Market Access RWE EU 2015 Highlights Report

Market access & real World evidence eU 2015 HigHligHts report

www.eyeforpharma.com/market-access-evidence-eu/ • 2

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Sustainable Funding of Innovative Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Tips on International Tender Management Across More Than 70 Countries . . . . . 5

Effective RWE Applications Throughout Drug Development Process . . . . . . . . . . . . 6

Taking Advantage of Data Assets to Provide Timely Business Insights . . . . . . . . . . . . 7

AZ Experience: Integrating Medicines with Devices to Improve Healthcare . . . . . 7

How to Make Market Access Excellence a Cross-functional Priority . . . . . . . . . . . . . . 8

Can We Handle All This Data? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Practical Tips On Winning Approval And Reimbursement In Germany . . . . . . . . . . 10

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

MARKET ACCESS & REAL WORLD EVIDENCE EU 2015Highlights Report



Meetings such as these are growing in number and demand as the health market, and in particular, the pharmaceutical and allied industries wake up to the need to demonstrate real world outcomes for disease management and treatment. We are moving, albeit kicking and screaming in some parts, away from the small molecule blockbuster era, to biologics and precision medicine, and ultimately a health, not disease-driven agenda.

The global cost of human disease is awe-inspiring, and unsustainable; most economies are still suffering from the 2008 meltdown, and whole generations are subject to mass unemployment, the denial of opportunity and the risk of ill health now and in later life. Sadly, we will reap the rewards of our current economic and political challenges for many decades yet. Healthcare is no oasis in this, and few countries can meet even today’s demands in responding to chronic diseases, societal vices and the impact of poverty.

Against this backdrop, the pharmaceutical and allied industries are under significant pressure to justify premium pricing and to demonstrate outcomes that will positively impact on real patient trajectories, versus the highly selected, artificial clinical trial cohorts needed for regulatory approval. Furthermore, there are only two types of data we need to be concerned with, data we own, and data we do not. For the former, clinical trial data, and data collected with the support of the pharmaceutical industry has been sufficient for many decades to date, in particular for regulatory authorities.

Now, for the latter, data derived from real clinical episodes, following a patient trajectory is not owned by the industry,

but by the clinician and ultimately the patient, with rapidly increasing importance, especially with reimbursement and pharmacovigilance as two key drivers. This importance will grow beyond these two drivers and will expand to meet the needs of a more holistic, granular understanding of what we are doing to avoid morbidity and mortality.

Hence, the industry has to collaborate, forming partnerships with those who are in a position to share data for research, audit and benchmarking under the right access conditions and governance, for mutual gain and insights. The eyeforpharma meeting reported on here explored this nascent environment and speaker presentations and panel discussions illustrated many of the lessons learned already and some of the early impact of this change.

In time, we as individuals will generate significant real-time health data en masse, and be the guardians of our health data, as clinicians are guardians of clinical data today. How we prepare for this now will dictate whether all stakeholders have a mutual role to play in the utilization of such data, or will be frustrated bystanders to the coming revolution in health, and not just disease, care.

Nigel HughesDirector, Integrative Healthcare Informatics, Janssen R&D

ForewordReal World Evidence (RWE) = Real World Data (RWD) + analytics. It seems apt to start the introduction to this year’s eyeforpharma RWE Europe meeting report with a formula, where more than one hundred participants interacted and listened to presentations from a cadre of international talent and expertise in Amsterdam, the Netherlands.



Health and Technology Assessments (HTA) and reimbursement processes are country-specific and require national and regional submissions and negotiations. As pressures on healthcare budgets increase, regulators, payers, and pharma are looking for solutions that would bring value to the forefront of the discussions ensuring that groundbreaking medicines reach individuals who need them. To achieve this, the gold standard of medical evidence needs to be redefined.

Market Access & Pricing Excellence 2015, co-located in Amsterdam with Real World Evidence Europe, gave key players the opportunity to discuss the future funding of innovative pharmaceuticals, approaches to incorporating real world evidence (RWE) into product development, and challenges associated with the growing body of patient data collected with the help of mobile devices.

