The healthcare landscape is changing and companies providing products and services to the industry need to evolve to keep up. In the spirit of a New Year almost upon us, CRC has selected what we believe may be hot topics for the pharmaceutical and medical device industries in 2018.

Biosimilars – much ado about nothing?

The pharmaceutical industry is experiencing a second wave of patent expiry and some of the most successful biological drugs may soon have competition from biosimilar products. The Australian government has pledged to drive the uptake of biosimilars and so has implemented the ‘Biosimilar Awareness Initiative’ to support awareness of, and confidence in, the use of biosimilars (1). Furthermore, changes in the way doctors prescribe biosimilars and new pricing mechanisms are planned to take effect in 2018 (2). While the intention is to encourage greater uptake, controversy around biosimilars remains. So what’s fueling this controversy?

In 2017, the first biosimilar product dispensed largely in community pharmacy was listed on the Pharmaceutical Benefits Scheme. The product is eligible for ‘a-flagging’ meaning that, like generics, it could be substituted by the pharmacist at the point of dispensing without input from the prescribing clinician (3, 4). As shown in Table 1, generic medicines are simple molecules identical to the reference product (5), therefore switching from brand to generic products is considered safe. Biosimilars, on the other hand, are complex molecules that cannot be considered identical to the original brand and so switching between brand and biosimilar is causing some concern (5, 6). However, it is recognised that education is key to building confidence in biosimilars, and so for this reason industry representatives raised the alarm when a planned online government education resource for HCPs was cancelled (7). Yet HCPs and consumers need unbiased, consistent, responsive and user-friendly information developed by independent credible sources (4, 6). Indeed, with the introduction of many new biosimilars expected in 2018 and beyond, now is the time for companies to address concerns around potential issues with multiple switches, product interchangeability and other relevant matters that will impact patient care (4, 6). More to come on this topic in a future blog…

Table 1. Overview of the main differences between generics and biosimilars

Table reproduced from Biosimilars vs Generics (5).

Forging new paths in reimbursement

In a previous blog, we discussed the increasing need to establish new reimbursement pathways for products that do not fit existing funding mechanisms (8). Recently, one company endeavoured to forge a new pathway following multiple rejections by the PBAC. In this case, a proposal was put to government detailing a unique PBS ‘swap out’ deal reported to be successful in another country (9). The deal under consideration by government could see the introduction of a long-term portfolio funding arrangement with the sponsor that has multiple innovative products in their pipeline and an active R&D program. If successful, this innovative funding option could possibly establish a mechanism whereby access to newly approved medicines would be guaranteed for eligible patients. Now that this request has been made, it’s likely we will see more of these types of ‘solutions’ by other companies in 2018.

Regulatory changes for medical devices

Inadequate clinical evidence is said to be the leading cause of rejection of medical device registration submissions by the TGA (10). A recent update of the TGA’s clinical evidence guidelines for medical devices aims to address this issue by detailing how to conduct clinical evaluations and how to present data in a clinical evidence report (10). Furthermore, the European Commission recently introduced a new Medical Devices Regulation (MDR) detailing a number of changes to be implemented over the next three years regarding the registration of medical devices. In keeping with the Australian Regulatory Authority’s policy of harmonisation with European standards, this new framework will likely impact Australian companies (11). Indeed, the impact of these changes may become more evident in 2018 and beyond and so regulatory teams who have been educated on how to implement the changes will likely have a head start over the competition.

CRC’s capability model is designed to deliver strategic and forward-thinking Medical Affairs solutions that can be adapted to external change and so continue to build value for our clients at all stages of the drug development lifecycle.


