Proposal to award sole supply of metoprolol tartrate injection in the community and DHB hospitals
PHARMAC is seeking feedback on a proposal for a sole supply arrangement for Mylan New Zealand Limited’s (Mylan) brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial (Metoprolol IV Mylan) as a result of a provisional agreement with Mylan.
In summary, this proposal would result in:
- Metoprolol IV Mylan being funded in the community and DHB hospitals from a date to be determined. Listing in the cardiovascular system group in the Pharmaceutical Schedule would occur subject to Medsafe approval of the pharmaceutical;
- Metoprolol IV Mylan being 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.
- the Lopresor brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial being delisted from the Pharmaceutical Schedule when Sole Supply Status and Hospital Supply Status of the Mylan brand is implemented.
Feedback sought
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm Tuesday, 26 July 2016 to:
Chloë Dimock
Procurement Manager
PHARMAC
PO Box 10 254
Wellington 6143
Email: procurement@pharmac.govt.nz
Fax: 04 460 4995
All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.
Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.
Details of the proposal
Following Medsafe approval, Mylan’s brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial (Metoprolol IV Mylan) would 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 would 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 would 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 would 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 would 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 would 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 |
Background
Product information and current listing
Metoprolol is a cardioselective beta-blocker indicated for patients with disturbances of cardiac rhythm (including supraventricular and ventricular arrhythmias), post myocardial infarction and hypertension. Intravenous metoprolol tartrate may also be used intraoperatively if the patient is hypertensive or there is electrocardiogram evidence of angina or myocardial infarction.
The Lopresor brand, supplied by Novartis New Zealand Ltd, of metoprolol tartrate inj 1 mg per ml, 5 ml vial is currently listed in Section B and Part II of Section H of the Pharmaceutical Schedule without any restrictions.
In April 2015, PHARMAC invited tenders for the supply of metoprolol succinate and metoprolol tartrate to DHB hospitals and/or community pharmacies. No tenders for metoprolol tartrate 1 mg per ml, 5 ml injection were awarded as a result of this Request for Tender (RFT).
PHARMAC has been notified that the current supplier, Novartis, has discontinued production of its brand of metoprolol tartrate inj 1 mg per ml, 5 ml vial (Lopresor injection). This proposal, subject to Medsafe approval of Metoprolol IV Mylan, would help ensure continuity of supply of this pharmaceutical. In the interim, PHARMAC have secured additional Lopresor injection stock from Novartis.