Decision relating to a number of respiratory products

Medicines Decision

PHARMAC is pleased to announce the approval of agreements with Boehringer Ingleheim and GlaxoSmithKline involving a number of respiratory products. These agreements were the subject of a consultation letter dated 18 December 2015. 

The proposal was approved as consulted on. In summary, from 1 March 2016, the effect of the decision is that:

  • Two new long-acting muscarinic antagonists (LAMAs) will be funded;
  • One of the LAMAs, Incruse Ellipta (umeclidinium), supplied by GlaxoSmithKline, will be funded without a Special Authority (an endorsement that the patient has been diagnosed with COPD by spirometry will apply);
  • Three new combination long-acting muscarinic antagonists/long-acting beta-adrenoceptor agonists (LAMA/LABAs) will be funded, subject to restrictions;
  • One new inhaled cortical steroid (ICS)/LABA will be funded;
  • Changes to the LAMA Special Authority renewal criteria will be made;
  • Price and subsidies will be reduced for certain currently listed ICS/LABA and LABA products;
  • Confidential rebates will apply to all products except the Volumatic spacer; and
  • The price of Volumatic will be reduced.

Details of the decision

From 1 March 2016, the price and subsidies for the following products in Section B and Part II of Section H of the Pharmaceutical Schedule will be as follows (prices are ex-manufacturer, exclusive of GST):

Therapeutic Class

Chemical

Presentation

Brand

Pack size

Price and subsidy

Supplier

 LAMA

Tiotropium bromide

Powder for inhalation 18 mcg per dose

Spiriva

30 dose

$70.00*

Boehringer Ingelheim

 LAMA

Tiotropium bromide

Soln for inhalation 2.5 mcg per dose

Spiriva Respimat

60 dose OP

$70.00

Boehringer Ingelheim

 LAMA/LABA

Tiotropium bromide with olodaterol

Sol for inhalation 2.5 mcg with olodaterol 2.5 mcg

Spiolto Respimat

60 dose OP

$81.00

Boehringer Ingelheim

 LAMA

Umeclidinium

Powder for inhalation 62.5 mcg per dose

Incruse Ellipta

30 dose OP

$61.50

GSK

 LAMA/LABA

Umeclidinium with vilanterol

Powder for inhalation 62.5 mcg with vilanterol 25 mcg

Anoro Ellipta

30 dose OP

$77.00

GSK

 ICS/LABA

Fluticasone furoate with vilanterol

Powder for inhalation 100 mcg with vilanterol 25 mcg

Breo Ellipta

30 dose OP

$44.08

GSK

Spacer

Spacer device

800 ml

Volumatic

1

$6.50**

GSK

 LAMA/LABA

glycopyrronium  with indacaterol

Powder for inhalation 50 mcg with indacaterol 110 mcg

Ultibro Breezhaler

30 dose OP

$110.00

Novartis
*            Currently funded, there will be no change to price or subsidy
**           Currently funded, price and subsidy will decrease from 1 March 2016.

  • Confidential rebates will apply to all the above products, reducing their net price, except the Volumatic spacer
  • Subsidy and delisting protection will apply until 1 March 2019 for the Boehringer Ingleheim products (tiotropium bromide and tiotropium bromide with olodaterol) and until 1 July 2019 for the GlaxoSmithKline products (umeclidinium, umeclidinium with vilanterol and fluticasone furoate with vilanterol).

LAMAs

  • Umeclidinium (Incruse Ellipta) will be listed without a Special Authority or HML restriction.  All umeclidinium prescriptions will require endorsement that the patient has been diagnosed as having COPD using spirometry to access subsidy. A note restricting subsidy to patients who are not receiving treatment with another LAMA will also apply to umeclidinium.
  • Both tiotropium bromide presentations (the currently supplied Handihaler and the new Respimat) and the currently listed glycopyrronium inhaler will be funded under the following Special Authority criteria (deletions in strike out, additions in bold):

Special Authority for Subsidy

Initial application from a general practitioner or relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

  1. To be used for the long-term maintenance treatment of bronchospasm and dyspnoea associated with COPD; and
  2. In addition to standard treatment, the patient has trialled a short acting bronchodilator dose of at least 40 µg ipratropium q.i.d for one month; and
  3. Either:
    The patient’s breathlessness according to the Medical Research Council (UK) dyspnoea scale is:
    1. 3Grade 4 (stops for breath after walking about 100 meters or after a few minutes on the level); or
    2. Grade 5 (too breathless to leave the house, or breathless when dressing or undressing); and
      Applicant must state recent measurement of:
  4. All of the following:
    1. Actual FEV1 (litres); and
    2. Predicted FEV1 (litres); and
    3. Actual FEV1 as a % of predicted (must be below 60%); and
  5. Either:
    1. Patient is not a smoker (for reporting purposes only); or
    2. Patient is a smoker and has been offered smoking cessation counselling; and
  6. The patient has been offered annual influenza immunization;

