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03 August 2010

Zoledronic acid funding approved

PHARMAC is pleased to announce the approval of funding for zoledronic acid (Aclasta) for Paget’s disease and osteoporosis (including glucocorticosteroid-induced osteoporosis), subject to Special Authority criteria, from 1 September 2010 through an agreement with Novartis New Zealand Ltd. This was the subject of a consultation letter dated 30 June 2010. In addition, the proposed amendment to the Special Authority criteria for alendronate has been approved to ensure that patients who receive an approval for zoledronic acid will be able to access alendronate.

Details of the decisions • From 1 September 2010, zoledronic acid (Aclasta) 5 mg in 100 ml solution for infusion will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at a price and subsidy of $600.00 (ex-manufacturer, excluding GST). Zoledronic acid will be subject to the following restrictions in Section B of the Pharmaceutical Schedule:

Initial application – (Paget’s disease) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria: All of the following: 1 Paget’s disease; and 2 Any of the following: 2.1 Bone or articular pain; or 2.2 Bone deformity; or 2.3 Bone, articular or neurological complications; or 2.4 Asymptomatic disease, but risk of complications; or 2.5 Preparation for orthopaedic surgery; and 3 The patient will not be prescribed more than one infusion in the 12-month approval period. Initial application – (Underlying cause - Osteoporosis) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria: Both: 1 Any of the following: 1.1 History of one significant osteoporotic fracture demonstrated radiologically and documented bone mineral density (BMD) ≥ 2.5 standard deviations below the mean normal value in young adults (i.e. T-Score ≤ -2.5) (see Note); or 1.2 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. It is unlikely that this provision would apply to many patients under 75 years of age; or 1.3 History of two significant osteoporotic fractures demonstrated radiologically; or

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Documented T-Score ≤ -3.0 (see Note); or A 10-year risk of hip fracture ≥ 3%, calculated using a published risk assessment algorithm (e.g. FRAX or Garvan) which incorporates BMD measurements (see Note); or 1.6 Patient has had a Special Authority approval for alendronate (Underlying cause – Osteoporosis); and The patient will not be prescribed more than one infusion in a 12-month period.

1.4 1.5

Initial application – (Underlying cause - glucocorticosteroid therapy) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria: All of the following: 1 The patient is receiving systemic glucocorticosteriod therapy (≥ 5 mg per day prednisone equivalents) and has already received or is expected to receive therapy for at least three months; and 2 Any of the following: 2.1 The patient has documented BMD ≥ 1.5 standard deviations below the mean normal value in young adults (i.e. T-Score ≤ -1.5) (see Note); or 2.2 The patient has a history of one significant osteoporotic fracture demonstrated radiologically; or 2.3 The patient has had a Special Authority approval for alendronate (Underlying cause – glucocorticosteroid therapy); and 3 The patient will not be prescribed more than one infusion in the 12-month approval period. Renewal – (Paget’s disease) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria: Both: 1 Any of the following: 1.1 The patient has relapsed (based on increases in serum alkaline phosphatase); or 1.2 The patient’s serum alkaline phosphatase has not normalised following previous treatment with zoledronic acid; or 1.3 Symptomatic disease (prescriber determined); and 2 The patient will not be prescribed more than one infusion in the 12-month approval period. The patient may not have had a prior approval for Paget’s disease within the last 12 months. Renewal – (Underlying cause was, and remains, glucocorticosteroid therapy) from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria: Both: 1 The patient is continuing systemic glucocorticosteriod therapy (≥ 5 mg per day prednisone equivalents); and 2 The patient will not be prescribed more than one infusion in the 12-month approval period. The patient may not have had a prior approval for underlying cause glucocorticosteroid therapy within the last 12 months. Renewal – (Underlying cause was glucocorticosteroid therapy but patient now meets the ‘Underlying cause – osteoporosis’ criteria) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria: Both: 1 Any of the following: 1.1 History of one significant osteoporotic fracture demonstrated radiologically and documented BMD ≥ 2.5 standard deviations below the mean normal value in young adults (i.e. T-Score ≤ -2.5) (see Note); or

