From among 4,500 abstracts to be presented at this year’s ASCO, an official pre-ASCO press cast featured results of 5 chief clinical trials. Regarding the press cast, Michael Link, MD, President of ASCO, said, “Today’s studies demonstrate improvements in precision medicine that identify and exploit cancer’s genetic weak spots to halt tumor growth and in some cases eradicate disease. Other studies give us valuable new tools and information to lessen the short- and long-term side effects of cancer treatment for our patients.”

The 5 highlighted studies were:
• Pre-adjuvant therapy of high-risk prostate cancer with abiraterone.
• Combining a BRAF inhibitor and a MEK1 inhibitor—two molecularly targeted agents—to treat advanced melanoma.
• Use of an antipsychotic medication to treat breakthrough chemotherapy-induced nausea/vomiting.
• Crizotinib in pediatric tumors driven by ALK genetic abnormalities.
• The sorry state of primary care physicians’ knowledge about late effects of chemotherapy in cancer survivors.

Pre-adjuvant Abiraterone Treatment
In a randomized Phase 2 trial, 6 months of treatment with abiraterone [Zytiga; Jansenn Biotech] along with hormonal therapy given prior to prostatectomy to men with high-risk early prostate cancer eradicated cancer cells in about one-third of patients. Abiraterone is currently FDA approved for metastatic prostate cancer. This trial was conducted in the pre-adjuvant setting.

The study included 58 men with 1 or more of these high-risk features:
• Gleason score 8-10 (71% of men)
• PSA level >20 ng/ml (19%)
• T3,T4 bulky disease (24%)
• High PSA velocity (16%)
• Extra nodal disease could be included

Patients were randomized to receive 3 months of treatment with leuprolide alone or 3 months of leuprolide plus abiraterone plus low-dose prednisone. After 3 months of treatment, all patients in the trial were treated for another 3 months of neoadjuvant therapy with abiraterone, leuprolide, and prednisone. After of 6 months of neoadjuvant therapy, radical prostatectomy was performed and pathological response evaluated.

pCR was 10% for those treated with abiraterone for 6 months vs 4% for those who received leuprolide for 3 months and then abiraterone for 3 months, and near pCR was observed in 24% and 11%, respectively. Total response rate was 34% vs 15%, respectively; the difference between groups was not statistically significant.

“These results are particularly amazing in this incredibly high-risk group of patients, and suggest that this combination therapy could improve outcomes for a substantial number of men, said lead author Mary-Ellen Taplin, MD, Harvard Medical School and the Dana-Farber Cancer Institute, Boston, MA. Larger, longer trials are needed to confirm this approach (i.e., neoadjuvant use of abiraterone plus hormones plus prednisone).

Combining a BRAF inhibitor and a MEK1 inhibitor in Advanced Melanoma
Results of an early Phase 1B trial found that combining two investigational oral targeted therapies—the BRAF inhibitor dabarafenib and the MEK inhibitor trametinib—appeared to halt disease progression in patients with metastatic melanoma and led to fewer skin side effects than have been reported with the single-agent BRAF inhibitor, vemurafenib (FDA approved for metastatic melanoma).

About 50% of all melanomas harbor a mutation in the BRAF gene, and the related MEK pathway is highly active in those patients, providing a rationale for the dual targeted approach. The Phase 1B study included a subset of 77 patients with advanced melanoma who were enrolled in a larger 4-part study. The trial identified the following dose as recommended for further study: dabarafenib 150 mg/trametinib
2 mg.

Use of the combination significantly decreased skin toxicity compared with that associated with vemurafenib, said lead author Jeffrey Weber, MD, H. Lee Moffitt Cancer Center, Tampa, FL. For example, only 3% of patients developed squamous cell carcinomas compared with about 15% to 25% of patients treated with other BRAF inhibitors; another 5% developed actinic keratosis which is much lower than with a BRAF inhibitor alone, Dr. Weber commented. Pyrexia was the only side effect that was slightly higher with the combination and this tended to occur along with chills, fatigue, and nausea; grade 3 pyrexia was reported in 8% of patients.

