<p> TA 188: REQUEST FOR FUNDING OF GROWTH HORMONE (SOMATROPIN) FOR THE TREATMENT OF GROWTH FAILURE IN CHILDREN Products covered: Genotropin, Humatrope, Norditropin, Nutropin Aq, Saizen, Omnitrope and Zomacton</p><p>This form to be used to obtain funding approval from the child’s commissioning organisation PRIOR to treatment initiation. Approved funding request will be for an initial 12 months, after which continued funding must be sought. The decision on product should be made with child and carer and advantages and disadvantages of products discussed. If more than one product is suitable, the least costly product should be chosen. </p><p>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 [email protected] </p><p>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.</p><p>Patient NHS No. Trust: GP Name: </p><p>Patient Hospital Number: Consultant Making GP code / Request: Practice code: Patient initials & DoB: Consultant Contact GP Post code: Details: Patient Criteria for Initiating Treatment For the purposes of funding all definitions are those set out in the NICE guidance that sets out the recommendations on use of this treatment. FUNDING WILL NOT BE APPROVED WITHOUT PATIENT GROWTH CHART. Patient has one of the following diagnoses (please tick):</p><p>Growth Hormone Deficiency Short stature homeobox-containing gene (SHOX) deficiency confirmed by Child’s current height cm and centile date DNA analysis</p><p>Mid parental height cm and centile Bone age Date of SHOX gene test: </p><p>Growth hormone stimulation test result: date Turner syndrome confirmed by chromosomal analysis Provide local reference range): Date of analysis TA 188GPA recommandation final______Last printed 1 Page of 8 IGF1 test result date provide normative range Prader Willi syndrome confirmed by : o Chromosomal analysis OR State any CNS pathology, surgery, or prior radiotherapy o Phenotype </p><p>Attach UK90 growth chart for patient Date of analysis </p><p>Born small for gestational age with subsequent growth failure at 4 Chronic Renal Insufficiency years or later Gestational age Birth Weight Renal function less than 50% normal </p><p>Child’s current height cm and centile date Confirmation that nutritional status and metabolic abnormalities have been optimised </p><p>Growth velocity in last year Confirmation that steroid therapy has been reduced to a minimum Mid parental height cm and centile </p><p>Attach UK90 growth chart for patient</p><p>Body weight used for dose calculation: Specify somatropin brand, formulation: </p><p>Body surface area: Has the length of treatment (12 months) and stopping criteria have been discussed with patient and carer: Date of measurement: Dose: Cost to be charged to the PCT per month: £ Expected Final Target Height range: Please note that this group prior approval is subject to initiation and If this patient is being jointly managed by a second consultant please state follow up of treatment response being undertaken by a specialist name here: paediatric endocrinology team.</p><p>I acknowledge and adhere to the cost effective use of somatropin as Name: Date: advocated in NICE TAG 188, and believe that within this Trust the above patient would be best managed as requested above: Signature (or email confirmation) by Trust Chief Pharmacist (or deputy) Name of supervising consultant: Name: Signature: Signature: Date: </p><p>TA 188GPA recommandation final______Last printed 2 Page of 8 For PCT Use PCT Informed: Date .by: Date: </p><p>TA 188GPA recommandation final______Last printed 3 Page of 8 ANNUAL TREATMENT REVIEW – THIS SECTION TO BE SENT TO THE PCT AT END OF YEAR 1, YEAR 2 AND YEAR 3 OF TREATMENT</p><p>Patient NHS No. Trust: GP Name: </p><p>Patient Hospital Number: Consultant Making GP code / Request: Practice code: Patient NHS Number: Hospital</p><p>Annual Treatment Review. Funding approval is for 12 months only Arrangements for review have been made: Y/ N Chronic renal impairment only: has patient received transplant? Y/ N Review date: Review parameters: Transplanted patients should discontinue growth hormone. Annual growth velocity in last 12 months: Date range over which measured: to For Prader Willi only: Please state reduction in BMI over last year: </p><p>Year following treatment Date Height in centimetres Annual reduction in skin fold thickness measurement: initiation</p><p>1 2 3 </p><p>Stopping Criteria Treatment with somatropin should be discontinued if any of the following apply:</p><p> Growth velocity in 1st 3 years for:</p><p> o If less than 50% above baseline value for year 1, 2 and 3. i.e. If baseline is 4cm, expected growth velocity each year is 6cm or more.</p><p> o Final height is approached and growth velocity is less than 2 cm total growth in 1 year Y/ N</p><p> There are insurmountable problems with adherence Y/ N</p><p> Final height is attained Y/ N</p><p>A positive response to any of the stopping criteria is an indication for treatment discontinuation.