Decision to update the access criteria for infliximab, etanercept, secukinumab, and rituximab

Special Authority for Subsidy

Initial application — (Stills disease - adult-onsetStills disease (AOSD)) only from a rheumatologist any relevant practitioner. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. Either:
      1.1.1  The pPatient has had an initial Special Authority approval for adalimumab and/or tocilizumab for adult-onset Still's disease AOSD; or and
      1.1.2      The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the HML rules; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab and/or tocilizumab; or
      2. The pPatient has received insufficient benefit to meet the renewal criteria from at least a three3-month trial of adalimumab and/or tocilizumab such that they do not meet the renewal criteria for AOSD; or
2. All of the following:
   1. Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19:424-430); and
   2. Patient has tried and not responded to received insufficient benefit from at least 6 months of glucocorticosteroids at a dose of at least 5 mg/kg prednisone-equivalents, non-steroidal anti-inflammatory drugs NSAIDs and methotrexate, unless contraindicated; and
   3. Patient has persistent symptoms of disabling poorly controlled and active disease. 

Renewal — (adult-onset Still's disease) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Applicant is a rheumatologist; or
   2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and
2. The patient has a sustained improvement in inflammatory markers and functional status.

Initial application — (ankylosing spondylitis) only from any rheumatologist relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for ankylosing spondylitis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for ankylosing spondylitis; or
2. All of the following:
   1. Patient has a confirmed diagnosis of ankylosing spondylitis present for more than six months; and
   2. Patient has low back pain and stiffness that is relieved by exercise but not by rest; and
   3. Patient has bilateral sacroiliitis demonstrated by radiologic imaging plain radiographs, CT or MRI scan; and
   4. Patient's ankylosing spondylitis Disease has not responded adequately to treatment with two or more non-steroidal anti-inflammatory drugs (NSAIDs) (unless contraindicated), in combination with anti-ulcer therapy if indicated, while patient was undergoing at least 3 months of a regular exercise regimen for ankylosing spondylitis; and
   5. Either:
   6. Patient has limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by the following Bath Ankylosing Spondylitis Metrology Index (BASMI) measures: a modified Schober's test of less than or equal to 4 cm and lumbar side flexion measurement of less than or equal to 10 cm (mean of left and right); or
   7. Patient has limitation of chest expansion by at least 2.5 cm below the average normal values corrected for age and gender (see Notes); and
   8. A Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 6 on a 01010-point scale completed after 3-month exercise trial before ceasing any previous pharmacological treatment and not more than 1 month before the application.

Notes: The BASDAI must have been determined at the completion of the 3 month exercise trial, but prior to ceasing NSAID treatment and The BASDAI measure must be no more than 1 month old at the time of initial application.
Average normal chest expansion corrected for age and gender:

18-24 years - Male: 7.0 cm; Female: 5.5 cm

25-34 years - Male: 7.5 cm; Female: 5.5 cm

35-44 years - Male: 6.5 cm; Female: 4.5 cm

45-54 years - Male: 6.0 cm; Female: 5.0 cm

55-64 years - Male: 5.5 cm; Female: 4.0 cm

65-74 years - Male: 4.0 cm; Female: 4.0 cm

75+ years - Male: 3.0 cm; Female: 2.5 cm

Renewal — (ankylosing spondylitis) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following: Both:

1.  Either:

1.1  Applicant is a rheumatologist; or

1.2  Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with adalimumab treatment; and

1. Following 12 weeks’ initial treatment and for subsequent renewals, Treatment has resulted in an improvement in BASDAI has improved from pre-treatment baseline of either by at least 4 or more points from pre-treatment baseline on a 10 point 10-point scale, or an improvement in BASDAI of by at least 50%, whichever is less; and
   3 Physician considers that the patient has benefited from treatment and that continued treatment is appropriate; and
2. 4. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Initial application — (arthritis - polyarticular course juvenile idiopathic arthritis) only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either Any of the following:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for polyarticular course juvenile idiopathic arthritis (JIA); and
   2. Either:
      1. 1.2.1 The pPatient has experienced intolerable side effects from adalimumab; or
      2. 1.2.2 The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for polyarticular course JIA; or
         
         2 All of the following:
         2.1 To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
         2.2 Patient has had polyarticular course JIA for 6 months duration or longer; and
         2.3 Any of the following:
2. 2.3.1 At least 5 active joints and at least 3 joints with pain, tenderness or a limited range of motion, pain, or tenderness after a 3-month trial of methotrexate at the maximum tolerated dose, unless contraindicated; or
3. 2.3.2 Moderate or high disease activity (cJADAS10 score of at least 2.5) after a 3-month trial of methotrexate at the maximum tolerated dose, unless contraindicated; or
4. 2.3.3 Low disease activity (cJADAS10 score between 1.1 and 2.5) after a 6-month trial of methotrexate.

Renewal — (arthritis - polyarticular course juvenile idiopathic arthritis) from any relevant practitioner only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and

2. Either:

1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Initial application — (arthritis - oligoarticular course juvenile idiopathic arthritis) only from a named specialist or rheumatologist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Either Any of the following:

1. Both:
   1. 1.1 The pPatient has had an initial Special Authority approval for adalimumab for oligoarticular course juvenile idiopathic arthritis (JIA); and
   2. 1.2 Either:
      1. 1.2.1 The pPatient has experienced intolerable side effects from adalimumab; or
      2. 1.2.2 The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for oligoarticular course JIA; or
         
         2 All of the following:
         2.1 To be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
         2.1 Patient has had oligoarticular course JIA for 6 months duration or longer; and
         
         3 Any of the following:
2. 3.1 At least 2 active joints with pain, tenderness or a limited range of motion, pain, or tenderness after a 3-month trial of methotrexate (at the maximum tolerated dose), unless contraindicated; or
3. 3.2 Moderate or high disease activity (cJADAS10 score greater than 1.5) with poor prognostic features after a 3-month trial of methotrexate (at the maximum tolerated dose), unless contraindicated.; or
   3.3 High disease activity (cJADAS10 score greater than 4) after a 6-month trial of methotrexate.

