Oncman 6'13

Performance Metrics in OncOlOgy

i n s i g h t s i n t o o n c o l o g y b u s i n e s s p r a c t i c e

Volume 2number 2

6.13

Measuring Quality Cancer Care p.5

Mining the Pipeline: Leading Investigational Products and Areas of Unmet Need p.8

Cost Versus Quality in Different Sites of Cancer Care p.11

Published in collaboration with

OncologyBusinessManagement

Performance Metrics in OncOlOgyBy Thomas R. Barr, MBA

t a b l e o f c o n t e n t s

2

Measuring Quality Cancer Care By Robert Gamble

Mining the Pipeline: leading investigational products and areas of unmet needBy Stephanie Hawthorne, PhD

Cost Versus Quality in Different Sites of Cancer Care By Zachary Hartman

Feature

Advisory Board Patrick Wayne Cobb, MDHematology-Oncology Centers of the

Northern RockiesBillings, MT

Jeffrey D. Dunn, PharmD, MBAFormulary and Contract ManagerSelect HealthMurray, UT

Gary Lyman, MD, MPH, FRCP(Edin)Duke University Medical CenterDurham, NC

Adam I. Riker, MDCancer ServicesOchsner Cancer InstituteNew Orleans, LA

Richard J. Rosenbluth, MD John Theurer Cancer CenterHackensack University Medical CenterHackensack, NJ

Lee Schwartzberg, MDThe West ClinicMemphis, TN

Jeffery C. Ward, MDOncologistPuget Sound Cancer CentersEdmonds, WA

H. Jack West, MDThoracic Oncology ProgramSwedish Cancer InstituteSeattle, WA

David B. Wilson, RPhOncology Pharmacy ManagerOncology Pharmacy Residency DirectorSt. Luke’s Mountain States Tumor

InstituteBoise, ID

Interested in contributing to Oncology Business Management? if you’d like to submit an article for consideration in an upcoming issue, please e-mail Devera pine at [email protected].

5

8

11

Volume 2number 2

6.13

OncologyBusinessManagement

ii 6.13 Oncology Business Management

Publishing Staff

Vice President, Oncology and Managed Marketslyn [email protected]

Senior Editorsanita t. shafferJason M. broderickbeth fand incollingo

Associate Editors lauren M. green ben leach

Web Editor, Social Strategy Managersilas inman

Assistant Web Editorandrew rothOncology Special Projects EditorDevera [email protected]

Art Director leighanne tillman

Vice President, Integrated Special Projects GroupDavid [email protected]

Associate Publishererik [email protected]

Director of SalesMike hennessy, [email protected]

National Accounts Managersrobert [email protected]

albert [email protected]

Sales & Marketing CoordinatorMegan o’connell

Vice President, Digital MediaJung Kim

Director of Operationsthomas J. Kanzler

Group Director, Circulation and ProductionJohn [email protected]

ControllerJonathan fisher, cpa

Assistant Controllerleah babitz, cpa

Chairman/Chief Executive OfficerMike hennessy

Chief Operating Officertighe blazier

Chief Financial Officerneil glasser, cpa / cfe

Executive Vice President, Executive Director of EducationJudy V. lum, Mpa

Vice President, OncologyJack lepping

Executive Assistant, Oncology lynne Detorre

Vice President, Executive Creative DirectorJeff brown

office center at princeton Meadowsbldg 300 • plainsboro, nJ 08536(609) 716-7777

Corporate

Operations & Finance

Digital Media

Sales & Marketing

Editorial & Production

f r o M t h e p u b l i s h e r

Integrated Delivery Networks and the Future of Cancer Carethis month we take a closer look at two key issues in cancer care: how to measure the quality of care, and balancing cost versus quality. on page 2, “performance Metrics in oncology,” by thomas r. barr, Mba, argues that the presence of specific, essential clinical information as structured data in the clinical database is necessary for oncology care management. “Measuring Quality cancer care,” by robert gamble, on page 5, notes that healthcare, particularly cancer care, seems to be the last industry to define, measure, benchmark, and promote quality, value, and positive outcomes. on page 11, an article from Oncology Business Review, “cost Versus Quality in Different sites of cancer care,” by Zachary hartman, concludes that consolidation of practices is contributing to rising costs of cancer care without producing gains in quality of care. also from Oncology Business Review is a look, on page 8, at leading investigational products in oncology and areas of unmet need.

We hope that you enjoy this issue and look forward to your comments. please contact our editorial staff at [email protected].

—Jack LeppingVICE PRESIDENT, ONCOLOgy

1 6.13

A great American tradition is now backed by the oncology CME leader.

The American Journal of Hematology/Oncology®, a peer-reviewed resource for accredited oncology education, harnesses the breadth and depth of the educational programs and renowned faculty in the Physicians’ Education Resource® stable of legacy meetings. Each issue features original research and concise reviews of the current treatment trends in specific disease states, and provides practicing oncologists with the tools and the science they need to improve outcomes and the delivery of care.

In 2013, The American Journal of Hematology/Oncology® —the gold standard in physician-led education—joins the OncLive® family of publications.

www.AJHO.com

Advancing Cancer Care Through Professional Education®

The Gold Standard in Physician-Led Education

A great American tradition is now backed by the oncology CME leader.

The American Journal of Hematology/Oncology®, a peer-reviewed resource for accredited oncology education, harnesses the breadth and depth of the educational programs and renowned faculty in the Physicians’ Education Resource® stable of legacy meetings. Each issue features original research and concise reviews of the current treatment trends in specific disease states, and provides practicing oncologists with the tools and the science they need to improve outcomes and the delivery of care.

