Table 3 presents the proposed item descriptors for OCT. For simplicity, it is proposed at this stage that the DVA fee of $91.75 is appropriate for MBS listing. The fee structure will be ultimately determined at the discretion of the Department of Health and Ageing in the event that the application for OCT services is successful. Table 3 Proposed MBS item descriptors for OCT for the determination of eligibility and efficacy assessment of treatment with ocriplasmin Item number to be assigned by department if MBS listed Category 2 – DIAGNOSTIC PROCEDURES AND INVESTIGATIONS MBS [xxxx] Optical coherence tomography by an ophthalmologist to determine if the requirements relating to vitreomacular traction including those associated with full thickness macular hole for access to ocriplasmin under the Pharmaceutical Benefits Scheme (PBS) are fulfilled. Fee: $91.75 Explanatory notes Suspected diagnosis of VMT and/or FTMH using baseline standard ophthalmic assessment (including biomicroscopy) by professional attendance of an ophthalmologist is required. MBS [xxxx] Optical coherence tomography requested by an ophthalmologist for the assessment of patient response to PBS-subsidised ocriplasmin, claimable only once per eye per lifetime. Fee: $91.75 Explanatory notes Single OCT assessment after one time injection of ocriplasmin As described in the proposed MBS listing, it is apparent that the listing completely depends on ocriplasmin becoming available on the PBS. The exact wording of the proposed ocriplasmin PBS Authority Required listing is yet to be finalised. However, it is envisaged that any such wording will specify the requirement of OCT for determination of patient eligibility and treatment outcome. For example, based on the trial eligibility criteria, access to ocriplasmin through the PBS could be restricted to patients with VMT with (or without) a FTMH of width ≤400µm as determined by OCT. The submission based assessment will include subgroup analyses from the clinical trials to determine the patient population that should be most appropriately targeted for the effective treatment with ocriplasmin. As treatment with ocriplasmin involves a single intravitreal injection, treatment continuation criteria are not necessary.
Table 3 presents the proposed item descriptors for OCT. For simplicity, it is proposed at this stage that the DVA fee of $91.75 is appropriate for MBS listing. The fee structure will be ultimately determined at the discretion of the Department of Health and Ageing in the event that the application for OCT services is successful. Table 3 Proposed MBS item descriptors for OCT for the determination of eligibility and efficacy assessment of treatment with ocriplasmin Item number to be assigned by department if MBS listed Category 2 – DIAGNOSTIC PROCEDURES AND INVESTIGATIONS MBS [xxxx] Optical coherence tomography by an ophthalmologist to determine if the requirements relating to vitreomacular traction including those associated with full thickness macular hole for access to ocriplasmin under the Pharmaceutical Benefits Scheme (PBS) are fulfilled. Fee: $91.75 Explanatory notes Suspected diagnosis of VMT and/or FTMH using baseline standard ophthalmic assessment (including biomicroscopy) by professional attendance of an ophthalmologist is required. MBS [xxxx] Optical coherence tomography requested by an ophthalmologist for the assessment of patient response to PBS-subsidised ocriplasmin, claimable only once per eye per lifetime. Fee: $91.75 Explanatory notes Single OCT assessment after one time injection of ocriplasmin As described in the proposed MBS listing, it is apparent that the listing completely depends on ocriplasmin becoming available on the PBS. The exact wording of the proposed ocriplasmin PBS Authority Required listing is yet to be finalised. However, it is envisaged that any such wording will specify the requirement of OCT for determination of patient eligibility and treatment outcome. For example, based on the trial eligibility criteria, access to ocriplasmin through the PBS could be restricted to patients with VMT with (or without) a FTMH of width ≤400µm as determined by OCT. The submission based assessment will include subgroup analyses from the clinical trials to determine the patient population that should be most appropriately targeted for the effective treatment with ocriplasmin. As treatment with ocriplasmin involves a single intravitreal injection, treatment continuation criteria are not necessary.
1370-OCT%20for%20sVMA%20-Final%20Protocol%20accessible(D14-1103373).docx