6 Qualifying criteria Please allow for I-RODS score changes to also be generated during assessment as an In the first instance, the additional outcome measure (see above for details) at #5 assessment method as currently proposed for GBS will be retained. 7 Qualifying criteria Initial therapy for GBS with significant disability and progression The qualifying criteria are Requested treatment for a GBS pt and addressed the criteria as follows believing that this unchanged in intention from would be sufficient to gain access. I Selected: the current version (2) but Criterion 1 have been reworded to Patient with GBS demonstrates significant disability as objectively measured by the GBS provide greater clarity of the disability Score of greater than one point(adapted from Hughes et al 1978) meaning of 'disease progression'. There are two However the Criteria also require selection of Criterion 3. requirements to the current Criterion 3 criteria: severity and a trend The progressive nature of the weakness indicates a trajectory to significant disability. towards worsening disability. If a patient has plateaued and Point of view is that if patient already has significant disability then their trajectory to there is no continuing significant disability is irrelevant. If criterion 2 is selected then you might also want the progression, then Ig is not patient to have criterion 3. This would make the logic: indicated, irrespective of the [Criteria Group 1] level of disability. Criterion 1 OR [Criteria Group 2] - Criterion 2 AND - Criterion 3 Inflammatory myopathies: Inclusion body myositis (IBM) 8 Qualifying criteria Dysphagia limiting dietary intake with involvement of pharyngeal muscles as An option has been added to demonstrated by videofluoroscopy support Ig treatment where speech pathology assessment Is video fluoroscopy readily available to use routinely to assess this? Is choking on food with indicates that a video
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
feedback-to-the-proposed-changes-to-the-criteria-and-nba-responses2015-without-names.docx