APPLICATION FOR SPECIAL AUTHORITY Fm SA1778 Subsidy f Infliximab Application Categy Page Graft vs host disease - Initial application... 2 Pulmonary sarcoidosis - Initial application... 2 Previous use - Initial application... 3 Rheumatoid arthritis - Initial application... 4 Ankylosing spondylitis - Initial application... 4 Psiatic arthritis - Initial application... 4 Severe ocular inflammation - Initial application... 5 Chronic ocular inflammation - Initial application... 5 Crohn's disease (adults) - Initial application... 6 Crohn's disease (children) - Initial application... 6 Fistulising Crohn's disease - Initial application... 7 Acute severe fulminant ulcerative colitis - Initial application... 7 Severe ulcerative colitis - Initial application... 7 Plaque psiasis - Initial application... 8 Neurosarcoidosis - Initial application... 9 Severe Behcet's disease - Initial application... 9 Rheumatoid arthritis - Renewal.. 10 Ankylosing spondylitis - Renewal... 10 Psiatic arthritis - Renewal... 10 Severe ocular inflammation - Renewal... 11 Chronic ocular inflammation - Renewal... 11 Crohn's disease (adults) - Renewal... 12 Crohn's disease (children) - Renewal... 12 Fistulising Crohn's disease - Renewal... 13 Severe fulminant ulcerative colitis - Renewal... 13 Severe ulcerative colitis - Renewal... 13 Plaque psiasis - Renewal... 14 Neurosarcoidosis - Renewal... 14 Severe Behcet's disease - Renewal... 15
APPLICANT (stamp sticker acceptable) Page 2 Fm SA1778 Infliximab INITIAL APPLICATION - Graft vs host disease Applications from any relevant practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick box where appropriate) patient has steroid-refracty acute graft vs. host disease of the gut INITIAL APPLICATION - Pulmonary sarcoidosis Applications from any relevant practitioner. Approvals valid without further renewal unless notified. Prerequisites (tick box where appropriate) patient has life-threatening pulmonary sarcoidosis diagnosed by a multidisciplinary team that is refracty to other treatments I confirm the above details are crect that in signing this fm I underst I may be audited.
Psiatic arthritis Severe ocular inflammation Chronic ocular inflammation Crohn s disease (adults) Crohn s disease (children) Fistulising Chron s disease Severe fulminant ulcerative colitis Severe ulcerative colitis Plaque psiasis Neurosarcoidosis Severe Behcet s disease Ministry of Health APPLICANT (stamp sticker acceptable) Page 3 Fm SA1778 INITIAL APPLICATION - previous use Applications from any relevant practitioner. Approvals valid f 6 months. Patient was being treated with infliximab pri to 1 Rheumatoid arthritis Ankylosing spondylitis I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 4 Fm SA1778 INITIAL APPLICATION - rheumatoid 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 adalimumab / etanercept f rheumatoid arthritis The patient has experienced intolerable side effects from a reasonable trial of adalimumab / etanercept Following at least a four month trial of adalimumab / etanercept, the patient did not meet the renewal criteria f adalimumab / etanercept Treatment is to be used as an adjunct to methotrexate therapy monotherapy where use of methotrexate is limited by toxicity intolerance INITIAL APPLICATION - ankylosing spondylitis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 3 months. The patient has had an initial Special Authity approval f adalimumab / etanercept f ankylosing spondylitis The patient has experienced intolerable side effects from a reasonable trial of adalimumab / etanercept Following 12 weeks of adalimumab / etanercept treatment, the patient did not meet the renewal criteria f adalimumab / etanercept f ankylosing spondylitis INITIAL APPLICATION - psiatic 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 adalimumab / etanercept f psiatic arthritis The patient has experienced intolerable side effects from a reasonable trial of adalimumab / etanercept Following 3-4 months' initial treatment with adalimumab / etanercept, the patient did not meet the renewal criteria f adalimumab / etanercept f psiatic arthritis I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 5 Fm SA1778 INITIAL APPLICATION - severe ocular inflammation Applications from any relevant practitioner. Approvals valid f 4 months. Patient has severe, vision-threatening ocular inflammation requiring rapid control Treatment with high-dose steroids (intravenous methylprednisolone) followed by high dose al steroids has proven ineffective at controlling symptomst Patient developed new inflammaty symptoms while receiving high dose steroids Patient is aged under 8 years treatment with high dose al steroids other immunosuppressants has proven ineffective at controlling symptoms INITIAL APPLICATION - chronic ocular inflammation Applications from any relevant practitioner. Approvals valid f 4 months. Patient has severe uveitis uncontrolled with treatment of steroids other immunosuppressants with a severe risk of vision loss Patient is 18 years older treatment with at least two other immunomodulaty agents has proven ineffective Patient is under 18 years treatment with methotrexate has proven ineffective is not tolerated at a therapeutic dose Patient is under 8 years treatment with steroids methotrexate has proven ineffective is not tolerated at a therapeutic dose; disease requires control to prevent irreversible vision loss pri to achieving a therapeutic dose of methotrexate I confirm the above details are crect that in signing this fm I underst I may be audited.
