Diagnosis is Yes By trial Clinical Patients are most likely to be treated by any required specialty Immunology of the listed specialists. Neurology Rheumatology Diagnosis No By which must be specialty verified Exclusion Sjogren’s syndrome associated vasculitic Vasculitic neuropathy in association with Criteria neuropathy Sjogren’s syndrome is excluded as is no evidence of benefit and alternative treatments are available. Severe, primary Sjogren’s syndrome associated Qualifying criteria have been developed and Qualifying neuropathy that is unresponsive to corticosteroid evidence items will capture the type of Criteria neuropathy (proven diagnosis) and the formal and immunosuppressant therapy. method of assessment that will be used to measure the clinical response and level of Primary Sjogren’s syndrome with proven neuropathy at qualifying (and that will be sensory or autonomic neuropathy applied for comparison at the initial and continuing reviews). AND The of assessment methods expected to Significant disability due to neuropathy as be used in new and existing patients include measured by Modified Rankin Score (MRS) clinical examination together with of at least 4 points investigations including nerve conduction studies, nerve biopsy, skin biopsy (IENFD), AND quantitative sensory testing, autonomic function tests or gastric emptying studies.
Diagnosis is required Yes By specialty Clinical Immunology Neurology Rheumatology Patients are most likely to be treated by any of the listed specialists. Diagnosis must be verified No By which specialty Exclusion Criteria Sjogren’s syndrome associated vasculitic neuropathy Vasculitic neuropathy in association with Sjogren’s syndrome is excluded as is no evidence of benefit and alternative treatments are available. Qualifying Criteria Severe, primary Sjogren’s syndrome associated neuropathy that is unresponsive to corticosteroid and immunosuppressant therapy. Primary Sjogren’s syndrome with proven sensory or autonomic neuropathy AND Significant disability due to neuropathy as measured by Modified Rankin Score (MRS) of at least 4 points AND trial Qualifying criteria have been developed and evidence items will capture the type of neuropathy (proven diagnosis) and the formal method of assessment that will be used to measure the clinical response and level of neuropathy at qualifying (and that will be applied for comparison at the initial and continuing reviews). The of assessment methods expected to be used in new and existing patients include clinical examination together with investigations including nerve conduction studies, nerve biopsy, skin biopsy (IENFD), quantitative sensory testing, autonomic function tests or gastric emptying studies.