Using a waterfall plot to assess tumor shrinkage on the combination therapy, Dr. Weber said: “This is among the best results I’ve seen. About 95% of patients had stable disease, partial response, or complete response.” Median PFS was 10.8 months, which he called “extremely encouraging.”

Olanzapine for Chemotherapy-Induced Nausea/Vomiting (CINV)
Olanzapine [Zyprexa; Eli Lilly], an approved antipsychotic agent, was more effective than metoclopramide (standard anti-emetic treatment) in controlling breakthrough CINV in patients treated with highly emetogenic chemotherapy who received guideline-recommended anti-emetic therapy.

“This is the first Phase 3 study to show that a treatment is effective for breakthrough CINV, which afflicts about 50% to 60% of patients taking highly emetogenic chemotherapy,” said lead author Rudolph Navari, MD, Indiana University School of Medicine, South Bend, IN.

The study enrolled 205 chemotherapy-naïve patients treated with cisplatin, doxorubicin, and cyclophosphamide. All patients received guideline-recommended drugs to prevent nausea and vomiting, but 80 patients experienced breakthrough CINV and were randomized to olanzapine (n=42) or metoclopramide (n=38) for 72 hours of treatment.

Control of emesis was achieved in 71% of those treated with olanzapine vs 32% of the metoclopramide group; nausea was controlled in 67% and 24%, respectively. Both of these results were statistically significant (P<.01); no grade 3 or 4 toxicity was observed in either group.

Crizotinib in ALK-driven Pediatric Tumors
An early Phase 1 study suggests that Pfizer’s crizotinib (Xalkori, approved to treat lung cancer) may be an effective approach to anaplastic large cell lymphoma (ALCL), inflammatory myofibroblastic tumors (IMT), and neuroblastoma in select children with aggressive forms of these cancers, which commonly have ALK gene abnormalities, said lead author Yael Mosse, MD, Children’s Hospital of Philadelphia, PA.

ALK gene abnormalities are present in 80% to 95% of ALCL cases, 50% of IMT cases, and 10% to 15% of aggressive neuroblastomas. The study included 70 children with these cancers who had progressed on standard therapies. Patients received one of 6 different doses of oral crizotinib twice daily and stayed on the drug until it was no longer well tolerated.

In ALCL, 88% (7/8) patients experienced complete response, with no detectable disease for as long as 18 months. The majority of 7 patients with IMT experienced effects ranging from tumor shrinkage to complete tumor regression. Of the 27 patients with neuroblastoma, 8 had known ALK mutations; of these, 2 of 8 had complete response, 2 had minor responses, and 1 had stable disease. Responses were also seen among 19 neuroblastoma patients with unknown ALK status; 1 complete response and 6 with prolonged stable disease.

The high degree of activity seen with crizotinib in these childhood tumors will lead to larger trials in ALCL and other childhood tumors, said Dr. Mosse.

Knowledge Gap About Late Effects of Chemotherapy Among Primary Care Providers
A large survey of 1,072 primary care providers (PCPs) and 1,030 medical oncologists who treat breast and colorectal cancer revealed a troubling knowledge gap among the PCPs regarding late effects of chemotherapy in cancer survivors. The survey asked questions about four commonly used chemotherapy agents: doxorubicin, cyclophosphamide, paclitaxel, and oxaliplatin.

Among PCPs, 55% correctly identified cardiac dysfunction as a late effect of doxorubicin compared with 95% of oncologists; 26% of PCPs correctly identified peripheral neuropathy as a late effect of paclitaxel compared with 97% of oncologists; 22% of PCPs correctly identified peripheral neuropathy as a late effect of oxaliplatin compared with 96% of oncologists. For cyclophosphamide, premature menopause was correctly identified as a late effect by 15% of PCPs and 71% of oncologists, and secondary malignancy was correctly identified as a late effect by 17% of PCPs and 62% of oncologists.

Lead author, Larissa Nekhlyudov, MD, Harvard Medical School, Boston, MA, noted that with more than 12 million cancer survivors, late effects of chemotherapy are becoming increasingly important. She said that survivorship plans should address this knowledge gap and relay information to patients and to PCPs so that they can provide optimal management to cancer survivors.

