August 2014, Vol 3, No 5
Personalized Medicine and Value:
Interview with the Innovators
An Interview with Faculty at the Fourth Annual Conference of the Association for Value-Based Cancer Care
C. Daniel Mullins, PhD, is a professor and former department chair of the Pharmaceutical Health Services Research Department at the University of Maryland School of Pharmacy.
Linda Bosserman, MD, is a community medical oncologist at Wilshire Oncology.
Andrew Stainthorpe, PhD, is associate director of the National Institute of Health and Care Excellence.
Gary Palmer, MD, is senior vice president, Medical Affairs, at Foundation Medicine.
Michael A. Kolodziej, MD, is the national medical director, Oncology Solutions, Office of the Chief Medical Officer, Aetna.
More than 250 oncology healthcare professionals, practice managers, and managed care executives recently convened in Los Angeles, California, for the Fourth Annual Conference of the Association for Value-Based Cancer Care (AVBCC). The expert faculty, with backgrounds in cancer care, healthcare policy, and managed care, provided a comprehensive program addressing the evolution of the value equation as it relates to cancer therapies.
The mission of AVBCC is to provide a forum for payers, providers, and the entire oncology team to consider and evaluate the cost-value issues particular to cancer treatments and their impact on patient care and outcomes. This unique focus is achieved through discussions and collaborations with those involved in evaluating therapies, treating patients, and paying for care.
PMO had the pleasure of interviewing several AVBCC faculty members, including Linda Bosserman, MD, of Wilshire Oncology; Michael A. Kolodziej, MD, of Aetna; C. Daniel Mullins, PhD, of the University of Maryland School of Pharmacy; Gary Palmer, MD, of Foundation Medicine; and Andrew Stainthorpe, PhD, of the National Institute of Health and Care Excellence. What follows is our insightful exchange.
PMO Thank you for meeting with us. To begin, please tell us how you define the concept of value in healthcare, and why it is so important today?
Dr Mullins The notion of value in healthcare is incredibly important, and thereâ€™s perhaps no better therapeutic area than oncology to look for value in healthcare. This is because there are so many new treatments that have come on the market in the last few years, and many more treatments that are in development. When we have options, we look for value, because we know that we can find health outcomes that will help people to live longer with better quality of life for their remaining time as a cancer survivor.
When we introduce cost into the equation, we see that there are value messages. We need to be able to understand those value messages and compare across our options, so that patients, in consultation with their healthcare providers, can make informed decisions.
Itâ€™s not just patients, however, that are looking for value. Insurance companies, both private and public payers, are looking for value. They are looking for evidence of cost and evidence of improved health outcomes. These 2 series of evidences taken together determine value.
PMO For our American contingency, what are the main value-based concerns for oncologists in the United States?
Dr Bosserman As we learn more about the growing costs of cancer care and the burden of patient copay, we have to better understand the full impact of the treatment weâ€™re giving to patients. That means outcomes â€“ not just progression-free survival and overall survival, but also the toxicities, the side effects, and the costs of the overall regimen to the patient.
Dr Kolodziej I think the biggest challenge that oncologists in the United States are facing is the uncertainty of the reimbursement environment. Itâ€™s concerning to think you may not be able to continue to deliver care in the fashion that you would like.
Dr Palmer There are many value-based concerns among oncologists in the United States. I think any therapy that a physician uses is probably selected by considering both its clinical effectiveness and its cost.
Itâ€™s difficult, though, to take the overall cost of the healthcare system into account. Tests such as FoundaÂtionOne, I think, may very well have a good economic picture in the whole healthcare system. We can take the place of many other tests that are done. If our test is used earlier, the targeted therapies that it suggests may take the place of some forms of chemotherapy. I think taking that global approach to healthcare costs is important.
Itâ€™s hard for oncologists to do that. They, of course, are concerned mostly about benefits to their patients. But theyâ€™re also concerned about whether they can get a test paid for and the access to the patient. I think some of the more global approaches to pricing and economic impacts are of importance to the oncologist, even though they might not have a good sense as to how that all works.
PMO Dr Stainthorpe, what are the main value-based concerns for oncologists in Europe?
Dr Stainthorpe The main value-based concern for oncologists is having a broad range of medicines that provide benefits to patients with minimal side effects. As oncologists, we need first-, second-, and third-line, or a range of options for patients that show value.