Patient has evidence of sht gut syndrome would be at risk of sht gut syndrome with further bowel resection Patient has an ileostomy colostomy, has intestinal inflammation Ministry of Health APPLICANT (stamp sticker acceptable) Page 6 Fm SA1778 INITIAL APPLICATION - Crohn's disease (adults) Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 3 months. Patient has severe active Crohn's disease Patient has a Crohn's Disease Activity Index (CDAI) sce of greater than equal to 300 Patient has extensive small intestine disease affecting me than 50 cm of the small intestine Patient has tried but had an inadequate response to, has experienced intolerable side effects from, pri systemic therapy with immunomodulats at maximum tolerated doses (unless contraindicated) cticosteroids Surgery ( further surgery) is considered to be clinically inappropriate Patient must be reassessed f continuation after 3 months of therapy INITIAL APPLICATION - Crohn's disease (children) Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 3 months. Paediatric patient has severe active Crohn's disease Patient has a Paediatric Crohn's Disease Activity Index (PCDAI) sce of greater than equal to 30 Patient has extensive small intestine disease Patient has tried but had an inadequate response to, has experienced intolerable side effects from, pri systemic therapy with immunomodulats at maximum tolerated doses (unless contraindicated) cticosteroids Surgery ( further surgery) is considered to be clinically inappropriate Patient must be reassessed f continuation after 3 months of therapy I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 7 Fm SA1778 INITIAL APPLICATION - fistulising Crohn's disease Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 4 months. Patient has confirmed Crohn's disease Patient has one me complex externally draining enterocutaneous fistula(e) Patient has one me rectovaginal fistula(e) INITIAL APPLICATION - acute severe fulminant ulcerative colitis Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 weeks. Patient has acute, severe fulminant ulcerative colitis Treatment with intravenous high dose al cticosteroids has not been successful INITIAL APPLICATION - severe ulcerative colitis Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 3 months. Patient has histologically confirmed ulcerative colitis Patient is 18 years older the Simple Clinical Colitis Activity Index (SCCAI) is greater than equal to 4 Patient is under 18 years the Paediatric Ulcerative Colitis Activity Index (PUCAI) sce is greater than equal to 65 Patient has tried but had an inadequate response to, has experienced intolerable side effects from, pri systemic therapy with immunomodulats at maximum tolerated doses f an adequate duration (unless contraindicated) cticosteroids Surgery ( further surgery) is considered to be clinically inappropriate I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 8 Fm SA1778 INITIAL APPLICATION - plaque psiasis Applications only from a dermatologist Practitioner on the recommendation of a dermatologist. Approvals valid f 3 months. The patient has had an initial Special Authity approval f adalimumab etanercept f severe chronic plaque psiasis The patient has experienced intolerable side effects from adalimumab etanercept The patient has received insufficient benefit from adalimumab etanercept to meet the renewal criteria f adalimumab etanercept f severe chronic plaque psiasis Patient has "whole body" severe chronic plaque psiasis with a Psiasis Area Severity Index (PASI) sce of greater than 15, where lesions have been present f at least 6 months from the time of initial diagnosis Patient has severe chronic plaque psiasis of the face, palm of a h sole of a foot, where the plaque plaques have been present f at least 6 months from the time of initial diagnosis Patient has tried, but had an inadequate response (see Note) to, has experienced intolerable side effects from, at least three of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclospin, acitretin A PASI assessment has been completed f at least the most recent pri treatment course (but preferably all pri treatment courses), preferably while still on treatment but no longer than 1 month following cessation of each pri treatment course The most recent PASI assessment is no me than 1 month old at the time of initiation Note: "Inadequate response" is defined as: f whole body severe chronic plaque psiasis, a PASI sce of greater than 15, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent pri treatment; f severe chronic plaque psiasis of the face, h foot, at least 2 of the 3 PASI symptom subsces f erythema, thickness scaling are rated as severe very severe, the skin area affected is 30% me