Notification to remove the Special Authority Criteria from various oncology products and pioglitazone

Hospital devices Decision

PHARMAC is pleased to announce the approval of a proposal to widen funded access on a number of products from 1 December 2012 by removing the Special Authority restrictions that currently apply.

This was the subject of a consultation letter dated 26 October 2012.

The effect of the decision is that from 1 December 2012, the Special Authority criteria will be removed from the following pharmaceuticals listed in Section B of the Pharmaceuticals Schedule:

  • Anagrelide hydrochloride cap 0.5 mg
  • Gemcitabine hydrochloride inj 1 g, inj 200 mg and inj 1 mg for ECP
  • Irinotecan inj 20 mg per ml, 2 ml, inj 20 mg per ml, 5 ml, and inj 1 mg for ECP
  • Oxaliplatin inj 50 mg, inj 100 mg and inj 1 mg for ECP
  • Vinorelbine inj 10 mg per ml, 1 ml, inj 10 mg per ml, 5 ml and inj 1 mg for ECP
  • Capecitabine tab 150 mg and 500 mg
  • Octreotide (somatostatin analogue) inj 50 µg per ml, 1 ml, 100 µg per ml, 1 ml, and 500 µg per ml, 1 ml
  • Pioglitazone tab 15 mg, 30 mg and 45 mg

Please note octreotide Inj LAR 10 mg, Inj LAR 20 mg and Inj LAR 30 mg prefilled syringes will remain listed subject to their existing Special Authority criteria.

The decision means that these treatments can now be funded for any patient, and it is expected to be particularly beneficial for breast, stomach and pancreatic cancer patients.

As well as enabling these treatments to be funding for more patients this decision will significantly reduce the administrative burden on clinicians, pharmacists, PHARMAC and Ministry of Health staff of applying for, and processing, approximately 4,000 Special Authority applications annually.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 9 November 2012 were considered in their entirety in making a decision on the proposal. All responders supported the proposal. Key issues raised and PHARMAC comments on these issues are discussed in the table on the next page:

Theme PHARMAC Comment
One responder considered that Special Authority should remain on pioglitazone due to safety concerns We acknowledge that all pharmaceuticals have risks and benefits and note that the MedSafe approved product datasheet is the appropriate source of such information for prescribers. PHARMAC’s use of access restrictions is principally to reduce financial risk to the Pharmaceutical Budget by targeting treatments to patients that benefit most. We consider that colleges, societies and registration authorities are primarily responsible for ensuring their members prescribe pioglitazone, and other pharmaceuticals, appropriately and safely.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.