Proposal to widen access to denosumab for osteoporosis and people with high calcium levels associated with cancer
What we’re proposing
We’re seeking feedback on a proposal to widen access to denosumab (branded as Prolia and Xgeva), through an agreement with Amgen Australia Pty Limited.
This proposal would result in the following:
- from 1 February 2025, a new strength and presentation of denosumab (Xgeva, 120 mg solution for injection) would be listed, for people with hypercalcaemia (high calcium levels) associated with cancer, subject to eligibility criteria.
- from 1 March 2025, access would be widened to denosumab (Prolia) for more people with osteoporosis, subject to eligibility criteria.
The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.
Questions and Answers on the budget increase
We want to hear your feedback about our proposal. Consultation closes at 5 pm, Thursday 14 November 2024 and feedback can be:
- submitted through our online form
- emailed to consult@pharmac.govt.nz
What would the effect be?
Bisphosphonates are a type of medicine which is used by people to treat osteoporosis. Denosumab (Prolia) is currently funded for people with severe, established osteoporosis who meet certain criteria.
From 1 February, we are proposing to list denosumab (Xgeva) for people with hypercalcaemia (high calcium levels) associated with cancer, who have kidney damage. Xgeva is a different strength and presentation of denosumab (120 mg solution for injection) that would be listed for use by this group of people.
From 1 March, we are proposing to widen access to denosumab (Prolia) for people who:
- are unable to use other funded bisphosphonates because they are contraindicated, or
- experience intolerable side effects from other funded bisphosphonates, or
- do not receive adequate benefit from other funded bisphosphonates.
Denosumab (Prolia) is Medsafe approved for osteoporosis and denosumab (Xgeva) is Medsafe approved for hypercalcaemia associated with cancer.
We anticipate around 1,900 more people would receive denosumab for osteoporosis during the first year of funding, and approximately 20 people would access denosumab for hypercalcemia. We estimate that this would increase, and by the fifth year of funding around 12,600 additional people would be receiving denosumab for both osteoporosis and hypercalcaemia.
Effects on the health sector
We expect that widening access to denosumab for osteoporosis may require more time from healthcare professionals, for those who require support from a healthcare professional to administer denosumab.
However, we anticipate that this proposal would reduce the fracture-related care required for people with osteoporosis.
We expect that funding denosumab for people with hypercalcaemia associated with cancer would reduce the number of hospitalisations as well as reduce the time people may spend in hospital for management of their hypercalcaemia.
Who we think will be interested
- People with osteoporosis or cancer, their whānau, and caregivers
- Groups who support and advocate for people with osteoporosis or cancer
- Healthcare professionals who support people with osteoporosis or cancer
- Health New Zealand | Te Whatu Ora Hospitals
- Pharmacies and wholesalers
- Pharmaceutical suppliers
About osteoporosis, hypercalcaemia and denosumab
Osteoporosis
Osteoporosis is a condition that affects people’s bones. It happens when a person’s body breaks down more bone than it makes. This reduces a person’s bone strength, increasing their risk of fractures. People with osteoporosis can experience a bone fracture (break a bone) easily. Osteoporosis usually develops as people get older and is usually life-long.
There are several funded treatments for osteoporosis. These are called bisphosphonates, or anti-resorptive agents. They help slow down the rate a person’s body breaks down their bone.
The currently funded treatments may not provide benefit for all people or may cause unwanted side effects for some people. Others, like those with kidney damage are unable to use the funded treatments because they are contraindicated.
Hypercalcaemia associated with cancer
Hypercalcaemia occurs when someone has high calcium levels in their blood. This can sometimes be associated with cancer. It is difficult to know what symptoms are caused by the cancer, and what symptoms are caused by the high calcium levels.
Currently, people who have severe hypercalcaemia associated with cancer are usually admitted to hospital and given intravenous hydration and a medicine called zoledronic acid. A person with hypercalcaemia may need to spend several days in hospital for treatment. Some people may not be able to use the funded treatments, for example if they have kidney damage.
Denosumab
Denosumab is a type of medicine called a biologic. Denosumab helps stop certain cells in the body from breaking down old bone material, which can strengthen a person’s bones and reduce the calcium levels in their blood.
Denosumab (Prolia) is administered every six months, as a 60 mg subcutaneous injection, for osteoporosis. It can be self-administered or administered by a caregiver or by a healthcare professional.
Denosumab (Xgeva) is administered every four weeks, as a 120 mg subcutaneous injection, for hypercalcaemia associated with cancer. When starting treatment, a person needs two extra injections in the first month. Xgeva is usually administered by a healthcare professional.
Medsafe data sheet for denosumab inj 60 mg (Prolia) [PDF](external link)
Medsafe data sheet for denosumab inj 120 mg (Xgeva) [PDF](external link)
Why we’re proposing this
Osteoporosis
In March 2021, the Endocrinology Subcommittee of PTAC (now the Endocrinology Advisory Committee) recommended that access be widened to denosumab for people with osteoporosis [PDF, 508 KB].
