Keith Lerro, MD, is the sole oncologist at his Wilson, North Carolina practice and often puts in seven day weeks. That is despite the fact that his practice, Regional Oncology Medical Center, employs no fewer than six administrators to manage business accounts, interact with payers, and arrange care and payment for underinsured patients. In 2003, a practice of Regional’s size could have gotten by with one or two administrators, Lerro estimates. But things have changed.

Many doctors in oncology are pushing themselves to similar extremes. Longer workdays have become a fact of life. Physicians interviewed for this article said they are spending less and less time with patients and more time on the phone with payers, more time in late night business meetings, and more time filling out electronic health records (EHR). Their personal time also has evaporated as the complexity of running an independent practice has grown. Doctors said they no longer have enough time for relaxing activities that ease the stress of putting in so many work hours.

Working With Payers Is One of the Biggest Challenges

Lerro said that he may owe his longevity in this now-grueling profession to the business exposure he received at his former practice, Southeastern Medical Oncology, also of Wilson. When he was there, he voluntarily attended business meetings because he was interested in that side of practicing oncology. Little did he realize that the knowledge he was acquiring would be critical for sustaining his current practice. Without that knowhow, he would have been underequipped for managing today’s reporting quality measures and more restrictive payment policies of insurers. “The evolution of the mandates and the shrinking margins have forced many private practices out of business,” he said. “Many of them were reasonably well run, but they just couldn’t survive.”

Now, working with payers consumes more of the workday than ever before, oncologists said. In addition, much more concentration, skill, and knowledge are needed to work successfully with payer policies and government regulations. Even after putting in additional time and effort, oncologists find it difficult to get approvals for the treatments they think are most appropriate. “The role of the physician has shifted into being a mediator between the insurance company and the patient,” Lerro said. “The doctor cannot treat the patient based on his own evidence-based review of the literature. He needs to know all of the treatment options possible and choose the one that the insurance company will pay for and the patient’s copay can handle.”

Part of the additional effort that has to be invested comes in the form of actually confronting payers over denials that seem unjustified based on evidence and standards of care, according to Myron Bednar, MD, a medical oncologist at Hunterdon Hematology and Oncology in Flemington, New Jersey, who said he is spending much more time on paperwork, phone calls, and case reviews with payer representatives. “Even when we follow [National Comprehensive Cancer Network] guidelines, we get pushback or denial from insurance companies, and we have to present our cases through peer-to-peer meetings or by written letter to get approval,” he said.

Bednar said one heartbreaking example of this involved a fruitless, eightweek struggle to get a payer to cover a promising, off-label treatment for a stage IV breast cancer patient. The patient had failed multiple treatment options and was unable to obtain insurance coverage for a targeted agent, which had been approved for kidney cancer and was predicted to work based on the gene sequencing of the woman’s tumor. Eventually, after the payer wouldn’t budge on its coverage decision, Bednar was able to get the treatment through a program from the pharmaceutical company. The patient is responding well to the drug several months later, but Bednar stated the case is an example of how meetings, letters, and phone calls are not always successful and take time away from patient care.

Genomic testing and targeted therapies may have improved the likelihood that treatment decisions will succeed, but carte blanche freedom to prescribe is a thing of the past, Bednar said. “When I first started practicing 16 years ago, we could use a drug, even if it was approved for a different disease state, because it was [FDA] approved and available,” said Bednar. “We’re doing a lot more multiplex gene testing that predicts response to therapies and, based on the genomics of the tumor, it may predict response to a drug approved for another disease. Sometimes, I’m not able to treat patients with what I think might be the best treatment.”

Sometimes, payer policies are not up-to-date with advances in modern medicine, and this requires that physicians spend time arguing with payers approved therapy pathways are too restrictive said Robin Zon, MD, a medical oncologist at Michiana Hematology Oncology of Indiana. Clinical pathways policies also reduce physician autonomy and stand in opposition to the effort to individualize therapy based on patient and tumor characteristics, she said. “Medical oncologists want to deliver state-of-the-art care with highlevel evidence. The problem is that there is a lot of interference because of the payers’ requirements for preauthorization and their denials of coverage.”

Electronic records result in better standardization of care and provide many other benefits, but physicians find that these systems for aggregating data and sharing it across platforms are gluttons for time. Although many physicians would prefer to spend more face time with their patients, these computerized tasks are hogging increasingly larger portions of the day. Many physicians are skeptical that the net result is an improvement. More than 40% of respondents in the 2015 ASCO Trends Survey said that implementation of EHR makes it difficult or very difficult to improve efficiency, and only one-third reported being satisfied or very satisfied with their EHR.

Switching to Electronic Records Was Like Learning a Language Zon said the initial process of converting from paper to electronic records was like “learning a new language,” and although she stated that the system has become easier to manage over the years, the additional requirements to satisfy quality metrics for Centers for Medicare & Medicaid Services (CMS) payment have substantially increased her hours spent at work. Zon indicated that many of her colleagues spend several hours on weekends catching up on these requirements, and some have even hired scribes to ease the workload.

Similarly, Patrick Elwood, MD, medical oncologist and president of the Mark H. Zangmeister Center in Columbus, Ohio, estimated that the greater need for electronic recordkeeping means that over half of the time spent with each patient involves recording information on the computer. “It has effectively taken away 50% of our time with patients.”

Previously, there were financial incentives that made it worth the effort for physicians to participate in quality improvement programs. These incentives helped to pay for the overhead of maintaining computerized systems, Lerro said. Now, many of those incentives have disappeared, yet it has become necessary to participate in quality improvement programs in order to stave off financial disaster, he said. “Many of these [EHR] programs involve things that we’ve always done but now have to capture. That takes time, and the intellectual skills needed to comply with these federal mandates continue to increase.”

Zon and Bednar said their practices have in-house technology specialists whose job it is to confirm that CMS and private payer reporting requirements have been met. Zon said her practice has hired a business analyst to ensure that operations are cost-effective and in compliance with government regulations. Even with this help, she and her colleagues spend many evenings discussing how to manage the practice in the face of the shifting requirements. “Recently, we were in a business meeting until 9 pm, just to figure out how to keep our doors open with these requirements,” she said.

The increasing demands on physicians’ time are taking some of the enjoyment out of the profession. Symptoms of burnout are increasingly prevalent, and oncologists are retiring at earlier ages than before; and young physicians, who are aware of the higher workload and decreasing job satisfaction in oncology, have become harder to recruit.

A recent survey of randomly sampled ASCO members revealed that although the majority (>80%) of oncologists were satisfied with their choice of oncology as a career, 45% reported at least one symptom of burnout.

 In addition, only 33% were satisfied with their work-life balance.

