![]() ![]() Weeks 12 to 24 of the placebo arm from PREEMPT trials were used for transitions in discontinued patients. The transition probabilities for model cycles after 24 weeks were based on the trial results from weeks 24 to 36 of the Ona A arm and topiramate arm, for Ona A transitions and topiramate transitions, respectively. topiramate were informed by the FORWARD trials. The transition probabilities for the scenario analysis comparison vs. The transition probabilities for model cycles after 24 weeks were based on the trial results from the weeks 24 to 56 of the Ona A arm for Ona A transitions and from weeks 12 to 24 of the placebo arm for BSC transitions. Transition probabilities between HDPM health states for Ona A and BSC treatment groups were informed by PREEMPT trials. As the definition of CM includes at least 15 HDPM, those who have HDPM severity below this level at baseline should not be modelled. topiramate.Ī small proportion of the ITT population in PREEMPT (1/1384 patients) and ▬▬▬▬▬. BSC, and from FORWARD trial for the scenario analysis comparison vs. Half of the adverse events were assumed to result in a physician visit.Īge and sex distribution parameters were from the ITT population in PREEMPT trials for the base-case comparison vs. Treatment-related adverse events that occurred in more than 2% of patients in the PREEMPT trials were modelled, although these adverse events were not assumed to affect health utilities in the base-case analysis. ![]() ![]() Patients could also transition to a death state based on the mortality risk of the general Canadian population. 5 In a scenario analysis, patients who achieved zero to three headaches per month for 24 weeks were also assumed to discontinue treatment, and restart treatment when headache frequency increased to at least 15 headaches per month once again. A stopping rule based on treatment response was applied such that those who do not experience a reduction of at least 50% (30% in a scenario analysis) in headache frequency after two cycles of treatment (24 weeks) discontinued treatment (red arrows in Figure 1), reflecting current clinical guidelines 7 and reimbursement criteria. Headache frequency health states were treatment-dependent and the additional five health states included in the resubmission allowed the model to track potential changes in headache frequency for patients who discontinue treatment. 4 Patients based on PREEMPT trial patients, who predominantly had chronic migraine (CM), receiving either onabotulinumtoxA (Ona A) or best supportive care (BSC) (or Ona A or topiramate in a scenario analysis), entered the model, and could transition every 12 weeks to health states of more- or less-frequent headaches over a three-year model time horizon. In the resubmission, the manufacturer submitted an updated cost-utility analysis that modelled 13 health states ( Figure 1), 6 an increase from eight in the original submission. ![]()
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