PMO Should oncologists concern themselves with cost issues, specifically the cost of treatment to payers and to patients? Or is this beyond their clinical focus?
Dr Mullins The job of oncologists is changing. While we canâ€™t expect oncologists to be economists, it is important that oncologists recognize that cost is an important consideration for their patients. As such, they need to be sensitive to the cost issues.
We donâ€™t expect that a physician would know the price of every new drug that comes on the market. But we would expect that their offices would be set up so that patients can get their questions answered, not just about which drugs work best for patients like themselves, but also the cost to the insurer, as well as the cost to the patient, for getting these life-saving and life-improving drugs.
Dr Bosserman In todayâ€™s environment, there is no way the oncologist can avoid understanding the costs and outcome issue if weâ€™re going to help our patients evaluate the value of their treatment regimens, including total treatment course, toxicity profiles, expected outcomes, and what their cost is going to be.
Dr Stainthorpe Cost is a societal factor in the provision of medicines. Oncologists should work in the best interests of their patients and provide the treatments that give patients the most benefit, the fewest side effects, and the best chances of survival. Some clinicians may step outside that care provision service and move into providing advice on reimbursement. In those situations, then, cost should be part of the considerations.
Dr Kolodziej The question has now come up as to whether oncologists are not just responsible for the care of the individual patient but also stewards of a scarce resource.
This notion became politicized around rationing care, and thatâ€™s not what this is about. This is about recognizing that there are treatments that are roughly equal in terms of efficacy, but theyâ€™re not equal in terms of costs, and just helping patients in a shared decision model to make good choices in how they want to spend their healthcare dollar.
Dr Palmer I agree that oncologists have to concern themselves with cost issues. Back when I first started to see patients, we really didnâ€™t take cost into account. We didnâ€™t know what the cost of many therapies or tests actually were. Now, most oncologists I know do consider costs. I think since they order therapies, to have a sense as to how it impacts the healthcare system is a good idea.
PMO Thereâ€™s a growing push toward involving the patient in treatment decisions, including the cost of treatment. Should this apply to oncology as well, or does the fact that we are dealing with a life-and-death situation in oncology change the equation?
Dr Palmer I feel fairly strongly that it has changed the equation. Thereâ€™s been a big movement to involve patients in decision making and to move away from the old style of a paternal-type doctor who tells you what to do.
I think patients need to be aware of their choices. If they decide not to spend the money, thatâ€™s fine. However, there will still be patients who wonâ€™t want to discuss it, who feel that whatever the doctor recommends is what theyâ€™re going to do. But having a frank discussion about not only the benefits of treatment but also the potential costs, both side effect and financial, is something that should happen.
Dr Mullins At some level, cancer patients have always been thinking about cost. They just havenâ€™t been talking about costs with their providers. The new patient-centered focus in healthcare suggests that patients will have new conversations with their doctors. This will include conversations about how much theyâ€™re willing to pay for treatments.
In some cases, patients arenâ€™t taking their medicines because they canâ€™t afford them. What we need to do is set up social services for these individuals so they can afford their medicines.
Dr Bosserman As an oncologist who has practiced for 35 years, I think patients want to be actively involved. Sometimes they may appoint a family member to assist with this, but they want to know the truth.
They have marketing materials about treatments. They are on the Internet. But they also want to understand from their doctor the comprehensive treatment program, expected health outcomes, short- and long-term toxicities, and patient copay responsibility.
In our own practice, we have found it essential to provide patients with individual chemotherapy teaching and also separate financial teaching.
PMO Dr Mullins, weâ€™d like to ask you how members of the Academy of Managed Care Pharmacy can affect policy decisions with patient care in the United States.
Dr Mullins One of the bodies thatâ€™s going to weigh in on the cost-effectiveness of cancer therapies is the Academy of Managed Care Pharmacy. This managed care group of professionals systematically reviews evidence on both effectiveness and cost and is strategically positioned to help bring some sense to the discussion about value in healthcare in general and value in oncology.
PMO Is there a concern that cost-effectiveness analyses do not adequately consider the impact of side effects?
