Lomustine discontinuation and proposal to widen access to temozolomide
What is happening?
The supplier of lomustine (branded as CeeNU) has advised Pharmac that it is discontinuing global production of the medicine. Lomustine is an oral anti-cancer medicine, often used as part of a chemotherapy regimen for people with brain cancer (glioma). CeeNU is the only brand of lomustine with Medsafe approval in New Zealand.
To date, Pharmac has been unable to secure ongoing supply of this medicine, which we understand would result in a significant unmet health need for people with brain cancer. At current usage, we expect supply of lomustine would be depleted by mid-2024 and be unavailable thereafter.
Each year around 70 people receive treatment with lomustine and we understand that all of this use occurs in people with gliomas. We understand that over the last two years, around 5% those who received lomustine were Māori.
What we’re proposing
To manage the impact from the discontinuation of lomustine we are proposing to widen access to temozolomide from 1 October 2023. Temozolomide is another oral anti-cancer medicine used for the treatment of people with brain cancer. Our clinical advisors have indicated to us that widened access to temozolomide would help address much of the unmet need resulting from this discontinuation.
We do however acknowledge that this may not address the full health need arising from this discontinuation, so we welcome feedback on other options to manage and support this situation.
From 1 January 2024 we are proposing to limit the use of available lomustine to only those people who are already receiving this treatment, in order to ensure availability for those who have already commenced treatment.
The consultation closes at 5pm 25 August 2023 and feedback can be emailed to consult@pharmac.govt.nz
What would the effect be?
Temozolomide is currently funded for people with newly diagnosed high grade gliomas (Special Authority criteria(external link)).
From 1 October 2023 access to temozolomide would be widened to all people with gliomas, including those with low grade and recurrent/relapsed gliomas.
If this proposal is approved, the requirements for concomitant radiotherapy and dosing restrictions would be removed from the criteria and eligibility would only be restricted to people with glioma requiring treatment.
From 1 January 2024, alternative options, including temozolomide, would need to be considered for any new person requiring treatment for glioma.
Who we think will be 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
About glioma (a type of brain cancer) and temozolomide
Gliomas are a type of brain tumour derived from glial cells and are graded using the World Health Organisation grading score. Low grade gliomas (grade II) are usually localised and grow slowly, whereas high grade gliomas (grade III and IV) grow rapidly.
Brain tumours, particularly high grade tumours, commonly result in death. Less than 10% of people living with high grade glioma survive five years following diagnosis. People with low grade gliomas often have a better prognosis, however the glioma tends to return and/or progress to high grade tumours within five to ten years. All brain cancers are considered incurable.
Temozolomide belongs to a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body. It is Medsafe approved(external link) for the treatment of people with:
- newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.
- patients with recurrent high grade glioma, such as glioblastoma multiforme or anaplastic astrocytoma
What expert advice have we received?
The Cancer Treatments Advisory Committee (CTAC) has advised us that there would be a health benefit from access to temozolomide for people with low grade gliomas and recurrent glioblastomas, given the discontinuation of lomustine.
CTAC considered it would be reasonable to limit new individuals starting treatment with lomustine to ensure people are not required to change from lomustine in the middle of their treatment course.
Details about our proposal
Temozolomide
Temozolomide would 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 would be amended in Section B from 1 October 2023 to be:
Special Authority for Subsidy
Initial application — (gliomas) only from a relevant specialist. Approvals valid for 12 months for patients with glioma requiring treatment.
Renewal — (gliomas) only from a relevant specialist. Approvals valid for 12 months where treatment remains appropriate and patient is benefitting from treatment
Note that there is no change to the Special Authority criteria for the treatment of people with neuroendocrine tumours or Ewing’s sarcoma.
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A similar restriction would apply in Part II of Section H of the Pharmaceutical Schedule.
Lomustine
The Special Authority criteria for lomustine (both cap 10 mg and cap 40 mg) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule to restrict access to only those patients who were receiving lomustine prior to 1 January 2024. Pharmacists would be able to annotate the prescription as endorsed where there exists a record of prior dispensing of lomustine.
We are not proposing to set a specific date for delisting of lomustine capsules at this time as this would depend on available stock and the expiry of that stock.
To provide feedback
Send us an email: consult@pharmac.govt.nz by 5pm 24 August 2023.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
We would welcome specific feedback on the:
- appropriateness of temozolomide to address the health need remaining as a result of the lomustine discontinuation
- timing of the restriction for remaining lomustine stock to be reserved for patients already undergoing a treatment course with lomustine
- people that we should be specifically engaging with in relation to this.
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