Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Vision threatening non-infectious uveitis

Initial treatment

Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND

Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent; or

Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy; or

Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; or

Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND

The treatment must not exceed 25 weeks under this restriction; AND

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

Vision threatening disease is defined as at least 1 of the following:

(a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;

(b) A 2-step increase in anterior chamber cells or vitreous haze;

(c) New retinal vasculitis;

(d) New retinal or choroidal lesions;

(e) Other signs of disease progression including visual field changes or electroretinogram changes

A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient's medical record.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Vision threatening non-infectious uveitis

Recommencement of treatment

Patient must have a documented history of non-infectious uveitis that is vision threatening; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND

The treatment must not exceed 25 weeks under this restriction; AND

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

An adequate response to treatment is defined as:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.