FREEDOM OF INFORMATION ACT 2000 Dudley CCG - Growth Hormone Prescribing- Ref: RFI0222

Transcription

1 Freedom of Information Team Dudley CCG Response by 2nd Floor, Brierley Hill Health and Social Care Centre Venture Way Brierley Hill DY5 1RU 27 th August 2015 FREEDOM OF INFORMATION ACT 2000 Dudley CCG - Growth Hormone Prescribing- Ref: RFI0222 Thank you for your request received 10 th August You asked for information regarding the above. Your request for information has now been considered. I will answer your queries below: We would like to request the following information regarding the prescribing of growth hormones within Dudley CCG 1. We have the following formularies listed as used by your organisation. Please confirm if they are correct and if not, please provide a link/copy of relevant formularies. Dudley Formulary Birmingham Women's NHS Foundation Trust Formulary The formulary used by Dudley Health Economy is accessed via the link below Please provide a copy or link to any supporting guidelines containing growth hormone product prescribing recommendations that are in addition to the published formulary. If none are available, please confirm if they are currently being developed/drafted. Please see attached Effective Shared Care Agreement (ESCA) which is provided as further background information. The review date for this ESCA has now expired. This will now be the subject of a review to determine whether it is still required. 3. Where guidelines are held in addition to the published formulary, please confirm which has dominance when prescribing growth hormones. Chair: Dr David Hegarty Chief Executive Officer: Mr Paul Maubach

2 As the guidance attached is currently under review the formulary is dominant. Request for Re-use If your organisation does hold this information and is in a position to pass it on, then I would like to submit the following request for re-using the information:- We (IMSHealth) request permission to re-use as a part of an independent analysis into NHS prescribing of growth hormones, which has been commissioned by one of our clients. The contents of the report will not be made available publically, but may be used by other IMSHealth Group entities and service suppliers. The information in the report will be presented in a factual manner with all publication details staying true to the publisher. If you have any queries or concerns, or are dissatisfied with the handling of your request please contact the Head of Communications & Public Insight at Dudley CCG, Brierley Hill Health & Social Care Centre, Venture Way, Brierley Hill DY5 1RU. The contact telephone number is or alternatively Laura.Broster@dudleyccg.nhs.uk. You can also refer to the Information Commissioner at: Information Commissioner s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF Telephone: Yours sincerely Matthew Hartland Chief Operating & Finance Officer Chair: Dr David Hegarty Chief Executive Officer: Mr Paul Maubach

3 SHARED CARE PROTOCOL FOR THE USE OF GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE DEFICIENCY For Patient Patient signature Consultant approval signature Consultant name and date General Practitioner approval signature GP name and date Approved by the Dudley Area Medicines Management Committee Originally Approved December 2005 Latest review June 2010 Review date June 2012

4 Page No CONTENTS 2 1. Introduction: Shared Care 3 2. Growth Hormone Deficiency in Adults Actions of Growth Hormone Causes of Growth Hormone Deficiency Signs and Symptoms of Growth Hormone Deficiency The Benefits of Replacement Therapy Diagnosis of GH Deficiency Baseline Assessment Initiation of Treatment Monitoring the Dose Availability and Delivery Side-effects Re-assessment 7 3. Shared Care The Hospital s Role The Role of General Practice 8 4. Contacts 8 2

5 1. INTRODUCTION: SHARED CARE The NHS reforms have set an agenda to work towards a primary care led system of health care. This means that clinicians no longer work in isolation and they can now draw upon the wider experience and resources offered by the new NHS. The Government specifies in the directive EL-91/127 that there should be a minimum of out-patient prescribing to be provided by hospitals. The letter focuses on the concept of shared care and emphasises the need for proper hand-over procedures from hospital to bring about real benefits for patients. With appropriate hospital back-up GPs can now be invited to participate in the day-to-day management of more specialised conditions, avoiding unnecessary attendance at hospital units for patients and giving GPs a more familiar perspective of the treatment. An example of a new disease area where shared care guidelines are particularly pertinent is in the treatment of Growth Hormone (GH) deficiency in adults. GH deficiency has long been recognised as a condition in children. It is only since the late 1980s that it has been realised that adults are also physically and psychologically disadvantaged as a result of GH deficiency and can benefit from replacement therapy. In the future an increased awareness of this endocrine deficiency and a consequent increase in diagnosis will lead to an expansion in this treatment area. With an estimated incidence of 1:10 000, growth hormone deficiency in adults is a condition which general practitioners will now occasionally come into contact with in the course of their work. The Midlands Therapeutic Review and Advisory Committee (MTRAC) have reviewed the use of GH replacement in GH deficient adults and have recommended that where GPs are exceptionally prepared to support specialist units, growth hormone should only be prescribed to adults for licensed indications, within the guidance of a well defined, locally determined shared care arrangement (VS96/25 November 1996). NICE TAG 64 Human growth hormone (somatropin) in adults with growth hormone deficiency states that Initiation of GH treatment, dose titration and assessment of response during trial periods should be undertaken by a consultant endocrinologist with a special interest in the management of GH disorders. Thereafter, if maintenance treatment is to be prescribed in primary care, it is recommended that this should be under an agreed shared-care protocol. These guidelines are intended to provide information for GPs about the use of GH in the treatment of adults with pronounced GH deficiency and should be read in conjunction with the manufacturers data sheet. NICE TAG 64 - HUMAN GROWTH HORMONE (somatropin) IN ADULTS WITH GROWTH HORMONE DEFICIENCY states that treatment is recommended for the treatment of adults with growth hormone deficiency only if they fulfil all three of the following criteria. 1. Patient has severe GH deficiency, defined as a peak GH response of less than 9mU/litre (3ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test. 2. Patient has a perceived impairment of quality of life as demonstrated by a reported score of at least 11 in the disease-specific quality of life assessment of growth hormone deficiency in adults (QoL-AGHDA) questionnaire. 3. Patient is already receiving treatment for any other pituitary hormone deficiencies as required. 3

