Proposed changes for dermatology conditions (excluding plaque psoriasis)

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:

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.

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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.

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

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.

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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.

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

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.

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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.