6 Qualifying criteria Please allow for I-RODS score changes to also be generated during assessment as an additional outcome measure (see above for details) at #5 In the first instance, the assessment method as currently proposed for GBS will be retained. 7 Qualifying criteria Initial therapy for GBS with significant disability and progression Requested treatment for a GBS pt and addressed the criteria as follows believing that this would be sufficient to gain access. I Selected: Criterion 1 Patient with GBS demonstrates significant disability as objectively measured by the GBS disability Score of greater than one point(adapted from Hughes et al 1978) However the Criteria also require selection of Criterion 3. Criterion 3 The progressive nature of the weakness indicates a trajectory to significant disability. Point of view is that if patient already has significant disability then their trajectory to significant disability is irrelevant. If criterion 2 is selected then you might also want the patient to have criterion 3. This would make the logic: [Criteria Group 1] Criterion 1 OR [Criteria Group 2] - Criterion 2 AND - Criterion 3 The qualifying criteria are unchanged in intention from the current version (2) but have been reworded to provide greater clarity of the meaning of 'disease progression'. There are two requirements to the current criteria: severity and a trend towards worsening disability. If a patient has plateaued and there is no continuing progression, then Ig is not indicated, irrespective of the level of disability. Inflammatory myopathies: Inclusion body myositis (IBM) 8 Qualifying criteria Dysphagia limiting dietary intake with involvement of pharyngeal muscles as demonstrated by videofluoroscopy Is video fluoroscopy readily available to use routinely to assess this? Is choking on food with An option has been added to support Ig treatment where speech pathology assessment indicates that a video
If RODS becomes used regularly by PN Society in MMN studies in next couple of years, then a RODS measurement will need to be added as an option for patients who might be part of larger studies. Appeal mechanism please. for all the scoring methods used within the Criteria will be provided and be accessible within BloodSTAR. 2. BloodSTAR will be sufficiently flexible to support change and updating of scoring systems as required by changes in the standard of care. 3. A national process for appeal mechanisms for ineligible patients will be considered by governments in due course. 20 Dose 1. Not all funded IVIgs have a Therapeutic Goods Administration (TGA) approved indication for ClDP or MMN. 2. The recommendation to Refer to the current product information sheet for further information under 'Dose' may be misleading as not all IVIgs are indicated for the condition and will not contain further information in the Product Information. 3. Where a funded IVIg has a TGA approved indication in ClDP &MMN there is no guidance for dosage in the Product Information for 'Relapse of ClDP or MMN patients within six months of commencement of trial off immunoglobulin therapy' 1. Noted. 2. and 3. Referral to the product insert is included to refer users for additional information (other than dose) that is not included in the publication of the Criteria for use or BloodSTAR (eg risks of adverse events). Myasthenia gravis (MG) 21 Qualifying criteria Myasthenia Gravis Composite Score These scales may not be routinely used in the clinical area. Can they be accessed on the database? Full details with references for all the scoring methods used within the Criteria will be
ongoing dosing with IVIG. 49 Qualifying criteria Adult ITP HIV-associated ITP There needs to be a similar emphasis on bleeding. Would suggest this category be amended as follows:- Failure of anti-retroviral therapy AND One of the following:- 1. Intracranial haemorrhage and platelet count < 80-100 x 10^9/L 2. Other life-threatening haemorrhage and platelet count < 50 x 10^9/L 3. Risk of clinically significant bleeding with platelet count < 30 x 10^9/L The criteria have been revised in line with the feedback. 50 Review criteria Adult ITP All indications Outcome date to be measured should include the following: Resolution of bleeding Prevention of bleeding Maximum platelet count achieved within 7 days of IVIG Outcome data have been revised in line with the feedback. 51 Review criteria Newly diagnosed or persistent ITP - subsequent therapy (diagnosis ≤ 12 Review must be undertaken six monthly by haematologist. Response to qualify for ongoing therapy includes as any of the following:- 1. Resolution of active bleeding 2. A reduction in evidence of bleeding correlating with a doubling of baseline platelet count or an increment in platelet count > 10^9/L within 7 days 3. In patients without active bleeding a doubling of baseline platelet count and a rise in platelet count > 30 x 10^9/L was demonstrated within 7 days of previous IVIG Ongoing use of IVIG should be primarily to prevent bleeding while other treatment options are explored including splenectomy. Approval for 6 months Agreed - the outcome and response data have been revised in line with feedback. 52 Review criteria Chronic ITP - subsequent therapy (diagnosis > 12 months) Review must be undertaken six monthly by haematologist. Response to qualify for ongoing therapy includes as any of the following:- Agreed - the outcome and response data have been revised in line with feedback.
