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:
- Step therapy (i.e., limiting Botox use to only patients who failed to have treatment success on other effective therapeutic options (e.g., triptans).)
- 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.
Reference
https://www.nice.org.uk/guidance/ta260/chapter/1-Guidance
Limited evidence for the value of various medication options
- Medications not labelled for migraine are often covered to increase both affordability and management options.
- Studies of the outcomes and costs produced by medication are needed.
- To keep track of developments in the value of migraine treatments, see:
- Institute for Clinical and Economic Review (https://icer-review.org/)
- National Institute for Clinical Evaluation, United Kingdom.
https://www.nice.org.uk/guidance/ta260/chapter/1-Guidance - US Medicare:
https://www.cms.gov/medicare-coverage-database/
