Innovation and change are the driving forces behind the evolving healthcare environment in South Africa. Join VI Research as we delve into strategic solutions that harness the power of cross-functional collaboration to successfully navigate this paradigm shift.
CEO’s, MD’s, functional managers of Pharmaceutical, Devices & Diagnostic Companies.
Looking back at life, most people will be able to identify definitive (often pivotal) moments that changed their life. Some were positive moments, while inevitably, some were negative moments, but with a positive impact over time.
In this brief post, I will share four of the most profound lessons I learned in my adult life. They shaped me, they formed me, and they challenged me. The four lessons all come from mentors. Interestingly these are people whom I have never met. I have listened to them but mostly read their books. It makes me think about another lesson I learned: “You will be the same person from five years now, except for the people you meet and the books you read”. Or, stated differently: “Leaders are readers”.
The first lesson: “If you change, everything will change for you”. These words of wisdom came to me when I was fresh out of Business School—full of dreams and ambition, ready to change the world but with a business on the verge of failure. It just did not make sense: how can I fail? On that day, when I heard those words, I realised that change needed to come from within. I could not change the world, only myself. And on that day I started my journey of focussing on what I can change. I read philosophy, psychology, neuroscience, leadership, biographies of both failures and successes, and much more. And over the years, it prepared me for the next lesson.
The second lesson: “Work harder on yourself than on your job”. It emphasized that one needs balance. One needs to make sure that as an employee/employer, I needed not only to be excellent at my job, but also excellent at myself. This insight paved the way for my continued journey of reading and engaging with people and learning from them.
The third lesson: “Luck is something you attract by the person you become”. This was further validation of the above lessons. We are seldom lucky. One can rarely attribute success to only luck. I learned that by developing my own skills and talents, I was becoming more “attractive” to the world out there. When the opportunity came knocking at my door, and the door opened, it saw a much more attractive prospect which invariably led to success.
The fourth lesson: “First education, then philosophy, then attitude”. All the above came together in this fourth lesson I learned. Success always starts with education. Not just formal education, but self-education too. We must start there. For, only if we learn and explore, can we formalize our own philosophy about life, work, relationships, success, etc. Once we have crafted our own life philosophy, we culture a unique attitude to life. In my case, an attitude of gratitude and positive expectation. If you mix these around, starting with attitude, you land up with an idiot with an attitude.
Enjoy the journey!
Article written by Dr Tienie Stander
When the context moves from data collection to the communication of the science:
It is what you do with data that is science – the interpretation you make, the story you tell. (Mimi Zeiger, Essentials of Writing Biomedical Research Papers 2000)
At VI Research, we are passionate about science and story-telling. Whether it be a scientific publication, a regulatory document or a conference poster, we provide clear, effective and accurate communication for a wide range of audiences. We like to keep the reader interested, we cut the clutter, dive into the detail and deliver punchy take-home messages.
Medical writing forms an integral part of the all-important drug and medical device development process. It plays a vital role in communicating health and medicine-related information in a clear and appropriate manner to the target audience. It may take many forms, ranging from medical journalism, medical education, medical marketing of healthcare products, publication/presentation, research documents and regulatory documents.
Our regulatory writing generally covers the spectrum of documents that are involved in the drug or medical device development process, ranging from late-phase study documents to marketing application submission dossiers and on to post-marketing documentation. These include:
Medical Communications (‘med comms’) is the generation of written, audiovisual, oral or online materials dealing with medicine and healthcare. We provide med comms services to the pharmaceutical industry to help raise awareness of medicines via education and promotion. These include:
For further information on Medical Writing, contact us on value@valueinresearch.com
Article written by Dr Helen Miller- Janson
I am not sure if it’s only me, but lately, I feel that I am suffering from Covid-small-talk-burnout (let’s call it CSTB, yet another acronym!). Almost, without exception, it seems that any interaction, with anybody, being work, friends or family-related, starts with the latest “news” on Covid. Inevitably, when you join a virtual meeting and there are a few minutes’ before all the attendees join, the discussion will be Covid. When colleagues “meet” up again after some time of absence, the meeting starts with Covid. When meeting with friends for lunch or dinner, Covid always seems to creep into the discussion. We compare notes; it almost becomes an Olympic game about who has the most extreme news.