Dr Mullins Methods for conducting comparative effectiveness research, as well as cost-effectiveness research, are evolving. We have good methods for evaluating the effectiveness of treatments, but sometimes when it comes to cost, we leave things out.
As an example, sometimes we look at survival benefits and major effectiveness components, but we forget about some of the adverse events or side effects that are really important to patients.
Some of these may not lead the patient to go back to see their doctor. They may not lead to a hospitalization or an emergency department visit, but they represent a significant burden to patients. Those types of costs, which are sometimes hidden costs, need to be part of a cost-effectiveness analysis in order for us to understand the true value of using improved therapies that reduce side effects.
PMO There was a lot of talk regarding quality in healthcare. Quality often conflicts with the cost of care. Is there a way to reconcile this?
Dr Mullins Thereâ€™s a perception that quality and costs are always at odds with each other. As a general rule, life-saving treatments that provide a high quality of life do come at a higher cost, but what people forget is that sometimes we provide poor quality of care. That leads to the wasteful spending that we hear policy makers talk about.
When we provide low-quality care for patients with cancer, we end up having to spend more to fix the problems that we create because of that poor quality, so itâ€™s not always the case that quality and cost go in opposite directions. When we provide high-quality care, we can save money by reducing wasteful spending, fixing problems that we could have avoided.
PMO Dr Bosserman, are you concerned with the level of copay faced by many patients with cancer?
Dr Bosserman Patientsâ€™ copay is a daily issue our doctors and staff have to deal with. Particularly, even in the Senior Advantage Plans, patients are getting 20% copays back on increasingly expensive regimens. For many this is unaffordable.
It isnâ€™t just copays for chemotherapy or other treatments; itâ€™s copays for visits, for medications, and for multiple treatment courses that are really becoming unaffordable to patients.
More and more of our patients are coming back and saying, â€śI canâ€™t afford that regimen. What are the alternatives? What are the costs? What are the trade-offs with a cheaper option?â€ť We as physicians have had to learn it. And our staffs have had to learn it.
Weâ€™ve put in active programs for copay assistance when possible, because weâ€™re in a partnership with our patients to have treatments that improve their health.
PMO Opening this up to the group, what can and should be done to alleviate the cost burden on patients with cancer?
Dr Stainthorpe The cost of oncology products can be ameliorated to some extent for payers and patients by using imaginative reimbursement approaches. Some may involve risk shares. Some may involve other managed entry schemes that pay by outcomes, and those can help with the burden of cost for patients and payers.
Dr Kolodziej The fashion by which we do help patients recognize the path to making a good value-driven decision requires several things that are not in the system right now. The first is price transparency. It is unbelievable how little providers and patients know about how much things cost. Thatâ€™s got to change.
In addition to considerations of transparency in cost, there needs to be some improvement in the ability to educate patients about what is the real outcome thatâ€™s associated with a certain decision. This especially is relevant in cancer when the patient has an incurable, advanced malignancy, and choices may have wildly different value propositions associated with them, both in terms of monetary cost and in cost to the patient in terms of quality of life and impact on family and caregivers.
Dr Bosserman When you look at the growing burden on individual patients paying for cancer care, we need to come together as payers, providers, industry, and government and ask ourselves why cancer patients have an unfair burden of their copays compared with other diseases, and what a fair copay is for treatments.
If we were in an ideal world in a value-based system, we might have no copays for things that were highly effective and increased cure or markedly improved survival and quality of life.
Perhaps as we got into further lines of treatment with lesser, even questionable benefit, there would be more responsibility on the part of the patient.
There are many ideas out there, but we have got to come up with a solution, because right now itâ€™s becoming unaffordable for patients in America.
PMO Is there one theme that underlines patient care no matter where it is delivered in the United States?
Dr Bosserman There is one theme that ought to underline everything we do â€“ we are in medicine to improve our patientsâ€™ health: to use our scientific knowledge and our years of training â€“ 12 to 14 years for an oncologist â€“ to work with our patients to meet their needs, educate them, and walk with them through the path of their treatment â€“ whether itâ€™s for prevention, cure, or end-of-life â€“ to improve their health, or relieve suffering.
PMO There is continued concern regarding the consequences of community practices being absorbed into the hospital setting. How does the setting in which care is offered impact the quality of care?
Dr Bosserman In the past 10 years, 85% of patients in America have received their treatment in the community.
