Innovation in Healthcare

MAY-JUNE 2018|BY ALEXANDRA LOLI

The healthcare sector has changed massively in post-referendum Greece. Business Partners’ Thought Leaders, prominent representatives of the academic, political, medical and business communities, discuss the latest developments in health policy in a changing socio-economic environment. Thought Leaders in Healthcare brings together thoughts and proposals on HTA, policy reform, the importance of predictability in shaping sustainable policy, streamlined pharmaceutical budgets as a key to stable healthcare, the healthcare industry’s contribution to driving growth prospects in the country, the impact of embracing digital technologies and digitization, and the vital role of innovation.

Investing in Innovation for Growth and Sustainable Healthcare

ELENA CHOULIARA, PRESIDENT AND MANAGING DIRECTOR, ΑSTRAZENECA GREECE AND CYPRUS

During the decade-long recession, the Greek pharmaceutical sector has been placed in the center of fiscal consolidation, facing extreme reductions in public pharmaceutical expenditure and putting at risk patients’ access to medicines. The pharmaceutical industry and patients themselves have been called to finance the excess in public pharmaceutical spending not covered by the state, with one in four medicines in outpatient settings and one in three in hospital settings paid for by the industry through compulsory rebates and clawbacks.

Meanwhile, the current framework for the reimbursement of new innovative medicines disincentivizes investment in R&D, essentially penalizing innovation in Greece. The additional 25% rebate imposed on top of existing volume-scaled rebates and clawbacks, and stricter criteria requiring prior launch and reimbursement of a new medicine in multiple EU countries, may result in delayed or no launch of certain innovative medicines in the Greek market. Access to new, reimbursed personalized breakthrough medicines is further hampered by the lack of reimbursement for the biomarker tests required to identify eligible patients.

Access to innovative medicines is crucial for the health status of the population. A reliable local HTA body and a comprehensive National Pharmaceutical Policy are key to ensuring timely patient access to the right treatment. An increase of public pharmaceutical expenditure is also essential, and must reflect existing medical needs, as proven by the increasing participation of patients and pharmaceutical companies.

Now is the time to take bold decisions and formulate a healthcare policy that ensures timely access of patients to innovative medicines and supports a sustainable healthcare system in which pharmaceutical companies can contribute to the country’s return to growth.

A Call for Change: Structural Reforms for a Sustainable Healthcare System

ANNE NIJS, GENERAL MANAGER, ROCHE HELLAS

For many years now, the indisputable need to rationalize the costs of the Greek healthcare system has been addressed through a solely budget-centric perspective.

The recent imposition of a 25% mandatory discount on new products is a telling example of how this approach affects both patients and the industry. In addition, the budget for hospital drugs is far below the needs and the demand of Greek patients and hospitals. As a result, all new therapies that attempt to enter the Greek healthcare system are indirectly denied funding, and their cost is ultimately covered by the industry through clawbacks. All the above, from clawbacks to the additional mandatory discounts, result in starting prices for the negotiation of new medicines being 65% or more below its ex-factory price.

It is clear that in this environment of overtaxation of all goods and services, medicines are not excluded. This threatens the sustainability of the pharmaceutical industry and subsequently patients’ access to new therapies, as well as the future of thousands of employees and all the investments that are associated with operating in the country.

Positive steps have been taken in the direction of rationalizing the system, including the introduction of the forthcoming HTA body, which has to be activated immediately and operate according to international guidelines in order to secure timely access to innovative medicines.

We remain willing to contribute to a productive dialogue with all healthcare stakeholders for the development of a rational and efficient pharmaceutical policy that will add value to the country’s healthcare system, creating long-term benefits for Greek patients, the industry and the economy.

Value Assessment: A Long-Term Commitment

SPIROS GKIKAS, GENERAL MANAGER GREECE & CYPRUS, GE HEALTHCARE

Financial constraints, ageing populations, chronic diseases and rising patient consumerism continue to put a strain on healthcare systems worldwide. In light of this and with an aim to reengineer care delivery, the healthcare industry has introduced the term value. Value-based healthcare focuses on improving health outcomes while maintaining or lowering the cost of care. Yet, even today, the concept of value and its dimensions is not always clear among the various stakeholders in the healthcare ecosystem.