 Symptoms of burnout and levels of satisfaction with work-life balance were the strongest predictors of whether physicians intended to reduce clinical hours or retire early. Burnout and job dissatisfaction are two factors, along with an aging population and increased rates of cancer survival, that are expected to cause a shortage of medical oncologists by 2020.

“Many physicians who are reaching the age of 60 years are beginning to wonder whether the extra work is worth it, said Richard Brown, executive director of the Mark H. Zangmeister Center. “They went into medicine to take care of patients, but they’re finding less of that because of the obligations from the government and insurance carriers.” He said it has become harder for him to recruit younger physicians and retain senior-level ones.

Zon said that the shift from time with patients to time spent on EHR reporting that does not directly benefit her or her patients further contributes to dissatisfaction with work. “I am happiest when I’m in the room with the patient and the family. I am least happy when I’m sitting in front of a computer at night clicking boxes, trying to make sure I’m ready for the next day and that my pathway compliances have been met,” she said.

Oncology Is Still a Very Rewarding Profession

Furthermore, physicians are more likely to experience burnout if they don’t have opportunities to work off the stress, such as by engaging in exercise or meditation, Zon said.

Bednar said that oncology continues to be extremely rewarding when he is working with patients, but he said the job can be highly demanding, given the complexity of cancer and the difficulty of helping patients manage their personal and professional lives as they undergo treatment. Bednar stated that interaction with colleagues from other specialties at weekly tumor board meetings helps him to manage these challenges. Practice pressures are also reduced with the aid of a social worker, who not only works with patients at Bednar’s practice but also attends the tumor board meetings and addresses medical and social issues that the oncologists may have when caring for patients. “With some of the situations we’re faced with, it is helpful to bounce ideas off each other,” said Bednar.

Zon said medical societies should continue to collaborate to solve the problems of increasing workload and burnout that afflict professionals in all medical specialties. She said ASCO’s The State of Cancer Care in America reports, which began in 2014, and special sessions at the organization’s 2015 annual meeting were helpful in boosting awareness of the problems of overwork. She said that such efforts may lead to interventions that promote a fulfilling, productive environment for physicians and their patients.

ASCO. The state of cancer care in America, 2016: a report by the American Society of Clinical Oncology. 

. 2016 Apr;12(4):339-383. doi: 10.1200/JOP.2015.010462.

Shanafelt TD, Gradishar WJ, Kosty M, et al. Burnout and career satisfaction among US oncologists.

 2014 Mar 1;32(7):678-686. doi: 10.1200/JCO.2013.51.8480.

Shanafelt TD, Raymond M, Kosty M, et al. Satisfaction with work-life balance and the career and retirement plans of US oncologists. 

 2014 Apr 10;32(11):1127-1135. doi: 10.1200/ JCO.2013.53.4560.

Erikson C, Salsberg E, Forte G, et al. Future supply and demand for oncologists: challenges to assuring access to oncology services.

 3:79-86, 2007. doi: 10.1200/JOP.0723601.

Articles

Many doctors in oncology are pushing themselves to the extreme, and longer workdays have become a fact of life.

Finding Time for Stress Relief Increasingly Difficult for Oncologists

Two researchers have challenged the notion that money can be saved by packaging medications in sizes that conform more closely to patient weight and dosing needs.

Distributing oncology drugs in larger or smaller portions would not lead to significant savings because the raw-materials cost of a drug is not a key factor in how much pharmaceutical companies charge, said Sherry Glied, PhD, dean of New York University’s Robert F. Wagner Graduate School of Public Service, and Bhaven Sampat, PhD, associate professor of health policy and management at Columbia University.

Drug manufacturers have many marketing and development costs associated with drugs, and in many instances those factors outweigh the chemical costs, they said. Furthermore, producers enjoy virtual monopolies on the production of certain drugs. This means that they will price them according to what the market will bear, Glied and Sampat wrote in a blog for Health Affairs,

“A drug manufacturer holding a patent seeks to price its product at the highest price consumers are willing to pay for it. The willingness of chemotherapy consumers to pay for a drug doesn’t depend on their body weight and how many milligrams of the drug they use—it depends only on whether the optimal course of treatment will improve and extend lives or not,” they wrote.

Their argument was in response to a study, published in 

 March 1 of this year, that concluded oversized drug packaging results in large quantities of leftover drugs that cannot be used.

 Also, lead author Peter B. Bach, MD, director of The Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, and his fellow researchers alleged that oversized packaging has given rise to various fraudulent practices. They said that the cost of drugs could be reduced if packages and their contents are sized according to actual need.

The authors of the Health Affairs blog agreed with Bach et al that chemotherapy dosing is based on body size, and that drugs—particularly chemotherapy drugs&mdash;are often packaged in quantities that exceed what is required, but they argued that production costs would not scale down with package size. “Assuming the cost of an excess drug is proportional to the amount of drug in the package…, the cost of the wasted drug is very substantial,” Glied and Sampat wrote. “It is wrong, however, to assume that production cost is proportional to package size. That’s because much of the cost of the product&mdash;product development, marketing, distribution, testing, packaging, labeling&mdash;is entirely or nearly invariant to unit size. The cost of an additional unit of the product itself, the marginal cost, is usually quite low relative to these fixed costs,” they said.

The researchers gave the example of a large Starbucks container that holds 67% more coffee than a smaller size but costs only 29% more. They said the same principle applies in the retail industry where different sizes of a particular type of clothing are priced the same.

If required to package their drugs according to patient need, manufacturers still would adjust pricing for maximum possible gain, Glied and Sampat wrote. They said such a requirement could actually lead to a decline in production efficiency as producers generate and distribute multiple sizes of drug packages. “Overall, the costs of production would rise, while consumers would see little change.”

Bach and his colleagues estimate that up to 33% of drug package contents are going to waste. They said that in 2016 that waste will amount to $1.8 billion in pharmaceutical company revenues from just the top 20 cancer drugs. They said that oncology practices benefit from higher prices charged for excess quantity because they mark their drugs up accordingly. They also alleged that some physicians split the contents of oversized vials among different patients and bill each for a full vial. Some space out doses of a drug in order to use more vials per patient, the 

 study authors said. Bach and his fellow researchers suggested that waste could be minimized by requiring manufacturers to distribute drugs in dose appropriate sizes, refunding the cost of leftover drugs, and implementing safe vial sharing practices, so that unused content does not need to be thrown away.

Glied S, Sampat B. Would a wider variety of vial sizes reduce the cost of chemotherapy? Not likely. Health Affairs. Published May 11, 2016. http://healthaffairs.org/blog/2016/05/11/would-a-widervariety- of-vial-sizes-reduce-the-cost-of-chemotherapy-not-likely/. Accessed May 16, 2016.

