Partnership Paradigm w02 - Syneos Health · 2018-11-07 · Clinical trial imperatives ... 6 The New Partnership Paradigm: What Patient Advocates Seek From Pharmaceutical Partners

Dramatic changes in U.S. healthcare over the last few years have forced a rethinking of the partnerships pharmaceutical companies form with groups representing patients and families. Syneos Health™ interviewed dozens of patient advocacy organizations to understand how they view the changes and what they seek from their pharma partners.

The New Partnership Paradigm: What Patient Advocates Seek

From Pharmaceutical Partners

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Partnerships between patient advo-cacy groups and pharma companies play a unique role in assuring that new medications arriving on the market meet the needs of people with devastating diseases. To both sides, these relationships bring value. For advocacy groups, partnerships provide both capital and information about treatments in the pipeline that may have life-or-death implications. Drug companies gain a window onto the patients’ desires, their interactions with doctors and insurers, their will-ingness to participate in clinical trials and whether they will go to bat for a new drug when it comes to reim-bursement and formulary placement.

Despite these mutual advantages, in the five years since the Afford-able Care Act (ACA) was signed into law, partnerships have come under pressure and, in some cases, veered toward disappointment or discord. To cite just one flashpoint, rising co-in-surance in many health plans under the ACA, as well as narrowing formu-laries and physician networks, have exposed patients with rare cancers and other orphan diseases to more burdensome costs. Pharma-ceutical partners aren’t always able or

willing to alleviate their pain. When drug companies fail to respond to cost concerns, patient groups feel abandoned by their pharma partners.

This spring, Syneos Health Com-munications conducted in-depth interviews with 43 patient advocacy organizations based or operating in the United States. The objective for Syneos Health Communications, which has strong ties to patients and their support organizations, was to discover how these industry/advo-cacy relationships are weathering the stresses caused by a fast-trans-forming healthcare landscape, and where the patient groups sense a need for change. Most of the organi-zations we interviewed were focused on oncology, rare diseases, mental health and Parkinson’s disease. We asked them to describe actions they would like their industry partners to take, and how they envision them-selves operating more effectively in an increasingly competitive environment. Their responses to these questions have enormous significance for the pharma sector, for insurers and other healthcare stakeholders, and for the trajectory of U.S. healthcare evolution and innovation.

Introduction

The New Partnership Paradigm: What Patient Advocates Seek From Pharmaceutical Partners

Shifting healthcare landscape........................................................4

Finding balance..................................................................................5

Patient advocacy wish list...............................................................5

Authenticity and transparency.......................................................6

Clinical trial imperatives..................................................................7

Money better spent...........................................................................8

Collaboration now.............................................................................9

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

Table of Contents

3Syneos Health Communications

No organization keeps precise tabs on how many patient advocacy groups spring up each year in markets around the globe. However, we know the number is large and growing. PatientView, a UK-based consultancy that conducts surveys of patient organizations, says it reaches out to as many as 120,000 such groups, covering more than 1,000 disease specialties as part of its research.

Whatever the tally may be, groups serving patients in different disease areas often identify points of common concern. Many organizations in the United States say they’re grappling with disruptive changes triggered by the ACA. One issue is the dramatic expansion in federal marketplaces and state Medicaid programs, and the accompanying influx of millions of previously uninsured patients. This expansion, welcome as it is in public health terms, has increased cost

pressures. It has also intensified challenges to medication access for many patients and groups that serve them — either because the medicines they seek aren’t on the formulary or because increased cost-sharing (insurance premiums, co-pays, etc.) make the drugs prohibitively expensive.

“We’re hearing more and more from our clients about insurance regulations and narrow networks,” says Trish Goldsmith, CEO of CancerCare, a national organization whose free programs and services help 170,000 patients a year. “Access to leading specialists is so important in cancer,” she explains, “and narrow networks that patients often learn about during their cancer diagnosis may end up precluding their opportunities to take advantage of the most advanced therapies.” Physicians can feel compelled to put patients on treatment pathways under pressure from insurance

companies, she contends. “The problem is that patients don’t know about [it] and don’t know what questions to ask.”

