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Gastrointestinal stromal tumour GIST

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					                                       Gastrointestinal stromal tumour
                                         PBS authority application

Important information                                                     Patients who fail to achieve a response to 400 mg per
                                                                          day, after a minimum of three months treatment, may
You must lodge this form for an adult patient starting                    have their dose increased to 600 mg per day. Authority
initial Pharmaceutical Benefit Scheme (PBS)                               applications for doses higher than 600 mg per day will
subsidised treatment with imatinib for metastatic or                      not be approved.
unresectable malignant gastrointestinal stromal tumour.
                                                                          All applications for continuing treatment may be made
All applications must be in writing and must include                      by telephone to 1800 700 270* and select option 3 (8
sufficient information to determine the patient’s eligibility             am and 5 pm EST Monday to Friday).
according to the PBS criteria.
For all initial applications supply:                                      Assistance
•	 a copy of the pathology report supporting diagnosis                    If you need assistance in completing this form, call
   of a gastrointestinal stromal tumour and confirming                    Medicare Australia on 1800 700 270* and select
                                                                          option 3 (8 am to 5 pm EST Monday to Friday), or visit
   the presence of CD117 on immunohistochemical
                                                                          www.medicareaustralia.gov.au
   staining
•	 a copy of the most recent (within two months of
                                                                          Lodgement
   application), computer tomography (CT) scan,
   magnetic resonance imaging (MRI) or ultrasound                         Send the completed authority application form, all
   assessment of the tumour(s) including whether or                       relevant attachments and a completed authority
   not there is evidence of metastatic disease                            prescription form to:
                                                                          Medicare Australia
•	 written evidence to support an application which is
                                                                          Prior written approval of specialised drugs
   being made on the basis of an unresectable tumour.                     Reply Paid 9826
All patients must start treatment at a dose of imatinib                   GPO Box 9826
not exceeding 400 mg per day for three months.                            Hobart TAS 7001
Authority prescriptions for a higher dose will not be                     (no stamp required if posted in Australia)
approved during this initial treatment period.
The information on this form is correct at the time of                    Tick where applicable ✓
publishing and is subject to change.
                                                                          * Call charges apply from mobile or pay phones only

Authority prescription form
A completed authority prescription form must be
included with this document.
The medical indication section of the authority
prescription form does not need to be completed when
submitted with this supporting information form.


Applications for continuing treatment
Patients who achieve a response to treatment at an
imatinib dose of 400 mg per day should be continued
at this dose and assessed for response at regular
intervals.
A response to treatment is defined as a decrease from
baseline in the sum of the products of the perpendicular
diameters of all measurable lesions of 50% or greater.
(Response definition based on the Southwest Oncology
Group standard criteria, see Demetri et al. N Engl J Med
2002; 347: 472-80.)

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                                         Gastrointestinal stromal tumour
                                           PBS authority application
                                            Supporting information
For initial PBS subsidised treatment of adult patients                   Treatment date range
with imatinib for metastatic or unresectable malignant                              /   /                 /   /
gastrointestinal stromal tumour.                                         from                      to
                                                                         and
Complete all parts of the application                                    has, within two months of the date of this application,
Print neatly in BLOCK LETTERS                                            had assessment of the tumour(s) by either:
                                                                         a computer tomography (CT scan)
Patient’s details                                                        or
1 Medicare/DVA card number                                               a magnetic resonance imaging (MRI) scan
                                                                         or
                                        Reference number
                                                                         an ultrasound assessment
2 Dr     Mr    Mrs        Miss     Ms       Other
                                                                              Attach all relevant reports and a completed
   Family name                                                                authority prescription form.


   First given name                                                  Prescriber’s details
                                                                     5 Prescriber number
3 Date of birth
        /   /                                                        6 Family name

Conditions, criteria and prior treatment
                                                                         First given name
4 To qualify for PBS authority approval, under this
   criterion, the following conditions must be met.
   The patient:                                                      7 Work phone number
   has metastatic malignant gastrointestinal                             (      )
   stromal tumour(s)
   or                                                                    Alternative phone number
   an unresectable malignant gastrointestinal stromal
   tumour (written evidence must be supplied)                            Fax number
   and                                                                   (      )
   has a pathology report which confirms the presence
   of CD117 on immunohistochemical staining                          Prescriber’s declaration
   Give the following details from the report
                                                                     8 I declare that the information provided on this form is
   Approved pathology authority (APA) name                               true and correct.
                                                                         Prescriber’s signature
   Date of report                                                                                                 Date

        /   /                                                            -                                               /   /
   and
                                                                     Privacy note
   has not received any prior treatment with
   imatinib for GIST                                                 The information provided on this form will be used to
   or                                                                assess applications and eligibility for the nominated patient
   is currently receiving unsubsidised treatment                     under the restrictions for PBS subsidised treatment for
   with imatinib for GIST                                            gastrointestinal stromal tumour. The collection of this
   Provide details of dose and duration of treatment                 information is authorised by the National Health Act 1953
                                                                     and may be disclosed to the Department of Health and
   Dose             mg/day                                           Ageing, or as authorised or required by law.

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