Our advisors told us that the currently funded treatments may not be suitable for everyone and that denosumab would be easier for people to access and administer. They told us that it would reduce the risk of fractures and help to keep people healthy in their communities.
Our advisors also told us that there may be an additional cost to the healthcare system as nurses may be required to administer the medicine. However, there would be greater savings to the sector from reduced fracture-related treatment and care over time.
There are two funding applications for denosumab for osteoporosis ranked on our Options for Investment (OFI) list:
This proposal covers both of these funding applications.
Hypercalcemia associated with cancer
In November 2018 Pharmacology and therapeutics Advisory Committee (PTAC) recommended that access be widened to denosumab [PDF, 364 KB] for people with hypercalcaemia associated with cancer. PTAC told us that severe hypercalcaemia can have serious effects, and that denosumab would lower calcium levels, improve symptoms and quality of life for people and help them to avoid repeated hospitalisations.
Further detail is available on the Application Tracker – people with hypercalcaemia associated with cancer(external link)
Details about our proposal
Denosumab (Prolia and Xgeva) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, as follows:
|
CHEMICAL |
FORMULATION |
BRAND |
PACK SIZE |
CURRENT PRICE AND SUBSIDY |
NEW PRICE AND SUBSIDY |
|---|---|---|---|---|---|
|
Denosumab |
Inj 60 mg per 1 ml prefilled syringe |
Prolia |
1 |
$326.00 |
$250.00 |
|
Denosumab |
Inj 120 mg per 1.7 ml vial |
Xgeva |
1 |
Not currently funded |
$500.00 |
The price of denosumab (Prolia and Xgeva) would reduce from the following dates; 1 December 2025, 1 December 2026 and 1 December 2027.
Price support would be provided by the supplier to wholesalers to support all price changes.
Prolia and Xgeva would have protection from delisting and subsidy reduction until 31 January 2027.
We are proposing criteria that would apply to the chemical ‘denosumab’ to enable access to denosumab for these two indications. However, we understand that denosumab (Xgeva) would be used for the treatment of hypercalcaemia associated with cancer and denosumab (Prolia) would be used for the treatment of osteoporosis.
Hypercalcaemia associated with cancer
From 1 February 2025, the eligibility criteria would be amended in Section B of the Pharmaceutical Schedule to include the following indication (new criteria shown only):
Initial application – (hypercalcaemia of malignancy) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
All of the following:
- Patient has hypercalcaemia of malignancy; and
- Patient has severe renal impairment; and
- Patient’s hypercalcaemia is refractory to treatment with bisphosphonates.
Note: Denosumab Inj 120 mg per 1.7 ml vial is Medsafe approved for use in hypercalcaemia of malignancy’
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Osteoporosis
From 1 March 2025, the eligibility criteria for osteoporosis would be amended in Section B of the Pharmaceutical Schedule to replace the current criteria(external link) as follows (new criteria shown only):
All of the following:
- The patient has severe, established osteoporosis, and
- Any of the following:
- History of one significant osteoporotic fracture, demonstrated radiologically and documented bone mineral density (BMD) greater than or equal to -2.5, measured using dual-energy x-ray absorptiometry (DEXA); or
- History of one significant osteoporotic fracture, demonstrated radiologically, and either the patient is elderly, or densitometry scanning cannot be performed because of major logistical, technical or pathophysiological reasons; or
- History of two significant osteoporotic fractures demonstrated radiologically; or
- Documented T-Score less than or equal to -3.0; or
- A 10-year risk of hip fracture greater than or equal to 3%, calculated using a published risk assessment algorithm which incorporates BMD measurements measured using DEXA; and
- Any of the following:
- Bisphosphonates are contraindicated because the patient’s eGFR is less than 35 mL/min; or
- The patient has experienced at least two symptomatic new fractures or a BMD loss greater than 2% per year, after at least 12 months’ continuous therapy with a funded antiresorptive agent; or
- Bisphosphonates are not tolerated; or
- Intravenous bisphosphonates cannot be administered due to logistical or technical reasons.
Note: Denosumab Inj 60 mg per 1 ml pre-filled syringe is Medsafe approved for use in osteoporosis.
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Prescribing of denosumab outside of Medsafe approved indications would need to be 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)
To provide feedback
Fill out our online form or send us an email: consult@pharmac.govt.nz by 5 pm, Thursday 14 November 2024.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
Your feedback may be shared
When you give feedback on a consultation, your feedback becomes official information that Pharmac holds. Pharmac has legal responsibilities for how we manage this official information, under laws such as the Official Information Act and Privacy Act.
Pharmac may receive a request from people for official information, which could include your feedback. Legally, Pharmac must consider whether your feedback should be released.
We will consider your views when assessing whether the feedback has to be released.
If your feedback is proposed for release, then Pharmac will contact you, unless there is a legal reason that we can't.
Note that Pharmac collects and holds your information in line with our Privacy Statement. Tell us if there is anything about your feedback that you would prefer wasn’t released.