INTRAVITREAL RANIBIZUMAB FOR TREATING CHOROIDAL NEOVASCULAR MEMBRANE (CNV) ASSOCIATED WITH PATHOLOGICAL MYOPIA, NICE TA 298 (NOVEMBER 2013) Patient NHS No. Patient Hospital Number: Patient initials Trust: Consultant Making Request: Consultant Contact Details: GP Name: GP Practice code: GP Post code: & DoB: 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 enhccgdrugrequests@nhs.net 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. Please complete below to demonstrate that the patient meets the NICE and locally agreed commissioning criteria: 1. Patient has a diagnosis of choroidal neovascularisation associated with pathological myopia Yes No 2. Which eye(s) is treatment for? 3. In the eye to be treated, the patient has a best corrected visual acuity between 6/9 and 6/96 Right Yes Left No 4. The patient has no permanent structural damage to the central fovea Yes No 5. In the eye to be treated, the lesion size is less than or equal to 12 disc areas in greater linear dimension Yes No 6. In the eye to be treated, there is evidence of recent presumed disease progression Yes No 7. Please confirm that 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 patient access scheme agreed as part of TA298. Any other drug costs charged to the commissioner will be challenged. Yes No Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG) 1 8. Please confirm that activity will be charged as an outpatient procedure tariff, BZ23Z: vitreous retinal procedures 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 also recorded this discussion in the patient’s notes. I confirm the risks and benefits of treatment have been 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 criteria and cost effective use of this treatment as advocated in NICE TA298 and by local specialist agreement, and believe that within this Trust the above patient would be best managed using the treatment as requested above. Yes No 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 deputy) Name: Signature: Date: Name of supervising consultant: Signature: Date: Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG) 2 NICE TA 298: Ranibizumab for treating choroidal neovascularisation (CNV) associated with pathological myopia, November 2013 Ranibizumab is recommended as an option for treating visual impairment due to choroidal neovascularisation secondary to pathological myopia when the manufacturer provides ranibizumab with the discount agreed in the patient access scheme. Posology for the treatment of visual impairment due to CNV secondary to PM (taken from ranibizumab SPC, accessed on www.medicines.org.uk 18/03/2014) Treatment is initiated with a single injection. If monitoring reveals signs of disease activity, e.g. reduced visual acuity and/or signs of lesion activity, further treatment is recommended. Monitoring for disease activity may include clinical examination, optical coherence tomography (OCT) or fluorescein angiography (FA). While many patients may only need one or two injections during the first year, some patients may need more frequent treatment. Therefore, monitoring is recommended monthly for the first two months and at least every three months thereafter during the first year. After the first year, the frequency of monitoring should be determined by the treating physician. The interval between two doses should not be shorter than one month Commissioning criteria for treatment, local agreement: All of the circumstances apply in the eye to be treated: The best-corrected visual acuity is between 6/9 and 6/96 there is NO permanent structural damage to the 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 In line with the activity charges included in the economic evaluation which informed the NICE TA recommendation, commissioners will only pay, for each administration of ranibizumab, an outpatient procedure tariff, BZ23Z: vitreous retinal procedures Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG) 3