of the face, palm of a h sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent pri treatment. I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 9 Fm SA1778 INITIAL APPLICATION - neurosarcoidosis Applications only from a neurologist Practitioner on the recommendation of a neurologist. Approvals valid f 18 months. Patient has been diagnosed with neurosarcoiosis by a multidisciplinary team Patient has CNS involvement Patient has steroid-refracty disease IV cyclophosphamide has been tried Treatment with IV cyclophosphamide is clinically inappropriate INITIAL APPLICATION - severe Behcet's disease Applications from any relevant practitioner. Approvals valid f 4 months. The patient has severe Behcet's disease which is significantly impacting the patient s quality of life (see Notes) The patient has severe ocular, neurological / vasculitic symptoms has not responded adequately to one me treatment(s) appropriate f the particular symptom(s) (see Notes) The patient has severe gastrointestinal, rheumatologic / mucocutaneous symptoms has not responded adequately to two me treatment appropriate f the particular symptom(s) (see Notes) The patient is experiencing significant loss of quality of life Note: Behcet s disease diagnosed accding to the International Study Group f Behcet s Disease. Lancet 1990;335(8697):1078-80. Quality of life measured using an appropriate quality of life scale such as that published in Gilwth et al J Rheumatol. 2004;31:931-7. Treatments appropriate f the particular symptoms are those that are considered stard conventional treatments f these symptoms, f example intravenous/al steroids other immunosuppressants f ocular symptoms; azathioprine, steroids, thalidomide, interferon alpha ciclospin f mucocutaneous symptoms; colchicine, steroids methotrexate f rheumatological symptoms. I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 10 Fm SA1778 RENEWAL - rheumatoid 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 from baseline a clinically significant response to treatment in the opinion of the physician 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 Infliximab to be administered at doses no greater than 3 mg/kg every 8 weeks RENEWAL - ankylosing spondylitis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Following 12 weeks of infliximab treatment, BASDAI has improved by 4 me points from pre-infliximab baseline on a 10 point scale, by 50%, whichever is less Physician considers that the patient has benefited from treatment that continued treatment is appropriate Infliximab to be administered at doses no greater than 5 mg/kg every 6-8 weeks RENEWAL - psiatic arthritis Applications only from a rheumatologist Practitioner on the recommendation of a rheumatologist. Approvals valid f 6 months. Following 3 to 4 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 The patient demonstrates at least a continuing 30% improvement in active joint count from baseline a clinically significant response to pri infliximab treatment in the opinion of the treating physician Infliximab to be administered at doses no greater than 5 mg/kg every 8 weeks I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 11 Fm SA1778 RENEWAL - severe ocular inflammation Applications from any relevant practitioner. Approvals valid f 12 months. The patient has had a good clinical response following 3 initial doses The patient has had a sustained reduction in inflammation (Stardisation of Uveitis Nomenclature (SUN) criteria < ½+ anteri chamber vitreous cells, absence of active vitreous retinal lesions, resolution of uveitic cystoid macular oedema), following 12 months treatment The patient has a sustained steroid sparing effect, allowing reduction in prednisone to <10mg daily, steroid drops less than twice daily if under 18 years old, following 12 months treatment Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if infliximab is withdrawn. RENEWAL - chronic ocular inflammation Applications from any relevant practitioner. Approvals valid f 12 months. The patient has had a good clinical response following 3 initial doses The patient has had a sustained reduction in inflammation (Stardisation of Uveitis Nomenclature (SUN) criteria < ½+ anteri chamber vitreous cells, absence of active vitreous retinal lesions, resolution of uveitic cystoid macular oedema), following 12 months treatment The patient has a sustained steroid sparing effect, allowing reduction in prednisone to <10mg daily, steroid drops less than twice daily if under 18 years old, following 12 months treatment Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if infliximab is withdrawn. I confirm the above details are crect that in signing this fm I underst I may be audited.