Throughout the far-ranging conversations, a need emerged for a methodological solution that would enable the reliable acquisition of health data outside of randomized clinical trials. It appeared necessary, however, to combine such advancements with a change in attitudes among regulators and payers that would enable them to recognize the value of RWE. This would shift the focus from price to value, delivering benefits to all stakeholders.

Time will tell how this can be accomplished, although promising projects are currently under way. For example, GlaxoSmithKline are already running a pragmatic trial, which will deliver insights into the effectiveness of novel asthma and chronic obstructive pulmonary disease (COPD) drugs in day-to-day clinical practice. “People tend to be comfortable with using RWE post-launch, but there are things that can be done already in phase III to help us understand the effectiveness of the medicine,” Chris Chinn, VP & Head of Real World Evidence, Global Value Evidence & Outcomes Group, said. “Pragmatic trials that are built upon existing standards of care, [rather than rigid protocols], are much more focused on the question of the value of a drug,” he added.

But access to reliable RWE, and awareness of its relevance, can benefit organizations internally as well. The experience of Pfizer demonstrated how making data available in a user-friendly management system can make a difference to the functioning of non-technical teams that rely on numerical insights, but can’t gain them easily. “Commercial teams are often presented with business development opportunities that they need to evaluate. We built a special dashboard for them that allows them to answer the questions they have in a simple, but powerful way,” Vitalii Doban, Senior Director of Real World Data & Analytics, Pfizer, explained.

The two conferences provided a forum in which experts defined key challenges and shared validated as well as emerging approaches to tackling them. At eyeforpharma, we are happy to provide you with the highlights, hoping you will identify practices that can inform the policies at your organization.

Zuzanna Fimińska, Writer, eyeforpharma

executive Summary



sustainable Funding of innovative drugs

Payers are reluctant to pay for high-cost specialty drugs and a new way of financing those medicines must be created. While enormous innovation is happening in pharmaceuticals, the costs associated with those new drugs are escalating, raising a question which challenges economists to reconcile delivering groundbreaking treatments to patients while maintaining sustainable budgets.

Pharmaceuticals are one of a kind as an industry due to fierce competition for a small slice of the overall budget. In most countries, prescription drugs account for 10-15% of healthcare spending. Budgets are fixed in silos meaning that, regardless of where innovation is happening within healthcare, resources can’t be moved. Even if savings are being generated, money has to stay within a particular silo and cannot be used for investments in other sectors. In addition, as budgets are set on an annual basis, there is pressure on executives to spend everything in a given year so as not to risk having to give the money back or seeing cuts the following year. This practice is strikingly different from other industries where people are often happy to invest more in a given year, if that means bigger returns in the future. This isn’t an option in healthcare.

“Those two things lead to a fundamental misalignment between value generation and the payment system”, said Soeren Mattke, Senior Scientist, RAND. “This has always been a constraint on public budgets, but it is particularly acute now when we’re seeing so much innovation in one sector of the economy.”

An innovative financing scheme for high-cost, groundbreaking products should be introduced. For example, how would you finance a vaccine that can wipe out a disease if you vaccinate the whole population? Remember that the cost of care for the disease goes up each year as healthcare costs increase and the population grows. Vaccinating the entire population would mean investing a substantial amount of money upfront, when you have to vaccinate the entire population, and a continuous

spending of a relatively small amount of money in the coming years vaccinating babies and immigrants. To eradicate the disease will require a a big investment in year one, but you will see large savings over time.

“Unfortunately, within healthcare, the program is not affordable given the price tag in year one – it would blow up the budget for that year. Of course, in any other industry, if you were to buy new machinery or new software necessary for the expansion of your business,you would just borrow. In healthcare, borrowing is not an option. What would happen if it were?” asked Mattke.

If the government decided to borrow the money needed to finance the vaccination scheme, it would probably face a 12% interest rate and payment in installments over 10 years, to make it sustainable for consecutive budgets. “Net savings appear already in year three. You save on not having to treat the disease. At a fully discounted rate, that investment would have a 1.5 return for every dollar spent. Note that this is not hypothetical; such vaccines are already in the pipeline.”