Rapid scientific advances also are remaking the world of medicine, from high-priced cures for hepatitis C to breakthroughs in cancer immunotherapy whose commercial reality looms — large and very expensive — on the near horizon.

Amidst these developments, advocacy groups also say they’re struggling with healthcare policy paralysis on Capitol Hill, stemming in no small part from partisan discord surrounding the ACA. While advocates continue to conduct Hill days to meet with their elected officials on matters of research funding and reimbursement, they’re also forced to pursue less direct channels, meeting with federal health and science agencies and state health officials.

Shifting Healthcare Landscape

Narrow networks may end up limiting patient opportunities to take advantage of the most advanced therapies, and physicians can feel compelled to put patients on treatment pathways under pressure from insurance companies.

4 The New Partnership Paradigm: What Patient Advocates Seek From Pharmaceutical Partners


Finding Balance

Patient Advocacy Wish List

Policy reform and the ACA are not the only societal forces affecting advocacy groups. Advances in social media have transformed health-related communications, with both attractive and troubling consequences for partner-ships between pharma companies and advocacy groups. Some patient organizations complain that social chan-nels give pharmaceutical company funders a false sense of intimacy with patients and their support and service groups. “As a patient advocacy organization, we’ve had to be careful about that level of social intimacy,” says Kimberly Haugstad, executive director of the Hemophil-ia Federation of America. If a problem arises between patients and the supplier of the medication, “we need to maintain the opportunity to advocate for our families,” she explains. “Many of our members can get confused by the blurring of those boundaries.”

Conversely, some advocates fault drug companies for failing to take advantage of new communication chan-nels to provide timely clinical or pricing information on their products. Instead, drug makers often hold patient organizations at arm’s length — the opposite of what healthcare consumers expect in the age of Facebook and PatientsLikeMe.

While these complaints may sound harsh and, at times, contradictory, advocacy organizations often pair their objections with constructive self-criticism. Many patient groups, for instance, say they themselves could behave more professionally in these relationships and do a bet-ter job delivering on their promises to industry.

Improve transparency and authenticity

Seek our input in the design and execution of clinical trials

Involve us in awareness and education campaignsfor patients, healthcare providers (HCPs) and caregivers

Provide follow-up when meetings are con-vened to seek our counsel on unmet needs

Use request for proposal (RFP)/grant giving process to reward collaboration among pa-tient groups, not competition

Before looking in greater detail at some of these issues, it’s helpful to summarize what, exactly, is on the wish list of the advocacy groups we interviewed, and how the groups themselves understand their changing responsibilities toward industry partners.

How the pharmaceutical industry can better serve us:

What we can do on behalf of our pharma partners:

ONE ONE

TWO

TWO

THREE

THREE

FOUR

FOUR

FIVE

FIVE

Be more clear about lines we aren’t willing to cross

Behave more like businesses, meeting our commitments in a timely fashion

Stay focused on core mission and avoid initiating programs simply to chase more funding

Frequently report back to funders on the impact of dollars raised and spent

Establish more patient registries that pharma can use for drug trial recruitment and outreach


For years, pharma companies have strived to present themselves as “pa-tient-centric.” But some advocacy groups worry the drug industry’s goals may trump activities that would bring more concrete benefits to the patient groups. Leaders say industry often doesn’t know enough about the lives and illness narratives of health consumers and their families to claim the patient-centric mantle. “If pharma is going to enter into a disease space, they need to be open to hearing directly from patients,” says Christine S. Brown, executive director of the National PKU Alliance — a group organized around a rare, inherited metabolic disorder called phenylketonuria. “They need to hear [patients’] stories and connect with them.”

Emphasizing the importance of pa-tient-centered needs and concerns, Amy Copeland, director of medical outreach at Lung Cancer Alliance, America’s oldest nonprofit organi-zation for the disease, notes: “Your clients are the people you serve, not industry. There are companies out there who will push you to not be authentic and to be more loyal to companies than patients,” she says. “You have to discuss as an organiza-tion what your boundaries are and stay true to them.” There’s a risk, Copeland adds, that beliefs or values could be compromised in a partnership. “We’re very loyal to our patient population. We won’t agree to things we don’t feel good about. This approach helps with partners in respecting us and in maintaining the trust of the people we serve.”