6 2. GROWTH HORMONE DEFICIENCY IN ADULTS 2.1 Actions of Growth Hormone GH is released from the pituitary gland with secretion rates peaking during the night. Although production of GH does decline after adolescence, it continues to play a key metabolic role throughout adult life. GH has widespread effects including stimulating bone and cartilage growth a lipolytic action which leads to a decrease in body fat an anabolic action which leads to an increase in cell mass an antinatriuretic action which leads to an increase in extra-cellular water direct and indirect effects on mental function and quality of life 2.2 Causes of Growth Hormone Deficiency Adult GH deficiency is a relatively rare condition, affecting about 1 in 10,000 of the total population. The majority of cases are in patients with pituitary or peripituitary tumours, or those who have been treated for such a tumour in the past. GH deficiency is a side effect of cranial radiotherapy for other cancers affecting pituitary function. Approximately one third of children with idiopathic GH deficiency will be GH deficient as adults. 2.3 Signs and Symptoms of Growth Hormone Deficiency GH has an important role in the control of metabolism, consequently its deficiency results in a number of physical and psychological signs: increase in body fat (central adiposity) reduction in muscle mass reduction in bone density reduced exercise capacity poor physical performance raised serum cholesterol reduction in cardiac muscle impaired cardiac function depressed mood anxiety low energy levels social isolation lack of positive well-being In addition, there is some evidence to suggest that changes associated with GH deficiency may be responsible for the increased morbidity and mortality from cardiovascular disease seen in these patients. 2.4 The Benefits of Replacement Therapy The majority of GH deficient adults will find that many of the psychological and physical features of the deficiency are improved by replacement therapy. Clinical trials have shown the following improvements in these patients: 4

7 reduction in body fat normalisation of body cell mass and extra-cellular water improvement in bone mineralisation increase in exercise capacity improvement in lipid profile improvement in cardiac structure and function improvement in renal function increased vitality improved well-being and quality of life While GH replacement also improves a range of cardiovascular markers, further studies are required to confirm the effects of therapy on cardiovascular related morbidity and mortality. 2.5 Diagnosis of GH Deficiency This condition is diagnosed at hospital level by initial clinical suspicion of those patients likely to have GH deficiency. The level of GH is measured using appropriate provocation tests, e.g. an insulin tolerance test (ITT), consistent with the product licence recommendation. An accepted definition of GH deficiency is defined as a peak response <3mcg/l (9mU/l). Patients under clinical suspicion known or suspected hypothalamic or pituitary disease received cranial irradiation deficient in one or more of the other pituitary hormones undergone hypophysectomy received GH in childhood for GH deficiency When to test diagnostic test after stabilised treatment of other deficiencies diagnostic test at least one month after pituitary surgery childhood treatment should be interrupted for an appropriate period before retesting 2.6 Baseline Assessment On diagnosis each patient should have a baseline assessment from which any subsequent change can be monitored. Clinical assessment current medical history full history of hypothalamic disease surgical and radiological assessment number of pituitary hormone deficiencies current replacement regimen previous growth hormone treatment quality of life assessment using the GHD disease specific questionnaire 5

