Approval of amendments to the listing of some respiratory products

Medicines

Decision

PHARMAC is pleased to announce the approval of amendments to existing listing agreements with Novartis New Zealand Ltd and AstraZeneca Limited for some respiratory products. These agreements were the subject of a consultation letter dated 26 January 2016.

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):

Chemical Presentation Brand Pack size Price and subsidy
Glycopyrronium with indacaterol Powder for inhalation 50 mcg with indacaterol 110 mcg Ultibro Breezhaler 30 dose OP $110.00
$81.00
  • 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):

Chemical Presentation Brand Pack size Price and subsidy
Budesonide with eformoterol Powder for inhalation 100 mcg with eformoterol fumarate 6 mcg Symbicort Turbuhaler 100/6 120 dose OP $55.00
$33.74
Budesonide with eformoterol Powder for inhalation 200 mcg with eformoterol fumarate 6 mcg Symbicort Turbuhaler 200/6 120 dose OP $60.00
$44.08
Budesonide with eformoterol Powder for inhalation 400 mcg with eformoterol fumarate 12 mcg Symbicort Turbuhaler 400/12 60 dose OP $60.00
$44.08

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:

Theme Comment
One respondent was concerned that the proposal may limit future competition in this market by providing price protection. There is no change to the subsidy or delisting protection for these products as a result of this decision.
One respondent would like to see the Special Authority removed from Symbicort Turbuhaler. Removal of the Special Authority for Symbicort Turbuhalers from 1 March 2016 was notified on 3 February 2016.
Concerns were raised about how to manage outstanding repeat dispensings for patients with existing Special Authority (SA) approvals for glycopyrronium once the SA was removed and an endorsement applied. We have made changes to the Subsidy by Endorsement following consideration of this feedback. It has been amended to allow pharmacists to annotate the prescription where a patient had a valid SA at 29 February 2016. This will possible from 1 March to 31 May 2016 which will enable outstanding repeats to be dispensed fully funded. From 1 June 2016, the Subsidy by Endorsement all prescriptions will need to be endorsed by prescribers.

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:

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