Download Ranibizumab and aflibercept for Diabetic Macular Oedema TA274

Ranibizumab and aflibercept for treating diabetic macular oedema (DMO), NICE TA274, February 2013 (rapid
review of TA237) and TA346, July 2015
Only fully completed forms will be accepted for consideration
The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at [email protected]
If the patient does not fulfil routine commissioning criteria
 The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient specific
funding application form.
 Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund treatment
that meets the commissioned pathway.
 Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please check the
commissioner websites for contact details of the IFR team .
Payment by the commissioner will only be made if the completed form is received no later than 15 days after INITIAL treatment commences
Patient NHS No.
Trust:
GP Name:
Patient Hospital
Number:
Consultant Making
Request:
Patient initials:
Patient Dob:
GP code / Practice
code:
/
/
GP Post code:
Criteria for initiation
1. The patient is an adult with visual impairment due to DMO?
2. The following VEGF inhibitor will be prescribed within its licensed indication for DMO (confirm choice):
3. Which eye(s) is to be treated?
Yes
No
Ranibizumab
Aflibercept
Left eye
Right eye
Both eyes
4. The eye(s) to be treated has a central retinal thickness at the start of treatment ≥400 micrometres?
Yes
No
5. The eye(s) to be treated has not received previous treatment with a VEGF inhibitor?
Yes
No
6. The commissioner will only be charged the actual acquisition cost of the drug to the provider at the time of
treatment, in accordance with the agreed patient access scheme?
Yes
No
7. Visual acuity, & central retinal thickness, measured by OCT, will be recorded at each monitoring visit?
Yes
No
8. Treatment will be discontinued if there is no improvement over the course of the first 3 injections?
9. If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment,
treatment will be discontinued?
Yes
No
Yes
No
10. If both eyes are to be treated the same VEGF inhibitor will be used in both eyes?
Yes
No
11. The treatment activity will be charged as BZ23Z Vitreous retinal procedures cat 1, out-patient procedure?
Yes
No
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Pharmacy and Medicines Optimisation Team, East & North Herts Clinical Commissioning Group (ENHCCG)
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Clinician’s Declaration
I confirm that I have discussed with the patient and that they understand and consent to their personal information being shared with
commissioning and commissioning support organisations for the purposes of processing this funding request and validating subsequent invoices. I
have recorded/will record this discussion in the patient’s notes.
I confirm the risks and benefits of treatment have been/will be fully discussed with the patient and documented.
I confirm that funding approval is subject to initiation and follow up of treatment response being undertaken by a specialist ophthalmology team.
I acknowledge and adhere to the cost effective use of ranibizumab as advocated in NICE TA274 or aflibercept as advocated in NICE TA346 and
believe that within this Trust the above patient would be best managed using the agent as requested above.
Name of consultant (or clinician delegated by consultant):
Signature (electronic signature):
Date:
/
/
If this patient is being jointly managed by a second consultant, please state
name here:
Name:
Date:
Signature (or email confirmation) by Trust Chief Pharmacist (or nominated
deputy)
Name:
Signature:
Date:
/
/
COMMISSIONING ARRANGEMENTS FOR RANIBIZUMAB AND AFLIBERCEPT FOR DIABETIC MACULAR OEDEMA
RANIBIZUMAB
NICE recommendation (TA 274 published Feb 2013) http://www.nice.org.uk/guidance/ta274
Ranibizumab is recommended as an option for treating visual impairment due to diabetic macular oedema only if:
 the eye to be treated has a central retinal thickness of 400 micrometres or more at the start of treatment and
 the manufacturer provides ranibizumab with the discount agreed in the patient access scheme.
The summary of product characteristics states that treatment is initiated with one injection per month until maximum visual acuity is achieved and/or
there are no signs of disease activity i.e.no change in visual acuity and in other signs and symptoms of the disease under continued treatment. Initially,
three or more consecutive, monthly injections may be needed. The interval between two doses injected into the same eye should be at least four weeks.
Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual
acuity and/or anatomical parameters. If, in the physician's opinion, visual and anatomic parameters indicate that the patient is not benefiting from
continued treatment, treatment should be discontinued. If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity
is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual
impairment recur. The treatment interval may be extended by up to one month at a time for DME. If disease activity recurs, the treatment interval should
be shortened accordingly.
v1 October 2015
Pharmacy and Medicines Optimisation Team, East & North Herts Clinical Commissioning Group (ENHCCG)
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AFLIBERCEPT
NICE Recommendation (TA346 published July 2015) http://www.nice.org.uk/guidance/ta346
Aflibercept solution for injection is recommended as an option for treating visual impairment caused by diabetic macular oedema only if:
 the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and
 the company provides aflibercept with the discount agreed in the patient access scheme.
The summary of product characteristics states that treatment is initiated with one injection per month for 5 consecutive doses, followed by one injection
every 2 months. There is no requirement for monitoring between injections. After the first 12 months of treatment, the treatment interval may be extended
based on visual and/or anatomic outcomes. The schedule for monitoring should be determined by the treating physician. If visual and anatomic outcomes
indicate that the patient is not benefiting from continued treatment, treatment should be discontinued.
Other Commissioning Information
 Treatment should be discontinued if there is no response following the initial 3 injections.
 If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, treatment should be discontinued.
 Visual acuity, and central retinal thickness (CRT), measured by OCT, should be recorded at each monitoring visit. This data may be requested by
commissioning or commissioning support organisations in order to audit the effectiveness of the commissioned service.
 Outpatient administration activity tariff only will be funded.
 If both eyes are to be treated the same vascular endothelial growth factor inhibitor must be used in both eyes.
 Sequential use of aflibercept after ranibizumab or ranibizumab after aflibercept is not recommended.
If treatments are not provided in line with the criteria laid out in this document, ENHCCG reserves the right to re-claim money from providers for the
relevant drug and activity costs. ENHCCG may request an audit around patient outcomes on an annual basis.
v1 October 2015
Pharmacy and Medicines Optimisation Team, East & North Herts Clinical Commissioning Group (ENHCCG)
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