Decisions to widen access to rituximab and zoledronic acid

17 March 2022

Medicines Decision

See below for our decision to widen access to rituximab and zoledronic acid

On this page

What we’re doing

We are widening access to the following treatments from 1 April 2022 as follows:

rituximab (Riximyo) for pemphigus
zoledronic acid (Zoledronic acid Mylan) inj 4 mg per 5 ml for symptomatic hypercalcaemia
zoledronic acid (Zoledronic acid Mylan) inj 4 mg per 5 ml for early breast cancer to allow additional doses
zoledronic acid (Aclasta) inj 0.05 mg per ml, 100 ml for the prevention of bone loss after spinal cord injury.

These decisions mean more people can access funded rituximab and zoledronic acid from 1 April 2022. We estimate that approximately 1,750 patients will benefit from these decisions each year.

Any changes to the original proposal?

These decisions were subject to a consultation dated 14 February 2022.

We’re really grateful for the time people took to respond to this consultation. People who responded were supportive of the proposal and highlighted some important things for us to consider.

Changes have been made to the proposals to widen access to rituximab for pemphigus and zoledronic acid for the prevention of bone loss after spinal cord injury in response to the consultation feedback we received. These are detailed below in the relevant sections.

A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are available below.

Rituximab for people with pemphigus

Who we think will be most interested

People with pemphigus and their whānau
Healthcare professionals involved in the management of pemphigus
Community and hospital pharmacies and DHBs
Suppliers and wholesalers

Detail about this decision

From 1 April 2022, funded access to rituximab (Riximyo) will be widened to include the treatment of people with pemphigus.

New criteria for funded access to rituximab (Riximyo) will be added in Section B of the Pharmaceutical Schedule from 1 April 2022 as follows (new criteria shown only, changes in response to consultation shown – additions in bold and deletions in strikethrough):

Special Authority for Subsidy

Initial Application - (pemphigus*) only from a dermatologist or relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

All of the following:
1. Patient has severe rapidly progressive pemphigus; and
2. Is used in combination with systemic corticosteroids (20 mg/day); and
3. Any of the following:
  1. Skin involvement is at least 5% body surface area; or
  2. Significant mucosal involvement (10 or more mucosal erosions), or diffuse gingivitis, or confluent large erosions; or
  3. Involvement of two or more mucosal sites; or
Both:
1. Patient has pemphigus; and
2. Patient has not experienced adequate clinical benefit from systemic corticosteroids (20 mg/day) in combination with a steroid sparing agent, unless contraindicated.

Note: Indications marked with * are unapproved indications.

Renewal – (pemphigus*) only from a dermatologist or relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

Both:
1. Patient has experienced adequate clinical benefit from rituximab treatment, with improvement in symptoms and healing of skin ulceration and reduction in corticosteroid requirement; and
2. Patient has not received rituximab in the previous 6 months.

Note: Indications marked with * are unapproved indications.

Similar restrictions will be added to Part II of Section H of the Pharmaceutical Schedule.

There are no proposed changes to other existing Special Authority criteria or hospital restrictions for rituximab (Riximyo).

Rituximab (Riximyo) is not approved by Medsafe for use in pemphigus. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

Our response to what you told us about rituximab for pemphigus

We’re really grateful for the time people took to respond to the consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made is set out below:

Theme	Comment
Support for the proposal.	We are really grateful to the people who took the time to provide feedback in support of this proposal, particularly the individuals who wrote about the impact pemphigus has had on them and their whānau.
Request to apply wastage to the 100 mg per 10 ml presentation of rituximab (Riximyo).	We have not applied wastage as this item is listed in Section B of the Pharmaceutical Schedule as ‘PCT only’ and therefore is not held by community pharmacies. DHB hospitals can claim wastage via a different mechanism.
Amend criterion 1.3.2 to clarify a person is only required to have one of the signs to be eligible for rituximab.	We have amended the relevant criterion as requested to ensure clarity among prescribers. We consider these changes would not result in a change to patient numbers but would clarify the intent of the criteria and ensure consistent interpretation.
There is limited access to dermatology services in the public sector.	We acknowledge there is a shortage of dermatologists and dermatology services in the public healthcare system within New Zealand. The criteria allow applications from a dermatologist or any relevant specialist to reflect the nature of multi-disciplinary teams in DHB hospitals, and to support all patients in accessing timely treatment.
Request to widen access to rituximab to include people with symptomatic Epstein-Barr Virus (EBV) disease due to an underlying immune disorder.	The use of rituximab in the treatment of symptomatic EBV is a different indication to the funding proposal we consulted on, so would need to be considered as a separate funding application. We would welcome a funding application for the use of rituximab in this setting.

Zoledronic acid for people with symptomatic hypercalcaemia

Who we think will be most interested

People with symptomatic hypercalcaemia and their whānau
Healthcare professionals involved in the management of hypercalcaemia
Community and hospital pharmacies and DHBs
Suppliers and wholesalers

Detail about this decision

From 1 April 2022, funded access to zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) will be widened to include the treatment of people with symptomatic hypercalcaemia.

New criteria for funded access will be added in Section B of the Pharmaceutical Schedule from 1 April 2022 as follows (new criteria shown only):

Special Authority for Subsidy

Initial application — (symptomatic hypercalcaemia*) from any relevant practitioner. Approvals valid without further renewal unless notified where the patient has symptomatic hypercalcaemia.

Note: Indications marked with * are unapproved indications.

Similar restrictions will be added to Part II of Section H of the Pharmaceutical Schedule.

Access to zoledronic acid for symptomatic hypercalcaemia would only apply to zoledronic acid inj 4 mg per 5 ml vial (Zoledronic acid Mylan).

Zoledronic acid inj 4 mg per 5 ml vial (Zoledronic acid Mylan) is not approved by Medsafe for use in symptomatic hypercalcaemia. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

Our response to what you told us about zoledronic acid for symptomatic hypercalcaemia

We’re really grateful for the time people took to respond to the consultation. All feedback received was supportive of the proposal. The responses we received regarding zoledronic acid in general are noted at the end of this notification.

Zoledronic acid for people with early breast cancer

Who we think will be most interested

People with early breast cancer and their whānau
Oncologists, general practitioners, and healthcare professionals involved in the management of breast cancer
Organisations supporting people with breast cancer
Community and hospital pharmacies and DHBs
Suppliers and wholesalers

Detail about this decision

From 1 April 2022, funded access to zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) for use in early breast cancer will be widened to allow an additional two doses per treatment course.

The criteria for funded access will be amended in Section B of the Pharmaceutical Schedule from 1 April 2022 as follows (amended criteria shown only – additions in bold and deletions in strikethrough):

Special Authority for Subsidy

Initial application — (early breast cancer*) from any relevant practitioner. Approvals valid for 2 years 3 years for applications meeting the following criteria:

All of the following:

Treatment to be used as adjuvant therapy for early breast cancer; and
Patient has been amenorrhoeic for 12 months or greater, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and
Treatment to be administered at a minimum interval of 6-monthly for a maximum of 2 years 3 years.

Note: Indications marked with * are unapproved indications.

Similar restrictions will apply to Part II of Section H of the Pharmaceutical Schedule.

Widened access to zoledronic acid for early breast cancer would only apply to zoledronic acid inj 4 mg per 5 ml vial (Zoledronic acid Mylan).

Zoledronic acid inj 4 mg per 5 ml vial (Zoledronic acid Mylan) is not approved by Medsafe for use in early breast cancer. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

Our response to what you told us about zoledronic acid for early breast cancer

We’re really grateful for the time people took to respond to the consultation. A summary of the main themes raised in feedback relating to this proposal, our responses to the feedback received, and changes we have made are set out below. The responses we received regarding zoledronic acid in general are noted at the end of this notification.

