Clinical criteria:

• Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

• The condition must be unresectable locally advanced disease or metastatic disease,

AND

• The condition must be World Health Organisation (WHO) grade 1 or 2,

AND

• The treatment must be the sole PBS-subsidised therapy for this condition.

Population criteria:

• Patient must be aged 18 years or older.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Clinical criteria:

Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

The condition must be causing intractable symptoms,

AND

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

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate,

AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg 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.

Clinical criteria:

Patient must have previously received PBS-subsidised treatment with this drug for this condition,

AND

The condition must be active,

AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre,

AND

The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated,

AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose),

AND

The treatment must cease if IGF1 is not lower after 3 months of treatment,

AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.