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Treatment phase |
Eculizumab |
Ravulizumab |
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Initial and initial switching criteria |
4 week loading dose available, 12 vials and nil repeats, once patient has met criteria |
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2 week loading dose, dose dependent on body weight
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See the aHUS dosage schedule table on the Resources page
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Initial treatment: balance of supply |
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ADAMTS-13 test must be supplied and patients are then eligible for a further 20 weeks of treatment
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If ADAMTS-13 test is provided when initial paperwork is submitted, approval can be given at the same time as the initial loading dose.
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20 weeks of treatment available (4 x repeats) can be given under this restriction i.e. 8 vials if > 40kg
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See the aHUS dosage schedule table on the Resources page if weight is < 40kg
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ADAMTS-13 test must be supplied and patients are then eligible for a further 24 weeks of treatment (8 weeks and up to 2 repeats)
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If ADAMTS-13 test is provided when initial paperwork is submitted, approval can be given at the same time as the initial loading dose
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See the aHUS dosage schedule table on the Resources page
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Continuing |
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Available to patients that meet criteria after they’ve had the initial, or to patients who received eculizumab under the switch from ravulizumab in initial or continuing treatment phase
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Total of 80 weeks treatment available under this restriction
Or
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Not more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if patient had switched C5 inhibitors during the course of initial and continuing treatment
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24 weeks treatment available per course (5 x repeats) under this restriction. 8 vials if over 40kg
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the aHUS dosage schedule table on the Resources page if weight is < 40kg
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Patients have 3 options after having a total of 104 weeks of treatment, if the patient demonstrates a response, and also the following:
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no treatment failure, and
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has perilous organ damage, or
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a high risk of aHUS recurrence in the short term without eculizumab, they will be eligible for extended continuing treatment
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demonstrate a response and flare whilst off medication, they will be eligible for recommencement
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failed to respond, no further treatment is available
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Available to patients that meet criteria after they’ve had the initial or grandfather, or to patients who received ravulizumab under the switch from eculizumab in continuing treatment phase
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Total of 72 weeks treatment available under this restriction
Or
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Not more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if patient had switched C5 inhibitors during the course of initial and continuing treatment
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24 weeks treatment available per course (8 weeks and 2 repeats)
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See the aHUS dosage schedule table on the Resources page
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Patients have 3 options after having a total of 104 weeks of treatment, if the patient demonstrates a response, and also the following:
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no treatment failure, and
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has perilous organ damage, or
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a high risk of aHUS recurrence in the short term without ravulizumab, they will be eligible for extended continuing treatment
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demonstrate a response and flare whilst off medication, they will be eligible for recommencement
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failed to respond, no further treatment is available
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Extended continuing |
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Available to patients that have demonstrated a response to the medication and the following:
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had no treatment failures
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have perilous organ damage, or
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a high risk of aHUS recurrence in the short term without eculizumab
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Once patients are in this restriction ‘loop’, they are eligible for continuing criteria indefinitely if:
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they demonstrate a response every 24 weeks with no treatment failure, and
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perilous organ damage, or
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a high risk of aHUS recurrence in the short term without eculizumab
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24 weeks treatment is available (5 x repeats) under this restriction i.e. 8 vials if over 40kg
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See the aHUS dosage schedule table on the Resources page if weight is < 40kg
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Available to patients that have demonstrated a response to the medication and the following:
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had no treatment failures
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have perilous organ damage, or
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a high risk of aHUS recurrence in the short term without ravulizumab
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Once patients are in this restriction ‘loop’, they are eligible for continuing criteria indefinitely if:
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they demonstrate a response every 24 weeks with no treatment failure, and
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perilous organ damage, or
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a high risk of aHUS recurrence in the short term without ravulizumab
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24 weeks treatment is available (8 weeks and up to 2 repeats) under this restriction
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See the aHUS dosage schedule table on the Resources page
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Recommencement |
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Available for patients that have had treatment with eculizumab, demonstrated a response to treatment and flared while off eculizumab or for patients who received eculizumab under the switch from ravulizumab in the recommencement treatment phase
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Patients may qualify for a reload to the medication at this stage. 12 vials and nil repeats + 8 vials and 4 repeats (total of 24 weeks)
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24 weeks treatment is available (5 x repeats) under this restriction. That is, 8 vials if > 40kg
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See the aHUS dosage schedule table on the Resources page if weight is < 40kg
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Available for patients that have demonstrated a response to treatment with a PBS-subsidised C5 inhibitor
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2 week loading dose, dose dependent on body weight
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See the aHUS dosage schedule table on the Resources page
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Recommencement of treatment: balance of supply |
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Available to patients who have received eculizumab recommencement supply
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20 weeks of treatment available (4 x repeats) can be given under this restriction i.e. 8 vials if > 40kg
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See the aHUS dosage schedule table on the Resources page if weight is < 40kg
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Available for patients that have demonstrated a response to treatment with a PBS-subsidised C5 inhibitor
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24 weeks of treatment available (8 weeks and up to 2 repeats)
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See the aHUS dosage schedule table on the Resources page
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Continuing recommencement |
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Once patients are in this restriction 'loop' they are eligible for continuing criteria indefinitely if they demonstrate a response every 24 weeks with no treatment failure
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24 weeks treatment is available (5 x repeats) under this restriction. 8 vials if > 40kg
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See the aHUS dosage schedule table on the Resources page if weight is < 40kg
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Once patients are in this restriction 'loop' they are eligible for continuing criteria indefinitely if they demonstrate a response every 24 weeks with no treatment failure
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24 weeks treatment is available (8 weeks and 2 repeats) per course under this restriction
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See the aHUS dosage schedule table on the Resources page
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Grandfather |
Not applicable |
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8 weeks and up to 2 repeats can be sought to provide sufficient drug for the balance of the current treatment phase
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See the aHUS dosage schedule table on the Resources page
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Demonstrating a response |
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At any stage during the patient’s treatment, the prescriber can elect to send a demonstration of response
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If the patient flares, they will be eligible to go on the recommencement restriction if they meet criteria
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The prescriber may also elect to send the demonstration of response through when the patient flares
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Update the previous database line to Responded not current
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At any stage during the patient’s treatment, the prescriber can elect to send a demonstration of response
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If the patient flares, they will be eligible to go on the recommencement restriction if they meet criteria
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The prescriber may also elect to send the demonstration of response through when the patient flares
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Update the previous database line to Responded not current
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Add on |
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Patients are able to increase their dose while receiving a plasma exchange. This will be classified as an add on, no weeks to be entered into the database
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A request would need to be submitted in writing and reviewed by a PA
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To approve, use the previous item and restriction codes the patient was approved under
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Patients are able to increase their dose while receiving a plasma exchange. This will be classified as an add on, no weeks to be entered into the database
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A request would need to be submitted in writing and reviewed by a PA
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To approve, use the previous item and restriction codes the patient was approved under
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