In Southern California, Iâ€™m not sure there will be many practitioners left within 2 years. Theyâ€™re going to join academic centers, hospitals, or systems.
In the big picture, this could become very beneficial to patients. If you look at the Kaiser system in California, which has 40% market share, itâ€™s a completely integrated system. Between the pharmacy, the medical benefits, the physicians, the surgeons, the oncologists, the radiation oncologists, supportive care, rehabilitation, hospice, and survivorship, itâ€™s all integrated on behalf of that patient.
Ultimately, a patient should understand the health outcomes, the survival rates, the quality of life, and the cost in system A versus B or C. Because, right now, the consumers have no way to know if the care theyâ€™re getting is in their best interest and for their best outcome.
PMO What do you think are the key components of high-quality breast cancer care?
Dr Bosserman As a breast cancer specialist, there are many components to breast cancer quality care, from the point of view of the patient, the health plan, and the clinician. If you look at reengineering care from day 1, when a woman is first diagnosed, we have to determine if there is someone to talk with her, to comfort her, to walk her through the system. Can she get into treatment immediately to begin dealing with whatever the aspects of her diagnosis are? Does she have information about how sheâ€™s going to get through treatment, what her health outcome expectations would be, and what the treatment plan is? It means, for most women, having a core biopsy and becoming educated on the features of that cancer.
I think high quality means you have someone to navigate, whether itâ€™s a medical oncologist or a nurse navigator, who helps you walk through and coordinate your care, understand the costs, and have the psychosocial, emotional, and family support thatâ€™s critical to caregivers and to patients. Then it ensures that every patient, with their specific diagnosis, has a personalized care plan taking the patientâ€™s preferences into consideration. Are they in childbearing age? Are they menopausal? Are they already having menopausal symptoms? Do they have bone loss? Do they have hyperlipidemia? How do we coordinate their overall health with their breast cancer treatment to achieve the best health outcome?
Those are the quality metrics that patients want to know. If they have advanced disease, they want to know a team is going to help relieve their symptoms and help them with the emotional issues.
If they are breast cancer survivors, they have significant emotional challenges, concerns, and side effects that need long-term management and support.
PMO What can be done to increase awareness among legislators, public officials, and government committees about the needs of cancer patients?
Dr Bosserman We work in a very political world of regulators and policy makers. Itâ€™s very important that the oncology community fully engage with legislators, policy bodies, and national organizations to bring the voice and concerns of patients with cancer to the attention of those who make these policies. Organizations like ASCO [American Society of Clinical Oncology], ACCC [Association of Community Cancer Centers], as well as the state societies are very important in bringing this real voice on the ground to our national policy makers.
PMO What can physicians and practice managers do to boost awareness and participation in clinical trials?
Dr Bosserman At my practice, we promote our clinical trials at our practice level. We also encourage patients to find out about clinical trials.
In reality, the ClinicalTrials.gov website does not work well. Iâ€™ve done searches, trying to find active treatment protocols for patients. Itâ€™s more complicated than patients can sort through themselves with eligibility and ineligibility requirements, and then when you think you have active clinical trials and you make phone calls, you find out that theyâ€™re not available. That system needs to be improved.
As we educate patients about clinical trials, theyâ€™re very open to participation, but they want it to be integrated into their health plan, into their treatment routine, and as close to home as is possible.
Itâ€™s a very important value to patients, but the system itself needs to be revamped, even though weâ€™re making people aware of it at the practice level.
PMO What insider tips would you share with members of the patientâ€™s healthcare team â€“ that being nurses, navigators, PAs [physician assistants], NPs [nurse practitioners], to facilitate access of care for their patients?
Dr Bosserman Most of us, whether weâ€™re in an academic or community practice, are now working in a team approach, teams of medical oncologists, surgeons, radiation oncologists, plastic surgeons, and physical therapists, but also within our team in the practice.
At the practice level we have secretaries who do intake and financial analysis and access and authorization. We have medical assistants who gather and enter data and talk to patients about medications and get their vital signs.
We have nurses who deliver chemotherapy. We have advanced practice practitioners, the APPs, otherwise known as nurse practitioners, and PAs, and the physicians themselves, who determine, review, and oversee treatment plans and toxicities, and we have our administrators to facilitate all the work as well as the billing and collections to run the practice, and compliance to ensure we are doing things the right way.