Bach PB, Conti RM, Muller RJ, Schnorr GC, Saltz LB. Overspending driven by oversized single dose vials of cancer drugs. 

Two researchers have challenged the notion that money can be saved
by packaging medications in sizes that conform more closely to
patient weight and dosing needs.

Experts: No Savings From Smaller Cancer Drug Packages

Mark Robson, MD, is clinical director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center (MSKCC) in New York and a medical oncologist with 20 years’ experience in clinical cancer genetics; however, under Cigna’s new policy on coverage for hereditary genetic testing, Robson is not qualified to order genetic tests for cancer susceptibility. In contrast, a freshly board certified prenatal counselor who has not undergone specialized cancer genetics training is qualified to do so. Robson finds this illogical. “According to Cigna, a prenatal genetic counselor who has never seen a cancer patient is allowed to order and certify a test simply because they have an MGC after their name. Whereas I, who have been doing this for a very long time, am not, because I have an MD after my name. That doesn’t really seem to make much sense to me.”

Cigna’s new policy is an extension of a previous Cigna requirement for the use of certified genetic counselors for breast, ovarian, and colorectal cancer genetic tests. Robson says it is illogical because an understanding of cancer susceptibility testing is an integral part of modern oncology. His position is shared by ASCO. In May, the professional society of those who care for cancer patients issued a statement in opposition to Cigna’s new policy, which it said “introduces an unnecessary barrier to the appropriate use of genetic testing services and has the potential to negatively impact care provided to patients with cancer.” The group contends that adding this requirement may result in patients opting out of potentially beneficial genetic testing because of the barrier of the additional referral. ASCO also contends that unnecessary additional services may increase costs.

“The question is ‘Who is capable of obtaining that informed consent or providing patients with enough information to give that informed consent?’” Robson said. “ASCO has stated quite firmly that medical oncologists are very much trained and capable of obtaining informed consent for genetic testing for cancer patients. It’s part of what we’re trained to do. It’s part of what the organization educates its membership to do, and it’s a part of oncologic care.”

Cigna counters that genetics testing has become exponentially more complicated over the years, to the point where many hours of training and regular updates are needed for healthcare professionals to have a reliable understanding of how to fully prepare patients for tests and provide the necessary interpretation afterward. The payer contends that not all oncologists have time to keep up with rapid advances in the field or to give patients all of the counseling that they need. In addition, the payer contends that physicians are increasingly ordering large panel gene tests that cost more and yield information that may not have value.

“We’re not trying to be a barrier here,” said Jeffrey Hankoff, MD, a medical officer at Cigna. “We’re not trying to interrupt the physician/patient relationship. We’re really trying to get to the point where we have an educated, knowledgeable patient and consumer who very well understands the implications of testing, what the tests mean, and, when the results come back, what the implications are not only for them but for everyone else in their family, and not just their children, but their sisters, their brothers, their aunts, their uncles, and so on.”

According to ASCO, other payers have introduced requirements for the use of certified genetic professionals. However, the organization notes that The Centers for Medicare & Medicaid Services has decided not to institute such a requirement for genetics testing. Robson said that in New York he has the convenience of having a number of certified genetic counselors on staff, but physicians elsewhere in the country do not have that luxury, he said, adding that shortages of certified counselors exist, especially in rural areas and in institutions caring for underserved populations. Cigna provides a list of available counselors in each state and also recommends the use of telephone-based counseling. Professional counselor organizations say their members are amply available geographically and by phone. Hankoff said the payer is not trying to make it difficult to find people who can qualify for acceptance as certified counselors.

“One doesn’t have to be a genetic counselor to achieve certification and qualify to work with patients under the Cigna policy,” he said. “Nurses can undergo specialized training, and Cigna also will allow medical geneticists to do the counseling. Physicians who enroll in specialized courses also may qualify. City of Hope [a California-based healthcare system], which is one of the premier facilities for treating malignancy, offers a 100 hour course for oncologists or for anyone else who wants to take that, to bring people up to speed in terms of the entire area. There are additional segments they can do to make sure that they stay current.”

Robson noted that ASCO has compiled a substantial body of material to help physicians gain sufficient competency in understanding genetic tests and do the counseling. In addition, “Every [ASCO] annual meeting has multiple sessions discussing various aspects of genetic testing,” Robson said. “Genetic testing and genetic counseling for cancer susceptibility is part of the core competency in the fellowship training for medical oncology. Medical oncologists can digest the information that’s necessary to provide chemotherapy. I think that it’s not a stretch to say that they can digest the information that’s necessary for them to provide a diagnostic test, particularly if that diagnostic test is clearly indicated by the patient’s presentation itself.”

Cigna’s position is that even equipped with the knowledge needed for effective counseling, oncologists may not have enough time to review essentials with patients. “Physician resources are really stretched, and Cigna’s position is that even equipped with the knowledge needed for effective counseling, oncologists may not have enough time to review essentials with patients. “Physician resources are really stretched, and particularly around patient care activities,” Hankoff says. “To spend the same amount of time that a genetic counselor would spend to conduct a thorough counseling session—that’s asking a lot of a busy practicing physician.”

Cigna recommends that patients spend at least 45 minutes in the initial meeting with a certified counselor and the same amount after the test results become available. Robson said his opinion is that oncologists will spend as much time as is necessary to deliver essential information to patients. “If an ovarian cancer patient needs this test to determine whether they’re eligible for a PARP inhibitor, an FDA approved drug, certainly that’s something that can be explained, just like you can explain an Oncotype test. If the breast surgeon needs to explain that they need this information because it helps determine contralateral risk and therefore decisions about mastectomy versus lumpectomy and radiation, that’s something that is part of the workup.”

Furthermore, physicians are capable of exercising discretion so that counseling is appropriately tailored to the situation, Robson said. “You can split up the model a little bit, focus on the thing that’s important to the patient right now, focus on why the information is relevant to them right now, and defer the other elements of it until later.”

In some cases a full-blown counseling session is well justified, such as when an unaffected patient needs to be prepared for the possibility of a positive result, Robson said. “So it may well be that there are places where the information that’s required for a patient to understand why he or she is undergoing a genetic test is delivered better by different providers. But I just don’t think there’s a one-size-fits-all solution, and particularly if that one-size-fits-all solution provides a barrier to getting something that’s necessary for oncologic care,” he said.