Many breakthrough drugs are coming to the market, but they might not reach their intended populations due to budget constraints that afflict even high-income countries. Resource reallocation and a novel way of financing healthcare are necessary to ensure that patients have access to quality care.

tips on international tender Management across More than 70 countries

Successful tender management requires a tool, a process and an organizational function focused on tenders and contracting. The importance of internal investment into tender acquisition should not be underestimated; 25-30% of global pharmaceutical market goes through tenders and contracting and as much as 50% of off-patent revenue is accounted for by tenders. In addition, 10% of the biggest tender opportunities equal as much as 80% of revenue potential, so it is important to manage these well.

Soeren Mattke, Senior Scientist, RAND

Nico Bacharidis, Global Tender & Contracting Lead, Pfizer



Although tenders are price-driven, about 30% of criteria that inform decision-making are qualitative, which means there is a way to differentiate your product from the rest. Most importantly, tenders can be planned ahead; they have a start date and a completion date. It’s a cycle that requires a strategic approach accounting for prices, dates, volumes and people involved. Here is how it works at Pfizer:

1. Countries put together strategies for the biggest opportunities. “We have a tool that facilitates planning,” said Nico Bacharidis, Global Tender & Contracting Lead, Pfizer. “Once the proposal is in place, we look at it centrally and help the countries come up with the best offer possible by doing, for example, cost-volume optimizations. We look at the volumes and calculate whether they allow us to cut production costs and, therefore, come up with a better price.” Individual countries handle customers directly, but there is a central record of wins and loses, which allows for better planning the following year.

2. A data management tool informs decisions by providing insights necessary for a successful bid. This tool has been implemented three years ago and is now functioning across 70 countries. It tracks price trends and probabilities to win, allows countries to communicate with each other, share experiences and offer support. “One of the most important features of the platform is the ability to track supply capabilities. There is nothing worse than winning a bid and not being able to deliver,” Bacharidis stressed.

3. Key performance indicators are clearly defined, allowing to plan tenders and track each country’s success rate.

A global tender system is necessary for international pharma companies. It allows to improve efficiency, clarify processes, and share experiences between countries, enabling continuous improvements of the procedures, leading to more bids won.

effective rWe applications throughout drug development process

When thinking of real world evidence, many people immediately jump to post-launch processes, but GlaxoSmithKline’s experience demonstrates that there is potential to use RWE before market authorization to gather better data on effectiveness of the product. Chris Chinn, VP & Head of Real World Evidence, Global Value

Evidence & Outcomes Group, spoke about the company’s pioneering project into pragmatic trials, which aim to assess the value of medicines in clinical practice conditions before decisions on access and reimbursement are made. To achieve that, they set out a number of conditions:

1. RWE and pragmatic RCTs need to be scientifically valid and valued by the regulators and payers.

2. Infrastructure for this kind of research, different from RCTs and observational studies, must be put in place.

3. Understanding of what distinct types of study designs bring to the table must be improved to make variety more accepted across the board.

“People tend to be comfortable with using RWE post-launch, but there are things that can be done already in phase III to help us understand the effectiveness of the medicine,” Chinn said. “Pragmatic trials that are built upon existing standards of care are much more focused on the question of the value of a drug.”

Pragmatic trials are different from RCTs in 11 ways. Although steps are the same for both designs, they are operationalized specifically for each. For example, the population under study is different. In RCTs the population is controlled by strict eligibility criteria that aim to make comparator groups as homogenous as possible. In pragmatic trials, relaxed inclusion and exclusion requirements enable to enroll people who,as much as possible, resemble patients who will be using the drug. Although randomization is common for both types of trials, in pragmatic trials you probably would not blind.

“Pragmatic trials that are built upon existing standards of care are much more focused on the question of the value of a drug.”Chris Chinn, VP & Head of Real World Evidence, Global Value Evidence & Outcomes Group.

Chris Chinn, VP & Head of Real World Evidence



End points are different; pragmatic trials measure outcomes relevant to patients rather than focusing on what the regulators want to see in a submission dossier. In addition, the standard of care and the number of follow-up visits are not set by the protocol, but by a physician, bringing the set up as close to the real world as possible. “[With a pragmatic trial] you get a set of results that tell you something about the relative performance of two treatments. The focus shifts from efficacy to effectiveness,” Chinn said.

