3 July 2009 Proposal for funding potassium iodate Proposal summary PHARMAC is seeking feedback on a proposal to fund an iodine supplement for the treatment of iodine deficiency with effect from 1 September 2009. Further details of the proposal can be found below and on the following page. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm on Friday 17 July 2009 to: Mike Bignall Therapeutic Group Manager PHARMAC Email: mike.bignall@pharmac.govt.nz Fax: 04 460 4995 Post: PO Box 10 254, Wellington 6143 All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal. Details of the proposal We have entered into a provisional agreement with Alaron Products Limited to list potassium iodate in Section B of the Pharmaceutical Schedule without any restrictions from 1 September 2009 at the following price and subsidy (ex-manufacturer, excluding GST): Pack Size 90 Proposed price and subsidy $7.55 Pharmaceutical Brand Form and Strength Potassium Iodate NeuroKare Tablet 150 µg NeuroKare is currently being evaluated by Medsafe and the listing would only occur if the product gains Medsafe approval. The price of NeuroKare would be reduced, and remained at the reduced price based on the volume of potassium iodate that has been subsidised following the listing of NeuroKare on the Pharmaceutical Schedule, as follows (ex-manufacturer, excluding GST): A272320 Page 1 of 2 Trigger Volume Adjust Price for NeuroKare (Packs of 90 NeuroKare tablets) 165,001 300,001 500,001 750,001 900,001 1,150,001 $6.53 per pack $6.28 per pack $6.03 per pack $5.78 per pack $5.65 per pack $5.53 per pack NeuroKare would have protection from delisting and subsidy reduction until 1 July 2012. Background to the Proposal In 2008, the Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed an application from the Ministry of Health for the listing of an iodine supplement on the Pharmaceutical Schedule for the treatment of iodine deficiency in pregnant and breastfeeding women. The Committee noted that iodine deficiency and goitre was endemic in New Zealand until the iodisation of salt and the use of iodine containing sanitisation agents by the dairy industry. However, the Committee also noted that since the early 1990’s iodine dietary intake has reduced, presumably due to a reduction in salt intake and the switch to noniodine containing agents by the dairy industry. The Committee noted several New Zealand studies which suggest that New Zealand pregnant and breastfeeding women and their infants are at least mildly if not moderately iodine deficient. The Committee noted that the consequences of mild-to-moderate iodine deficiency in pregnancy are not as clear as those of severe iodine deficiency; however, they are likely to include sub-optimal neurological development and delayed psychomotor development. The Committee considered that the current salt iodisation programme was not sufficient for pregnant and breastfeeding women and despite the upcoming mandatory fortification of bread with iodine from 1 September 2009, pregnant and breastfeeding women and their infants could still be at risk of iodine deficiency. PTAC recommended that a tablet containing an iodine dose of 150 mcg to 200 mcg be listed on the Pharmaceutical Schedule with a high priority for pregnant and breast feeding women. We estimate that approximately 65,000 people may receive funding of iodine should this proposal be approved. A272320 Page 2 of 2