My Health Record (MHR) is a new secure online summary of consenting individuals’ health information, enabling centralised storage of health documents such as hospital discharge summaries, pathology reports, prescription documents, organ donor registration details and Medicare documents (1). While there are many benefits to implementing MHR, there are also concerns around the secondary use of data, as well as cybersecurity, data errors, risks to patient safety and medico-legal implications for healthcare providers (HCPs).

Aligned with the increasing focus on patient centricity among pharmaceutical and medical device companies, there is a need to access better patient data and develop an improved understanding of the patient journey. In this brave new digital age, electronic health records provide a rich data source of insights about the impact of treatments on patient outcomes. However, there is a disparity between the perception of big data as the ‘holy grail’ for insights and an apparent lack of confidence among consumers and HCPs in committing their information to MHR, given recent public debate.

Benefits of My Health Record

The age of digital healthcare is upon us and many countries have implemented centralised electronic health records systems, similar to MHR, to integrate health data from multiple sources that is accessible by relevant stakeholders. Peak health bodies including the Australian Medical Association, the Royal College of Australian GPs and the Pharmacy Guild of Australia are in support of MHR for its potential to positively impact patient care and support practitioners (2). Australia has approximately 230,000 medication misadventures a year costing the healthcare system $1.2 billion (3). It is hoped that one of the many advantages of implementing the MHR system in Australia will be a reduction in these costly, often preventable adverse drug events.

The intention is that each individual’s record will eventually be populated with data that provides a complete digital health record in one place that is accessible to all relevant HCPs. With more work, the system should provide timely access to health information which saves vital time in emergencies and allows for more time spent treating patients. Enabling doctors to see a range of clinical, prescription and health information about a patient should reduce medication errors, as well as unnecessary duplication of pathology and imaging tests (4). Community pharmacists will also benefit through access to clinical information in a shared health summary which is useful for performing MedsChecks and Home Medication Reviews (4).

Data Security, Misuse and Medico-legal Concerns

The perceived benefits of the MHR system have been largely overshadowed in the media by concerns around data security and misuse of data. To ease concerns around data privacy, the Australian Parliament introduced amendments to prohibit insurers and employers from accessing records. Only certain government agencies can access records including the Australian Digital Health Agency, the Department of Health and Medicare. Additionally, law enforcement authorities require a court document to access information, all access to the system will be logged and heavy penalties will be imposed on those who access information illegally.

Despite these safeguards, vulnerable communities including those with mental health issues, people with HIV and victims of abuse or domestic violence remain unconvinced that their data will remain secure. The issue of accountability for medical errors caused by incomplete or incorrect data also remains unresolved. Good medical practice relies on accurate information, and in situations where multiple people can enter and edit data the potential for error increases. GPs have raised concerns about the medico-legal implications in situations where treatment decisions based on incomplete or inaccurate information cause harm to a patient (5). Uncertainty remains around medical indemnity, malpractice liability and what recourse is available to patients if mistakes are made.

Nevertheless, My Health Record, is a reality and so it is hoped that the various concerns raised can be resolved over time.

CRC’s experienced Medical Affairs team has the expertise to understand and utilise digital healthcare data for the purpose of demonstrating therapy value and supporting Medical Affairs related projects.

References:

1. What is My Health Record? Australian Digital Health Agency. Accesses 30^th January 2019. Available at: https://bit.ly/2B5N3On
2. Zhou N. My Health Record: privacy, cybersecurity and the hacking risk. 2018. The Guardian. Available at: https://bit.ly/2Ldk8hW
3. My Health Record can help prevent medication misadventures. Australian Digital Health Agency. Available at: https://bit.ly/2HKiUtM
4. Margo J., My Health Record: the benefits and risks explained. 2018. Australian Financial Review. Available at: https://bit.ly/2CUn0Ns
5. GPs raise fresh concerns about the legal risks of My Health Record. 2019. ABC Radio Interview with Dr Kerryn Phelps. Accesses 31^st January 2019. Available at: https://ab.co/2SiGvpA

Artificial intelligence (AI) is set to bring a paradigm shift to the healthcare industry facilitated by technological advances, the availability of vast amounts of healthcare data and rapid development of big data analytical methods (1). AI systems analyse immense amounts of data from an array of sources to draw connections and predict outcomes which can be applied in several ways to healthcare (1). AI involves the use of software and algorithms to analyse data in a way that aims to mimic processes related to human intelligence such as reasoning, learning and adaptation, sensory understanding and interaction (1, 2).

