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

Medicines

Decision

PHARMAC is pleased to announce that a decision has been made to award Sole Supply Status in the Community and Hospital Supply Status in DHB hospitals to AFT Pharmaceuticals Limited for its brand of metoprolol succinate.

This decision follows:

  • A Request for Tender (RFT) for the supply of metoprolol succinate and metoprolol tartrate to DHB hospitals and/or community pharmacies, issued on 20 April 2015.
  • A consultation letter dated 4 June 2015.

In summary, the effect of the decision is that:

  • Sole Supply Status for metoprolol succinate has been awarded to AFT Pharmaceuticals Limited for its Metoprolol-AFT CR brand of long-acting tablets: 23.75 mg, 47.5 mg, 95 mg and 190 mg from 1 July 2016 until 30 June 2018.
  • Hospital Supply Status for metoprolol succinate has been awarded to AFT Pharmaceuticals Limited for its Metoprolol-AFT CR brand of long-acting tablets: 23.75 mg, 47.5 mg, 95 mg and 190 mg from 1 April 2016 until 30 June 2018 with a 1% DV limit.

This decision results in:

  • Tablet appearance, marking and size for each strength remaining the same;
  • The brand remaining the same;
  • A change in pack size from 30 to 90 tablets per pack; and
  • A reduction in price across all four presentations.

There will be no changes to the current arrangements for metoprolol tartrate as a result of this decision. No proposals have been developed yet with regard to awarding Sole Supply Status and Hospital Supply Status to any metoprolol tartrate bids received via the RFT.

Details of the decision

Metoprolol-AFT CR (metoprolol succinate) long-acting tablets, 90 tablet packs, will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy from 1 February 2016:

Chemical Presentation Brand Pack size Current price and subsidy (ex GST, ex manuf) Proposed price and subsidy (ex GST, ex manuf)
Metoprolol succinate Tab long-acting 23.75 mg Metoprolol-AFT CR 90 $0.96 per 30 tab $2.39
Metoprolol succinate Tab long-acting 47.5 mg Metoprolol-AFT CR 90 $1.41 per 30 tab $3.48
Metoprolol succinate Tab long-acting 95 mg Metoprolol-AFT CR 90 $2.42 per 30 tab $5.73
Metoprolol succinate Tab long-acting 190 mg Metoprolol-AFT CR 90 $4.66 per 30 tab $11.54

AFT-Metoprolol CR brand of long-acting tablets, 90 tablet packs: 23.75 mg, 47.5 mg, 95 mg and 190 mg will have:

  • Sole Supply Status for metoprolol succinate from 1 July 2016 until 30 June 2018; and
  • Hospital Supply Status for metoprolol succinate from 1 April 2016 until 30 June 2018, with a 1% DV limit.

The tablets and blister packing will remain exactly the same as the currently subsidised metoprolol succinate tablets in the 30 tablet pack size. The only change is that the pack size has increased from three blister strips of ten tablets (30) to nine blister strips of ten tablets (90).  

The subsidy for the 30 tablet pack sizes of AFT-Metoprolol long-acting tablets will reduce from 1 April 2016 and they will be delisted from:

  • 1 July 2016 from Section B of the Pharmaceutical Schedule; and
  • 1 April 2016 from Part II of Section H of the Pharmaceutical Schedule. 

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by Friday, 19 June 2015 were considered in their entirety in making a decision on the proposed changes. The majority of responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme PHARMAC comment

A concern was raised relating to the continuing availability of the 23.75mg tablets and potential safety risks when half a tablet is prescribed (11.875mg) but misread as 118.75mg.

The respondent noted that it would require a major change management required to switch salts and requested consideration of labelling changes to avoid strengths with two decimal places.

PHARMAC is aware of the safety issue noted in this response and that a long term strategy that addresses safety risks whilst minimising patient and clinician disruption is required. Labelling changes require significant development, evaluation and implementation.

We note that there are a number of organisations involved in this area and that this strategy will take time to develop.

PHARMAC intends to seek advice on this from its specialist clinical advisors through the relevant Pharmacology and Therapeutics Advisory Committee (PTAC) Subcommittee.  We will also commence discussions with the Health, Quality and Safety Commission and other relevant organisations.

This decision secures supply and enables sufficient time to comprehensively address the issues identified for this large patient group.

PHARMAC ensure two metoprolol salts remain listed.

No changes to the currently listed metoprolol tartrate strengths and formulations will occur as a result of this decision.

A DHB hospital pharmacy highlighted the increased pack size would take up more shelf space and create additional work packing down ward stock. They also suggested boxes of 190 mg would expire before fully used.

PHARMAC notes the savings from changing to the larger pack size and that the majority of dispensings are three-monthly in the community.

PHARMAC does not consider expiry costs would be significant particularly given the price per box and long shelf life.

A question was raised as to whether sole supply would lead to potential supply issues.

Metoprolol succinate was previously under a sole supply agreement without any supply issues. PHARMAC considers that having multiple brands of a product in a market does not necessarily improve security of supply.  When there is one supplier, our experience is that supplier forecasting is more accurate which helps prevent out-of-stock situations. Further, in exchange for market exclusivity, the supply contracts we have in place require suppliers to agree to rigorous conditions to prevent and manage potential out-of-stocks.

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.