Table 4 Current treatment recommendations by staging as described by applicant advisory board and by MSAC Stagea Description of Proposed treatment Current treatment (comparator) stage Advisory board a MSAC 1116b Stage 1a VMT/ Ocriplasmin Watchful waiting, typically Clinical observation involving regular OCT “The comparator for OCT in initial Stage 1b assessments. Patients with diagnosis of tractional diseases is intolerable symptoms or standard clinical examination plus progressive symptoms would observation. OCT is considered an be considered for vitrectomy additional test to standard clinical examination.” [MSAC 1116 page 25] Stage 2 FTMH <400µm Ocriplasmin Vitrectomyd Vitrectomy “Vitrectomy may be offered to Stage 3 FTMH >400µm No change patients with stage 2 holes or (ocriplasmin not above” [MSAC 1116 page 11] indicated) Stage 4 FTMH with No change Vitrectomy – however in some complete PVD cases where a patient has a (ocriplasmin not large chronic FTMH, it may not indicated) 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 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
1370-OCT%20for%20sVMA%20-Final%20Protocol%20accessible(D14-1103373).docx