Download NWL Wet Age Related Macular Degeneration

2015/2016 PBR Exclusions –Funding Application for
Aflibercept or Ranibizumab for Wet Age-related Macular Degeneration
(INTERIM version 1: Last updated 23.7.15)
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
Please note: For South West London (SWL) patients aflibercept is preferred for anti-VEGF naïve
eye(s) as it requires less frequent follow up visits.
2. Please confirm which eye(s) is/are to be treated:
Right eye
Left eye
Bilateral treatment
3. The current best-corrected visual acuity is between 6/12 and 6/96 in the eye(s) to be treated?
Right eye BCVA:
Left eye BCVA:
4. One of these statements applies (please tick):
Patient has not had aflibercept or ranibizumab for Wet-Age-related Macular Degeneration before (go to 8)
Patient has had aflibercept or ranibizumab for one eye and now requires treatment for the other eye (go to 8)
Patient is currently receiving ranibizumab for the eye to be treated and a clinical decision has been made to
switch to Aflibercept (go to 5)
5. I confirm that:
Patient has responded to ranibizumab and would have qualified for further treatment as per RCO guidelines
AND
There is still potential for improvement in vision if treatment is switched from ranibizumab to further treatment
with aflibercept.
Please check
Yes
No
Yes
No
Yes
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.
No
Contact details:
Form completed by:
Email:
Phone:
Date of completion:
Yes
Additional Information: :
Please note that sequential anti VEGF treatment in the same eye is not currently routinely commissioned
for non-responders.
6. There was no persistent deterioration in visual acuity while being treated with ranibizumab i.e.
BCVA in the eye to be treated is greater than 15 letters absolute AND
BCVA has not reduced by 30 letters or more compared to baseline and/ or best recorded level since baseline
7. Anatomical changes in the retina indicate that there is an adequate response to ranibizumab (i.e. there is no
evidence of deterioration of the lesion morphology) (go to 10)
8. For North West London patients only go to 9. For SWL patients please select one of these statements:
Aflibercept is used in treatment naïve eye
I am aware that aflibercept is the preferred anti VEGF for treatment naïve eyes but I wish to use
ranibizumab for the following reason (please explain):
9. There is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein
angiography, or recent visual acuity changes)
10. There is no permanent structural damage to the central fovea in the eye(s) to be treated
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Participating CCGs: NWL CCGs
This form should be returned to the named contact at the relevant CCG/CSU
11. 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):
12. The manufacturer will provide requested drug with the discount agreed in the current patient access scheme
13. Treatment will only be continued as outlined in The Royal College of Ophthalmologists’ guidelines
(September 2013) ‘Age-related macular degeneration: guidelines for management’ (until any further National
Guidance is issued which will take precedent (see Appendix I)
14. 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
£
Yes
No
Yes
No
Yes
No
/month
FOR CCG/CSU USE ONLY
After the initial 3 monthly doses of aflibercept or ranibizumab, aflibercept should be continued at 8 weekly intervals for the
first 12 months and ranibizumab should be continued at 4 weekly intervals until maximum visual acuity is achieved i.e. the
patient’s visual acuity is stable for three consecutive monthly assessments performed while on treatment. Thereafter
patients should be monitored according to the summary of product characteristics. 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’ guidelines (September 2013) (see Appendix I). 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
 Switching from ranibizumab to aflibercept in a patient that is responding to treatment (Note that sequential anti
VEGF treatment in the same eye is not currently routinely commissioned for non-responders).
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.
2
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
Appendix 1
The Royal College of Ophthalmologists - Age-related macular degeneration: guidelines for management (September 2013)
9.6 Criteria for Continuation of treatment
After the three initial doses, ranibizumab should be continued at 4 weekly intervals and aflibercept at 8 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).
Where there is recurrence of CNV activity, treatment is reinstated until lesion stabilisation is achieved as indicated by BCVA and or lesion morphology
9.7 Drug Holding and Cessation of therapy
Consider temporarily discontinuing treatment if:
(1) There is no disease activity
The disease should be considered to have become inactive when there is:
a) 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.
b) No re-appearance or further worsening of OCT indicators of CNV disease activity on subsequent follow up following recent discontinuation of treatment.
b) No additional lesion growth or other new signs of disease activity on subsequent follow up following recent discontinuation of treatment.
c) No deterioration in vision that can be attributed to CNV activity.
(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
3
d) ongoing periocular infections
e) other serious ocular complications attributable to an anti-VEGF agent 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
an anti-VEGF agent
g) other serious adverse events (SAE) e.g. hospitalisation
Consider discontinuing treatment permanently if there is:
1. A hypersensitivity reaction to a licensed anti-VEGF agent is established or suspected.
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.
3. 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
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 a 3 consecutive visits.
9.8 Discharging patient from Hospital eye clinic follow up
Consider discharging the patient from long term hospital follow up if:
1. The decision to discontinue a licensed anti-VEGF agent permanently has been made
2. There is no evidence of other ocular pathology requiring investigation or treatment
3. There is low risk of further worsening or reactivation of nvAMD that could benefit from restarting treatment e.g. very poor central vision and a large, non-progressive,
macular scar.
SWL agreed care pathway:
Age related macular degeneration
Previously treated with Anti-VEGF
Anti-VEGF treatment naïve eye
Responder
1st line: Aflibercept (Eylea®)
This is the preferred choice of treatment, as
it requires less frequent follow-up visits.
Ranibizumab (Lucentis®)
Repeat treatment of the same eye because
the visual acuity deteriorated following
treatment withdrawal after initially
responding.
®
Aflibercept (Eylea )
-‘Heavy Users” a sub-group of patients who
have been heavy users of ranibizumab
-Where there is a clinical/patient preference
to change due to less frequent follow up
visits.
4
Non-Responder
Aflibercept (Eylea®)
Not commissioned for non-responders to
ranibizumab. The effectiveness in this
group is not known
Ranibizumab(Lucentis®)
Not commissioned for patients who have
not responded to aflibercept
Switching- there is no evidence that
patients who fail to respond to one antiVEGF will respond to another.