I am not in any way questioning the severity of the pandemic. I do have big concerns about the impact on society at a micro and macro level. I get it. It is a huge tragedy. It is newsworthy. It is important.
However, my call-out today is this: let’s stop placing Covid at the center stage of our daily informal discussions. Let’s remember that there are so many other good things to talk about. Let’s get some balance back in our lives when it comes to the things, we “small-talk”. Let’s resist CSTB. Rather talk about the relief brought by the recent rain, the full moon of last night, the amazing sunrise last week, your child’s first step or words, your colleague’s great accomplishment. Ask questions to your audience, be genuinely interested in them and their world, family, achievements, and challenges. Tell a joke of a funny story that happened to you or someone you know.
An attitude of gratitude and positive expectation goes a long way to turn negatives into positives. When we make this a habit, our brain’s neuroplasticity creates pathways that leads to repetitive behavior. The old saying “Whether you say you can or you can’t, you’re right”, holds true. In this context, seeing is not really believing. Believing is seeing. What we believe is what we see (also called our biases). When we believe we can, we usually can.
I argue that we all can make a choice to focus on a balanced “small-talk” agenda and decide not to be captured by Covid in all our activities. But, in the final analysis, whether you say you can do this, or cannot do it, you’re right.
Article written by Dr Tienie Stander
By this time, reading this short article, I assume you know our company, VI Research, where we operate and what we do. However, do you really know us? Do you know the softer side of the company construct and what we stand for and what we aspire to? As a young man, I was exposed to the Johari Window concept by a friend. It is a framework created by two psychologists to better understand and manage our self-relationship and relationships with each other. It argues that the more you know yourself and the more you allow others to know about you, the better the relationship (that is, opening the Johari Window). From the MD’s Desk is Kumen Chetty’s brainchild and is an attempt to allow us to open that window on VI Research: to allow you to see more about us. It is an attempt to showcase the softer side of the company and to leave the strategy and commercials behind for a while. Kumen suggested that we share something about the company, monthly and that we thereby open the VI Research Johari window to those who are curious to know us better and ultimately foster even greater relationships. Accordingly, this is the first of these monthly short articles.
“From the MD’s Desk” is NOT about the MD, or his personal brand or a brag session. It is about the company we love to work for and the values that drive us. Therefore, the vision of “From the MD’s Desk” is to communicate the actualization of the values we aspire for in VI Research. Actualization in this context means how we make these values real, tangible, and part of our day-to-day operations. Our monthly posts will therefore circulate around practical ways in which we live our professional lives. In this way it will become an exposition of the value-centered company clients are dealing with.
To begin with, I, therefore, want to start opening the window to our DNA. I want to talk about or vision and purpose and values. Our slogan “Let our work and actions benefit humanity” as well as the five values that guide us, is a collective of our personal aspirations and values. That is what makes us cohesive and is part of what makes us get up in the morning to do our job. Our values revolve around passion: Passion for people; passion for integrity; passion for robust science, quality and innovation; and passion for a sustainable future through a new world company.
Allow me to focus on the last one today, namely our passion for a sustainable future through a new world company. Over the years we have been grappling with what a new world company looks like; how do we move towards that envisioned future; how do we balance these aspirations with commercial realities, and in these deliberations, we came up with a rough framework of what a new world company looks like.
The first pillar of this framework is that an employee (we prefer team member) should be viewed as a total being. Team members are partly employees, but as much; they have families, friends, social structures, challenges and life as it happens. As a new world company, we aspire to view team members as such, a complete ecosystem of which work is only one part.