Renewal — (arthritis - oligoarticular course juvenile idiopathic arthritis) from any relevant practitioner. only from a named specialist, rheumatologist or Practitioner on the recommendation of a named specialist or rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Subsidised as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and

2. Either

1. Following 3 to 4 months’ initial treatment, the patient has at least a 50% decrease in active joint count and an improvement in physician's global assessment from baseline; or
2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count and continued improvement in physician's global assessment from baseline.

Initial application — (pyoderma gangrenosum*) only from any relevant practitioner a dermatologist. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

All of the following: Both:

1. Patient has pyoderma gangrenosum*; and

1. Patient has received insufficient benefit from three 3 months of conventional therapy including a minimum of three 3 pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response. Where conventional pharmaceuticals are contraindicated, a 3 month trial has occurred of those that are not contraindicated; and
2. A mMaximum of 8 doses every 4 months.

Note: Indications marked with * are unapproved indications.

Renewal — (pyoderma gangrenosum) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has shown clinical improvement; and
2. Patient continues to require treatment; and
3. A maximum of 8 doses.

Initial application — (Aarthritis - rheumatoid) only from any relevant practitioner a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The p Patient has had an initial Special Authority approval for adalimumab for rheumatoid arthritis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects; or
      2. The pPatient has received insufficient benefit to meet the renewal criteria for rheumatoid arthritis; or
2. All of the following:
   1. Patient has had rheumatoid arthritis (either confirmed by radiology radiologic imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
   2. Treatment is to be use as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
   3. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate at a maximum tolerated dose (unless contraindicated); and
   4. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate (at maximum tolerated doses unless contraindicated); and
   5. Either:
      1. Patient has tried and not responded to received insufficient benefit from at least 3 three months of methotrexate in combination with the maximum tolerated dose of ciclosporin, unless contraindicated; or
      2. Patient has tried and not responded to received insufficient benefit from at least 3 three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with methotrexate, unless contraindicated; and
   6. Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least 4 four joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip.

Renewal — (Aarthritis - rheumatoid) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both: All of the following:

1. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and

1. Either:
   1. Following initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
2. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Initial application — (severe chronic pPlaque psoriasis) only from a dermatologist or any relevant practitioner on the recommendation of a dermatologist. Approvals valid for 4 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for severe chronic plaque psoriasis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from etanercept to meet the renewal criteria for severe chronic plaque psoriasis; or
2. All of the following:
   1. Any of the following:
      1. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 10 where lesions have been present for at least 6 months from the time of initial diagnosis; or
      2. Patient has severe chronic plaque psoriasis of the face, or palm of a hand, or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; or
      3. Patient has severe chronic localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months form the time of initial diagnosis, and with a Dermatology Life Quality Index (DLQI) score greater than 10; and
   2. Patient has tried, but had an inadequate response (see Note) to received insufficient benefit from (see Note), or has experienced intolerable side effects from, at least three 3 of the following at maximum tolerated doses (unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
      1. A PASI assessment or Dermatology Quality of Life Index (DLQI) assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than within 1 month of stopping following cessation of each prior treatment course that treatment; and
      2. The most recent PASI or DLQI assessment is no more than within 1 month old at the time of before the application

Note: "Inadequate response Insufficient benefit " is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 10, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand, foot, genital or flexural areas at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and for the face, palm of a hand or sole of a foot the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, aAs assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.

Renewal — (severe chronic pPlaque psoriasis) from any relevant practitioner. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Any of the following:
   1. Both:
      1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
      2. Either:
         1. Following each prior etanercept treatment course the pPatient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-treatment baseline value; or
         2. Following each prior etanercept treatment course the pPatient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, when compared with the pre-treatment baseline value; or
   2. Both:
      1. Patient had severe chronic plaque psoriasis of the face, or palm of a hand, or sole of a foot at the start of treatment; and
      2. Either:
         1. Following each prior etanercept treatment course the pPatient has a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-treatment course baseline values; or
         2. Following each prior etanercept treatment course the pPatient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
   3. Both:
      1. Patient has severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
      2. Either:
         1. The pPatient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
         2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to the pre-treatment baseline DLQI prior to commencing etanercept; and
2. Etanercept to be administered at doses no greater than Maximum dose 50 mg every 7 days.

Note: A treatment course is defined as a minimum of 12 weeks etanercept treatment

Initial application — (undifferentiated spondyloarthritis*) only from a rheumatologist any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1. Patient has undifferentiated peripheral spondyloarthritis* with active peripheral joint arthritis in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder, or hip; and
2. Patient has tried and not responded to received insufficient benefit from at least three 3 months of oral or parenteral each of methotrexate, sulfasalazine, and leflunomide at a dose of at least 20 mg weekly or a maximum tolerated doses, unless contraindicated; and
   
   3. Patient has tried and not responded to at least three months of sulfasalazine at a dose of at least 2 g per day (or maximum tolerated dose); and
   
   4. Patient has tried and not responded to at least three months of leflunomide at a dose of up to 20 mg daily (or maximum tolerated dose); and
3. 5. Any of the following:
   1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
   2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour measured no more than within one month prior to the date of this before the application; or
   3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than three months.

Note: Indications marked with * are unapproved indications.