In 2013, The American Journal of Hematology/Oncology® —the gold standard in physician-led education—joins the OncLive® family of publications.

www.AJHO.com

Advancing Cancer Care Through Professional Education®

The Gold Standard in Physician-Led Education

Performance Metrics in OncOlOgyBy Thomas R. Barr, MBA

While management of clinical care using modern information technology is important to providers and payers of oncology care, it is critical to those of us who have a cancer diagnosis in our family or in our future—and that is just about everyone. providers must par-ticipate in the move to active measurement of clinical variables or become obsolete. they must also integrate reporting and measurement of important process mea-sures into routine clinical management. payers have a critical role in promoting this technology adoption. they are positioned to promote payment methodologies that support and reward clinical measurement. Without such support, innovative practices suffer economically as they push toward rational care. We all should expect ba-sic quality process measures that are indicative of good clinical management of cancer care for our families and

2 6.13 Oncology Business Management

In 2011, the Medicare Electronic Health Record (EHR) Incentive Program began paying physicians and hospitals for the measurement and reporting of performance metrics through the utilization of certified electronic medical record (EMR) software. This epic program began in earnest the irrevocable shift in the provision of healthcare from an individual craft-based art to a structured, evidence-based system. The EHR Incentive Program has three specific phases that progressively build from data capture and reporting, through clinical process refinement, to the final goal of achieving measurably improved healthcare outcomes.1 Currently, we are in the first phase of this transition, and in oncology, trends are emerging about what metrics are important to three key groups—patients, payers, and providers. Each seeks improvements to quality and lower—or at least stable—costs for cancer care. The broad utilization of EMR technology has, for the first time in history, enabled systematic measures of care delivery on a broad scale.

3

and the promise that being measured offers improve-ment. to be scientifically sound, there must be sub-stantial, explicit evidence with validity, reliability, and sufficient specificity to patient factors to be clinically useful. feasibility requires an explicit definition of the numerator and denominator needed for the measure from data that are available at low cost and with low administrative burden. today, the fact is that payment drives process measurement, and most systematic data are about billing, not about medical care. the ehr incentive program, coupled with many providers and payers seeking a departure from fee for service, are fac-tors driving oncology data feasibility toward important, scientifically sound measurements.

the presence of specific, essential clinical information as structured data in the clinical database is necessary for oncology care management. these data support pathway and guideline adherence, reduce treatment variability, take advantage of emerging companion treat-ment diagnostics, and promote cost savings through the avoidance of valueless care. in oncology, six basic elements are needed to enable such measurement. for every patient, we need to have structured data in the electronic medical record for stage, intent of therapy, toxicity, disease status, patient status, and line of ther-

apy. When there is substantial data density for these six process measures, the foundation is in place to begin to measure clinical outcomes across large populations of patients, and then in real time, see what is working.

so how do we get from low den-sity, as presently observed in oncol-ogy eMr data, to

CoverStory

The presence of specific, essential clinical information as structured data in the clinical database is necessary for oncology care management.

ourselves. successful payers and providers will encour-age patients to seek care where these quality indicators are available and exemplary.

Discussionthree visions of performance metrics in oncology were presented at the cancer center business summit held october 11-12, 2012, in fort Worth, texas. the theme of the conference was transitioning to value-based oncol-ogy, and most of the program content, including the full program that is summarized in this article, is avail-able online.2 While the three perspectives are different, there were consistent themes throughout. all speakers endorsed the use of available data, keeping metrics simple, delivering measurements to the care providers who can affect the numerator, and showing these pro-viders how they compare with peers. the speakers all understand that current payment methodology does not support process optimization, yet view that as a transi-tional barrier that will not persist.

i presented the three criteria that are generally ac-cepted for choosing clinical performance measures.3 to be successful, measures must be important, scientifi-cally sound, and feasible. importance is measured by the relevance of the measure to patients and providers,

Thomas R. Barr, MBA

high density on these process measures? Figure 1 shows data from an oncology Metrics survey per-formed in 2009 and reveals that physicians directly enter most of these data as part of their clinical man-agement activity.

there is ample evidence that peer review does alter physician behavior. oncologists who received feedback about the amount of chemotherapy that they were giv-ing at the end of life decreased from 50% of patients to 20% of patients in only 6 months.4 structured clinical data offer the opportunity to show individuals how they compare with named physicians in their own practice. additionally, this lets the physician know that others see his score too (Figure 2).

Deb hood, vice president of the national oncology service line of catholic health initiatives (chi), spoke about the experience of her institution in beginning to establish what she called value-based care metrics. While there are five dimensions to their hospital per-

Figure 1. Survey Data Showing Who Is Entering Information Into the EMR

Figure 2. Sample Process Metric Presented to Physicians

3 6.13

tionality could be created in a cloud-based relational database but noted that these two types of information are not standardized. this shortcoming limits the ability of process measurement to provide compelling informa-tion about problems addressed and determine if im-provements are realized. to achieve process control and improvement, it is necessary to define the process and train process operators, collect process performance data, and then audit process for compliance. none of

this functionality is present in large-scale systems today and this is a limiting reality to the application of tested process management technology that is used in the manufacturing environment. to no small degree, this fractioning of healthcare is part of the payment meth-odology. fee for service provides incentives for more process steps and leads to variable endpoints, unco-ordinated care, and undocumented outcomes. When healthcare delivery and payment more closely resemble typical manufacturing environments, characterized by a drive to reduce process steps and maximize value, then the tools from that sector will become applicable.

REFEREnCES

1. EHR incentive programs. Centers for Medicare & Medicaid Services website. www.cms.gov/Regulations-and-guidance/Legislation/EHRIncentivePrograms/index.html. Accessed May 22, 2013.

2. Cancer Center Business Summit website. www.cancerbusinesssummit.com/program.htm. Accessed May 22, 2013.

3. Center for Health Policy Studies, Harvard School of Public Health, Center for Quality of Care Research and Education. Understanding and choosing clinical performance measures for quality improvement: development of typology: final report. Rockville, MD: Agency for Healthcare Research and Quality; 1995.

4. Blayney DW, McNiff K, Hanauer D, et al. Implementation of quality practice initiative at a university comprehensive cancer center. J Clin Oncol. 2009;27(23):3802-3807.

