Category Archives: Real-world evidence

AstraZeneca recognized as top evidence development influencer

evidenceHealthNetwork Communications has compiled a list of the Top 25 influencers in evidence development. Individuals from AstraZeneca and our partner HealthCore topped the list based on their experience, career achievements and contributions to evidence development.

Brian Sweet, the Executive Director of U.S. Payer & Real World Evidence at AstraZeneca, was named the No. 3 influencer in evidence development. At AstraZeneca, he focuses on our initiatives in real world evidence (RWE) and comparative effectiveness research, as well as RWE with U.S. payers and integrating delivery networks.

Marcus Wilson, the president and co-founder of HealthCore, the health outcomes research subsidiary of WellPoint, Inc., was named the No. 1 influencer in evidence development. HealthCore is AstraZeneca’s founding partner in the RWE Health Collaborative.

AstraZeneca is investing in RWE because we want to be more informed about our products and how they work in real-world settings. Our RWE capability allows us to generate the insights that both AstraZeneca needs, and our customers want, to help make informed decisions about clinical options and the value of these options.

Our approach to RWE goes far beyond examining claims data to be inclusive of clinical datasets like Registries and Electronic Health Records so we can have a full understanding of how our products help to improve patient health and impact total cost of care.  This provides insights into what is happening in the real world (evaluate benefits design, clinical guidelines, and patient demographics and adherence), which can help answer the question “why” we are seeing the real world utilization and costs in the market.

We are also focused on how we can help reduce the time it takes to get from generating the evidence to using it in practical ways.

RWE helps us fill important information gaps that matter to payers, providers and patients.

‘Deep data,’ pharma and payers

MM&M takes a look at how pharmaceutical companies and payers are using "deep data."

MM&M takes a look at how pharmaceutical companies and payers are using “deep data” on to benefit patients.

Check out the cover story in the new Medical Marketing & Media, which takes a look at an issue that is very important to AstraZeneca: using data to inform how payers and providers evaluate medicines for coverage.

For instance, AstraZeneca has leveraged clinical evidence derived from administrative claims and (electronic health records) to look at the effect of formulary decisions on total cost of care for some late-stage commercial products.

“[We] showed that the removal of a branded medicine in our portfolio from the preferred-tier status actually resulted in higher overall costs, which were related to cost of office and [ER] visits as well as disease-state related tests,” reports Brian Sweet, AstraZeneca executive director of health alliances. Considering such study results has helped the company “solidify tier-placement decisions with respect to our medication that are more favorable than what you would expect with a generic market where we have to compete with a late-stage commercial product,” he adds.

Give the whole article a read, which looks at AstraZeneca’s real world evidence collaboration with HealthCore, the health outcomes research subsidiary of WellPoint, Inc. – as well as what is going on at other companies.

Individual differences matter when making treatment decisions

A conference hosted by the National Pharmaceutical Council examines the many factors that go into individual treatment decisions.

When many options are available – medicines, devices, surgery, lifestyle changes – how do doctors and patients decide what is the right course of treatment for that one person at that time? What role do treatment guidelines, research, personal preferences and other factors play in these important decisions? What role should these factors play in determining how treatment options are covered through health insurance?

These questions and others will be examined at a meeting convened by the National Pharmaceutical Council on Friday, November 30 in Washington, DC. The conference, “The Myth of Average—Why Individual Patient Differences Matter,” will explore the role and challenges of individual treatment effects in developing treatment recommendations, practice guidelines, and coverage and reimbursement policies for patients. It is being sponsored by the National Pharmaceutical Council, the National Health Council and WellPoint, as well as 17 other patient, provider and health care organizations.

This conference comes at a critical time in determining how comparative effectiveness research (CER) will be conducted and implemented. As we’ve discussed here, CER studies examine how different types of treatments compare in improving patient health outcomes.

Through a series of expert panels, the conference will address questions about how to balance findings from CER research with the needs of the individual patient. Panelists also will examine how CER might shape future patient care and coverage models being considered by policy leaders and payers.