Those who go for the additional training required to become a certified counselor are not in opposition to Cigna’s policy, Hankoff said. In addition, part of the goal is to ensure that patients are empowered to participate in their own treatment decisions. “The push has been for the patient to be a meaningful part of the conversation, so we’re having an educated patient who is getting intimately involved and fully educated. We didn’t do this because we were trying to save money. It was really about improving the quality.” That said, there is concern at Cigna that not enough restraint is being applied in the use of the newer and more sophisticated tests that have become available. “More and more, we’re seeing panels being ordered, and the panels are having an increasing number of individual genetic tests on them, some of which don’t really have any proven actionable information that comes out of the results. We’re asking the people ordering the tests to be more discriminating,” Hankoff said. The American Board of Genetic Counseling (ABGC) believes that certified genetic counselors should be involved in genetic testing, including ordering and pre- and post-test counseling, said Sheila O’Neal, executive director of the organization. Citing studies by Cigna and the National Society of Genetic Counselors, O’Neal said “genetic testing is most cost effective and efficient when a genetics professional is involved in determining what specific tests to order, as it decreases the number of incorrect or inapplicable tests.”

She said policies by Cigna and UnitedHealthcare have substantially increased utilization of certified counselors, whose numbers have swelled roughly 80% over the past 10 years and continue to rise 6% to 7% annually.

Cigna's new policy is an extension of a previous Cigna requirement for the use of certified genetic counselors for breast, ovarian, and colorectal cancer genetic tests.

Feeling Chafed by Cigna's Genetics Policy

Castine believes the biggest impact on the growth of the hematology market may be the power of new drugs to reduce cancer to the status of a chronic disease. Patients are already living dramatically longer, which is in stark contrast to the days when Castine was in residency. “The growth is patients living longer and taking therapies longer, which is something that we never had before. I completed my training 20 years ago, and the average life expectancy for a chronic myeloid leukemia patient was 3 to 5 years. If you had a match, you’d have a transplant in the first year. There were very few people who survived or were cured, and now we have people walking around on Gleevec [imatinib] for 10, 12, 15 years. It’s the same with myeloma. Myeloma had a 40- to 44-month life expectancy 20 years ago, and now it’s almost out to 71 or 72 months, and that doesn’t even include the three drugs that were approved last year,” he said.

Generics and biosimilars such as are anticipated by the GBI Research report (page 24) hold the potential to reduce costs of care, but an equally likely scenario is that these drugs will be used in tandem with newer, more costly therapies, Castine said. “As patients come off these [older] drugs they’re going to be going onto novel drugs; and at the same time, novel drugs are finding their way closer and closer to front line therapy.” Gleevec appears fated for such a transition, he added. “There’s already competing data from other tyrosine kinase inhibitors: Tasigna (nilotinib) has better data up against Gleevec in the initial line of therapy.”

Even though new generics and biosimilars will cost less, hematologists may not automatically make the switch from brand name drugs, Castine said. The quality and reliability of the supply of substitute drugs also will play a role in their acceptance. The Baton Rouge clinic uses generics as much as possible, but with some of them the side effects can be more severe. This happened with a generic form of Taxotere (docetaxel), Castine said. “More women receiving Taxotere now are having skin peeling— palmar-plantar erythrodysesthesia&mdash;than I’ve ever seen with Taxotere in the past. I saw it a little bit, but now I see it a lot.” Separately, generic drugs were also suspected when platelet counts dropped among patients with colon cancer. “I had more trouble with thrombocytopenia in my patients and I couldn’t figure it out. After I saw the fourth patient within 2 days having grade 3 thrombocytopenia&mdash;they were early in treatment&mdash;I went back to talk to the nurses, and they said, ‘Yes, we’re buying generic now.’” The brand name drug was reinstituted and the problem went away, Castine said.

Generics that adhere to the formula for brand name drugs are considered to be much more easily manufactured than biosimilars, but cases like those mentioned above give rise to doubts, Castine said. “The thing that scares me the most is that the vetting process is not as rigorous as we would like it to be.”

In addition, supplies of generic drugs, even essential ones, are subject to market forces and are sometimes irregular, giving rise to deeply troubling concerns, Castine said. He recalled an interruption in supplies of the inhibitor VP-16. His practice had to triage by taking patients with metastatic lung cancer off the drug to make sure there was enough for curable testicular patients. “I never thought I would have to make that decision.”

New drugs and drug replacements aside, the proposed Medicare Part B payment change could have a very dramatic change on practice revenues, Castine said. If CMS enacts the rule change that would reduce the drug handling percentage for in-house drug dispensing, hematology practices would have to avoid financial losses by sending many more patients to hospitals for treatment, Castine predicted. “Whether we prescribe a generic drug like Taxotere or whether it’s a name brand drug like Velcade, we’re going to get hurt.”

Hospitals that have access to the 340B drug discount program can come out ahead, Castine said. Small independents will suffer the most, he said. “If the so-called experiment occurs, it’ll crush the rural people a lot more than it will the metropolitan people, at first. But it will certainly be a blow to us." His practice has four physicians and two nurse practitioners. That won’t influence the practice’s policy of putting patient care ahead of financial concerns, he said. “We’ll send the patient to the hospital, but we still want them to get the best treatment possible."

Incoming generic and biosimilar substitutes for dominant, brandname hematology drugs may lead to less costly treatment, but a lot will depend on the quality and supply of these new products, says Michael J. Castine, MD, of the Hematology Oncology Clinic of Baton Rouge, Louisiana. The use of generics and biosimilars will also be affected by the strength of newer therapies and their ability to transform cancer care, he said.

Incoming generic and biosimilar substitutes for dominant, brandname hematology drugs may lead to less costly treatment, but a lot will depend on the quality and supply of these new products,

Patient Longevity Will Be Key Driver in Hematology Market Growth

Chief Innovations Officer, Professor, and Vice President of Cancer Services

John Theurer Cancer Center at Hackensack University Medical Center

President, Regional Cancer Care Associates, LLC

“Oncologists choose drug treatments based on a core principle: provide the right drug to the right patient at the right time,” ASCO President Julie M. Vose, MD, MBA, FASCO, told CMS in response to the proposed Medicare Part B drug payment change. “This demonstration will do nothing to further the Administration’s goals for health reform. It will not improve health, it will not enhance quality, and it will not lower cost,” she said. It seems to be that there is a “minor” disagreement between ASCO and CMS about the approach to address value in cancer care delivery. I know Dr. Vose and have no doubt that she truly believes, in representing ASCO, that the proposed plan by CMS will not address the issue and can potentially harm patients. I also have worked with the professionals from CMS and The Centers for Medicare and Medicaid Innovation. They truly want to do the correct thing for patients with cancer but also have the responsibility to keep healthcare affordable so it is accessible now and in the future. So, the question is, how is it possible for two groups of caring and knowledgeable professionals to have such divergent views?

Let us start with the views of ASCO. ASCO asserts that Phase 1 of the proposed demo is “essentially a mandatory experiment on seniors with cancer, but without accepted patient safeguards in place. Patients cannot opt out of the demo and receive no informed consent, as is mandatory in ethical clinical research.

