Decision to award sole supply of metoprolol tartrate injection in the community and in DHB hospitals

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Mylan New Zealand Limited’s (Mylan) for metoprolol tartrate injection.

This was the subject of a consultation letter dated 12 July 2016. The decision is as consulted on. In summary, the effect of the decision is that:

  • Metoprolol IV Mylan will be funded in the community and DHB hospitals from a date to be determined.  Listing in the cardiovascular system group in the Pharmaceutical Schedule will occur subject to Medsafe approval of the pharmaceutical;
  • Metoprolol IV Mylan will be the only subsidised brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial in the community (Sole Supply Status) and DHB hospitals (Hospital Supply Status) for a period of three years following a transition period to be determined by PHARMAC;
  • Lopresor brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial being delisted when sole supply is implemented.

Details of the decision

Following Medsafe approval, Mylan’s brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial (Metoprolol IV Mylan) will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Chemical

Presentation

Brand

Pack size

Proposed price and/or subsidy

Metoprolol tartrate

Inj 1 mg per ml, 5 ml vial

Metoprolol IV Mylan

5

$29.50

  • Metoprolol IV Mylan will be listed as soon as practicable following Mylan’s notification to PHARMAC that Medsafe has granted registration.
  • Following the listing of Metoprolol IV Mylan there will be a transition period until Sole Supply Status and Hospital Supply Status are implemented (duration to be determined by PHARMAC) after which Metoprolol IV Mylan will have Sole Supply Status in the community and Hospital Supply Status with a 1% Discretionary Variance (DV) limit in DHB hospitals for a period of three years.
  • The currently listed Lopresor brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule when Sole Supply Status and Hospital Supply Status of the Mylan brand is implemented.
  • The price and subsidy (ex-manufacturer and ex-GST) for Metoprolol IV Mylan will be reduced two years after the commencement of Sole Supply Status in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Chemical

Presentation

Brand

Pack size

Proposed price and subsidy

Metoprolol tartrate

Inj 1 mg per ml, 5 ml vial

Metoprolol IV Mylan

5

$26.50

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 26 July 2016 were considered in their entirety in making a decision on the proposed change. The following point was raised in relation to specific aspects of the proposal:

Theme Comment
Would the Lopresor brand still be available while Metoprolol IV Mylan undergoes Medsafe registration PHARMAC has secured additional Lopresor stock from Novartis which will enable continued supply until the Mylan product is registered.

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.