Decision to secure supply of nadolol tablets

Medicines Decision

We have secured ongoing supply of nadolol 40 mg and 80 mg tablets.

What we’re doing

We're pleased to announce that we have secured ongoing supply of nadolol 40 mg and 80 mg tablets.

This decision means that:

  • The Nadolol BNM brand of 40 mg and 80 mg nadolol tablets supplied by Boucher & Muir will be listed on the Pharmaceutical Schedule from 1 October 2021 and is expected to be available in New Zealand from late October 2021.
  • The Apo-Nadolol brand of 40 mg and 80 mg nadolol tablets supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 March 2022.
  • From 1 March 2022 Nadolol BNM will be the only funded brand of 40 mg and 80 mg nadolol tablets.

What does this decision mean?

People taking nadolol tablets will need to change brands by 1 March 2022 to continue accessing a funded brand. After this date, the Apo-Nadolol brand, which is supplied by Apotex New Zealand Limited (Apotex) will no longer be funded in New Zealand.

It is anticipated that the Nadolol BNM brand of 40 mg and 80 mg nadolol tablets will not have Medsafe approval when they are listed on the Pharmaceutical Schedule. This means that they would initially 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 consultation period and consideration of the feedback no changes have been made to this proposal.

Who we think will be most interested

  • People using this medicine and their family, whānau or caregivers.
  • Hospital and community pharmacists, DHBs and wholesalers.
  • Clinicians and other prescribers of this medicine.
  • 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. Apotex currently supplies the funded brand of nadolol tablets to the New Zealand market. To continue accessing a funded brand of nadolol tablets, people will need to change brands.

From 1 October 2021 the following brand of nadolol 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 &
Subsidy

Nadolol

Tab 40 mg

Nadolol BNM

100

$19.19

Nadolol

Tab 80 mg

Nadolol BNM

100

$30.39

We have been advised by Boucher & Muir that the Nadolol BNM brand of nadolol tablets is expected to be available in New Zealand in late October 2021.

From 1 March 2022 the Apo-Nadolol brand of these medicines will be delisted from the Pharmaceutical Schedule and the Nadolol BNM brand will be the only funded brand until at least 30 June 2024.

A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. 

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.

We are pleased that we have been able to secure ongoing supply of nadolol tablets for New Zealanders.

Funding of unapproved medicines

Noted concerns and impacts resulting from the funding of unapproved medicines that are commonly used in the community as not all current prescribers such as, nurse practitioners and other registered nurse prescribers are able to prescribe unapproved medicines.

 

In our view Nadolol BNM is the best available option for ongoing supply of this product which is considered of high importance by our clinical advisors.

We acknowledge there are some drawbacks to funding an unapproved product however, we consider progressing with this award to be appropriate for the following reasons:

  • Boucher & Muir has noted it would commence the regulatory approval process for its brand of nadolol tablets following notification from Pharmac of preferred bidder status; and
  • Boucher & Muir is an experienced supplier and is familiar with the New Zealand regulatory approval process.
  • Medsafe approval is not guaranteed, however Boucher & Muir is a known supplier with experience supplying the New Zealand market. Boucher & Muir is confident in the safety, efficacy, identity and effectiveness of its product.

Healthcare professionals and people using the medicines included in this proposal will be supported with appropriate information to manage the brand changes. Including information to support the prescribing of unapproved medicines.

Information about the provision of section 29 medicines is currently available:

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.

 

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.

Nadolol BNM will be supplied under section 29 of the Medicines Act 1981 and so will be eligible for fees associated with the dispensing of unapproved subsidised medicines. 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 brand of nadolol tablets supplied by Apotex and the Nadolol BNM brand of nadolol tablets 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 nadolol tablets 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.