The second pillar revolves around the work environment and how we might create the best, most conducive work environment, and obviously, working from home seemed to be the optimal work environment for the team. When Covid reared its head in 2020, we were already far along this road and had discussions of how to operationalize this. We now have a flexible hybrid model working from home, but access to office space as and when needed or preferred by team members.
The third pillar revolved around shared values. We believe that a new world company will be driven more by purpose than profit. We believe that to have a shared purpose, we need to ensure that we share the same core values. Therefore, in recruiting talent, the number one criterium will be to assess the value system of new candidates.
The fourth pillar is the active endorsement and adoption of the digital transformation that is happening now and is bound to escalate as we move deeper and deeper in the 4th Industrial revolution. This principle goes hand in hand with a new world company and we, therefore, need to be at the forefront of digital innovation and creativity, both internally and for our clients. A new world company needs to disrupt the status quo.
Let me end off with a quote by Gandhi:
“Your beliefs become your thoughts,
Your thoughts become your words,
Your words become your actions,
Your actions become your habits,
Your habits become your values,
Your values become your destiny.”
Article written by Dr Tienie Stander
VI Research presented an online workshop on Alternative Reimbursement Models (ARMs). The event was well attended and the topic sparked significant debate regarding the challenges faced to implement these models at a country level.
The discussions were insightful and provided the delegates with a better understanding of these challenges and the proposed solutions on how to respond to them. Therefore, in the spirit of continuing debate, I think it is of value to share this insight with a greater audience.
Conventional wisdom dictates that one always starts with “Why?” Why do we want to consider ARMs and what problems are we trying to solve? An effective ARM seeks to align high-quality, cost-effective, integrated treatment with a focus on improving patient outcomes. Stakeholders need to consider the reality of the problems that exist and put forward ARMs as a feasible solution to address these problems. For example, if the problem is affordability or equity for a subgroup of patients, one could position ARMs as a mechanism to improve affordability and equitable access to healthcare. Therefore, communicating the reason why an ARM is a feasible solution is an important starting point.
The first challenge to the successful implementation of ARMs relates to a country’s readiness. This applies to both the legal environment as well as the technical skills and experience required to consider adopting innovative funding mechanisms.
This article will focus on the first challenge and pose the following questions:
Once there is agreement on the “Why?” one can move to the “How?” The latter is a function of (amongst other aspects) the legal and regulatory framework of a specific country. By law, some countries do not allow any form of discounting on medicines or medical devices. How does one ensure that one remains compliant with a country’s Laws and Regulations when considering an ARM?
The following is a proposed approach:
Step 1: Engage with stakeholders to ensure that there is agreement on the “Why?” Ensure that there is a shared, compelling reason why an ARM would benefit patients (improved outcomes) and all other stakeholders involved. Importantly, consideration of ARMs relates to international benchmark pricing (more on this in a future article);
Step 2: Build trust by showing aligned commitment towards the “Why?” Ensure that all who are involved benefit — most importantly the patients. Building trust is the key to success!
Step 3: Engage and design the ARM with an open mind. Do not focus on the specific construct of the ARM solution (at this stage) but rather on the shared values; the “Why?” that drives the initiative; and the resultant benefits; and
Step 4: Test the proposed design against the legal backdrop of your country and reach a go-no-go decision.
Article written by Dr Tienie Stander.
For any enquiries, contact Kumen – kumen@valueinresearch.com
Facilitated by:
An initial poll indicated that over 60% of participants had joined the workshop because they see Alternative Reimbursement Models (ARMs) as an important future mechanism to improve access and affordability.
Dr Tienie Stander opened the workshop by setting out the context for the discussion: quality, access and cost form healthcare’s ‘Iron Triangle’ where difficult choices have to be made in light of limited healthcare budgets. Constrained budgets require priority setting and robust scientific decision-making about where resources should be spent. In this context, Health Technology Assessments for pharmaceuticals and medical devices have a key role to play in minimising opportunity cost.