  1. The Department of Health website. 2017. Biosimilar Awareness Initiative. Available at: http://www.health.gov.au/biosimilars
  2. Owen J. and Currey R. 2017. Government moves to legislate to increase generic and biosimilar medicine uptake and cut medicine prices. Available at: https://www.twobirds.com/en/news/articles/2017/australia/government-moves-to-increase-generic-and-biosimilar-medicine-uptake-and-cut-medicine-prices
  3. Rowley D. 2017. Brenzys lists amid ‘misinformation’. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=11810
  4. Scully R. P. 2015. The controversy over biosimilars: What’s the deal? Medical Republic. Available at: http://medicalrepublic.com.au/the-controversy-over-biosimilars-whats-the-deal/1592
  5. Amgen website. Biosimilars vs Generics. Available at: http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/
  6. McKinnon R. and Ward M. 2016. Safety considerations of biosimilars. Australian Prescriber. Available at: https://www.nps.org.au/australian-prescriber/articles/safety-considerations-of-biosimilars
  7. Rowley D. 2016. Key plank of biosim awareness dumped. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=11437
  8. O’Reilly N. 2017. The Challenges of Market Access. Available at: https://crcaustralia.com/media-releases/ – Link for November blog
  9. Brodie M. Govt weighs radical PBS ‘swap out’. Pharma in Focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12654
  10. Ahmadzada T. 2017. TGA publishes final Clinical Evidence Guidelines for Medical Devices. Brandwood Biomedical Blog. Available at: http://brandwoodbiomedical.com/tga-publishes-final-clinical-evidence-guidelines-for-medical-devices/
  11. Loh E. and Boumans R. 2017. Understanding Europe’s new Medical Devices Regulation. Emergo White Paper. Available at: https://www.emergogroup.com/resources/articles/whitepaper-understanding-europes-medical-devices-regulation



With little over a month to go until the end of 2017, now is timely to revisit market access as an issue that saw much attention focused on reimbursement delays in Australia, as well as some complex negotiations, which at times fuelled controversy during the year. Most likely market access challenges will continue to be a focus for pharmaceutical and biotechnology companies into 2018 and beyond.

Among various reimbursement challenges that raised an eyebrow was one case involving a company’s refusal to access a substantial 90% reduction in the reimbursed price for their therapy as this would not be commercially viable and could jeopardise their global pricing. However, among reimbursement obstacles identified, it has also been noted that pharmaceutical companies in Australia are not offering their “best price” early in reimbursement discussions due to their international head offices’ pricing policies, which leads to reimbursement delays (1).

In another case, reimbursement approval for a “revolutionary” therapy that would reduce the number of self-injections from two per day to one per week came through five years after product registration.

Taking market access challenges one step further, what about innovative therapies that do not fit into any existing funding mechanisms and so face an almost impossible reimbursement barrier? One could argue there should be as much focus on establishing new funding pathways for these therapies as there is on the Pharmaceutical Benefits Scheme (PBS) process.

Reimbursement pathways – which way?

While regulatory approval pathways are for the most part globally harmonised, reimbursement pathways vary among countries and are often complex and unpredictable (2). Product sponsors provide comprehensive clinical and economic evidence as part of a health technology assessment (HTA) used by government as the (usual) payer when deciding whether or not to fund a therapy. However, often there is difficulty in capturing many value aspects of medicines during the assessment process, which makes the longer-term health outcome and economic benefits of therapies less obvious (3).

Reimbursement may also follow a different pathway depending on the type of therapy. For example, the PBS has a rigorous assessment process for evaluating the cost-effectiveness of medicines and hence the value of innovative therapies, which considers clinical effectiveness, other health outcomes such as quality of life and associated costs. Yet blood products such as recombinant clotting factors are subject to a tender process in Australia for which the key focus is minimising price. This creates considerable challenges in demonstrating therapy value because while procurement tends to minimise the cost to government budgets, it is not a mechanism for recognising and rewarding therapy innovation. Indeed, tendering typically restricts choice of therapy for prescribers and patients.

In general, Australia’s reimbursement environment has caused frustration among pharmaceutical companies’ due to the cost-effectiveness hurdles of demonstrating value at prices often lower than a sponsor company’s global floor price (2, 4, 5). Many companies have also been impacted by “comparator erosion”, which is when a new therapy is priced against a generic product or relatively old therapy with a low price (2,5). Yet there is acknowledgement among stakeholders, namely, government, the Pharmaceutical Benefits Advisory Committee and the pharmaceutical industry of the need for a collaborative approach to improve reimbursement evaluation processes so that new therapies are affordable and accessible to patients (6 – 8).

