Decision to widen access to budesonide with eformoterol (Symbicort Turbuhaler and Vannair)

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with AstraZeneca Limited involving the listing of budesonide with eformoterol inhalers (Symbicort and Vannair).  This was the subject of a consultation letter dated 15 December 2015.

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

  • there will be a reduction in expenditure for budesonide with eformoterol inhalers (Symbicort Turbuhaler and Vannair); and
  • the funding restrictions for budesonide with eformoterol in Section B and Part II of Section H of the Pharmaceutical Schedule will be removed.

Details of the decision

The price and subsidies for Symbicort Turbuhaler and Vannair in Section B of the Pharmaceutical Schedule from 1 March 2016 will reduce as follows (prices are ex-manufacturer, exclusive of GST):

Pharmaceutical

Brand

Presentation

Pack size

Current subsidy and price

New price and subsidy

Budesonide with eformoterol

Vannair

Aerosol inhaler 100 mcg with eformoterol fumarate 6 mcg

120 dose OP

$26.49

$18.23

Budesonide with eformoterol

Vannair

Aerosol inhaler 200 mcg with eformoterol fumarate 6 mcg

120 dose OP

$31.25

$21.40

Budesonide with eformoterol

Symbicort Turbuhaler 100/6

Powder for inhalation 100 mcg with eformoterol fumarate 6 mcg

120 dose OP

$55.00

$37.48*

Budesonide with eformoterol

Symbicort Turbuhaler 200/6

Powder for inhalation 200 mcg with eformoterol fumarate 6 mcg

120 dose OP

$60.00

$49.69*

Budesonide with eformoterol

Symbicort Turbuhaler 400/6

Powder for inhalation 400 mcg with eformoterol fumarate 6 mcg

60 dose OP

$60.00

$49.69*

  • A confidential rebate will apply to Symbicort Turbuhaler reducing its net price.
  • Symbicort Turbuhaler and Vannair will have subsidy and delisting protection until 1 January 2019.
  • The Special Authority criteria for budesonide with eformoterol in Section B of the Pharmaceutical Schedule will be removed from 1 March 2016 as follows (deletions in strikethrough):

Special Authority for Subsidy

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

Either:

1. All of the following:

1.1.   Patient is a child under the age of 12; and
1.2.   Has been treated with inhaled corticosteroids of at least 400 mcg per day beclomethasone or budesonide, or 200 mcg per day fluticasone; and
1.3.   The prescriber considers that the patient would receive additional clinical benefit from switching to a combination product; or

2. All of the following:

2.1.   Patient is over the age of 12; and
2.2.   Has been treated with inhaled corticosteroids of at least 800 mcg per day beclomethasone or budesonide, or 500 mcg per day fluticasone; and
2.3.   The prescriber considers that the patient would receive additional clinical benefit from switching to a combination product.

Renewal from any relevant practitioner. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

  • The restrictions for budesonide with eformoterol on the Hospital Medicines List (HML) will also be removed from 1 March 2016. 
  • The dose maximum rule that currently applies to Symbicort Turbuhaler 400/12 will remain. 

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. All responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Several respondents commented that they did not consider there is a need for the 400/12 presentation of Symbicort as there is a risk of overdosing. This presentation was listed in the Schedule in 2006.  There are a small number of patients prescribed this strength. There is a dispensing restriction on this strength restricting use to no more than 2 doses per day.

More information

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