Further, there is also no way to monitor potential adverse consequences in real-time.” This would appear to be true, particularly because if doctors shy away from more expensive drugs that are just too expensive to risk buying and storing—and it is these drugs that have better outcomes&mdash;it will be only after the fact that this will be known to the public. Furthering this problem is that, according to ASCO, “CMS would reimburse practices for less than the acquisition cost of many oncology drugs&mdash;forcing many independent oncology practices to send their Medicare patients to other facilities for treatment.”

Another potential unintended consequence of this proposed approach, according to ASCO, is that “the changes in Part B reimbursement rates proposed in the demo will likely push a greater number of patients with cancer to the outpatient hospital setting,” even though treating patients costs significantly less in community-based cancer clinics for both patients and the Medicare program. In 2014, Medicare spending for patients receiving chemotherapy was 34% higher in outpatient hospital departments than in independent community oncology practices, ASCO said, adding that patient out-of-pocket costs are also approximately 10% lower in community clinics than in hospital settings, “resulting in more than $650 saved for each Medicare beneficiary fighting cancer per year.” This shift in site of care seems likely to occur because CMS cannot force physicians to accept economic terms adverse to them even if it lowers cost for CMS.

CMS has enough data to believe that the approach being presented will reduce expenditures on drugs. I fear that the extrapolation that this will translate to value for anyone—CMS, oncologists, society, or most importantly patients&mdash;may not be true. We must drive value into the system to reduce waste and unnecessary care but not at the expense of clinical outcomes. No one wants this to happen&mdash;not ASCO, not Dr. Vose, and not CMS.

 It seems to be that there is a "minor" disagreement between ASCO and CMS about the approach to address value in cancer care delivery. 

A Value Proposal That Will Raise Costs

 is a book that could have been written by the folks at  Florida Cancer Specialists & Research Institute. The group has acquired 37 practices in its history and 27 since 2009, said Brad Prechtl, CEO of the operation, which over its 32 year history has expanded from Naples and Tampa to Central Florida, Orlando, the Gulf Coast, and most recently, the Panhandle. “In 2009, we had 45 doctors and 17 locations,” Prechtl said in a discussion of Florida Cancer Specialists & Research Institute's merger trajectory at the 2016 Community Oncology Conference in April. Florida Cancer Specialists & Research Institute now has 93 locations, around 200 physicians, and many nurse around 200 physicians, and many nurse practitioners and other providers. “It’s not that we had a specific strategy for growth,” Prechtl said of the early days of expansion, “but we knew that bringing physicians together was going to benefit the patient and ultimately keep community oncology together.”

Florida Cancer Specialists & Research Institute has honed its merger strategy into a finely tuned regimen that goes from due diligence to planning to implementation and follow-up, all in a period as short as 120 days. Not every practice makes the cut, but for those that do, the advantages in terms of economies of scale and enhanced patient offerings and compensation can be “incredible,” Prechtl said, posting many numbers on the screen for the benefit of an audience of numerous industry professionals. One byproduct of Florida Cancer Specialists & Research Institute's expansion is that group malpractice premiums have declined 64% on average since 2009, dropping to $7300 from $22,000 per physician for up to $3 million of lifetime coverage.

Prechtl’s presentation could have been a sales pitch for joining his organization; and doubtless, there are many reasons for oncology practices to be thinking about mergers or sales of their operations these days. Prechtl explained that the revenue efficiencies Florida Cancer Specialists & Research Institute has been able to achieve have given his partner oncologists enormous reason to feel more confident about their competitive standing in their communities. “We’ll see 60,000 new patients this year alone. We’ll have over 1 million follow-up visits. We’re trying in the state of Florida to bring practices together to keep independent oncology alive and well,” Prechtl said.

Based on modeling of independent practices considering joining Florida Cancer Specialists & Research Institute. Source: Florida Cancer Specialists & Research Institute

 The typical merger begins with senior management going out to meet with a prospective group of physicians, Prechtl said. “There has to be a lot of diligence on the front end. We also do a compliance review.” Physicians are told what will happen to their practice when they join, how their employees will be affected, how the electronic health record (EHR) conversion will be managed, and what will happen to legacy benefits and accounts receivable. Prechtl said Florida Cancer Specialists & Research Institute aims for a high degree of transparency in its dealings, though appropriate levels of confidentiality are maintained: “We don’t share what groups we’re talking to or what groups are coming in.” Similarly, Florida Cancer Specialists & Research Institute wants to be careful it has all relevant data before making a decision about bringing a practice into the fold. “It’s very important to do due diligence so that we’re not going to put the Florida Cancer Specialists & Research Institute reputation at risk by bringing in somebody who’s not going to meet the standards that we have,” Prechtl said.

 Physicians are presented with a range of compensation models, and compensation can start right away, beginning with a $25,000 monthly draw per physician to tide them over until the practice under the group umbrella breaks even. In addition, prospective merger partners are given an income assessment that compares what their practice made in the previous year with what they would have earned as full partners in the business during the same period, Prechtl said.

Physicians still manage their own call schedules and vacation time, as long as Florida Cancer Specialists & Research Institute has appropriate staffing for its patient flow. The extensive, centralized back-office functions liberate many physicians from having to spend as many hours on management as before. Overall governance of the operation is handled by a board of directors who are geographically distributed to represent a fair cross-section of the practices. Florida Cancer Specialists & Research Institute will buy drug inventory but will not assume accounts receivable or purchase real estate.

A lot of emphasis is placed on appropriate training of physicians and other employees coming into the practice, Prechtl said. For physicians, there is often a period of personal adjustment as they get used to the way Florida Cancer Specialists & Research Institute does business. Florida Cancer Specialists & Research Institute does a lot of its own lab testing in centralized facilities to achieve efficiencies, and physicians sometimes don’t like not being able to get these tests done in their own locations until they discover how quickly and well the tests are done by Florida Cancer Specialists & Research Institute, Prechtl said.

Florida Cancer Specialists & Research Institute

Source: Florida Cancer Specialists & Research Institute

Everybody is on the same electronic management system, and practices are rigorously benchmarked to ensure proper performance. Prechtl said they look closely at collections, drug cost ratios, total overhead, staffing levels, and quality of care. “It allows us to manage our sites as effectively as we can, and I think size and scope allow you to do these things in a unique way.” The payoffs of large-scale integration are not to be denied. Prechtl noted that Florida Cancer Specialists & Research Institute has been able to diversify its revenue stream in a way that lowers its reliance on chemotherapy and broadens its footing in oncology pharmacy, which is of increasing importance as oral drugs become more important in the treatment of cancer 

.  Reducing dependence on chemotherapy is especially important given that potential changes in Medicare Part B compensation could diminish earnings in that regard, Prechtl said. “The typical community oncology practice would have 81% of their collection base in the chemotherapy bucket. Think about 81 cents of every dollar you collect in chemo. Talk about the Medicare ‘Experiment’! What a devastating effect that would have on a practice—probably causing many to be under water from a reimbursement standpoint on chemotherapy.” By developing alternative sources of revenue, Florida Cancer Specialists & Research Institute has managed to reduce its chemotherapy income to 63 cents of every dollar, Prechtl said.

