Download Etanercept and Infliximab for the treatment of

2014/2015 PBR Exclusions – Notification Funding Application for
Aflibercept or Ranibizumab for Wet Age-related Macular Degeneration
(Final version 1: last updated 01/04/14)
Before providing patient identifiable data on this form, please confirm that the patient (or in the case of a minor or vulnerable adult with the parent/legal guardian/carer) has given appropriate
explicit consent for sensitive personal information on this form to be passed to the CCG and/or CSU for processing this funding request and validating subsequent invoices. Consent given:
Patient NHS No.
Patient Hospital No:
Patient’s birth year:
Confirm patient status:
(yyyy)
NHS
Private
Overseas
Trust:
GP Name:
Consultant Making Request:
Consultant Contact Details:
GP code / Practice code:
GP Post code:
Yes
(* select 1 option)
Please indicate whether patient meets the following criteria
1. Aflibercept or Ranibizumab is to be prescribed within its licensed indications, as monotherapy for wet AMD.
Please specify which drug is requested:
Aflibercept
Ranibizumab
2. One of these statements applies (please tick):
Patient has not had aflibercept or ranibizumab for Wet-Age-related Macular Degeneration before
Patient requires retreatment of the same eye with the same drug because improved visual acuity which was
stable for 3 months deteriorated when treatment was stopped
Patient has had aflibercept or ranibizumab for one eye and now requires treatment for the other eye
Please note that 2nd line anti-VEGF treatment in the same eye is not currently routinely commissioned
until treatment pathways and commissioning arrangements are reviewed.
3. Please confirm which eye(s) is/are to be treated:
Right eye
Left eye
Bilateral treatment
4. The best-corrected visual acuity is between 6/12 and 6/96 in the eye(s) to be treated?
Right eye BCVA:
Left eye BCVA:
5. There is no permanent structural damage to the central fovea in the eye(s) to be treated
6. The lesion size is ≤12 disc areas (DA) in greatest linear dimension in the eye(s) to be treated
Right eye lesion size (DA):
Left eye lesion size (DA):
7. There is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein
angiography, or recent visual acuity changes)
8. The manufacturer will provide requested drug with the discount agreed in the current patient access scheme
9. Treatment will only be continued as outlined in The Royal College of Ophthalmologists’ recommendations
(June 2008) ‘RANIBIZUMAB: The Clinician’s Guide to commencing, continuing and discontinuing treatment’
(until any further National Guidance is issued which will take precedent (see Appendix II ))
10. Acquisition cost (inc. discounts) –commercial in confidence in NHS (CCG/CSU& Hospital)
Funding approved for up to 12
months initially (or until
stopping criteria overleaf are
reached)?
Yes
No
Funding re-approved for up to
12 months (or until stopping
criteria overleaf are reached)
Yes
No
Please check
£
Yes
No
Yes
No
Yes
No
Yes
Yes
No
Yes
No
Yes
No
Yes
No
No
Only fully completed forms will be
accepted by CCGs/CSUs for
consideration.
If the answer to any of these questions is
NO, please consider if there are patient
specific exceptional clinical
circumstances demonstrated. If so, a full
individual funding request (IFR) form
will need to be completed. This may
be obtained from the named contact at
the relevant CCG/CSU/Trust. Please
refer to the individual CCG IFR policy for
further details.
Contact details:
Form completed by:
Email:
Phone:
Date of completion:
Additional Information: :
/month
FOR CCG/CSU USE ONLY
Ranibizumab treatment should continue until maximum visual acuity is achieved i.e. the patient`s visual acuity is stable for
three consecutive monthly assessments performed while on ranibizumab treatment. Thereafter patients should be
monitored monthly for visual acuity. Ranibizumab and Aflibercept treatment should be discontinued if there is persistent
deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to
therapy as described in criteria for discontinuation in The Royal College of Ophthalmologists’ recommendations (June
2008) (see Appendix). A new application is required for:
 Repeat treatment of the same eye because the visual acuity deteriorated following treatment withdrawal after initial
response. Note: Funding will only be re-approved if the patient has shown an improvement of visual acuity
 Treatment of the other eye
Participating CCGs: Barking&Dagenham; Barnet; Brent; Camden; Central London; City and Hackney; Croydon; Ealing; Enfield; Hammersmith&Fulham; Haringey; Harrow; Havering; Hillingdon;
Hounslow; Islington; Kingston; Merton, Newham; Redbridge; Richmond; Sutton; Tower Hamlets; Waltham Forest; Wandsworth; West London.
This form should be returned to the named contact at the relevant CCG/CSU
Ranibizumab and pegaptanib for the treatment of wet age-related macular degeneration (NICE TA 155: August 2008; re-issued May 2012)
1.1
1.2
1.3
1.4
5.3
Ranibizumab, within its marketing authorisation, is recommended as an option for the treatment of wet age-related macular degeneration if:
 all of the following circumstances apply in the eye to be treated:
o the best-corrected visual acuity is between 6/12 and 6/96
o there is no permanent structural damage to the central fovea
o the lesion size is less than or equal to 12 disc areas in greatest linear dimension
o there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes) AND
 the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012).