Communicating therapy value

In recent years, advances in drug discovery and research have led to the development of innovative yet often expensive therapies. Sponsor companies absorb the risk and high cost of the drug development process, which can be offset with higher therapy prices and so the onus is on them to demonstrate the value of their product to achieve timely reimbursement (3). However, this may be difficult where no comparator therapy exists, the current comparator is an old therapy or a generic medicine (2).

It also seems there may be an imbalance between showing cost-effectiveness versus other elements that contribute to demonstrating therapy value and so perhaps the pharmaceutical industry as a whole could improve on how it communicates value to payers and other stakeholders. For example, factors such as meeting a high clinical need, improving quality of life and productivity gains (i.e. returning people to the workforce) are important, yet may not always translate to a cost-effectiveness ratio. Nevertheless, there remains the need to effectively communicate to all stakeholders on how the cost of an innovative therapy is justified by the clinical, economic and social benefits it delivers to patients.

CRC’s dedicated Medical Affairs experts are well equipped to implement effective market access strategies and communicate therapy value for clients bringing innovative products to market.


  1. Rowley D. 2017. Local pharma hostage to global pricing says PBAC chief. Pharma in focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12520
  1. Aris R. 2013. Pricing and reimbursement in Australia. Available at: https://pharmaphorum.com/views-and-analysis/pricing-and-reimbursement-in-australia/
  1. Rowley D. 2017. Public doesn’t get the value of medicines. Pharma in focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12448
  1. Tower K. 2017. Big Pharma’s had a gutful of PBS. The Australian. Available at: http://www.theaustralian.com.au/national-affairs/health/big-pharmas-had-a-gutful-of-pbs-report/news-story/e65d776b0d298327a58e850233202043
  1. Challenges and Change: A report on the Australian pharmaceutical industry. Available at:https://www.pwc.com.au/industry/healthcare/assets/challengesa-and-changes-final.pdf
  1. Rowley D. 2017. Patient data key to faster PBS-listing says DoH. Pharma in focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12410
  1. Brodie M. 2017. New PBS fast track essential say pharmas. Pharma in focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12444
  1. Rowley D. 2017. PBAC chair: time to review and renew policy. Pharma in focus. Available at: http://www.pharmainfocus.com.au/news.asp?newsid=12447




Increasing consumerism and patient empowerment has driven a change in how the healthcare industry engages with patients to provide therapeutic solutions. The final installment of our three-part blog series explores how the rise of patient centricity is impacting the design of patient support programs (PSPs).

Adding value to patient support programs

Pharmaceutical and medical device companies develop PSPs to help patients gain maximum benefit from their prescribed treatment to improve patient health outcomes and promote the quality use of medicines. These programs play a key role in supporting patients, providing information about their condition, helping patients adhere to their medication taking and making better lifestyle choices. Traditional PSPs have often taken a “one-size fits all” approach to address patient non-adherence. 1

In this era of patient empowerment, however, there needs to be a different approach to designing PSPs that complements the role of healthcare professionals (HCPs) in patient care. Patients need to see the value for themselves in participating in a company’s program. Forward thinking healthcare companies understand the benefits of investing in holistic PSPs and will undertake patient research to gain insights into the support services they really need and provide platforms for patients to participate in their care. Figure 1 shows the structure of a “beyond the pill” holistic PSP whereby the program has clinical relevance beyond simple medication adherence. 1 For example, a valuable support service for patients beginning a biological therapy for example is to provide training on how to administer injections, which is also beneficial for HCPs since this added support can shorten the time to starting the patient on a new therapy. 2 Designing a holistic PSP can have multiple benefits for pharmaceutical companies including enhancing patient engagement, assisting quality use of medicines prescribing, providing evidence to payers of added value for patients and also retaining brand loyalty. 1,3