In this context, value assessment frameworks (e.g. ACC-AHA, ASCO, ICER) and methods (e.g. EUnetHTA) have been developed to identify the value stemming from a healthcare option and support evidence-based decisions towards patient outcome optimization. Often, they also aim at providing guidance on the pricing of pharmaceuticals and interventions, facilitating rationalized coverage and budget planning. In countries throughout Europe, including Greece, health technology assessment debates and initiatives are being carried out to ensure the adoption of technological advances and the implementation of health policies that drive best value.

The dialogue on health technology assessment, even though primarily focused on pharmaceuticals, can contribute to a deeper consensus on what constitutes value. Medical devices are very different from pharmaceuticals, but both in medtech and in the pharma industry, value assessment requires transparency, broad stakeholder engagement and innovation stimuli. Above all, however, the value of a medical device must be considered throughout its lifecycle. Healthcare policies or procurement procedures, which are mainly guided by the front-heavy costs of medical technology, can have limited future clinical, operational or financial benefits. In other words, a value–based technology assessment must be long-term, comprehensive and continuous.

Current Challenges in the Healthcare Environment and Healthcare System

ELIZABETH PRODROMOU, COUNTRY MANAGER, BRISTOL-MYERS SQUIBB GREECE

The sustainability of healthcare systems is a key challenge for the majority of countries, even those with advanced healthcare services. All the challenges that have emerged in Greece due to the financial and fiscal crisis and the subsequent deterioration of demographic and healthcare indicators need to be addressed with urgency.

Healthcare reforms that will reinforce the value of innovative pharmaceutical technologies are required in an effort to prioritize the improvement of Greek healthcare indicators. Several health authorities across Europe have implemented such reforms, which don’t focus necessarily only on pharmaceutical expenditure but treat the health spend holistically, ultimately supporting the financial sustainability of health systems.

Innovation is critical to address healthcare challenges. Today, enormous investment is required for an innovative treatment to reach the market and for patients to ultimately have access to it. Policy makers can help remove barriers in order to further stimulate research, clinical development and innovation in healthcare for the benefit of patients.

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for advances in cancer treatment focuses on R&D of translational immuno-oncology (IO) therapies to improve treatment outcomes in various cancer types. We are looking at next generation treatments, including IO combination therapies and biomarkers as an indication to enable clinically and cost effective treatments. We understand that achieving our promises requires—in addition to innovation and research—constructive dialogue with our stakeholders, including Health Authorities. We will continue working together with them to offer new therapeutic options to patients.

Embracing Data and Digital in the Healthcare Sector

SUSANNE KOHOUT, COUNTRY PRESIDENT AND MANAGING DIRECTOR, NOVARTIS HELLAS

Patients are our priority, and we have an obligation to meet them in the new digital world, providing new and more holistic solutions that lead to better outcomes and reduce the burden of illness.

Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation. The companies that will be most successful in the future are those that view this transformation as an opportunity to go beyond the traditional operating model and offer to the healthcare ecosystem advanced solutions to major health challenges.

The digitization of R&D—clinical trials included—with real-world data from diverse sources, advanced data storage, management and analysis, and the acceleration of AI, enhances our understanding of diseases progression and development of treatments. New technologies can mine vast datasets to generate insights and find novel molecular entities in a way that is beyond the threshold of human intelligence. Digital solutions also help us to democratize the medical research process, increasing our ability to reach previously underserved and understudied groups of people.

Pharma companies need to embrace the change brought about by the agile world of technology. Blending these capabilities and culturing with our own expertise will advance the long and highly complex journey of drug development and discovery, and help secure regulatory approval for medicines.

At Novartis, our approach is to lead in fostering the vast ecosystem of partners across the healthcare and tech sectors. Digital advancement in healthcare needs to be sector-wide, cross-functional, inclusive and, first and foremost, patient-centric.

The Value of Innovation

AGATA JACONCIC, MANAGING DIRECTOR, MSD GREECE, CYPRUS AND MALTA

Leading pharmaceutical companies have always been at the front lines of research and invention, working relentlessly to find solutions to many of the world’s most devastating diseases. This dedication to pushing the boundaries of science in order to deliver medicines that improve the health status of populations is at the heart of the industry’s contribution to society. And it’s precisely this cutting-edge research and innovation, and the promise it holds for better health across demographics, that has been put at risk by successive cuts to healthcare spending in Greece over the past decade.