5. Bloomberg highlights Vermont cancer pilot; PCD partners plays key HIT role. PCD Systems website. http://pcdsys.com/bloomberg-highlights-vermont-cancer-pilot/. Published August 24, 2012. Accessed May 22, 2013.

6. Decreasing complexity, improving care quality, and reducing cost in oncology. http://pcdsys.com/care-quality-in-oncology/. PCD Systems website. Published July 5, 2012. Accessed May 22, 2013.

CoverStory

spective, she emphasized improvement in quality and reduction of cost. although there are many quality met-rics in oncology, chi has decided to focus on data that are readily available and easy to audit. the best data source for them is registry data, as they are extracted in real time and encompass more that 30,000 new cases each year. from these data, they have created “dashboards” for breast cancer, exception reporting for chemotherapy and radiation therapy, readmission tracking for all oncology patients, and pharmaceutical expense tracking. to leverage these reports to create measurable improvement in care, they are presenting comparative measures at the institutional level with color coding to promote easy understanding. green signifies compliance, yellow is nearly in range, and red is out of compliance standard. a sample of such a report card is shown in Figure 3.

Wes chapman, president and ceo of pcD partners, provided an overview of the application of iso 9001 and lean six sigma in two large-scale projects.5,6 noting that outcome metrics are only viable in the context of a uniform process, and understanding that healthcare provision is not at all a uniform process, useful metrics are limited to process metrics (Figure 4).

to adequately measure processes in large systems, the integration of documents and data into a single system is necessary. chapman said that this novel func-

Figure 3. Service Line Dashboard From Catholic Health Initiatives

Figure 4. Hierarchy of Metrics and the Organizational Sponsors

Transitioning to Value-Based Oncology: Strategies to Survive and Thrive

Metrics/Quality & Process Change

process Metrics:• Measure compliance• almost all metrics are

process metrics

outcome Metrics:• only viable in context

of uniform processes


Two of my favorite activities are running and salt-water fishing. Both are very pre-cise and numbers-oriented activities. Run-ning is about time, pace, distance, calorie burn rates, and heart rate zones, among other factors. When talking with runners, it does not take long for the conversation to come around to the essential ques-tions: “What is your PR (personal record) for a half (or full) marathon?” or “What is your average weekly miles?” Both of these questions reflect standard benchmarks of the level of accomplishment in the sport.

fishing, or as we say in the south, “fishin’,” has its own set of standards. before we graduate to the point of hoping the fish do not bother us, we are watchful of length, weight, creel limit, and also making sure the catch falls within season. Measurement is serious business, to the point that the fishing industry has its own “golden rule”—an official calibrated tool to measure the length of a fish. Woe to the person who is

caught with a fish under or over the size requirements. the fisherman strives to have the best answer to the routine question, “Did you catch anything?” if that is answered in the affirmative, the next question will hopefully be answered with a boast: “any size?”

both of these activities have finite and very specific criteria of what is considered “good” or “excellent.” Why is it we struggle with the similar concepts in healthcare, and particularly cancer care? it is interesting that health-care accounted for 15.2% of gDp in 2008.1 fishing (even when included in the category of agriculture, hunting, forestry, and fishing) is only 1.1% of gDp.2 the running industry is not even high enough to score a 1/100 of a percent. if healthcare consumes so much of our world, why is it then that we focus so little attention on the specifics of quality or value or outcomes in healthcare?

Defining Quality, Value, and Outcome Measuresthe lack of attention in systematically measuring quali-ty and value in cancer care became particularly obvious when working with the oncology Medical home (oMh) steering committee on its objective of defining 16 quality, value, and outcome measures for cancer care.

Measuring Quality Cancer CareBy Robert gamble

f e a t u r e

The lack of attention in systematically measuring quality and value in cancer care became particularly obvious when working with the Oncology Medical Home (OMH) Steering Committee on its objective of defining 16 quality, value, and outcome measures for cancer care.

Robert Gamble

5 6.13

this cross-section and balanced approach to defining key determinants to patient care, resource utilization, survivorship, and end-of-life care may prove challeng-ing, but its time is past due. for example, as an outdoor enthusiast, my hope is that i will be called home while running, fishing, or simply walking on a trail. for a cancer patient, the hope is that he or she may leave this earth among family or friends and surrounded by a known and friendly environment—peacefully and qui-etly. Dying at home would seem to be the choice for all, if we had a choice. and there is no better indicator of the quality of life, at end of life, than the place of death. however, it seems that the national death registry does not record a “place” of death. the standard death certificate includes the following choices for place of death: “hospital inpatient, er/outpatient or Doa; nursing home, residence or other (specify).” it would seem that it would be beneficial to include these data in the national death registry and to recognize same as a quality and value indicator for all of healthcare, not just cancer care. this seems to be an easy fix.

and somewhat related is the entire discussion sur-rounding end-of-life care conversations. patients and families need open and honest dialogue regarding their current status, their wishes, and how their wishes are to be carried out. this goes beyond the simple question of asking patients if they are ready to meet their maker. one of several programs that attempt to remedy this issue is the “5 Wishes” program.3 this program asks 5 probing questions regarding assigning decision mak-ers, medical treatment preferences, preferred comfort levels, preferences on interactions with others, and last wishes. this program provides specific guidance on how to conduct these conversations. Dr John sprandio (pennsylvania) and Dr John fox (Michigan) have indi-cated that when these discussions occur, and at the right time, patients have made decisions to discontinue aggressive cancer treatment. the end result is more

comfortable end-of-life care. although some patients (or family members) may resist these discussions, they should be required for any healthcare team charged with managing any terminal disease. When done prop-erly, the door is left open for miracles, but the patient and family are able to make informed decisions regard-ing care. electronic medical record vendors will need to enhance their data capture fields from a simple “advanced directive on file – y or n” to a more detailed and comprehensive approach to this question if we are to raise the bar in care and compassion. there should be similar guidelines for the specifics of care plans and cancer survivorship plans.

another milestone by the community oncology alli-ance (coa) oMh steering committee was the endorse-ment that all cancer care providers should calculate their own 5-year survival rates for breast, colon, and lung cancers. this is completely logical and is a measurement whose time has come. as a former manager of a cancer center, i often wondered what i would say when asked for our own 5-year survival rate for stage 3 breast cancer. it would seem to be a logical and reasonable question but one that currently has no answer—at least not for an individual cancer center. “survival” rates, when they are the only measure, are not necessarily a good indica-tion of quality, particularly if a patient is being kept alive through artificial means and against the wishes of the patient or family. but, when combined with other stan-dards and educational requirements, this information can be very helpful to patients and their families in plan-ning and in the celebration of significant milestones.