Figure 1. Holistic disease management approach to PSP

Adapted from “Creating Value Through Patient Support Programs”. 1

Patient support program key stakeholders

Understanding the patient journey

Each patient’s journey has various phases and companies should consider the needs of individual patients at these different times. 1 It is important to develop a deep understanding of the patient journey from the path to diagnosis, through to ongoing interactions with HCPs, treatment decisions for ongoing care, managing treatment side effects and re-evaluating the treatment plan. Developing knowledge of the patient journey in this way can reveal important opportunities to engage with patients and provide individualised support services at appropriate touch points when they are most receptive. Seeking out these opportunities is important because the way in which a patient and their support network respond to certain situations along the journey can impact their long-term health outcomes. 4

The effects of a patient’s illness on their life and the side effects of their treatment are often subjective and difficult to quantify such as when considering emotional, cognitive, psychological and social factors. Progressive PSPs ensure that patients are supported holistically in these ways in managing their illness and that the program itself is clinically relevant, i.e. has the ability to improve clinical outcomes even without the drug.5 This is particularly important for patients with a chronic illness who suffer relentless psychological, emotional and social effects of their disease and the challenge to remain adherent to their treatment regimen. Therapy adherence involves more than education or reminder services – it’s about the patient correlating an improvement in their overall well-being with medication taking and improved symptoms, which helps build patient loyalty to a brand. 2

CRC’s experienced Medical Affairs team can engage key stakeholders to inform development of PSPs that are not just about the medication taking but also encompass holistic disease management elements.


  1. Ockvirk A. 2016. Drug discovery and development magazine. Creating Value Through Patient Support Programs. Available at: https://www.dddmag.com/article/2016/03/creating-value-through-patient-support-programs
  2. Hensley E. Martini J. 2015. ZS Associates. Patient support programs that deliver results. Available at: https://www.zs.com/publications/articles/patient-support-programs-that-deliver-results.aspx
  3. Robinson R. 2014. PharmaVoice. Payers: Addressing the needs of payers. Available from: http://www.pharmavoice.com/article/payers/
  4. Ockvirk A. 2016. SKIM Group Presentation. Available at:https://www.slideshare.net/SKIMgroup/creating-value-through-patient-support-programs
  5. Butler A. 2015. LinkedIn Pulse. The five foundations of digital patient support programmes. Available at: https://www.linkedin.com/pulse/five-foundations-digital-patient-support-programmes-alex-butler




This second installment of our three-part series discusses how the Medical Affairs function is evolving to provide solutions that address the three areas of change discussed in last month’s blog, i.e. greater consumer empowerment, complex regulatory pathways and informing payers about real-world data.

Looking through ‘multiple lenses’ – the importance of stakeholder engagement

The most competitive pharmaceutical and medical device companies are those who integrate rapid technological developments, use of big-data and real-world evidence into their medical affairs functions (1). Medical affairs teams link scientific and clinical results to patient outcomes and communicate these insights strategically to stakeholders throughout the product lifecycle. Responding to changes in the healthcare industry requires innovative stakeholder engagement strategies driven by understanding the needs of patients, healthcare providers, regulators, payers and government.

One example of the importance of stakeholder engagement in an evolving medical affairs function is the rise of medical science liaisons (MSLs) in response to restrictions on the activities of sales representatives in promoting therapeutic products to healthcare professionals. MSLs are now more likely to gain access to medical key opinion leaders (KOLs) to hold peer-to-peer discussions and gain insights that can inform clinical strategies and contribute to building competitive advantage.

Patient engagement strategies

Harnessing patient insights has been shown to impact positively across multiple business areas in the pharmaceutical and medical device industries, yet patient-centricity remains somewhat an aspiration for some companies (2). The use of digital platforms such as apps to allow patients to communicate with healthcare professionals (HCPs) via video journal during clinical trials is increasingly popular. However, medical affairs teams who embrace this type of technology must be careful to cater first to the patient’s needs before the business needs. For example, apps can allow the HCP to respond to patient queries or schedule an earlier visit if they are concerned with their patient’s progress or side effects. These apps can then have the secondary goal of providing a tool for companies to gather insights that can later be disseminated to regulators, payers and other relevant stakeholders as part of the business strategy. Companies relying solely on data from patient-physician interactions are limiting their potential to gain insights about the patient journey and so need to realise the importance of innovation to improve on current standards of patient engagement (3).