How to set up a pragmatic trial:1. Identify areas where appropriate infrastructure exists. 2. Go where the patients are, don’t expect them to come to

you.3. Train primary care physicians to be investigators. 4. Set up partnerships. Work with investigators, pharmacists,

EHR partners, HTA regulators.

Pragmatic trials might be a way forward as they have the potential to deliver better insights into how a drug really works. But before they’re accepted, culture around medical evidence needs to change and stakeholders need to recognize the value of RWE.

taking advantage of data assets to provide timely Business insights

RWE comes largely directly from patients who share their experiences with their communities, or from mobile devices that people wear. Both can be used to generate customized data sets for specific studies. But to have your business benefit from those data sets, you need to bring the analytics team to the forefront of your organization.

“Analytics teams are very sophisticated, they can provide useful insights, but they’re often isolated. It’s difficult to get in touch with them, and when you do, you usually need a translator,” said Vitaly Doban, Senior Director of Real World Data & Analytics, Pfizer.

To solve the problem, Doban’s team

devised an analytics tool that can be used across the enterprise, including people who are not technically savvy. While intricate calculations remain the domain of the data whizzes, people working in other departments such as clinical or commercial can get access to the data they need to take their projects forward. “Commercial teams are often presented with business development opportunities that they need to evaluate. We built a special dashboard for them that allows them to answer the questions they have in a simple, but powerful way.”

The platform allows non-technical teams to extract relevant indicators from large dataset including treatment location and stats on prescriptions, e.g. what patterns of medication choices people follow throughout their patient journey. The solution provides a user-friendly way of quick data turnaround opening doors to wider applications of data-driven insights within an organization. Non-technical teams no longer have to wait for their technical colleagues to answer their questions, while statisticians get more time to focus on tasks that require their specialized skills.

aZ experience: integrating Medicines with devices to improve Healthcare

Intelligent pharmaceuticals aim to integrate medicines with devices to drive patient engagement by delivering knowledge that would lead to good health outcomes. According to Google, more people currently have access to a smartphone than to a toothbrush, it would be shortsighted to overlook the opportunity granted by this device.

“With intelligent pharmaceuticals our goal is to help patients manage their diseases by ensuring they achieve what’s been set out in their health plan. To do that, we need data from patients and an ability to validate our approach in a randomized clinical trial,” explained Andy Jones, VP Pharmaceutical Innovation, AstraZeneca.

When you come to your physician for management of

Vitaly Doban, Senior Director of Real World Data & Analytics, Pfizer

Andy Jones, VP Pharmaceutical Innovation, AstraZeneca



a chronic condition, you will receive a care plan that will outline your health goals for the coming months or years and some advice on how to achieve them. You will be followed up periodically and measured to see how you’re doing. You will need support outside of the consultation room to reach those goals. According to AZ, clever use of a smartphone can help patients stay on track and reach their targets. Currently, despite there being tens of thousands of health apps available in digital stores, you could count the number of products with evidence of clinical efficacy using only one hand. Intelligent pharmaceuticals want to fill that gap. “We want to gather data on patient behaviors, beliefs, and disease state to tailor the message to them. We want to combine smartphones with sensors to gather physiological information directly. In addition, we want to introduce a way of acquiring data directly from medicines so we know how they’re being used.”

Intelligent pharmaceuticals aspire to change people’s behaviors by providing them with continuous feedback on their performance. Maximizing and combining the benefits of technologies developed outside of healthcare, AZ are hoping to bring customized support to individuals giving patients ownership over their own care.

How to Make Market access excellence a cross-functional priority

The role of a pharma market access function is becoming more challenging as medical innovation is facing roadblocks from national regulators and regional payers. Payers also increasingly require evidence of value throughout the lifecycle of a product renegotiating prices every few years, making market access a continuous process no longer focused exclusively on national reimbursement. Such shift in responsibilities means that market access teams need to have a different status within the organization. Two Roche delegates, Jan Weinreich, Director Market Access, and Jennifer Rowell, Head of Market Access Excellence, shared their experience on how to accomplish that:

1. Incorporate insights from market access teams into product design.

2. Map out key roles and responsibilities of market access and

communicate them to other teams.3. Have a clear and transparent governance of relevant

processes.4. Provide a clear and consistent message to the rest

of the organization about the upcoming pricing and reimbursement challenges.