–Alice Goodman

Roundtable sessions at NCCN meetings get to the heart of today’s oncology issues. The topics are diverse and offer differing perspectives from panelists who bring broad insights to prevalent discussions. For example, a roundtable at the recently held NCCN annual meeting titled, “Cancer in Corporate America – Business as Usual?” explored the role of US corporations in today’s health and cancer care continuum.

Our system of having employers providing health insurance is fairly unique as compared with the single payer systems in Europe and elsewhere. In this roundtable discussion, moderated by the veteran ABC News correspondent Sam Donaldson, the high cost of cancer care is a given, and the panel moved beyond that issue to discuss the role an employer has in covering the cost of cancer care.

According to Donaldson, “58% of non-elderly people in the US get their primary health insurance from their employers,” and he asked the panel to discuss just what does business as usual mean in this case, and what does an employer owe its employees? As the cost of cancer and healthcare continues to rise, it could be the employer that is thrust to the center of the debate.

Robert W. Carlson, MD, of Stanford Cancer Institute, Stanford CA, pointed out that almost always when someone is diagnosed with cancer, the first question he or she asks is “How will this change my life?” But, to Carlson, what that person is really asking is: What does this mean to my job security? Is my insurance adequate? And, will my employer discriminate? To answer Donaldson’s question, Carlson said that “Businesses owe their employees support both professional (your job is safe) and emotional (such as a phone call from the employer).”

Following up on that thought, Helen Darling, President, CEO of the National Business Group on Health, a non-profit organization devoted exclusively to representing large employers’ perspective on national health policy issues, said that “employees are the only appreciable asset a company has, most every other asset depreciates over time, and great companies invest in their employees.” That investment, she indicated, includes healthcare coverage for cancer. She says that companies have to be sure that employees have the tools and resources they need when diagnosed with cancer.

Practical in his perspective, J. Randall MacDonald, Senior VP of HR at IBM, which employs more than 500,000 people with healthcare benefits, said that “investing in employees is a business proposition. A healthy employee is a productive employee, and a productive employee is an innovative employee.” MacDonald believes that patients, providers, and plans all need to collaborate with each other in order to provide a means of prevention, detection, and evidence-based medicine to deal with health concerns effectively.

But, Sheri McCoy, Vice Chairman of the Executive Committee of Johnson & Johnson offered that in order to move from disease care to preventive care, education and an environmental shift is required. For instance, at J&J, she informed, they have eliminated all smoking in the workplace, they focus on healthy diet, and the company has put gyms and fitness centers throughout the workplace. “These tactics help us achieve a return on investment with employees,” she concluded.

The Goodyear Tire & Rubber Company, represented by J. Brent Pawlecki, MD, said that their company goal is to have healthy, engaged, productive employees. In order to meet these goals, he says, Goodyear plans on providing prevention whenever possible, and when prevention isn’t possible to get employees into the right care, and when the right care is no longer available, the company plans to ensure a dignified and respectful exit. Mr. Pawlecki says that “corporate America has covered prevention and treatment well enough, but that Goodyear and others need to do more to help employees with the inevitable.”

At this point in the discussion, Mr. Donaldson shifted the emphasis of the panel over to the cost of healthcare coverage.

According to MacDonald, out of the roughly $1.2 billion IBM spends on healthcare benefits, about $110 million of that is for cancer care. “Obviously, IBM has to pay attention to cost, and is trying to reduce healthcare costs. Oftentimes, controlling costs leads to very difficult decisions,” but, MacDonald thinks that IBM has the best interests of the employee in mind.

Discussing the important topic of waste, Darling said that “we know that there is something around 20%-30% waste in the healthcare system” and removing that waste would allow more room for effective care.

Dr. Carlson responded that Stanford struggles with costs almost every day, and those struggles are mostly related to structures such as prior authorizations overlaid on the medical system to control costs while adhering to evidence-based medicine. He added that companies are usually advocates for employees, and that when it comes to controlling costs, companies are mostly negotiating coverage with insurance providers.