Strategies to engage payers

The rising cost of healthcare has caused payers to seek cost-containment measures and new forms of evidence in showing the cost-effectiveness of therapies (4). Simultaneously, the pharmaceutical industry has become increasingly frustrated with the uncertainty around the funding of new therapies and so there is a growing need for companies to develop a new model of interaction with payers (4). One suggestion is for early and ongoing engagement with payers similar to the approach that pharmaceutical companies often take with KOL engagement (5). Some examples of strategies that can add value to payer engagement are the use of real-world data, incorporating support services that optimise the value of a therapy for patients, as well as tools to help payers assess the quality of those services and negotiating risk-sharing arrangements such as pay-for- performance (4, 5). By developing an evidence based relationship, payers and the pharmaceutical industry can collaborate to bring the most clinically effective and best value solutions to patients.

CRC’s experienced Medical Affairs team can develop effective engagement and market access strategies tailored to a client’s needs for building effective stakeholder relationships.


  1. Loic P, Schlegel C, Gordian M. 2017. Reinventing the role of medical affairs. Available at: http://www.bain.com/publications/articles/reinventing-the- role-of-medical-affairs.aspx
  2. Kinapse. 2015. Capitalising on Patient Insights. Available at: http://www.kinapse.com/media/1237/capitalising-on- patient-insights- kinapse-white-paper- february-2015.pdf
  3. Champagne D, Hung A, Leclerc O. 2015. McKinsey & Company How pharma can win in a digital world. Available at: http://www.mckinsey.com/industries/pharmaceuticals-and- medical-products/our-insights/how- pharma-can- win-in- a-digital- world
  4. Robinson R. 2014. PharmaVoice. Payers: Addressing the needs of payers. Available from: http://www.pharmavoice.com/article/payers/
  5. de Cent N. 2014. EyeforPharma. It’s time to go on the payer journey. Available at: http://social.eyeforpharma.com/evidence/its-time- go-payer- journey




Medical Affairs is undergoing an evolution of sorts. This is the first of a three-part series looking at three key areas where external landscape changes are impacting the Medical Affairs function.

1. Greater Consumer Empowerment

Unprecedented access to healthcare information has allowed patients to become more discerning about their health needs, which is influencing pharmaceutical and medical device companies to integrate patient centric strategies that impact across the organisation (1). Empowered consumers leverage knowledge to demand more sophisticated, convenient and personalised therapies (2).Traditionally, companies focused on satisfying the needs of regulators, payers and prescribers throughout the product life cycle, while patient insights were gathered indirectly via healthcare providers (3). However, patients have found their voice and the onus now is on industry to engage with them as key stakeholders and implement solutions that provide more considered support to patients.

Medical Affairs teams can respond to this by taking a ‘360-degree’ approach to engaging with patient communities in designing patient support programs (PSPs) that facilitate holistic disease management. This means the PSP does not simply focus on medication adherence but aims to demonstrate a deep understanding of how the disease and the therapy impact patient outcomes, which informs those services most meaningful to patients for improving their lives (3, 4). For example, PSPs developed for patients with diabetes may need to address the emotional, social and psychological impact of their condition, it’s monitoring and adhering to therapy, while a PSP for an oncology drug may require more focus on managing treatment side effects and how these impact patient lives.

2. Complex regulatory pathways

Innovative therapies, especially biological medicines, are being developed at an accelerated rate, which has created pressure on regulators to implement effective risk management solutions. In Australia, a series of reforms shown below have added to the burden of risk management activities for pharmaceutical and medical device companies (5).

