Application for continued supply of growth hormone for the

PBS Growth Hormone Programme
Application for continued supply of growth hormone
for the treatment of Prader-Willi Syndrome
Section 100 arrangements
Growth hormone (somatropin) is subsidised by the Australian Government through special Pharmaceutical Benefits Scheme (PBS)
arrangements under Section 100 of the National Health Act 1953.
The supply of growth hormone (GH) under Section 100 is governed by the National Health (Growth Hormone Program) Special
Arrangement 2011. The Guidelines for the Pharmaceutical Benefits Scheme Growth Hormone Programme support the Special
Arrangement. The PBS GH Programme, including the determination of eligibility for subsidised GH, is administered by the Department of
Health in accordance with the Special Arrangement.
It is recommended that you read the Guidelines before completing this application form. Applications to continue GH treatment will be
assessed primarily according to the following sections of the Guidelines: continuation criteria (Section 3.10.3); response criteria (Section
4.2.4); dose levels (Section 4.2); and exclusion criteria (Section 3.11).
The Guidelines are available from the Department of Health's website at www.health.gov.au/hgh
Important Information
l
l
l
l
l
All pages of the form must be submitted every 6 months to allow an assessment to take place. If you have a preformatted clinical data
sheet that contains all the required information, it may be submitted in place of pages 4 and 5.
Application forms must be signed and dated at each application and must be submitted by a specialist paediatric endocrinologist,
specialist paediatrician, or registered medical practitioner in consultation with a specialist paediatric endocrinologist or specialist
paediatrician.
Forms are due at least 4 weeks before current GH supplies are due to run out.
It is the responsibility of the treating clinician to ensure that the patient's family is informed of arrangements for continuing treatment,
including dose.
Completed forms may be emailed, faxed or posted to the Department using the contact details provided below. Data checklists are
available at www.health.gov.au/hgh to assist clinicians with ensuring required information is supplied.
Patient details
Patient Family Name:
Patient Given Name:
Date of Birth:
H Number:
Date Treatment First Commenced (must be supplied at the first reapplication):
Prescribing Doctor's details
I declare that:
l To the best of my knowledge and belief, all the information provided on this form and any attachments is true; and
l This patient does not have a condition listed in the Guidelines at Section 3.11, which would exclude them from GH treatment.
Doctor's Family Name:
Doctor's Given Name:
Signature of Doctor:@
Signature Date:
Have details recently changed?
No (go to next section)
Yes (please detail below)
Prescriber Number (Mandatory for change of doctor):
Speciality:
Paediatric Endocrinologist
Paediatrician
Registered medical practitioner (in consultation with a paediatric
endocrinologist or paediatrician)
Postal Address:
City:
Phone:
State:
Fax:
Postcode:
Email:
PBS Growth Hormone Programme, Department of Health, MDP 901, GPO Box 9848, CANBERRA ACT 2601
Telephone: (02) 6289 7274
Fax: (02) 6289 3175 Email: [email protected]
Web: www.health.gov.au/hgh
Effective date of this form: 1 March 2014
1 of 5
PBS Growth Hormone Programme
Application for continued supply of growth hormone
for the treatment of Prader-Willi Syndrome
Patient Family Name:
H Number:
Patient Given Name:
Delivery Address
• GH can only be delivered to a hospital or community pharmacy
• The delivery addressee must agree to be the delivery point for the patient's growth
hormone supplies.
Pharmacy Name:
Have details recently changed?
No (go to next section)
Yes (please detail below)
Contact Person:
Street Address:
City:
State:
Phone:
Postcode:
Fax:
Email:
Re-evaluation for airway obstruction and apnoea within the first 6 months on GH treatment (ideally within
the first 8 weeks) (Required at the first reapplication only)
Date of Evaluation:
Result:
Summary of recommended interventions and related outcomes:
Sections on product, dose and number of cartridges remaining must be completed at each application for continuing
treatment. Failure to provide this information may result in a delay in ordering of new supplies of growth hormone.
Product Requested
Same as previous supply (go to next section)
Change of product (please detail below)
Where multiple forms of an individual brand of growth hormone are available, the treation doctor must identify the specific
form he/she wishes to prescribe (refer to attachment 6.1 of the Guidelines).
