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Fifty years of independent expert advice on prescription medicines
The role of the ACPM today
The ACPM provides advice and makes recommendations about prescription medicines to the TGA, the Secretary of Health and the Minister/Assistant Minister of Health. This advice is an important component of the decision making process undertaken by the TGA in relation to prescription medicines.
The members carefully consider the information available and provide advice on the questions posed by the TGA decision-makers as well as how the Product Information and Consumer Medicine Information might be worded to communicate effectively the available information.
Committee members are appointed by the Minister and must have expertise in at least one of the fields specified in the Therapeutic Goods Regulations.
Our current 30 members together cover an impressively wide range of expertise, come from highly regarded Australian institutions and include professors and a number of Members of the Order of Australia.
The agenda papers for one meeting in 2003 sometimes weighed four kilograms! Nowadays, all the information is able to be viewed on laptops or tablets, but the amount of information has not diminished: for a single agenda item one committee member was asked to read almost 8000 pages.
Professor Martin Tattersall AO, ScD, MA, MD, FRCP, FRACP, seventh chair, 1997-2007
Professor Tattersall works at the University of Sydney and the Royal Prince Alfred Hospital. He has pioneered consultation audio-recordings to assist cancer patient recall and the development of question prompt lists for patient use in consultations. He has helped to develop a cancer clinical trial website to inform Australian cancer patients of available clinical trials.
Looking at the medicines considered by ACPM over the past four years, we can see the impacts of demographic changes in our community and the changing patterns of illness.
With our ageing population and lifestyle-related problems such as obesity, the health landscape is now dominated by chronic illnesses such as diabetes and cancer.
New vaccines continue to be an important preventative health strategy, with twenty positive recommendations for vaccines, including vaccines for invasive bacterial illnesses such as pneumococcal, meningococcal and haemophilus influenzae B (HiB) disease, and vaccines for pandemic influenza strains A(H1N1) and A(H5N1) and the first quadrivalent seasonal influenza vaccine.
It is not surprising that of the applications supported by the ACPM over the last four years, 24 new medicines and 28 extensions of indications and other major variations were for cancer treatment. Not only the sheer volume of new cancer medicines, but the complexity and mode of action have changed over time.
The era of 'personalised medicine' has seen new cancer treatments linked to particular genetic variations, necessitating identification of these 'biomarkers' to identify the eligible cancer subgroups for whom these medicines will potentially work most effectively. These medicines (for example trastuzumab emtansine) are now often delivered clinically to patients in much smaller quantities, with the part of the medicine that is toxic to cancer cells bound to an antibody (ie. an antibody-drug conjugate), which increases their effectiveness and reduces side-effects by targeting cancer cells. Monoclonal antibody agents, or '-mabs', have not only revolutionised cancer care, but have challenged our ACPM members to be current with advances in medicine development.
ACPM has also made ten positive recommendations for medicines that, while not for treating cancer, are intended for cancer patients. These have included agents for nausea and vomiting and to combat neutropenia (suppression of white blood cells by cancer treatments), which may leave cancer patients vulnerable to life-threatening infections.
Diabetes, particularly type 2, has increased significantly over the past two decades: the rate of diabetes in the Australian population was 1.5% in 1989, but 4.2% in 2011-12 (AIHW, 2013). Over the last four years the ACPM has recommended the registration of 13 new hypoglycaemic agents, with new classes of agents including the 'gliptins' and the emergence of fixed dose combination medicines, often in combination with the older, but still highly-effective, biguanide medicine metformin. These have improved the variety of treatment options available for patients.
The treatment of central nervous system disorders has progressed significantly with three new medicines for Parkinson's disease and seven positive recommendations for registration of medicines for multiple sclerosis during this four year period. In particular, the orally-acting agents for multiple sclerosis have been a breakthrough in the treatment of this degenerative neurological disorder. ACPM has recommended authorisation of three medicines to treat epilepsy and six for mental health indications, including four for schizophrenia.
The advice of the ACPM aids the TGA decision maker in assessing the expanding number of important new therapies.
ACPM made a world-leading recommendation to register the Australian-developed quadrivalent vaccine for human papillomavirus to prevent cervical cancer in women (March 2010). Subsequently, in August 2011, ACPM recommended broadening the indication for use in young men. Vaccination programs with Gardasil are now operating throughout the world, including developing countries. This vaccine, Gardasil, is the first registered vaccine in the world designed to prevent cancer: what an important breakthrough!
Another breakthrough in modern medicine is ivacaftor, recommended for authorisation by ACPM in 2013 and used to treat the 5% of cystic fibrosis patients with the genetic mutation G551D in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) protein. Instead of relieving symptoms, ivacaftor targets the actual disease mechanism of cystic fibrosis, by increasing the chloride transport of G551D CFTR. This is an example of a medicine being suitable for a subgroup of patients who need to be identified using a genetic biomarker before the medicine is used.
Associate Professor Geoffrey Herkes MB, BS, PhD, FRACP, last chair of ADEC (2008-2009), first chair of ACPM (from 2010)
Associate Professor Herkes provides expertise in neurology, conducts research in neuropharmacology and epilepsy, and works at the Royal North Shore Hospital, where he was Head of the Department of Neurology from 2008 to 2013.
Other important recommendations by ACPM have been in the area of antiviral treatments for Hepatitis B and Hepatitis C. And there have continued to be improvements in combination therapies for HIV AIDS - a well known example of a previously untreatable disease becoming more manageable as a result of new medicines.
The first new oral anticoagulant (NOAC) for the prevention of venous thromboembolism was authorised in 2010, with subsequent recommendations for registration of several other in-class agents. For suitable patients, the NOAC medicines mean that for the first time many do not need regular 'INR' blood tests, which are necessary for the older oral anticoagulant warfarin.
One worrying trend is the decreased number of new antibiotics in the development 'pipeline' and the rise and rise of antimicrobial resistance in the hospital and community settings. While ten positive recommendations have been made by ACPM for the entire anti-infective class, including systemic anti-fungal agents, topical antibiotics, and inhaled agents for chronic lung infection, only two antibiotics have been authorised for systemic treatment of bacterial infections in the last four years.
It is essential that the advice given by ACPM is objective and impartial. Occasionally a committee member will have a personal interest in a particular matter. When this situation arises:
- The member declares the potential conflict of interest.
- The committee, in the absence of the member, decides whether the member may be present during relevant deliberations.
- All declarations and how they are dealt with are recorded in the meeting minutes.
The TGA decision maker is aware of all this before making the final decision.
The depth of knowledge of ACPM members and their significant level of expertise across a wide range of clinical disciplines has meant that TGA decision makers have received the very best advice prior to our registration decisions for prescription medicines.