8 Medical and biochemical assessment Height, weight and body mass index waist/hip ratio body composition blood pressure HbA1c, blood glucose lipid profile IGF-1 (insulin-like growth factor 1) recent pituitary imaging visual field measurement, where relevant 2.7 Initiation of Treatment In the first instance GH is usually commenced for a trial assessment period, which should allow for adjustment and stabilisation of the dose of growth hormone. Most patients are likely to be stabilised within two months of commencing GH therapy. GH is usually started at a low dose, which is gradually increased. Sensitivity of GH treatment varies with age, weight and possibly gender, therefore dosage and administration schedule should be tailored to the individual patient. The dose should be calculated by the hospital endocrinologist in accordance with data sheet recommendations. 2.8 Monitoring the Dose A recognised technique for monitoring the GH dose is to take regular measurements of serum insulin-like growth factor 1 (IGF-1). IGF-1 levels should increase during therapy. The aim is to find the dose of GH which maintains IGF-1 levels within the normal range. The patient will require one or two monthly IGF-1 blood tests until the optimum maintenance dose is reached and six-monthly/annual assessment thereafter. As well as IGF-1 levels, side effects should be used as guidance for dose titration. The minimum effective dose should be used and dose requirements may decrease with age. 2.9 Availabilty and Delivery Somatropin (Biosynthetic growth hormone) BNF section: Tradename: GENOTROPIN NORDITROPIN HUMATROPE NUTROPIN AQ OMINITROPE SAIZEN ZOMACTON Dudley preferred brand for new patients Manufacturer: Pharmacia Novo Nordisk Lilly Ipsen Sandoz Merck Serono Ferring 6

9 GH is given daily by subcutaneous injection, which the patient is taught to self-administer. Physiological GH release peaks during sleep therefore the injection should be given in the evening before bedtime. Instruction on the use of devices available for injection will be supplied separately. Additionally, further information may be obtained from the hospital s endocrine clinic if required (see section 4: Contacts) Side-effects Fluid retention is the most commonly reported side effect of GH replacement therapy. Fluid retention, with occasional mild ankle oedema, is a normal part of growth hormone action. This tends to decrease as therapy continues but may occasionally require dose reduction. Joint and muscle aches ( growing pains ), carpal tunnel syndrome and headache have been among reported side effects. These effects, if they occur, are usually mild and selflimiting. A reduction in the GH dose may be required while they persist. GH therapy has also been shown to reduce insulin sensitivity in these patients by antagonising the action of insulin and may therefore increase the risk of diabetes. A severe and persistent headache should be reported immediately to the endocrinology department. There is no evidence to suggest that GH therapy will increase the risk of abnormal or neoplastic growth, either a new growth or a resurgence of an old tumour. There is no clinical experience of use of GH during pregnancy Reassessment On completion of an initial three to six month period on GH therapy, the patient should be re-evaluated repeating the baseline clinical, medical and biochemical assessment. The decision to continue therapy should be taken after discussion between the patient, the GP and the endocrinologist. The decision will be based on a number of factors. The improvement noted in quality of life and any return to a more normal body composition should be taken into account. Additionally, the long-term effects of cardiovascular risk factors should be considered. Evidence suggests that GH deficiency in adults increases the risk of cardiovascular disease, although long-term observations are required to confirm the effects of therapy. At this stage it is usual to see a decrease in bone mineral density due to an increase in bone turnover, improvement generally being noted from approximately one year after the start of therapy. 7

10 3. SHARED CARE RESPONSIBILITIES The optimal management of patients continuing with GH replacement therapy will depend upon the shared care co-operation between hospital and general practice 3.1 The Hospital s Role Aspects of care for which the hospital consultant is responsible: diagnosis and assessment of the suitability of the patient for GH replacement baseline assessment (as outlined in section 2.6) initiation of treatment provision of patient training in drug administration by specialist nurse provision of injection devices, aids and materials stabilisation of patient on optimal dose ongoing medical and biochemical assessment of response to therapy, including body composition measurements, lipid profile, serum IGF-1, HbA1c, blood pressure, quality of life assessment, pituitary function tests, pituitary imaging and visual field measurement, where relevant monitoring the patient s overall health and well-being liaison with GP on patient s progress discussion with patient of any adverse effects monitoring of self-administration and compliance 3.2 The Role of General Practice Aspects of care for which the GP is responsible: prescription of GH observation and report of any unexpected side-effects to the hospital endocrinologist monitoring of patient s overall health and well-being monitoring of self administration and compliance in conjunction with specialist nurse liaison with hospital endocrinologist to reach joint decision about further treatment 4. CONTACTS If you would like further information about these shared care guidelines or about your patient s clinical condition, please do not hesitate to contact the endocrine department: Dr J Dale Dr K Ashawesh Dr H Siddique Endocrine Outpatient Clinic Appointments Pharmacy Department Jane Elvidge NHS Dudley Prescribing Team

11 PATIENT SUPPORT GROUP The Pituitary Foundation 17/18 The Courtyard Woodlands Almondsbury Bristol BS12 4NQ Tel: