NICE (Multiple) Technology Appraisal Guidance No 155 – Ranibizumab and Pegaptanib for Age-related Macular Degeneration

The following NICE appraisal, re-issued today, 23 May 2012, has been considered by Healthcare Improvement Scotland through its procedure of processing of NICE appraisals:

NICE (Multiple) Technology Appraisal Guidance No 155 – Ranibizumab and Pegaotanib for Age-related Macular Degeneration

This guidance states that:

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:

• the best-corrected visual acuity is between 6/12 and 6/96
• there is no permanent structural damage to the central fovea
•  the lesion size is less than or equal to 12 disc areas in greatest linear dimension
• 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.

Web reference for appraisal and other related documents: http://www.nice.org.uk/guidance/TA155

NHSScotland should note that:

1. No important differences were identified for this NICE appraisal and Healthcare Improvement Scotland advises that the recommendations are as valid for Scotland as for England and Wales. The Patient Access Scheme Advisory Group (PASAG) for NHSScotland have approved the Patient Access Scheme as valid for NHSScotland. 

2. The Scottish Medicines Consortium (SMC) has previously issued guidance to NHSScotland on the use of ranibizumab and pegatanib in this indication (381/07; 290/06). This NICE MTA guidance supersedes the SMC advice.

For ranibizumab, there is no material difference between the recommendations of NICE and SMC. SMC advised that ranibizumab was accepted for use in NHSScotland, and it should be stopped if visual acuity falls persistently below 6/60 during treatment (381/07). For pegaptanib, the recommendations of NICE and SMC are not consistent. SMC advised that pegaptanib was accepted for restricted use within NHSScotland (290/06).

3. NHSScotland should take account of the NICE appraisal and this Healthcare Improvement Scotland email in its planning, funding and provision of services to ensure that recommended drugs or treatments are made available to meet clinical need.

4. Copies of the NICE appraisal can be downloaded from http://www.nice.org.uk  Also on the website are tools (a costing template/statement and audit criteria) that NICE has developed to help organisations implement this guidance. NICE MTA costing templates now include the NHSScotland boards. However, please note that the care pathway described in the costing tool may not completely reflect practice in NHSScotland.

Finally, an easy to read summary of the appraisal, called "understanding NICE guidance" is published on the NICE website to provide information for patients and the public.

5. Healthcare Improvement Scotland advice represents the evidence-based view of Healthcare Improvement Scotland.

6. This advice does not override or replace the individual responsibility of health professionals to make appropriate decisions in the circumstances of their individual patients, in consultation with the patient and/or guardian or carer.

7. No other publications on the NICE appraisal will be issued by Healthcare Improvement Scotland.

8. Healthcare Improvement Scotland advice is all available on the Healthcare Improvement Scotland website (www.healthcareimprovementscotland.org/).

If you need further assistance, please contact Eleanor Brownlee in the first instance. tel 0141 225 6873