Proposals to fund treatments for people with breast and blood cancers
We are seeking feedback on the proposals to fund treatments for people with breast and blood cancers
On this page
What we’re proposing
We are seeking feedback on proposals to:
- Widen access to trastuzumab emtansine (Kadcyla) for people with early breast cancer; and
- Fund gemtuzumab ozogamicin (Mylotarg) for people with newly diagnosed, CD33-positive acute myeloid leukaemia (AML) through a provisional agreement with Pfizer New Zealand Limited (Pfizer); and
- Widen access to obinutuzumab (Gazyva) for people with relapsed/refractory marginal zone or follicular lymphoma; and
- Widen access to azacitidine for treatment related myelodysplastic syndromes (MDS) and AML
Further details of this proposals, including how to provide feedback, eligibility criteria and background information, can be found below.
Consultation closes at 4 pm on Thursday 2 June 2022 and feedback can be emailed to consult@pharmac.govt.nz.
Who we think will be interested
- People with breast cancer, acute myeloid leukaemia, non-Hodgkin lymphoma and myelodysplastic syndromes and their whānau/carers
- DHBs and other organisations who deliver services and support for people, and their families and whānau who are affected breast cancer, acute myeloid leukaemia, non-Hodgkin lymphoma and myelodysplastic syndromes
- Healthcare professionals who treat patients with breast cancer, acute myeloid leukaemia, non-Hodgkin lymphoma and myelodysplastic syndromes
- People interested in the funding of medicines for people with cancer
- Pharmaceutical suppliers
- Hospital pharmacies and DHBs
Trastuzumab emtansine for early breast cancer
What would the effect of this proposal be?
This proposal would mean that people with early stage HER2-positive breast cancer, with residual disease after initial treatment to shrink the tumour would have access to trastuzumab emtansine post-surgery.
We estimate approximately 110 people per year would be eligible for treatment with trastuzumab emtansine in this setting.
We expect that this proposal would result in approximately 10% fewer women needing treatment for metastatic breast cancer and the number of women relapsing following treatment post adjuvant therapy would also be expected to decrease.
If funded for this group of patients, trastuzumab emtansine would replace trastuzumab in this setting. As this would be expected to replace current treatment with trastuzumab, we consider that there would be limited impact on service provision.
About HER2-positive early breast cancer and trastuzumab emtansine
HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2. Treatment for HER2-positive early breast cancer was identified as a gap for breast cancer in the publication "Understanding the Gap: an analysis of the availability of cancer medicines in Aotearoa - Te Aho o Te Kahu", as it is used with curative intent and was considered likely to have substantial clinical benefit.
In New Zealand, around 80% of people with breast cancer are diagnosed with either stage I or stage II disease, with similar proportions for Māori. This proportion is slightly lower for Pacific people. Around 15% of people with breast cancer are HER2-positive, with similar proportions for Māori. The proportion of people with HER2-positive breast cancer is higher for Pacific peoples.
Trastuzumab emtansine is a HER2-targeted antibody-drug conjugate that contains trastuzumab linked to microtubule inhibitory emtansine. It is Medsafe approved:
- for the treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination; and
- for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after pre-operative systemic treatment.
Trastuzumab emtansine must be reconstituted and diluted prior to administration. It is given by intravenous infusion every three weeks for a maximum of fourteen cycles, or until disease progression or unacceptable toxicity.
Why we’re proposing this
Details about our proposal
Access to trastuzumab emtansine would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2022 as follows (additions in bold):
Special Authority for Subsidy - PCT only – Specialist
Initial application - (early breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
- Patient has early breast cancer expressing HER2 IHC3+ or ISH+; and
- Documentation of pathological invasive residual disease in the breast and/or auxiliary lymph nodes following completion of surgery; and
- Patient has completed systemic neoadjuvant therapy with trastuzumab and chemotherapy prior to surgery; and
- Disease has not progressed during neoadjuvant therapy; and
- Patients has left ventricular ejection fraction of 45% or greater; and
- Adjuvant treatment with trastuzumab emtansine to be commenced within 12 weeks of surgery; and
- Trastuzumab emtansine to be discontinued at disease progression; and
- Total adjuvant treatment duration must not exceed 42 weeks (14 cycles).
Initial application – (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:
All of the following:
- Patient has metastatic breast cancer expressing HER2 IHC 3+ or ISH+ (including FISH or other current technology); and
- Patient has previously received trastuzumab and chemotherapy, separately or in combination and
- Either:
- The patient has received prior therapy for metastatic disease*; or
- The patient developed disease recurrence during, or within six months of completing adjuvant therapy*; and
- Patient has a good performance status (ECOG 0-1); and
- Either:
- 5.1 Patient does not have symptomatic brain metastases; or
- 5.2 Patient has brain metastases and has received prior local CNS therapy; and
- Patient has not received prior funded trastuzumab emtansine treatment; and
- Treatment to be discontinued at disease progression
Renewal - (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:
Both:
- The cancer has not progressed at any time point during the previous approval period whilst on trastuzumab emtansine; and
- Treatment to be discontinued at disease progression.
