Decision to award sole supply of metoprolol succinate

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with AstraZeneca Pty Limited for the supply of metoprolol succinate long-acting tablets.

In summary, the effect of the decision is that:

From 1 July 2017:

  • AstraZeneca’s Betaloc CR 23.75 mg long-acting tablets will be listed in Section B of the Pharmaceutical Schedule with no restrictions.

From 1 October 2017:

  • AstraZeneca’s Betaloc CR 190 mg long-acting tablets will be listed in Section B of the Pharmaceutical Schedule with no restrictions. The price and subsidy of AstraZeneca’s Betaloc CR 47.5 mg and 95 mg long-acting tablets, currently listed in Section B of the Pharmaceutical Schedule, will be reduced.
  • All four presentations of AstraZeneca’s Betaloc CR will be listed in Part II of Section H (Hospital Medicines List) of the Pharmaceutical Schedule with no restrictions.

From 1 March 2018:

  • Sole Supply Status and Hospital Supply Status, with a 1% DV Limit for hospitals, for metoprolol succinate long-acting tablets would be applied to AstraZeneca’s Betaloc CR brand until 30 June 2020.
  • All other brands of metoprolol succinate would be delisted from Section B and Part II of Section H (Hospital Medicines List) of the Pharmaceutical Schedule.

Details of the decision

Section B

From 1 July 2017:

  • Betaloc CR 23.75 mg tab long-acting will be listed at the price and subsidy as set out in the table below.

From 1 October 2017:

  • Betaloc CR 190 mg tab long-acting will be listed at the price and subsidy as set out in the table below.
  • Betaloc CR 47.5 mg and 95 mg tabs long-acting will be reduced in price and subsidy as set out in the table below.
Chemical Presentation Brand Pack size Current price and subsidy 
(ex-man., ex. GST)
New price and subsidy
(ex-man., ex. GST)
Metoprolol succinate Tab long-acting 23.75 mg Betaloc CR 30 N/A $1.03
Metoprolol succinate Tab long-acting 47.5 mg Betaloc CR 30 $7.50 $1.25
Metoprolol succinate Tab long-acting 95 mg Betaloc CR 30 $7.50 $1.99
Metoprolol succinate Tab long-acting 190 mg Betaloc CR 30 N/A  $3.00

Section H (Hospital Medicines List)

From 1 October 2017: 

  • Betaloc CR tab long-acting 23.75 mg, 47.5 mg, 95 mg and 190 mg will be listed at the following prices:
Chemical Presentation Brand Pack size Current price
(ex-man., ex. GST)
New Price
(ex-man., ex. GST)
Metoprolol succinate Tab long-acting 23.75 mg Betaloc CR 30 N/A $1.03
Metoprolol succinate Tab long-acting 47.5 mg Betaloc CR 30 N/A $1.25
Metoprolol succinate Tab long-acting 95 mg Betaloc CR 30 N/A $1.99
Metoprolol succinate Tab long-acting 190 mg Betaloc CR 30 N/A $3.00

Sections B & H

From 1 March 2018:

  • Betaloc CR tab long-acting 23.75 mg, 47.5 mg, 95 mg and 190 mg will have Sole Supply Status and Hospital Supply Status for metoprolol succinate tab long-acting, with a 1% DV Limit for hospitals, to until 30 June 2020.
  • All other brands of metoprolol succinate tab long-acting will be delisted from Section B and Part II of Section H (Hospital Medicines List) 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 11th April 2017 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme

PHARMAC comment

Concern with sole supply issues / arrangements to ensure continuity of supply

PHARMAC considers that sole supply generally provides greater assurance of supply than multiple suppliers. With one supplier wholly responsible to meet all orders from the market, forecasting demand is easier and contractual continuity of supply obligations are easier to enforce. Compared to international markets with dual (or multiple suppliers) of pharmaceuticals, it appears that New Zealand generally has a lower level of patient level supply interruption.

During supply disruptions to metoprolol succinate in 2016 & 2017 the contractual obligations on AFT, the suspension of all-at-once dispensing and the collaborative work by the supply chain (including AFT, alternative suppliers, wholesalers & distributors and community pharmacy) prevented a patient level out of stock.

Given New Zealand is an outlier in its high usage of metoprolol succinate vs other beta blocker treatments compared with most other international markets, PHARMAC and AstraZeneca have agreed that four months of stock will be held by AstraZeneca in New Zealand, rather than the usual two months.  This stockholding is in addition to any stock that may be available in the distribution chain (which we understand is generally around 6 weeks’ supply). This approach will ensure there would be more time to source an alternative in the event of an unanticipated short-stock situation.

Request for Brand Switch Fee to be paid to Pharmacy

Brand switch payments were paid to pharmacy in 2016 for brand changes for metoprolol.  Given pharmacy have had experience with multiple brand availability, and some patients will be used to taking metoprolol succinate from more than one supplier, (including AZ supplied metoprolol succinate), we do not consider a further brand switch fee to be appropriate.

Slight disappointment with the change in pack size from 90 to 30 tablets; and comment that the Betaloc CR calendar pack will be a better compliance packaging.

Noted.

General support noting that a return to stat dispensing and reliable supply would bring stability to patients and pharmacists.

Noted.  Stat dispensing was reintroduced from 1 May 2017.

Request for stat dispensing for bisoprolol fumerate

Noted. This is outside of the scope of the proposal that was consulted on; however, PHARMAC will consider the request including seeking clinical advice if necessary.

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.  Further information is also available on the PHARMAC website [link no longer available].