This is the text extract for Sole Supply of Metoprolol Succinate and Metoprolol Tartrate; Contact: Notifications, browse documents here.

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6 December 2011

Sole Supply of Metoprolol Succinate and Metoprolol Tartrate

The PHARMAC Board has approved sole supply proposals for metoprolol succinate (tablets) and metoprolol tartrate (tablets and injection). In summary, the decisions will mean that:  Metoprolol succinate tablets - AFT’s Metoprolol-AFT CR brand will be the sole supply brand from 1 September 2012 - the Betaloc CR and Myloc CR brands will be reference priced (1 June 2012) then delisted (1 September 2012). Metoprolol tartate tablets - Novartis’ Lopresor and Slow-Lopresor (long-acting) brands will be the sole supply brands from 1 August 2012 – there are no other brands currently funded/available therefore there will effectively be no change. Metoprolol tartrate injection – Novartis’ Lopresor brand will be fully funded and will be the sole supply brand from 1 August 2012 – the supplier of the current Betaloc brand has notified us that it will be withdrawn from the market from 1 January 2012.

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The sole supply brands will be the only funded brands in the Community and the only brands available in DHB hospitals from the sole supply date until 30 June 2015. The decisions are expected to result in savings in excess of $5 million per annum. These savings will be used for the funding of other medicines. These proposals arose from a Request for Proposals process and were the subject of a consultation letter dated 30 September 2011. This can be found on PHARMAC’s website at

http://www.pharmac.govt.nz/2011/09/30?q=metoprolol

Details of the decisions Listings and Sole Supply The following brands of metoprolol succinate tablets and metoprolol tartrate tablets and injection have been awarded Sole Supply Status and Hospital Supply Status. This means that they will be the only brands subsidised on the Pharmaceutical Schedule, and the only brands available in DHB hospitals subject to a discretionary variance limit of 1%.

Chemical Metoprolol succinate long-acting tablets 23.75 mg, 47.5 mg, 95 mg and 190 mg Metoprolol tartrate tablets 50 mg and 100 mg Metoprolol tartrate long-acting tablets 200 mg Metoprolol tartrate injection 1 mg per ml, 5 ml Sole Supply Brand Metoprolol-AFT CR Lopresor Slow-Lopresor Lopresor Brands to be delisted Betaloc CR Myloc CR None None Betaloc

Sole Supply Status and Hospital Supply Status will be effective from 1 August 2012 for metoprolol tartrate and from 1 September 2012 for metoprolol succinate with Sole Supply

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Status expiring on 30 June 2015 for all products. The implementation timeline will be as follows:  1 May 2012 – Price reductions for Metoprolol-AFT CR, Lopresor (tablets) and SlowLopresor. – Reference pricing of Betaloc (injection) to Lopresor (injection).    1 June 2012 – Reference pricing of Betaloc CR and Myloc CR to Metoprolol-AFT CR. 1 August 2012 – Delisting of Betaloc (injection). 1 September 2012 – Delisting of Betaloc CR and Myloc CR.

The timing of the metoprolol succinate and metoprolol tartrate price and subsidy (exmanufacturer, excluding GST) changes are shown below (we note that the supplier of Betaloc injection has notified of its withdrawal from the market from 1 January 2012): Metoprolol Succinate

Strength Brand Pack Size Subsidy and Price (Price in brackets if different to subsidy) Current* 1 May 2012* 1 June to 31 1 September August 2012* 2012* $2.18 $2.18 $2.74 $2.74 $4.71 $4.71 $8.51 $8.51 $0.96 $2.18 $1.41 $2.74 $2.42 $4.71 $4.66 $8.51 $0.96 $0.96 ($2.18) $1.41 $1.41 ($2.74) $2.42 $2.42 ($4.71) $4.66 $4.66 ($8.51) $0.96 Delisted $1.41 Delisted $2.42 Delisted $4.66 Delisted

23.75 mg long-acting tablet 47.5 mg long-acting tablet 95 mg long-acting tablet 190 mg long-acting tablet

Metoprolol-AFT CR Betaloc CR & Myloc CR Metoprolol-AFT CR Betaloc CR & Myloc CR Metoprolol-AFT CR Betaloc CR & Myloc CR Metoprolol-AFT CR Betaloc CR & Myloc CR

30 30 30 30 30 30 30 30

*Subsidies and prices ex-manufacturer, excluding GST

Metoprolol Tartrate

Strength Brand Pack Size Subsidy and Price (Price in brackets if different to subsidy) Current* 1 May 2012 to 1 August 31 July 2012* 2012* $16.50 $16.00 $16.00 $21.80 $18.40 Listed 1 December 2011 at $24.00 $24.08 ($34.00) $21.00 $18.00 $24.00 $24.00 ($34.00) $21.00 $18.00 $24.00 Delisted

50 mg tablet 100 mg tablet 200 mg longacting tablet 1 mg per ml, 5 ml injection

Lopresor Lopresor Slow-Lopresor Lopresor Betaloc

100 60 28 5 5

*Subsidies and prices ex-manufacturer, excluding GST

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Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 14 October 2011 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal given the size of the savings and the therapeutic equivalence of the products however the following issues were raised in relation to specific aspects of the proposal:

Theme There have been issues with AFT’s brand of Metoprolol-AFT CR being short dated. Comment AFT has over-labelled some stock. The issues that caused this have been resolved and we do not expect over-labelling to occur in the future. PHARMAC will provide pharmacists with brandswitch materials and advertisements will be placed in New Zealand Doctor, in addition to a number of other measures. . Awarding sole supply status for a period of time generally enables PHARMAC to obtain better pricing than would otherwise be the case. The pricing obtained in this case has enabled the Lopresor brand to be fully funded. We note the supplier of Betaloc injection has notified that it will be withdrawing its product from 1 January 2012. The highest strength of both the Betaloc CR and the Metoprolol-AFT CR tablets are large. While Metoprolol-AFT CR is larger, the difference in size of these oval tablets is no more than 2 mm in either direction (17 mm x 8.5 mm versus 19 mm x 10 mm). Metoprolol-AFT CR has been approved by Medsafe and clinical advice that we have received is that either brand is acceptable. This included consideration of the tablet sizes. If patients have difficulties swallowing the tablets (this could be the case for either brand), Metoprolol-AFT CR is scored and there are also a number of alternative medicines available. The brand is changing, not the medicine. The new brand is a new brand of the same medicine and it has been approved by Medsafe as being bioequivalent.

Patients switching brands will require education. PHARMAC or AFT should fund a campaign particularly if this brand switch does not attract a pharmacy brand-switch payment. The Betaloc brand of metoprolol tartrate injection should remain listed alongside the new Lopresor brand with a part-charge to allow patients to choose which brand is most suitable for them.

The Metoprolol-AFT CR tablets are larger than the Betaloc CR tablets and this may result in swallowing difficulties at higher strengths.

Moving moderate to severe heart failure patients to a new medicine presents the risk of life threatening adverse events.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

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