Medicines have played a substantial role in enabling us to live longer and enjoy a better quality of life, and this has come through innovation. Even though the benefits of innovative medicines and vaccines can look marginal in small time frames, the cumulative value of innovation is nothing less than a phenomenal achievement. The only instances in which innovation does not materialize its full positive impact are when the right to benefit from innovation is restricted. Innovation must be a priority, and equal access to innovative treatments for all patients should be the vision of every healthcare system in Europe.

At MSD we have always been and always will be inventing, and we do it for the single greatest purpose: life. For more than a century, MSD has been inventing medicines and vaccines for the world’s most challenging diseases. We believe in the value of innovation and have experienced the tremendous benefits that innovative medicines can bring to patients in the treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases and infectious diseases such as HIV, Ebola and tuberculosis.

Our Shared Responsibility and Commitment

MAKIS PAPATAXIARCHIS, MANAGING DIRECTOR OF JANSSEN GREECE, PRESIDENT OF PHRMA INNOVATION FORUM, AND CHAIRMAN OF AMCHAM’S PHARMACEUTICAL COMMITTEE

For innovative pharmaceutical companies, the all-important question is this: How can we make the biggest difference in the lives of patients around the world?

We are faced with the huge challenge of providing meaningful, differentiated, value-added access to healthcare in an economically sustainable way. This unprecedented challenge—and, at the same time, opportunity—requires an equally unprecedented approach and continuous efforts, centered around three key pillars. First and foremost, innovation, not only in R&D but in everything we do; excellence in execution, in keeping our commitments and continuing to challenge ourselves to be better; and, of course, customer focus. We believe that we are uniquely positioned to partner with all relative stakeholders around the world, to serve the unmet needs of patients and the community.

As the rapid transformations we’re experiencing technologically, socially, economically, politically and within the healthcare industry happen, the needs of patients, consumers and customers continue to rapidly evolve. An agile mindset and a pro-active attitude help us to evolve with them, always sharing our common responsibility and commitment to fulfill our purpose. One thing is beyond doubt, that the march of progress for patients has been nothing short of remarkable in recent years. This is the reason why we remain confident in the strength and potential of our industry and optimistic about the future. Innovative pharmaceutical companies can truly change the trajectory of health for humanity.

Sustainable Pharmaceutical Environments Need State-Patient-Industry Consensus

MARTHA CHRISTOPOULOU, GENERAL MANAGER, BAXTER GREECE & CYPRUS

Public pharmaceutical expenditure in Greece has been cut by 62% since the beginning of the crisis, reduced to just 50% of the European average. This has led to a highly uncertain and industry-unfriendly investing environment. Despite this turbulence, pharmaceutical companies have shown remarkable resilience and have even provided the main funding of the healthcare system in critical circumstances (via various mandated rebates and clawbacks) and supported the system with adequate supply of medicines and services. Subsequently, the collapse of the primary healthcare system has led to the overload of secondary care, creating a huge increase in public expenditure and jeopardizing the quality of healthcare provision.

Therefore, it is a matter of high public importance to promote and implement as soon as possible the profound structural changes required for the Greek health system, under a coherent national strategy. The introduction and implementation of registries, therapeutic guidelines, updated DRGs, managed entry agreements for true innovative medicines based on Real World Evidence and a health technology assessment mechanism that connects actual medical results with cost efficiency are realistic and applicable structural changes, with proven results in other European countries.

These reforms can and will work only with proper design and consultation with all stakeholders—including patient groups and the healthcare industry—to enhance the primary health system, gain social consensus, and safeguard patients’ access to a modern and sustainable health system.

The first crucial step is the redefinition of the pharmaceutical budget based on the actual needs of Greek society, a step that everyone, including the Ministry of Health, identifies as a necessity.

Innovation Happens When You Put Customers First

HARA ANGELONIDI, MARKETING/SCIENTIFIC AFFAIRS & EDUCATION LEADER, SOUTH EAST EUROPE REGION, MEDICAL BUSINESS/3M HEALTH CARE BUSINESS GROUP, 3M HELLAS MEPE

As healthcare is evolving more rapidly than ever, transformation within the system is needed to confront challenges like reimbursement changes, rising costs, diminishing healthcare budgets, more stringent patient requirements, and new care delivery models.