Different AI techniques can be applied to healthcare data in structured and unstructured formats. Machine learning (ML) is useful for analysis of structured data from diagnostic imaging, genetic testing and electrophysiological data. Natural language processing (NLP) is used to analyse unstructured data such as clinical notes or medical journals by turning text into machine-readable structured data (1). The application of these technologies has great potential to unlock clinically relevant information in healthcare data from multiple sources to assist in clinical decision making (1).

Challenges to AI in Healthcare

There are challenges that must be overcome before the full potential of AI in real-life healthcare applications can be realised including privacy issues relating to the storage, use and sharing of sensitive health data, as well as the lack of adequate regulatory and legal frameworks. In America the FDA has approved a number of healthcare algorithms, however the guidance on how these algorithms are being reviewed and regulated has been described as unclear by industry stakeholders (3).

For example, AI technologies based on ML algorithms that are designed to learn from patient data and adapt as increasing amounts of data are analysed (4). Systems such as this will need to enable sharing of sensitive patient data while keeping protected information safe in compliance with government privacy regulations. A further challenge is developing a framework for how ML algorithms should be regulated and implemented in clinical practice, since these algorithms incorporate ‘new learning’ and adapt in response to increasing amounts of patient data (4).

In Australia, current Therapeutic Goods Administration (TGA) regulations do not adequately capture all ‘Software as a Medical Device’ (SaMD) under the risk-based classification used for medical devices. At present many SaMD products are classified by the TGA as low risk even though the potential risk for users may be higher. Therefore, the regulator will soon be consulting on changes to the regulations relating to emerging technologies including  diagnostic AI systems, as well as health apps and 3D printing of body parts (5).

 AI for Diagnosis of Disease

The first AI-based diagnostic system designed to provide an autonomous screening decision without the need for clinician interpretation was authorised by the FDA in 2018 (3, 6). The technology enables automated analysis of images to detect fluid on the retina for the detection of diabetic retinopathy, which is the leading cause of vision loss in adults. Diabetic retinopathy represents a significant healthcare challenge and will affect an estimated 191 million people globally by 2030. The software provides a quick result indicating that either diabetic retinopathy is present and the patient should be referred to an eye care specialist, or that the screen is negative and should be repeated in 12 months (6). In this case AI provides a result that can be interpreted by a non-specialist, making it feasible that patients could be screened in the primary care setting thus easing the healthcare system burden and potentially lowering costs.

It is increasingly evident that Medical Affairs will have a unique and expanded role in the healthcare industry as digital technologies such as AI transform how healthcare is delivered, as well as how drugs are researched and discovered.

CRC’s experienced Medical Affairs team has the expertise to provide tailored strategic solutions and communicate the value of clients’ products that incorporate artificial intelligence and other new age digital healthcare innovations.

References:

1. Jiang F., et al. Artificial intelligence in healthcare: past, present and future. 2017 Stroke and Vascular Neurology.
2. Is There a Role of Artificial Intelligence in Medical Affairs? 2018 MarksMan Healthcare. Available at: https://bit.ly/2TKBlQr
3. Muoio D. Roundup: 12 healthcare algorithms cleared by the FDA. 2018 Mobihealth News. Available at: https://bit.ly/2qQd0w4
4. Teich D. Artificial Intelligence (AI), Healthcare and Regulatory Compliance. 2018 Forbes. Available at: https://bit.ly/2QMwPim
5. Regulation of Software as a Medical Device. 2018. Available at: https://bit.ly/2CmzQAE
6. Muoio D. FDA permits marketing of AI software that autonomously detects diabetic retinopathy. 2018 Mobihealth News. Available at: https://bit.ly/2syIojH

Healthcare systems globally are facing numerous challenges. Among these is managing the health of ageing populations and a growing number of people with chronic lifestyle related diseases, which are placing increasing pressure on healthcare budgets. As 2019 fast approaches, it is timely to reflect on the evolving role of medical affairs as a strategic function in an increasingly complex healthcare landscape.

