The Burden of Low Testosterone on Patients, Healthcare Professionals and Government: An Australian Perspective

Published: 1 Sep 2016

Executive Summary

Testosterone replacement therapy is important in addressing hypogonadism (low testosterone levels) in men. Characterised by a deficiency in testosterone, hypogonadism is also associated with health and well-being issues, such as mood swings and low libido, which can adversely impact the quality of life. Additionally, it is linked to other negative health outcomes, including a higher risk of osteoporosis and cardiovascular disease.

A range of testosterone therapies is available to treat testosterone deficiency, administered in transdermal, injectable and oral formulations. In recent years, the use of these treatments has increased, due to greater awareness about the benefits of treatment, the launch of new improved forms of therapy and growth in the number of men in older age cohorts who are most susceptible to testosterone deficiency. In Australia, the government offers subsidised testosterone therapies via the Pharmaceutical Benefits Scheme (PBS). Under the scheme, typically patients have had their symptoms identified, testosterone serum levels assessed, and have obtained the appropriate treatment from general practitioners (GPs) in a primary care setting. Subsidised treatments have been available to patients that meet the clinical definition of hypogonadism, determined as having a testosterone serum level of 8 nmol/L or below.

The number of PBS prescriptions for testosterone treatments has grown in recent years off a very low base, reflecting the availability of new products, greater awareness of the benefits of therapy, and growth in the patient population. Despite the increase, hypogonadism remains significantly undertreated in Australia, with only around 20% of affected men estimated to be receiving therapy.

However, starting April 2015, the government announced tougher new PBS criteria for testosterone prescribing and subsidised products to patients. The main changes in the new rules involve a reduction in the upper limit for subsidized treatments to below 6 nmol/L. Patients with testosterone levels above this are no longer eligible for subsidised treatments, even if they have received it previously. Additionally, GPs can no longer initiate treatment without a referral to a specialist, despite the fact that diagnosis and treatment of hypogonadism are relatively straightforward, and have been adequately performed in primary care settings in the past. The stricter regulations now make it significantly more difficult and costly for patients with hypogonadism to receive PBS-subsidised therapy.

The new regulations are generating debate in the healthcare industry, demonstrating the need for more insight into evaluating the impact of the changes to the PBS reimbursement process and criteria. To gain a better understanding of the effect of the new PBS reimbursement process, now in place for a year, and its impact on the ability of patients to access suitable testosterone replacement therapy in Australia, Frost & Sullivan conducted a survey of 250 GPs in collaboration with research company Prospection.

Our findings indicate that the tightening of criteria to access PBS-subsidised testosterone replacement therapies is resulting in a significantly lower number of patients receiving treatment. While some patients are moving to private prescriptions, the additional cost and effort in obtaining subsidised treatment result in a considerable number of patients missing out on therapy altogether. Given that hypogonadism is undertreated in Australia, the new reimbursement guidelines are likely to lead to detrimental health outcomes. A decreased quality of life, increased risk of osteoporosis and cardiovascular disease, and higher chance of rehospitalisation are some of the long-term effects of hypogonadism in older, male Australians. The changes to the PBS reimbursement process and criteria are likely to increase these impacts as fewer patients benefit from treatment.

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