This is the text extract for 2009-03 Analgesic Subcommittee minutes, browse documents here.

Analgesic Subcommittee of PTAC meeting held 12 March 2009 (minutes for web publishing)

Analgesic Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008: Note that this document is not necessarily a complete record of the Analgesic Subcommittee meeting; only the Minutes relating to Analgesic Subcommittee discussions about an application that contain a recommendation in relation to an application are published. The Analgesic Subcommittee may: (a) recommend that a pharmaceutical be listed by PHARMAC on the Pharmaceutical Schedule and the priority it gives to such a listing; (b) defer a final recommendation, and give reasons for the deferral (such as the supply of further information) and what is required before further review; or (c) recommend that PHARMAC decline to list a pharmaceutical on the Pharmaceutical Schedule.

Contents

1 Octreotide............................................................................................................2

1

1

1.1

Octreotide

The Subcommittee considered the possible funding of octreotide to control nausea and vomiting in patients with intestinal obstruction resulting from metastatic cancer with intestinal spread, and for patients with high-output stomas and fistulae relating to metastatic cancer or inflammatory bowel disease, at the request of the Hospital Exceptional Circumstances (HEC) Panel, the PCMWG and PHARMAC staff. The Subcommittee considered that evidence for use of octreotide in stomas and fistulae was lacking and, therefore, the discussion focussed solely on the use of octreotide in controlling nausea and vomiting in patients with intestinal obstruction. The Subcommittee noted that HEC received about 15 applications per year for octreotide in this indication, almost all of which were approved. The Subcommittee noted that this was not a registered indication for octreotide. The Subcommittee reviewed the literature search provided by PHARMAC staff, including several randomised controlled trials. The Subcommittee considered that there was a reasonable amount of good evidence in support of the effectiveness of octreotide in this indication. The Subcommittee considered that there were no funded treatments that could be considered similar to octreotide. The Subcommittee noted that there were no funded alternatives for patients in whom first-line treatment with antiemetics and analgesics (eg cyclizine and hyoscine injection with dexamethasone) had failed and, therefore, considered the level of unmet clinical need to be high. The Subcommittee noted that octreotide has dramatic benefits in some patients, and considered that the quality of life for patients (and their caregivers) would be significantly improved by the reduction in faecal vomiting afforded by octreotide. The Subcommittee considered that most patients would receive octreotide for between 1 and 3 weeks, at an average dose of approximately 300–600 mg per day (outside range 0.2–1.2 mg per day). The Subcommittee considered that there would be cases where patients received longer-term treatment, but that those cases would be rare. The Subcommittee considered that the long-acting depot preparation of octreotide would not be used for this indication. The Subcommittee considered that if access to octreotide was widened, the Special Authority should be amended to include the following criteria: 1.1 Management of nausea and vomiting in patients with malignant bowel

obstruction unresponsive to first-line treatment with muscarinic agents, steroids and antiemetics.* 1.2 Note: indication marked with * is an Unapproved Indication.

1.2 1.3 1.4

1.5

1.6

1.7

1.8

2

1.9

The Subcommittee considered that if access to octreotide was widened as proposed there would be approximately 50–60 patients per year who would be likely to access ocreotide (including the patients currently accessing it under HEC); however, the Subcommittee noted that this was a “best estimate” and not based on any prevalence data. The Subcommittee noted that this number could be confirmed by using estimates based on the proportion of patients with pelvic and rectal malignancies that get bowel obstruction.

1.10 The Subcommittee recommended that access to octreotide be widened under the restrictions as proposed. The Subcommittee considered that, within the context of the analgesics/anaesthetics therapeutic area, this recommendation should be considered a high priority. 1.11 The Decision Criteria particularly relevant to this recommendation are: (i) The health needs of all eligible people within New Zealand; (iii) The availability and suitability of existing medicines, therapeutic medical devices and related products and related things; (iv) The clinical benefits and risks of pharmaceuticals; and (v) The cost-effectiveness of meeting health needs by funding pharmaceuticals rather than using other publicly funded health and disability support services.

3