Victoria Barr introduced some key concepts in ARMs, including that of value-based healthcare. (58% of participants said they were already very familiar or quite familiar with this concept.)
Value in healthcare is defined as patient outcomes delivered for money spent. Value-based healthcare is therefore healthcare which seeks to maximise patient outcomes and/or minimise the cost of delivering those outcomes. This agenda has been driven globally by Michael Porter of Harvard Business School, who presented a six-pronged approach in his 2013 article ‘The strategy that will fix healthcare’.
In this context, it is important to be clear on the difference between quality and outcomes; these terms are often used interchangeably but describe significantly different concepts. An outcome is something which people care about in and of itself, while clinical quality of care is only important in so much as it delivers better patient outcomes. Both concepts can be considered from both a patient perspective and a clinical perspective: quality can be thought of both in terms of patient experience of care and clinical quality of care, while we have both patient-reported health outcomes (e.g. mobility, pain) and clinical health outcomes (e.g. hospital admissions).
Contracts where payment is tied to outcomes have three major advantages: they focus attention on what really matters to patients, rather than inputs or processes; they empower providers to innovate and deliver care as they think best; and they facilitate team-based working and more integrated service delivery.
ARMs take slightly different forms in the context of pharmaceutical pricing and payment for other forms of healthcare, but the concept which ties these together is value. In pharmaceuticals and devices, ARMs are largely aimed at managing uncertainty around value (the cost or performance of a drug or device is unknown) and often involve risk-sharing between funder and manufacturer. In healthcare services, ARMs are generally used to incentivise better value delivery of care (better outcomes and/or lower cost). There are in fact many situations where the ‘Iron Triangle’ does not hold true: improved outcomes AND lower cost can both be achieved because of waste in the system. Value-based payment models often cover multiple components of the patient pathway (and can include medicines) because this allows for the maximisation of value between settings or different modes of care by internalising trade-offs within a single contract.
Around one third of participants had some experience of implementing an ARM for pharmaceuticals or devices, either as a funder or manufacturer. When asked to use one word to summarise their experience, the top three most popular terms were ‘challenging’, ‘complicated’ and ‘legal nightmare’, although ‘good’ and ‘efficient’ also appeared.
The large number of different and overlapping types of ARMs, as well as the accompanying jargon, can be confusing and off-putting. It is helpful to think of ARMs for pharmaceuticals as falling into two categories, mirroring the two components of value: those which focus on health outcomes and those which focus on cost (financial or utilisation-based models).
The international literature on ARMs presents a mixed picture. Preferences for different types of agreement seem to be moving in different directions in different countries, for example, the UK and the Netherlands are moving away from health outcome-based arrangements, while the use of these models in the USA appears to be increasing. While there have been notable successes and failures, the evidence base on the effectiveness of ARMs remains surprisingly limited, possibly because of the confidential nature of many agreements. Despite this, ARMs will continue to be implemented because the issues that they are intended to address (reducing uncertainty, improving patient outcomes, increasing realised value, and improving access to medicines) remain as relevant as ever.
Victoria outlined five key principles for developing an ARM:
A third of participants had implemented an ARM for healthcare services at least once. The stand-out word used to describe these experiences was ‘challenging’, with ‘complex’, ‘concerned’, ‘confused’ and ‘successful’ also featuring.
Current approaches to contracting in healthcare create unhelpful financial incentives which lead to higher costs and poor patient outcomes. However, in the case of chronic conditions like diabetes, innovative contracting models can incentivise earlier investment in condition management, which results in better outcomes for patients and lower costs.
There is no single perfect payment mechanism; all models have advantages and disadvantages, and even the same characteristic, for example, encouraging activity, can be desirable or undesirable, depending on the context. The key is to choose the payment model which will best achieve the objectives of care.
