Easier access to medicines for men with enlarged prostates following medicine reimbursement changes

Australian men with an enlarged prostate are set to benefit from changes to the Pharmaceutical Benefits Scheme (PBS) which now allow General Practitioners (GPs) to initiate PBS prescriptions for GSK’s Duodart^® (dutasteride/tamsulosin hydrochloride) for the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Duodart¹ PBS prescriptions previously needed to be initiated by a urologist. The changes to the PBS criteria to initiate Duodart by GPs came into effect from 1^st June 2016, simplifying how the treatment is accessed for this common men’s health condition.²

Around one in three Australian men aged over 50 suffer from an enlarged prostate³. The condition can cause difficulty in starting to urinate, interrupted and weak urinary stream and more frequent urination, especially at night.⁴

The move has been welcomed by Professor Simon Willcock who is the Director of Primary Care Services at Macquarie University Hospital in Sydney. Professor Willcock has a special interest in the role played by GPs in men’s health.

“This is an important development, especially for men in regional and remote Australia, who have specific challenges in accessing healthcare professionals. Overall I think this change will help men who are not engaged with a specialist receive effective treatment for BPH by consulting with their GP,” said Professor Willcock.

“Anything we can do to smooth the path to effective treatment for BPH in men who have this condition is a positive move.”

Sydney-based urologist Associate Professor Manish Patel, says specialists will still play a key role in the treatment of BPH.

“Clearly there will still be cases where the GP considers referral to a specialist as the appropriate treatment path. But in cases where the diagnosis is clear, GPs will be able to initiate treatment. I think overall this is a positive development,” said Associate Professor Patel. 

Consumer Medicine Information is available at au.gsk.com

Important safety information for Duodart^® in Australia

Duodart is listed on the PBS for the treatment of Lower Urinary Tract Symptoms in patients with moderate to severe benign prostatic hyperplasia (BPH).¹

In the management of conditions, healthcare professionals in consultation with their patients consider both the potential risks (e.g. side effects) and benefits (e.g. effectiveness) of each medicine. Information is available from the Consumer Medicine Information (CMI) and Product Information (PI for healthcare professionals). A summary of this information is provided below, please review the CMI for further information.⁴

Duodart is a combination of two medicine; dutasteride and tamulosin hydrochloride. Dutasteride belongs to a group of medcines called 5-alpha reductase enzyme inhibitors and tamsulosin hydrochloride belongs to a group of medicines called alpha-blockers. These medicines can be used either alone or in combination in men who have BPH.⁴

Duodart should not be used in patients who have had an allergic reaction to dutasteride or any of the ingredients listed in the CMI, women or children, patients who have a history of orthostatic hypotension, patients with severe liver disease, patients with severe kidney disease or patients who are taking other medications that relax the smooth muscle of blood vessels (e.g. Flomaxtra, Minipress, Hytrin). Patients should inform their GP if they have any allergies to sulphur.⁴

Duodart capsules should be swallowed whole with some water, approximately 30 minutes after the same meal each day. Like all medicines, Duodart can cause side effects to some patients. Common side effects include: impotence (inability to achieve or maintain an erection), decrease in libido (sex drive), difficulty with ejaculation, breast swelling or tenderness, dizziness and difficulty in sleeping (insomnia).⁴

If you are going to have eye surgery for cataracts, please tell your surgeon that you are taking or have taken Duodart.⁴

Do not donate blood. Duodart decreases your PSA (prostate-specific antigen) levels.  Therefore, if you are having a blood test to measure your PSA levels, tell your doctor you are taking Duodart.⁴

Patients should inform their GPs of any medical conditions or any medication they are currently taking including medicines you buy without a prescription such as vitamin supplements or herbal medicines.⁴

Healthcare professionals are advised to refer to the Full Product Information for further information regarding the safety of the product, including contraindications and precautions.⁵

Additional notes:

For full product information, information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC.

If you are an Australian healthcare professional please visit au.gsk.com for more information on Duodart.

Duodart^® is a registered trade mark of the GSK group of companies.

The information contained within this media release does not contain all the available information. It does not take the place of talking to healthcare professionals.

In relation to this GSK media announcement, no honorarium was provided to Professor Simon Willcock or Associate Professor Manish Patel and the opinions expressed are their own. Professor Simon Willcock and Associate Professor Manish Patel have been briefed by GSK on the objectives behind this media release and its context within the DUSC review.

You can follow GSK on Twitter for more Australian updates @GSK_AU.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life. For further information please visit au.gsk.com

References:

1. Pharmaceutical Benefits Scheme (PBS). http://www.pbs.gov.au. Last accessed June 2016.
2. Andrology Australia. Male reproductive health statistics. https://www.andrologyaustralia.org/mens-health-statistics/. Last accessed June 2016.
3. Homma. (2007). Epidemiologic Survey of Lower Urinary Tract Symptoms in Asia and Australia Using the International Prostate Symptom Score. International Journal of Urology, 4, 40-46. http://onlinelibrary.wiley.com/doi/10.1111/j.1442-2042.1997.tb00138.x/pdf
4. GSK. Duodart^® Consumer Medicine Information. http://au.gsk.com/media/290841/duodart_cmi_au_011_approved.pdf.
5. GSK. Duodart^® Approved Product Information v11. http://au.gsk.com/media/290878/duodart_pi_011_approved.pdf.

This media release has been issued by Palin Communications on behalf of GSK.

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