APPLICATION FOR SPECIAL AUTHORITY. Subsidy for Tocilizumab

Transcription

1 APPLICATION FOR SPECIAL AUTHORITY Fm SA1781 Subsidy f Tocilizumab Application Categy Page Cytokine release syndrome - Initial application... 2 Previous use - Initial application... 2 Rheumatoid Arthritis (patients previously treated with adalimumab etanercept) - Initial application... 3 Rheumatoid Arthritis - Initial application... 4 Systemic juvenile idiopathic arthritis - Initial application... 4 Adult-onset Still's disease - Initial application... 5 Polyarticular juvenile idiopathic arthritis - Initial application... 6 Idiopathic multicentric Castleman's disease - Initial application... 6 Rheumatoid Arthritis - Renewal... 7 Systemic juvenile idiopathic arthritis - Renewal... 7 Adult-onset Still's disease - Renewal... 7 Polyarticular juvenile idiopathic arthritis - Renewal... 7 Idiopathic multicentric Castleman's disease - Renewal... 8

2 adult-onset Still's disease polyarticular juvenile idiopathic arthritis idiopathic multicentric Castleman's disease Ministry of Health APPLICANT (stamp sticker acceptable) Page 2 Fm SA1781 Tocilizumab INITIAL APPLICATION - cytokine release syndrome Applications from any relevant practitioner. Approvals valid without further renewal unless notified. The patient is enrolled in the Children's Oncology Group AALL1331 trial The patient has developed grade 3 4 cytokine release syndrome associated with the administration of blinatumomab f the treatment of acute lymphoblastic leukaemia Tocilizumab is to be administered at doses no greater than 8 mg/kg IV f a maximum of 3 doses The patient is enrolled in the Malaghan Institute of Medical Research Phase I ENABLE trial The patient has developed CRS CAR T-Cell Related Encephalopathy Syndrome (CRES) associated with the administration of CAR T- cell therapy f the treatment of relapsed refracty B-cell non-hodgkin lymphoma Tocilizumab is to be administered accding to the consensus guidelines f CRS CRES f CAR T-cell therapy (Neelapu et al. Nat Rev Clin Oncol 2018;15:47-62) at doses no greater than 8 mg/kg IV f a maximum of 3 doses INITIAL APPLICATION - previous use Applications from any relevant practitioner. Approvals valid f 6 months. Patient was being treated with tocilizumab pri to 1 rheumatoid arthritis systemic juvenile idiopathic arthritis I confirm the above details are crect that in signing this fm I underst I may be audited.

3 APPLICANT (stamp sticker acceptable) Page 3 Fm SA1781 INITIAL APPLICATION - Rheumatoid Arthritis (patients previously treated with adalimumab etanercept) Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. The patient has had an initial Special Authity approval f adalimumab / etanercept f rheumatoid arthritis The patient has experienced intolerable side effects from adalimumab / etanercept The patient has received insufficient benefit from at least a three-month trial of adalimumab / etanercept such that they do not meet the renewal criteria f rheumatoid arthritis The patient is seronegative f both anti-cyclic citrullinated peptide (CCP) antibodies rheumatoid fact The patient has been started on rituximab f rheumatoid arthritis in a DHB hospital in accdance with the Section H rules The patient has experienced intolerable side effects from rituximab At four months following the initial course of rituximab the patient has received insufficient benefit such that they do not meet the renewal criteria f rheumatoid arthritis I confirm the above details are crect that in signing this fm I underst I may be audited.

4 APPLICANT (stamp sticker acceptable) Page 4 Fm SA1781 INITIAL APPLICATION - Rheumatoid Arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Patient has had severe active erosive rheumatoid arthritis (either confirmed by radiology imaging, the patient is cyclic citrullinated peptide (CCP) antibody positive) f six months duration longer Tocilizumab is to be used as monotherapy Treatment with methotrexate is contraindicated Patient has tried did not tolerate al / parenteral methotrexate Patient has tried not responded to at least three months therapy at the maximum tolerated dose of ciclospin alone in combination with another agent Patient has tried not responded to at least three months therapy at the maximum tolerated dose of leflunomide alone in combination with another agent Patient has persistent symptoms of poly controlled active disease in at least 20 active, swollen, tender joints Patient has persistent symptoms of poly controlled active disease in at least four active joints from the following: wrist, elbow, knee, ankle, either shoulder hip Patient has a C-reactive protein level greater than 15 mg/l measured no me than one month pri to the date of this application C-reactive protein levels not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day has done so f me than three months INITIAL APPLICATION - systemic juvenile idiopathic arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Patient diagnosed with systemic juvenile idiopathic arthritis Patient has tried not responded to a reasonable trial of all of the following, either alone in combination: al parenteral methotrexate; non-steroidal anti-inflammaty drugs (NSAIDs); systemic cticosteroids I confirm the above details are crect that in signing this fm I underst I may be audited.

