This is the text extract for Proposal for sole supply of Respiratory Devices; Closing Date: Closed; Contact: Christine Chapman, browse documents here.

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14 October 2011

Proposal for sole supply of Respiratory Devices (peak flow meters, spacer devices, paediatric masks)

As a result of a request for proposals (RFP) for the sole supply of peak flow meters, spacer devices and paediatric masks for use with spacer devices in New Zealand, PHARMAC has signed provisional agreements with GlaxoSmithKline NZ Limited and Air Flow Products Ltd. and is seeking feedback on the following proposals (all to take effect 1 December 2011). In summary, these proposals would result in sole supply status until June 2015 in the community, and listing in Part II of Section H of the Pharmaceutical Schedule for:    GlaxoSmithKline’s Volumatic brand of spacer device, 800 ml; Air Flow Ltd’s EZ-fit brand of paediatric mask for use with spacer devices; Air Flow Ltd’s Space Chamber Plus brand of spacer device 230 ml (single patient); and, Air Flow Ltd’s Breath-Alert brands of low and normal range peak flow meters.

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In addition, we propose to amend the chemical heading and reduce the PSO quantity for the 230 ml (autoclavable) spacer device from 20 per PSO to 5 per PSO. Further details of these proposals can be found on the following page.

Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 2 November 2011 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 Acting Chief Executive acting under delegated authority) prior to making a decision on this proposal.

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Details of the proposals GlaxoSmithKline Products We have entered a provisional agreement with GlaxoSmithKline NZ Limited to continue to list Volumatic, Spacer Device, 800 ml in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 December 2011 as follows:

Chemical Spacer Device Presentation 800 ml Brand Volumatic Pack size 1 Price and subsidy $8.50

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A confidential rebate would apply to Volumatic. Volumatic would be listed in Section B of the Pharmaceutical Schedule with sole supply status from 1 December 2011 to 30 June 2015. Volumatic would have price and delisting protection in Part II of Section H of the Pharmaceutical Schedule until 1 July 2015.

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Air Flow Products We have entered a provisional agreement with Air Flow Products Ltd to: 1. List Space Chamber Plus and EZ-fit Paediatric Mask in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 December 2011 as follows:

Chemical Mask for Spacer device Spacer Device Presentation Size 2 230 ml (single patient) Brand EZ-fit Paediatric Mask Space Chamber Plus Pack size 1 1 Price and subsidy $2.99 $4.72

These products would replace the current Foremount Child’s Silicone Mask ($3.28 per mask) and current Air Flow Space Chamber ($8.38 per spacer) brands. EZ-fit Paediatric Mask is a name change only from Foremount Child’s Silicone mask. There is no change to the product itself. Air Flow Products Ltd Space Chamber Plus differs from its current Space Chamber in the valve design and the dimensions. The supplier claims these modifications would lead to improved drug delivery with an increase in the weight of drug exiting the device. Members of the Respiratory Subcommittee of PTAC considered the new spacer device appropriate and noted that while the increased dose would not impact on the majority of patients some may experience increased side effects. They considered that clinicians, respiratory nurses and patients should be informed of the changes if implemented. In the event that the proposal is approved, both PHARMAC and Air Flow Products will provide implementation material.

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Anderson Cascade Impactor Test Results (performed by the Aerosols Group of the School of Paediatrics and child Health at the University of Western Australia)

Device

Weight of drug per actuation (µg) Exiting Device Mean 19.8 SD 4.4 Mean 36.2 SD 8.3 Mean 40.9 Particles <4.7µm 18.3 4.4 32.7 7.5 37.5 5.0 MMAD* (µm) 2.36 0.11 2.42 0.23 2.57 0.01

Space Chamber Space Chamber Plus Volumatic Spacer

SD 5.3 *MMAD Mass median aerodynamic diameter.

2. Reduce the price and subsidy for Breath-Alert peak flow meters in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2011 as follows:

Chemical Peak Flow Meter Peak Flow Meter Presentation Low range Normal range Brand Breath-Alert Breath-Alert Pack size 1 1 Current Price/Subsidy $13.75 $13.75 Proposed Price/Subsidy $11.44 $11.44

3. Award Community sole supply status (Section B of the Pharmaceutical Schedule) to Space Chamber Plus, EZ-fit Paediatric Mask and Breath Alert (both presentations) from 1 December 2011 to 30 June 2015. In addition they would have price and delisting protection in Part II of Section H of the Pharmaceutical Schedule until 1 July 2015. Change to the listing of the Autoclavable Spacer Device PHARMAC proposes to create a new chemical heading in Section B of the Pharmaceutical Schedule and amend the listing of the 230 ml (autoclavable) spacer device from 1 December 2011 as follows:

Chemical Spacer Device Autoclavable Presentation 230 ml (Autoclavable) Brand Space Chamber Pack size 1 Price and subsidy $11.60

a) Up to 5 dev available on a PSO b) Only on a PSO c) Subsidy by endorsement Available where the prescriber requires a spacer device that is capable of sterilization in an autoclave and the PSO is endorsed accordingly.

This proposal would reduce the number of autoclavable devices available on PSO from 20 to 5. Autoclavable devices should only be ordered when the intention is to use the device in a training capacity, with autoclaving between patients, not for supply to patients.

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