He provided a case example of a woman with breast cancer whose insurance company would not provide coverage of an FDA-approved regimen or coverage of any breast cancer therapy that was not generic, meaning the patient could not take advantage of any of the new breast cancer agents and regimens. “Perhaps an extreme example,” he said, “but discouraging nonetheless.” In this case, the manufacturers “stepped up to the plate” and provided the medication free of charge.

When the discussion moved into healthcare reform, Kavita Patel, MD, MSHS, of the Brookings Institution’s Engelberg Center for Health Care Reform was given the opportunity to bring her unique perspective to the panel. Mr. Donaldson asked, “If you’re a cancer patient, does the ACA help you?” Dr. Patel thought it helped immediately, because the ACA removes the opportunity for a health insurance company to not accept a person into their plan because of a pre-existing condition. “They call it an even playing field now because this stipulation makes private insurance just as accountable as employer-based insurance,” she said.

Insurance exchanges, said Dr. Patel, “will help cancer patients because the ACA allows you to purchase insurance that is not outrageously expensive if you don’t qualify for Medicare/Medicaid and you do not work for a company that provides health insurance. Unfortunately most of these people can only afford catastrophic care in the current system.”

Although the new ACA law will not go into full effect until 2017, Donaldson asked the panel if they liked the ACA provisions. Ms. Darling made the point that it is a big step forward for uninsured people to gain access to insurance coverage.

What bothers Mr. MacDonald of IBM is not the content of ACA, but the unknown. For example, multi-state employers like IBM have a single control point at the federal level rather than having 50 different benefit departments. He says that they are worried that some of the ability to control healthcare will be delegated to the States and they may ignore the federal regulations; especially when it comes to healthcare exchanges and the employer’s only recourse is to sue the State to protect the employee. Then there is the perception that the employer is therefore against healthcare. Managing the unknown can get expensive.

Analysis
As legislators, justices, doctors, insurance companies, employers, and importantly patients struggle with how to manage the burden of cost in the US healthcare system, it is clear that there isn’t a easy answer and that sacrifices will need to be made. One thing about this particular panel is that there seemed to be agreement that some employers are doing the right thing in providing coverage and advocating for employees, and that there is hope that all companies in the US will follow those providing excellent examples.

by Don Sharpe

What is threatening cancer care the most these days? The most reflexive answer is the high cost of the drugs. The answer comes up immediately because if patients can’t afford the price tag on the new drugs, then advanced clinical outcomes won’t be achievable. Another answer may be that it is policy, federal or commercial, that is threatening cancer care. But let us not forget about the primary point of contact, the medical oncologist. Maybe the loss of autonomy by the oncologist is the single greatest factor threatening the delivery of quality cancer care today.

In a morning roundtable at the annual NCCN meeting in Hollywood, FL the topic of which cancer stakeholder has the largest role in decision-making was discussed. The title of the roundtable was “Optimal Care for Patients: Who Decides?” and featured: Karen Alban, RN, BSN, OCN, Oncology Nursing Society; Al B. Benson III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Nancy Davenport-Ennis, National Patient Advocate Foundation; Scott Gottlieb, MD, American Enterprise Institute; Shari M. Ling, MD, Centers for Medicare & Medicaid Services (CMS); Ray Lynch, CPA, MBA, Huntsman Cancer Hospital; Lee N. Newcomer, MD, MHA, UnitedHealthcare; and David G. Pfister, MD, Memorial Sloan-Kettering Cancer Center. The roundtable was moderated by Clifford Goodman, PhD, of The Lewin Group, as he does every year.

Dr. Goodman set the stage by asking – who is really in charge here? And how might that be changing? With that question as a launching point, Dr. Goodman probed the members of the roundtable to gather the different perspectives and help elucidate how the dynamics between physician and cancer patients are changing.

Karen Alban referred to the treatment team as an “inner circle” because cancer care is not a “one and done” proposition. She points out that cancer care decisions occur over the course of the illness, and the patient often invites multiple inputs over the course of the disease. As might be expected, Ms. Alban provided expertise on what nurses can offer to the patient including acting as a buffer, between the patient and the doctor or other members of the inner circle by educating the patient and the patient’s family, and filling some of the gaps between the patient and their primary care physician and their oncologist.