</p><p>TA 188GPA recommandation final______Last printed 4 Page of 8 Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG) </p><p>PLEASE SEE CRITERIA FOR TREATMENT FOR EACH CONDITION ON PAGES 4 & 5</p><p>Criteria for Treatment</p><p>Born small for gestational age with subsequent growth failure at 4 years or later: Criteria for treatment (note: all of the following must be met): Over 4 years of age Birth weight on or below 0.4th centile More than -2SDS (standard deviation score) below average height centile for age (below 3rd centile after the age of 5) More than -2.5SDS below the parental adjusted height (child’s centile is more than 2.5 centiles less than the mean parental height centile) Height velocity SDS is less than 0 over the past year (child is falling below their centile over the previous year). </p><p>Growth hormone deficiency: Criteria for treatment (note: all of the following must be met except for the last : o Height is > 2.5 SDS less than the mid parental height centile (i.e. the centile against which the child’s height is plotted is > 2.5 centiles lower than the centile on which mid parental height falls) NB: the growth charts include height and weight & the centiles for each. The provider plots the height in centimetres. The commissioner looks at which HEIGHT centile the child falls under. Centiles are marked as follows: 0.4th; 2nd, 9th, 25th, 50th, 75th, 91st, 98th, 99.6th. Each centile is one SDS. o Peak growth hormone following stimulation test BELOW THE REFERENCE CUT OFF RANGE FOR LABORATORY OR below 7mcg/l (GOSH) o IGF 1 test result at lower end of normative range given. o Exceptions: where there is clear evidence of CNS pathology, surgery OR prior radiotherapy, one growth hormone test showing deficiency is acceptable without a second test result. In such instances, child may not be -2.5 SD below mid-parental height.</p><p>Short stature homeobox-containing gene (SHOX) deficiency confirmed by DNA analysis Date of SHOX gene test Bone age <13 years for girls and <16 years for boys</p><p>TA 188GPA recommandation final______Last printed 5 Page of 8 Preparations of Somatropin Available in the U.K. These prices are applicable from February 2011</p><p>Growth Hormone brand Presentation (milligrams) Cost £/mg of growth hormone Genotropin (Pfizer) 5.3 mg Pen cartridge £23.18 12.0 mg Pen cartridge £23.18 0.2-2.0mg MiniQuick, in 0.2mg increments £23.18 Humatrope (Eli Lilly) 6 mg Pen cartridge £18.00 12 mg Pen cartridge £18.00 24 mg Pen cartridge £18.00 Norditropin SimpleXx (Novo Nordisk) 5 mg Pen cartridge £21.27 10 mg Pen cartridge £21.27 15 mg Pen cartridge £21.27 Nutropin Aq (Ipsen) 10 mg Pen cartridge £20.30 Omnitrope (Sandoz) 5 mg Pen cartridge £17.35 Saizen (Serono) 8.0 mg Click-Easy cartridge £23.18 Zomacton (Ferring) 4 mg vial £19.92</p><p>East of England Paediatric Endocrinology Services</p><p>TA 188GPA recommandation final______Last printed 6 Page of 8 Local Supporting Hospital centre Lead pediatrician / Tertiary Endocrine centre / Endocrinologist Paediatric Endocrinologist </p><p>Dr Carlo Acerini Addenbrooke’s Hospital Prof David Dunger N/A Cambridge Prof Ieuan Hughes Dr Ken Ong</p><p>Cambridge Bedford Dr Ramesh Mehta Prof Ieuan Hughes</p><p>Queen Elizabeth Hospital Cambridge Dr Sue Rubin Kings Lynn Prof Ieuan Hughes</p><p>Cambridge Peterborough Dr Vijith Puthi Prof David Dunger</p><p>Cambridge Ipswich Dr Jackie Buck Prof David Dunger</p><p>Hinchingbrooke Hospital Cambridge Dr Rajiv Goonetilleke Huntingdon Dr Carlo Acerini</p><p>West Suffolk Hospital Cambridge Dr Binu Anand Bury St Edmunds Dr Carlo Acerini</p><p>Dr Nandu Thalange Cambridge Norwich Dr Vipan Datta Dr Carlo Acerini</p><p>Norwich Great Yarmouth Dr Viji Raman Dr Nandu Thalange</p><p>Barts & Royal London Basildon Dr Birgit Van-Meigaarden Dr Jeremy Allgrove</p><p>Barts & Royal London Chelmsford Dr Sharon Lim Dr Jeremy Allgrove TA 188GPA recommandation final______Last printed 7 Page of 8 Local Supporting Hospital centre Lead pediatrician / Tertiary Endocrine centre / Endocrinologist Paediatric Endocrinologist </p><p>GOSH, London Colchester Dr Nicola Cacket Dr Caroline Brain</p><p>Harlow Dr T Balakumar tbc</p><p>Southend Dr Ravi Chetan tbc</p><p>GOSH, London Luton Dr Nisha Nathwani Prof Mehul Dattani Prof Pete Hindmarsh</p><p>GOSH, London Stevenage tbc Prof Mehul Dattani</p><p>Dr Heather Mitchell GOSH, London Watford Dr Vasanta Nanduri Prof Mehul Dattani Prof Pete Hindmarsh</p><p>Addenbrooke’s Hospital contact details</p><p>Specialist Post Telephone Specialist nurses Specialist nurses 01223 217496 Dr C Acerini Consultant 01223 274311 Dr K Ong Consultant 01223 274311 Prof D Dunger Consultant 01223 274311 Prof I Hughes Consultant 01223 274311</p><p>TA 188GPA recommandation final______Last printed 8 Page of 8</p>