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Considerations for initiation of therapy
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| Would patients who do not respond or lost response to treatment with eculizumab benefit from ravulizumab treatment? | The clinical experts noted that there is no evidence of this; however, ravulizumab does give an immediate, complete, and more sustained C5 inhibition when compared to eculizumab and therefore this may be considered in individual cases. There is also evidence that some patients develop tachyphylaxis to specific biologics and still retain some responsiveness to biosimilars. CDEC agreed with the clinical experts. |
| Can a patient restart ravulizumab if they responded to previous treatment? If so, under what clinical conditions? | The clinical experts stated that if a patient redevelops a TMA related to aHUS, ravulizumab needs to be restarted to prevent end-organ damage. Note that discontinuation of C5 inhibitors, when they have been maintaining remission and withdrawal has subsequently caused relapse, may cause irreversible damage resulting in progression of organ damage. Therefore, if a patient were in this situation and progressed to end-stage kidney disease with no history of other organ involvement, it may be futile to restart the medication as the patient would remain on dialysis - restarting the medication post-transplant would be necessary, if the patient were deemed a suitable transplant candidate. CDEC agreed with the clinical experts. |
| Consider alignment with current Canadian public drug plan initiation criteria for eculizumab. | CDEC discussed this input from public drug plans. |
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Considerations for continuation or renewal of therapy
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| Consider alignment with renewal criteria for eculizumab. | CDEC discussed this input from public drug plans. |
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Considerations for prescribing of therapy
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| Consider alignment with prescribing criteria for eculizumab (Soliris) — prescribed by or in consultation with a pediatric nephrologist, a nephrologist (for adults), a pediatric hematologist or a hematologist (for adults). | CDEC discussed this input from public drug plans. Based on clinical expert input, ravulizumab can be given at home with nursing support or at an infusion centre. A specialist, such as a nephrologist or hematologist with expertise in TMA, is needed to monitor the patients. |
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System and economic issues
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| The submitted price for ravulizumab (Ultomiris) is $7,296.67/vial and the annual cost of treatment is expected to range from $94,857 to $569,140, depending on patient weight. The annual cost of treatment with eculizumab (Soliris) is expected to range from $116,861 to $701,168, depending on a patient’s weight. It is expected that patients will transition from eculizumab to ravulizumab. The patent expiry for eculizumab is 2027 and for ravulizumab is 2035. If patients transition to the new, more convenient C5 inhibitor then savings that could be obtained by the entry of biosimilars may be lost. | CDEC acknowledged that biosimilars for eculizumab and/or ravulizumab may enter the market at some point; however, presently there is no information available on the comparative efficacy or costs of any biosimilar products. |