Overutilization of Hospital Servicesone of the more elusive measures but one that has great significance in the value department is the use, or overuse, of hospital services. some patients and healthcare providers are quick to utilize these expen-sive inpatient, outpatient, or emergency department (eD) resources over a less expensive setting such as the exam or procedure room of their medical home. governmental and commercial payers all agree that the overuse of these resources represents a significant expense and an opportunity to realize savings in time and dollars to the payer and patient. the challenge with curbing this misuse of resources is that the person who should know of these encounters, the patient’s medical home physician, does not always know when they oc-cur. the hospital staff will be the first to know, the pa-tient’s payer may be the second to know, but the per-son who should know first, the patient’s physician, may never know if or when this event occurs. some com-mercial insurance companies are providing financial incentives to curb unnecessary eD visits or hospitaliza-tions. this is why the coa oMh steering committee has endorsed this measure. perhaps we need to revise this notion of “precertification” and insert the patient’s medical home provider as the “Mother may i” authority before these services are rendered. this procedural change would allow the patient’s main care team to in-tervene with, hopefully, a more efficient solution, and it would also assist in nurturing the relationship between the patient and his or her medical home physician. only then will we be able to measure and benchmark the utilization of these valuable resources and reward those care teams that use them appropriately.

Applying Our Own “Golden Rule”other industries seem to have a head start on defining quality statements. healthcare, and particularly cancer care, seems to be the last industry to define, measure, benchmark, and promote quality, value, and positive outcomes. perhaps it is because we have been busy taking care of others that we have not been able to focus on such a mammoth undertaking. now may be the time to apply our own “golden rule” to measuring quality and value in cancer care. after all, and as i am sometimes re-minded, there is more to life than running and fishing.

REFEREnCES

1. Health care in the United States. http://en.wikipedia.org/wiki/Health_care_in_the_United_States. Accessed May 22, 2013.

2. OECD. StatExtracts. http://stats.oecd.org/Index.aspx?DatasetCode=SNA_TABLE1. Accessed May 22, 2013.

3. Aging with Dignity website. www.agingwithdignity.org/five-wishes.php. Accessed May 22, 2013.

f e a t u r e

Perhaps we need to revise this notion of “precertification” and insert the patient’s medical home provider as the “Mother may I” authority before these services are rendered.

—Robert Gamble


Thousands of referring physicians and healthcare professionals rely on Memorial Sloan-Kettering for a steady stream of news and information on advances in cancer prevention and treatment, clinical trials and upcoming CME programs.

Your trusted resource for oncology information.

TO REFER A PATIENT, CALL 1-866-218-8132.

Scan this code to receive our free bi-monthly physician e-newsletter, OncoNotes and learn about all the resources we offer healthcare professionals at www.mskcc.org/healthprofessionals

Thousands of referring physicians and healthcare professionals rely on Memorial Sloan-Kettering for a steady stream of news and information on advances in cancer prevention and treatment, clinical trials and upcoming CME programs.

Your trusted resource for oncology information.

TO REFER A PATIENT, CALL 1-866-218-8132.

Scan this code to receive our free bi-monthly physician e-newsletter, OncoNotes and learn about all the resources we offer healthcare professionals at www.mskcc.org/healthprofessionals

Oncology continues to be a significant focus of development in the pharmaceuti-cal market. The field is crowded, despite the fact that the agents in development target a broad range of tumor types. Kan-tar Health has profiled 69 pipeline agents that are in pivotal clinical development, in addition to the vast number of pivotal trials ongoing as part of lifecycle manage-ment (LCM) for launched oncology prod-ucts. Here, we take a sneak peek focused on some of the late-stage drugs in devel-opment in the oncology pipeline.

in our analysis, over one-half of oncology pipeline agents possess novel mechanisms of action (Moa) and are vying to be first-in-class. perhaps not surprisingly, the vast majority of these agents currently seeking first market entry are only being evaluated in one pivotal study (Figure 1). one-quarter of these pipeline agents are, however, being studied in multiple phase iii trials (predominantly targeting multiple tumor types), with

these multiple trials initiated before defini-tively established activity in patients.

it’s worthwhile to note that these pipeline compounds are nearly equally being devel-oped by “big pharma” and “small biotechs,” with only a handful in development by Mid-size/emerging pharma or as a collabora-tive effort. however, pipeline agents with multiple pivotal trials ongoing are heavily weighted toward those in development by big pharma or as part of a collaborative ef-fort. conversely, those agents with a single pivotal trial ongoing, trend toward those in development by smaller biotechs; this po-tentially reflects limited resources for r&D, especially considering that the mechanisms of action of two-thirds of these agents have the potential to support development in multiple indications.

interestingly, the majority of the indications in which these 69 agents are being developed target rather small indications in terms of patient population size. as Figure 2 shows, 60% of the ongoing pivotal trials are being conducted in indications with a target population

of less than 12,500 patients.1 this is in contrast to a decade ago, when most agents in pivotal development were targeting the largest patient populations, such as breast cancer, non-small cell lung cancer (nsclc), and colorec-tal cancer (crc).