We all work as a team and try to divide up the work to improve access and discussion, education, and treatment for our patients. No one doctor can do all this, and the team approach is critical.
Thatâ€™s often a challenge to explain to patients and make sure theyâ€™re comfortable with the whole team being there to meet their needs.
PMO What are the advantages of Commission on Cancer accreditation? What are the disadvantages of not being accredited?
Dr Bosserman Accreditation is important for setting standards, whether you want to get ASCO QOPI [Quality Oncology Practice Initiative] certified or American College of Surgeons or Commission on Cancer certified. The hospitals use the Commission on Cancer to certify their programs.
It has certainly encouraged community hospitals to put resources toward the work, elevating the work of tumor boards, documentation, educational outreach for the community, and having special cancer screening days in the community and at academic centers.
While I think itâ€™s important, I donâ€™t think patients pay much attention to the level of accreditation. As the money has dried up at the community hospitals, I have seen a significant cutback in their willingness to put up funding for the certification that no one is requiring.
Setting standards is wonderful, so we can all be on the same page together and try to do our best as teams, but they also have to have realistic funding and value-Âbased relevance.
PMO Why should people participate in associations and networks like AVBCC?
Dr Kolodziej After spending more than 20 years in clinical practice, I moved to the health plan. I quickly learned all the things I didnâ€™t know.
The great thing about participating in an organization like AVBCC as opposed to participating in ASCO or NCCN [National Comprehensive Cancer Network], which are really good clinical platforms, is that there are aspects of cancer care that you just donâ€™t think about every day but are potentially tremendously impactful in how youâ€™re going to do your job and do it well.
I come to the AVBCC meeting and I meet somebody from NICE [National Institute for Health and Care Excellence]. Talking to the guy is fascinating because of the way care is delivered in the UK as opposed to the US. Or I hear people who spend their whole day thinking about the employer approach to healthcare and the diversity of thought, and the willingness of the people who get invited to participate is great. Itâ€™s just a way to expand your horizon, and really, maybe refocus the way you look at the question.
Iâ€™ve been fortunate to participate in the AVBCC meetings since its inception 4 years ago. One thing thatâ€™s absolutely striking is how much things have changed year over year. There are very few forums where the rapidity of that change is presented in an organized format with really top-notch talent discussing it. Iâ€™m looking forward to seeing how things change between this year and next year, because Iâ€™m sure things will be quite different a year from now.
There are a limited number of publications that accurately capture the very timely information regarding the evolution of care delivery in oncology, and Value-Based Cancer Care is one of them. The content is well reported and accurate.
Dr Bosserman Associations and networks like AVBCC, COA, ASCO, and ACCC are the organizations that represent the issues that we, as clinicians, and our patients are facing.
We need to be speaking to our policy makers. We need to realize that legislation is critical. Government has a major role not only in funding cancer care appropriately, but funding the NIH, funding research, having appropriate regulations that let us bring new advances to our patients in an effective way. We canâ€™t do it alone.
Working in organizations where we can come together with all the stakeholders, bring the best of those ideas together, develop new solutions, new pilots, and new ways of us doing better care, having more research, and doing it at the lowest cost possible, is going to help all of us in meeting the needs of our patients going forward.
PMO Should the FDA take drug cost into account, considering the approval of very expensive medications, similar to the way this is done by NICE in the UK?
Dr Stainthorpe The FDA has a regulatory function that is probably best kept without looking at the costs of the medicines. That role is probably best for an independent HDA [health data analytics] organization like NICE. In Europe, the role of the EMA [European Medicines Agency] and of the HDA organization are 2 separate things. That model works very well there.
PMO How do oncologists handle the cost of treatment in the UK? What advice do you have for the United States?
Dr Stainthorpe Oncologists should take advantage of the best guidance available from the research thatâ€™s being conducted by the industry and by other clinicians, and that should feature all the relevant outcomes. It should take into account issues related to patient benefit, quality of life, and relevant information about the service impact and the even wider societal benefit in sort of a value-based assessment approach.
PMO As physicians move toward personalizing cancer treatment based on the patientâ€™s unique genetic profile, tumor protein expression, and molecular pathways, has research kept pace with this demand?