Renewal — (undifferentiated spondyloarthritis*) from any relevant practitioner only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following Both:

1. Either:

1.1  Applicant is a rheumatologist; or

1.2  Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with etanercept treatment; and

1. Either:
   1. Following 3 to 4 months’ initial treatment, the patient has experienced at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. The pPatient demonstrates has experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior etanercept treatment in the opinion of the treating physician; and
2. Etanercept to be administered at doses no greater than Maximum dose 50 mg dose every 7 days.

Special Authority for Subsidy

Initial application — (ankylosing spondylitis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist any relevant practitioner. Approvals valid for 3 6 months for applications meeting the following criteria:

Both All of the following:

1. Patient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. Following 12 weeks of adalimumab and/or etanercept treatment, the pPatient has received insufficient benefit did not to meet the renewal criteria for adalimumab and/or etanercept for ankylosing spondylitis; and
3. Following initial induction doses, maximum dose 5mg/kg every 6-8 weeks.

Renewal — (ankylosing spondylitis) only from any relevant practitioner a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following: Both:

1. Following 12 weeks of infliximab treatment, BASDAI has improved from pre-treatment baseline either by at least 4 or more points from pre-infliximab baseline on a 10 point 10-point scale, or by at least 50%, whichever is less; and
2. Physician considered that the patient has benefited from treatment and that continued treatment is appropriate; and
3. Infliximab is to be administered at doses no greater than Maximum dose 5mg/kg every 6-8 weeks.

Initial application - (chronic ocular inflammation – chronic*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority for adalimumab for chronic ocular inflammation; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for chronic ocular inflammation; or
2. Both:
   1. Patient has severe uveitis with a severe risk of vision loss uncontrolled with by treatment with of corticosteroids and other immunosuppressants with a severe risk of vision loss; and
   2. Any of the following:
      1. Patient is 18 years or older and treatment with at least two other immunomodulatory agents has proven been ineffective or are contraindicated; or
      2. Patient is under 18 years and treatment with methotrexate has proven been ineffective, is contraindicated or is not tolerated at a therapeutic dose; or
      3. Patient is under 8 years and treatment with corticosteroids or methotrexate has proven been ineffective, is contraindicated or is not tolerated at a therapeutic dose; or disease requires control to prevent irreversible vision loss prior to achieving a therapeutic dose of methotrexate.

Note: Indications marked with * are unapproved indications.

Renewal (chronic ocular inflammation – chronic*) from any relevant practitioner. Approvals valid for 2 years 12 months for applications meeting the following criteria:

Any of the following:

1. The pPatient has received had a good clinical response following 3 initial doses; or
2. Following each 2 year 12 month treatment period, the patient has experienced had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
3. Following each 2 year 12 month treatment period, the patient has a sustained corticosteroid sparing effect, allowing reduction in prednisone to < 10mg daily, or corticosteroid drops less than twice daily if under 18 years old.

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.

Indications marked with * are unapproved indications

Initial application — (plaque psoriasis) only from a dermatologist or any relevant practitioner on the recommendation of a dermatologist any relevant practitioner.

Approvals valid for 3 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient had an initial Special Authority approval for adalimumab, etanercept or secukinumab for severe chronic plaque psoriasis; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab, etanercept or secukinumab; or
      2. The pPatient has received insufficient benefit from adalimumab, etanercept or secukinumab to meet the renewal criteria for adalimumab, etanercept or secukinumab for severe chronic plaque psoriasis; or
2. All of the following:
   1. Any of the following:
      1. Patient has "whole body" severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 10 where lesions have been present for at least 6 months from the time of initial diagnosis; or
      2. Patient has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; or
      3. Patient has severe chronic localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months from the time of initial diagnosis, and with a Dermatology Life Quality Index (DLQI) score greater than 10; and
   2. Patient has tried, but had an inadequate response received insufficient benefit (see Note) or has experienced intolerable side effects from, at least three 3 of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
   3. A PASI assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than within 1 month following cessation of each prior treatment course of stopping that treatment; and
   4. The most recent PASI assessment is within 1 month before the application.

Note: "Inadequate response Insufficient benefit" is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 10, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand, foot, genital or flexural areas at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and for the face, palm of a hand or sole of a foot the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.

Renewal — (plaque psoriasis) from any relevant practitioner. Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Any of the following:
   1. Both:
      1. Patient had "whole body" severe chronic plaque psoriasis at the start of treatment; and
      2. Following each prior infliximab treatment course the pPatient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-infliximab treatment baseline value; or
   2. Both:
      1. Patient had severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot at the start of treatment; and
      2. Either:
         1. Following each prior infliximab treatment course pPatient has a reduction in the PASI symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-infliximab treatment course baseline values; or
         2. Following each prior infliximab treatment course the pPatient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-infliximab treatment baseline value; or
   3. Both:
      1. Patient had severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
      2. Either:
         1. The pPatient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-treatment baseline value; or
         2. The pPatient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to the pre-infliximab baseline DLQI prior to commencing infliximab; and
2. Infliximab to be administered at doses no greater than Maximum dose 5mg/kg every 8 weeks.

Initial application — (arthritis - psoriatic arthritis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist any relevant practitioner.

Approvals valid for 4 6 months for applications meeting the following criteria:

Both All of the following:

1. The pPatient has had an initial Special Authority approval for adalimumab, and/or etanercept, and/or secukinumab for psoriatic arthritis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from adalimumab and/or etanercept and/or secukinumab; or
   2. Following 3-4 months' initial treatment with adalimumab and/or etanercept and/or secukinumab, the pPatient has received insufficient benefit did not to meet the renewal criteria for adalimumab, and/or etanercept and/or secukinumab for psoriatic arthritis; and
3. Following initial induction doses, maximum dose 5mg/kg every 8 weeks.