some of the smaller indications represent tumors in which the incidence of the disease overall is rather small, such as acute lym-phocytic leukemia (all) and soft tissue sarcoma, whereas others represent biomarker

subsets of larger tumor types, such as Met+ nsclc or nras mutant melanoma. however, despite the oncology community’s growing focus on personalized medicine, only 22% of pipeline agents currently in pivotal trials are being developed in a biomarker-de-fined patient population. two-thirds of ongoing pivotal studies with pipeline agents are being conducted in indications with relatively low unmet need (Figure 3).

of course, all cancer indications have rather high unmet need compared to non-oncology indications due to the life-threatening nature of the disease; however, among the numerous cancer indications, the level of need may vary considerably.

through extensive analysis based on a combination of product and indication attributes, Kantar health has evaluated and rated these 69 pipeline agents to identify those with the greatest likelihood of clinical impact in the next three years. our analysis identified the top 10 pipeline agents with the greatest potential for impact on the oncology market (Table 1).

separately, five pipeline agents have emerged as having significant “breakthrough” potential, based

Figure 1. number of Trials Each Agent is Participating In

source: Kantar health

50

20

40

10

30

0

50

One Trial

TwoTrials

ThreeTrials

PIVOTAL TRIALS ONGOING

PIPE

LIN

E AG

ENTS

FourTrials

FiveTrials

125

1 1

Figure 2. Agents in Pivotal Trials, by Market Size


<2500

2500-7500

12500-17

500

7500-12500

17500-25000

>25000

NUMBER OF ELIGIBLE PATIENTS

30

23

10

4

12

16


Mining the Pipeline: leading investigational products and areas of unmet need

By Stephanie Hawthorne, PhD

primarily on the merits of their clinical data and independent of target indica-tion attributes. We believe these five agents have the potential to dramatically improve efficacy outcomes and may transform the standard of care in their target indications.

1. Dabrafenib + Trametinibfor metastatic melanoma, 2011 was a transformative year with the approval of yervoy (bristol-Myers squibb) and Zelboraf (genentech/roche). glaxo- smithKline is developing the braf inhibitor dabrafenib and the MeK inhibitor trametinib as challengers to Zelboraf’s foothold as the new standard of care in patients with the BRAF muta-tion. as monotherapies, neither dab-rafenib nor trametinib raises eyebrows. in combination, however, they may be a force to be reckoned with.

in randomized phase ii data re-ported at the 2012 european society for Medical oncology (esMo) annual meeting (long, abstract lba27), the combination significantly prolonged pro-gression-free survival (pfs) compared with dabrafenib alone (9.4 months vs 5.8 months; hr = 0.39; P<0.0001) while also reducing the incidence of key toxicities associated with this class of agents. these data are currently being explored in two phase iii trials, evaluat-ing the combination of dabrafenib plus trametinib in first-line metastatic melanoma, and in the adjuvant setting for patients with stage iii disease.

fDa approval of each agent as a monotherapy is expected in 2013, but Kantar health anticipates that the na-tional comprehensive cancer network (nccn) will recommend use of the com-bination regimen based on the highly positive randomized phase ii data, giving this combination a near-term impact on the melanoma market. With the poor prognosis of patients with BRAF-mutant melanoma, the strong phase ii data that nearly doubles the pfs for these patients, and the biologic potential to

expand into other indications, this combination can be viewed as a regimen with breakthrough potential.

2. Ibrutinibthe bruton’s tyrosine kinase (btk) pathway is a downstream mediator of the b-cell receptor pathway, making ibrutinib a novel mechanistic approach to the treatment of b-cell malignancies. ibrutinib has dem-onstrated robust activity in heavily pretreated chronic lymphocytic leukemia (cll) and mantle cell lymphoma (Mcl). interestingly, ibrutinib activity does not seem to be dependent upon prior therapies or poor-risk features that typically produce varied results with other treatments. as a single agent, it produced response rates in 68% of treatment-naïve patients and in 71% of relapsed/refractory and high-risk patients with cll (byrd, abstract 189, ash 2012).

furthermore, ibrutinib is amazingly well tolerated, with very few serious adverse events. the lack of signifi-cant toxicity opens the door for it to be combined with current standards of care. capitalizing on the early effi-cacy signals, pharmacyclics and Johnson & Johnson are pursuing multiple pivotal trials of ibrutinib in relapsed/refractory cll and Mcl. With robust clinical activity and a favorable safety profile, ibrutinib makes Kantar health’s list of potential breakthrough agents to watch.

3. Idelalisibthe pi3K pathway undoubtedly represents one of the hottest drug targets in oncology. idelalisib is the most advanced of the isoform-specific pi3K inhibitors, and it made a big splash when its clinical data was first reported at ash 2011, showing a high response rate and pfs achieved in heavily pretreated cll and non-hodgkin’s lymphoma (nhl) (coutre, abstract 6631, asco 2011; de Vos, abstract 2699, ash 2011).

in cll, idelalisib in combination with rituximab (ritux-an; genentech/roche) and/or bendamustine (treanda; teva) produced response rates in the range of 78% to 87% in patients who had received a median of three pri-or therapies, which is impressive activity compared with historical standards in this setting. further follow-up of these studies continues to support the hype. although it’s not without toxicity, the observed toxicities don’t overlap with those associated with current standards of care in cll and nhl, leaving open the possibility for idelalisib to be combined with existing regimens.

following its 2011 acquisition of calistoga, gilead has charged ahead with the development of idelalisib, initiating four phase iii trials in relapsed/refractory cll and indolent nhl. in cll, idelalisib will com-

Table 1. Pipeline Agents with the Greatest Potential Impact in Oncology

Drug in Development Manufacturer Indications

Afatinib boehringer ingelheim

breast, nsclc, head and neck

Radium-223 algeta/bayer prostate

Astuprotimut-r glaxosmithKline Melanoma, nsclc

Dabrafenib + Trametinib

glaxosmithKline Melanoma

Ibrutinib pharmacyclics/ Johnson & Johnson

chronic lymphocytic leukemia, mantle cell leukemia

nivolumab bristol-Myers squibb Melanoma, nsclc, renal cell carcinoma

Onartuzumab genentech/roche gastric, nsclc

Ramucirumab eli lilly breast, colorectal, gastric, hepatoceullular carcinoma, nsclc

Palbociclib pfizer breast

Rivantinib arQule/ Daiichi sankyo

hepatocellular carcinoma

attributes that were scored included mechanistic innovation, strength of prior published data, target indication population size, and level of competition. for more in-depth information on Kantar health’s scoring methodology, please e-mail [email protected].