The patient has demonstrated an adequate response to treatment but CDAI sce cannot be assessed The patient has demonstrated an adequate response to treatment but PCDAI sce cannot be assessed Ministry of Health APPLICANT (stamp sticker acceptable) Page 12 Fm SA1778 RENEWAL - Crohn's disease (adults) Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 months. CDAI sce has reduced by 100 points from the CDAI sce when the patient was initiated on infliximab CDAI sce is 150 less Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks ( equivalent) can be used f up to 3 doses if required f secondary non-response to treatment f re-induction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle. Up to 10 mg/kg every 8 weeks ( equivalent) may be used f patients treated with this dose pri to 1 RENEWAL - Crohn's disease (children) Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 months. PCDAI sce has reduced by 10 points from the PCDAI sce when the patient was initiated on infliximab PCDAI sce is 15 less Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks ( equivalent) can be used f up to 3 doses if required f secondary non-response to treatment f re-induction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle. Up to 10 mg/kg every 8 weeks ( equivalent) may be used f patients treated with this dose pri to 1 I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 13 Fm SA1778 RENEWAL - fistulising Crohn's disease Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 months. The number of open draining fistulae have decreased from baseline by at least 50% There has been a marked reduction in drainage of all fistula(e) from baseline (in the case of adult patients, as demonstrated by a reduction in the Fistula Assessment sce), together with less induration patient repted pain Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks ( equivalent) can be used f up to 3 doses if required f secondary non-response to treatment f re-induction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle. Up to 10 mg/kg every 8 weeks ( equivalent) may be used f patients treated with this dose pri to 1 RENEWAL - severe fulminant ulcerative colitis Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 months. Where maintenance treatment is considered appropriate, infliximab should be used in combination with immunomodulats reassessed every 6 months Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks ( equivalent) can be used f up to 3 doses if required f secondary non-response to treatment f re-induction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle. Up to 10 mg/kg every 8 weeks ( equivalent) may be used f patients treated with this dose pri to 1 RENEWAL - severe ulcerative colitis Applications only from a gastroenterologist Practitioner on the recommendation of a gastroenterologist. Approvals valid f 6 months. Patient is continuing to maintain remission the benefit of continuing infliximab outweighs the risks Patient is 18 years older the SCCAI sce has reduced by 2 points me from the SCCAI sce when the patient was initiated on infliximab Patient is under 18 years the PUCAI sce has reduced by 30 points me from the PUCAI sce when the patient was initiated on infliximab Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks ( equivalent) can be used f up to 3 doses if required f secondary non-response to treatment f re-induction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle. Up to 10 mg/kg every 8 weeks ( equivalent) may be used f patients treated with this dose pri to 1 I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 14 Fm SA1778 RENEWAL - plaque psiasis Applications only from a dermatologist Practitioner on the recommendation of a dermatologist. Approvals valid f 6 months. Patient had "whole body" severe chronic plaque psiasis at the start of treatment Following each pri infliximab treatment course the patient has a PASI sce which is reduced by 75% me, is sustained at this level, when compared with the pre-infliximab treatment baseline value Patient had severe chronic plaque psiasis of the face, palm of a h sole of a foot at the start of treatment Following each pri infliximab treatment course the patient has a reduction in the PASI symptom subsces f all 3 of erythema, thickness scaling, to slight better, sustained at this level, as compared to the treatment course baseline values Following each pri infliximab treatment course the patient has a reduction of 75% me in the skin area affected, sustained at this level, as compared to the pre-infliximab treatment baseline value Infliximab to be administered at doses no greater than 5 mg/kg every 8 weeks RENEWAL - neurosarcoidosis Applications only from a neurologist Practitioner on the recommendation of a neurologist. Approvals valid f 18 months. A withdrawal period has been tried the patient has relapsed A withdrawal period has been considered but would not be clinically appropriate There has been a marked reduction in prednisone dose There has been an improvement in MRI appearances Marked improvement in other symptomology I confirm the above details are crect that in signing this fm I underst I may be audited.
APPLICANT (stamp sticker acceptable) Page 15 Fm SA1778 RENEWAL - severe Behcet's disease Applications from any relevant practitioner. Approvals valid f 6 months. Patient has had a good clinical response to initial treatment with measurably improved quality of life Infliximab to be administered at doses no greater than 5 mg/kg every 8 weeks I confirm the above details are crect that in signing this fm I underst I may be audited.