For more information and to register, please visit www.npcnow.org/myth2012. There is no charge to attend.

Health Affairs examines how we talk about research

Comparative effectiveness research can help inform physician-patient decisions about treatment options

In a special issue released today, Health Affairs examines the “Current Challenges in Comparative Effectiveness Research” and how the findings from this kind of research may – or may not – be promoted and used by pharmaceutical companies, payers, providers and others involved in health care decision-making.

Comparative effectiveness research evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care. It is designed to inform health-care decisions by looking at existing evidence and generating new evidence.

The call for evidence-based medicine is not new, but the topic has generated more attention in recent years with increased funding for comparative effectiveness research through the stimulus act and health care law. One-billion dollars in funding has been given to Federal agencies to scale up their efforts on comparative effectiveness research.

With funding for CER in place, some of the questions now being asked are: how can CER be done appropriately and how can communication of these findings be done in a way that is fair?

AstraZeneca supports research that helps inform physician-patient decisions and healthcare that works. Through our work in real-world evidence, we look beyond the information needed for FDA approval. We look to analyze how medicines and treatments already on the market are working in a number of disease areas and improving quality and managing total cost of care.

Unlike randomized controlled clinical trials used for regulatory filings, most real-world evidence studies use observational, naturalistic, and other types of non randomized clinical trial data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on health outcomes important to patients.

But, as Health Affairs points out, there are limitations to what the pharmaceutical industry is allowed to say regarding its research while other stakeholders have considerably less regulation over their communications. This asymmetry in communications could ultimately hurt patients because providers and other decision makers do not have all of the available information.

While randomized, controlled clinical trials are the regulatory standard by which safety and efficacy of drugs are demonstrated in the United States, these studies often are designed with numerous controls that may limit the ability to answer questions related to the real-world delivery of healthcare. Studying the use of a drug, device or other treatment in a real-world setting can yield insights into costs, optimum co-therapies, and medical best practices that the focus of clinical trials cannot.

Today’s release of the October issue of Health Affairs is accompanied by a symposium with a variety of health care stakeholders. This issue and forum was supported by the National Pharmaceutical Council.

Real-world evidence answering key healthcare questions

AZ’s Brian Sweet a featured presenter at the AMCP 2012 Educational Conference

How is AstraZeneca using real-world evidence to shed more light on how our medicines are actually being used to help improve patient health? How are we using the insights from our collaboration with HealthCore to inform business decisions from the earliest days of discovery to the end of a product’s lifecycle?

AstraZeneca’s Brian Sweet, Executive Director of Health Alliances, answered these and other frequently asked questions about our work in real-world evidence at the Association of Managed Care Pharmacy’s 2012 Educational Conference this week.

Q: In what ways is AstraZeneca using real-world evidence? 

Brian: Our RWE capability is generating valuable insights that we are using to inform business decisions we make every day in discovery, business development and commercial development of launch to late-stage products.

We begin talking to payers and health technology appraisers early in and throughout medicines development to discuss where the greatest clinical needs are and what type of data will be needed to provide the evidence to support access and reimbursement in specific healthcare settings.

For example, we worked with a national health plan to understand the effect of a formulary decision on the total cost of care for one of our late stage commercial products. The removal of a branded medicine from a preferred tier status resulted in higher overall costs, related to the cost of office and emergency room visits as well as disease state-related tests.

Q: How has RWE informed AZ’s decisions around working with external partners to develop a medicine?

Brian: If we don’t believe we will be able to demonstrate the value and unmet medical need of an investigational medicine to those who will pay for it, we won’t invest in it.

For example, we did an evaluation of in-hospital and multiple health plan data to provide insight as to whether a late stage product had a role in treating infants with a suspected condition in which all clinical trials had failed.

In another situation, we established the incidence, prevalence, and course of health treatment for a specific disease to evaluate a business development opportunity for a medication intended for patients with biopsy-confirmation of this disease.

 Q: Who else is collaborating with AZ and HealthCore on RWE?

