Proposed structure of economic evaluation (decision-analytic) 5: Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be Healthcare assessed resources to be considered Patients 15 Injection of Best current Safety: Cost of the ≥ headache days per practice, i.e. 1st and Bleeding injection of BOTOX® into head • month, of which 8 2nd line prophylactic Infection following BOTOX® into head and neck areas • are with migraine, pharmaceuticals treatment and neck areas who either fail or Safety of long-term • experience repeat injections Size of the chronic inadequate into the same migraine patient improvement with location population 1st and 2nd line Pain from the • prophylactics injections Size of the episodic Cosmetic side- migraine patient • effects population and the Generalised • potential for weakness ‘leakage’ Hyper-sensitivity • (allergic) reaction Anticholinergic • effects Headache • Myalgia • Seizures • Weakness remote • from the injection site Effectiveness: Freq. of headache • episodes Freq. of headache • days Freq. of migraine • episodes Freq. of migraine • days Freq. of acute pain • medication intake Freq. of • prophylactic medication intake Change in no. of • moderate/severe headache days Change in • cumulative headache hrs on headache days Changes in HIT • score % of patients with • severe HIT score
Proposed structure of economic evaluation (decision-analytic) 5: Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Patients ≥ 15 headache days per month, of which 8 are with migraine, who either fail or experience inadequate improvement with 1st and 2nd line prophylactics Injection of BOTOX® into head and neck areas Best current practice, i.e. 1st and 2nd line prophylactic pharmaceuticals Safety: • Bleeding • Infection following treatment • Safety of long-term repeat injections into the same location • Pain from the injections • Cosmetic side- effects • Generalised weakness • Hyper-sensitivity (allergic) reaction • Anticholinergic effects • Headache • Myalgia • Seizures • Weakness remote from the injection site Effectiveness: • Freq. of headache episodes • Freq. of headache days • Freq. of migraine episodes • Freq. of migraine days • Freq. of acute pain medication intake • Freq. of prophylactic medication intake • Change in no. of moderate/severe headache days • Change in cumulative headache hrs on headache days • Changes in HIT score • % of patients with severe HIT score Cost of the injection of BOTOX® into head and neck areas Size of the chronic migraine patient population Size of the episodic migraine patient population and the potential for ‘leakage’
1168-Botox-for-Migraine-Final-DAP-Accessible.docx