Preauthorisation for Prescription/Dispensation of anti-VEGF
Preauthorisation request for LUCENTIS received
| Decision Step | Implication |
| 1) Medical indication/diagnosis:· Noe-vascular (wet) age-related muscular degeneration (AMD) (1.1)
· Visual impairment due to diabetic macular edema (DME)(1.2) · Visual impairment due to macular edema secondary to retinal vein occlusion (RVO)(1.3) · Diabetic Retinopathy (DR) in patients with DME (1.4) · Visual impairment due to choroidal neo vascularisation (CNV) secondary to pathologic myopia (1.5) |
Yes : continue (2)No : reject |
| 2) Physician speciality – Ophthalmologist | Yes :continue(3)No :reject |
| 3) Patient’s age >18 yrs | Yes :continue(4)No :reject |
| 4)Medical preauthorisation criteria documentation for • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
|
|
| Is Neovascular(AMD) Diagnosis confirmed by:4a) Optical Coherence Tomography report(Mandatory) | Yes :continue (4b)No :reject |
| 4b) Macular Examination shows presence of:· exudative macular lesion
· presence of drusen(Lesions with lipid & protein deposits in retina)(≥63 microns in diameter) · pigmentary irregularities |
Yes :continue (4c)No :reject |
| 4c) Slit lamp biomicroscopy Examination shows:· Subretinal or sub-RPE neovascularisation which may be visible as grey green lesions
· Serous detachment of the neurosensory retina · RPE(retinal pigment epithelium) detachment · Haemorrhages- subretinal pigment epithelial, subretinal, intraretinal or preretinal · Hard exudates (lipids) within the macular area · Epiretinal, intraretinal, subretinal or sub-pigment epithelial scar/glial tissue or fibrin-like deposits. · Retinal angiomatous proliferations and retinochoroidal anatastamosis. |
Yes :continue (4d)No :reject |
| 4d) Fundus Fluorescein angiography(FFA) Report indicating :· Extent, type, size and location of CNV. | Yes :continue (5a or 6a as per request)No :reject |
| 5) Criteria for LUCENTIS Initiation
|
|
| 5a)The best corrected visual acuity (BCVA) is between 6/12 and 6/96 (6 metre Notation) or 20/40 and 20/320 (US notation) or 1.00 to 0.06 (decimal notation) or 100 to 40 (VAS notation) | Yes :continue (5b)No :reject |
| 5b)There is no permanent structural damage to the central fovea. (longstanding fibrosis or atrophy in the fovea, or a significant chronic disciform scar) | Yes :continue (5c)No : reject |
| 5c)The lesion size is less than or equal to 12 disc areas in greatest linear dimension | Yes :continue (5d)No :reject |
| 5d)There is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes) | Yes : rejectNo : continue (5e) |
| 5e)There is active subfoveal neovascularisation of any lesion type. | Yes :rejectNo :continue (5f) |
| 5f)In patients with occult CNV with minimal symptoms if there is:
· Evidence of new haemorrhage and/or subretinal fluid. · A documented recent visual decline in the presence of CNV. · An increase in CNV size between visits. |
Yes :rejectNo :continue (9a) |
| 6) Criteria for LUCENTIS continuation
|
|
| After the three initial doses, LUCENTIS should be continued at 4 weekly intervals Only if:
6a)Evidence of benefit to visual acuity following 3 consecutive monthly administrations.(improved BCVA score) |
Yes : continue (6b)No : reject |
| 6b) There is persistent evidence of lesion activity in OCT/FA | Yes :rejectNo :continue (6c) |
| 6c) The lesion continues to respond to repeated treatment | Yes : continue (6d)No : reject |
| 6d) If there is any below contra-indications as determined clinically and/or on OCT to continuing treatment.
· retinal, subretinal, or sub-RPE fluid or haemorrhage · lesion growth on FFA (morphological) · there is recurrence of CNV activity
|
Yes :rejectNo :continue (7a) |
| 7) Criteria for Temporary Discontinuation of LUCENTIS | |
| If there is no disease activity.The disease should be considered to have become inactive when there is:
7a) Absence of FFA leakage or other evidence of disease activity in the form of increasing lesion size, or new haemorrhage or exudates (i.e. no increase in lesion size, new haemorrhage or exudates) even if there is persistent fluid (intraretinal cysts or tubulation denoting chronic changes) on OCT. |
Yes : continue (7b)No : continue (9e) |
| 7b) No re-appearance or further worsening of OCT indicators of CNV disease activity on subsequent follow up following recent discontinuation of treatment. | Yes : continue (7c)No : continue (9e) |
| 7c) No additional lesion growth or other new signs of disease activity on subsequent follow up following recent discontinuation of treatment. | Yes : continue (7d)No : continue (9e) |
| 7d) No deterioration in vision that can be attributed to CNV activity.(Improving BCVA score) | Yes : Reject/review (continue 8a if optional)No : continue (9e) |
| 8) Criteria for Permanent Discontinuation of LUCENTIS | |
| 8a) A hypersensitivity reaction to LUCENTIS is established or suspected | Yes : continue (8b)No : continue (9e) |
| 8b) Reduction of BCVA in the treated eye to less than 15 letters (absolute) on 2 consecutive visits in the treated eye, attributable to AMD in the absence of other pathology. | Yes : continue (8c)No : continue (9e) |
| 8c) Reduction in BCVA of 30 letters or more compared to either baseline and/or best recorded level since baseline as this may indicate lack of responsiveness to treatment, or adverse event or both | Yes : continue (8d)No : continue (9e) |
| 8d) There is evidence of deterioration of the lesion morphology despite optimum treatment indicated by:· progressive increase in lesion size confirmed with FFA
· worsening of OCT indicators of CNV disease activity · significant new haemorrhage or exudates despite over a 3 consecutive visits |
Yes : RejectNo : continue (9e) |
| 9) Contraindications | |
| 9a)A hypersensitivity reaction to LUCENTIS is established or suspected | Yes : rejectNo : continue (9b) |
| 9b)Raised intraocular pressure (>30mm Hg) | Yes : rejectNo : continue (9c) |
| 9c)Active Ocular or periocular infections | Yes : rejectNo : continue (9e) |
| 9e)Previous administration of LUCENTIS in the past month (Anti-VEGF can only be prescribed once a month) | Yes : rejectNo : APPROV |