Dr Stainthorpe To an extent, it has. The more we know about an individualâ€™s genetic makeup, the more the medicines can be targeted to their needs, and the more benefit they will gain. Subgroups are being identified already, and the direction of travel is to find ways to use markers that can focus that medicine provision more specifically, so youâ€™ll get less waste and youâ€™d get better performance and youâ€™d get a known outcome.
Yes, research is heading that way, but thereâ€™s still a long way to go.
PMO What are some of the challenges of bringing personalized medicine to Asia and Europe?
Dr Stainthorpe The challenges of bringing personalized medicine to Europe and the rest of the world are the same. Itâ€™s finding out more about the mechanisms by which disease pathways work and the ways in which markers can be found to identify those so you get better diagnostic tests, and then you can tailor the medicines to provide either amelioration of the condition and respites, or ultimately, the aim would be to provide a cure.
PMO Dr Palmer, as cancer therapies have evolved, weâ€™ve learned that underlying alterations in DNA have a substantial impact on cancer proliferation. Based on this understanding, how is Foundation Medicine working to improve cancer therapies and personalize medicine at a molecular level?
Dr Palmer Cancer is basically a disease of the genome. We know that most cancers are caused by changes at the DNA level, whether itâ€™s caused from radiation or cigarette smoking or unknown factors. DNA changes are really what drive cancer.
At Foundation Medicine, we have developed a fully informative genomic profile to determine those relevant DNA changes that can then lead directly to therapies for the patients. We can find all classes of alterations, mutations, copy number alterations, and amplifications in 1 test with very small amounts of tissue.
By doing our test, the oncologist and the patient will likely be able to find any and all treatable alterations in the DNA that are relevant to his or her tumor.
PMO It is estimated that more than 1.6 million people in the US will face a cancer diagnosis this year. Based on your experience, not just as a medical oncologist but also within Foundation Medicine and the pharma and biotech industries, what advice would you give these patients as they try to understand their cancer as well as current treatment options?
Dr Palmer Cancers, of course, present at different stages. There are cancers that present very superficially on the skin that can be removed from a surgeonâ€™s point of view.
I think that understanding alterations in the DNA, which is what our tests FoundationOne and Foundation- One Heme do, is most relevant when treatment beyond surgery is needed, when the cancer has spread. Thatâ€™s still a lot of patients, though. In fact, one could argue all patients with metastatic disease could potentially benefit from knowing the DNA drivers of their cancer. Thatâ€™s the group that is going to benefit from having drugs available to retard the growth of the cancer.
PMO As physicians move toward personalizing cancer treatment based on a patientâ€™s unique genetic profile, tumor protein expression, and molecular pathways, has research kept pace with this demand?
Dr Palmer I think in many ways research is ahead of where the clinician and the patient are at this point. A large part of what we need to do at Foundation Medicine is educate the physician and the patients that a test like ours is available today to give them full information about their DNA and what drives the cancer.
Most oncologists think this is something thatâ€™s going to happen down the road, but the research has gotten to the point now where a test like ours is available today. I think in many ways the research is ahead of where the clinician and the patients are.
We still have a long ways to go, for instance, trying to find out how genes and alterations interact with each other to drive cancer rather than just finding them individually. At Foundation Medicine, weâ€™re leading that field by closing what we call the clinical genomic loop, coordinating clinical information along with the alterations that we find so we really can get a complete picture of how the DNA changes are affecting the cancer.
PMO How well are the research efforts within academia, as well as pharma and biotech industries, translated into meaningful outcomes in personalized medicine?
Dr Palmer I think weâ€™re getting there very quickly. One of the big questions is, how do these research findings translate, as you say, to treatment for patients? We can find whatâ€™s driving a particular cancer, but the question is, will a treatment directed at that particular change in the DNA actually affect the outcomes of patients?
Weâ€™re getting more and more data, in fact, that knowledge is directly transferable across different tumors to the outcome of patients. I think the research is translating, actually, quite well to patient benefit as we go forward.
PMO How can we better establish clinical utility for tests that are being conducted in personalized medicine?
