Decision to secure supply of various cardiovascular medicines
We have secured ongoing supply of medicines used in the treatment of various cardiovascular conditions.
What we’re doing
We're pleased to announce that we have secured ongoing supply of the following medicines used in the treatment of various cardiovascular conditions:
- furosemide 40 mg tablets
- metoprolol tartrate 50 mg and 100 mg tablets
- propranolol 10 mg and 40 mg tablets
This decision means that:
Furosemide
- the IPCA-Furosemide brand of 40 mg furosemide tablets supplied by Miro will be funded from 1 October 2021.
- the Apo-Furosemide brand of 40 mg furosemide tablets supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 March 2022.
- from 1 March 2022 IPCA-Furosemide will be the only funded brand of 40 mg furosemide tablets.
Metoprolol tartrate
- the IPCA-Metoprolol brand of 50 mg and 100 mg metoprolol tartrate tablets supplied by Miro will be funded from 1 October 2021.
- the Apo-Metoprolol brand of 50 mg and 100 mg metoprolol tartrate tablets supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 March 2022.
- from 1 March 2022 IPCA-Metoprolol will be the only funded brand of 50 mg and 100 mg metoprolol tartrate tablets.
Propranolol
- the Propranolol Teva brand of 10 mg propranolol tablets supplied by Teva will be funded from 1 October 2021.
- the IPCA-Propranolol brand of 40 mg propranolol tablets supplied by Miro will be funded from 1 October 2021.
- the Apo-Propranolol brand of 10 mg and 40 mg propranolol tablets supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 March 2022.
- from 1 March 2022 Propranolol Teva and IPCA-Propranolol will be the only funded brands of 10 mg and 40 mg propranolol tablets respectively.
What does this decision mean?
People taking these medicines will need to change brands by 1 March 2022 to continue accessing funded brands of these medicines. After this date, the currently funded brands of these medicines, which are supplied by Apotex New Zealand Limited (Apotex) will no longer be funded in New Zealand.
It is anticipated that the Propranolol Teva brand of 10 mg propranolol tablets will not have Medsafe approval when it is funded from 1 October 2021. This means that it would initially need to be prescribed and supplied under section 29 of the Medicines Act.
More information on what this means is below.
Any changes to the original proposal?
These decisions were subject to a consultation letter dated 19 February 2021.
Further consultation was undertaken in May 2021.
Following the consideration of the feedback to consultation we have made the following changes:
- The Propranolol Teva brand of 10 mg propranolol tablets will be listed on the Pharmaceutical Schedule from 1 October 2021 rather than 1 September 2021 as proposed in the May 2021 consultation.
- The IPCA-Furosemide brand of 40 mg furosemide tablets, the IPCA-Metoprolol brand of 50 mg and 100 mg metoprolol tartrate tablets and the IPCA-Propranolol brand of 40 mg propanol tablets will be listed on the Pharmaceutical Schedule from 1 October 2021 rather than 1 November 2021 as proposed in the May 2021 consultation.
- No other changes have been made to this proposal.
Who we think will be most interested
- People using these medicines and their family, whānau or caregivers.
- Hospital and community pharmacists, DHBs and wholesalers.
- Clinicians and other prescribers of these medicines.
- Suppliers of medicines to the New Zealand market.
Details about this decision
This decision follows Apotex’s decision to consolidate its international presence and leave the New Zealand market.All products impacted by this decision are currently supplied by Apotex. To continue accessing funded brands of these medicines, people will need to change brands.
From 1 October 2021 the following brands of furosemide tablets, metoprolol tartrate tablets and propranolol tablets will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:
|
Chemical |
Presentation |
Brand |
Pack size |
Price & |
|---|---|---|---|---|
|
Furosemide |
Tab 40 mg |
IPCA-Furosemide |
1,000 |
$8.00 |
|
Metoprolol Tartrate |
Tab 50 mg |
IPCA-Metoprolol |
100 |
$5.66 |
|
Metoprolol Tartrate |
Tab 100 mg |
IPCA-Metoprolol |
60 |
$7.55 |
|
Propranolol |
Tab 10 mg |
Propranolol Teva |
100 |
$7.04 |
|
Propranolol |
Tab 40 mg |
IPCA-Propranolol |
100 |
$8.75 |
From 1 March 2022 the Apo-Furosemide, Apo-Metoprolol and Apo-Propranolol brands of these medicines will be delisted from the Pharmaceutical Schedule and the brands listed in the table above will be the only funded brands until at least 30 June 2024.
A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. This means, 99% of the total volume purchases of furosemide tablets, metoprolol tartrate tablets and propranolol tablets are required to be these brands.
Our response to what you told us
We’re grateful for the time people took to respond to the consultation. The table provides a summary of the main themes raised in feedback and our responses to the feedback received.
|
Theme |
Pharmac comment |
|---|---|
|
Support of the proposal |
|
|
Respondents supported the proposal noting that it will ensure continued supply of medicines for New Zealanders. |
Noted. |
|
Noted concerns and impacts resulting from the funding of unapproved medicines that are commonly used in the community. Not all current prescribers, such as Nurse Practitioners and other Registered Nurse Prescribers, are able to prescribe unapproved medicines.
|
Propranolol In our view splitting this market across two suppliers despite one product not having regulatory approval (Propranolol Teva) is the best available option for ongoing supply of propranolol tablets. We acknowledge there are some draw backs to sourcing an unapproved product however, we consider progressing with this proposal be appropriate for the following reasons:
|
|
Requests that Section 29 of the Medicines Act 1981 be updated to allow Nurse Prescribers to prescribe unapproved medicines |
We are unable to make changes to provisions in the Medicines Act 1981 relating to the prescribing of unapproved medicines. The Ministry of Health is responsible for the Medicines Act 1981. This feedback has been shared with Ministry of Health staff. |
|
Education and resources |
|
|
Requests for support and education for patients and clinicians to support the brand changes, including information for prescribers to ensure they are able meet their obligations to their patients under the Code of Health and Disability Services Consumer’s Rights (Code of Rights) in relation to the prescribing of unapproved medicines |
We will make sure there is information to support the change in brands available on the Pharmac website. Information about the provision of section 29 medicines is currently available: |
|
Request for brand switch fee |
|
|
Requests for a brand switch fee be applied to medicines used in the treatment of chronic conditions. |
We have considered the request for a Brand Swich Fee and have determined that they will not be applied to these medicines. Metoprolol tartrate and propranolol tablets have undergone recent brand changes. Consequently, we have determined that a Brand Switch Fee is not required for this medicine. |
|
Transition Period |
|
|
Requests for a five-month transition period where both the incoming bands and the currently funded brands of these medicines would be listed on the Pharmaceutical Schedule. |
There will be a five-month period where both the currently funded brands that are supplied by Apotex and the incoming brands of these medicines will be funded and listed on the Pharmaceutical Schedule. The actual transition period may be shorter or longer than this, depending on the rate Apotex’s remaining stock of these medicines is used. |
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.