The Effect of Burnout on Oncology Practices...shift from traditional randomized clinical trials to pragmatic clinical trials conducted in real-world settings. There has also been an

volume 17, issue 1 - Spring 2018

The Effect of Burnout

on Oncology Practices

2 | Oncologistics

As true leaders in industry, true innovators in care

and true partners in service, ION Solutions has

been dedicated to fighting for community oncology for 20 years.

One of the ways we demonstrate our

commitment to independent community

oncology is through our advocacy efforts on

Capitol Hill.

Since 2015, Community Counts has raised

awareness on the impact of sequestration,

the Part B Demo Project, and other issues

paramount to the viability of the community

setting. Just last year, more than 500

individuals contacted 280 legislators through

this outreach program.

True leaders.

True innovators.

True partners.

YEARS

ION SOLUTIONS

As true leaders in industry, true innovators in care

and true partners in service, ION Solutions has

been dedicated to fighting for community oncology for 20 years.

One of the ways we demonstrate our

commitment to independent community

oncology is through our advocacy efforts on

Capitol Hill.

Since 2015, Community Counts has raised

awareness on the impact of sequestration,

the Part B Demo Project, and other issues

paramount to the viability of the community

setting. Just last year, more than 500

individuals contacted 280 legislators through

this outreach program.

True leaders.

True innovators.

True partners.

YEARS

ION SOLUTIONS

INNOVATIONcancer

The Innovation Cancer solutions portfolio

offered by ION Solutions and

Oncology Supply exemplifies our

commitment enabling community

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Table of ContentsSpring 2018

6 Helping Specialty Practices Bridge the Clinical Research Gap

By Susan Weidner

14 The Impact of Burnout on Oncology Practices

By Gordon Kuntz

17 MIPS Tips

Information to help your practice successfully meet MIPS measures

21 What’s News at ION

volume 17, issue 1 - spring 2018

Editorial & Design staff:

· Chris Vorce Senior Director, Marketing & Communications, ION Solutions

· Tricia Musslewhite Manager, Marketing & Communications, ION Solutions

· Sylvia Mugica Manager, Graphic Design, ION Solutions

oncologisticsION Solutions article and advertising submissions:

Article submissions and suggestions, as well as advertising inquiries, may be sent to:

Tricia MusslewhiteManaging Editor, Oncologisticsc/o ION Solutions3101 Gaylord ParkwayFrisco, TX 75034

Information presented in Oncologistics is not intended as a substitute for the personalized advice given by a healthcare provider. The opinions expressed on the pages of Oncologistics magazine are those of the authors and do not necessarily reflect the views of ION Solutions or AmerisourceBergen. Although Oncologistics strives to present only current and accurate information, readers should not consider it as professional advice or endorsement of any position. Although great care has been taken in compiling and checking the information given in this publication to ensure accuracy, the authors, ION Solutions, and its employees or agents shall not be responsible or in any way liable for the continued currency of the information or for any errors, omissions, or inaccuracies in this magazine, whether arising from negligence or otherwise or for any consequence arising therefrom. The staff of Oncologistics provides columns and other editorial support. In no way are they responsible for the specific views presented in Oncologistics. Oncologistics magazine is published by ION Solutions, an AmerisourceBergen company.

All archived issues of Oncologistics are available online at www.iononline.com.

oneononewith Brian Ansay

According to a Feb. 2017 article in HemOnc Today, national surveys indicate approximately 40 percent of physicians experience some form of burnout. However, the burnout rate among oncologists has reached an all-time high, with various surveys showing incidence exceeds 50 percent.

In this issue of Oncologistics, we look at how burnout affects you, your colleagues, your family and your patients. Take a short break and turn to page 14.

In today’s complicated marketplace, differentiating your practice is more important than ever. Offering your patients access to clinical research is an opportunity to stand apart, but it’s not without challenges. On page six, learn how our research program, AdvanceIQ Network, simplifies and

streamlines the process of helping practices identify, qualify for and enroll in sponsored clinical trials.

This issue also features information to help your practice stay up-to-date in the move to value-based care. Just another example of how we – as the nation’s premier community oncology GPO – provide tools and services that help your practice deliver quality patient care today and prepare for the challenges of tomorrow.

Thank you for your continued partnership,

Brian Ansay President, ION Solutions

Helping Specialty Practices Bridge the Clinical Research GapBy Susan Weidner

Oncologistics | 7

Participating in clinical research offers several important benefits for specialty provider practices. It can generate new revenue opportunities, expand the potential patient pool and even help to ensure compliance with new and evolving regulatory mandates. Clinical research can also play a key role in helping practices maintain competitive differentiation. And in today’s complicated marketplace, any opportunity to stand apart is an important one.

