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Cost and Effectiveness of Select Treatments

Learning Objectives

  • Based on clinical trial data, identify which one of the treatments listed in the following pairs presents the best value in terms of relative cost and effectiveness:
    • Cefaly versus metroproprolol
    • Botox versus placebo
  • List 2 strategies used by insurance companies to manage the value of migraine therapies, and specifically Botox.
  • Identify at least one resource for keeping up to date about the comparative effectiveness and cost-effectiveness of various migraine treatment options.

Cost-Effectiveness of Cefaly vs. Metroprolol

  • Based in clinical trial data and gold-standard methods for economic evaluation,
  • Cefaly is both more expensive and less effective than metropolol, a commonly used generic medication for episodic migraine:
Treatment Patients with >= 50% reduction in migraine frequency Annual treatment cost Incremental Cost-effectiveness ratio
Cephaly 382 per 1,000 $449 (2014 costs) Dominated
Metroprolol 395 per 1,000 $49 Dominant
  • The difference is so large that for Cephaly to become dominant, it would have to have nearly double its effectiveness and cut its price by about 85% (to $76).

Cost-Effectiveness of BOTOX

Trials compared BOTOX to sham injections only. Among patients with very high baseline frequencies of migraine (20 days per month), BOTOX is cost-effective ($4 per migraine day averted). The placebo effect was powerful in studies, however, ad cost-effectiveness falls with reduced frequency.

Trial Treatment and Control Groups N Headache Days Per Month Daily cost of chronic migraine management
Aurora 2010 Botulinum 341 7.1 $40
PREEMPT 1        
  Sham injections 338 8.1 0
Diener 2010 Botulinum 347 11.2 $40
Preempt 2 (Europe, N America 66 Centers) Sham injections 358 13.4 0

2 Insurance Strategies to Manage Value

  • Migraine etiology and specific classification raise many questions, making precise targeting of treatment difficult.
  • Botox: The high cost compared to other therapies and the strong placebo effect found in clinical trials have led many insurers to use:
    1. Step therapy (i.e., limiting Botox use to only patients who failed to have treatment success on other effective therapeutic options (e.g., triptans).)
    2. Stopping rules for lack of response to treatment

Example Coverage for BOTOX Prophylaxis

  • Recommended for prophylaxis of:
    • headache in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine):
    • Requires Step Therapy: Use only for patients who have not responded ≥ 3 prior pharmacological prophylaxis therapies and
    • whose condition is appropriately managed for medication overuse.
  • Stopping Rules:
    • < 30% reduction in headache days per month after two treatment cycles) or
    • Changed to episodic migraine (defined as fewer than 15 headache days per month) for 3 consecutive months.

https://www.nice.org.uk/guidance/ta260/chapter/1-Guidance

Limited evidence for the value of various medication options

Reference

Institute for Clinical and Economic Review. (2014) Action plan for the treatment of migraine: Payers and policymakers.

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