Decision to fund lanreotide for various indications

Initial application - (malignant bowel obstruction) from any relevant practitioner. Approvals valid for 2 months for applications meeting the following criteria:

All of the following:

1. The patient has nausea* and vomiting* due to malignant bowel obstruction*; and
2. Treatment with antiemetics, rehydration, antimuscarinic agents, corticosteroids, and analgesics for at least 48 hours has not been successful; and
3. Treatment to be given for up to 4 weeks

Note: Indications marked with * are unapproved indications

Renewal - (malignant bowel obstruction) from any relevant practitioner. Approvals valid for 3 months where the treatment remains appropriate and the patient is benefiting from treatment.

Initial application - (acromegaly) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

1. The patient has acromegaly; and
2. Either:
   1. Treatment with surgery and radiotherapy is not suitable or was unsuccessful; or
   2. Treatment is for an interim period while awaiting the beneficial effects of radiotherapy; and
3. Treatment with a dopamine agonist has been unsuccessful.

Renewal - (acromegaly) from any relevant practitioner. Approvals valid for 2 years for applications where IGF1 levels have decreased since starting treatment.

Note: In patients with acromegaly, treatment should be discontinued if IGF1 levels have not decreased 3 months after treatment. In patients treated with radiotherapy treatment should be withdrawn every 2 years, for 1 month, for assessment of remission. Treatment should be stopped where there is biochemical evidence of remission (normal IGF1 levels) following treatment withdrawal for at least 4 weeks.

Renewal — (Acromegaly - pandemic circumstances) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

1 Patient has acromegaly; and

2 The patient is clinically benefiting from treatment and continued treatment remains appropriate; and

3 The regular Special Authority renewal requirements cannot be met due to COVID-19 constraints on the health sector.

Initial application - (pre-operative acromegaly) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has acromegaly; and
2. Patient has a large pituitary tumour, greater than 10 mm at its widest; and
3. Patient is scheduled to undergo pituitary surgery in the next six months.

Initial application - (Other indications) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following:

1. VIPomas and glucagonomas – for patients who are seriously ill in order to improve their clinical state prior to definitive surgery; or
2. Both:
   1. Gastrinoma; and
   2. Either:
      1. Surgery has been unsuccessful; or
      2. Patient has metastatic disease after treatment with H2 antagonist or proton pump inhibitors has been unsuccessful; or
3.  Both:
   1. Insulinomas; and
   2. Surgery is contraindicated or has not been successful; or
4. For pre-operative control of hypoglycaemia and for maintenance therapy; or
5. Both
   1. Carcinoid syndrome (diagnosed by tissue pathology and/or urinary 5HIAA analysis); and
   2. Disabling symptoms not controlled by maximal medical therapy.

Note: The use of a long-acting somatostatin analogue in patients with fistulae, oesophageal varices, miscellaneous diarrhoea and hypotension will not be funded under Special Authority.

Renewal - (Other indications) from any relevant practitioner. Approvals valid for 2 years for applications where the treatment remains appropriate and the patient is benefitting from treatment.