Proposed changes for ophthalmology conditions

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 - (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 

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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

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:

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

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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