Changing healthcare landscape

Some key challenges facing healthcare stakeholders include responding to complex changes in health policy and regulations, engaging consumers and improving the patient experience, as well as implementing more outcomes focused value-based healthcare models (1, 2). Precision medicines represent a new era of therapies that have emerged in recent years as a result of innovative medical research and are challenging the status quo of the healthcare landscape. These therapies require patients to undergo testing with a companion diagnostic to enable selection of those patients who will benefit the most from treatment (3). This maximises the value of medicines by way of delivering improved health outcomes and/or quality of life for a cohort expected to positively respond, while it may also lead to reduced healthcare costs whereby ineffective treatments and other interventions are avoided.

Australians have also indicated their readiness to embrace elements of the modern healthcare landscape with 75% of people in a recent poll claiming they are willing to use genetic testing to identify the most effective drug for their treatment needs, while 95% would share their test results to improve treatments for future patients (4). From a pharmaceutical industry perspective, it is suggested that industry has a presence on the Medical Services Advisory Committee (MSAC), which is the body responsible for appraising new companion diagnostics, as well as novel cell-based therapies such as CAR-T cell therapy (5). Such a move could enable improved feedback to companies from the Committee that would help to inform strategic medical affairs plans.

Communicating therapy value

 The medical affairs function is recognised as increasingly important in bridging the clinical and commercial interests of pharmaceutical and medical device companies to enable effective communication of the value of their products with a variety of stakeholders. To achieve this, medical affairs teams are increasingly drawing on not only clinical and cost effectiveness data, but also real-world evidence (RWE) or patient-outcomes data gathered outside of randomised controlled trials (2).

With a growing focus on implementing outcomes-based healthcare models, companies are placing emphasis on understanding the patient journey and seeking to add value at various touch points along this journey with their therapies. In addition, they are also focused on providing tailored support such as various digital tools in aiming to ease the burden of disease management. RWE can help provide a more holistic view of the patient journey and highlight the benefits of a treatment regime (therapy and any additional supports), as well as assist in communicating therapy value to relevant stakeholders.

The New Year is promising an influx of therapies awaiting regulatory approval from the TGA (6). However, securing registration approval is only the beginning for companies seeking to commercialise healthcare products in Australia. Forward thinking healthcare companies increasingly understand the necessity to invest in implementing a well-planned medical affairs strategy to help maximise therapy value in contributing to the achievement of commercial goals.

CRC’s experienced Medical Affairs team has the expertise to provide tailored strategic solutions across the entire product development life cycle that extract maximum value for our clients’ product portfolios in contributing to commercial success.

References:

1. Global health care outlook, the evolution of smart health care. Deloitte, 2018. Available at: https://bit.ly/2iCKU0U
2. Muratore, B. Why medical affairs is the most important role in the future of pharma. PharmaTimes, 2018. Available at: https://bit.ly/2CjMRfW
3. McCarthy, C. The Evolving Role of Medical Affairs – And 2 Ways to Keep Up. 2018. Available at: https://bit.ly/2Um5ZAB
4. Beardmore, F. Australians embrace health and medical research in a changing landscape of healthcare. Australian Research, 2018. Available at: https://bit.ly/2Qo7w7h
5. Brodie, M. MA eyes MSAC seat. Pharma in Focus, 2018. Available at: https://bit.ly/2G3Tbf0
6. Yajun, M. Thirty new drugs await 2019. Pharma in Focus, 2018. Available at: https://bit.ly/2QDBjMh

An increasing focus on biological therapies in recent years has meant that many pharmaceutical companies have scaled down their efforts to research and develop chemically synthesised “small molecule” drugs (1, 2). Biological therapy sales generate an increasing portion of pharmaceutical market share and arguably the most interest, yet they currently treat a limited range of diseases and can also be prohibitively expensive and inaccessible to patients if not reimbursed.