Similarly, through its in-house pharmacy, Rx To Go, Florida Cancer Specialists & Research Institute now fills 85% of the scripts generated by its own staff, “which I think most people in specialty pharmacy would agree, that’s a pretty high percentage,” Prechtl said. “We purchased over $1 billion worth of drugs in 2015.” Prescription fills average 2 to 4 days, a turnaround time that Prechtl boasted is of great significance to physicians and also to patients, who sometimes wait up to two weeks for a specialty pharmacy to package and deliver. “The difference between 4 days versus 14 days can have an incredible impact on a patient’s health and well-being.”

 Other measures of practice efficiency shared with the COA crowd included a comparison of compensation as a percentage of collections. In 2009, compensation and benefits measured 9.42% of collections. That figure has since dropped to 8.01%, and the money saved has enabled Florida Cancer Specialists & Research Institute to invest in new facilities and operations, Prechtl said. Another measure shown was the cost of centralized services as a percentage of collections, and that figure has dropped from 3.55% in 2010 to 2.99% in 2015. One additional measure of business efficiency given was the average number of days an unpaid invoice remains in accounts receivable, and in 2014 that figure averaged around 30 days, versus an industry average of 35 days, Prechtl said. Bad debt is less than 1% of receivables, and this is achieved by “proper patient counseling on the front end,” he said. “We meet with every single new patient. We verify insurance benefits. We talk about what their responsibility is versus what their insurance benefits cover, to make sure they understand what co-pays they’re going to cover when they come into the practice. Clearly, not every patient can pay for their services, so we access a lot of foundations. We also provide a lot of free care for our patients, but our goal is to treat 100% of the patients who walk in the door at Florida Cancer Specialists & Research Institute.”

Florida Cancer Specialists & Research Institute has honed its merger strategy into a finely tuned regimen that goes from due diligence to planning to implementation and follow-up, all in a period as short as 120 days.

Florida Practices Band Together for Strength

The saying on Wall Street is “sell in May and go away,” but there’s no detaching from the cliffhanger that CMS has left in the air. It’s anybody’s guess what will happen with Medicare Part B and the proposal to change the drug payment formula for drugs administered in a physician’s office. The Community Oncology Alliance (COA), ASCO, and other physician groups have stirred up such a rumble in Congress over this potential rule change that CMS can hardly pretend not to notice. There are no signs of disquiet behind the grey façade of the CMS headquarters building in Maryland, but although the official public comment period on this controversial payment adjustment has ended, it is clear that physicians will not allow the matter to rest. Stay tuned, and visit OncLive.com often for updates.

Our issue of Oncology Business Management this month is packed with insightful material on ongoing issues that are highly relevant to your practice operations. Our story on direct contracting by Meir Rinde asks whether bypassing the payer has any potential for improving patient care and practice health in the oncology community. We talked again with Comprehensive Care Centers of Nevada, which has negotiated a successful direct contracting deal with a 57,000 member culinary union in Las Vegas. We learned how that deal works and how similar forms of direct contracting could succeed elsewhere in the country. The Florida Health Care Coalition is working to pioneer a similar program that would launch in January. This is a story well worth updating, so be sure to read this month’s article and expect to see more.

On the subject of scale, Florida Cancer Specialists & Research Institute has engineered 37 mergers with independent practices and continues to grow. At the Community Oncology Alliance (COA) annual meeting in April, Florida Cancer Specialists & Research Institute CEO Brad Prechtl gave a thorough rundown on the science of merging practices and the economies that can be achieved.

Florida Cancer Specialists & Research Institute measures 2176 employees and still considers itself an independent. It has added 135 physicians in just the last five years, for a total of 204. Centralized functions have cut expenses dramatically, and scale has enabled the practice to add numerous offerings that smaller independents couldn’t provide.

Prechtl, perhaps hoping to land a few prospective merger partners at the COA conference, did not hold back on the numbers. Diversification of revenues has enabled Florida Cancer Specialists & Research Institute to lower its dependence on chemotherapy revenues. Chemo is just over 63% of the group’s revenue base, as opposed to an industry average of 81%. Malpractice coverage has dropped 64% since 2009, and accounts receivable collections are achieved, on average, five days faster than the industry average. Florida Cancer Specialists & Research Institute achieved all of this without having to fold into a hospital system. Could this be a model for the rest of the country? Read all about it in this month’s issue.

There’s lots more on the menu this month. How to divide up the workday is the oncologist’s constant dilemma. Three of our stories address the time element from different angles. Our story on busy doctors by Gina Battaglia addresses the growing demands on oncologists’ time. Our story on potential Maintenance of Certification changes talks about how the American Board of Internal Medicine plans to ease the burden of keeping up with assessment needs. And our story on payer requirements for genetic counseling discusses whether oncologists have the time and required expertise to continue performing this function themselves.

The saying on Wall Street is "sell in May and go away," but there's no detaching from the cliffhanger that CMS has left in the air.

CMS Puts On Its Poker Face

Imagine treating patients without having to seek preauthorizations, argue with medical directors on the phone, or deal with an insurance company at all. It may seem like an impossible dream in the community oncology setting, but such a nirvana does exist—at one practice, at least — and healthcare finance experts say healthcare could be seeing more such arrangements in the years to come.

Under this alternative model, called direct contracting, a provider signs an agreement with a business or membership organization outlining the care to be provided and the payment scheme, cutting out the insurer completely. A 2014 survey by Aon Hewitt found that 11% of employers were using some form of direct contracting with hospitals or physicians, and 28% anticipated doing so within 3 to 5 years.

So far direct contracting is used mainly by very large companies that contract with hospital networks in areas where the firms have many workers. Boeing started contracting with two networks in Seattle in 2014 and last year added two more in Charleston, South Carolina, and St. Louis, Missouri, areas where it has tens of thousands of employees. Intel has a similar contract in New Mexico, and Walmart and Lowe’s have contracts with “center of excellence” hospitals for travel surgery.

In a few places mid-size companies or multi-employer coalitions have also engaged in direct contracting. In St. Louis, municipalities and utilities have contracts with Mercy Health, a network that also has agreements with Boeing and other large employers. Coalitions in Iowa, Minnesota, Wisconsin, and other states have helped their members set up contracts with hospital networks for two decades.