Dr Palmer Itâ€™s very important to take all of these research developments, finding new changes in the DNA, and actually show that they are benefiting patients â€“
so-called clinical utility that these are useful findings in the clinic. Of course, you need to go that 1 step from finding, letâ€™s say, a new mutation in DNA to showing that, in fact, this does help patients.
But the paradigm is changing. Each patient can have a somewhat different profile of their tumor, so to do a study that lumps together patients of different profiles can be difficult.
Weâ€™re coming to grips with that now; there are designs; new studies are being instituted all the time that take that into account. Already we have many case reports of drugs working against the profiles in particular patients.
We are currently doing several studies like this to make those findings as generalizable as possible. For example, if we find a new alteration, never been seen before, we can be fairly certain if a drug will, in fact, work against that new alteration, based on the mechanism and the biology.
PMO Are there any applications that Foundation Medicine has used in oncology clinical work that can relate to other categories, such as cardiovascular, neurology, and rheumatology?
Dr Palmer At this point, Foundation Medicine is exclusively an oncology company. But our next-generation sequencing technique, with which we can deep sequence hundreds of genes with world-class laboratory capability and world-class computational biology capability, certainly has potential applicability outside of oncology.
Immunotherapy comes to mind. Immunotherapy now is an up and coming area of cancer therapy. We may start to look at immune genes and immune therapy. This could have applicability to autoimmune diseases, for instance, outside of cancer. I think the answer is yes, this technique could very well be valuable in diseases other than cancer.
PMO Dr Kolodziej, Aetna is working on new collaborations with provider organizations. Are these collaborations also targeting oncology providers?
Dr Kolodziej All of the pilots that Iâ€™m working on are specifically for oncology providers. We have predominantly been focusing on community-based providers as opposed to institutional providers.
There are a lot of reasons for that. We want to promote community oncology as a delivery model. We think itâ€™s a very efficient and high-value model, so we want to do what we can to promote that model.
Weâ€™ve also been somewhat involved in looking at how oncology fits into an integrated delivery system, so models in which, for example, a hospital system wants to become an ACO [accountable care organization], and thinking about how oncology fits with that ACO.
PMO Please describe how these provider-payer collaborations are different from the traditional payer-provider relationships.
Dr Kolodziej The traditional payer-provider relationship is really a transactional one. Thereâ€™s very little exchange of clinical information, thereâ€™s little exchange of cost information, and there is no exchange around outcomes.
One of the major changes is that the lines of dialogue are really opened up in these relationships. They also involve looking at alternative payment models, so that in exchange for good clinical performance, we want to reward the providers who participate with us in these programs by giving them more money.
The system is cost constrained, so itâ€™s not that weâ€™re looking to put more money in the system. Rather, most of our pilots involve taking the savings that we can generate, and sharing that with the practice.
All of them to this point still operate on a fundamental fee-for-service basis, but we do think, ultimately, that the knowledge we gain from this relationship that we form with the practices will allow us to evolve into a more episode-based reimbursement model. Thatâ€™s a little ways away.
PMO Does any of the provider-payer pilots that youâ€™re engaging in involve downside risk?
Dr Kolodziej At this point, we can view the pilots that weâ€™re involved in as pay for performance, so there is, by definition, no downside risk. However, as we become more comfortable with performance metrics of practices and cost structures of various delivery systems, I think itâ€™s inevitable that we will get to a situation where downside risk is involved.
PMO Do you already have data to show the impact of this new collaborative approach, such as improved patient outcomes, improved efficiencies, or new reimbursement approaches?
Dr Kolodziej Our work in this area is relatively young, and not mature. We have some preliminary experience in work thatâ€™s been done in the last couple of years.
Specifically, we have some data from work that weâ€™ve done with US Oncology in Texas, in the commercial population, where we showed that implementation of a strategy that focused on evidence-based medicine, practice-based case management, and an enhanced end-of-life program did result in about a 12% reduction in ER and hospitalization rates. There was clearly measurable impact there.
We also have some pilots in the clinical decision support space, or the pathways space, that confirm that there is value to implementing that type of a program with respect to the cost of care. The magnitude of benefit is on the order of 15%.
We have a lot of pilots that are just getting off the ground and are at this point accruing patients. We havenâ€™t even looked at the claims on those patients yet.