Figure 3. Agents in Pivotal Trials, by Unmet need


the level of unmet needs was calculated based on the number of existing treat-ment options in the target indication (with fewer treatment options correlating with higher need), the rate of treatment (with high non-treatment rates correlating with higher need), and efficacy outcomes achieved with current options (with short survival times correlating with higher need). high overall scores for the sum of these three attributes were considered to be a high unmet need, whereas low overall scores were considered to be a low unmet need.

<10(Low Need)

10-19 20-29 30+(High Need)

UNMET NEED SCORE

51

26

14

5

9 6.13

60% of the ongoing pivotal trials are being conducted in indications with a target population of less than 12,500 patients.

pete strongly with ibrutinib, as they are both being developed in nearly identical clinical studies, so the commercial success of each agent will depend in part on the success of the other. although limited data are available on idelalisib, the strong clinical efficacy that has been observed, coupled with the promise of pi3K inhibition gives this agent breakthrough potential.

4. Nivolumabone of the hottest topics at the 2012 american society of clinical oncology (asco) annual meeting was the role of pD-1 in suppression of antitumor im-munity, most notably captured in the results of a large first-in-human phase i trial of nivolumab (bristol-Myers squibb). these data have been discussed at length previously, but the short story is that nivolumab dem-onstrated impressive activity, with durable objective responses observed in several solid tumors. the level of activity was so exciting, based largely on the fact that they were achieved with a single-agent immuno-therapeutic in patients with heavily pretreated disease.

preliminary data also suggest that pD-l1 expres-sion may serve as a biomarker to select patients for response to nivolumab, which could further increase its efficacy in a selected population. on top of these efficacy outcomes, nivolumab impressed with its rather tolerable safety profile. from this single (albeit large) phase i trial, bristol-Myers squibb plowed ahead, initiat-ing five phase iii trials in three tumor types (melanoma, nsclc, and renal cell carcinoma—the three indications with strongest efficacy signals in phase i). such a quick move from phase i to phase iii is not always advised, but it has been successful for several other agents in recent years (eg, Xalkori [pfizer] in alK+ nsclc).

the strong phase i data, good safety profile, broad

applicability across multiple tumors, and the possibility for a predictive biomarker all contribute to nivolumab’s potential breakthrough status.

5. Palbociclib (PD-0332991)pD-0332991 (palbociclib; pfizer) wowed the audience at the 2012 san antonio breast cancer symposium (sabcs) annual meeting with its Kaplan-Meier curve for pfs in a randomized phase ii trial of letrozole with or without pD-0332991 as first-line therapy for er+ metastatic breast cancer. at the median, the addition of pD-0332991 increased pfs by 18.6 months, with an overall 63% reduction in the risk of progression or death (finn, abstract s1-6, sabcs 2012).

the drug was associated with significant hemato-logic toxicity, which appeared all the more significant when considered in the space of hormone therapy for breast cancer that has very few serious adverse events. While this high level of toxicity might have raised concerns, the ability to manage these toxicities through supportive care measures keeps the excite-ment level for this agent from being downgraded.

as a cDK 4/6 inhibitor, it will be first-in-class if it hits the market, although inhibitors of other cDKs are also in late-stage development (eg, dinaciclib [Merck] is a cDK-1/2/5/9 inhibitor being studied in cll). although currently in pivotal development only for metastatic breast cancer, the eventual development of this regimen in earlier-stage breast cancer can be foreseen, and pfizer is also investigating the drug in a number of other solid tumors. With broad applicabil-ity and stunning phase ii data, pD-0332991 has the ability to be a breakthrough agent in the treatment of cancer.

these five agents are just the tip of the iceberg. the

oncology pipeline continues to grow, and the number of novel Moas in development offer significant promise toward improving outcomes in a variety of indications. the past couple of years have seen some significant breakthroughs in cancer management, and the next few years have great potential to similarly transform care and outcomes.

RefeRence1. Kantar health, cancerMpact® Patient Metrics, u.s., www.Kantar-

health.com. accessed March 25, 2013

About the contRibutoRstephanie hawthorne, phD, is Director, clinical and scientific assessment at Kantar health.

Kantar health is a leading global healthcare advisory firm and trusted advisor to the world’s largest pharmaceutical, biotech, and medical device and diagnostic companies. it combines evidence-based research capabili-ties with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and marketing expertise to help clients launch products and differentiate their brands in the marketplace.

Kantar health’s oncology-related offers include the cancerMpact® Future Trends and Insights module, which explores potential changes in treatment practices in the u.s., Western europe, and Japan based on a critical evaluation of recently published clinical data, regulatory advances/setbacks, and ongoing clinical trials.

if you would like us to act as catalysts for you, contact us at www.kantarhealth.com/contactus.

This article was originally published online on Oncology Business Review, OBR Green.http://oncbiz.com/obrgreen


11 6.13

Over the past decade, more oncology pro-viders have shifted toward consolidation of practices to remain viable. In fact, in the last 4 years, 524 private practices have entered into agreements with or have been acquired by hospitals.1 As a result of private practices closing, an increas-ing amount of oncology patient care has migrated toward the outpatient hospital setting. But, is this phenomenon a positive or a negative for healthcare on the whole? Data from recently published white papers and surveys suggest that consolidation of practices may provide significant financial stability for providers, but it may also be contributing to the ever-rising costs to the cancer care industry without tangible gains in quality of care.