Renewal — (arthritis - psoriatic arthritis) only from any relevant practitioner a rheumatologist or Practitioner on the recommendation of a rheumatologist.

Approvals valid for 2 years 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. The patient demonstrates at At least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior infliximab treatment in the opinion of the treating physician; and
2. Infliximab to be administered at doses no greater than Maximum dose 5 mg/kg every 8 weeks.

Initial application — (arthritis - rheumatoid arthritis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist any relevant practitioner.

Approvals valid for 4 6 months for applications meeting the following criteria:

All of the following:

1. The pPatient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. Following at least a four month trial of adalimumab and/or etanercept, the The pPatient has received insufficient benefit did not to meet the renewal criteria for adalimumab and/or etanercept rheumatoid arthritis; and
3. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance. Following initial induction doses, maximum dose 3mg/kg every 8 weeks.

Renewal — (arthritis - rheumatoid arthritis) only from any relevant practitioner a rheumatologist or Practitioner on the recommendation of a rheumatologist.

Approvals valid for 2 years 6 months for applications meeting the following criteria:

All of the following Both:

1. Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
2. Either:
   1. Following 3 to 4 months' initial treatment, the patient has experienced at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. The pPatient demonstrates has experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
3. Infliximab to be administered at doses no greater than Maximum dose 3 mg/kg every 8 weeks.

Initial application — (severe Behcet's disease) from any relevant practitioner. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

All of the following:

1. The pPatient has severe Behcet's disease which is significantly impacting the patient’s their quality of life (see Notes); and
2. Either:
   1. The pPatient has severe ocular, neurological and/or vasculitic symptoms and has not responded adequately to received insufficient benefit from one 1 or more treatment(s) appropriate for the particular symptom(s) (see Notes); or
   2. The pPatient has severe gastrointestinal, rheumatologic and/or mucocutaneous symptoms and has not responded adequately to received insufficient benefit from 2 two or more treatments appropriate for the particular symptom(s) (see Notes); and
3. Following initial loading doses, maximum dose 5mg/kg every 8 weeks.
   
   4. The patient is experiencing significant loss of quality of life.

Notes: Behcet’s disease diagnosed according to the International Study Group for 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 Gilworth et al J Rheumatol. 2004;31:931-7. Treatments appropriate for the particular symptoms are those that are considered standard conventional treatments for these symptoms, for example intravenous/oral steroids and other immunosuppressants for ocular symptoms; azathioprine, steroids, thalidomide, interferon alpha and ciclosporin for mucocutaneous symptoms; and colchicine, steroids and methotrexate for rheumatological symptoms.

Renewal — (severe Behcet's disease) from any relevant practitioner.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Patient has had a good clinical response to initial treatment with measurably improved quality of life; and
2. Infliximab to be administered at doses no greater than 5 mg/kg every 8 weeks.

Initial application — (severe ocular inflammation – severe*) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

Either:

1. Both:
   1. The pPatient has had an initial Special Authority approval for adalimumab for severe ocular inflammation; and
   2. Either:
      1. The pPatient has experienced intolerable side effects from adalimumab; or
      2. The pPatient has received insufficient benefit from adalimumab to meet the renewal criteria for adalimumab for severe ocular inflammation; or
2. Both:
   1. Patient has severe, vision-threatening ocular inflammation requiring rapid control; and
   2. Any of the following:
      1. Treatment with high-dose IV corticosteroids (intravenous methylprednisolone) followed by high dose oral corticosteroids has proven been ineffective at controlling symptoms; or
      2. Patient developed new inflammatory symptoms while receiving high dose corticosteroids; or
      3. Patient is aged under 8 years and treatment with high dose oral corticosteroids and other immunosuppressants has proven been ineffective at controlling symptoms; or
      4. High dose corticosteroids are contraindicated.

Note: Indications marked with * are unapproved indications.

Renewal — (severe ocular inflammation – severe*) from any relevant practitioner. Approvals valid for 2 years 12 months for applications meeting the following criteria:

Any of the following:

1. The pPatient has had received a good clinical response following 3 initial doses; or
2. Following each 2 year 12 month treatment period, the patient has experienced had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
3. Following each 2 year 12 month treatment period, patient has a sustained corticosteroid sparing effect, allowing reduction in prednisone to < 10mg daily, or corticosteroid drops less than twice daily if under 18 years old.

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.

Indications marked with * are unapproved indications.

Initial application — (pyoderma gangrenosum*) only from any relevant practitioner a dermatologist. Approvals valid without further renewal unless notified for 4 months for applications meeting the following criteria:

All of the following: Both:

1. Patient has pyoderma gangrenosum*; and

1. 2. Patient has received insufficient benefit from three 3 months of conventional therapy including a minimum of three 3 pharmaceuticals (e.g. prednisone, ciclosporin, azathioprine, or methotrexate) and not received an adequate response. Where conventional pharmaceuticals are contraindicated, a 3-month trial has occurred of those that are not contraindicated; and
2. A mMaximum of 8 doses every 4 months.

Note: Indications marked with * are unapproved indications.

Renewal — (pyoderma gangrenosum) only from a dermatologist or Practitioner on the recommendation of a dermatologist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1. Patient has shown clinical improvement; and
2. Patient continues to require treatment; and
3. A maximum of 8 doses.