Weâ€™re trying to do a lot of subtly different delivery models with different type providers, because different type providers have different aptitudes for delivering on this enhanced clinical support model. Ask me in a year. Iâ€™ll have a lot more information then.
PMO What are the main expectations from this value-based approach to patient care?
Dr Kolodziej The expectations we have really depend on what prism you look through at the question. For example, what we expect from the patient perspective is that theyâ€™re going to like the care theyâ€™re getting; theyâ€™re going to feel much more closely aligned with their physician and their physicianâ€™s staff, and, at the end of the day, theyâ€™ll spend less time in the ER, less time in the hospital, and have measurable improvement in the quality of care.
From the payer perspective, weâ€™d like to control cost and be able to measure and promote quality. Ultimately, weâ€™d like to be able to say, â€śThese are our guys. We like the way they do things, and we want to promote them.â€ť
Then, from the provider perspective, what we like to do is help the practices by giving them data and having dialogue with them, help the practices evolve so that they will be, really, potentially in a very dominant position in their respective markets, so that they can be the go-to provider for the health plan and for our self-insured customers.
PMO Cost growth is a major issue in healthcare, but, especially in oncology. Are you concerned with the level of cost sharing that is being faced by patients with cancer today?
Dr Kolodziej The majority of Americans get health insurance through employer-sponsored health insurance plans, and Medicare is another big payer.
Over time, and especially now, thereâ€™s been a lot of discussion about passing over some of these price increases, cost increases, to the patient. I think thatâ€™s really a challenge. Itâ€™s a challenge for patients, and itâ€™s a challenge for the plan, because we do not want patients to make bad decisions because of cost.
We do not want to promote nonadherence with oral drugs, for example, because of cost, and yet we would like patients to feel that they have some skin in the game, that their decisions are not cost insensitive. Thereâ€™s a very fine line here because of the cost of cancer therapy.
I think we have to be really careful about how far this goes. We should also never forget that the maximum amount of out-of-pocket cost has been defined by the ACA. This may not seem like a lot of money if you are a doctor or a lawyer, but for the average American family, itâ€™s a heck of a lot of money. How we ask patients to participate in a value-driven fashion, thatâ€™s going to be a real trick.
PMO Do you expect that ACOs will have a positive impact on oncology and on patients with cancer?
Dr Kolodziej The delivery model of integrated care or ACOs has become a very popular solution to sevÂeral of the challenges we face in medical care. The ability of that system to improve cancer care is a little bit unclear right now. This is not exclusive to cancer care. I think itâ€™s true of all subspecialties here. The way that the subspecialists fit in with the structure of what is predominantly a primary care delivery model has yet to be defined.
We talk about this all the time. To some extent we say, â€śIf we can make an oncology practice really function as a medical home, then that is exactly the kind of practice that will succeed in an ACO model.â€ť
PMO Can ACOs improve quality and lower or at least contain costs?
Dr Kolodziej The real potential advantage of an ACO from a cancer perspective is improved integration of care, coordination of care. Every oncologist in the world will tell you, and it doesnâ€™t matter if they are employed by a hospital or not, that the quality of the dialogue between other physicians and the oncologist is just not good enough. The communication is commonly precipitated by emergencies, and itâ€™s absolutely maddening to all providers involved.
PMO Are there specific initiatives at Aetna that other health plans can adopt for value-based cancer care?
Dr Kolodziej The law of the land precludes me from knowing too much about what other health plans are doing. We do talk to each other about our vision. I think when you come to a meeting like the AVBCC meeting, you realize that thereâ€™s a certain consistency in the vision people have.
I think a lot about smaller health plans that may lack the oncology expertise to build the programs we are building. If we can get practices to really fire on all cylinders, they have a very, very compelling case to bring their dominant regional payer into the discussion and utilize the platform that we help them build so they could succeed with that payer. I think that that is the most likely way this is going to happen.
The relative consistency and approach of all the major national payers suggest that all of us want practices to think about how theyâ€™re using evidence-based medicine. All of us are interested in getting a better end-of-life approach, some sort of standardized process where you have dialogue with a patient and find out whatâ€™s important to them. And all of us are interested in keeping people out of the ER and hospital, because ER use and at least half of hospitalizations are wasteful and potentially avoidable.
PMO Thank you all very much for talking with us today and our best to you for continued success.
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