Companies should consider and acknowledge that any product or service that contributes to transforming the system must feature high-quality elements and an innovative structure in order to confront the resistance that transformational changes bring into complex and slow-moving systems such as healthcare.

All stakeholders need to innovate with a purpose, empower individuals to address issues they want to impact, and collaborate with their customers and communities to take on shared global challenges. Innovation happens when inspiration meets and exceeds customer needs, and that occurs when companies are willing to listen to, understand and collaborate closely with their customers, adopting an effective customer-centric strategy.

Customer-centric companies succeed because they listen to their customers, bring their perspectives into focus, accompany them on their journeys, provide exceptional customer experiences, and maintain consistency in their actions at every step, creating value overall.

At 3M Health Care, as we innovate, science is at the heart of everything we do. We understand clinician efforts and needs, and we strive to make their job easier with reliable, high-quality solutions, such as medical products that help prevent infection and promote healing. Putting our customers first gives us the opportunity to pursue our mission of improving patient outcomes, ensuring patient and clinician safety and preventing the risks of costly complications.

The takeaway is clear: Transformative innovation that puts customers first brings value to both businesses and society.

Predictability as a Key to the Development of a Healthy Business Environment

SAVAS CHARALAMPIDIS, GENERAL MANAGER GREECE AND CYPRUS, GILEAD SCIENCES

In the last few years, we have seen a series of budgetary measures imposed on healthcare in Greece, the impact of which on pharmaceutical expenditure and the overall sustainability of the healthcare system has never been properly assessed. Case in point, there have been over 150 new regulations on medicines alone over the past eight years.

During the recession, healthcare policy was subject to bailout program obligations to curtail spending and included a number of regulations that were just as problematic as those that gave rise to the—undeniable—problems that have riddled healthcare policy in the past. In other words, pharmaceutical policy continues to focus on cost cutting, doing so through a succession of haphazard legislative measures that are driven almost exclusively by the pressure resulting from exceeding set budgets.

This unstable environment, and a string of hasty—and largely unanticipated—state interventions, have resulted in a complete lack of predictability, and predictability is a fundamental requirement for doing business. A company’s ability to plan for the short term and, most importantly, the long term is vital to achieving its goals and realizing its growth potential.

It is now more pressing than ever to reform pharmaceutical policy, as this has been shaped in recent years, based on a proper evaluation of the effectiveness of the various measures that have been introduced. This will allow us to escape the fiscal unilateralism of budget cuts, creating the necessary space for implementing crucial structural reforms in healthcare and giving rise to much-needed predictability and stability.

The Value of Pharmaceutical Innovation in Greece

MATTI ARVELA, GENERAL MANAGER GREECE & CYPRUS, AMGEN

One of the discussions currently unfolding is whether innovative companies and their products are part of the problem or the solution for the future of healthcare in Greece, yet most debates are myopically limited to the price of innovative medicines and omit the holistic view.

So, what is the value of innovation in Greece?

It is the value to patients. Innovative medicines enabled Greek citizens’ life expectancy to increase by 2 years over the last 15 years and Greek citizens to live on average 5.5 years longer compared to Eastern Europeans.

It is the value to the economy. Innovative pharmaceutical companies are estimated to contribute more than €6b to the Greek GDP and support, directly and indirectly, a total of 87,000 jobs. In 2017, innovative companies invested €80m in clinical trials. Each €10 million investment in clinical trials is estimated to bring an overall increase of €22 million in the GDP and generate 436 new jobs.

It is the value to society. Since 2012, innovative companies alone have donated 182,124 packages of medicines, amounting to €3.250m. Meanwhile, they have developed more than 1,000 different programs that impact the lives of over five million people. These programs contribute to local communities and support the companies’ work in the healthcare and scientific fields, including support of patient group activities with investments of over €30m.

These facts are just a small fraction of the value of innovation in Greece. Amgen is among the innovative companies that are keen to engage with all stakeholders and find solutions to the Greek healthcare system’s challenges, contributing towards a sustainable future.

The Current Challenging Healthcare Environment and Healthcare System Change

SPYROS FILIOTIS, VICE PRESIDENT AND GENERAL MANAGER, PHARMASERVE LILLY

All of us in healthcare sometimes need to remind ourselves that the reason we exist is for the benefit of another person who, for some amount of time, becomes a patient. The mission of the Greek healthcare system is twofold: to keep the population healthy so that it takes longer before we become patients and to embrace people who do become patients and guide them to their best possible health in the least possible time.

