This is the text extract for Approval of proposal to fund Jadelle., browse documents here.

1 July 2010

Jadelle (levonorgestrel 2 x 75 mg rods) funding proposal approved

PHARMAC is pleased to announce that the approval of an agreement with Bayer New Zealand Limited for the listing and supply of levonorgestrel 2 x 75 mg rods (Jadelle). In summary, the effect of the decision is that: § Levonorgestrel 2 x 75 mg rods (Jadelle) will be funded without any access criteria from 1 August 2010.

This was the subject of a consultation letter dated 2 June 2010. Details of the proposal § Jadelle will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST) from 1 August 2010:

Chemical Levonorgestrel Presentation Subdermal implant (2 x 75 mg rods) Brand Jadelle Pack size 1 Price and Subsidy $133.65

§

Jadelle will be the sole subsidised Hormonal Long Acting Reversible Contraceptive in the Progesterone-only Contraceptives, Contraceptives – Hormonal sub-group on the Genito-Urinary System of section B of the Pharmaceutical schedule From 1 August 2010 to 31 December 2013. Bayer New Zealand Limited will provide training and insertion tools for clinicians (please contact Bayer for details).

§

Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 16 June 2010 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

A365086 Page 1 of 2

Theme Some responders said that while they welcomed the funding of a hormonal LARC they would prefer Implanon to Jadelle as they found it easier to insert.

Comment Prior to issuing the request for proposals for the supply of a hormonal LARC PHARMAC had received clinical advice that either implant would be satisfactory. The agreement between Bayer New Zealand and PHARMAC was conditional on Bayer New Zealand providing adequate training to ensure clinicians are comfortable in the insertion and removal technique.

Some responders suggested that an intensive post marketing programme be put in place.

Post marketing surveillance activities come under the auspices of either Medsafe or the supplier and PHARMAC have passed this suggestion to the supplier.

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.

A365086

Page 2 of 2