Debate in Favor of Oncology Practice Consolidationan argument could be made that the changes in Medicare reimbursement due to implementation of the Medicare Modernization act of 2003 that revised the reimbursement methodology to asp +6% is the major driver of today’s practice consolidation. accord-ing to the 2012 national benchmarking survey, that reimbursement modification is seen as an increased difficulty for community practices in maintaining op-erational margins, a phenomenon colloquially referred to as “the squeeze.”2

Many community cancer care sites have also found this reimbursement model to be insufficient to stay in business. further complicating matters, the patient protection and affordable care act (aca) fails to ad-dress the issues connected to the sustainable growth rate, which calculates Medicare’s formula for determin-ing annual updates to physician reimbursements for

services. the aca’s independent payment advisory board has yet to be implemented, and there are still many unknown consequences providers will have to face.

arguments in favor of practice consolidation are many. for start-ers, a large hospital typically has access to a larger variety of re-sources than a private practice can afford to invest in, such as psycho-logical and financial counseling not directly related to oncology care. by offering more services, a hospi-tal setting has more opportunities to create cost-savings through effi-ciency than a community practice.

although some may argue that these additional services drive up the cost of treatment, the practice of cost-shifting allows hospitals to ride out economic storms for short periods of time without major labor-force upheavals or service cuts. cost-shifting towards higher prices for treatments therefore grants a measure of financial stability to the hospital. the negative is that cost-shifting can also become a ne-cessity because hospitals, being nonprofit organiza-tions, are required to maintain a certain amount of charity work to earn tax benefits. this practice does not improve quality, per se, but it can become an ef-fective “rainy day” strategy for many hospitals.

charity work itself points to another benefit of consoli-dation: wider access to healthcare for the poor. private practices can either accept or refer patients at their discretion, leaving hospitals to absorb the high costs of treating uninsured and unhealthier patients requiring more extensive care. approximately 24% of all cancer treatment occurs exclusively in the hospital outpatient setting, meaning hospitals are likely not handling a majority of the “ideal” patients for treatment.3 a higher rate of comorbidity in patients treated at hospitals may account for, and justify, higher treatment costs overall.

hospitals, being more centrally run as a business have more resources and wherewithal to figure out what works to improve efficiency, and then implement changes. an oncologist running a private practice may have neither the time nor the drive to do the same. it’s of paramount importance, though, that changes are made to labor structures, since this expenditure is among the fastest-growing in all of cancer care, and operating costs are climbing faster than revenues (Figure 1).2 a hospital is better-positioned to absorb these rising labor costs than a private practice.

size confers another important benefit to hospitals: leverage. the lowering tide of reimbursement by payers like Medicare can be mitigated by hospitals because the threat of losing a large client base may allow pay-ment negotiations to open up considerably. a hospital can use this leverage to earn a more favorable payment plan to cover rising costs.

consolidation is also an important investment vehicle for hospitals. initially, they may lose money by hiring more doctors while absorbing practices.4 however, hospitals may reap significant rewards and remain competitive as accountable care organizations (acos) are formed as per provisions outlined in the

Cost Versus Quality in Different Sites of Cancer Care By Zachary Hartman

Figure 1. Trends in Costs and Revenue from 2005-2011

source: barr tr, towle el. J Oncol Pract. 2012 ;8(5):292-297.

AM

OU

NT

($)

5,500,000 Total Medical RevenueTotal Operating CostspMedical and Surgical

Supplies (cost of drugs)

R2 = 0.8596

R2 = 0.8703

R2 = 0.4533

5,000,000

4,500,000

4,000,000

3,500,000

3,000,000

2,500,000

2,000,000

1,500,0002005 20092007 20112006 20102008 2012


aca. although the future impact of acos is not yet fully understood, Michael Kolodziej, MD, national Medical Director for on-cology strategies at aet-na, told us that the aca was implemented with the intention of driving toward more integrated, seamless care. “acos,” he said, “are

going to change the game of oncology care. it is just not yet known exactly how this will take place.”

Kolodziej remains optimistic. to him, consolidation is a transitory state that will force both community and hospital-based providers to improve infrastructure and efficiency. With consolidation, hospitals are better positioning themselves by bringing in new talent, and strengthening their internal referral base and servicing more patients.4 “the more forward-thinking hospitals are already considering how to change to decrease the cost and improve the quality of care.”

Debate Against Oncology Practice ConsolidationManaging the cost of healthcare is important to payers and the economy at large, since healthcare spending is a large portion of our gross domestic product.5 in a recently published amerisourcebergen white paper, it is suggested that one problem with the consolida-tion of practices is that while the quality of care is not significantly better,6 it is more expensive. supporting this evidence is an avalere health report from a study it conducted, which found an average increase of 24% in costs associated with chemotherapeutic care in the outpatient hospital setting compared with community practices.7

another analysis by Milliman, inc. demonstrated that the average annual cost of chemotherapy covered by Medicare from 2006 through 2009 was $47,500 for privately owned practices, while similar services performed in the outpatient hospital setting incurred a cost of $54,000 on average.3

as discussed in the “Value of community oncology site of care cost analysis,” rising costs in the hospital outpatient setting have not translated to better patient outcome.6 a retrospective analysis as part of the synthesis project reported that hospital consolidation reduces quality of care at the same time that it in-creases costs.8 even if both consolidated hospitals and community practices are meeting similar standards of care and improving outcomes for oncology patients, innovation in the form of clinical trials is carried out primarily by community practices.9 consolidation may

result in stunted development of new generations of cancer therapeutics.

