Proposed changes to infliximab access criteria

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Ankylosing spondylitis

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

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

All of the following:

Patient has had a Special Authority approval for adalimumab or etanercept for ankylosing spondylitis; and
Either:
1. Patient has experienced intolerable side effects; or
2. Patient has received insufficient benefit to meet the renewal criteria for ankylosing spondylitis; and
Following initial induction doses, maximum dose 5mg/kg every 6-8 weeks.

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

BASDAI has improved from pre-treatment baseline either by at least 4 points on a 10-point scale, or by at least 50%; and
Maximum dose 5mg/kg every 6-8 weeks.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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:

Patient has had an initial Special Authority approval for adalimumab and/or etanercept for ankylosing spondylitis; and
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
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:

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
Physician considered that the patient has benefited from treatment and that continued treatment is appropriate; and
Infliximab is to be administered at doses no greater than Maximum dose 5mg/kg every 6-8 weeks.

Ocular inflammation – chronic

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

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

Either:

Both:
1. Patient has had a Special Authority for adalimumab for chronic ocular inflammation; and
2. Either:
  1. Patient has experienced intolerable side effects; or
  2. Patient has received insufficient benefit to meet the renewal criteria for chronic ocular inflammation; or
Both:
1. Patient has severe uveitis with a severe risk of vision loss uncontrolled by treatment with corticosteroids and other immunosuppressants; and
2. Any of the following:
  1. Patient is 18 years or older and treatment with at least two other immunomodulatory agents has been ineffective or are contraindicated; or
  2. Patient is under 18 years and treatment with methotrexate has 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 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 – (ocular inflammation – chronic*) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following:

Patient has received a good clinical response following 3 initial doses; or
Following each 2 year treatment period, the patient has experienced 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
Following each 2 year 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

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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

Either:

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; orBoth:
3. 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
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:

The pPatient has received had a good clinical response following 3 initial doses; or
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
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

Plaque psoriasis

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

Initial application — (plaque psoriasis) from any relevant practitioner.

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

Either:

Both:
1. Patient has had a Special Authority approval for adalimumab, etanercept or secukinumab 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; or
All of the following:
1. Any of the following:
  1. Patient has "whole body" plaque psoriasis with a PASI score of greater than 10; or
  2. Patient has plaque psoriasis of the face, or palm of a hand or sole of a foot; or
  3. Patient has localised genital or flexural plaque psoriasis 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 DLQI assessment is within 1 month before the application.

Note: "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 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 for applications meeting the following criteria:

Both:

Any of the following:
1. Both:
  1. Patient had "whole body" plaque psoriasis at the start of treatment; and
  2. Patient has a PASI score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-infliximab baseline; or
2. Both:
  1. Patient had plaque psoriasis of the face, or palm of a hand or sole of a foot at the start of treatment; and
  2. Either:
    1. Patient 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 baseline; or
    2. Patient has a reduction of 75% or more in the skin area affected, or sustained at this level, as compared to the pre-infliximab baseline; and
3. Both:
  1. Patient had 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-treatment baseline; or
    2. Patient has a DLQI improvement of 5 or more, as compared to the pre-infliximab baseline; and
Maximum dose 5mg/kg every 8 weeks

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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 4 months for applications meeting the following criteria:

Either:

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
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 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 following cessation of each prior treatment course of stopping that treatment; and
4. The most recent PASI or DLQI 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, aAs 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:

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
Infliximab to be administered at doses no greater than Maximum dose 5mg/kg every 8 weeks.

Arthritis – psoriatic

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

Initial application — (arthritis – psoriatic) from any relevant practitioner.

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

All of the following:

Patient has had a Special Authority approval for adalimumab, or etanercept, or secukinumab for psoriatic arthritis; and
Either:
1. Patient has experienced intolerable side effects; or
2. Patient has received insufficient benefit to meet the renewal criteria for psoriatic arthritis; and
Following initial induction doses, maximum dose 5mg/kg every 6-8 weeks.

Renewal — Arthritis - psoriatic from any relevant practitioner.

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

Both:

Either:
1. Following initial treatment, at least a 50% decrease in active joint count from baseline; or
2. At least a continuing 30% improvement in active joint count from baseline; and
Maximum dose 5 mg/kg every 8 weeks.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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:

The pPatient has had an initial Special Authority approval for adalimumab, and/or etanercept, and/or secukinumab for psoriatic arthritis; and
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
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:

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
Infliximab to be administered at doses no greater than Maximum dose 5 mg/kg every 8 weeks.

Arthritis – rheumatoid

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

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

All of the following:

Patient has had a Special Authority approval for adalimumab or etanercept for rheumatoid arthritis; and
Either:
1. Patient has experienced intolerable side effects; or
2. Patient has received insufficient benefit to meet the renewal criteria for rheumatoid arthritis; and
Following initial induction doses, maximum dose 3mg/kg every 8 weeks.

Renewal – (Arthritis – rheumatoid) from any relevant practitioner.

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

Both:

Either:
1. Following initial treatment, the patient has experienced at least a 50% decrease in active joint count from baseline; or
2. Patient has experienced at least a continuing 30% improvement in active joint count from baseline; and
Maximum dose 3 mg/kg every 8 weeks.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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:

The pPatient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
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
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:

Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and
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
Infliximab to be administered at doses no greater than Maximum dose 3 mg/kg every 8 weeks.

Behcet disease – severe

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

Initial application – (Behcet disease) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

Patient has severe Behcet disease which is significantly impacting their quality of life; and
Either:
1. Patient has severe ocular, neurological and/or vasculitic symptoms and has received insufficient benefit from 1 or more treatment(s) appropriate for the particular symptom(s); or
2. Patient has severe gastrointestinal, rheumatologic and/or mucocutaneous symptoms and has received insufficient benefit from 2 or more treatments appropriate for the particular symptom(s); and
Following initial loading doses, maximum dose 5 mg/kg every 8 weeks.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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:

The pPatient has severe Behcet's disease which is significantly impacting the patient’s their quality of life (see Notes); and
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
Following initial loading doses, maximum dose 5mg/kg every 8 weeks.
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:

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

Ocular inflammation – severe

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

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

Either:

Both:
1. Patient has had an initial Special Authority approval for adalimumab for severe ocular inflammation; and
2. Either:
  1. Patient has experienced intolerable side effects; or
  2. Patient has received insufficient benefit to meet the renewal criteria for severe ocular inflammation; or
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 followed by high dose oral corticosteroids has 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 been ineffective at controlling symptoms; or
  4. High dose corticosteroids are contraindicated.

Note: Indications marked with * are unapproved indications

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

Any of the following:

Patient has received a good clinical response following 3 initial doses; or
Following each 2 year treatment period, the patient has experienced 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
Following each 2 year 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

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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

Either:

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
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:

The pPatient has had received a good clinical response following 3 initial doses; or
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
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

Pyoderma gangrenosum

Click to see criteria as they would substantively look in the Pharmaceutical Schedule:

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

Both:

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

Note: Indications marked with * are unapproved indications.

Changes that would be made to the eligibility criteria with additions in bold, deletions in strikethrough:

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

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
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:

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

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