Special Authority for Subsidy

Initial application — (Nneuromyelitis Ooptica Sspectrum Ddisorder (NMOSD)*) only from any relevant practitioner a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria:

BothAll of the following:

1. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m² administered weekly for four weeks Cumulative dose up to 1,500 mg/m² body surface area up to 2,000 mg total per cycle; and
2. Either
   1. The pPatient has experienced a severe episode or attack of NMOSD (rapidly progressing symptoms and with supporting supportive clinical investigations supportive of a severe attack of NMOSD); or
   2. All of the following:
      1. The pPatient has experienced a breakthrough attack of NMOSD; and
      2. The pPatient is receiving treatment with mycophenolate unless contraindicated or not tolerated; and
      3. The pPatient is receiving treatment with corticosteroids unless contraindicated or not tolerated; and
3. Each treatment cycle at least 6 months apart.

Note: Indications marked with * are unapproved indications.

Renewal — Neuromyelitis Optica Spectrum Disorder (NMOSD) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

1. One of the following dose regimens is to be used: 2 doses of 1,000 mg rituximab administered fortnightly, or 4 doses of 375 mg/m² administered weekly for four weeks; and
2. The patient has responded to the most recent course of rituximab; and
3. The patient has not received rituximab in the previous 6 months.

Initial application — (Severe Rrefractory Mmyasthenia Ggravis*) only from a neurologist or medical any relevant practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:

Both:

1. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart; and Cumulative dose up to 1,500 mg/m² body surface area up to 2,000 mg total per cycle; and
2. Either
   1. Treatment with corticosteroids and at least one other immunosuppressant for at least a minimum period of 12 months has been ineffective; or
   2. Both:
      1. Treatment with at least one other immunosuppressant for a period of at least 12 months; and
      2. Corticosteroids have been trialled for at least 12 months and have been discontinued due to unacceptable side effects.

Note: Indications marked with * are unapproved indications.

Renewal — (Severe Rrefractory Mmyasthenia Ggravis*) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

1. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart; and Cumulative dose up to 1,500 mg/m² body surface area up to 2,000 mg total per cycle; and
2. An initial response lasting at least 12 months was demonstrated; and
3. Either:
   1. The pPatient has relapsed despite treatment with corticosteroids and at least one other immunosuppressant for a period of at least 12 months; or
   2. Both:
      1. The pPatient’s myasthenia gravis has relapsed despite treatment with at least one immunosuppressant for a period of at least 12 months; and
      2. Corticosteroids have been trialled for at least 12 months and have been discontinued due to unacceptable side effects.

Note: Indications marked with * are unapproved indications.

Initial application — (Steroid dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS)) only from a nephrologist or any relevant Ppractitioner on the recommendation of a nephrologist. Approvals valid for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient is a child with SDNS* or FRNS*; and
2. Treatment with corticosteroids, ciclosporin, and mycophenolate for at least a period of 3 months for each agent has been ineffective, not tolerated, or is contraindicated or associated with evidence of steroid toxicity; and
   3.  Treatment with ciclosporin for at least a period of 3 months has been ineffective and/or discontinued due to unacceptable side effects; an
   4.  Treatment with mycophenolate for at least a period of 3 months with no reduction in disease relapses; and
3. The total rituximab dose used would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

Note: Indications marked with * are unapproved indications.

Renewal — (Steroid dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS)) only from a nephrologist or any relevant Ppractitioner on the recommendation of a nephrologist. Approvals valid for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient who was previously treated with rituximab for nephrotic syndrome*; and
2. Treatment with rituximab was previously successful and has demonstrated sustained response for greater than 6 months, but the condition has relapsed and the patient now requires repeat treatment; and
3. The total rituximab dose used would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

Note: Indications marked with * are unapproved indications.

Initial application — (Steroid resistant nephrotic syndrome (SRNS)*) only from a nephrologist or any relevant Ppractitioner on the recommendation of a nephrologist. Approvals valid for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient is a child with SRNS* where and treatment with corticosteroids, and ciclosporin and tacrolimus for at least 3 months for each agent have has been ineffective, not tolerated, or is contraindicated; and
   2.  Treatment with tacrolimus for at least 3 months has been ineffective; and
2. 3. Genetic causes of nephrotic syndrome have been excluded; and
3. 4. The total rituximab dose used per cycle would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

Note: Indications marked with * are unapproved indications.

Renewal — (Steroid resistant nephrotic syndrome (SRNS)*) only from a nephrologist or Practitioner on the recommendation of a nephrologist. Approvals valid for 8 weeks for applications meeting the following criteria:

All of the following:

1. Patient who was previously treated with rituximab for nephrotic syndrome*; and
2. Treatment with rituximab was previously successful and has demonstrated sustained response for greater than 6 months, but the condition has relapsed and the patient now requires repeat treatment; and
3. The total rituximab dose used would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks.

Note: Indications marked with * are unapproved indications.

Initial application — (thrombotic thrombocytopenic purpura (TTP)*) only from a haematologist or any relevant Ppractitioner on the recommendation of a haematologist. Approvals valid for without further renewal unless notified 8 weeks for applications meeting the following criteria:

BothAll of the following:

1. The total rituximab dose used per cycle would not exceed the equivalent of 375 mg/m² of body surface area per week for a total of 4 weeks; and
2. Each treatment cycle at least 6 months apart; and
3. Either
   1. Patient has thrombotic thrombocytopenic purpura* and has experienced progression of clinical symptoms or persistent thrombocytopenia despite plasma exchange; or
   2. Patient has acute idiopathic thrombotic thrombocytopenic purpuraTTP* with neurological or cardiovascular pathology.

Note: Indications marked with * are unapproved indications.

Renewal — (thrombotic thrombocytopenic purpura (TTP)) only from a haematologist or Practitioner on the recommendation of a haematologist. Approvals valid for 8 weeks for applications meeting the following criteria.