Dr. Benson added that the first encounter between physician and patient can often be the most important encounter because it establishes tone and future interactions. If the physician can sense that the decision making process is likely to include financial or psychological help the physician can involve those factors immediately and set the tone for what happens over time.

When asked by Dr. Goodman, Nancy Davenport-Ennis told the audience that in 2011 3.5 million consumers called the National Patient Advocate Foundation (NPAF) for information, clearly making them part of the “inner circle”. Ms. Davenport-Ennis says that the tendency to include others in the decision making process is shifting now because years ago decisions were made primarily between the doctor and the patient, but today NPAF hears from patients about the payer, and specifically the type of benefits the consumer has.

Dr. Scott Gottlieb, a fellow at the American Enterprise Institute, an attending physician, and having held roles at CMS and FDA, brings a different perspective to the “who’s in charge here?” discussion. In Dr. Gottlieb’s opinion it depends on the type of coverage – private versus federal insurance. As more practices consolidate into hospitals and we see more capitation agreements as a result, we will see more narrow network types of plans rolled out by insurers. He believes the ACA will likely drive the move toward narrow network plans too.

Similarly, a move toward centralization of decision-making will be seen in the government sector but in this case driven by budgetary constraints and political realities. As Dr. Gottlieb says, “it is a gradual evolution, but there is no doubt the locus is changing.“ CMS wants to get more authority to make more granular decisions about what should and shouldn’t be covered in different contexts, and in the new political environment it will be easier for CMS to get these authorities.

Dr. David Pfister, from MSKCC, says the whole process of cancer care has become much more transparent. Big cancer centers like MSKCC have multi-disciplinary teams impacting on care decisions, and resources like the NCCN guidelines, including the patient guidelines, are important sources of information that impact on decision-making. There is also an increasing list of patient education materials that are having an impact on patient decision-making.

Ms. Davenport-Ennis was asked whether she felt as though there is patient satisfaction that preferences are being heard. She pointed out that it depends on the insurance plan. For example, if a patient is in a high deductible plan with a health savings account and is in a position to fully satisfy the annual amount required in the high deductible plan, he has more autonomy in the decision making process. If patients are in a position to self-pay there is great autonomy and great satisfaction. too But as there is a diverse spectrum of insurance plans, there is less autonomy causing more and more frustration for patients.

Bringing in the payer perspective, Dr. Goodman probed Dr. Newcomer of UnitedHealthcare and Dr. Ling of CMS about who is most responsible for cancer patient care decisions. Dr. Newcomer doesn’t think it is surprising that patients take finances into consideration when making treatment decisions. He points out that there are about as many different insurance coverage plans as there are patients, so it depends on the individual and the plan. “In the fee for service world just about everything gets paid for in one way or the other,” he said.

Dr. Ling says that optimal care is “care that is safe, well coordinated, centered on patients and their families, includes safe transitions from clinic to hospital to outpatient infusion centers, and meets the patient’s goals. Dr. Ling says that Medicare can’t possibly know the individual’s preferences, which is why coverage becomes dependent on evidence of improved outcomes. To determine coverage based on outcomes, CMS has to have a very good data source.

Dr. Benson pointed out that decision-making is increasingly complex as care moves into an era of patient selection based on molecular profiling. He added that we’re a country based on the individual and in the healthcare arena we’re witnessing tension between what the individual wants and what might be best for society as a whole.

The discussion then led toward guidelines, pathways, compliance, and variation in care. Ms. Davenport-Ennis says that she hears more and more patients discussing the pathways and guidelines they are complying with. She says that is a dramatic shift.

Dr. Newcomer related UHC’s experience with community oncology practices and episode-based payments and compliance with guidelines. A few things have been surmised between provider and payer and perhaps most importantly, the fact that there is common interest between parties to identify gaps to improve quality of care by reducing waste. It was also found that everyone wants to incorporate more of the positive advances, like genetic tests that have clinical utility.

Dr. Newcomer shared that compliance to UHC’s physician-chosen guidelines was only about 60%, and that more attention to standardization according to guidelines would reduce variability and waste. Furthermore, guidelines are written to reflect what is known as best care today and it is hard to conceive why there would be a deviation from the best known care.

