1370 Final Protocol to guide the assessment of optical coherence tomography for the determination of eligibility and efficacy assessment of treatment with ocriplasmin (JETREA®) May 2014 Table of Contents MSAC and PASC 5 Purpose of this document 5 Purpose of application 6 Background 6 Vitreoretinal interface disorders 6 Ocriplasmin 10 OCT 10 Regulatory status 11 OCT 12 Ocriplasmin 12 Current arrangements for public reimbursement 12 OCT 12 Ocriplasmin 14 Intervention 14
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 4 Current treatment recommendations by staging as described by applicant advisory board and by MSAC Stagea Description of stage Proposed treatment Current treatment (comparator) Advisory board a MSAC 1116b Stage 1a Stage 1b VMT/ Ocriplasmin Watchful waiting, typically involving regular OCT assessments. Patients with intolerable symptoms or progressive symptoms would be considered for vitrectomy Clinical observation “The comparator for OCT in initial diagnosis of tractional diseases is standard clinical examination plus observation. OCT is considered an additional test to standard clinical examination.” [MSAC 1116 page 25] Stage 2 FTMH <400µm Ocriplasmin Vitrectomyd Vitrectomy “Vitrectomy may be offered to patients with stage 2 holes or above” [MSAC 1116 page 11] Stage 3 FTMH >400µm No change (ocriplasmin not indicated) Stage 4 FTMH with complete PVD No change (ocriplasmin not indicated) Vitrectomy – however in some cases where a patient has a large chronic FTMH, it may not be worth operating and would depend on the individual patients need and the benefits of surgery would be at the clinician’s discretion a Reference: Gass et al. 1988 (same staging used in MSAC assessment 1116 of OCT) b Alcon advisory board of Australian Vitreo-retinal specialists, 31 May 2013 c MSAC assessment 1116 of OCT d Assuming that the patient is willing and fit enough to undergo surgery
Table 6 Summary of PPICO to define research questions to investigate the effectiveness and cost-effectiveness of OCT as a means of identifying patients eligible for treatment with ocriplasmin on the PBS Population Prior tests Intervention Direct evidence comparator Reference standard/ evidentiary standard Outcomes to be assessed Patients who have undergone clinical and baseline ophthalmic assessment and in whom the treating ophthalmologists suspects will have a condition consistent with the PBS Authority Required listing for ocriplasmin Biomicroscopy Clinical examination OCT Standard ophthalmic assessment without OCT Surgery Or watchful waiting The reference standard for determining the “accuracy” of OCT is the ocriplasmin clinical trial evidence base. Current practice without OCT would need to be as accurate and effective as this method for identifying patients to ensure OCT adds no value. Natural history to provide support for the case of OCT in the absence of any other standard.including the rationale behind current clinical guidelines or criteria Efficacy outcomes: Clinical utility Clinical validity Analytical validity Safety/Adverse events Not assessed Modelled endpoints: Likelihood the test will lead to an improved health outcome i.e., linked evidence approach of the ability of OCT to change treatment decisions