Extract from EFFECTIVE CLINICAL COMMISSIONING POLICIES CBA = criteria based access to treatment PA = prior approval must be obtained from the CCG prior to referral = intervention not normally funded; Individual Funding Request must have been approved by the IFR Panel prior to referral Specialised Commissioning: NHS Commissioning Board Specialised Prescribed Services effective from April 2013. http://www.england.nhs.uk/wp-content/uploads/2012/12/pss-manual.pdf October 2012 Updated in view of NHS CB polices March 2013 OTHER INDEX Bobath therapy 2 CBA+PA Botulinum toxin for the treatment of chronic anal fissure H56.8 2 and X85.1 Botulinum toxin for hyperhidrosis S53.2 2 Cannabinoids for spasticity associated with multiple sclerosis 2 Chronic fatigue syndrome or myalgic encephalomyelitis (ME) 3 residential treatment programmes CBA+PA Continuous Glucose Monitoring systems for type 1 diabetes 3 CBA+PA Cough Assist 3 CBA Fibroscan for assessment of hepatic fibrosis 4 CBA+PA Functional electrical stimulation for drop foot A70.1 A70.7 4 High cost, non-nice approved, PbR excluded medicines 4 Interventions that are not covered by a PCT commissioning policy 4 that are not already well established and commonly provided on the NHS. Lung volume reduction surgery in emphysema E54.6 5 CBA Lycra splinting for paediatric patients with cerebral palsy/movement disorders 5 CBA Lymphoedema 5
Multiple chemical sensitivity 6 Occipital nerve stimulation 7 CBA/ Specialised Commissioning Rituximab for non-malignant indications policy (for review) 7 OTHER Bobath therapy Bobath therapy is not normally funded. CBA+PA Botulinum Toxin A for the treatment of chronic anal fissure A single treatment is commissioned where the anal fissure fails to heal spontaneously; AND chronic symptoms persist for more than six weeks; AND all other appropriate non-surgical, medical and dietary treatment have failed. Botulinum toxin for hyperhidrosis Botulinum Toxin treatment by injection for Hyperhidrosis is not routinely funded. Where a patient is suffering from Hyperhidrosis which causes functional impairment which prevents the individual from fulfilling work/study/carer or domestic responsibilities, the patient should be treated conservatively, including advising to use extra strength antiperspirant and deodorant, and topical aluminium chloride. Cannabinoids for spasticity associated with multiple sclerosis NHS Swindon and Gloucestershire has considered the evidence for the use of cannabinoids for spasticity associated with multiple sclerosis (MS) and considers that the clinical effectiveness, likely cost effectiveness and affordability for the use of Sativex is insufficient to support its routine use and considers the treatment low priority. 2
Chronic fatigue syndrome or myalgic encephalomyelitis (ME), residential treatment programmes Residential treatment programmes are not normally funded. CBA+PA Continuous Glucose Monitoring systems for type 1 diabetes Diabetes is associated with significant morbidity in the form of both microvascular and macrovascular complications which have been shown to reduce by improved glycaemic control. Intermittent capillary blood glucose monitoring of blood glucose is a key element in implementing intensive therapy. This provides feedback on the effects of diet, exercise and stress on the actual blood glucose, however, it provides a snapshot and not the trends in fluctuations of blood glucose levels over time. Minimally invasive continuous glucose monitoring devices have been developed to provide detailed information and analyses of trends of blood glucose. It is expected that that this additional information will lead to more appropriately targeted advice and improved glycaemic control in patients who have particular difficulties with their glycaemic control using intermittent monitoring. NHS Swindon supports the commissioning and use of CGM systems for both children over the age of 8 years and adults who are having difficulties despite maximum efforts to adjust to life with diabetes and have repeated and persistent hyper or hypoglycaemia episodes or hypoglycaemia unawareness or are unresponsive to conventional insulin dose adjustment Provider of CGM service should seek prior approval from the commissioners for new patients that they consider suitable for treatment. CBA+PA Cough Assist - mechanical insufflation/exsufflation device (MI-E) Cough assist devises are funded for paediatric patients with neuromuscular conditions in the following circumstances: Children who are clinically very weak Children with loss of bulbar function Children who cannot co-operate with manual cough assist or air-stacking methods or these methods have not been effective AND The patient suffers from recurrent respiratory tract infections, diagnosed and treated by a primary or secondary care doctor. Recurrent infection defined as 3 or more episodes over a single winter period or on-going infections greater than once every two months throughout the year. 3
Providers of MI-E should seek prior approval from the commissioners for new patients that they consider suitable for treatment. CBA Fibroscan for assessment of hepatic fibrosis Only funded where patient is co-infected with HIV and hepatitis virus B or C. Patient has declined a liver biopsy or has had a previous liver biopsy that demonstrated no or intermediate harm. CBA+PA Functional electrical stimulation for drop foot (FES) There is limited clinical evidence to support the use of FES but conservative modelling shows that it is likely to be a cost-effective intervention. FES using skin surface electrodes will be commissioned for patients meeting all of the following criteria: The patient has foot drop caused by upper level nerve damage Patient s gait is not satisfactorily controlled using ankle foot orthoses There is documented evidence that foot drop has caused trips or falls and gait issues causing significant clinical problems The patient can physically manage a FES (+/- minimal assistance) Clear treatment goals and expectations of benefit have been outlined to the patient FES using implantable electrodes will only be commissioned if the patient meets the criteria for surface stimulation but is unable to continue its use due to clinical problems and there is evidence of benefit from using FES. Providers of FES services should seek prior approval from the commissioners for new patients that they consider suitable for treatment. High cost, non NICE approved, PbR excluded medicines Not normally funded. Interventions that are not covered by a PCT commissioning policy that are not already well established and commonly provided on the NHS. Not normally funded. 4