5 APPLICANT (stamp sticker acceptable) Page 5 Fm SA1781 INITIAL APPLICATION - adult-onset Still's disease Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. The patient has had an initial Special Authity approval f adalimumab / etanercept f adult-onset Still's disease (AOSD) The patient has been started on tocilizumab f AOSD in a DHB hospital in accdance with the General Rules of the Pharmaceutical Schedule The patient has experienced intolerable side effects from adalimumab / etanercept The patient has received insufficient benefit from at least a three-month trial of adalimumab / etanercept such that they do not meet the renewal criteria f AOSD Patient diagnosed with AOSD accding to the Yamaguchi criteria (J Rheumatol 1992;19: ) Patient has tried not responded to at least 6 months of glucocticosteroids at a dose of at least 0.5 mg/kg, non-steroidal antiinflammaty drugs (NSAIDs) methotrexate Patient has persistent symptoms of disabling poly controlled active disease I confirm the above details are crect that in signing this fm I underst I may be audited.

6 APPLICANT (stamp sticker acceptable) Page 6 Fm SA1781 INITIAL APPLICATION - polyarticular juvenile idiopathic arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 4 months. The patient has had an initial Special Authity approval f both etanercept adalimumab f juvenile idiopathic arthritis (JIA) The patient has experienced intolerable side effects, has received insufficient benefit from, both etanercept adalimumab Treatment with a tumour necrosis fact alpha inhibit is contraindicated Patient has had severe active polyarticular course JIA f 6 months duration longer Patient has tried not responded to at least three months of al parenteral methotrexate (at a dose of mg/m² weekly at the maximum tolerated dose) in combination with either al cticosteroids (prednisone 0.25 mg/kg at the maximum tolerated dose) a full trial of serial intra-articular cticosteroid injections To be used as an adjunct to methotrexate therapy monotherapy where use of methotrexate is limited by toxicity intolerance Patient has persistent symptoms of poly-controlled active disease in at least 20 swollen, tender joints Patient has persistent symptoms of poly-controlled active disease in at least four joints from the following: wrist, elbow, knee, ankle, shoulder, cervical spine, hip Physician's global assessment indicating severe disease INITIAL APPLICATION - idiopathic multicentric Castleman's disease Applications only from a haematologist, rheumatologist Practitioner on the recommendation of a haematologist rheumatologist. Approvals valid f 6 months. Patient has severe HHV-8 negative idiopathic multicentric Castleman's disease Treatment with an adequate trial of cticosteroids has proven ineffective Tocilizumab to be administered at doses no greater than 8 mg/kg IV every 3-4 weeks I confirm the above details are crect that in signing this fm I underst I may be audited.

7 APPLICANT (stamp sticker acceptable) Page 7 Fm SA1781 RENEWAL - Rheumatoid Arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Following 6 months' initial treatment, the patient has at least a 50% decrease in active joint count from baseline a clinically significant response to treatment in the opinion of the physician On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline a clinically significant response to treatment in the opinion of the physician RENEWAL - systemic juvenile idiopathic arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Following up to 6 months' initial treatment, the patient has achieved at least an American College of Rheumatology paediatric 30% improvement criteria (ACR Pedi 30) response from baseline On subsequent reapplications, the patient demonstrates at least a continuing ACR Pedi 30 response from baseline RENEWAL - adult-onset Still's disease Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Prerequisites (tick box where appropriate) the patient has a sustained improvement in inflammaty markers functional status RENEWAL - polyarticular juvenile idiopathic arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Treatment is to be used as an adjunct to methotrexate therapy monotherapy where use of methotrexate is limited by toxicity intolerance Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count an improvement in physician's global assessment from baseline On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count continued improvement in physician's global assessment from baseline I confirm the above details are crect that in signing this fm I underst I may be audited.

8 APPLICANT (stamp sticker acceptable) Page 8 Fm SA1781 RENEWAL - idiopathic multicentric Castleman's disease Applications only from a haematologist, rheumatologist Practitioner on the recommendation of a haematologist rheumatologist. Approvals valid f 12 months. Prerequisites (tick box where appropriate) the treatment remains appropriate the patient has a sustained improvement in inflammaty markers functional status I confirm the above details are crect that in signing this fm I underst I may be audited.