Renewal onlyfrom a general practitioner or relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

Both All of the following:

  1. Patient is compliant with the medication; and
  2. Patient has experienced improved COPD symptom control (prescriber determined).; and
    Applicant must state recent measurement of:
  3. All of the following:
    1. Actual FEV1 (litres); and
    2. Predicted FEV1 (litres); and
    3. Actual FEV1 as a % of predicted.
  • The LAMA Special Authority will remain interchangeable between tiotropium bromide and glycopyrronium. 
  • HML restrictions will remain unchanged for tiotropium bromide presentations (the currently supplied Handihaler and the new Respimat) and the currently listed glycopyrronium inhaler.
  • The note restricting subsidy to patients who are not receiving treatment with another LAMA will also continue to apply.

LAMA/LABAs

  • The LAMA/LABA combination products tiotropium bromide with olodaterol,  umeclidinium with vilanterol and indacaterol with glycopyronnium  will be listed under the following restrictions (Special Authority in the community and HML restriction in DHB hospitals):

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Both:

  1. Patient has been stabilised on a long acting muscarinic antagonist; and
  2. The prescriber considers that the patient would receive additional benefit from switching to a combination product.

Renewal only from any relevant practitioner.  Approvals valid for 2 years for applications meeting the following criteria:

Both:

  1. Patient is compliant with the medication; and
  2. Patient has experienced improved COPD symptom control (prescriber determined).
  • The LAMA/LABA combination products will be listed with the following restriction in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Note: Combination long acting muscarinic antagonist and long acting beta-2 agonist will not be subsidised if patient is also receiving treatment with a combination inhaled corticosteroid and long acting beta-2 agonist.

ICS/LABA

  • Fluticasone furoate with vilanterol (Breo Ellipta) will be listed with no restrictions.

Currently listed ICS/LABA and LABA products

The prices of Seretide, Seretide Accuhaler, Serevent and Serevent Accuhaler will reduce effective from 1 March 2016 as follows (prices are ex-manufacturer, exclusive of GST): 

Presentation of Pharmaceutical

Current Price and subsidy 

Price and subsidyfrom 1 March 2016

Fluticasone with salmeterol aerosol inhaler 50 mcg with salmeterol 25 mcg, 120 dose OP (Seretide)

$37.48

$33.74

Fluticasone with salmeterol aerosol inhaler125 mcg with salmeterol 25 mcg, 120 dose OP (Seretide)

$49.69

$44.08

Fluticasone with salmeterol powder for inhalation100 mcg with salmeterol 50 mcg, 60 dose OP

(Seretide Accuhaler)

$37.48

$33.74

Fluticasone with salmeterol powder for inhalation 250 mcg with salmeterol 50 mcg , 60 dose OP

(Seretide Accuhaler)

$49.69

$44.08

Salmeterol aerosol inhaler CFC-free, 25 mcg per dose, 120 dose OP (Serevent)

$26.46

$25.00

Salmeterol powder for inhalation, 50 mcg per dose, breath activated,

60 dose OP (Serevent Accuhaler)

$26.46

$25.00

Confidential rebates will continue to apply to Seretide and Seretide Accuhaler.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 8 January 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
A number of respondents commented that they considered it was inappropriate to continue with the Special Authority criteria for tiotropium. At this stage, PHARMAC has been unable to reach an acceptable commercial arrangement with the supplier to enable the removal of the Special Authority from tiotropium.
One respondent considers the Respimat formulations may expose patients to unnecessary risk. PHARMAC staff note that the Respimat formulations have been granted market approval in New Zealand by Medsafe. Safety and efficacy of products are the responsibility of Medsafe to assess.
One respondent considered some patients are better treated with separate LAMA and LABA inhalers which would appear to be more expensive than a combination LAMA/LABA inhaler. Confidential net prices apply to all new products in this proposal so the published price may not reflect the net price of individual inhalers. 
One respondent asked if the Rex Medical respiratory inhalers would continue to be fully subsidised now that Seretide and Symbicort are less expensive. There will be no change to the subsidies for the Rex Medical supplied inhalers at this stage.
One respondent welcomed the LAMA/LABA combinations but as prior LAMA use is a pre-requisite considers the combination may be restricted to patients with an FEV1 <60%, leading to the continual inappropriate use of the ISC/LABA combinations. The LAMA/LABA Special Authority criteria do not stipulate which LAMA must be used prior to prescribing a combination product.

Please Note: As a result of the consultation on these agreements PHARMAC received proposals from Novartis New Zealand Limited and AstraZeneca Limited.  These proposals would result in the removal of the Special Authority criteria from Seebri Breezhaler (glycopyrronium) and price reductions on Ultibro Breezhaler (indacaterol with glycopyrronium) and the three eformoterol with budesonide (Symbicort Turbuhaler) presentations.  This was the result of a consultation dated 26 January 2016. 

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.