Note: *Note: Prior or adjuvant therapy includes anthracycline, other chemotherapy, biological drugs, or endocrine therapy.
Gemtuzumab ozogamicin for newly diagnosed CD33 positive AML
What would the effect of this proposal be?
This proposal would mean that people with newly diagnosed CD33-positive AML would have access to gemtuzumab ozogamicin. It is expected that treatment with gemtuzumab ozogamicin would improve survival and the reduce the likelihood of relapse for people with AML.
In New Zealand, Māori have an increased risk of AML compared with non-Māori non-Pacific peoples, and worse outcomes once diagnosed:
- Gurney et al. 2020 - The most commonly diagnosed and most common causes of cancer death for Māori New Zealanders(external link);
- The State of Cancer in New Zealand report (Te Aho o Te Kahu)(external link).
We estimate that approximately 70 patients per year would be eligible for treatment with gemtuzumab ozogamicin under the proposed criteria.
We expect that this proposal would result in improvements in event free and overall survival for those patients eligible for treatment.
We consider that there would likely be limited impact on infusion resource as this would be funded for one dose only that is provided alongside induction chemotherapy.
About AML and gemtuzumab ozogamicin
AML is a type of blood cancer that starts with young white blood cells (called blasts) in the bone marrow. In AML, the bone marrow produces white blood cells that grow and divide too fast. These abnormal white blood cells build up in the bone marrow, reducing the body’s ability to produce healthy blood cells. These abnormal white blood cells then spread to other parts of the body.
People with AML have a significant unmet health need. With the currently available treatments, 25-50% of people affected by AML are likely to be alive five years after their diagnosis.
Gemtuzumab ozogamicin is a targeted cancer therapy. Targeted cancer therapies work by ‘targeting’ the changes in cancer cells that help a cancer cell to survive and grow within the body.
Gemtuzumab ozogamicin is made up of a monoclonal antibody (gemtuzumab) that recognises the CD33 cell surface antigen, attached to a chemotherapy agent (ozogamicin). It is given intravenously in combination with chemotherapy (standard anthracycline and cytarabine) to treat patients with CD33-positive newly diagnosed AML.
This is based on our advisor’s view of the benefit of additional doses and the potential toxicity of this treatment.
Why we’re proposing this
Gemtuzumab ozogamicin has been assessed via our parallel assessment process for cancer medicines.
This process speeds up the time it takes for a funding application to be assessed, as it enables the receipt and assessment of funding applications from suppliers at the same time as Medsafe evaluation.
Details about our proposal
Gemtuzumab ozogamicin (Mylotarg) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 July 2022 at the following price and subsidy (ex-manufacturer, excluding GST):
|
Chemical |
Formulation |
Brand |
Pack size |
Proposed price and subsidy |
|---|---|---|---|---|
|
Gemtuzumab ozogamicin |
Inj 5 mg vial |
Mylotarg |
1 |
$12,973.00 |
A confidential rebate would apply to Mylotarg that would reduce the net price to the Funder.
Mylotarg would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to the following eligibility criteria:
Special Authority for Subsidy
Initial application - only from a haematologist. Approvals valid for 3 months for applications meeting the following criteria:
All of the following:
- Patient has not received prior chemotherapy for this condition; and
- Patient has de novo CD33-positive acute myeloid leukaemia; and
- Patient does not have acute promyelocytic leukaemia; and
- Gemtuzumab ozogamicin will be used in combination with standard anthracycline and cytarabine (AraC); and
- Patient is being treated with curative intent; and
- Patient’s disease risk has been assessed by cytogenetic testing to be good or intermediate; and
- Patient must be considered eligible for standard intensive remission induction chemotherapy with daunorubicin and cytarabine (AraC); and
- Gemtuzumab ozogamicin to be funded for one dose only; and
- Gemtuzumab ozogamicin to be administered at a dose of 3 mg per m2 body surface area.
Notes: Acute myeloid leukaemia excludes acute promyelocytic leukaemia and acute myeloid leukaemia that is secondary to another haematological disorder (eg myelodysplasia or myeloproliferative disorder).
Mylotarg would be listed as a PCT only - Specialist pharmaceutical in Section B of the Pharmaceutical Schedule. This means only DHB hospitals would be able to make a subsidy claim.
Obinutuzumab for the treatment of relapsed or refractory marginal zone and follicular lymphoma
What would the effect of this proposal be?
This proposal would mean that people with Follicular lymphoma (FL) and Marginal zone lymphoma (MZL) that has relapsed after, or is refractory to, a rituximab-containing regimen would be able to access obinutuzumab.
Should access be widened, we estimate that approximately 50 more people in the first year, and 35 people in subsequent years, would be eligible for treatment with obinutuzumab.
This proposal would be expected to result in improvements in progression free and overall survival for those patients eligible for treatment.
We expect that it would require similar infusion resources to the administration of maintenance rituximab. However, we note obinutuzumab may be more challenging to administer than rituximab.