Theme	Comment
Support for the proposal.	We are really grateful to the people who took the time to provide feedback in support of this proposal. We are pleased to be funding a proposal that will improve the health of New Zealanders.
Request for funding beyond three years	Extending funding to three years aligns with the most recent request from the Breast Cancer Specialist Interest Group to align access with the ABCSG-12 analysis in which zoledronic acid was given for a total of three years treatment. You can read about the clinical advice we received when originally assessing the proposal to fund zoledronic acid for early breast cancer, and the trials considered on the Pharmac application tracker here.(external link) We acknowledge that there are trials and guidelines that recommend access to zoledronic for 3-5 years. We would be pleased to consider funding a longer duration of treatment if further information that has not already been considered by our clinical advisors is provided to support this.

Theme

Comment

Support for the proposal.

We are really grateful to the people who took the time to provide feedback in support of this proposal. We are pleased to be funding a proposal that will improve the health of New Zealanders.

Request for funding beyond three years

Extending funding to three years aligns with the most recent request from the Breast Cancer Specialist Interest Group to align access with the ABCSG-12 analysis in which zoledronic acid was given for a total of three years treatment.

You can read about the clinical advice we received when originally assessing the proposal to fund zoledronic acid for early breast cancer, and the trials considered on the Pharmac application tracker here.(external link)

We acknowledge that there are trials and guidelines that recommend access to zoledronic for 3-5 years. We would be pleased to consider funding a longer duration of treatment if further information that has not already been considered by our clinical advisors is provided to support this.

Zoledronic acid for prevention of bone loss post spinal cord injury

Who we think will be most interested

People who have experienced a spinal cord injury and their whānau
Healthcare professionals involved in the management of spinal cord injury
Community and hospital pharmacies and DHBs
Suppliers and wholesalers

Detail about this decision

From 1 April 2022, funded access to zoledronic acid inj 0.05 mg per ml, 100 ml (Aclasta) will be widened to include the prevention of bone loss for people with spinal cord injury.

New criteria for funded access will be added in Section B of the Pharmaceutical Schedule from 1 April 2022 as follows (new criteria shown only, changes in response to consultation shown – additions in bold and deletions in strikethrough):

Special Authority for Subsidy

Initial application — (spinal cord injury*) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

1. Patient has experienced an acute traumatic spinal cord injury in the last six months; and

2. Patient is being managed in by a specialist spinal acute care and rehabilitation unit; and

3. Patient is contraindicated to, or has trialled and is unable to tolerate, oral bisphosphonate therapy; and

3. The patient will not be prescribed more than 5 mg of zoledronic acid in a 12-month period.

Note: Indications marked with * are unapproved indications.

Renewal – (spinal cord injury*) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both All of the following:

1. The patient remains unable to tolerate oral bisphosphonate therapy; and

1. The patient will not be prescribed more than 5 mg of zoledronic acid in a 12-month period; and

2. The patient has not received more than two doses of zoledronic acid for this indication.

Note: The patient must not have had more than 1 prior approval. No further renewals will be subsidised. A maximum of 2 vials of zoledronic acid treatment for spinal cord injury will be subsidised.

Indications marked with * are unapproved indications.

Similar restrictions will be added to Part II of Section H of the Pharmaceutical Schedule.

Access to zoledronic acid for the prevention of bone loss after spinal cord injury would only apply to zoledronic acid inj 0.05 mg per ml, 100 ml (Aclasta).

Zoledronic acid inj 0.05 mg per ml, 100 ml (Aclasta) is not approved by Medsafe for use in prevention of bone loss for people with spinal cord injury. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.

Our response to what you told us about zoledronic acid for the prevention of bone loss after spinal cord injury

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback relating to this proposal, our responses to the feedback received, and changes we have made is set out below. The responses we received regarding zoledronic acid in general are noted at the end of this notification.