Brian: We have agreements in place with Delaware’s state Medicaid program, a large employer group and some provider groups. We are at different stages of conversations with multiple other stakeholders about how we can work together. Most of our agreements are confidential at this point, but we expect to announce some soon.

Engaging with stakeholders about RWE has taught us how important it is that we are clear and transparent about critical issues such as data security and privacy, data integrity and conducting studies that truly add value to each organization.

To learn more about AstraZeneca’s work in RWE, please visit recent blog posts here and here.

Medical affairs: A key strategic function

Dr. John Yee is the U.S. Head Medical Officer at AstraZeneca.

A recent PharmaVOICE feature discussed the role that medical affairs organizations play as a channel between internal stakeholders and their external clients. Medical affairs leaders are beginning to position themselves at the forefront of new pharmaceutical industry commercial models.

In the article, AstraZeneca’s U.S. Head Medical Officer, John Yee, M.D. offered his perspective on the changing role of the medical affairs function:

“As our healthcare system focuses on increasing value by improving outcomes while managing costs, the medical affairs function will evolve from being an essential support function to becoming a key strategic function.”

“The medical affairs team has the unique opportunity to gain alignment and lead “win-win” initiatives toward the fundamental mission shared by all parties: the desire to make a meaningful difference in improving patient health. In our medical affairs team at AstraZeneca, we hold the strong belief that as we work together to improve the health of patients, we also increase the strength of our business.”

Dr. Yee says that internally, the medical affairs function serves as an essential bridge between the R&D and commercial organizations. While externally, he says, the medical affairs team engages providers, payers, and policymakers about issues of shared concern such as the development and use of real-world evidence.

AstraZeneca’s collaboration with HealthCore designs real-world studies to determine how to most effectively and economically treat disease. Analysis of the resulting data can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.

Real world expectations about real-world evidence

The National Pharmaceutical Council released survey findings on how comparative effectiveness research is used in decision-making

A key to improving the quality of health care is having studies that show what is and isn’t working in the real world when it comes to improving patient health while managing costs.

As these kinds of real-world studies become more commonplace with new technology, analytical tools and collaborative efforts taking hold, it is important to understand if and how they are informing health care decisions made by insurers, providers, patients and other stakeholders.

The National Pharmaceutical Council has released the findings from its second Annual Survey of Health Care Stakeholders on Attitudes and Expectations for Comparative Effectiveness Research (CER).

The survey findings show that the vast majority (95 percent) of stakeholders believe that CER is “somewhat” or “very important” to them and that the majority (77 percent) expect these studies will help improve decision-making in the next three years.

Together with HealthCore, the health outcomes research subsidiary of WellPoint, Inc., AstraZeneca is building a real-world evidence (RWE) capability. Through RWE, we conduct observational studies, taking information outside of controlled trials to create insights that  stakeholders need to make better informed decisions.

Insights about unmet needs, the burden and cost of illness, treatment pathways, safety and the real-life cost effectiveness of specific therapeutic options will become more readily accessible in the years ahead. We look forward to continuing to work with stakeholders on building and applying this important research to improve patient health.

Delaware joins real-world evidence collaboration

Delaware Governor Jack Markell. Photo via Dave Chambers/Delaware State News

In 2011, 207,000 Delawareans received their health coverage through Medicaid. This population is expected to grow by 25,000 beneficiaries when Medicaid eligibility expands in 2014.

Like many other states, Delaware is focused on finding new ways to improve quality and manage the costs for Medicaid beneficiaries. Today, we announced that Delaware has become the first state to participate in the Real-World Evidence Collaboration with AstraZeneca and HealthCore. Delaware Governor Jack Markell offers his insights on how this new initiative supports the state’s goals for a healthier Medicaid population.

Q: What do you hope the State of Delaware will gain from this collaboration?

We want healthier Delawareans, and a healthier Medicaid population. Not only is this in the best interest of individuals; it’s also in the best interest of the state. The number of Medicaid enrollees is growing and the cost of medical expenses is increasing. We simply can’t sustain the rising costs of Medicaid.