All of the following:

1. Patient was previously treated with rituximab for thrombotic thrombocytopenic purpura*; and
2. An initial response lasting at least 12 months was demonstrated; and
3. Patient now requires repeat treatment; and
4. The total rituximab dose used would not exceed the equivalent of 375 mg/m2 of body surface area per week for a total of 4 weeks

Note: Indications marked with * are unapproved indications.

Initial application — (treatment refractory systemic lupus erythematosus (SLE)*) only from a rheumatologist, nephrologist or any relevant PpPractitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid without further renewal unless notified for 7 months for applications meeting the following criteria:

All of the following:

1. The pPatient has severe, immediately life- or organ-threatening SLE*; and
2. The disease condition has been proved refractory to treatment with corticosteroids at a dose of at least 1 mg/kg unless contraindicated; and
3. The disease condition has relapsed following prior treatment for at least 6 months with maximal tolerated doses of azathioprine, mycophenolate mofetil, and high dose cyclophosphamide, or cyclophosphamide is contraindicated; and
4. Initial treatment Mmaximum of four 1000 mg infusions of rituximab; and
5. Treatment for relapse following initial partial response to rituximab up to a maximum of two 1000 mg infusions every 6 months.

Note: Indications marked with * are unapproved indications.

Renewal — (treatment refractory systemic lupus erythematosus (SLE)) only from a rheumatologist, nephrologist, or Practitioner on the recommendation of a rheumatologist or nephrologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s SLE* achieved at least a partial response was achieved from to the previous round of prior rituximab treatment; and
2. The disease has subsequently relapsed.; and
3. Maximum of two 1000 mg infusions of rituximab

Note: Indications marked with * are unapproved indications.

Initial application — (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for without further renewal unless notified 12 months for applications meeting the following criteria.

All of the following:

1.  Patient has confirmed antisynthetase syndrome; and

1. 2. Patient has severe, immediately life- or organ-threatening disease, including interstitial lung disease; and
2. 3. Either:
   1. 3.1Treatment with at least 3 immunosuppressants (oral corticosteroids, cyclophosphamide, methotrexate, mycophenolate, ciclosporin, azathioprine) has not be been ineffective at controlling active disease; or
   2. 3.2 Rapid treatment is required due to for life threatening complications.; and
3. 4. Maximum of four two 1,0001000 mg infusions of rituximab every 6 months.

Renewal — (severe antisynthetase syndrome) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in inflammatory markers, muscle strength, and pulmonary function; and
2. The patient has not received rituximab in the previous 6 months.; and
3. Maximum of two cycles of 2 × 1,000mg infusions of rituximab given two weeks apart

Initial application – (severe chronic inflammatory demyelinating polyneuropathy (CIPD)*) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria.

All of the following:

1. Patient has severe chronic inflammatory demyelinating polyneuropathy (CIPD); and

1. Either:
   1. 2.1  Both:
      1. 2.1.1   Treatment with corticosteroids and intravenous immunoglobulin and/or plasma exchange has not been ineffective at controlling active disease, is not tolerated, or is contraindicated; and
      2. 2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) is not tolerated or has not been ineffective at controlling active disease. If an immunosuppressant is contraindicated, a trial has occurred of one of those which is not contraindicated (unless all are contraindicated); or
   2. 2.2  Rapid treatment is required due to for life threatening complications; and
2. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart. Cumulative dose up to 1500 mg/m² body surface area up to 2000 mg total per cycle; and
3. Each treatment cycle at least 6 months apart.

Note: Indications marked with * are unapproved indications

Renewal – (severe chronic inflammatory demyelinating polyneuropathy) only from a neurologist or any medical practitioner on the recommendation of a neurologist Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function compared to baseline; and
2. The patient has not received rituximab in the previous 6 months; and
3. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Initial application – (anti-NMDA receptor autoimmune encephalitis*) only from a neurologist or any relevant medical practitioner on the recommendation of a neurologist. Approvals valid without further renewal unless notified for 6 months for applications meeting the following criteria.

All of the following:

1. Patient has severe anti-NMDA receptor autoimmune encephalitis; and

1. 2 Either:
   1. 2.1  Both:
      1. 2.1.1   Treatment with corticosteroids and intravenous immunoglobulin and/or plasma exchange has not been effective at controlling has been ineffective controlling active disease, is not tolerated or is contraindicated; and
      2. 2.1.2   At least one other immunosuppressant (cyclophosphamide, ciclosporin, tacrolimus, mycophenolate) has not been effective at controlling has been ineffective controlling active disease, is not tolerated or is contraindicated; or
   2. 2.2 Rapid treatment is required due to for life threatening complications; and
2. One of the following dose regimens is to be used 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000mg doses given two weeks apart Cumulative dose up to 1500 mg/m² body surface area up to 2000 mg total per cycle; and
3. Each treatment cycle at least 6 months apart.

Note: Indications marked with * are unapproved indications.

Renewal – (anti-NMDA receptor autoimmune encephalitis) only from a neurologist or any medical practitioner on the recommendation of a neurologist. Approvals valid for 6 months for applications meeting the following criteria.

All of the following:

1. Patient’s disease has responded to the previous rituximab treatment with demonstrated improvement in neurological function; and
2. The patient has not received rituximab in the previous 6 months; and
3. The patient has experienced a relapse and now requires further treatment; and
4. One of the following dose regimens is to be used: 375 mg/m² of body surface area per week for a total of four weeks, or 500 mg once weekly for four weeks, or two 1,000 mg doses given two weeks apart.

Initial application — (Mmembranous nephropathy) only from a nephrologist or any relevant practitioner on the recommendation of a nephrologist. Approvals valid without further renewal unless notified for 6 weeks for applications meeting the following criteria.

