Approval of amendments to the listing of some respiratory products

In summary, from 1 March 2016, the effect of the decision is that:

• The Special Authority relating to glycopyrronium powder for inhalation 50 mcg per dose (Seebri Breezhaler) will be removed (an endorsement that the patient had been diagnosed with chronic obstructive pulmonary disease (COPD) by spirometry will be required);
• The ex-manufacturer price of Novartis’ combination glycopyrronium with indacaterol (Ultibro Breezhaler) will be reduced; and
• The ex-manufacturer prices of AstraZeneca’s budesonide with eformoterol combination inhalers (Symbicort Turbuhaler) will be reduced.

The proposal was approved as consulted on, except for an amendment to the glycopyrronium endorsement. To enable funded access to continue for existing patients who have outstanding repeat dispensings at 1 March 2016, an annotation of the prescription will be required by the dispensing pharmacist that the patient had a valid Special Authority approval at 29 February 2016.

Details of the decision

The effect of the decision is to approve an amendment to an existing listing agreement with Novartis New Zealand Ltd as follows:

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 will be as follows (ex-manufacturer, exclusive of GST, deletions in strike through and additions in bold):

• Note the decision to list Ultibro Breezhaler from 1 March 2016 was notified on 3 February 2016.
• The Special Authority criteria and Hospital Medicine List (HML) restrictions applying to glycopyrronium powder for inhalation 50 mcg per dose (Seebri Breezhaler) will be removed from Section B of the Pharmaceutical Schedule and from Part II Section H of the Pharmaceutical Schedule. An endorsement will be required on prescriptions that the patient has been diagnosed as having COPD using spirometry to access subsidy.
• To enable funded access to continue for patients with outstanding repeat dispensings of glycopyrronium (Seebri Breezhaler) powder for inhalation 50 mcg at 1 March 2016, the dispensing pharmacist may annotate the prescription where a patient has a valid Special Authority approval at 29 February 2016. All new initial dispensings of glycopyrronium powder for inhalation 50 mcg from 1 March 2016 must be endorsed by the prescriber to gain subsidy. The Subsidy by Endorsement from 1 March 2016 until 31 May 2016 will be as follows:

Subsidy by Endorsement

Glycopyrronium powder for inhalation 50 mcg per dose is subsidised only for patients who have been diagnosed as having COPD using spirometry, and the prescription is endorsed accordingly. From 1 March 2016 until 31 May 2016 pharmacists may annotate the prescription as endorsed where the patient has outstanding repeat dispensings at 1 March 2016 and the patient had a valid Special Authority approval at 29 February 2016.

• From 1 June 2016, the Subsidy by Endorsement for glycopyrronium (Seebri Breezhaler) powder for inhalation 50 mcg will be updated so only prescribers can endorse, as originally consulted on. The amended endorsement will be as follows:

Subsidy by Endorsement

Glycopyrronium powder for inhalation 50 mcg per dose is subsidised only for patients who have been diagnosed as having COPD using spirometry, and the prescription is endorsed accordingly.

• The Special Authority criteria will continue to apply to tiotropium (Spiriva and Spiriva Respimat) listed in the Long-Acting Musarinic Antagonists therapeutic sub-group. Note the Special Authority will no longer apply to other pharmaceuticals listed in the Long-Acting Musarinic Antagonists therapeutic sub-group as notified on 3 February 2016.

The effect of the decision to approve an amendment to a 2012 agreement with AstraZeneca Ltd is that:

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

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 5 February 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

More information

These changes have been made as a result of commercial proposals from Novartis and AstraZeneca received during consultation on agreements with GlaxoSmithKline and Boehringer Ingelheim for listing new COPD products and price reductions on some currently listed products. Further information on these can be found at the following links:

• Decision relating to a number of respiratory products - 2016-02-03
• Decision to widen access to budesonide with eformoterol (Symbicort Turbuhaler and Vannair) - 2016-02-03

In summary, those agreements have resulted in the following changes for respiratory products from 1 March 2016:

• Special Authority criteria will be removed from eformoterol with budesonide combination asthma inhalers (Symbicort Turbuhaler and Vannair);
• Special Authority criteria and restrictions will be removed from glycopyrronium powder for inhalation for the treatment of COPD;
• Prescriptions for glycopyrronium powder for inhalation 50 mcg and the newly listed umeclidinium will need to be endorsed by the prescriber that the patient has been diagnosed as having COPD using spirometry;
• Three new combination long-acting muscarinic antagonists/long-acting beta-adrenoceptor agonists (LAMA/LABAs) being funded subject to restrictions;
• There will be price reductions for Symbicort Turbuhaler, Vannair, Seretide, Flixotide and the Volumatic spacer device;
• A new once daily inhaled corticosteroid (ICS)/LABA will be funded; and
• The FEV₁ requirements from the tiotropium bromide Special Authority renewal criteria will be removed.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz