This is the text extract for Consultation on the listing of various pharmaceuticals on the Pharmaceutical Schedule. Closed, browse documents here.

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05 August 2010

Consultation on the listing of various pharmaceuticals on the Pharmaceutical Schedule PHARMAC is seeking feedback on a proposal to list various pharmaceuticals in Section B and Part II of Section H of the Pharmaceutical Schedule and to amend the listing for one existing pharmaceutical as a result of a provisional agreement between PHARMAC and AFT Pharmaceuticals Ltd. In summary, this proposal would result in: Funding of a new brand of budesonide (Budenocort), which is a dry powder inhaler used for the management of asthma; Funding of a new brand of anastrozole (Aremed) that is used for the treatment of breast cancer; Funding of beclomethasone (AFT), in a dry powder inhaler form, for use in the management of asthma; Funding of a new brand of acetylcysteine injection (Acetadote), that is used in the treatment of paracetamol overdose; An amendment to the listing of the anaesthetic propofol, a short acting general anaesthetic. Beclomethasone (AFT) and acetylcysteine injection (Acetadote) would only be funded if they were given regulatory approval by Medsafe. For the avoidance of doubt, none of the products included in this proposal would involve reference pricing or sole supply status in the community or hospital. Details of the proposals follow on the following pages.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 20 August 2010 to: Christine Chapman Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: christine.chapman@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.

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Details of the proposal The following pharmaceuticals would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex manufacturer and excl GST) from 1 October 2010:

Chemical Budesonide Budesonide Anastrozole Presentation Powder for inhalation 200 µg per dose Powder for inhalation 400 µg per dose Tablet 1 mg Brand Budenocort Budenocort Aremed Pack size 200 dose OP 200 dose OP 30 Price and subsidy $19.00 $32.00 $26.55

The following pharmaceuticals would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex manufacturer and excl GST) as soon as practicable following all necessary consents being held:

Chemical Beclomethasone Presentation Powder for inhalation 100µg per dose Brand AFT Pack size 200 dose OP Price and subsidy $12.00

The following pharmaceutical would be listed in Part II of Section H the Pharmaceutical Schedule at the following price (ex manufacturer and excl GST) as soon as practicable following all necessary consents being held:

Chemical Acetylcysteine Presentation Vial 200 mg per ml, 30 ml Brand Acetadote Pack size 4 Price $219.00

The following pharmaceuticals would be listed in Part II of Section H of the Pharmaceutical Schedule, replacing the Provive 1% brand, at the following prices (ex manufacturer and excl GST) from 1 November 2010:

Chemical Propofol Propofol Propofol Presentation Inj 1%, 20 ml Inj 1%, 50 ml Inj 1%, 100 ml Brand Provive MCTLCT 1% Provive MCTLCT 1% Provive MCTLCT 1% Pack size 5 1 1 Price $10.21 $5.56 $9.28

Future Price reductions The following price and subsidy (ex manufacturer excl GST) reduction would apply to Budenocort in Section B and Part II of Section H of the Pharmaceutical Schedule effective from 1 October 2011:

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Chemical Budesonide Budesonide

Presentation Powder for inhalation 200 µg per dose Powder for inhalation 400 µg per dose

Brand Budenocort Budenocort

Pack size 200 dose OP 200 dose OP

Price and subsidy $15.20 $25.60

The following price and subsidy (ex manufacturer excl GST) reduction would apply to Beclomethasone (AFT) in Section B and Part II of Section H of the Pharmaceutical Schedule effective from the date that is 12 months following the date of listing:

Chemical Beclomethasone Presentation Powder for inhalation 100 µg per dose Brand AFT Pack size 200 dose OP Price and subsidy $10.00

Background Budenocort The Respiratory Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed an application from AFT Pharmaceuticals for the listing of its brand of budesonide (Budenocort) at its October 2008 meeting. The Subcommittee requested some further information from the supplier, which was provided and then considered at its February 2010 meeting. The Subcommittee supported the listing of Budenocort. Aremed Two other brands of anastrozole, Arimidex and DP-Anastrozole, are currently listed in Section B of the Pharmaceutical Schedule. Listing Aremed would add a further funded brand. Acetylcysteine One other form of acetylcysteine injection is currently listed in Part II of Section H of the Pharmaceutical Schedule. Listing Acetadote would add a further brand. We note that Acetadote has a larger volume per vial (30 ml vs 10 ml) which we understand may be more convenient to prepare. Beclomethasone 100 µg per dose Beclomethasone dipropionate is currently listed in Section B of the Pharmaceutical Schedule in aerosol inhaler and metered aqueous nasal spray forms. AFT’s brand of beclomethasone would be supplied in the form of a powder for inhalation, which clinicians may consider more appropriate for some patients. Propofol inj 1% AFT currently supplies the Provive 1% brand to the hospital market. Provive 1% has a lipid base of long chain triglycerides only. The Provive MCT-LCT 1% brand has a lipid base of both medium chain triglycerides and long chain triglycerides which we understand may reduce the pain at injection site

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