Life; D012189:Retrospective Studies
chemical_list: D009465:Neuromuscular Agents; C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A