What are we paying for? A cost-effectiveness analysis of patented denosumab and generic alendronate for postmenopausal osteoporotic women in Australia.

Nneka Orji,Ainul Shakirah Shafie,Sofoora Kawsar Usman,Jonathan Karnon

doi:10.1186/s12962-016-0060-5

Nneka Orji, Ainul Shakirah Shafie

Open Access

https://doi.org/10.1186/s12962-016-0060-5

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Abstract

ObjectiveZoledronic acid and denosumab were funded by the Australian government for the management of osteoporosis at an equivalent price to alendronate. The price of alendronate has declined by around 65 %, but the price of the other two therapies has remained stable. Using data published since the listing, this paper reports current estimates of the value of denosumab compared to alendronate from an Australian health system perspective.MethodsA cohort-based state transition model was developed that predicted changes in bone mineral density (BMD), and calibrated fracture probabilities as a function of BMD, age and previous fracture to estimate differences in costs and QALYs gained over a 10-year time horizon.ResultsThe base-case incremental cost per QALY gained for denosumab versus alendronate was $246,749. There is a near zero probability that denosumab is cost-effective at a threshold value of $100,000 per QALY gained. If the price of denosumab was reduced by 50 %, the incremental cost per QALY gained falls to $50,068.DiscussionCurrent Australian legislation precludes price reviews when comparator therapies come off patent. The presented analysis illustrates a review process, incorporating clinical data collected since the original submission to inform a price at which denosumab would provide value for money.

Highlights

Osteoporosis is a disease of the bony structure in which there is demineralization leading to a reduction in bone density, and increased risk of fracture
Increasing risk over time in the no treatment group is consistent with observational data that indicates risk increases with age in the non-treated population, whilst the trend towards decreasing risks with time for patients remaining on denosumab is consistent with the extension phase of the FREEDOM trial, which shows reducing fracture risk in years 4 and 5, as bone mineral density (BMD) continues to increase
This paper has presented an economic evaluation of denosumab compared to alendronate to re-assess the value of denosumab to the Australian community, which was evaluated for listing on the pharmaceutical benefits schedule (PBS) in 2010

Summary

Introduction

Osteoporosis is a disease of the bony structure in which there is demineralization leading to a reduction in bone density, and increased risk of fracture. A recent burden of disease study estimated that there were 140,822 fractures due to osteoporosis and osteopenia in Australians in 2012, The pharmaceutical benefits schedule (PBS) in Australia lists denosumab, alendronate, risedronate, strontium and zoledronic acid for the treatment of postmenopausal osteoporotic women. In 2012, the Australian government introduced the expanded and accelerated price disclosure (EAPD) program that has led to significant reductions in the prices the government pays for pharmaceuticals once they come off patent [3]. Since 2010, Karnon et al Cost Eff Resour Alloc (2016) 14:11 the price of alendronate has declined by around 65 %, whilst the prices of zoledronic acid and denosumab have remained stable. In the financial year 2014/15, the government spent $120 million and $108 million on zoledronic acid and denosumab, respectively

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