Sarilumab (Kevzara)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Kevzara be reimbursed by public drug plans for adult patients with polymyalgia rheumatica (PMR) whose disease has responded inadequately to corticosteroids, or whose disease has relapsed during corticosteroid taper, if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined it is uncertain whether Kevzara demonstrates acceptable clinical value versus corticosteroid taper in adult patients with PMR whose disease has responded inadequately to corticosteroids, or whose disease has relapsed during corticosteroid taper. Given that Kevzara is expected to be an additive to corticosteroid taper, acceptable clinical value refers to added value versus corticosteroid taper alone.
• Evidence from 1 phase III, double-blind, randomized controlled trial (the SAPHYR trial, N = 118) demonstrated that treatment with Kevzara plus a 14-week prednisone taper may result in added clinical benefit in patients with PMR whose disease has responded inadequately or has relapsed during corticosteroid taper, compared to treatment with placebo plus a 52-week prednisone taper. Kevzara plus a 14-week prednisone taper, compared to placebo plus a 52-week prednisone taper, may lead to a clinically meaningful increase in the proportion of patients who achieve sustained remission at week 52. Despite the positive findings favouring Kevzara, there was uncertainty in the evidence due to several limitations identified in the SAPHYR trial, such as a potential prognostic imbalance between study groups, missing outcome data, and invalid assumptions for time-to-event analyses.
• Symptoms of PMR, such as muscle pain, fatigue, and stiffness, had an extensive impact on patients’ quality of life. Further, long duration of corticosteroid treatment is associated with an increased risk of side effects, such as infection, osteoporosis, diabetes, accelerated atherosclerosis, weight gain, adipose redistribution, cataract formation, and avascular necrosis. Kevzara plus a 14-week prednisone taper may meet some of patients’ unmet clinical needs with an acceptable level of certainty in clinical value, notably increasing sustained symptom remission and improving patients’ health-related quality of life. Based on all the preceding considerations, CDEC recommended that Kevzara be reimbursed.
• Kevzara should only be reimbursed if it is initiated in adults aged 50 years or older with a confirmed diagnosis of PMR who have been treated with prednisone at a dose of at least 10 mg/day (or equivalent) for at least 8 weeks, have experienced at least 1 documented PMR flare within the previous 12 weeks while tapering prednisone at a dose of at least 7.5 mg/day (or equivalent), and have evidence of active disease (erythrocyte sedimentation rate ≥ 30 mm/hour or CRP levels ≥ 10 mg/L) within the same period. Kevzara must not be used in patients with a concurrent diagnosis of giant cell arteritis.
• Kevzara should only be reimbursed if initiated in combination with a tapering course of corticosteroids, and if the cost of Kevzara is reduced. The recommended period for initial reimbursement is 14 weeks. Initial renewal is recommended to be based on improvements in the signs and symptoms of PMR and normalization of CRP levels (< 10 mg/L), with subsequent renewals requiring sustained improvement of signs and symptoms with resolution by 1 year and continued normalization of CRP levels. Renewal assessments should occur at least every 3 months to confirm ongoing clinical benefit. When a patient’s condition is stable, assessment for renewal should occur at least every 6 months. Reimbursement must be discontinued if there are unacceptable side effects, after 18 months of treatment, or if PMR has been in remission for at least 1 year after starting Kevzara.