The aims and objectives of market access functions are changing as HTA and reimbursement processes become more complex. Relevant teams need more recognition and support from the rest of the organization, but the work of other teams would benefit from market access knowledge and experience. Ensuring that this expertise trickles down your organization can improve your success rate in negotiations in the future.

can We Handle all this data?

Real World Evidence holds an unprecedented potential for innovation, provided we collect the right data, analyze it appropriately, and allow the conclusions to inform the day-to-day functioning of the healthcare systems. The key to developing solutions that are to benefit from RWE is to take a sensible approach andmanaging expectations.

First, discern what’s important. “Before you start [collecting data], you need to articulate the questions you want to answer. What are you really looking for? Without that, you’ll be drowning in data and thirsting for information,” cautioned Nigel Hughes, Director Integrative Healthcare Informatics, Janssen, in a panel discussion. This was echoed by Eddie Chan, Global Head, Search & Evaluation, Sanofi, who said that while he saw no technological challenges awaiting regarding data storage and management, he was concerned about the industry’s ability to engage with the data on specific case basis. “[Pharma’s] business model so far has been based on [people] taking a pill. There was no need to engage with the data. Now we need to figure out what specifically we want from the data and how to transform those use cases into marketable products.”

Eddie Chan, Global Head, Search & Evaluation, Sanofi



Second, translate the data you collect into insights that benefit individuals. Ensuring that the data collected from patients is returned in a form of practical advice is fundamental to getting people to participate in data acquisition. “We can already fill bunkers full of data,” Andreas Caduff, CEO, Biovotion, pointed out. “But what’s needed is a method of delivering digestible instructions. We need to incorporate case specific knowledge into analytics to make things actionable. This is yet to be done.”

Third, help create a cohesive environment for data collection, management, and sharing. Pharma used tobe concerned only with data they themselves generated. This is a thing of the past. Increasingly, the data that lands on the industry executive’s desks, e.g. on real-life outcomes, comes from external sources. Hosted on distinct platforms, coded in an institution-specific ways, and protected by discrete pieces of legislation, the data lacks the ability to be readily accessed and combined. Although the standards are there, creating an ecosystem in which they are compatible should be high on the agenda.

Fourth, give the public a reason to trust you. Pharma is facing a significant roadblock on their way to making RWE useful. That is people’s willingness to collect physiological information about themselves and share it with the industry. This is

fundamental to progress as the future of pharma depends on their ability to demonstrate value. In the world increasingly focused on outcome-based payments, the ability to prove to all stakeholders – including patients, physicians, and payers – that your product does what you said it would do might be the difference between staying afloat and going out of business. To be a relevant player in the game, you have to convince people to help you.

Fifth, be aware of the increasing consumerizaton of healthcare. Pharma need to figure out a way to become relevant to people as consumers. Once upon a time, patients were restricted in their decisions, relying exclusively on the scarce information provided by their physician and often acting on their authority. However, in 2015, patients are informed and empowered, often encouraged to take an active role in their care, make informed decisions about their treatment, and cooperate with physicians in a partnership. Pharma need to catch on to this trend by offering products that are convenient and beneficial to use. Illness is never divorced from the rest of a person’s life and pharma must recognize that whatever they want people to do, it must fit in with their lifestyles and habits. “It’s not normal or comfortable to wear a device that collects data,” Caduff pointed out. “The benefit that comes from that device has to far outweigh the burden of wearing it.” Chan added: “I think of myself as a consumer and I give everything up within two weeks [if it’s not convenient]. The device that collects the data has to be invisible. Otherwise I will always be conscious of it, and that’s not what I want.”