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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. It is unlikely that this provision would apply to many patients under 75 years of age; or 1.3 History of two significant osteoporotic fractures demonstrated radiologically; or 1.4 Documented T-Score ≤ -3.0 (see Note); or 1.5 A 10-year risk of hip fracture ≥ 3%, calculated using a published risk assessment algorithm (e.g. FRAX or Garvan) which incorporates BMD measurements (see Note); or 1.6 Patient has had a Special Authority approval for alendronate (Underlying cause was glucocorticosteroid therapy but patient now meets the ‘Underlying cause – Osteoporosis’ criteria); and The patient will not be prescribed more than one infusion in a 12-month period.

1.2

Notes: 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 used by National Institute for Health and Clinical Excellence (NICE) guidance indicates 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 ≤ -2.5, and therefore do not require BMD measurement for treatment with bisphosphonates. 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.

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Hospital sales and community claims of Aclasta will be subject to a rebate which will reduce the net price and subsidy paid by the Funder. Aclasta will have protection from subsidy reduction and delisting until 1 September 2013. The Special Authority for alendronate will be amended from 1 September 2010 to add “patient has had a Special Authority approval for zoledronic acid” in the same places that the “patient has had a Special Authority approval for alendronate” criterion appears in the Special Authority for zoledronic acid. In addition, all references to “Dubbo” in the alendronate Special Authority will be replaced with “Garvan.”

Feedback received We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal. The following key issues were raised in relation to specific aspects of the proposal:

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Theme Several responders expressed concerns that community practices would not be adequately equipped to administer zoledronic acid and that patients would be charged for such a service where it was available.

Comment We acknowledge that this is likely to be the case, and note that this is a situation that PHARMAC has no control over. The listing of zoledronic acid will provide clinicians with another option for the treatment of osteoporosis where community administration is an option. We note that it is not uncommon for there to be costs to the patient associated with accessing funded pharmaceuticals (eg visits to the doctor, some diagnostic tests and pharmacy copayments).

One responder queried the inclusion of glucocorticosteroid-induced osteoporosis as a funded indication for zoledronic acid.

The commercial arrangement with Novartis allowed the inclusion of glucocorticosteroidinduced osteoporosis as a funded indication. We note that this is a Medsafe-registered indication for zoledronic acid and that there would be no obligation for clinicians to prescribe zoledronic acid for this indication if they felt it would be inappropriate for their patient. Generally, we consider that it is the responsibility of the prescriber to ensure that they are aware of the risks and benefits of treatments they prescribe and to prescribe appropriately. The purpose of the Special Authority for zoledronic acid is to target the treatment to the patient groups at greatest need, taking into account the cost and benefits of the medication. For these reasons we do not consider that, for example, a review of the patient’s oral health should be a pre-requisite for zoledronic acid funding. However, we appreciate the concerns that some clinicians may not be aware of the risks associated with bisphosphonate treatments and, therefore, we will arrange for these to be highlighted in the next available issue of Best Practice Journal (most likely issue 30). All instances of “Dubbo” in both the zoledronic acid and alendronate Special Authorities will be replaced with “Garvan”

Several responders considered that the proposed Special Authority criteria should be amended to help address concerns relating to the safety profile of zoledronic acid and the potential for adverse effects associated with inappropriate prescribing, including: lack of longer-term (>3 years) safety data; risk of irreversibility should an adverse event occur; risk of adverse effects in patients who are inadequately hydrated or with impaired renal function; and risk of osteonecrosis of the jaw, in particular in patients with poor dental hygiene and/or active dental infection. Responders also noted that supplementation with vitamin D and calcium would be needed in most cases. One responder advised that the Dubbo Osteoporosis Epidemiological Study derived fracture risk tool is now called the Garvan Institute Fracture Risk Calculator.

More information If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

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