It is recommended that treatment with ranibizumab should be continued only in people who maintain adequate response to therapy. Criteria for discontinuation should
include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. It is recommended that a
national protocol specifying criteria for discontinuation is developed.
Pegaptanib is not recommended for the treatment of wet age-related macular degeneration.
People who are currently receiving pegaptanib for any lesion type should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
The Department of Health and the manufacturer have agreed that ranibizumab will be available to the NHS with a patient access scheme (as revised in 2012) which makes
ranibizumab available at a reduced cost to the NHS. The size of the discount is commercial in confidence. It is the responsibility of the manufacturer to communicate details
of the discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme should be directed to Novartis Pharmaceuticals
UK by emailing [email protected] or calling 01276 698717.
Aflibercept solution for injection for treating wet age-related macular degeneration (NICE TA 294: July 2013)
1.1
1.2
Aflibercept solution for injection is recommended as an option for treating wet age-related macular degeneration only if:
 it is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155 (re-issued in May 2012) and
 the manufacturer provides aflibercept solution for injection with the discount agreed in the patient access scheme.
People currently receiving aflibercept solution for injection whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician
consider it appropriate to stop.
Summary of Product Characteristics- Ranibizumab (Lucentis®) (ref: www.medicines.org.uk. Accessed 23/03/14; SPC last updated 7/3/2014)
Treatment of wet AMD: The recommended dose for Lucentis is 0.5 mg given monthly as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.
Treatment is given monthly and continued until maximum visual acuity is achieved i.e. the patient`s visual acuity is stable for three consecutive monthly assessments
performed while on ranibizumab treatment. Thereafter patients should be monitored monthly for visual acuity.
Treatment is resumed when monitoring indicates loss of visual acuity due to wet AMD. Monthly injections should then be administered until stable visual acuity is reached
again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.
Summary of Product Characteristics- Aflibercept (Eylea®) (ref: www.medicines.org.uk. Accessed 23/03/14; SPC last updated 10/09/2013)
Treatment of wet AMD: The recommended dose for Eylea is 2 mg aflibercept, equivalent to 50 microlitres. Eylea treatment is initiated with one injection per month for three
consecutive doses, followed by one injection every two months. There is no requirement for monitoring between injections. After the first 12 months of treatment with Eylea, the
treatment interval may be extended based on visual and anatomic outcomes. In this case the schedule for monitoring should be determined by the treating physician and may
be more frequent than the schedule of injections.
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Appendix
The Royal College of Ophthalmologists: ‘RANIBIZUMAB: The Clinician’s Guide to commencing, continuing and discontinuing
treatment’ (June 2008):
2.0 Criteria for Continuation of treatment
It is recommended that after the three loading doses, ranibizumab should be continued at 4 weekly intervals if:
a) There is persistent evidence of lesion activity
b) The lesion continues to respond to repeated treatment
c) There are no contra-indications (see below) to continuing treatment.
Disease activity is denoted by retinal, subretinal, or sub-RPE fluid or haemorrhage, as determined clinically and/or on OCT, lesion growth on FFA (morphological),
and/or deterioration of vision (functional).
3.0 Criteria for temporarily discontinuing treatment (dose withholding)
Consider temporarily discontinuing treatment if:
3.1 There is no disease activity
The disease should be considered to have become inactive when there is:
a) Persistent fluid in the 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)
b) No re-appearance or further worsening of OCT indicators of CNV disease activity on subsequent follow up following recent discontinuation of treatment.
c) No additional lesion growth or other new signs of disease activity on subsequent follow up following recent discontinuation of treatment.
d) No deterioration in vision that can be attributed to CNV activity.
3.2 There has been one or more adverse events related to drug or injection procedure including:
a) endophthalmitis
b) retinal detachment
c) severe uncontrolled uveitis
d) ongoing periocular infections
e) other serious ocular complications attributable to ranibizumab (drug) or injection procedure f) thrombo-embolic phenomena, including MI or CVA in the preceding 3
months, or recurrent thrombo-embolic phenomena which are thought to be related to treatment with ranibizumab
g) other serious adverse events (SAE) e.g. hospitalisation.
4.0. Criteria for Permanent discontinuation of treatment
Consider discontinuing treatment permanently if there is:
4.1
a hypersensitivity reaction to ranibizumab is established or suspected
4.2
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
4.3
Reduction in BCVA of 30 letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment
effect or adverse event or both
4.4
There is evidence of deterioration of the lesion morphology despite optimum treatment. Such evidence includes progressive increase in lesion size confirmed
with FFA, worsening of OCT indicators of CNV disease activity or other evidence of disease activity in the form of significant new haemorrhage or exudates
despite optimum therapy over 3 consecutive visits.
5.0 Criteria for discontinuing treatment and discharging patient from hospital eye clinic follow up
Consider discharging the patient from long term hospital follow up if:
5.1
Decision to discontinue ranibizumab permanently has been made
5.2
There is no evidence of other ocular pathology requiring investigation or treatment
5.3
There is low risk of further worsening or reactivation of wet AMD that could benefit from restarting treatment e.g. very poor central vision and a large, nonprogressive, macular scar.
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