Proposals to widen access to rituximab and zoledronic acid
We are seeking feedback on four proposals to widen access to rituximab and zoledronic acid
On this page
What we’re proposing
We are seeking feedback on four proposals to widen 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.
We are particularly interested in understanding the impact of these changes on DHB infusion services.
These proposals would mean more people can access funded rituximab and zoledronic acid. We estimate that approximately 1,750 patients would benefit from these proposals each year. Access to rituximab and zoledronic acid would continue to be subject to funding restrictions.
We consider these proposals would result in health benefits to patients. We also consider that the proposals for treatment of pemphigus, treatment of hypercalcaemia and prevention of bone loss would provide savings to the healthcare sector.
Consultation closes at 5 pm Tuesday 1 March 2022 and feedback can be emailed to consult@pharmac.govt.nz.
We fund two different presentations of zoledronic acid. Each presentation is funded for different uses. This proposal would result in changes to the funding of both presentations, as detailed below.
Zoledronic acid inj 0.05 mg per ml, 100 ml (current brand Aclasta) is subject to an unresolved tender, as part of the 2021/22 Invitation to Tender. No decision has been made regarding the tender for this presentation of zoledronic acid. We are still assessing the proposal to remove all restrictions (ie open-list) zoledronic acid.
Rituximab for people with pemphigus
- People with pemphigus and their whānau
- Healthcare professionals involved in the management of pemphigus
- Community and hospital pharmacies and DHBs
- Suppliers and wholesalers
What would the effect be?
This proposal would mean that from 1 April 2022, funded access to rituximab would be widened to include the treatment of people with pemphigus.
We estimate that approximately 15 people would benefit from this proposal each year. We also estimate that this proposal would provide savings to the healthcare sector, due to a reduction in hospitalisations.
Some patients receive funded rituximab for pemphigus through our Named Patient Pharmaceutical Assessment pathway. This proposal would make rituximab more accessible for more patients and reduce the administrative burden for prescribers.
About pemphigus and rituximab
Pemphigus is a group of chronic, autoimmune skin diseases that result in blisters in mucous membranes and the skin. There are several subtypes of pemphigus. This proposal would result in the funding of rituximab (Riximyo) for any type of severe, rapidly progressing pemphigus or pemphigus that does not respond to systemic corticosteroids.
Rituximab is a monoclonal antibody medicine currently funded for use in a variety of indications, including cancer, rheumatoid arthritis, autoimmune and haematological conditions. It is administered as an intravenous infusion.
Riximyo is the current sole supply brand of rituximab. It is a biosimilar rituximab product.
Rituximab is Medsafe approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis. Rituximab is not Medsafe approved for use in pemphigus. It would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website.(external link)
Why we’re proposing this
A funding application for rituximab for the treatment of pemphigus was reviewed by the Dermatology Advisory Committee in November 2020. The Dermatology Advisory Committee recommended that rituximab be funded for pemphigus with a high priority, in the context of dermatology treatments, subject to Special Authority criteria.
We consider this proposal would provide substantial health benefits to people with pemphigus and result in overall savings to the healthcare sector, due to a reduction in hospitalisations.
Details about this proposal
The criteria for funded access to rituximab (Riximyo) would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2022 to include people with pemphigus as follows (new criteria shown only):
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:
- Patient has severe rapidly progressive pemphigus; and
- Is used in combination with systemic corticosteroids (20 mg/day); and
- Any of the following:
- Skin involvement is at least 5% body surface area; or
- Significant mucosal involvement (10 or more mucosal erosions), diffuse gingivitis, confluent large erosions; or
- Involvement of two or more mucosal sites; or
- Both:
- Patient has pemphigus; and
- 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:
- Patient has experienced adequate clinical benefit from rituximab treatment, with improvement in symptoms and healing of skin ulceration and reduction in corticosteroid requirement; and
- Patient has not received rituximab in the previous 6 months.
Note: Indications marked with * are unapproved indications.
There are no proposed changes to other existing Special Authority criteria or hospital restrictions for rituximab (Riximyo).
Zoledronic acid for people with symptomatic hypercalcaemia
Who we think will be 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
What would the effect be?
This proposal would mean that from 1 April 2022, funded access to zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) would be widened to include the treatment of people with symptomatic hypercalcaemia.
We estimate that more than 1,200 people would benefit from this proposal each year. We also estimate this proposal would provide savings to DHBs, due to the reduction in required infusion services. People would be able to receive zoledronic acid to treat symptomatic hypercalcaemia, rather than pamidronate disodium. Pamidronate disodium requires a two-hour infusion whereas zoledronic acid only requires a fifteen-minute infusion. Our clinical advisors also told us that zoledronic acid infusions would be required less frequently than pamidronate disodium infusions.
About hypercalcaemia and zoledronic acid
Hypercalcaemia occurs when calcium levels in the blood are higher than normal. Hypercalcaemia can result in a range of symptoms, often severe, including increased thirst and urination, fatigue, bone pain, nausea, and neuropsychiatric changes.
Zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) is currently funded for use in tumour-induced hypercalcaemia and early breast cancer.
Zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) is Medsafe approved for the treatment of tumour-induced hypercalcaemia and prevention of skeletal related events in patients with advanced malignancies involving bone. It is not Medsafe approved for use in early breast cancer or symptomatic hypercalcaemia and would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website.(external link)
Why we’re proposing this
A funding application for zoledronic acid for hypercalcaemia was reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2021. PTAC recommended access to zoledronic acid be widened with a high priority, subject to Special Authority.
Details about this proposal
Funded access to zoledronic acid inj 4 mg per 5 ml, vial would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2022 to include people with symptomatic hypercalcaemia 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.