Theme	Comment
Some people may require zoledronic acid for longer than two years if they still cannot tolerate oral bisphosphonates.	Funding treatment for 24 months is in line with the duration recommended by our expert clinical advisors. Our advisors considered that the rate of reduction in Bone Mineral Density generally plateaus 24 months following injury. Therefore our advisors recommended access criteria which target funding to the 24 months after injury. You can see the advice received from PTAC on the Pharmac application tracker here.(external link) We would be happy to consider an application for widened access to enable longer durations of zoledronic acid after spinal cord injury.
Request to amend the eligibility criteria: Patient is managed by a special care unit (rather than in a special care unit) Remove requirement to be contraindicated to, or have experienced intolerable side effects, to oral bisphosphonates as oral bisphosphonates are not suitable for people with a recent spinal cord injury.	We have amended the criteria as requested to better reflect the potential healthcare journeys people may have after spinal cord injury. We understand that people with a recent spinal cord injury are unable to remain upright for at least 30 minutes, which is required for the administration of oral bisphosphonates. We have removed this requirement.

Theme

Comment

Some people may require zoledronic acid for longer than two years if they still cannot tolerate oral bisphosphonates.

Funding treatment for 24 months is in line with the duration recommended by our expert clinical advisors. Our advisors considered that the rate of reduction in Bone Mineral Density generally plateaus 24 months following injury. Therefore our advisors recommended access criteria which target funding to the 24 months after injury.

You can see the advice received from PTAC on the Pharmac application tracker here.(external link)

We would be happy to consider an application for widened access to enable longer durations of zoledronic acid after spinal cord injury.

Request to amend the eligibility criteria:

Patient is managed by a special care unit (rather than in a special care unit)
Remove requirement to be contraindicated to, or have experienced intolerable side effects, to oral bisphosphonates as oral bisphosphonates are not suitable for people with a recent spinal cord injury.

We have amended the criteria as requested to better reflect the potential healthcare journeys people may have after spinal cord injury.

We understand that people with a recent spinal cord injury are unable to remain upright for at least 30 minutes, which is required for the administration of oral bisphosphonates. We have removed this requirement.

Our response to what you told us about widening access to zoledronic acid

We received some general feedback about zoledronic acid. A summary of the main themes raised in feedback and our responses is set out below. The responses relating to specific proposals are included in the relevant parts of this consultation.

Theme	Comment
Support for the widening of access for zoledronic acid.	We are really grateful to the people who took the time to provide feedback in support of this proposal. We are pleased to be funding a proposal that will improve the health of New Zealanders.
Request to remove the eligibility criteria for zoledronic acid (ie. open-list).	We acknowledge more people would be able to benefit and there would be a reduction in administrative burden if we removed eligibility criteria. The proposal to open-list zoledronic acid is ranked on the Options for Investment list. This means it is something we would like to fund if we have available budget. Unfortunately, we are unable to remove the eligibility criteria on zoledronic acid at this stage. However, we continue to work to progress proposals and fund more medicines for New Zealanders. You can see the progress of the proposal to open-list zoledronic acid on the Pharmac application tracker here.(external link)
Noted the resource requirements for the increased infusions.	We are really grateful for the information on infusion service impact, which has helped us inform our understanding of how these proposals would work in practice.
Concern around supply and availability of Section 25 medicines.	Both presentations of zoledronic acid are approved and therefore can be stocked by pharmacies. Zoledronic acid would need to be prescribed under Section 25 of the Medicines Act for the indications in this notification.
Concern regarding prescription errors as there are two different presentations of zoledronic acid funded.	Both presentations of zoledronic acid are currently funded, and for different indications. With any medicine which has more than one funded presentation, there is the risk of prescription errors. We will continue to engage with other sector groups to promote appropriate and safe medicine prescribing and use. We encourage prescribers, pharmacists and administering healthcare professionals to continue to check the dosage and formulation prescribed for patients is appropriate for the indication in which it is being used.

If you have any questions about these decisions, 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.