PBS updates

Cequa (Ciclosporin)

ciclosporin 0.09% eye drops, 60 x 0.25 mL ampoules · APPLICATION_TO_THE_EYE · PBS code 13284E

AUTHORITY_REQUIRED

• • First listed on the PBS: 2023-06-01.
• • Repeats: 5.
• • PBS program: GE.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

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

Chronic severe dry eye disease with keratitis

Initial treatment for up to the first 180 days of treatment

Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of: (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND

Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND

The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or

Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND

Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment; AND

Patient must be at least 18 years of age.

Prescribing instruction:

State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of: (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23).

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

Chronic severe dry eye disease with keratitis

Continuing treatment

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

The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND

The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or

Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines.

Prescribing instructions:

State in the first continuing treatment authority application for this drug:

(i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).

State in all continuing treatment authority applications:

(ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application).

Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.