Table reproduced from: https://www.tga.gov.au/sites/default/files/presentation-mmdr-consultation-strengthening-monitoring-of-medicines-in-australia-170426.pdf

These reforms include the introduction of the Black Triangle Scheme in Australia in 2017 (Figure 1), which has been in effect in the EU since 2013 (6). Black triangle notices will apply for a period of 5 years to biological medicines and therapies that contain a new active substance to indicate the medicine is subject to additional monitoring, as well as highlight the location of safety information along with details of how to report adverse reactions (5-7). These changes reflect the increasing concern of regulators and consumers about the long-term safety risk of some new medications,specifically biologicals that can cause increased risk of adverse events (7). These reforms can only benefit patient outcomes via the increased safety vigilance and risk management, however companies may be challenged by the increased workload and resource implications.

Figure 1. Example of new product labelling under the Black Triangle Scheme.

3. Informing payers about real world data

Healthcare systems globally are evolving from high cost fee-for-service based models towards value-based systems linking payment to performance and, as discussed previously, Australia has been slow to implement these changes (8). There is increasing pressure on pharmaceutical and medical device companies to demonstrate not just clinical effectiveness but the value for money their products provide. This is no longer achieved solely through traditional evidence based medicine in the form of clinical studies to prove the safety and efficacy of a therapy. In fact, companies are now facing unpredictable reimbursement decisions and are challenged to implement strategies to prove long-term, real-world clinical and cost-effectiveness outcomes in securing funding for new therapies (9, 10). Industry as a whole could therefore benefit from coming together as ‘change agents’to face this challenge by working with payers to establish the appropriate mechanism in progressing the collection and use of real world evidence to support therapy funding.

CRC’s mission is to increase our clients’ competitive edge by implementing Medical Affairs solutions to maximize commercial opportunities. Our dedicated Medical Affairs experts are well equipped to find strategic approaches for the current challenges facing industry and implement them with our clients.


  1. Taylor K, Steedman M, Sanghera A. 2017. Deloitte. Pharma and the connected patient – How digital technology is enabling patient centricity. Available at: https://www2.deloitte.com/content/dam/Deloitte/uk/Documents/life-sciences-health-care/deloitte-uk-pharma-and-the-connected-patient.pdf
  2. Figgis P, Walters C. The Empowered Consumer. Available at: http://www.pwc.com/gx/en/industries/healthcare/emerging-trends-pwc-healthcare/new-entrants-healthcare-provision.html
  3. Gosling H. 2016. Patient-centricity: Ghost in the machine. Available at: http://www.pharmatimes.com/magazine/2016/may_2016/patient-centricity_ghost_in_the_machine
  4. Ocvirk A. 2016. Creating value through patient support programs. Available at: https://www.dddmag.com/article/2016/03/creating-value-through-patient-support-programs
  5. Cook J. 2017. Therapeutic Goods Administration. Strengthening monitoring of medicines in Australia. Available at: https://www.tga.gov.au/sites/default/files/presentation-mmdr-consultation-strengthening-monitoring-of-medicines-in-australia-170426.pdf
  6. European Medicines Agency. 2013. Medicines under additional monitoring. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp
  7. Scott S, Griffiths M. 2017. ABC News. Therapeutic Goods Administration considering new ‘black triangle’ warnings to make medicine safer. Available at: http://www.abc.net.au/news/2017-03-20/new-black-triangle-warnings-aim-to-make-medicine-safer/8369530
  8. O’Reilly N. 2017. From evidence based medicines to value based healthcare – is Australia ready? Available at: https://crcaustralia.com/media-releases/from-evidence-based-medicine-to-value-based-healthcare-is-australia-ready/
  9. Sackman J, Kuchenreuther M. 2015. BioPharm International. Market Access Outlook for Australia. Available at: http://www.biopharminternational.com/market-access-outlook-australia?__hstc=40333757.a7b8394010b2114973f462b41afaf8dc.1494816515259.1500334787588.1500422925924.13&__hssc=40333757.1.1500422925924&__hsfp=2974958270
  10. Loic P, Schlegel C, Gordian M. 2017. Reinventing the role of medical affairs. Available at: http://www.bain.com/publications/articles/reinventing-the-role-of-medical-affairs.aspx

CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.

© Copyright 2017 Clinical Research Corporation. All Rights Reserved.