Lung volume reduction surgery in emphysema Not normally funded. CBA Lycra splinting for paediatric patients with cerebral palsy/movement disorders Lycra splinting services is commissioned for paediatric patients who meet the following criteria: children aged between 3 and 18 years* with a diagnosis of cerebral palsy or other neurological condition following multidisciplinary team assessment by the Occupational Therapist and Physiotherapist and support from a Consultant Paediatrician that the child is likely to achieve an improvement in (or maintain) functional abilities regarding balance or movement control where the child and family/carers are motivated to support the introduction and maintenance of use of the intervention. Contraindications for lycra splinting include severe or uncontrolled epilepsy, vascular, or chronic respiratory problems. Regular monitoring at appropriate intervals by the multidisciplinary team (including Physiotherapist, Occupational Therapist and Consultant Paediatrician) to assess progress or maintenance of functional ability is required. Use of the splint will be discontinued if benefits cease to be achieved or maintained. *Replacement splints will be funded automatically to the age of 16. Requests for new or replacement splints for children aged 17-18 will be considered by the Individual Funding Request Panel. CBA Lymphoedema for patients with severe complicated lymphoedema Patients can be referred directly to the lymphoedema service if they meet the following criteria: Have a diagnosis of severe, chronic lymphoedema confirmed by a Consultant Surgeon from the following o Vascular services o Dermatology services o Out of county specialist lymphoedema centres (Vascular status must be assessed prior to the fitting of any compression therapy). Have a diagnosis of lymphoedema/ oedema associated with cancer or cancer treatment. (This patient group are predisposed to lymphoedema). Have severe dependency oedema and fulfil the following o Have had unsuccessful intervention by community nursing services including, District nurses, Practice nurses and Clinical Specialists such as tissue viability. 5
Therefore specialist lymphoedema services are needed. o Have been assessed as suitable for compression therapy and specialist intervention is needed. (Patients with complex problems which cannot be treated by routine care need specialist treatment to prevent deterioration in condition. Have oedema associated with obesity and fulfil the following: o Have had generalist HCP intervention with little success. o Have been assessed by Dietetic services and are concordant with a weight reduction programme. o Can be managed with maintenance lymphoedema care by community services or their GP, once assessed by the GLS and fitted with appropriate compression therapy. (Obesity is known to cause oedema which over time causes the secondary skin changes associated with lymphoedema. Patients with oedema associated with obesity will not benefit from lymphoedema treatment long term unless they reduce their body weight. Patients who reduce their body weight to within accepted BMI guidelines usually find oedema resolves without treatment. GLS cannot offer care to this patient group on a long term basis and as such will work with HCP to try to develop intervention so that patients can be cared for appropriately). Have a combined vascular/lymphatic oedema confirmed by a GP and/or consultant doctor and the following criterion are satisfied: o Vascular status is confirmed by a Consultant o Joint care is arranged between the specialist service and community nursing services. (Patients with a mixed oedema do not necessarily benefit from lymphoedema treatment. In most cases of this type of mixed oedema, lymphoedema treatments have to be modified. It is therefore more appropriate that limited lymphoedema treatments are reserved for patients who will most benefit. There are other health services and professionals who can help patients with mixed oedema, for example vascular nurse specialists). Multiple chemical sensitivity In the absence of consensus amongst clinicians that Multiple Chemical Sensitivity is considered to be a recognised clinical syndrome, it will not be recognised by NHS Gloucestershire. The health needs of patients who choose to classify themselves using this description should be treated by local NHS services which may include medical and psychological assessment and treatment. 6
Occipital nerve stimulation Occipital nerve stimulation (ONS) is not normally funded for severe refractory headaches. CBA/ Specialised Commissioning Rituximab for non-malignant indications FOR REVIEW Rituximab for non-malignant indications Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells. It is used mainly in the treatment of types of lymphomas, leukaemias, transplant rejection and some autoimmune disorders. NHS Swindon supports the use the use of Rituximab for indications approved by NICE (Rheumatoid Arthritis, Chronic Lymphocytic Leukaemia, and follicular Non-Hodgkins Lymphoma). This policy aims to develop a set of criteria and processes for NHS Swindon funding the use of rituximab for other indications. This is in response to the increasing use of rituximab for various non-cancer conditions that may not be a licensed indication and have not been and are unlikely to be approved by NICE. If the request is for one of the following conditions prior approval is not required Steroid refractory autoimmune haemolytic anaemia Steroid refractory Idiopathic Thrombocytopenic Purpura ) Multicentric Castleman Disease ANCA associated vasculitis ( Churg-Strauss syndrome, Wegener granulomatosis, Microscopic polyangiitis Severe (organ threatening) connective tissue disease especially Lupus and Sjogrens Post-transplant lymphoproliferative disorder Prophylaxis of rejection in sensitized kidney transplant recipients with donor specific antibodies Corticosteroid-refractory pemphigus vulgaris or pemphigus foliaceus GWH is expected to provide three monthly returns to NHS Swindon Commissioning Directorate identifying the amount given and for which conditions. Total prescribing cost is expected to be within pre-specified annual maximum contracting costs of 36,000. If the clinician is requesting to use rituximab for a patient with a cancer or indications not covered by NICE guidance or the agreed list above, an Individual Funding Request should be made via the usual route. The use of Rituximab for these other indications will need to demonstrate that the following criteria have been applied in order for its use to be approved. Evidence of systematic review of high quality randomized control trials Evidence of robust randomised controlled trials showing cost effective benefit. In rare or orphan conditions where randomised controlled trials are not possible, authorative peer reviewed and accepted guidelines e.g. British Rheumatological Society 7
guidelines that have been accepted as good practice. 8