All of the following:

1. Either:
   1. Patient has biopsy-proven primary/idiopathic membranous nephropathy*; or
   2. Patient has PLA2 antibodies with no evidence of secondary cause, and an eGFR of >60 ml/min/1.73m²; and
2. Patient remains at high risk of progression to end-stage kidney disease despite more than 3 months of treatment with conservative measures (see Note) that include (unless contraindicated or the patient has experienced intolerable side effects) renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents; and
3. The total rituximab dose per cycle would not exceed the equivalent of 375mg/m2 of body surface area per week for a total of 4 weeks; and
4. Subsequent retreatment only for disease relapse or after partial response.

Note: Indications marked with * are unapproved indications.

Renewal — (Membranous nephropathy) only from a nephrologist or any relevant practitioner on the recommendation of a nephrologist. Approvals valid for 6 weeks for applications meeting the following criteria.

All of the following:

1. Patient was previously treated with rituximab for membranous nephropathy*; and
2. Either:
   1. Treatment with rituximab was previously successful, but the condition has relapsed, and the patient now requires repeat treatment; or
   2. Patient achieved partial response to treatment and requires repeat treatment (see Note); and
3. The total rituximab dose used would not exceed the equivalent of 375 mg/m2 of body surface area per week for a total of 4 weeks

Note:

a) Indications marked with * are unapproved indications.

b) High risk of progression to end-stage kidney disease defined as >5 g/day proteinuria.

c) Conservative measures include renin-angiotensin system blockade, blood-pressure management, dietary sodium and protein restriction, treatment of dyslipidaemia, and anticoagulation agents unless contraindicated or the patient has experienced intolerable side effects.

d) Partial response defined as a reduction of proteinuria of at least 50% from baseline, and between 0.3 grams and 3.5 grams per 24 hours.

Special Authority for Subsidy

Initial application — (arthritis - rheumatoid arthritis - TNF inhibitors contraindicated) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:                                                                            

1. Treatment with a Tumour Necrosis Factor alpha inhibitor is contraindicated; and
2. Patient has had severe and active erosive rheumatoid arthritis (either confirmed by radiology radiologic imaging, or the patient is cyclic citrullinated peptide (CCP) antibody positive) for six months duration or longer; and
3. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose, unless contraindicated; and
4. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate in combination with sulfasalazine and hydroxychloroquine sulphate (at maximum tolerated doses), unless contraindicated; and
5. Any of the following Either:
   1. Patient has tried and Disease has not responded to at least 3three months of oral or parenteral methotrexate in combination with the maximum tolerated dose of ciclosporin, unless contraindicated; or
      5.2  Patient has tried and not responded to at least three months of oral or parenteral methotrexate in combination with intramuscular gold; or
   2. Patient has tried and Disease has not responded to at least 3three months of therapy at the maximum tolerated dose of leflunomide alone or in combination with oral or parenteral methotrexate, unless contraindicated; and
6. Either:
   1. Patient has persistent symptoms of poorly controlled and active disease in at least 20 swollen, tender joints; or
   2. Patient has persistent symptoms of poorly controlled and active disease in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder, or hip; and
7. Either:
   1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
   2. C-reactive protein levels CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than 3three months; and
      8 Either:
         8.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
         8.2 Patient is contraindicated to both m Methotrexate and leflunomide are contraindicated, requiring use of rituximab monotherapy to be used; and
8. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Initial application — (arthritis - rheumatoid arthritis - prior TNF inhibitor use) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

1 Both:

1. 1.1 The pPatient has had an initial community Special Authority approval for at least one of etanercept and/or adalimumab for rheumatoid arthritis; and
2. 1.2 Either:
   1. 1.2.1 The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. 1.2.2 Following at least a four4 month trial of adalimumab and/or etanercept, the patient did not meet the renewal criteria for adalimumab and/or etanercept for rheumatoid arthritis were not met; and
      
      2 Either:
         2.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
         2.2 Patient is contraindicated to both m Methotrexate and leflunomide are contraindicated, requiring rituximab monotherapy to be used.; and
3. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Renewal — (arthritis - rheumatoid arthritis – retreatment in ‘partial responders'’ for people who have experienced a partial response to rituximab) from any relevant practitioner. Approvals valid for 4 months 12 months for applications meeting the following criteria:

All of the following:

1. Any of the following:
   1. At 4 months fFollowing the initial course of rituximab infusions the patient had experienced between a 30% and 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. At 4 months fFollowing the second course of rituximab infusions the patient had experienced at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   3. At 4 months fFollowing the third and subsequent courses of rituximab infusions, the patient demonstrates experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
   
   3.  Either:
      3.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
      3.2 Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy. to be used.; and
3. Maximum of two 1,000 1000 mg infusions of rituximab given two weeks apart.

Renewal — (arthritis - rheumatoid arthritis – retreatment in for people who experience a response ‘responders’ to rituximab) from any relevant practitioner. Approvals valid for 4 months 12 months for applications meeting the following criteria:

All of the following:

1. Either:
   1. At 4 months fFollowing the initial course of rituximab infusions the patient had experienced at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. At 4 months fFollowing the second and subsequent courses of rituximab infusions, the patient demonstrates experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and
2. Rituximab re-treatment not to be given within 6 months of the previous course of treatment; and
   
   3 Either:
      3.1 Rituximab to be used as an adjunct to methotrexate or leflunomide therapy; or
      3.2 Patient is contraindicated to both methotrexate and leflunomide, requiring rituximab monotherapy to be used; and
   
   
3. Maximum of two 1,000 1000 mg infusions of rituximab per course given two weeks apart.

Initial application — (ankylosing spondylitis – second-line biologic) only from a rheumatologist or any relevant pPractitioner on the recommendation of a rheumatologist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. The pPatient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
2. Either:
   1. The pPatient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or
   2. Following 12 weeks of adalimumab and/or etanercept treatment, the pPatient has received insufficient benefit to did not meet the renewal criteria for adalimumab and/or etanercept for ankylosing spondylitis.