In addition to hospitals, practice groups have contracted with employers in some places. Karen van Caulil, president and CEO of the Florida Health Care Coalition, said her member employers have agreements for bundled payments for hip and knee replacements and for heart surgery. There appear to be very few oncology groups in direct contracting arrangements, though van Caulil said a provider network her organization will launch in January will include community oncologists, hospitals, and cancer centers.

Comprehensive Care Centers of Nevada (CCCN) in Las Vegas is a rare example of an oncology group that was able to enter into a direct contract on its own due to a set of unique circumstances, according to James D. Sanchez, MD, the practice president. The casino town has a huge, 57,000-member culinary union with a sophisticated understanding of health benefits issues, while CCCN has 50 physicians at 15 offices in southern Nevada and northern Arizona. The group has had a long relationship with the union, and the practice has access to US Oncology’s data analysis capabilities, which were needed to create a viable plan.

Sanchez said he initially approached the culinary union about providing more efficient bundled care for breast surgery patients through a direct contract, whereas the union wanted to get a handle on radiation oncology costs that varied from provider to provider.

Eventually the union suggested a contract for all the lines of service CCCN provides, which was signed in 2014 and is up for renewal at the end of this year, Sanchez said.

The contract uses a version of capitation, with the union paying a monthly fee during a member’s treatment that excludes drugs, he said. The union pays for drugs separately, and the practice agreed to curb use of very expensive therapies. CCCN has already been using clinical pathways for more than a decade.

For the union, the benefits of the deal include quality improvements and the cost predictability that comes from using one provider with a fixed fee structure, Sanchez said. He did not know how the deal has affected the union’s spending, in part because drug costs continue to rise.

He said the deal has not been a huge source of new profit for CCCN, but it has increased revenue and ensured a steady source of patients across the practice’s different lines of service, strengthening its financial stability. CCCN can also avoid many of the usual hassles of managed care, like payment and treatment plan denials. Disputes are hashed out in monthly meetings with union administrators, and practice staff spend less time pulling up medical records and filing endless prior authorization requests, Sanchez said.

“There’s been good transparency between ourselves and the culinary union. We share information, and we talk about any grievances that occur, without getting into shouting matches. It’s a very collegial atmosphere when we sit down and talk. There’s too much stress out there in healthcare, so this has been a great, low-stress, or no-stress type of an agreement,” he said. “The agreement also could be a springboard to possible other changes in contracting, both with culinary and as a platform we are considering using in contracting with other larger employers.”

CCCN has approached other businesses about establishing similar direct contracts but has yet to ink additional deals, he said.

As beneficial as the arrangement has been, Sanchez said it was hard to imagine many similar contracts being signed around the country, because large employers aren’t interested in talking to physicians from group practices. Robert Gamble, director of strategic practice initiatives at the Community Oncology Alliance (COA), said employers and oncologists barely even share a vocabulary to discuss healthcare, and physicians are typically leery of approaching their patients’ companies directly.

“For whatever reason, it’s just hard for them to say, ‘Oh, I need to talk to my employers,’” Gamble said. “We’ve suggesting things like, take them some coffee, take them some ice cream. Buy them some donuts. Get to know them. When it happens, and you help nurture it and develop it, some great things can happen. But you’ve got to start there.”

That said, some savvy employers are motivated to bridge the divide with providers in the interest of improving the quality of care for their employees’ families at reasonable cost, said Cheryl Larson, vice president of the Midwest Business Group on Health, a large employer consortium. Larson, who spoke at COA’s annual conference in April, said that’s a different priority than many insurers have.

“In the health plan environment, they’re often driven by pressures from the average employer, who is focused only on cost savings,” Larson said. “More progressive employers recognize the importance of high quality, and they’re willing to pay a little more for better quality.”

Cost does matter to employers, but not at the expense of quality care, she said. Meanwhile, participating providers may or may not see higher profit margins, but they can gain more business, reduce some costs, and achieve other benefits by dealing directly with employers, she said. “From my perspective, it is not about the community oncologist making more money. It’s about them providing the best care they can and getting a consistent revenue stream instead of being nickel and dimed all the time by the managed care community,” she said.

Smaller community practices will have a tougher time taking advantage of such opportunities, especially if they are not located in an area with a high density of patients from large, self-insured employers, Larson said. Oncology is also difficult because of the many different types of cancers and treatments, which require more complex facilities and contract terms than a straightforward service like knee replacement, she said.

To overcome those barriers, groups like COA could help practices in a geographic area band together to create networks that provide a set of services and quality-improvement systems that are attractive to employers, Larson said.

In places where direct contracting is a possibility, there are several issues providers and employers must consider first, and a few key steps to take. The first, possibly lengthy step for the practice is to create a good ongoing relationship with the owner of a self-insured company that has many workers served by the provider, Sanchez said. The goal is to get the employer to start thinking about the cost and quality of the employee healthcare they are paying for, and the potential for improvements.

“Exploring direct contracting opens the door between employers and providers for discussions about cost, quality, and patient satisfaction that typically do not occur with the health plans in the middle,” van Caulil said. The practice then needs hard proof, in the form of data or experience with clinical pathways, that it can provide the promised benefits, Sanchez said. It has to be able to do a business analysis of the potential patient population and pay rates to formulate a financially realistic proposal, which may require depending on consultants or a partner like US Oncology. The employer must in turn have a business office that can process and monitor financial and possibly clinical data.

“Direct contracting is not easily accomplished, because it takes the insurance company out of the equation and the mechanics of the direct relationship must be worked out,” van Caulil said. She cited claims processing as an example of a responsibility the employer must take on. Employers also need to make sure their existing network agreements allow them to do direct contracting, redesign their benefit plans, and develop a communication plan for employees and families, as the new arrangements will likely be different for them, she said.

Gamble, who managed a cancer center for 13 years, said the contracts themselves are not difficult to set up. They need to include timeframes, he said; for example, a provider must send the employer a claim form within 48 hours after seeing a patient and the employer must pay claims within 10 days. Employers should process payments the way they handle any other invoice. And contracts must lay out the process for exchanging and reconciling information on the treatments provided and a system for measuring outcomes and patient satisfaction, Gamble said.

Aon Hewitt 2014 Health Care Survey. http://www.aon.com/attachments/ human-capital-consulting/2014-Aon-Health-Care-Survey.pdf. Accessed 20 May 2016.

Under direct
contracting, a provider signs an agreement with a
business or membership organization outlining the
care to be provided and the payment scheme,
cutting out the insurer completely.

Direct Contracting Is the Key to Bypassing the Payer

 Hematological practices can expect a slate of new generics to replace long-established brand drugs going off patent, as well as new blockbuster blood therapies that will significantly improve the treatment of some malignancies, according to an analysis of the hematology drug pipeline through 2022 by GBI Research, of Britain.