Dr. Benson followed that point by adding that at the Lurie Comprehensive Cancer Center a guidelines enforcement policy is not in place, but they are incorporating guidelines into training programs and multi-disciplinary tumor conferences. While variation in cancer care is expected at the Cancer Center, use of evidence-based guidelines is presented to assist in treatment decision making.

At this point the discussion progressed to the subject of the Independent Payment Advisory Board (IPAB). Dr. Goodman asked Dr. Gottlieb about the board and Dr. Gottlieb told the audience that IPAB has 15 members who will serve 6 year appointments and they have the mandate to cap the growth rate in Medicare spending.

Dr. Gottlieb elaborated that if Medicare spending is growing at a rate above the Consumer Price Index (CPI), IPAB has to come up with a set of proposals to bring spending back in line with the CPI.

As a result of the IPAB recommendations, Congress has 30 days to come up with alternative proposals to bring spending down or any proposals the IPAB makes will go into effect (and we all know Congress can’t act in 30 days). Dr. Gottlieb described IPAB as a clever way to side-step Congress.

Dr. Gottlieb expects IPAB to identify areas of large expenditure and look for easy ways to cut spending such as move from ASP +6% to ASP +4%, or if price controls (such as VA pricing) are working in one market they’ll move them into another market.

Ms. Davenport-Ennis agreed with Dr. Gottlieb, and added that the end result of IPAB reducing spending is less access to therapies for patients.

As the roundtable concluded, it became increasingly clear that today’s healthcare system is in the midst of an evolutionary shift in terms of delivery of cancer care. External influences are impacting decision-making, and increased information sources combined with impending reductions in spending are making the business of evidence-based medicine increasingly complex.

The outcome of this trend toward including more perspectives in the “inner circle” is that medical oncologists have to spend more of their time coordinating care and managing external dynamics, and thus individualizing care is increasingly difficult and time consuming. When the medical oncologist doesn’t have the autonomy to make therapeutic choices independently, and their job satisfaction goes down accordingly, that may be the real threat to the delivery of quality care.

Andrew Pecora, MD, FACP, CPE, is President of the newly formed Regional Cancer Care Associates—a statewide group of 76 oncologists who have consolidated their practices into a new oncology network in New Jersey. This new network is supported by 500 employees at 20 cancer care delivery sites that stretches from Cape May in the south all the way up to the northern part of the state, and includes the state-of-the-art John Theurer Cancer Center at Hackensack University Medical Center where Dr Pecora is vice president of cancer services. Size matters in today’s environment, and the new network provides care to more than 17,000 new patients annually, in addition to the 230,000 patients that already participate in the provider network. Regional Cancer Care Associates is a “value-based” cancer care network that will allow the network to bargain as a group with insurance companies and drug companies to provide quality cancer care to patients while reducing the cost of that care.

Although each participating practice will retain autonomy in terms of making specific medical decisions for the care of their patients, a doctor-dominated board of trustees will standardize that care—meaning, for example, that the trustees will decide how many diagnostic tests are to be ordered or decide on the effectiveness of certain chemotherapies for treatment. When we heard about the creation of a new network, we thought it would be important to discuss the details with Dr. Pecora.

OBR: First, what was the motivation that got you to the point where you wanted to combine all these forces under one umbrella?

AP: It was a number of things. I wish I could explain it all in a sound bite, but I can’t. Things have occurred over the last couple of decades that have now come to a focal point, and to me, they’re pretty frightening. Societies have invested hundreds of billions of dollars in disease research and clinical trials over the past 60 years to find new methods of treatment, and have been unbelievably successful in not all, but some of these disease areas. As an example, we’ve been able to change the paradigm of cancer care where if a patient had metastatic breast cancer two decades ago she was gone in 2 or 3 years. Today, those patients can live 15, 20 years after diagnosis, and that kind of care is only accelerating. And that’s just cancer. Cardiologists and infectious disease specialists are both doing an amazing job as well in preventing people from dying prematurely from cardiac disease and infections.