used to encourage prescribers to consider the lowest possible effective dose. 56 Condition name The term Immune thrombocytopenia, rather than idiopathic (autoimmune thrombocytopenic purpura is now more favoured. When I search for ITP under dose it does not come up. I needed to write idiopathic Agreed - the condition name has been changed to Immune Thrombocytopenic Purpura for conditions relating to both children and adults. 57 Qualifying criteria Refractory acute ITP - initial therapy Statement: There has been no improvement in response to conventionaI doses of corticosteroid therapy for at least 14 days (unless valid reason is provided) Comment: 14 days is too long to wait for a response to steroids, especially if the platelet count is <10. Suggest 5 days instead In the absence of bleeding, 14 days is thought to be a safe period for response to steroid treatment. If the patient is bleeding, this would be a valid reason to prescribe Ig in less than 14 days which is supported by the criteria and the BloodSTAR system. 58 Qualifying criteria ITP with life-threatening haemorrhage or the potential for life- threatening haemorrhage Statement: When conventional doses of corticosteroids (for at least 14 days) have failed to improve count (unless a valid reason is provided) Comment: 14 days is too long to wait for a response to steroids, especially if the platelet count is <10. Suggest 5 days instead In the absence of bleeding, 14 days is thought to be a safe period for response to steroid treatment. If the patient is bleeding, this would be a valid reason to prescribe Ig in less than 14 days which is supported by the criteria and the BloodSTAR system. 59 Qualifying criteria Refractory acute ITP -splenectomy failed or contra indicated and second-line agent unsuccessful Statement: At least a two-fold increase in platelet count (and platelet count >30x109/L) was demonstrated within 72 hours of previous immunoglobulin (lg) treatment The Criteria for clinical response has been revised including extending the timeframe before improvement in platelet count
of vials in relation to dosing has been developed and corrected. 2. Review has indicated that there is insufficient evidence for higher dosing in women with a history of previous fetus with ICH, at this time. 62 Dose 1. No IVIg has a TGA approved indication for NH. 2. The recommendation to Refer to the current product information sheet for further information under 'Dose' is misleading as no IVIg is indicated for the condition and available Product Information will not contain further information for this condition. 1. Noted. 2. Referral to the product insert is included for additional information (other than dose) that is not included in the publication of the Criteria for use or BloodSTAR (eg risks of adverse events). Post-transfusion purpura (PTP) 63 Qualifying criteria and review criteria The use of criteria to judge response, i.e. platelet count of >30 or doubling of pre-treatment count within 72 hours is made without any evidence in this rare disorder. These criteria are the same as that proposed for ITP, for which we have indicated above are too stringent, leading to the potential exclusion of patients who have experienced clinical benefit from receiving further treatment . A level of platelet count or its doubling cannot be a substitute for clinical judgment as to whether a clinical benefit has been achieved eg in the prevention of bleeding. It is also not appropriate to simply transfer the criteria for ITP to PTP which are completely different disorders. In PTP, the creation of outcome measures is for the recording of data only. The qualifying criteria for Ig are the same for every dose that may be required (clinical diagnosis or suspicion of PTP with platelet count <30x10 9/L and a risk of life threatening bleeding. Therefore, responder status is irrelevant in the qualifying criteria for PTP. However, a text box to support