In addition, lifestyle factors and the aging of the baby boom population in the United States will contribute to a rise in the number of patients requiring hematological care, resulting in a domestic market expansion to $39.3 billion by 2022, up from $18 billion currently, according to the GBI forecast. The US market for hematological drugs is expected to grow at a compound annual rate of 11.8% through 2022, by which time the US market will amount to just about half of the global total, according to GBI.

The rosy outlook on spending and blockbuster drug potential comes at a time when US hematologists are worried that CMS may trim Medicare Part B drug compensation. Because the reduction would bite deeply into the payments hematologists receive for high-cost drugs administered in their offices, The American Society of Hematology is particularly opposed to it. According to GBI, significant drug pricing changes could happen as three leading brand-name targeted therapy drugs lose their patent protection: Rituxan (rituximab), Gleevec (imatinib), and Velcade (bortezomib). Rituximab, approved in the United States for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia, and rheumatoid arthritis, faces patent expiration in September of this year. However, it is a monoclonal antibody (mAb) therapy and its competition would fall into the biosimilar category. Because the barriers to approval and market entry are high for biosimilars in the United States, the price of this therapy is not expected to drop precipitously in the near term, according to GBI.

The tyrosine-kinase inhibitor imatinib, for chronic myelogenous leukemia and other cancers, is already exposed to competition by patent expiration, and bortezomib, a proteasome inhibitor for multiple myeloma and mantle cell lymphoma, will face competition in 2017. Imatinib and bortezomib, being small molecule drugs and relatively easy to reproduce, are likely to face substantial price competition from generics, GBI stated.

Figure 1: Hematological Cancers Therapeutics Market, Global, Annual Revenue for Rituxan ($bn), 2006—2022

So far, manufacturers have not succeeded in developing a biosimilar equivalent that could capture a share of the market from Rituxan. FDA requirements for market introduction of biosimilars have been a factor. Teva Pharmaceuticals, Samsung, and Boehringer Ingelheim Pharmaceuticals each have dropped attempts to reproduce the drug. However, the high revenues earned by rituximab, a Genentech drug, combined with the broad number of therapeutic uses for the drug, make it likely that biosimilar competition will eventually emerge for this product, said Yasser Mushtaq, a senior analyst at GBI. He noted that pharmaceutical company Amgen is an example of a company that continues to work on its own version of rituximab.

Mushtaq expects that competition will lower Rituxan sales to $4 billion by 2022 from the current $7.5 billion mark, “which is not an insignificant sum in comparison to the revenue losses expected for Gleevec and Velcade,” he said. These two drugs will face strong generic price competition, he predicts.

A generic version of imatinib has already been developed by Sun Pharmaceuticals and approved by the FDA. “It’s forecast that the revenue for Gleevec will be almost completely diminished by 2021,” Mushtaq said. A similar picture could develop for Velcade. GBI predicts that Velcade sales will measure $3 billion in 2017, when the drug loses its patent, and will drop to $0.9 billion by 2022.

Two pipeline drugs that promise to revolutionize care and command high prices in the marketplace are KTE-C19, a Kite Pharma chimeric antigen receptor T-cell (CART) therapy for refractory aggressive NHL, and CTL019, a Novartis CART therapy for use in relapsed or refractory NHL. In the realm of aggressive B-cell malignancies, “there are very limited treatment options,” so these therapies may have significant market exclusivity, according to Mushtaq. Kite Pharma’s KTE-C19 could fetch $1.5 billion in revenues by 2022, and the Novartis therapy could generate $1.1 billion in annual revenues by then, GBI estimates.

Another strong candidate for blockbuster status in hematological cancer is the Novartis kinase inhibitor PKC412 (midostaurin) for acute myeloid leukemia (AML). Granted breakthrough therapy designation by the FDA earlier this year, the drug targets the mutation FLT3, which is found in nearly one-third of the AML population, according to Mushtaq. GBI forecasts an $800-million market for midostaurin in 2022. Pembrolizumab (Keytruda), the Merck treatment for advanced melanoma and non—small cell lung cancer, gained fame for its success in the treatment of former President Jimmy Carter. The mAb is also undergoing phase III trials for use in multiple myeloma and refractory multiple myeloma, as well as phase II trials for lymphoma. Consequently, GBI anticipates continous market growth for this therapy.

Other pipeline drugs that are not currently marketed have blockbuster potential, too, according to GBI. These include polatuzumab vedotin, an antibody drug conjugate developed by Genetech/Roche that binds to cells expressing CD79b and allows for the release of a cytotoxic agent. In addition, selinexor, which inhibits proteins in the nucleus of cancer cells, thereby activating tumor suppressors, is a first-in-class drug candidate and shows blockbuster promise, GBI said.

Figure 2: Hematological Cancers Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016

The drug is being developed by Karyopharm Therapeutics. Also, venetoclax (Venclexta), from Genentech and AbbVie, emerged into the field of FDA-approved drugs in April of this year. The formulation for chronic lymphocytic leukemia (CLL) targets a B-cell lymphoma 2 protein that supports cancer growth and is overexpressed in patients with CLL.

All of these therapies are innovative and stand out from others in terms of having unique potential to successfully address disease conditions, Mushtaq said. “Although it’s notable that a number of them are for the relapsed setting, one or two of them are in development for newly diagnosed patients. A common theme is that they are under development for a variety of oncological diseases within cancers, which gives them the potential to reposition. Those factors will offset or dampen the impact of generic erosion over the years.”

Figure 3: US Hematological Cancers Market Size

Hematology practices that are employing breakthrough targeted agents are already steeped in the unique storage and handling requirements for these products, but rapid advances in treatment will require a commensurate investment in time to develop the knowledge and skills to manage these therapies effectively, Mushtaq said. For all of oncology, there are 6,976 therapy candidates currently in development, according to GBI. Of those, 1207 are for hematological cancers, a level of pharmaceutical investment that strongly illustrates the revenue potential that is believed to exist in this category. Other totals include 772 therapy candidates for leukemia, 539 for lymphoma, and 389 for myeloma.

“In terms of new products which will likely be approved, they will follow a similar path of being targeted therapies,” Mushtaq said.

“Hematologists will need to adopt methods to manage and store therapeutics. This is especially the case for cell therapies. There is also an issue of the increasingly targeted therapies and cell therapies not being applicable to all patients.” In addition, “There’s diversity among patients in terms of their genetic background and the makeup of disease. There will therefore be a need to identify and really profile patients before applying these medications.”

Hematological practices can expect a slate of new generics to replace long-established brand drugs going off patent, as well as new blockbuster blood therapies that will significantly improve the treatment of some malignancies.

June 2016 | Oncology Business News®