Decision to widen funded access to temozolomide for treatment of neuroendocrine tumours and high grade gliomas

10 June 2016

Medicines Decision

PHARMAC is pleased to announce the widening of access to fully-funded temozolomide for the treatment of neuroendocrine tumours and high grade gliomas in conjunction with the awarding of temozolomide tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender.

This was the subject of a consultation letter dated 4 May 2016.

In summary, the effect of the decision is that:

The Special Authority criteria applying to temozolomide will be amended from 1 December 2016 to include treatment beyond 6 cycles for high grade gliomas – glioblastoma multiforme or anaplastic astrocytoma and metastatic or unresectable well-differentiated neuroendocrine tumours.
Sole Supply Status has been awarded to Orion Laboratories (NZ) Ltd for its Orion Temozolomide brand of 5 mg, 20 mg, 100 mg and 250 mg capsules from 1 May 2017 until 30 June 2019.
Hospital Supply Status has been awarded to Orion Laboratories (NZ) Ltd for its Orion Temozolomide brand of 5 mg, 20 mg, 100 mg and 250 mg capsules from 1 February 2017 until 30 June 2019 with a DV limit of 1%.

This decision will result in a change in funded brand of temozolomide cap 5 mg, 20 mg, 100 mg and 250 mg from Temaccord, supplied by Douglas Pharmaceuticals Ltd, to Orion Temozolomide supplied by Orion Laboratories (NZ) Ltd.

Having considered consultation feedback, we have made a change to the proposed access criteria to remove the note referring to performance status and partial resection.

Details of the decision

The Special Authority criteria applying to temozolomide cap 5 mg, 20 mg, 100 mg and 250 mg will be amended in Section B of the Pharmaceutical Schedule from 1 December 2016 as follows (additions in bold, deletions in strikethrough):

Initial application - (high grade gliomas) only from a relevant specialist. Approvals valid for 10 12 months for applications meeting the following criteria:

All of the following:

1. Either:

1.1. Patient has newly diagnosed glioblastoma multiforme; or
1.2. Patient has newly diagnosed anaplastic astrocytoma*; and

1. Temozolomide is to be (or has been) given concomitantly with radiotherapy; and

2. Following concomitant treatment adjuvant temozolomide is to be used in 5 day treatment cycles ~~for a maximum of six cycles of 5 days treatment~~ at a maximum dose of 200 mg/m² per day.

Renewal application - (high grade gliomas) only from a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

Either:

1. Both:

1.1. Patient has glioblastoma multiforme; and
1.2. The treatment remains appropriate and the patient is benefitting from treatment; or

2. All of the following

2.1. Patient has anaplastic astrocytoma*; and
2.2. The treatment remains appropriate and the patient is benefitting from treatment; and
2.3. Adjuvant temozolomide is to be used for a maximum of 24 months.

Initial application - (neuroendocrine tumours) only from a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

Patient has been diagnosed with metastatic or unresectable well-differentiated neuroendocrine tumour*; and
Temozolomide is to be given in combination with capecitabine; and
Temozolomide is to be used in 28 day treatment cycles for a maximum of 5 days treatment per cycle at a maximum dose of 200 mg/m² per day; and
Temozolomide to be discontinued at disease progression.

Renewal application - (neuroendocrine tumours) only from a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

No evidence of disease progression; and
The treatment remains appropriate and the patient is benefitting from treatment.

Notes: Indication marked with a * is an Unapproved Indication. Temozolomide is not subsidised for the treatment of relapsed glioblastoma multiforme. ~~Reapplications will not be approved. Studies of temozolomide show that its benefit is predominantly in those patients with a good performance~~ ~~status (WHO grade 0 or 1 or Karnofsky score >80), and in patients who have had at least a partial resection of the tumour.~~

The restrictions for temozolomide in Part II of Section H of the Pharmaceutical Schedule will be amended in the same way.
Orion Laboratories (NZ) Ltd’s brand of temozolomide cap 5 mg, 20 mg, 100 mg, and 250 mg will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2016 as follows (ex manufacturer, excluding GST):