Media reports about innovation in the pharmaceutical industry are often prolific with acronyms such as CAR-T, PD-L1, PARP, CRISPR and mAb in referring to a range of cell based, biological and gene editing therapies. These therapies capture the imagination and draw attention for introducing innovative never-before-seen ways to treat serious disease. However, many of these treatments have yet to be tested by long term real world post-market use, while some can also cause serious side effects that negatively impact patient quality of life.

In 2017, the ten most prescribed and commonly used drugs in Australia were “small molecule” therapies (3). These are mostly well established drugs proven to be effective in treating common and chronic disease symptoms. However, small molecule doesn’t necessarily mean old drug (1). Indeed, there are a growing number of companies focusing on developing new, cutting edge chemically derived drugs. For example, ivacaftor is a small molecule drug tailored to treat specific subsets of people with cystic fibrosis for the first time targeting the underlying causes of the disease.

Another company has shown that an innovative approach to delivering of a small molecule drug via inhalation could set their product apart from competitors (4). This therapy is designed to block a molecule highly expressed in cells involved in scarring in the lungs of people with idiopathic pulmonary fibrosis (4). Another approach is to revamp and improve old drugs such as platinum chemotherapy which is effective but highly toxic resulting in side effects that can limit a patient’s tolerability to treatment. Clever reengineering of platinum chemotherapies could enable their targeted delivery in a way that effectively kills cancer cells thus limiting toxicity to patients (5).

Media reports often praise biological therapies or “large molecules” as providing ground breaking healthcare solutions, yet the above mentioned cases are just three examples showing that “small molecules” too can play in this space and compete with the “big guns” in the innovation stakes.

CRC’s experienced Medical Affairs team has the expertise to bring the value story of new molecules, big and small, to life via evidence generation initiatives and solid communication strategies.   

References:

1. Cohen, Y. Small Molecules: The Silent Majority of Pharmaceutical Pipelines. Xconomy Inc, 2015. Available at: https://bit.ly/2OJKV36
2. Dale, A. New British Biotech Receives £3M to Develop Small Molecules that Fight Cancer. Labiotech, 2017. Available at: https://bit.ly/2OKlbUe
3. Top 10 drugs 2016-17. Australian Prescriber, 2017. Available at: https://bit.ly/2Q6nQfP
4. Smith, J. Danish biotech closes 79M Euro Series C to develop inhaled lung disease drug. Labiotech, 2018. Available at: https://bit.ly/2TeBqMP
5. Toohey, M. UT’s inventor of the year, challenges odd in life work. 2017. Available at: https://atxne.ws/2DHwQCj

October is breast cancer awareness month and Breast Cancer Network Australia (BCNA) is hosting a series of events to raise awareness and generate funding for research (1). Australia’s National Breast Cancer Foundation is also celebrating 25 years by highlighting Australian research and fundraising milestones which has enhanced the understanding of breast cancer biology and contributed to better outcomes for patients (2). Here, we discuss the impact of breast cancer in Australia, how therapies have evolved and the emerging evidence that immunotherapies are providing new hope for the treatment of previously incurable breast cancers (5).

Increasing Incidence of Breast Cancer

Despite significant advancements in the diagnosis and treatment of breast cancer, it remains the second most common cause of death from cancer in Australian women (3). One in eight women are at risk of developing breast cancer by the age of 85 and it is estimated that 18,235 new cases of breast cancer will be diagnosed in Australia (148 males and 18,087 females) in 2018 (4). This represents an increase of over 1,400 new cases since 2014 (4). It is estimated that more than 3000 women will die from breast cancer in Australia this year (4).