Yet while many practices have recognized the advantages of participating in clinical research, there are inherent challenges that can undermine the feasibility of doing so. In one survey, physicians cited several reasons for not taking part in more research endeavors, including:

◾ A lack of opportunities

◾ The inability to meet the required time commitment

◾ Inadequate personnel support and resources

◾ Administrative burden1

Specialty practices must also contend with consistently low patient participation in clinical research. For example, one study found that only three percent of adults with cancer enter clinical trials2 — a figure that has remained steady for two decades. In recent years, this has been exacerbated by a continued reduction in the size of the targeted patient population resulting from a focus on niche and/or rare conditions, requiring increased use of biomarkers and companion diagnostics to qualify patients.

Low participation rates and increased potential indications have helped to evolve the research continuum itself, i.e., the shift from traditional randomized clinical trials to pragmatic clinical trials conducted in real-world settings. There has also been an increase in prospective patient registries and the extended monitoring of trial patients, along with an increased focus on patient-reported outcomes. These have become critical inputs for the quality and value assessments associated with shifting reimbursement methodologies such as the Medicare Access and CHIP Reauthorization Act.

But the news isn’t all bleak for provider practices seeking to become more involved in clinical research. Applying a little of the same innovative spirit and forward thinking that has propelled advancements in other areas of healthcare can also help cure what ails existing research study processes.

As a result, at least one coordinated initiative has been introduced to help bridge the gap between aspiring clinical investigators and the opportunities that may be eluding them. It does so by focusing on five key areas:

◾ Identifying qualified research sites based on existing patient populations, not just research expertise

◾ Implementing technology that enables patient identification and selection at the point of care, including integration with electronic medical records and pre-identification of patients already being treated by the practice

◾ Enrolling patients from a broader network than just those participating in trials to enable practices to compete against large academic and hospital institutions

◾ Leveraging technology to facilitate patient and caregiver participation. (As patient-reported outcomes become a bigger component of all research activities, it is increasingly important to implement technology to facilitate collaboration with patients and/or their caregivers)

◾ Enabling monitoring of patients’ post-study participation and helping them understand how their participation supported the approval and/or expanded access of that medication

Based on these tenets, the program is designed to simplify and streamline the process of helping practices identify, qualify for and enroll in sponsored clinical trials. It establishes a non-exclusive network that allows practices to join other specialty providers to locate the research opportunities that best suit their needs, including clinical trials, investigator research, prospective patient registries, retrospective outcomes research studies and panel studies. Practices provide access to de-identified patient information which is then made available for site feasibility analyses based on specific study criteria.

1. Taylor, H. 2004. Most physicians do not participate in clinical trials because of lack of opportunity, time, personnel support and resources. Harris

Interactive: Health Care News 4(9):1–8.

2. Institute of Medicine (US) Committee on Cancer Clinical Trials and the NCI Cooperative Group Program; Nass SJ, Moses HL, Mendelsohn J, editors.

A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington (DC): National

Academies Press (US); 2010. 4, Physician and Patient Participation in Cancer Clinical Trials. Available from: https://www.ncbi.nlm.nih.gov/books/

NBK220370/

The program helps both practices and life science organizations gain insight into opportunities and patients.

8 | Oncologistics

This centralized approach, which is fully regulation compliant and driven by cutting edge technology, is designed to allow patients most in need of study participation to gain access to it as efficiently and affordably as possible. It also seeks to remove the obstacles practices face by significantly lowering administrative overhead, time commitment and associated costs. As part of the program, participating practices and their physicians will receive support such as contract management resources, ongoing research education and training and grant submission coaching.

Perhaps most importantly, the program helps both practices and life science organizations gain insight into opportunities and patients, respectively, that they would otherwise be unaware of.

Given the increased prevalence of specialty care, it is critical to find ways to match patients to the innovative therapies found in clinical trials, and to connect provider practices with key research opportunities. In a way, it’s about access and a program that can provide that to patients and providers who otherwise don’t have it is both timely and necessary.

At the same time, as healthcare continues its trajectory toward eliminating siloes and facilitating collaboration among otherwise disparate entities, a program of this nature goes a long way toward aligning stakeholders and incentives. It is something of a healthcare holy grail in that each participant stands to gain with little or no compromise or downside; a true and rare win-win all around.

Susan Weidner is Senior Vice President, IntrinsiQ Specialty Solutions, an AmerisourceBergen company.

