Download Patient Criteria for Initiating Treatment

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
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.
Patients who do not meet the agreed eligibility criteria/incomplete forms
NHS Cambridgeshire will not normally fund any Growth Hormone treatment where the patient does not meet the agreed criteria as outlined in this Individual Prior
Approval, or where the form is not completed in full.
Payment Authorisation: The completed form must be sent to the High Cost Drugs/Exceptional Cases Team Cambridgeshire and Peterborough CCG via the local
commissioning team Email: [email protected]
Payment by the CCG will only be made if the completed form is received before INITIAL treatment commences.
Patient Consent
Delete as appropriate
Is the patient aware of this referral and the contents of this form and supporting documents?
YES/NO
I confirm that the patient consents to the CCG Exceptional Cases Team accessing personal clinical information about them that is held
YES/NO
by clinical staff involved with their care to enable full consideration of this GPA.
By submitting this GPA you are confirming that you have fully explained to the patient the proposed treatment and they have consented to you raising
this GPA on their behalf. It is NHS Cambridgeshire and Peterborough CCG’s policy to let the patient know of the outcome of the funding application
unless it is not clinically appropriate to do so.:
Mark as appropriate
I confirm that it is clinically appropriate for the patient to be copied into all correspondence.
I confirm that it is not clinically appropriate for the patient to be copied into all correspondence.
Mark this box to confirm
Please confirm that you have brought the CCG patient leaflet on the collection and use of patient data for the funding application
process to the patient’s attention: ‘Why we need to collect your personal confidential information and your rights’. The leaflet is
available on the following web page: http://www.cambsphn.nhs.uk/CCPF/ExcptnalandIFR.aspx
GPA Request
Patient NHS No:
Patient Hospital No:
Patient DoB:
Trust:
GP Name:
Page 1 of 8
Patient Name and
Address:
Confirm patient status:
NHS / Private/ Overseas*
(*select 1 option)
Consultant requesting
treatment (print name):
GP code /
Practice code:
Hospital commissioning
Consultant contact details
(unless same as*):
GP Post code:
Hospital commissioning
to complete
to complete
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):
Growth Hormone Deficiency
Child’s current height
cm and centile
Mid parental height
cm
date
Bone age
and centile
Growth hormone stimulation test result:
date
date
provide normative range
State any CNS pathology, surgery, or prior radiotherapy
Born small for gestational age with subsequent growth failure at 4
years or later
Gestational age
Birth Weight
cm and centile
date
Growth velocity in last year
Mid parental height
Turner syndrome confirmed by chromosomal analysis
Prader Willi syndrome confirmed by :
o Chromosomal analysis OR
o Phenotype
Date of analysis
Attach UK90 growth chart for patient
Child’s current height
Date of SHOX gene test:
Date of analysis
(Provide local reference range for GHI):
IGF1 test result
Short stature homeobox-containing gene (SHOX) deficiency confirmed
by DNA analysis
Chronic Renal Insufficiency
Renal function less than 50% normal
Confirmation that nutritional status and metabolic abnormalities have been optimised
Confirmation that steroid therapy has been reduced to a minimum
cm
and
centile
Attach UK90 growth chart for patient
Page 2 of 8
Body weight used for dose calculation:
Specify somatropin brand, formulation:
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
follow up of treatment response being undertaken by a specialist
paediatric endocrinology team.
If this patient is being jointly managed by a second consultant please state
name here:
I acknowledge and adhere to the cost effective use of somatropin as
advocated in NICE TAG 188, and believe that within this Trust the above
patient would be best managed as requested above:
Name of supervising consultant:
Name:
Signature:
Date:
Page 3 of 8
Date:
ANNUAL TREATMENT REVIEW – THIS SECTION TO BE SENT TO THE CCG AT END OF YEAR 1, YEAR 2 AND YEAR 3 OF TREATMENT
Patient NHS No.
Patient Hospital Number:
Patient NHS Number:
Trust:
GP Name:
Consultant Making
Request:
Hospital
GP code /
Practice code:
Annual Treatment Review. Funding approval is for 12 months only
Arrangements for review have been made:
Y/
N
Review date:
Review parameters:
Annual growth velocity in last 12 months:
Date range over which measured:
Chronic renal impairment only: has patient received transplant?
Transplanted patients should discontinue growth hormone.
For Prader Willi only: Please state reduction in BMI over last year:
to
Year following treatment
initiation
Date
Y/
Height in centimetres
Annual reduction in skin fold thickness measurement:
1
2
3
Stopping Criteria
Treatment with somatropin should be discontinued if any of the following apply:

Growth velocity in 1st 3 years for:
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.
o
Final height is approached and growth velocity is less than 2 cm total growth in 1 year

There are insurmountable problems with adherence

Final height is attained
Y/
Y/
N
N
A positive response to any of the stopping criteria is an indication for treatment discontinuation.
Page 4 of 8
Y/
N
N
PLEASE SEE CRITERIA FOR TREATMENT FOR EACH CONDITION ON PAGES 4 & 5
Criteria for Treatment
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).
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.
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
Page 5 of 8
Preparations of Somatropin Available in the U.K. These prices are applicable from February 2011
Growth Hormone brand
Genotropin (Pfizer)
Humatrope (Eli Lilly)
Presentation (milligrams)
5.3 mg Pen cartridge
Cost £/mg of growth hormone
£23.18
12.0 mg Pen cartridge
£23.18
0.2-2.0mg MiniQuick, in 0.2mg increments
£23.18
6 mg Pen cartridge
£18.00
12 mg Pen cartridge
£18.00
24 mg Pen cartridge
£18.00
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
Norditropin SimpleXx (Novo Nordisk)
Page 6 of 8
East of England
Paediatric Endocrinology Services
Hospital centre
Local
Lead pediatrician /
Paediatric Endocrinologist
Supporting
Tertiary Endocrine centre / Endocrinologist
Addenbrooke’s Hospital
Cambridge
Dr Carlo Acerini
Prof David Dunger
Prof Ieuan Hughes
Dr Ken Ong
N/A
Bedford
Dr Ramesh Mehta
Cambridge
Prof Ieuan Hughes
Queen Elizabeth Hospital
Kings Lynn
Dr Sue Rubin
Cambridge
Prof Ieuan Hughes
Peterborough
Dr Vijith Puthi
Cambridge
Prof David Dunger
Ipswich
Dr Jackie Buck
Cambridge
Prof David Dunger
Hinchingbrooke Hospital
Huntingdon
Dr Rajiv Goonetilleke
Cambridge
Dr Carlo Acerini
West Suffolk Hospital
Bury St Edmunds
Dr Binu Anand
Cambridge
Dr Carlo Acerini
Norwich
Dr Nandu Thalange
Dr Vipan Datta
Cambridge
Dr Carlo Acerini
Great Yarmouth
Dr Viji Raman
Norwich
Dr Nandu Thalange
Basildon
Dr Birgit Van-Meigaarden
Barts & Royal London
Dr Jeremy Allgrove
Page 7 of 8
Hospital centre
Local
Lead pediatrician /
Paediatric Endocrinologist
Supporting
Tertiary Endocrine centre / Endocrinologist
Chelmsford
Dr Sharon Lim
Barts & Royal London
Dr Jeremy Allgrove
Colchester
Dr Nicola Cacket
GOSH, London
Dr Caroline Brain
Harlow
Dr T Balakumar
tbc
Southend
Dr Ravi Chetan
tbc
Luton
Dr Nisha Nathwani
GOSH, London
Prof Mehul Dattani
Prof Pete Hindmarsh
Stevenage
tbc
GOSH, London
Prof Mehul Dattani
Watford
Dr Heather Mitchell
Dr Vasanta Nanduri
GOSH, London
Prof Mehul Dattani
Prof Pete Hindmarsh
Addenbrooke’s Hospital contact details
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
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