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 for people with early breast cancer
Who we think will be 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
What would the effect be?
This proposal would mean that from 1 April 2022, funded access to zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) for use in early breast cancer would be widened to allow an additional two doses per treatment course.
We estimate that approximately 235 people would benefit from this proposal each year. Zoledronic acid has been shown to reduce the risk of bone metastases and improve survival rates in post-menopausal early breast cancer patients.
This proposal would require DHBs to deliver an increased number of zoledronic acid infusions.
We are particularly interested in the impact this proposal would have on DHB infusion services.
About breast cancer and zoledronic acid
Approximately 3,000 people are diagnosed with breast cancer each year in New Zealand. Māori and Pacific women experience a higher incidence of breast cancer and mortality, compared with non-Māori, non-Pacific women.
Zoledronic acid is a bisphosphonate, a class of medicines which reduce bone turnover. Bisphosphonates are used to treat osteoporosis and to prevent, or treat, bone metastases. The treatment requires an infusion once every six months for a maximum of three years.
Zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) is currently funded for use in tumour-induced hypercalcaemia and early breast cancer.
Zoledronic acid inj 4 mg per 5 ml (Zoledronic acid Mylan) is Medsafe approved for the treatment of tumour-induced hypercalcaemia and prevention of skeletal related events in patients with advanced malignancies involving bone. It is not Medsafe approved for use in early breast cancer or symptomatic hypercalcaemia and would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website.(external link)
Why we’re proposing this
Zoledronic acid inj 4 mg per 5 ml was included in the 2020/21 Invitation to Tender.
We received a request from the New Zealand Breast Cancer Special Interest Group requesting access to longer funding for people with early breast cancer, for up to three years to align with updated evidence and international usage. Advice was sought from the Cancer Treatments Advisory Committee (previously CaTSoP), which was supportive of the request.
Details about this proposal
Funded access to zoledronic acid inj 4 mg per 5 ml vial would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2022, to allow an additional 12 months of funded access to zoledronic acid for people with early breast cancer 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.
Widened access to zoledronic acid for early breast cancer would only apply to zoledronic acid 4 mg per 5 ml vial (Zoledronic acid Mylan).
Zoledronic acid for prevention of bone loss post spinal cord injury
Who we think will be 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
What would the effect be?
This proposal would mean that from 1 April 2022, funded access to zoledronic acid infusions (Aclasta) would be widened to include the prevention of bone loss for people with spinal cord injury.
We estimate that approximately 300 people would benefit from this proposal each year. This proposal would increase the number of infusions delivered by DHBs. However, we estimate that the proposal overall would provide savings to the healthcare sector, due to a reduction in the costs of treating fractures.
We are particularly interested in the impact this proposal would have on DHB infusion services.
About spinal cord injury and zoledronic acid
Bone loss can increase following spinal cord injury. Preserving and maintaining bone mass with treatments such as zoledronic acid can decrease the risk of fractures following spinal cord injury.
Zoledronic acid is a bisphosphonate agent which reduces the rate of bone turnover. Zoledronic acid (Aclasta) is currently funded for use in Paget disease and osteoporosis. It is administered as a short, 15-minute, intravenous infusion.
Zoledronic acid (Aclasta) is Medsafe approved for the prevention and treatment of osteoporosis, treatment of Paget disease and prevention of clinical fractures in patients after hip fracture. It is not Medsafe approved for use in prevention of bone loss following spinal cord injury and would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981.
You can read more about section 25 of the Medicines Act 1981 on the Medsafe website.(external link)
Why we’re proposing this
A funding application for zoledronic acid for the prevention of bone loss post spinal cord injury was reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) in September 2020. PTAC recommended access to zoledronic acid be widened with a high priority, subject to Special Authority.
PTAC considered some people may require a second infusion as they may not have sufficiently recovered to be able to sit up and receive oral bisphosphonate treatment. Therefore the proposed restrictions allow for two infusions of zoledronic acid, at least 12 months apart.
We consider this proposal would result in significant savings to DHBs due to the reduction in fractures following spinal cord injury.
Details about this proposal
Funded access to zoledronic acid inj 0.05 mg per ml, 100 ml vial would be amended in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2022 to include people with spinal cord injury as follows (new criteria shown only):
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:
- Patient has experienced an acute traumatic spinal cord injury in the last six months; and
- Patient is being managed in a specialist spinal acute care and rehabilitation unit; and
- Patient is contraindicated to, or has trialled and is unable to tolerate, oral bisphosphonate therapy; and
- 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:
All of the following:
- The patient remains unable to tolerate oral bisphosphonate therapy; and
- The patient will not be prescribed more than 5 mg of zoledronic acid in a 12-month period; and
- 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.
Access to zoledronic acid for prevention of bone loss after spinal cord injury would only apply to zoledronic acid inj 0.05 mg per ml, 100 ml vial (Aclasta). There are no proposed changes to other existing Special Authority criteria or hospital restrictions for zoledronic acid inj 0.05 mg per ml, 100 ml vial (Aclasta) as part of this consultation.
Zoledronic acid inj 0.05 mg per ml, 100 ml (5 mg per ml) is subject to an unresolved tender, as part of the 2021/22 Invitation to Tender. No decision has been made regarding the tender for this presentation of zoledronic acid. We are still assessing the proposal to remove all restrictions (ie open-list) zoledronic acid through the tender.
You can read about the 2021/22 Invitation to Tender here.
To provide feedback
Please send us an email: consult@pharmac.govt.nz by 5 pm Tuesday 1 March 2022.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on these proposals.
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