Chemical	Presentation	Brand	Pack size	Price and subsidy
Temozolomide	cap 5 mg	Orion Temozolomide	5	$10.20
Temozolomide	cap 20 mg	Orion Temozolomide	5	$18.30
Temozolomide	cap 100 mg	Orion Temozolomide	5	$40.20
Temozolomide	cap 250 mg	Orion Temozolomide	5	$96.80

Orion Laboratories (NZ) Ltd brand of temozolomide cap 5 mg, 20 mg, 100 mg, 250 mg, will be awarded Sole Supply Status in the Community from 1 May 2017 until 30 June 2019.
A subsidy decrease will be applied to the other brands of the Community Pharmaceutical temozolomide cap 20 mg, 100 mg and 250 mg from 1 February 2017 as follows (ex manufacturer, excluding GST):

Chemical	Presentation	Brand	Pack size	Current subsidy	New subsidy
Temozolomide	cap 20 mg	Temaccord	5	$36.00	$18.30
Temozolomide	cap 100 mg	Temaccord	5	$175.00	$40.20
Temozolomide	cap 250 mg	Temaccord	5	$410.00	$96.80

Orion Laboratories (NZ) Ltd brand of temozolomide cap 5 mg, 20 mg, 100 mg, and 250 mg, will be awarded Hospital Supply Status from 1 February 2017 until 30 June 2019 with a DV limit of 1%.
Douglas’s brand of temozolomide cap 5 mg, 20 mg, 100 mg, and 250 mg (Temaccord) will be delisted from Section B of the Pharmaceutical Schedule on 1 May 2017 and from Part II of Section H of the Pharmaceutical Schedule on 1 February 2017.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 26 May 2016 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	Comment
One responder requested that the wastage rule be applied to the listing of temozolomide, given the dosing schedule and low volume dispensing.	We note that temozolomide is currently listed on the Schedule without a wastage rule. Awarding of this proposal would reduce the cost and increase the dispensing volume therefore we do not consider it necessary to apply the wastage rule to temozolomide.
One responder requested that the duration of initial approval be reduced to 6 months with renewal required 3 monthly if benefit demonstrated by clinical or radiological measures documented in patient notes.	We consider a 9 month initial special authority approval period is appropriate as this allows for a patient to receive the full course of therapy even if there are delays to initiation of treatment for any reason. We consider a 6 month renewal to be the appropriate length for renewal balancing cost, clinical workload and patient access.
One responder considered that temozolomide treatment should be available for use adjunct to peptide receptor radionuclide therapy (PRRT) where treatment is given less frequently and not in 28 day cycles and for relapsed disease.	Funding for use adjunct to PRRT and retreatment has not been considered by PTAC and therefore its use in these settings is not included in this proposal. We would welcome a funding application for use of temozolomide for this indication.

Theme

Comment

One responder requested that the wastage rule be applied to the listing of temozolomide, given the dosing schedule and low volume dispensing.

We note that temozolomide is currently listed on the Schedule without a wastage rule. Awarding of this proposal would reduce the cost and increase the dispensing volume therefore we do not consider it necessary to apply the wastage rule to temozolomide.

One responder requested that the duration of initial approval be reduced to 6 months with renewal required 3 monthly if benefit demonstrated by clinical or radiological measures documented in patient notes.

We consider a 9 month initial special authority approval period is appropriate as this allows for a patient to receive the full course of therapy even if there are delays to initiation of treatment for any reason. We consider a 6 month renewal to be the appropriate length for renewal balancing cost, clinical workload and patient access.

One responder considered that temozolomide treatment should be available for use adjunct to peptide receptor radionuclide therapy (PRRT) where treatment is given less frequently and not in 28 day cycles and for relapsed disease.

Funding for use adjunct to PRRT and retreatment has not been considered by PTAC and therefore its use in these settings is not included in this proposal. We would welcome a funding application for use of temozolomide for this indication.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.