Decision to widen access to denosumab for osteoporosis and people with high calcium levels associated with cancer

Denosumab

Inj 60 mg per 1 ml prefilled syringe

Prolia

1

1 March 2025

$326.00

$250.00

Denosumab

Inj 120 mg per 1.7 ml vial

Xgeva

1

1 February 2025

Not currently funded

$500.00

Support for the proposal, as this would improve the lives of people who experience fractures associated with weak bones (osteoporosis).

It would also help to reduce the cost to the health system from reduced fractures and provide a treatment option for patients who cannot afford the cost of infusions or experience intolerable side effects from other funded medicine options.

We appreciate this feedback and are pleased to be funding a proposal that benefits New Zealanders. This feedback aligns with the advice from our expert advisors and our assessment of this proposal.

Health New Zealand | Te Whatu Ora is responsible for funding and access to services such as DEXA scans. We have shared this feedback with Health New Zealand.

The eligibility criteria include ways to access funded denosumab without requiring a DEXA scan. For example, anyone who has had two fractures is eligible for funded treatment without a DEXA scan.

DEXA scans are the most common type of bone density screening. The clinical advice we’ve received considered that DEXA scans are more reliable for diagnosing osteoporosis and determining risk of bone fracture than other methods. This is why it is a part of our eligibility criteria. 

Estimates of patient numbers for osteoporosis that suggested denosumab may be used by less people than Pharmac’s estimates.

We anticipate that the uptake for denosumab would be around 1,900 people with osteoporosis in the first year of funding.

Our analysis is based on the number of people starting treatment for osteoporosis. In New Zealand this is approximately 16,000 to 22,000 people a year. We estimated approximately 12% of people would start on denosumab as:

• 5% of people are likely to be contraindicated to other funded medicines. 
• 1% of people would not receive any benefit from other funded medicines.
• 6% of people would experience intolerable side effects from other funded treatments.

We have also reviewed our estimates with data from overseas. We will monitor usage following funding.

Feedback that widening access to denosumab would not increase the demand for primary care. People who would be eligible for denosumab are already engaged with health services, and denosumab is simple to administer.

This aligns with the expert advice we have received. We understand most people would self-administer denosumab for osteoporosis at home. A small group of people may have this administered by a district nurse or receive their injections in a residential care facility, however this would be simple to administer.

Denosumab (Xgeva) is a vial presentation and would need to be drawn up into a syringe by a healthcare professional, every four weeks, for hypercalcaemia indications. All patients are likely to require nurse administration of the injection (whether in primary, secondary, or palliative care).

Requested changes to the eligibility criteria for osteoporosis, to make the criteria clearer:

• Remove reference to “severe” established osteoporosis
• Update “eGFR” to “calculated creatine clearance or eGFR”

Update wording for bone mineral density from ‘greater than or equal to -2.5 standard deviations’ to ‘T-score of less than -2.5’. 

We have updated the criteria in line with this feedback, to make the criteria clearer. Understanding how to improve our eligibility criteria is an important part of our consultation process. 

Request to widen access to teriparatide for people for whom it is indicated.

This proposal only considered the funding of denosumab. Changes to the funding of teriparatide were out of scope of this proposal. 

A funding application for teriparatide in people with osteoporosis and a clinical vertebral fracture(s) was considered by PTAC in August 2024(external link). Funding was recommended with a low priority for first-line treatment of very high-risk osteoporosis (which includes people who have had a vertebral fracture). The next step in our process will be to rank this proposal on our options for Investment list. More information on this advice and what happens next can be found here:

Application Tracker - Teriparatide(external link)

Pharmac would welcome a funding application for other indications outside of this funding application and would be pleased to meet with the responder to discuss further access to teriparatide.

Pharmac website - From application to funded medicine: Pharmac's process 

The responders requested that the criteria for hypercalcemia of malignancy be adjusted by removing the requirement for needing both severe kidney damage and high calcium refractory to bisphosphonates i.e.

1. Patient has hypercalcaemia of malignancy; and
2. Patient has severe renal impairment; OR
3. Hypercalcaemia is refractory to treatment with bisphosphonates.

Request to fund denosumab for people who have hypercalcemia, refractory to zoledronic acid and who have normal renal function.

The proposed access criteria for hypercalcaemia consulted on included all the following:

1. Patient has hypercalcaemia of malignancy; and
2. Patient has severe renal impairment; and
3. Hypercalcaemia is refractory to treatment with bisphosphonates.

After consideration of this feedback, we have amended the criteria above to remove the requirement for hypercalcaemia to be refractory to bisphosphonates from the criteria.

Feedback and clinical advice highlighted that oral and intravenous (IV) bisphosphonates are not recommended for people with severe kidney failure. For funded access, people will need to have high calcium associated with cancer and severe renal impairment. They will not need to have tried other funded treatments to be eligible. 

Amended criteria will be as follows:

1. Patient has hypercalcaemia of malignancy; and
2. Patient has severe renal impairment.

We understand there may be people who do not have renal impairment but may not receive benefit from currently funded treatments. We will create an application for this group and continue to assess it. 

Request that access be expanded for Xgeva to additional indications such as:

• Prevention of skeletal related events in patients with bone metastases from solid tumours.
• Prevention of skeletal related events in patients with multiple myeloma.
• For people with hypercalcemia who have normal, or relatively unimpaired renal function, when zoledronic acid is ineffective.

We have not previously received a funding application for these indications. We would need further information to seek expert advice on these indications, as part of our Schedule funding assessment pathway. We would welcome a funding application with further information.

Pharmac website - From application to funded medicine: Pharmac's process

Requested clarification of the definition of ‘renal impairment’. 

Renal impairment is not specified in our eligibility criteria. We encourage prescribers to use recognised guidelines to classify the severity of renal impairment when considering suitable treatment options.