About indolent NHL and obinutuzumab
Non-Hodgkin lymphoma (NHL) is a cancer that starts in particular white blood cells called lymphocytes. Lymphocytes are white blood cells that are part of the lymphatic system (which is part of the body’s immune system). Lymphoma occurs when these cells multiply without any proper order and travel to many parts of the body, forming tumours in these places. These cancers can spread quickly or slowly (“indolent”). The most common types of indolent non-Hodgkin lymphomas are FL and MZL.
In New Zealand, Māori have a similar incidence of NHL compared to non- Māori, but experience worse outcomes . However, we are uncertain of the relative impact of this proposal for our priority populations with FL and MZL.
Obinutuzumab is a targeted cancer therapy. Obinutuzumab is a monoclonal antibody that recognises the CD20 cell surface antigen. Obinutuzumab is Medsafe approved for use in combination with bendamustine maintenance for the treatment of patients with indolent non-Hodgkin lymphoma (iNHL) who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. We are proposing funding for the most common types of iNHL in line with the clinical advice that we have received.
Why we’re proposing this
Details about our proposal
Access to obinutuzumab would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2022 as follows (new criteria shown only):
Special Authority for Subsidy
Initial application - (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 9 months for applications meeting the following criteria:
All of the following:
- Either:
- Patient has follicular lymphoma; or
- Patient has marginal zone lymphoma; and
- Patient is refractory to any previous regimen containing rituximab within six months after treatment with rituximab; and
- Patient has an ECOG performance status of 0-2; and
- Patient has been previously treated with no more than four chemotherapy regimens; and
- Obinutuzumab to be administered at a maximum dose of 1000 mg in combination with bendamustine at a maximum dose of 90 mg/m2 for a maximum of 6 cycles; and
Renewal - (follicular / marginal zone lymphoma) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 24 months for applications meeting the following criteria:
All of the following:
- Patient has no evidence of disease progression following obinutuzumab induction therapy; and
- Obinutuzumab to be administered at a maximum of 1000 mg every 2 months for a maximum of 2 years; and
- Obinutuzumab to be discontinued at disease progression.
Azacitidine for treatment related MDS/AML
What would the effect of this proposal be?
This proposal would mean that people with therapy related MDS/AML would be able to access azacitidine.
Should access be widened, we estimate that approximately 10 more people per year would be eligible for treatment with azacitidine. We anticipate that this proposal would result in improvements in survival for those eligible for treatment.
About treatment related MDS/AML and azacitidine
MDS includes a group of blood cancers that affect the production of normal blood cells in the bone marrow. In MDS, abnormal blasts produce increased numbers of immature blood cells. These cells do not grow properly and often die prematurely. The blood cells that do survive are often of poor quality, are abnormal in shape (dysplastic) and are unable to function properly.
Therapy-related MDS/AML (t-MDS/AML) is a complication of cytotoxic therapy given for cancer or for non-malignant disorders. We are uncertain of the relative impact of this proposal for our priority populations with treatment related MDS/AML.
Azacitidine is a type of demethylation agent. This means it works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.
- Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS),
- Chronic Myelomonocytic Leukaemia,
- Acute Myeloid Leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to the World Health Organization (WHO) classification.
Why we’re proposing this
We have also assessed a funding application to widen access to azacitidine for patients with AML whose blast counts exceed 30%.
The Cancer Treatments Subcommittee recommended this be funded with a medium priority. [PDF, 481 KB]
We have ranked this application on our options for investment list. This means it is a treatment we would like to fund but are not proposing to fund this at this time. We are unable to provide a definitive timeframe for if, or when, a decision would be made to fund azacitidine for patients with AML who blast counts exceed 30%. This is because the relative priority of funding one pharmaceutical compared with other pharmaceuticals can change over time. Details like the relative health benefits, the amount of funding available, the success of negotiations with the suppliers and/or new clinical data, and the mix of other funding applications being considered at any one time, are all examples of factors that may change the relative priorities of funding choices.
Details about our proposal
Access to azacitidine would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2022 as follows (additions in bold, deletions in strikethrough):
Special Authority for Subsidy
Initial application only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 12 months for applications meeting the following criteria:
All of the following:
1. Any of the following:
1.1. The patient has International Prognostic Scoring System (IPSS) intermediate-2 or high risk myelodysplastic syndrome; or
1.2. The patient has chronic myelomonocytic leukaemia (10%-29% marrow blasts without myeloproliferative disorder); or
1.3 The patient has acute myeloid leukaemia* with 20-30% blasts and multi-lineage dysplasia, according to the World Health Organization (WHO) classification; and
2. The patient has performance status (WHO/ECOG) grade 0-2; and
3. The patient does not have secondary myelodysplastic syndrome resulting from chemical injury or prior treatment with chemotherapy and/or radiation for other diseases; and
3. The patient has an estimated life expectancy of at least 3 months; and
4. Azacitidine is to be used as primary therapy for AML/MDS.
Renewal only from a haematologist or medical practitioner on the recommendation of a haematologist. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- No evidence of disease progression; and
- The treatment remains appropriate and patient is benefitting from treatment.
To provide feedback
Please send us an email: consult@pharmac.govt.nz by 4 pm on Thursday 2 June 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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