Lanreotide Acetate (Somatuline Autogel®)
Highly Specialised Drugs Program Declaration Form*
| Patient's Name: | ____________________________________ |
| Medical Record Number: | ____________________________________ |
| Medicare Number: | ____________________________________ |
I certify that the above patient meets the Pharmaceutical Benefits Advisory Committee's criteria for funding under Section 100 of the National Health Act, 1953.
Criteria
Tick box to indicate the criterion that applies
Active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms/ Litre AND
(a) after failure of other therapy including dopamine agonists; OR
(b) as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated.
In a patient treated with radiotherapy. subsidisation through the HSD Program must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawan for at least 4 weeks (8 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Subsidisation through the HSD Program must cease if IGF1 is not lower after 3 months treatment.
Functional carcinoid tumour causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate.
Subsidisation through the HSD Program must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months of therapy at a dose of 120mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
*To be completed by the specialist initiating drug treatment, and retained by the hospital Pharmacy Department.
July 2007