Decision to fund denosumab for osteoporosis
We’re pleased to announce a decision to fund denosumab (Prolia) for the treatment of severe, established osteoporosis, subject to certain clinical criteria being met.
Any changes to the original proposal?
This decision relates to a proposal detailed in a consultation letter dated 16 March 2018. The final criteria are wider than those consulted on in that the restriction by gender has been removed.
Who we think will be most interested
- Health practitioners involved in the treatment of osteoporosis
- Patients with osteoporosis, or people at risk of developing it
- Organisations with an interest in osteoporosis and its treatment
- Hospital and community pharmacists, DHBs, suppliers and wholesalers.
Detail about this decision
- Denosumab (Prolia) will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 July 2018 at the following price and subsidy (ex-manufacturer, excluding GST):
Price and subsidy
Inj 60 mg prefilled syringe
- A confidential rebate will apply to Prolia that will reduce its net price to the Funder.
- Prolia will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:
Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
All of the following:
- The patient has severe, established osteoporosis; and
- The patient is female and postmenopausal; or
- The patient is male or non-binary; 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 standard deviations below the mean normal value in young adults (i.e. T-Score less than or equal to -2.5) (see Note); 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 (see Note); or
- A 10-year risk of hip fracture greater than or equal to 3%, calculated using a published risk assessment algorithm (e.g. FRAX or Garvan) which incorporates BMD measurements (see Note); or
- Patient has had a Special Authority approval for alendronate (Underlying cause - Osteoporosis) or raloxifene; and
- Zoledronic acid is contraindicated because the patient’s creatinine clearance is less than 35 mL/min; and
- The patient has experienced at least one symptomatic new fracture after at least 12 months’ continuous therapy with a funded antiresorptive agent at adequate doses (see Notes); and
- The patient must not receive concomitant treatment with any other funded antiresorptive agent for this condition or teriparatide.
a) BMD (including BMD used to derive T-Score) must be measured using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable.
b) Evidence suggests that patients aged 75 years and over who have a history of significant osteoporotic fracture demonstrated radiologically are very likely to have a T-Score less than or equal to -2.5 and, therefore, do not require BMD measurement for treatment with denosumab.
c) Osteoporotic fractures are the incident events for severe (established) osteoporosis and can be defined using the WHO definitions of osteoporosis and fragility fracture. The WHO defines severe (established) osteoporosis as a T-score below -2.5 with one or more associated fragility fractures. Fragility fractures are fractures that occur as a result of mechanical forces that would not ordinarily cause fracture (minimal trauma). The WHO has quantified this as forces equivalent to a fall from a standing height or less.
d) A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
e) Antiresorptive agents and their adequate doses for the purposes of this Special Authority are defined as: risedronate sodium tab 35 mg once weekly; alendronate sodium tab 70 mg or tab 70 mg with cholecalciferol 5,600 iu once weekly; raloxifene hydrochloride tab 60 mg once daily. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the use of one antiresorptive agent, an alternate antiresorptive agent must be trialled so that the patient achieves the minimum requirement of 12 months’ continuous therapy.
- The same restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).
Our response to what you told us
We appreciate the time people took to respond to this consultation. All responders supported the funding of denosumab for the treatment of osteoporosis. A summary of the main themes raised in feedback and our responses to the feedback received is below.
Men should not be excluded from the criteria.
Following consideration of consultation feedback and clinical advice, the criteria have been amended to remove gender restrictions.
Access should be widened to include other clinical situations, including:
The access criteria are in line with our clinical advice. We consider that further analysis and clinical advice is required before a decision could be made regarding the funding of denosumab for these groups.
We have received a new submission from the supplier of denosumab, which proposes widening access to groups 1 and 3 among others. We would also welcome other funding applications supported by published evidence for the use of denosumab in these settings.
Clarification requested as to whether accessing denosumab would require access to a specialist.
“Any relevant practitioner” will be able to apply for denosumab funding.
It is possible that some tests for severity specified in the access criteria may need specialist input, but a patient need only meet one of the six severity criteria.
Denosumab access should be ongoing as ceasing treatment leads to rapid bone loss.
Special Authority approvals for denosumab will not require renewal; they will be valid without further renewal. This means that patients with Special Authority approvals will be able to take funded denosumab for as long as is considered clinically appropriate.
Request to fund denosumab for juvenile Paget’s disease and for expansile skeletal osteolysis. The responder advised that there are only 3 patients in NZ with these conditions.
As these are different conditions to osteoporosis, we have not considered funding denosumab for these conditions.
We would welcome a funding application, supported by published evidence, for the use of denosumab in these populations.
Named Patient Pharmaceutical Assessment (NPPA) applications may be appropriate given the rarity of the conditions. More information about the NPPA process can be found on PHARMAC’s website.
If you have any questions about this decision, you can email us at firstname.lastname@example.org; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.