consolidation may also place undue burden on the supply of doctors. in years past, the end goal of an oncologist’s education was to open a business of his or her own. for many, the idea of working in a hospital and losing autonomy and career potential may be enough of a disincentive to prevent him or her from entering the oncology care field entirely. a generational shift of priorities may mitigate this problem, however, as many young doctors are willing to sacrifice some amount of career development in favor of the financial stability that is afforded by working for a hospital.4

Considering PerspectiveDespite the advantages conferred by hospitals absorb-ing private practices, continued consolidation is not likely to yield good returns for many reasons. private practices have traditionally been important delivery vehicles of quality treatment and screening to regions that make little economic sense to service, such as rural areas. the closure of these practices makes get-ting access to treatments more difficult in this case, necessitating longer trips for diagnosis and treatment. this difficulty could lead to higher-risk populations al-lowing a malignant disease to progress beyond a stage where treatment is economical or effective. commu-nity oncology also provides convenient, personalized care in large and small cities alike.

private practices also present an important cost balance against rising of costs by creating competition. the greater power wielded by hospitals in terms of pay-er negotiation can present a double-edged sword. re-imbursements can reach out-of-control levels, resulting in a greater burden on payers that is transferred to the consumer in the forms of higher premiums and taxes. cautionary tales of unchecked competitive positioning can be told about the california and Massachusetts markets.10,11 for example, in california consolidation has created some markets where a single “must-have” hospital can negotiate massively-inflated reimburse-ments.8 “Must-have” hospitals, by definition, have market leverage over health plans that cannot plausibly threaten to exclude them. importantly, “must-have” providers’ strong negotiating position is not necessar-ily derived from size, but rather by factors not typically part of antitrust analysis. that is, they are “must-have” for reasons other than large market share.

so the question remains: is consolidation working? the answer most likely depends on perspective. oncol-ogy practices consolidating may weather uncertain economic and legislative times, but they also lose their autonomy. the challenges of running a successful

oncology practice are many, and may be better handled by Mbas than MDs. improvements in efficiency can be more easily translated into big gains within a larger system such as a hospital. unfortunately, those savings have not been realized, since it still costs markedly more to treat cancer in the hospital outpatient setting compared with the community practice. from the payer and consumer perspective, consolidation has yet to pro-vide significant benefit. access is decreased (especially in rural areas); costs are elevated; and patient outcome is not enhanced. these problems must be engaged in order to help control the burgeoning cost of healthcare in the united states, and the trend of consolidation does not appear to be slowing any time soon.

RefeRences1. Community Oncology Practice Impact Report, april 4, 2012.2. barr tr, towle el. oncology practice trends from the national

practice benchmark. J Oncol Pract. 2012;8(5):292-7.3. finch K, pyenson b. site of Service Cost Differences for Medicare

Patients Receiving Chemotherapy. prepared by Milliman, inc. october 2011.

4. Kocher r, sahni nr. hospitals’ race to employ physicians--the logic behind a money-losing proposition. N Engl J Med. 2011 12;364(19):1790-1793.

5. roehr b. us spent $2.7 trillion on healthcare in 2011, but growth remains steady. BMJ. 2013 10;346:f199.

6. the Value of community oncology site of care cost analysis. http://www.ourcommunitycounts.org/assets/siteofcareWhite-paper.pdf. accessed May 22, 2013.

7. Total Cost of Cancer Care by Site of Service: Physician Office vs Outpatient Hospital. March 2012. prepared by avalere health, llc.

8. Vogt Wb, town r, Williams ch. how has hospital consolidation af-fected the price and quality of hospital care? Synth Proj Res Synth Rep. 2006 (9); pii: 15231.

9. blayney DW. commentary: six years of trends in oncology practice data. J Oncol Pract. 2011 sep;7(5):291-3.

10. berenson ra, ginsburg pb, Kemper n. unchecked provider clout in california foreshadows challenges to health reform. Health Aff (Millwood). 2010;29(4):699-705.

11. office of attorney general Martha coakley. Examination of Health Care Cost Trends and Cost Drivers. June 22, 2011.

This article was originally published online on Oncology Business Review, OBR Green.http://oncbiz.com/obrgreen

Michael Kolodziej, MD

With CancerCare, the difference comes from: • Professional oncology social workers• Free counseling • Education and practical help• Up-to-date information • CancerCare for Kids®

For needs that go beyond medical care, refer your patients and their loved ones to CancerCare.

CancerCare’s free services help people cope with the emotional and practical concerns arising from a cancer diagnosis and are integral to the standard of care for all cancer patients, as recommended by the Institute of Medicine.

makes all the difference

®

1-800-813-HOPE (4673)

www.cancercare.org

Help and Hope

41960ALT_Queen_v1 1 5/13/08 10:03:26 AM

We’re saving a place for you this July.

12th International Congress on the Future of Breast Cancer® July 18-20, 2013Hyatt Regency • Huntington Beach, CAThe12th International Congress on the Future of Breast Cancer® is a 3-day educational and scientific meeting that serves as an update on advances in the field with a focus on the clinical implications of breast cancer genetic and phenotypic subtyping.

Program Director: Joyce O’ Shaughnessy, MDThis activity is supported by educational grants from Bristol-Myers Squibb, Celgene Corporation and Lilly USA, LLC.

14th International Lung Cancer Congress®July 25-27, 2013Hyatt Regency • Huntington Beach, CAThe14th International Lung Cancer Congress® will provide current, practical information on the management of lung cancer, as well as a look at the novel agents and strategies that will shape the future of lung cancer therapy.

Program Directors: David R. Gandara, MD, and Roy Herbst, MD, PhDThis activity is supported by educational grants from Celgene Corporation, Eisai Inc. and Genentech.

Physicians’ Education Resource® is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Earn up to 20 AMA PRA Category 1 CreditsTM

Earn up to 19 AMA PRA Category 1 CreditsTM

Join us for two exciting meetings in Huntington Beach, CA!

PER_July2013_q.indd 1 4/15/13 2:41 PM

UPDATE NEEDED!!

Documents

Oncman 6'13