Transparency goes hand in hand with authenticity. In pharma, the word calls to mind the Sunshine Act, regulations governing transac-tions among pharmaceutical reps and physicians finalized in February 2013. But in industry/patient alli-ances, “transparency” means timely and detailed updates — whether the news is good or bad — on prod-ucts in the pipeline. And it means

clarity around what pharmaceutical companies expect from advocacy groups in return for financial support. “Industry needs to involve patients more in the beginning conversations with researchers — in all aspects of clinical trials, not just the end and the testing,” says one oncology orga-nization focused on prevention and early detection efforts.

Greater clarity about the company’s commitment to the advocacy organi-zation is the essence of this request. “A year or two before their medi-cation heads to generic status, the companies too often pull back from their support of the community,” says Elizabeth “Eli” Pollard, executive director of the World Parkinson Coa-lition. In doing so, companies haven’t fulfilled their commitment to treat advocacy groups as true partners. “[They] don’t have a sense of their corporate social responsibility. As soon as their profits are about to wane, they jump ship from supporting the community that helped make them loads of money. If they really support the community, they would make an effort to stay in the space somehow, not have their involvement only tied to profits,” Pollard says.

“We expect to come to the table with other organizations and with funders as true partners. This is a two-way street.”

Authentic & Transparent


A great many advocacy groups expressed a desire for greater recognition of their expertise in specific disease areas, based on their intimate connections to patients, families and physicians. The groups and their networks of volunteers know the doctors best able to treat an illness. They keep up with the research. They want to be consulted as respected experts in a therapeutic category. “We are not your grandmother’s advocacy group. We’ve become much more sophisticated about how we understand the disease and the population and the research,” says Wendy Selig, past president and CEO of the Melanoma Research Alliance and now founder & CEO of WSCollaborative, which advises clients on the best approaches to collaboration. “We expect to come to the table with other organizations and with funders as true partners. This is a two-way street.”

Across the board, the groups we interviewed said they should be involved earlier in the design and monitoring of clinical trials. Already many advocacy groups are developing their own patient registries. They can help pharma companies identify clinical investigators who are highly regarded in their field and have significant patient panels. Armed with insights from physicians and patients, the groups can help companies specify primary and secondary endpoints for clinical trials to make the trials safer, more comfortable and more convenient for patients. Industry partners in rare diseases, in particular, are learning that trials designed with input from patient advocacy groups are more likely to reach completion cost-effectively, with less patient drop out.

In the words of Lindsay Groff, executive director of the Barth Syndrome Foundation, serving patients with a rare genetic condition by that name: “There are all kinds of data that we can provide, [and] we have the ability to engage patients when it comes to a clinical trial, as opposed to pharma doing that.”

Clinical Trial Imperative“Industry needs to in-volve patients more in the beginning conversations with researchers — in all aspects of clinical trials, not just the end and the testing.”


In disease education, patient organizations say they’ve often done the work and could take charge of the process, sparing industry partners the expense of a du-plicative effort. Yet, according Jamie Bearse, CEO of ZERO - The End of Prostate Cancer, companies push forward with their own education materials without re-gard for what patient groups have already done. There are cases where industry funders have built a constituency campaign without looking around to see that “strategic partnerships may already have that database and may be a better return on investment for them while making an impact on the cause.”

To Mary Ellen Fitzgerald, director of Breathing Room Foundation, a support organization for families of people who have cancer, education includes the crit-ical role of helping patients navigate the healthcare system. “Not every patient has a social worker or advocate, and they don’t know they’re supposed to have one,” she says. “They need someone to guide them through their journey” at a time when providers are cutting social workers and staff for such roles. “I wish pharma would help fund those types of positions.”

