Decision to widen access to temozolomide for gliomas and list a brand of lomustine

13 September 2023

Medicines Decision

What we’re doing

We're pleased to announce that Pharmac has decided to:

widen access to temozolomide, an oral anti-cancer medicine, to all people with gliomas (a type of brain cancer) from 1 October 2023
list an alternative brand of lomustine (branded as Cecenu) from 1 July 2024.

We are making these changes to ensure people with gliomas have treatment options available and to minimise the impact of the discontinuation of the CeeNU brand of lomustine. We appreciate the feedback we have received from people who are affected by, or who are caring for individuals with, brain cancer.

The Cecenu product is not Medsafe approved and would need to be prescribed and dispensed in line with Section 29 of the Medicines Act 1981. Details about the supply and use of unapproved medicines is available from the Medsafe website(external link).

Any changes to the original proposal?

This decision was subject to a consultation letter dated 11 August 2023(external link). We are grateful for the time people took to provide us with their feedback which has helped determine our final decision.

Changes to the original proposal include:

Listing an alternative brand of lomustine
No restriction limiting access for new patients who require lomustine.

Through the consultation feedback we have heard about the high need for lomustine, particularly for people with recurrent high-grade gliomas.

We expect that the CeeNU brand of lomustine will not be available beyond mid-2024. We have identified another supplier of lomustine, so we are listing the Cecenu brand from 1 July 2024. This is not Medsafe approved, so would need to be prescribed and dispensed in line with Section 29 of the Medicines Act 1981. It is only available in the 40 mg strength.

We expect that some people will use temozolomide instead of lomustine, which may extend the time until the alternative brand of lomustine is needed. We will monitor stock levels to ensure the listing date for Cecenu remains appropriate. This also means we will not limit access to those currently receiving lomustine from 1 January 2024 as proposed in the consultation.

We appreciate that there is a desire that the 10 mg strength be available for people. We continue to seek certainty of supply of lomustine, including the 10 mg strength.

Who we think will be most interested

People with cancer, particularly brain cancer, their whānau, friends and caregivers
Healthcare professionals involved in the treatment and care of people with cancer
Te Whatu Ora – Health New Zealand hospitals and other organisations who deliver services and support for people, and their whānau who are affected by cancer
People or groups with an interest in treatments for cancer
Pharmacies and wholesalers
Pharmaceutical suppliers of cancer treatments

Detail about this decision

Temozolomide

Temozolomide will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the current list price and subsidy (ex-manufacturer, excluding GST).

The Special Authority criteria for temozolomide will be amended in Section B from 1 October 2023 (new criteria only):

Special Authority for Subsidy

Initial application — (gliomas) only from a relevant specialist. Approvals valid for 12 months where the patient has a glioma.

Renewal — (gliomas) only from a relevant specialist. Approvals valid for 12 months where treatment remains appropriate and patient is benefitting from treatment.

A similar restriction will apply in Part II of Section H of the Pharmaceutical Schedule.

Lomustine

The Cecenu brand of lomustine will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2024 as follows:

Chemical and presentation	Brand	Pack Size	Subsidy and price (ex-man., ex. GST)
Lomustine Cap 40 mg	Cecenu	20	$880.00

This product is not Medsafe approved and would need to be prescribed and dispensed in line with Section 29 of the Medicines Act 1981. Section 29 and wastage rules will apply to this listing in Section B of the Pharmaceutical Schedule.

Cecenu will not be subject to a listing agreement with Pharmac, and therefore continuity of supply will need to be managed closely.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were supportive of the proposal, while acknowledging the high unmet health need that would be left from the lomustine discontinuation and the importance of maintaining continuity of supply of this medicine.

A summary of the main themes raised in feedback and our responses are available below.

Theme	Pharmac Staff Comment
Supportive of the proposal	We thank everyone for the time they took to provide their feedback. We are pleased to hear that widening access to temozolomide would be beneficial in the treatment of gliomas.
Highlighted the significant unmet need arising from the discontinuation, noting the limited therapeutic options for people with these types of brain cancers. Feedback requested Pharmac explore all avenues to maintain supply.	We acknowledge the distress the discontinuation of lomustine would cause people with brain cancers and their whānau. We expect that through widening access to temozolomide, the CeeNU brand of lomustine will remain available for longer. We understand that this discontinuation is affecting all countries who use this medicine, such as Australia(external link) and Canada(external link). These countries are also taking steps to extend the supply of CeeNU and/or enabling access to another brand of lomustine. Pharmac funds medicines with the intention of continuity of supply. In this case, the major manufacturer has decided to discontinue the medicine globally and cease supply to New Zealand. We have identified a supplier of an unapproved brand of lomustine to help meet this need in the short to medium term. The Cecenu brand of lomustine will be listed from 1 July 2024, ahead of the expected date of CeeNU discontinuation. This date can be brought forward if needed. The Cecenu product is not Medsafe approved and is a 40mg capsule only, one of the two currently funded strengths. We will continue to seek certainty of supply and a more suitable solution for people should this be possible.
Requested funding of bevacizumab for high-grade recurrent gliomas	At this time the advice that we have received from CTAC is that bevacizumab would not replace lomustine in the treatment of gliomas. A proposal(external link) is currently under assessment by Pharmac after CTAC recommended funding with a low priority in April 2023(external link). Following our assessment of the proposal, it would be ranked on our Options for Investment list and its funding would be dependent on our budget availability and relative priority of the proposal against other investment options. We intend to also consider bevacizumab in combination with lomustine, given that an alternative brand of lomustine has been identified.

Theme

Pharmac Staff Comment

Supportive of the proposal

We thank everyone for the time they took to provide their feedback. We are pleased to hear that widening access to temozolomide would be beneficial in the treatment of gliomas.

Highlighted the significant unmet need arising from the discontinuation, noting the limited therapeutic options for people with these types of brain cancers.

Feedback requested Pharmac explore all avenues to maintain supply.

We acknowledge the distress the discontinuation of lomustine would cause people with brain cancers and their whānau. We expect that through widening access to temozolomide, the CeeNU brand of lomustine will remain available for longer.

We understand that this discontinuation is affecting all countries who use this medicine, such as Australia(external link) and Canada(external link). These countries are also taking steps to extend the supply of CeeNU and/or enabling access to another brand of lomustine.

Pharmac funds medicines with the intention of continuity of supply. In this case, the major manufacturer has decided to discontinue the medicine globally and cease supply to New Zealand.

We have identified a supplier of an unapproved brand of lomustine to help meet this need in the short to medium term. The Cecenu brand of lomustine will be listed from 1 July 2024, ahead of the expected date of CeeNU discontinuation. This date can be brought forward if needed. The Cecenu product is not Medsafe approved and is a 40mg capsule only, one of the two currently funded strengths.

We will continue to seek certainty of supply and a more suitable solution for people should this be possible.

Requested funding of bevacizumab for high-grade recurrent gliomas

At this time the advice that we have received from CTAC is that bevacizumab would not replace lomustine in the treatment of gliomas.

A proposal(external link) is currently under assessment by Pharmac after CTAC recommended funding with a low priority in April 2023(external link). Following our assessment of the proposal, it would be ranked on our Options for Investment list and its funding would be dependent on our budget availability and relative priority of the proposal against other investment options.

We intend to also consider bevacizumab in combination with lomustine, given that an alternative brand of lomustine has been identified.

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 660 050.