Proposal for community and hospital listings of respiratory devices

The proposal would result in the following listings in Section B and Part III of Section H of the Pharmaceutical Schedule with effect from 1 November 2015:

• Apex Medical’s e-chamber Turbo 220 ml (single patient) spacer
• Apex Medical’s e-chamber La Grande 510 ml (single patient) spacer
• Apex Medical’s e-chamber Mask (paediatric) for use with spacer devices
• EBOS’ Mini-Wright AFS Low Range (30-400 L/min) peak flow meter, and
• EBOS’ Mini-Wright Standard (60-800 L/min) peak flow meter.

Community Sole Supply Status would be awarded, from 1 February 2016 until 30 June 2018, to:

• Apex Medical’s e-chamber Turbo 220 ml (single patient) spacer
• Apex Medical’s e-chamber Mask (paediatric) for use with spacer devices
• EBOS’ Mini-Wright AFS Low Range (30-400 L/min) peak flow meter, and
• EBOS’ Mini-Wright Standard (60-800 L/min) peak flow meter.

Finally, from 1 February 2016, we propose to delist, from Section B of the Pharmaceutical Schedule, the following:

• Air Flow’s Space Chamber autoclavable spacer device 230 ml.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 4pm on Tuesday, 21 July 2015 to:

Christine Chapman
Senior Therapeutic Group Manager
PHARMAC
PO Box 10254
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 its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request 

Details of the proposals

Apex Medical NZ Limited

We have entered into a provisional agreement with Apex Medical NZ Limited to list e‑chamber Turbo, e-chamber La Grande and e-chamber Mask in Section B and Part III of Section H of the Pharmaceutical Schedule from 1 November 2015 as follows:

• e-chamber Turbo would be listed in Section B of the Pharmaceutical Schedule with Sole Supply Status from 1 February 2016 to 30 June 2018.
• e-chamber Turbo would be listed in Part III of Section H of the Pharmaceutical Schedule and have price and delisting protection until 30 June 2018.
• e-chamber La Grande would be listed in Section B of the Pharmaceutical Schedule with subsidy and delisting protection until 30 June 2018.
• e-chamber La Grande would be listed in Part III of Section H of the Pharmaceutical Schedule and have price and delisting protection until 30 June 2018.
• e-chamber Mask would be listed in Section B of the Pharmaceutical Schedule with Sole Supply Status from 1 February 2016 to 30 June 2018.
• e-chamber Mask would be listed in Part III of Section H of the Pharmaceutical Schedule and have price and delisting protection until 30 June 2018.
• Space Chamber Plus, the currently listed brand of spacer device, 230 ml (single patient) would be delisted from Section B and Part III of Section H of the Pharmaceutical Schedule from 1 February 2016.
• For the avoidance of doubt, no changes are proposed to the listing of the Volumatic 800 ml Spacer device (supplied by GlaxoSmithKline) in Section B and Part III of Section H of the Pharmaceutical Schedule.
• EZ-fit Paediatric Mask, the currently listed brand of mask for spacer device, size 2 would be delisted from Section B and Part III of Section H of the Pharmaceutical Schedule from 1 February 2016.

Additional relevant information

PHARMAC has sought specialist clinical advice on in-vitro particle size and output measurement studies conducted on the e-chamber Turbo and e-chamber La Grande. Based on this advice, PHARMAC considers the e-chamber Turbo non-inferior to the Space Chamber Plus and the e-chamber La Grande non-inferior to the Volumatic spacer.  PHARMAC also sought feedback from Asthma Nurse Educators who have experience with the proposed spacers and in all cases the feedback was positive.

The e-chamber Turbo and e-chamber La Grande spacer devices are manufactured from an antistatic polypropylene plastic. This plastic eliminates the need for the spacer to be primed prior to use. A standard MDI inhaler can be stored inside the e-chamber spacers when not in use.

The instructions for use and the cleaning method of the proposed e-chamber Turbo and La Grande spacer devices are similar to those of the currently subsidised Space Chamber Plus and Volumatic spacers. The supplier has agreed to print the cleaning method onto the spacer devices while the instructions for use will be available on the packaging.

The supplier has informed PHARMAC that the proposed e-chamber Turbo and La Grande spacer devices are 100 percent recyclable.

The e-chamber masks are made from medical grade silicone which is anatomically shaped for an effective seal and comfort. The masks are latex and BPA-free.

In the event that the proposal is approved, PHARMAC would provide implementation material outlining the differences between the proposed and currently subsidised spacers.

EBOS Group Limited

We have entered into a provisional agreement with EBOS Group Limited to list Mini-Wright AFS Low Range and Mini-Wright Standard peak flow meters in Section B and Part III of Section H of the Pharmaceutical Schedule from 1 November 2015 as follows:

• Mini-Wright AFS Low Range would be listed in Section B of the Pharmaceutical Schedule with Sole Supply Status from 1 February 2016 to 30 June 2018.
• Mini-Wright AFS Low Range would be listed in Part III of Section H of the Pharmaceutical Schedule and have price and delisting protection until 30 June 2018.
• Mini-Wright Standard would be listed in Section B of the Pharmaceutical Schedule with Sole Supply Status from 1 February 2016 to 30 June 2018.
• Mini-Wright Standard would be listed in Part III of Section H of the Pharmaceutical Schedule and have price and delisting protection until 30 June 2018.
• Breath-Alert, the currently listed brand of Peak flow meter, low range would be delisted from Section B and Part III of Section H of the Pharmaceutical Schedule with effect from 1 February 2016.
• Breath-Alert, the currently listed brand of Peak flow meter, normal range would be delisted from Section B and Part III of Section H of the Pharmaceutical Schedule with effect from 1 February 2016.

Clinicians may be familiar with the Mini-Wright AFS Low Range and Mini-Wright Standard as they have been widely used in New Zealand previously.

Delisting of Spacer Device Autoclavable

PHARMAC proposes to remove the Spacer device autoclavable, 230 ml (autoclavable) from Section B of the Pharmaceutical Schedule with effect from 1 February 2016.

It is likely that, given the volumes of the autoclavable spacer funded, a significant amount is being used in situations where an autoclavable device is clinically unnecessary.

Given its substantially higher cost, PHARMAC considers its continued inclusion in the Pharmaceutical Schedule is not justified. If the autoclavable spacer is delisted, a single patient spacer could be given to the patient to take home following a clinic appointment if spacer use is required.