We have more new, expensive therapies being developed every day and more people using the drugs. But with all these great advancements, comes the issue of the cost. Combine that with the general state of the U.S. economy, and all the demands to modulate the increased growth rate of healthcare costs and there’s a perfect storm brewing.

I started evaluating the economic pressures from a macro and micro level, and working in a consulting role with some payers, just trying to understand what it all means when it just hit me like a ton of bricks: The Great Britain health system is not “very nice”—there are drugs that work that are not being approved there. Meanwhile, here in the US we are talking about “death panels”, we have the emergence of ACOs (where we’re trying to empower primary care doctors), and hospitals are either struggling to stay in business, or are buying up practices, or are being bought by insurance companies. It all points in one direction—if you want to remain relevant, you’d better be big—and as big as we are at the John Theurer Cancer Center, we’re still not big enough to protect ourselves against market forces.

When it dawned on me that we weren’t big enough in the number of patients we saw, even though we’re one of the biggest providers of cancer care in the country, I started talking to other cancer doctors in the state about merging. What I learned isn’t surprising. We’re all concerned about our well being, but we’re also passionate about our profession and we cringe at the thought that, “I’ve waited all my career to have these wonderful drugs to offer people, and now I may not be able to afford them, or even worse, someone else is going to tell me I can’t use them.”

I know that is a little long-winded, but that was the genesis of Regional Cancer Care Associates. All those forces lining up lead me and several other oncologists, to go around the state and talk to our colleagues. The message we had resonated with them and we started building the network.

But that was only part one. Part two was the difficulty of coming up with a business plan that made sense. That took time and work, but we did it, and we were able to close on 10 practices and 74 doctors in 4 months, and get all the payers to go along with it, including Medicare.

OBR: When you say “remain relevant,” do you mean autonomous?

AP: No, I don’t think anyone’s going to be autonomous so let me define relevant. Relevant means that you’ll be at the decision table discussing how cancer care is going to be delivered, wherever that table is. You’re not going to be told by ACOs, “guess what, we don’t want to treat metastatic pancreatic cancer anymore, everyone has to go on hospice.” I’m not saying this would ever happen, but looking at what’s happening in Great Britain, I get very concerned about the future of cancer care here.

I’m worried about what happens if we shift to a single-payer health care system or what happens to cancer care delivery if we move to some sort of big integrated model. Being relevant means being able to help shape delivery of cancer care in a new model whatever that is.

OBR: How grassroots was your idea to join all these forces under one umbrella?

AP: It was like running for office. I drove around the state and went to every office, went to their partners meetings, presented, took their questions, looked them in the eye and suggested that this is what we have to do. With something this important, I felt it was necessary to use a grassroots approach.

OBR: Do you anticipate adding more offices?

AP: Yes. We’re going to probably add another 30 to 40 docs, another 5 or 7 offices because we have promised some of our local payers that we would have an office within 30 minutes of any patient in the state. We aren’t looking to leverage the size of our network and get paid more per unit service, but on average we want to make sure that if a practice or physician joins our network, he or she won’t be hurt economically.

OBR: It is impressive that you can do that. We hear a lot about office closures due to economics. Your network intends to leave the rural offices open through the strength of the network?

AP: Absolutely.

OBR: Please tell us about the board of trustees that is helping guide the clinical decision making?

AP: The board consists of partners (or members) from each of the practices. Their participation is determined by a ratio based on the number of doctors that are in that group. We also plan to add independent board members that are knowledgeable of today’s dynamics. For example we plan to add someone from the healthcare industry, a patient advocate, and an expert physician that’s not part of the network. We intend to be transparent about everything we do.

When we make a decision that has a clinical consequence, we’re not going to hide it. We’re going to post it and we’re going to provide an explanation for the decision. The idea is to get people comfortable with the fact that there is a way to mitigate the growth of healthcare expenditures, in cancer, and yet continue to offer the highest quality, cutting-edge care. That’s our mission; that’s why we came together.

OBR: You’ve been talking with payers about the network, has anyone asked to participate in the board and help with implementation of pathways?

AP: No payers have asked to be on our board. I don’t think they’d want to be and I’m not sure we would let them because there may be a conflict of interest. I can foresee us getting a payer representative on the board, but probably not someone from New Jersey.