Renewal — (ankylosing spondylitis – second-line biologic) only from any relevant practitioner a rheumatologist or medical practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following Both:

1. Following 12 weeks initial treatment of secukinumab treatment, BASDAI has improved by 4 or more points from the pre-secukinumab baseline either by at least 4 points on a 10 point 10-point scale, or by at least 50%, whichever is less; and
   2.  Physician considers that the patient has benefitted from treatment and that continued treatment is appropriate; and
2. Secukinumab to be administered at doses no greater than Maximum dose 300 mg monthly.

Initial application — (arthritis - psoriatic arthritis) only from a rheumatologist or any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

1. Both:
   1. Patient has had an initial Special Authority approval for adalimumab, etanercept or infliximab for psoriatic arthritis; and
   2. Either:
      1. Patient has experienced intolerable side effects from adalimumab, etanercept or infliximab; or
      2. Patient has received insufficient benefit from adalimumab, etanercept or infliximab to meet the renewal criteria for adalimumab, etanercept or infliximab for psoriatic arthritis; or
2. All of the following:
   2.1  Patient has had severe active psoriatic arthritis for six months duration or longer; and
   1. Patient has tried and not responded to received insufficient benefit from at least three 3 months of oral or parenteral methotrexate at a dose of at least 20 mg weekly or a maximum tolerated dose unless contraindicated; and
   2. Patient has tried and not responded to received insufficient benefit from at least three 3 months of sulfasalazine at a dose of at least 2 g per day or leflunomide at a dose of up to 20 mg daily (or maximum tolerated doses) unless contraindicated; and
   3. Either:
      1. Patient has persistent symptoms of poorly controlled and active disease in at least 15 swollen, tender joints; or
      2. Patient has persistent symptoms of poorly controlled and active disease in at least four 4 joints from the following: wrist, elbow, knee, ankle, and either shoulder or hip; and
   4. Any of the following:
      1. Patient has a C-reactive protein CRP level greater than 15 mg/L measured no more than within one month prior to the date of this before the application; or
      2. Patient has an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour measured within one month before the application; or
      3. ESR and CRP not measured as patient is currently receiving prednisone therapy at a dose of greater than 5 mg per day and has done so received for more than three 3

Renewal — (arthritis - psoriatic arthritis) only from any relevant practitioner a dermatologist or medical practitioner on the recommendation of a dermatologist.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Following 3 to 4 months' initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
   2. The patient demonstrates At least a continuing 30% improvement in active joint count from baseline and a clinically significant response to prior secukinumab treatment in the opinion of the treating physician; and
2. Secukinumab to be administered at doses no greater than Maximum dose 300 mg monthly

The current initial Special Authority criteria for secukinumab for severe chronic plaque psoriasis first line biologic and the initial Special Authority criteria for secukinumab for plaque psoriasis second line biologic will be removed and replaced with the following:

Initial application — (plaque psoriasis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either: 

1. All of the following:
   1. Any of the following:
      1. Patient has "whole body" plaque psoriasis with a PASI score of greater than 10, where lesions have been present for at least 6 months from the time of initial diagnosis; or
      2. Patient has plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; or
      3. Patient has localised genital or flexural plaque psoriasis where the plaques or lesions have been present for at least 6 months from the time of initial diagnosis, and with a DLQI score greater than 10; and
   2. Patient has received insufficient benefit (see Note) or has experienced intolerable side effects from at least 3 of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and
   3. A PASI assessment or DLQI assessment has been completed for the most recent prior treatment course, within 1 month of stopping that treatment; and
   4. The most recent PASI or DQLI assessment is within 1 month before the application; or
2. All of the following:
   1. Patient has had a Special Authority approval for adalimumab, etanercept, or infliximab, for plaque psoriasis; and
   2. Either:
      1. Patient has experienced intolerable side effects; or
      2. Patient has received insufficient benefit to meet the renewal criteria for plaque psoriasis; and
   3. A PASI assessment or DLQI assessment has been completed for the most recent prior treatment within 1 month of stopping that treatment; and
   4. The most recent PASI or DQLI assessment is within 1 month before the application.

Note: A treatment course is defined as a minimum of 12 weeks of treatment. "Insufficient benefit" is defined as: for whole body plaque psoriasis, a PASI score of greater than 10; for plaque psoriasis of the face, hand, foot, genital or flexural areas, at least 2 of the 3 PASI symptom sub scores for erythema, thickness and scaling are rated as severe or very severe, and for the face, palm of a hand or sole of a foot the skin area affected is 30% or more of the face, palm of a hand or sole of a foot. As assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment.

Special Authority for Subsidy

Renewal — (severe chronic plaque psoriasis – first and second-line biologic) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Any of the following:
   1. Patient’s PASI score has reduced by 75% or more (PASI 75) as compared to pre-secukinumab baseline PASI prior to commencing secukinumab; or
   2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to pre-secukinumab baseline DLQI prior to commencing secukinumab; or
   3.  Both:
      1. Patient had severe chronic localised genital or flexural plaque psoriasis at the start of treatment; and
      2. Either:
         1. Patient has experienced a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-secukinumab treatment baseline value; or
         2. Patient has a Dermatology Quality of Life Index (DLQI) improvement of 5 or more, as compared to pre-secukinumab baseline DLQI prior to commencing secukinumab; and
2. Secukinumab to be administered at a Maximum dose of 300 mg monthly.