How Targeted Therapies Have Changed Breast Cancer Treatment

Improvement in early diagnosis and new therapy options has led to an increase in the five-year survival rate among people diagnosed with breast cancer to 91% (4). Among the most significant advancements was the introduction of targeted therapies designed to attack a specific type of breast cancer based on the biological or molecular signature of the cancer cells. Unlike chemotherapy drugs, targeted therapies aim to kill cancer cells while causing little harm to healthy cells.

One example of an effective targeted therapy is trastuzumab for the treatment of patients with HER2 positive breast cancer. Overexpression of the HER2 receptor occurs in one in four women with breast cancer (7) and can cause rapidly growing cancer that spreads early. Trastuzumab works by attaching itself to HER2 receptors on the surface of breast cancer cells, blocking them from receiving growth signals. Since its availability on the Pharmaceutical Benefits Scheme (PBS) in 2010, trastuzumab has significantly improved survival rates among those with HER2 positive breast cancer (2).

However, there remains an unmet need for new therapies to treat patients with breast cancer that is unresponsive to currently available targeted and conventional therapies.

Immunotherapy in Breast Cancer

There is growing evidence that immuno-oncology therapies such as checkpoint inhibitors and chimeric antigen receptor T-cell (CAR-T) therapies may be effective for treating breast cancer (5, 6). Checkpoint inhibitor therapies (PD-1/PD-L1 and CTLA-4 blockades) bind to proteins on the surface of T-cells thereby allowing the T-cells to recognise and attack cancer cells. Checkpoint inhibitors are available in Australia for the treatment of melanoma, non-small cell lung cancer and urothelial cancer. The Pharmaceutical Benefits Advisory Committee will continue to review the clinical evidence for checkpoint inhibitors with appropriate consideration of unmet clinical needs, clinical effectiveness and cost-effectiveness (8).

There are multiple clinical studies underway to examine the use of checkpoint inhibitors for treating triple-negative breast cancer (TNBC) with preliminary data from two studies showing PD-1/PD-L1 inhibitors yield response rates of 19% in women with heavily pre-treated TNBC (5). TNBC is an aggressive form of breast cancer lacking expression of receptors linked to current targeted therapies.

The use of checkpoint inhibitors in treating breast cancer will likely require correlation to specific biomarkers identified using companion diagnostics (5). The use of biomarkers and companion diagnostics may help to ensure patients who are most likely to respond are selected for treatment, which is a useful strategy to maximise the clinical effectiveness and cost-effectiveness of these innovative therapies.

CRC’s range of medical affairs services includes expertise demonstrating the value of innovative immuno-oncology therapies for a range of different stakeholders.  

References:

1. Breast Cancer Network Australia, Events 2018. Available at: https://www.bcna.org.au/events/2018/
2. National Breast Cancer Foundation, 25 Years of Impact. 2018. Available at: https://nbcf.org.au/25years/
3. What is Breast Cancer. Cancer council Australia. 2018. Available at: https://www.pinkribbon.com.au/women-and-cancer/breast-cancer/
4. Australian Government, Breast Cancer Statistics. 2018. Available at: https://breast-cancer.canceraustralia.gov.au/statistics
5. McArthur H L. 2016. Breast Cancer in Focus. Checkpoint Inhibitors in Breast Cancer: Hype or Promise? Clinical Advances in Hematology & Oncology.
6. Tan A R. 2018. Checkpoint Inhibitors in Breast Cancer: Changing the Therapeutic Landscape. Available at: https://am.asco.org/checkpoint-inhibitors-breast-cancer-changing-therapeutic-landscape
7. Iverson D. The Herceptin debate: what price a woman’s life? Available at: https://media.uow.edu.au/opinions/UOW025806.html
8. August 2018 PBAC special meeting, Brief Outcome. Available at: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/august-2018-pbac-special-meeting