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									Meeting: Item No: Date: Author: Subject: 1.

Brighton & Hove City Teaching PCT Board Meeting 061/08 13 May 2008 Amanda Fadero, Director of Strategy Treatment of Age Related Macular Degeneration

Purpose This paper updates the Board on guidance relating to the treatment of Age Related Macular Degeneration (AMD) and proposes that the PCT’s policy is revised in line with National Institute for Health and Clinical Excellence (NICE) Appraisal Consultation Document (December 2007). Summary In the absence of definitive NICE guidance on the treatment of AMD, the PCT (in keeping with many others), agreed in July 2007 to follow criteria developed by Moorfields Eye Hospital and fund anti vascular endothelial growth factor (anti VEGF) drugs for the second affected eye. In December last year, NICE published preliminary guidance in the form of an Appraisal Consultation document in which it recommended the use of anti VEGF’s to a wider group of patients and treatment of the first presenting eye. Many PCTs (including East and West Sussex) have reviewed their criteria in light of this preliminary guidance and are now treating patients for the presenting eye. At its meeting on 26 February 2008, the Professional Executive Committee (PEC) endorsed the expansion of the eligibility criteria for the use of anti VEGF’s in line with the interim NICE guidance. It is estimated that the cost of treating a larger number of eligible patients in 2008/09 will be in the region of £700,000. This amount has been earmarked within the PCT’s annual Operating Plan.



Recommendations The Board is asked to approve the recommendation from the PEC to extend the eligibility criteria for treatment of wet AMD in line with the NICE Appraisal Consultation Document, pending the publication of more definitive NICE guidance later in the year. This will mean from this point forward, all patients with wet AMD are eligible and treatment will commence with the presenting eye.


The Board is asked to endorse PEC’s recommendation that for smokers, enrolment on a smoking cessation programme will be a requirement for treatment (as smoking is known to exacerbate AMD). Until NICE publishes its definitive guidance, it is recommended that patients requiring treatment continue to be referred to the prior approval panel for authorisation. Following the publication of guidance later in the year, eligibility criteria will be developed with the Ophthalmologists at Brighton and Sussex University Hospitals NHS Trust (BSUHT) and a method of auditing the new service will be agreed as part of the new service level agreement with BSUHT. The option of commissioning the non-licensed anti VEGF drug Avastin as the preferred treatment will be further investigated and if feasible will be the subject of a subsequent paper to the Board. 4. Background information AMD is characterised by irreversible damage to the central part of the retina, resulting in progressive loss of central vision. It is the leading cause of blindness in the UK. There are two forms of AMD – wet and dry. This proposal is concerned only with wet AMD. Photodynamic therapy (PDT) is approved by NICE for use in some types of wet AMD, but outside these groups, the only treatment is a range of drug treatments developed to target anti VEGF, which is a protein thought to contribute to the progression of wet AMD. Evidence indicates that anti VEGFs may be effective in treating all types of wet AMD, although definitive NICE treatment recommendations are expected in June 2008. There are currently two licensed drugs available Lucentis and Macugen. A third drug Avastin, is not currently licensed for AMD (it is licensed for use in colorectal cancer) but is being used off label by some Ophthalmologists who feel the drug will offer similar outcomes to Lucentis at considerably less cost. A national trial (the Ivan Trial) is about to start directly comparing the use of Lucentis with Avastin. Approximately 5-10 people are likely to be recruited from Brighton and Hove. Full results are not likely to be available for 3 years. Patients are expected to undergo a two year course of treatment but further studies may show that treatment is lifelong. NICE is negotiating with the manufacturers to pay for treatment costs for those who need treatment beyond the first 14 procedures.


Whilst NICE had not provided guidance on the on the funding of these drugs, in the face of growing evidence of their effectiveness and high public interest in this area, the PEC endorsed a policy on 24 th July 2007 of applying Moorfields Criteria on the treatment of AMD ie treating the second affected eye with Anti-VEGFs. This was in keeping with the policy recommendation of the HPSU published in April 2007. The agreed process requires patients to be referred for treatment via the PCT’s prior approval panel. Over the last year 66 applications for AntiVEGFs from BSUH were received, 23 of which were approved. We expect 99 incident cases in the coming year. More recently (December 2007), NICE published preliminary guidance in the form of an Appraisal Consultation document in which it recommended the use of Anti-VEGF’s to a wider group of patients with wet AMD. Many PCTs are now reviewing their criteria in light of this preliminary guidance and treating patients for the presenting eye (rather than waiting for blindness in the first eye before commencing treatment). Both East and West Sussex have responded to the interim guidance from NICE and agree to fund treatment for the first presenting eye. West Sussex is considering the use of Avastin (the non-licensed drug) because of the significant differences in cost. Avastin costs approximately £300 for both eyes, compared to Lucentis, which costs approximately £8,000 for one eye. In order to manage the indemnity issues associated with prescribing an off licence drug, West Sussex is considering commissioning the treatment from clinicians on a private basis. At its meeting on 26 February 2008 the PEC endorsed the expansion of the eligibility criteria for the use of anti VEGFs in line with interim NICE Guidance. 5. Link to corporate objectives 5.1 Health improvement and health outcomes A proportion of patients treated with anti VEGFs will retain their central vision for longer. Patients with AMD are primarily elderly. Treatment which aims to maintain sight at as early a stage as possible will greatly improved the quality of life for a section of this population. 5.2 Commissioning excellent health care services Expanding the eligibility criteria for anti VEGFs is consistent with NICE interim guidance and will enable patients to be treated at an earlier stage in their disease.



Public confidence The current policy of allowing patients to lose sight in one eye before commencing treatment in the second affected eye has not had the support of stakeholders or the public. The proposed amendments to the policy will help to restore public confidence. Finance, value for money and public confidence Anti VEGF drugs and the associated service costs are excluded from Payment by Results tariffs. The South East Coast Specialised Commissioning Team has estimated the costs of treating patients in line with the NICE Appraisal Document in Brighton & Hove per year as £761,100 pa. This amount has been earmarked as a contingency within the Operating Plan for 2008/09. However, it should be noted that accurate estimates of the cost of treatment are problematic in that: uptake is uncertain; an unknown proportion of non-responsive patients will have their treatment terminated after 3 months; and there will be a catch up period in treating prevalent cases.



Leadership and relationships The proposed amendments to the policy will help to strengthen relationships with stakeholders across the city.


Impact on health See section 5.1 above. Personnel issues BSUHT will need to expand clinic facilities in order to provide the diagnosis, treatment and follow-up for this service. Equalities issues Currently patients who are able to pay are receiving anti VEGFs (primarily Avastin) through the private sector. Expanding the eligibility criteria should reduce this inequality and ensure consistency of approach across Sussex. Financial implications including value for money See section 5.4 above. Consultation There is a very high level of public and political interest in the availability of these new drugs. An umbrella organisation AMD Alliance UK representing stakeholder groups has been involved at a national and local level advocating for the availability of anti VEGF drugs.







Appendices There are no appendices to this paper.


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