ARMs can be initiated by either the payer or the healthcare provider/pharmaceutical company, but the starting point should always be value for patients and how the service delivery model or treatment protocol can be changed to improve patient outcomes and reduce cost. The payment model is only important in so much as it supports and facilitates different service delivery models and encourages desired changes in behaviour; the payment model is not an end in itself.
Victoria presented the framework below, which she has used to develop a large number of value-based contracts both in the UK and South Africa. One of the key barriers to implementation of value-based contracts is the volume and complexity of the issues to be negotiated. The solution is therefore to work through the individual issues in a systematic and structured way, using the framework as a roadmap.
Four case studies of ARMs were presented:
Victoria outlined five key lessons from her experience of developing ARMs:
The following lessons were also reported by workshop participants:
80% of participants reported that they saw many opportunities for ARMs in their area of focus and the top three barriers to greater implementation were identified as:
The Q&A section of the workshop focused on the feasibility of implementing ARMs for pharmaceuticals in the South African context, given legal constraints and the need for approval from the Pricing Committee. There was a good discussion between representatives from the National Department of Health, the pharmaceutical industry and patient groups around how these barriers might be overcome.
For enquiries, kindly contact: kumen@valueinresearch.com
Different methods are available to combine or synthesise different data sources available from literature on the same subject, for instance, if one needs to determine the effect of drug A in reducing cardiac events compared to the effect of drug B in reducing cardiac events.
When head-to-head trials for drug A versus B are available, direct comparison is possible using a pairwise meta-analysis. Alternatively, a network meta-analysis might be required, where head-to-head trials are not available for drug A versus drug B directly, but where there are studies comparing drug A to drug C and drug B to drug C.
To statistically combine data on effect size from different sources with direct comparison data, one would typically employ a pairwise meta-analysis technique. Two different options are most widely available, namely a fixed-effects meta-analysis and a random-effects meta-analysis [1].
Fixed effects meta-analyses are usually used where the study does not intend to generalise the results beyond studies included in the analysis. Where there isn’t significant heterogeneity between studies (statistical, methodological, or clinical heterogeneity) and where the number of included studies is low (less than 5 studies)[1].
When one aims to generalise the results to studies outside of those included in the analysis, have significant heterogeneity between studies, or at least 5 studies included in the analysis, one would typically employ a random effects meta-analysis [1].
The outcome of either method would be a pooled effect size. This can be a relative effect size (such as relative risk RR or odds ratio OR for dichotomous variables) or an absolute effect size (such as risk difference RD, for dichotomous variables, or weighted mean difference or standardized mean difference, for continuous variables) [1].
The results of meta-analyses are typically reported as forest plots, showing the effect size and 95% confidence intervals for each study included in the analysis, as well as the pooled or summary effect size and 95% confidence intervals.
Indirect treatment comparisons or network meta-analyses (NMA) are performed when direct head-to-head trials are not available for drug A compared to drug B, but where there is a common comparator study for both drugs A and B with drug C. Further to this, multiple treatments can be compared at the same time, and by including direct and indirect evidence (mixed NMA) [2]. In addition, NMA can be used to rank different treatments.
Different NMA models are available, including the multivariate model and the hierarchical model. A reference treatment must be selected, to which all studies will be compared (usually placebo, or the treatment that is most commonly compared to).
The results are presented in a league or network table, which shows the summary estimates and 95% confidence intervals for the different comparisons. In addition, the ranking probabilities for each treatment in the comparison can be presented as a table or histogram.
Study effects can be synthesised using different statistical techniques, such as pairwise meta-analysis for direct comparisons, or network meta-analysis for mixed or indirect comparisons.
One needs to consider the different assumptions and limitations of each method, as well as the goal of the data synthesis, to select the relevant method.
On December 31, 2019, an official case of the novel respiratory disease of the species of coronaviruses was reported in Wuhan, China (WHO, 2020), marking the beginning of what has now proved to be one of the most devastating viral outbreaks in modern history.