This system includes prevention, diagnosis, treatment and management of chronic disease as well as protection of the mental and physical well-being of the population. Occasionally the system designers lose sight of the patient as the center.

As we have seen repeatedly in pharmaceutical history, the future will bring new therapies that completely change how we experience and live with illnesses that seem unstoppable today. As technology progresses and ever more innovative therapies become available, the healthcare system will have to evolve continuously.

The pharmaceutical industry has an important role to play in the design of the Greek healthcare system. Indeed, around Europe and the world the pharmaceutical industry is an essential partner to the healthcare system. Our industry employs very skilled and knowledgeable people with many years of experience in many countries and many healthcare systems.

The pharmaceutical industry has the knowledge, the resources and the willingness to be an important partner to healthcare systems designers. Let’s not let this asset go unused.

Streamlined Pharmaceutical Budgets Are the Key to Stable Healthcare Systems

YIANNIS VLONTZOS, MANAGING DIRECTOR GREECE AND CYPRUS, MERCK HELLAS SA, VICE PRESIDENT FOR HTA AND NEGOTIATION, HELLENIC ASSOCIATION OF PHARMACEUTICAL COMPANIES (SFEE), ΒOARD ΜEMBER OF PHRMA INNOVATION FORUM

After almost a decade of financial crisis in Greece, public pharmaceutical expenditure has been dramatically decreased. With a closed budget in place without any scientific rationale, expenditure has been transferred to the private sector, with patients and the industry contributing instead. In this context, a rational increase of pharmaceutical budget is imperative, implemented as part of an evidence-based approach that meets the real needs of the population for medicines.

Additionally, pharmaceutical budgets should be further streamlined, through the completion of structural reforms including patient registries, therapeutic protocols and Health Technology Assessment (HTA). Internationally, HTA is considered key to informed decision making with regards to financing medicines, by assessing innovation in terms of added value to patients and healthcare systems. In light of the upcoming establishment of a national HTA body in Greece, it is crucial to realize that, in our case, reference to a foreign system would not suffice. This is because each country’s characteristics vary, from demographics and epidemiology to existing infrastructure, the population’s real pharmaceutical needs, and even sources of public financing. There is no doubt that it takes time to shape the framework of a brand new reimbursement system to be adapted to the Greek healthcare system. However, it is imperative to create a robust model for our country, which will facilitate the development of patient-centered health policies and the rational use of available financial resources.

This way, the pharmaceutical industry will operate in a transparent and predictable environment, without retrospective measures and in close collaboration with health authorities.

Reinventing the Square Wheel

THEODORE LIAKOPOULOS, MANAGING DIRECTOR, JOHNSON & JOHNSON HELLAS SA

Greece is the cradle of Western civilization, being the birthplace of democracy and various sciences. Even today, the Hellenic spirit continues to promote scientific advancement, through the research conducted at Greek institutions and via one of our dearest exports: ourselves. I would personally like to believe that we Greeks have the spirit of innovation and invention inside us—though sometimes we try to re-invent the wheel, and sometimes we even make it square.

This can especially be applied to healthcare. It is generally acknowledged that many needed efforts for change have been made. In the medical devices and diagnostics (MD&D) market, examples include the partial arrears clearance, which gave a suffocating sector some much-needed breathing room, and promoting transparency through the surgery list. There is still much to improve, but such initiatives are certainly a move in the right direction.

Other attempts have not been as successful. Greece currently lacks processes for medical product evaluation. The current system mostly budgets products based on price, without considering the economic and clinical advantage of innovation. The price observatory treats medical device products as commodities, without considering quality and outcomes. European systems—including MEAT, HTA, and DRGs—have been misapplied. At the same time, European procurement systems are value oriented. Over the years, AmCham’s MD&D committee has created several proposals for the Greek healthcare system, offering its international expertise. Recommendations revolve around applying already tested systems and processes, promoting mid- and long-term outcomes, and budget savings.

We are committed to continuing our support and presence in the Greek healthcare environment, focusing on providing more to the patient, being open to constructive discussions and best-practice sharing.

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