However, in funding programs for the public good, it’s important to draw clear demarcations. Alies Muskin, the executive director of a mental health nonprofit called Anxiety & Depression Association of America, says blurred lines between self-interest and unbiased public education can undermine the whole endeav-or. If the goal is to improve health at large, says Muskin, “Pharma should have resources that are available through competitive grants, beyond funding that is tied to areas where they have drugs that are new to the market.”

Money Better Spent“Not every patient has a social worker or advocate, and they don’t know they’re supposed to have one. They need someone to guide them through their journey.”


Advocacy groups, for the most part, recognize that some of the obstacles they face are of their own making. Several advocacy leaders said duplica-tive efforts by multiple patient groups in the same disease area is a liability. “People forget that we all really have the same mission — to eliminate the challenges of rare disease. What dif-ferentiates each organization is their approach to pursuing that mission,” says Nicole Boice, founder and CEO of Global Genes, a global rare disease advocacy organization.

The rare disease sector comprises some 7,000 distinct illnesses. Togeth-er they affect as many as 30 million Americans, though each disease, by definition, strikes fewer than 200,000. “The approach we recommend is to look at each group’s core competen-cies, identify overlap, and determine where there are gaps. Then try to eliminate the overlap and figure out how to move forward addressing the

gaps, and work to do this collabora-tively.” says Boice. “The community needs to remember our common mission, and try to to play in the sandbox together. There is certainly enough work that needs to be done.”

Marcie Reeder, executive director of the National Comprehensive Cancer Network Foundation, says that while most organizations recognize the need for collaboration, some may not. “Traditionally, collaborative efforts were not a strategy employed to strengthen non-profit organizations and the potential benefits realized through strategic collaboration were not embraced,” Reeder explains. “Leadership worried that they may lose charitable support to other like organizations, or that brands would be confused with perceived competi-tors focused on a similar mission.” Yet, this is an “old school” thought pro-cess, Reeder contends. “Slowly this is changing for the better.”

Some advocacy leaders say industry could be the change agent, by incen-tivizing collaboration through the use of tools such as RFP and grant-giving processes. Janine Guglielmino, senior director of programs and partnerships at Living Beyond Breast Cancer, says drug companies could “give prefer-ence on funding decisions to orga-nizations that collaborate.” Indeed, companies could “encourage orga-nizations to do it by awarding higher scores to groups that cooperate.” Guglielmino wouldn’t mind receiving resources from industry that could help address the thorniest parts of collaboration among nonprofit orga-nizations, she says, including guide-lines on co-development of content, strategies for decisions on the voice used in the material and whether the organizations exchange money. “There’s a greater chance of success if such issues are discussed up front.”

Collaboration Now


Syneos Health thanks all of the organizations that gave freely of their time and their insights that contributed to this report. Please note: the opinions and conclusions in this report do not necessarily reflect the opinions of each group interviewed.


ConclusionIn some interviews, advocacy leaders warned pharma partners against “mission creep” as these alliances evolve in response to rapid change in the healthcare environment. “You’re in the business to provide a product. Provide a really good one,” says the Hemophilia Foundation’s Haugstad, addressing her point to the pharma sector at large. Social media give drug companies new channels of interaction with patients. But this frontier, still a regulatory gray area de-spite recent rulemaking, may create the illusion that drug companies can provide full support systems for a patient community. Proceed with caution, says Haugstad. “Allow the patient advocacy community to provide that, [and] instead, provide really good information about the drugs.”

Wendy Selig, the former CEO of the Melanoma Research Alliance, strikes an optimistic note. She told us some individ-uals in the pharma industry “get” the changing face of corporate/advocacy alliances. “They’re very forward thinking and totally understand the shift going on.” Still, she added, “while we’re making progress within companies to change the culture and make this new partnership model work, there are some companies behind the curve.”

Patient advocates say they understand that they can’t simply wait for pharmaceutical companies to catch up. Many of the groups interviewed by Syneos Health agree this is a critical moment for decisive action.

“Non-profit groups can’t just sit back and wait for industry,” Selig says. “We have a job to do to present our value proposition and what it will take to be good partners.”