The coronavirus pandemic (COVID-19) came as a rare and unprecedented event. Could this be what economists call a “black swan”? A black swan is an extremely rare event that is often unpredictable beforehand. Black swan events usher catastrophic damage to the economy as they negatively impact financial markets and investments. Some could argue that even the use of robust modelling cannot prevent a black swan (Staff, 2020).
In this article we will argue whether the COVID-19 pandemic is a true black swan event. The Black Swan theory was developed by professor, statistician, and former options trader Nassim Nicholas Taleb, and must meet three criteria:
Now, let us discuss the above attributes individually and hope to reach a conclusion.
History has proven that infectious diseases, epidemics, and pandemics are the number one mass killers. More people died in the 1918 flu outbreak than in the First World War (Jones, 2018), with the 1918 influenza pandemic being the worst severe pandemic in recent history. Scientists have recorded evidence of past possible coronavirus pandemics and according to an article by (Heing, 2020), experts warned of a possibility of a pandemic decades ago. Therefore, COVID-19 cannot be classified as an outlier but is merely part of a pattern of increasingly frequent epidemics that have coincided with urbanization, globalization, and climate change.
COVID-19 is not anticipated to have an impact even remotely close to that of the 1918 flu pandemic which saw at least fifty million deaths. However, with focus on the financial impact of COVID-19, it might be too early to compare previous recessions to the 2020 Coronavirus Crash, but it has been predicted that the current pandemic will continue to have an extreme impact on national economies.
In March 2020, the COVID-19 pandemic began decimating the economy. A mandatory lockdown was imposed across the globe resulting in global economic shutdowns, panic buying and supply disruptions which exacerbated the market, and thus mass hysteria ensued. The global stock market saw multiple severe drops, with the largest drop on Monday the 16th of March 2020, and this has since been nicknamed “Black Monday II”. Banks and reserves across the world have cut their interest rates, bank rates and cash-flow rates in an attempt to deal with the pandemic (Hutchens & Chalmers, 2020).
Since we are still in the midst of the COVID-19 pandemic crisis it cannot be said with certainty whether this pandemic will be normalized in retrospective.
Even though we cannot answer the third aspect of the Black Swan theory, we can already see that COVID-19 is not a Black Swan event by the mere fact that SARS-coronavirus outbreaks started in 2002 even though the world had nervously hoped that the outbreaks will be controlled before reaching the pandemic status. Instead, the COVID-19 pandemic can be defined as a White Swan event; something that would eventually take place with great certainty (Hutchins, 2020).
Heing, R. M., 2020. Experts warned of a pandemic decades ago. Why weren’t we ready?, s.l.: National Geographic.
Hutchens, G. & Chalmers, S., 2020. ABC News. [Online]
Available at: https://www.abc.net.au/news/2020-03-16/coronavirus-fears-see-australian-market-slump-to-start-new-week/12058904
[Accessed 18 November 2020].
Hutchins, G., 2020. Black Swans, Grey Swans, White Swans. [Online]
Available at: https://accendoreliability.com/black-swans-grey-swans-white-swans/
[Accessed 18 November 2020].
Jones, D., 2018. More People Died in the 1918 Flu Pandemic Than in WWI, s.l.: History.
Staff, I., 2020. Investopedia. [Online]
Available at: https://www.investopedia.com/terms/b/blackswan.asp#:~:text=A%20black%20swan%20is%20an,they%20were%20obvious%20in%20hindsight.
[Accessed 19 Nov 2020].
Taleb, N. N., 2011. Chapter 1: The Impact of the Highly Improbable. In: A. Lane, ed. The black swan : The impact of the highly improbable. s.l.:s.n.
WHO, 2020. Novel Coronavirus (2019-nCoV), s.l.: World Health Organization.
Pharmacoeconomic Analyst
VI Research