Sixth, be open about seeking commercial opportunity. As the panel discussion progressed, a member of the audience raised a concern about data collection being a thinly veiled commercial enterprise that’s aimed at making people thoughtless and predictable. She drew a parallel with supermarkets, which collect an enormous amount of data on customer purchases, speculating that one day it might get to a point in which when you get to a shop, a bag of groceries will already be waiting for you. The panel responded by admitting that yes, of course RWE is a commercial opportunity and that has to be communicated. They did pause, though, to stress that any commercial opportunity is tightly tied with clinical value and neither can exist in isolation. “If you don’t have a medical problem, you don’t wear the device. If you do have a problem, you can benefit from the device and the solution

Andreas Caduff, CEO, Biovotion



[that comes with it],” said Caduff. Hughes added: “We need to shift the emphasis from treatment to prevention, right now in the UK, the NHS is not a national health service, it is a national disease service. It does not prevent people from falling ill, it’s there to respond to illness. Those tools have a potential to change people’s behaviors and diminish the impact of illness on the system.”

Although a lot of work lays ahead, the processes and trends underway that rely on RWE are unstoppable. Pharma must adjust to the changing landscape and respond to the challenges on the way to realizing the RWE potential.

practical tips on Winning approval and reimbursement in germany

Evaluation of new pharmaceuticals (AMNOG) is a two-step process in Germany. The first step is the submission of a benefit dossier. The second step is price negotiations. The industry is tasked with convincing the payers that the newly-developed drug provides patient-relevant benefit. The process is informed by the following questions:

1. Is there any additional benefit compared to standard therapy?

2. How certain are the conclusions regarding the additional benefit?

3. How large is the additional benefit?

“German payers are only interested in treatments that provide added benefit compared with the current standard of care. If you can’t demonstrate your drug is better than the comparator, the process is over,” Ulf Maywald, Head of Drug Development, AOK Plus, said. Added benefit can only be demonstrated when the trial population is appropriate, the

comparator used is the therapeutic gold standard at a given time, and the end points under study are relevant to patients, including health-related quality of life. “Health-related quality

of life is very important,” said Friedhelm Leverkus, Director Health Technology Assessment & Outcomes, Pfizer. “The instruments used to measure it must be validated, responders must be clearly defined, and data must be robust – 20% or more of missing values will not be accepted,” he added.

To improve your trial protocol and maximize chances of success in AMNOG, make sure to:

1. Involve your internal HTA experts in the protocol development. They’re the ones who talk directly to the regulators and payers.

2. Take advantage of the early advice service provided by the GBA. “Don’t be afraid the system will know too much too early. Early input from the GBA will allow you to be more realistic in your assessment of your own evidence,” Maywald advised.

3. Be thorough when defining your target population, your patient-relevant outcomes, and what instruments you will use to measure outcomes. Only solid data can win you approval and reimbursement.

4. Excel in the hearing.

While this list of tips on how to make AMNOG a success is not exhaustive, it will help you plan and allocate resources appropriately.

“German payers are only interested in treatments that provide added benefit compared with the current standard of care. If you can’t demonstrate your drug is better than the comparator, the process is over.”Ulf Maywald, Head of Drug Development, AOK Plus.

Ulf Maywald, Head of Drug Development, AOK Plus

Friedhelm Leverkus, Director Health Technology Assessment & Outcomes, Pfizer


As the 2015 conference closed, it became clear that as RWE becomes ubiquitous, regulators need to realize its value and give it a more relevant place in their evaluation. For that to happen, data needs to be collected in a validated way that is representative of the target population. This presents an additional challenge for pharma. The industry needs to convince the public that drug manufacturers can be trusted without raising concerns that they want to “dumb down” the population

and push drugs without a clinical rationale.

Internally, companies are facing a need to raise awareness about the role and importance of market access function. As the processes become increasingly intricate and more critical than ever, market access teams need to share their expertise with and receive support from other divisions within the company to ensure successful negotiations.

concluSion

Market access & real World evidence eU brought together payers and pharma experts from across the world . Next year, the event is returning to Amsterdam on May 10 and 11 . Featuring over 300 attendees and 50 expert speakers, this event brings together Europe's most senior market access, pricing, reimbursement, HTA, real world data and HEOR professionals for 2 days that will change the way your stakeholders see your patient access models .

click here to register your interest in next year’s Market access & real World evidence eU summit

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Market Access RWE EU 2015 Highlights Report

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