Proposal to amend the listing of some respiratory products

The proposal is a result of provisional amendments to existing listing agreements with Novartis New Zealand Ltd and AstraZeneca Limited.

In summary, from 1 March 2016, this proposal would result in:

• The Special Authority relating to glycopyrronium powder for inhalation 50 mcg per dose (Seebri Breezhaler) being removed (an endorsement that the patient had been diagnosed with COPD by spirometry would be required);
• A reduction in the ex-manufacturer price of Novartis’ combination glycopyrronium with indacaterol (Ultibro Breezhaler)
• Reductions in the ex-manufacturer prices of AstraZeneca’s budesonide with eformoterol combination inhalers (Symbicort turbuhaler)

Note this proposal would be separate to and in addition to the proposals consulted on in December 2015 (refer to background section for details).

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 5 February 2016 to:

Caroline De Luca
Senior Therapeutic Group
Manager/Team Leader
PHARMAC
PO Box 10 254
Wellington 6143

Email: copdconsultation@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 proposal

Novartis New Zealand Ltd

From 1 March 2016, the price and subsidy for glycopyrronium with indacaterol in Section B and Part II of Section H of the Pharmaceutical Schedule would be as follows (ex-manufacturer, exclusive of GST, deletions in strike through and additions in bold):

• Note the listing for Ultibro Breezhaler was included in a consultation issued on 18 December 2015. A decision on that proposal is still pending.
• The Special Authority criteria applying to glycopyrronium powder for inhalation 50 mcg per dose would be removed from Section B of the Pharmaceutical Schedule and the Restrictions would be removed from Part II Section H of the Pharmaceutical Schedule. An endorsement would be required on prescriptions that the patient has been diagnosed as having COPD using spirometry to access subsidy.
• The Special Authority criteria would continue to apply to tiotropium (Spiriva) listed in the Long-Acting Musarinic Antagonists therapeutic sub-group (SA1485).

AstraZeneca Limited

From 1 March 2016, the price and subsidy for budesonide with eformoterol in Section B and of the Pharmaceutical Schedule would be as follows (ex-manufacturer, exclusive of GST, deletions in strike through and additions in bold):

Other terms, as outlined in the Consultation document issued on the 15^th of December, regarding Symbicort Turbuhaler would remain unchanged.

Background

Following a consultation dated 18 December 2015, relating to provisional agreements with Boehringer Ingelheim and GlaxoSmithKline, PHARMAC has reached a provisional agreement to amend the listing terms for Novartis’s COPD products, glycopyrronium (Seebri Breezhaler) and the combination product glycopyrronium with indacaterol (Ultibro Breezhaler).  The proposal would result in the removal of the Special Authority from Seebri Breezhaler and the list price of Ultibro Breezhaler being reduced.  Prescriptions for Seebri Breezhaler would require an endorsement by the prescriber that the patient has been diagnosed as having COPD by spirometry. Special Authority criteria would apply to Ultibro Breezhaler as per the December consultation.

The proposed amendment to the provisional agreement with AstraZeneca, the details of which are in the consultation document dated 15 December 2015, would result in a reduction in the ex-manufacturer prices of the budesonide with eformoterol inhalers, Symbicort Turbuhaler.