This is the text extract for Proposal regarding Sigma’s brands of furosemide tablets, ethambutol tablets and atopine eye drops. Closed, browse documents here.

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13 October 2009

Proposal regarding Sigma’s brands of furosemide tablets (Urex Forte), ethambutol tablets (Myambutol) and atopine eye drops (Atropt)

PHARMAC is seeking feedback on a provisional agreement with Sigma Pharmaceuticals (Australia) Pty Ltd regarding furosemide 500 mg tablets, ethambutol 100 mg and 400 mg tablets and atropine 1% eye drops. In summary, this agreement would result in Urex Forte (furosemide) 500 mg tablets and Myambutol (ethambutol) 100 mg tablets being listed in Section B and in Section H of the Pharmaceutical Schedule from 1 December 2009. These pharmaceuticals are currently undergoing Medsafe registration and would be supplied under Section 29 of the Medicines Act 1981 until they are registered. In addition: the price and subsidy for Atropt (atropine) 1% eye drops would increase from 1 December 2009; the price and subsidy for Urex Forte and Myambutol would decrease once they have gained Medsafe registration; and Urex Forte, Atropt and Myambutol would have subsidy and delisting protection until 1 December 2012. Further details and background to the proposal can be found on the next page. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 28 October 2009 to: Greg Williams Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: greg.williams@pharmac.govt.nz Fax: 04 460 4995

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.

A312605 Page 1 of 2

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Details of the proposal Sigma Pharmaceuticals (Australia) Pty Ltd’s Urex Forte, Myambutol and Atropt would be listed in Sections B and H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer and exclusive of GST) from 1 December 2009:

Chemical Presentation Brand Pack Size Current price and subsidy $4.40 N/A N/A Proposed price and subsidy $17.36 $57.81 $50.00

Atropine Ethambutol Furosemide

1% eye drop 100 mg tablet 500 mg tablet

Atropt Myambutol Urex Forte

15 ml 56 tablets 50 tablets

Upon gaining registration the prices and subsidies (ex-manufacturer and exclusive of GST) for Urex Forte and Myambutol (including the already listed 400 mg tablet) would reduce as follows:

Chemical Presentation Brand Pack Size Current/proposed price and subsidy New proposed price and subsidy $48.01 $49.34 $25.00

Ethambutol Ethambutol Furosemide

100 mg tablet 400 mg tablet 500 mg tablet

Myambutol Myambutol Urex Forte

56 tablets 56 tablets 50 tablets

$57.81 $56.84 $50.00

Background Mylan New Zealand Ltd is discontinuing supply of furosemide 500 mg (Diurin 500) tablets from 1 December 2009. The proposed listing of Sigma’s brand of furosemide would ensure continued subsidised supply in New Zealand. Furosemide 500 mg is used in the treatment of patients with severely impaired renal function. Ethambutol is indicated for the treatment of pulmonary tuberculosis. Currently, only the 400 mg tablet is listed on the Pharmaceutical Schedule (supplied under section 29 of the Medicines Act 1981). Clinicians prescribing the 100 mg strength of ethambutol need to apply for Exceptional Circumstances approval to access funding. The listing of a 100 mg strength tablet would remove this need. Atropine eye drops are used to dilate the pupil and to induce cycloplegia by paralysing the cilary muscles (paralyse accommodation)

A312605 - T09-325