Product & strength:
Administration method:
Injection frequency:
Pen Device
Requested order form the supplier:
Syringes
Pen Needles
Syringes
Needle/syringe size requested:
Any other comments or special requirements:
PBS Growth Hormone Programme, Department of Health, MDP 901, GPO Box 9848, CANBERRA ACT 2601
Telephone: (02) 6289 7274
Fax: (02) 6289 3175 Email: [email protected]
Web: www.health.gov.au/hgh
Effective date of this form: 1 March 2014
2 of 5
PBS Growth Hormone Programme
Application for continued supply of growth hormone
for the treatment of Prader-Willi Syndrome
Patient Family Name:
H Number:
Patient Given Name:
Dose (refer to Section 4 of the Guidelines)
Dose approved at last application:
* Note: Dose will be calculated based on ideal
weight for height if the patient has a BMI greater
than the 85th percentile for age.
mg/wk
Requested dose (tick one box only)
Maintain the dose level (mg/m2/wk) and adjust absolute dose to account for increased body surface area
Continue the same absolute dose (mg/wk)
Skeletal maturity dose - 0.04mg/kg/wk - patient has a bone age of > 15.5 yrs (males) or 13.5 yrs (females)
Increase to maximum dose as qualifies as older child
Dose increase to
mg/m2/wk =
mg/wk *refer to the dose tiltration chart, Section 4 of Guidelines
Reason for dose increase request:
Number of Cartridges Remaining (order date for further supplies will be based on remaining supply)
Number of cartridges/boxes at home:
Date cartridges/ boxes counted:
This remaining supply will last approximately:
weeks and
days.
What date was the supply expected to last until (based on the Department's previous approval letter):
Reason patient's supply lasted 3 or more weeks longer or ran out or 3 or more weeks earlier then expected (if
applicable):
Adverse Events
Has the patient experienced any adverse events attributable to GH therapy over the past 6 months?
No
Yes
If you answered 'Yes' to the above, please notify the Therapeutic Goods Administration (TGA) of the adverse event.
Information on how to notify the TGA is available at http://www.tga.gov.au/safety/problem.htm#medicine
PBS Growth Hormone Programme, Department of Health, MDP 901, GPO Box 9848, CANBERRA ACT 2601
Telephone: (02) 6289 7274
Fax: (02) 6289 3175 Email: [email protected]
Web: www.health.gov.au/hgh
Effective date of this form: 1 March 2014
3 of 5
PBS Growth Hormone Programme
Application for continued supply of growth hormone for the treatment of Prader-Willi Syndrome
CLINICAL DATA
This data may be submitted using your clinic's preformatted database print out, provided all mandatory data is included
l 6 months worth of growth data should be provided at each reapplication, with the most recent height, weight and waist measurements no more than 3 months old.
l A new bone age reading, IGF-1, TSH and FT4 results must be provided every 12 months.
Patient Family Name:
Mandatory Data
Date of Visit
Age at Visit
H Number:
Patient Given Name:
Height (cm)
Weight (kg)
Waist (cm)
Bone age
reading date
Bone age
Body
composition
data#
IGF-1
TSH
FT4
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
Date:
Date:
Date:
Results:
Results:
Results:
Range:
Range:
Range:
Units:
Units:
Units:
# Bioelectrical impedance (BI) or duel energy x-ray absorptiometry (DEXA) - provide if available
PBS Growth Hormone Programme, Department of Health, MDP 901, GPO Box 9848, CANBERRA ACT 2601
Telephone: (02) 6289 7274
Fax: (02) 6289 3175 Email: [email protected]
Web: www.health.gov.au/hgh
Effective date of this form: 1 March 2014
Page 4 of 5
PBS Growth Hormone Programme
Application for continued supply of growth hormone for the treatment of Prader-Willi Syndrome
CLINICAL DATA
This data may be submitted using your clinic's preformatted database print out, provided all mandatory data is included
Patient Family Name:
H Number:
Patient Given Name:
Additional data for use by GHAC and OZGROW (provide if available)
Date of
Visit
Pubic hair
Breast stage
stage
Genital
stage
Left testis Right testis
size (ml)
size (ml)
Menses
Head
circumference
(cm)
Scoliosis
Kyphosis
Hypotonia
Developmental Is the patient
delay
tube fed?
IGFBP-3
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Range:
Angle:
Units:
Date:
Results:
Angle:
Print Form
Range:
Angle:
Save Form
Units:
Attach Supporting
Documents
Submit by Email
(for electronically signed forms only)
PBS Growth Hormone Programme, Department of Health, MDP 901, GPO Box 9848, CANBERRA ACT 2601
Telephone: (02) 6289 7274
Fax: (02) 6289 3175 Email: [email protected]
Web: www.health.gov.au/hgh
Effective date of this form: 1 March 2014
Page 5 of 5

Download Report