Q: How does this new collaboration align with the State’s Medicaid strategy?

We must address staggering Medicaid costs and that means not spending money where we are not getting results. This analysis will help us harness data that will tell us more about our Medicaid population including people’s health, what is driving costs, where care is ineffective and how we can better manage care to keep people healthy. We’ll learn what’s working well and what’s not, so we can reward what works and change what doesn’t.  Ultimately, this is about making people healthier while driving down costs.

Q: How will Delawareans benefit from the real-world evidence studies the State conducts through this collaboration?

We want to be able to better identify opportunities for intervention before health problems reach an acute stage. If we do that effectively, we can reduce the amount of money we, as a state, spend on Medicaid, and we can also learn about the most effective strategies for the benefit of the broader population. This work will support physicians and the patients they treat with the best information possible, based on “real-world evidence,” to make informed decisions about their care. This is about improving care and reducing costs.

Q: What areas of study most interest the State?

We want a healthier Medicaid population. Every aspect of this study is integral to achieving that goal. We want to make sure the system we have is working toward the best outcomes for people. We also need to encourage healthy behavior and start ensuring that people take responsibility for making healthy choices, for their sake and for the sake of all of us who end up absorbing higher health costs. We want to move from a sick care system to a health care system and this study will help us start to do that.

Expanding our real-world evidence capabilities

AstraZeneca expands its real-world evidence capability to Europe.

Today, AstraZeneca announced an important milestone in our company’s work to build industry-leading real-world evidence capabilities around the world. Through a new three-year collaboration agreement with IMS Health, we will be advancing the use of real-world evidence that is based on observational and retrospective studies conducted throughout Europe.

The real-world evidence generated through this collaboration will inform the design of our clinical trial programs, enable us to track the impact of our medicines as well as optimize their performance in the real world.

Our first major data partnership in the U.S. with HealthCore, the health outcomes research subsidiary of WellPoint, provides access to the largest integrated database of the commercially insured population in the U.S.

Since initiating the partnership with HealthCore in February of 2011, we’ve focused significant effort on building relationships with specific public and private organizations to strengthen the existing real-world evidence data set so that it represents care given across different healthcare settings and reimbursed through different types of health insurance coverage.

Ultimately, we’re looking to integrate all medical and claims data from specific local communities so we can understand drivers of cost, utilization, quality, risk and outcomes for those receiving health care in those communities. We expect to engage in several community collaborations in the U.S. in 2012.

More about our real-world evidence vision may be found here.

Real-World Evidence: Some key learnings from 2011

AstraZeneca and HealthCore are collaborating with stakeholders on the use of real-world evidence to manage the total cost of care

In her article in the December issue of IN VIVO, “Pharma/Payor Deals An Important Step In The Shift To Value-Based R&D,” Ellen Licking examines the opportunities and challenges brought by a new generation of business relationships between pharmaceutical companies and payor organizations to gain deeper insights into a medicine’s true value.

As we near the one-year mark since we announced our agreement with HealthCore, we have learned  a great deal from engaging with physician practice groups and hospitals, governments, commercial payors, health information technology consortiums and other stakeholders actively looking at how to realize the promise of real-world evidence to improve health outcomes.

Among our learnings:

  • What’s the way when there is the will? There is significant interest among stakeholders from virtually every part of the health care sector to build health care data alliances. The rub is facilitating the interoperability of the different data sets and finding the resources to collect, analyze and apply the data.
  • What’s in a name? The concept of “real-world evidence” means different things to different people, so it’s important to get to that place of common understanding with potential partners.
  • Serving different needs. Colleagues are looking for ways to more efficiently link different data sources – medical claims, prescription claims, clinical data – to generate the insights they want in ways that meet privacy and security standards.

The IN VIVO blog is inviting readers to vote on their pharma “deal of the year,” and we’re proud that AstraZeneca/HealthCore was among the nominees. We’ll continue to share developments as we progress with this exciting new way of working with colleagues across the health care system to build a new data environment that can lead to better ways to manage the total cost of care for patients.

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