for all the scoring methods If RODS becomes used regularly by PN Society in MMN studies in next couple of years, then used within the Criteria will be a RODS measurement will need to be added as an option for patients who might be part of provided and be accessible larger studies. within BloodSTAR. 2. BloodSTAR will be Appeal mechanism please. 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 1. Noted. for ClDP or MMN. 2. and 3. Referral to the 2. The recommendation to Refer to the current product information sheet for further product insert is included to information under 'Dose' may be misleading as not all IVIgs are indicated for the condition refer users for additional and will not contain further information in the Product Information. information (other than dose) 3. Where a funded IVIg has a TGA approved indication in ClDP &MMN there is no guidance that is not included in the for dosage in the Product Information for 'Relapse of ClDP or MMN patients within six publication of the Criteria for months of commencement of trial off immunoglobulin therapy' use or BloodSTAR (eg risks of adverse events). Myasthenia gravis (MG) 21 Qualifying criteria Myasthenia Gravis Composite Score Full details with references for These scales may not be routinely used in the clinical area. Can they be accessed on the all the scoring methods used database? within the Criteria will be
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
feedback-to-the-proposed-changes-to-the-criteria-and-nba-responses2015-without-names.docx