But remember that payers don’t get up in the morning and say “alright, how do we squeeze another 10 base points out of our margin by not paying for things that we should pay for.”
What I want to do is offer payers a solution.

The doctors in our network all have 2 and 3 board certifications—they’re great people that care about the community. They’re the ones up at three in the morning taking care of the 20-year old leukemic. We want to keep these people motivated, just in case it’s one of your kids or family members that get cancer.

Given that kind of expertise and caring, I’m certain payers will work with us to find solutions.

OBR: Thinking of the logistics of the merger of these practices, are you going to try to integrate everybody into the same EMR for example?

AP: We’re going to have to integrate completely to be transparent, and that is part of our strategy. Obviously, an individual patient’s record won’t be transparent, but the outcomes of the care must be transparent to the public. A common EMR for our network practices will help us accomplish that goal.

OBR: You’re already making investments in the network then?

AP: We are, and the good news is that we’re pretty big and our collective revenue is not inconsequential. We have to take some of the revenue and invest it to accomplish our goals. But that challenge is a better one than just staying the way we were and fighting the fight individually.

While trying to keep the hyperbole to a minimum, I can honestly say that I don’t think I’ve ever seen a group of doctors more excited and more re-invigorated in their futures than I’ve seen at these meetings that we’ve had. There was a loss of control, a loss of dignity in the old model. Now I think we all see a possibility that our trade could come back in a way that’s quite rewarding for everyone.

by Don Sharpe

The Translational Genomics Research Institute (TGen) hosted the Pediatric Cancer Translational Genomics conference in Scottsdale, AZ on February 6-8. The 180 attendees were described as a “dream team” in pediatric oncology. They represented 29 U.S. states and 11 overseas nations, and their discussions focused on how to translate pediatric genomic data for personalized or precision oncology.

One challenge facing pediatric oncology, as explained by Peter Adamson, MD, chair of the Children’s Oncology Group (COG), is that its funding is currently much more dependent on the federal government than other types of medical oncology. Clinical research in pediatric oncology receives about 99% of its funds from the federal government, while medical oncology receives about 60% of its funds from industry. The business models play out that way because pediatric cancer does not have an economic driver. Pediatric cancer relies on the National Institutes of Health (NIH), which is likely to face a flat or decreased budget in the near future. Increasingly, public-private partnerships and perhaps more collaborative research funding from foundations will be needed to address the funding challenges of pediatric oncology.

The main concerns expressed by speakers and attendees about moving forward with translating genomic data from pediatric oncology were the need for more biopsies and the need for bioinformatics.

Because tumors change over time, they need to be sampled over time. When pediatric oncologists can sample tumors over time through multiple biopsies, they will be able to take advantage of differences at the time of recurrence so the treatment can adapt to the tumor that recurred. Tumors are a moving target, and findings from a biopsy can be game-changing. However, because biopsies pose more than a minimal risk to a child, regulations require that they must have the potential to benefit that child. The research community felt that they need to prove the potential benefits of biopsies to guide treatment decisions for recurrent tumors.

Bioinformatics was another area of concern, including the need to share, organize, store, and annotate information. Four major pediatric sequencing groups were represented: the KIDS (Knowledge Integration & Dynamic-interexchange System) Cloud project, which is a collaboration between TGen, Dell Computers, and the Van Andel Research Institute; the Pediatric Cancer Genome Project, which involves St Jude Children’s Research Hospital and The Genome Institute at Washington University; TARGET (Therapeutically Applicable Research to Generate Effective Treatments) from the National Cancer Institute; and MAGIC (Medulloblastoma Advanced Genetics International Consortium) from Sick Kids Hospital in Toronto, Canada.

“When it comes to access to clinical and pathological data, more is more,” stated Spyro Mousses, PhD, Director of the Center for BioIntelligence at TGen. Data sharing and collaborations were emphasized as a way to move research forward and connect current science with choices for patient treatments. Pediatric oncology includes rare and ultra-rare diseases, and only by pooling resources and data over several years can enough information be developed about these diseases to provide guidance on clinical decisions.

By Kathy Boltz PhD