Advocacy Organization Interviewees (left to right)

ROW 1: Sarah Arvey Research and Evaluation, Livestrong

Carla Barry-Austin Director of Marketing Communications, The Skin Cancer Foundation

Jamie Bearse CEO, ZERO: the end of prostate cancer

Julie Block Chief Executive Officer, National Eczema Association

Nicole Boice Executive Director/Founder, Global Genes Project

Christine S. Brown Executive Director, National PKU Alliance

ROW 2: Rhonda P. Buyers CEO/Executive Director, National Gaucher Foundation, Inc.

Joanne S. Buzaglo Vice President, Research and Training, Cancer Support Community

Catie Coman VP Marketing and Communications, National Psoriasis Foundation

Amy Copeland Director of Medical Outreach, Lung Cancer Alliance

Allen Doederlein President, Depression and Bipolar Support Alliance

Jeanne Ellinport Managing Director, External Affairs, Prevent Cancer Foundation

ROW 3: Jennifer Farmer Executive Director, Friedreich’s Ataxia Research Alliance

Mary Ellen Fitzgerald Director, Breathing Room Foundation

Patti Goldsmith CEO, CancerCare

Lindsay B. Groff Executive Director, Barth Syndrome Foundation

Janine Guglielmino Director, Programs and Strategic Initiatives, Living Beyond Breast Cancer

Charles R. Harman National Director, Strategic Alliances and Development, National Alliance on Mental Illness

ROW 4: Kimberly Haugstad Executive Director, Hemophilia Federation of America

Chuck Ingoglia Vice President, National Council for Behavioral Health

Tom Kirk CEO & President, Us Too

Dan Klein President & CEO, Patient Access Network Foundation

Danielle Leach Government Relations Director, St. Baldricks Foundation Co-chair, Alliance for Childhood Cancer

Alison Malmon Founder and Executive Director, Active Minds

ROW 5: Jenn McNary Director of Outreach and Advocacy, Jett Foundation: Fighting Duchenne Muscular Dystrophy

Mary Anne Meskis Executive Director, Dravet Syndrome Foundation

Debra Miller Founder, Cure Duchenne

Alies Muskin Executive Director, Anxiety and Depression Association of America

Joe Nadglowski President & CEO, Obesity Action Coalition

Joyce Oberdorf CEO, National Parkinson Foundation

ROW 6: Elizabeth “Eli” Pollard Executive Director, World Parkinson Coalition

Sandie J. Preiss Vice President, Advocacy and Access, Arthritis Foundation

Marcie Reeder Executive Director, National Comprehensive Cancer Network

Meghan Riley Associate Director, American Diabetes Association

Kari Rosbeck President & CEO, Tuberous Sclerosis Alliance

Jo Rosen President & Founder, Parkinson’s Resource Organization

ROW 7: Mark Schoeberl Executive Vice President, Advocacy & Health Quality American Heart Association

Wendy K.D. Selig Past President and CEO, Melanoma Research Alliance Current CEO, WSCollaborative

Saskia R.J. Thiadens Executive Director, National Lymphedema Network (NLN)

Ronnie Todaro VP, National Programs, Parkinson’s Disease Foundation

Louise Vetter Chief Executive Officer, Huntington’s Disease Society of America

Carol Walton CEO, The Parkinson Alliance

Syneos Health Communications is the only healthcare communications network that is part of a company on the frontlines of healthcare. Our advertising, public relations, medical communications, digital, data science, research and market access specialists have the ability to tap the expertise of clinical and commercial colleagues worldwide to infuse programs with deep therapeutic and analytic insights. We work in scalable, collaborative teams that partner across disciplines and geographies to deliver integrated communications strategies that accelerate brand performance.

Our ideas work in the real world because they were built there.

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Traditionally, the patient voice has been limited to discrete points later in the product development lifecycle. Syneos Health helps clients infuse the patient voice throughout clinical development and commercialization with input mechanisms providing a continual feedback loop.

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Partnership Paradigm w02 - Syneos Health · 2018-11-07 · Clinical trial imperatives ... 6 The New Partnership Paradigm: What Patient Advocates Seek From Pharmaceutical Partners

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