About AdvanceIQ Network

AdvanceIQ Network removes the obstacles to access for practices by providing a centralized approach that is regulation compliant and technology enabled. Practices benefit from improved visibility into research opportunities through a verified network of life sciences companies, giving them a direct process for qualification and enrollment.

Drawn from relationships with more than 1,000 specialty practices, AdvanceIQ Network capabilities give you the trusted and qualified connections you need to streamline your efforts, adding speed and efficiency to the data-rich, competitive necessity of clinical research.

Join AdvanceIQ Network and connect your patients to cutting-edge care. For more information, call 833-831-1167 or send an email to [email protected].

2018 Meeting ScheduleMeeting Date Meeting Name Location Venue

September 6-7 Precision Medicine Charlotte, NC Westin

September 7-8 Immuno-Oncology Charlotte, NC Westin

November 2-3 ION National Atlanta, GA Renaissance Waverly

*Meeting Dates Subject to Change*

Registration will be available approximately 60 days prior to each event. To register, visit www.iononline.com.

Educational Programs

EXTEND THE POSSIBILITIES.

EXTEND EFFICACY.For patients with multiple myeloma after 1 prior therapy

EXTEND THE POSSIBILITIES.The approval of the NINLARO® (ixazomib) regimen (NINLARO+lenalidomide+dexamethasone) was based on a statistically signifi cant ~6 month improvement in median PFS vs the placebo regimen (placebo+lenalidomide+dexamethasone).*• Median PFS: 20.6 vs 14.7 months (95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively); HR=0.74 (95% CI, 0.587-0.939); P=0.012

• Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

DRUG INTERACTIONS: Avoid concomitant administrationof NINLARO with strong CYP3A inducers.

*TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and e� cacy of NINLARO (an oral proteasome inhibitor) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory multiple myeloma who received 1-3 prior therapies.2

• Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the fi nal dose of NINLARO. Women using hormonal contraceptives should also use a barrier method of contraception.

ADVERSE REACTIONSThe most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%).

SPECIAL POPULATIONS• Hepatic Impairment: Reduce the NINLARO starting

dose to 3 mg in patients with moderate or severe hepatic impairment.

• Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONS• Thrombocytopenia has been reported with NINLARO.

During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

• Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.

• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in

the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

• Peripheral Edema was reported with NINLARO. Monitor for fl uid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.

• Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modifi cation.

• Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

The NCCN Guidelines are a work in progress that may be refi ned as often as new signifi cant data becomes available. The NCCN Guidelines are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NE=not evaluable; PFS=progression-free survival.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ixazomib in combination with lenalidomide and dexamethasone as a category 1 treatment option for previously treated multiple myeloma.1

Please see adjacent Brief Summary. USO/IXA/16/0100(3)d

THE FIRST AND ONLY ORAL PROTEASOME INHIBITOR Under contract with your GPO.Get more information at www.NINLAROhcp.com.


























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BRIEF SUMMARY OF PRESCRIBING INFORMATIONNINLARO (ixazomib) capsules, for oral use

1 INDICATIONNINLARO (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

5 WARNINGS AND PRECAUTIONS5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment. Less than 1% of patients in both regimens had a platelet count ≤ 5000/mm3 during treatment. Discontinuations due to thrombocytopenia were similar in both regimens (< 1% of patients in the NINLARO regimen and 2% of patients in the placebo regimen discontinued one or more of the three drugs).The rate of platelet transfusions was 6% in the NINLARO regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. Consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, have been reported with NINLARO, occasionally requiring use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea was reported in 42% of patients in the NINLARO regimen and 36% in the placebo regimen, constipation in 34% and 25%, respectively, nausea in 26% and 21%, respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at 2% in both regimens; there were no Grade 4 or serious adverse reactions. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Patients should be monitored for symptoms of neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification.5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen).Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral edema reported. There were no discontinuations reported due to peripheral edema. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 7% in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% in the placebo regimen). Grade 3 rash was reported in 3% of patients in the NINLARO regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type of rash reported in both regimens included maculo-papular and macular rash. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose.

Females of reproductive potential should be advised to avoid becoming pregnant while being treated with NINLARO. If NINLARO is used during pregnancy or if the patient becomes pregnant while taking NINLARO, the patient should be apprised of the potential hazard to the fetus. Advise females of reproductive potential that they must use effective contraception during treatment with NINLARO and for 90 days following the final dose. Women using hormonal contraceptives should also use a barrier method of contraception.

6 ADVERSE REACTIONSThe following adverse reactions are described in detail in other sections of the prescribing information:• Thrombocytopenia [see Warnings and Precautions (5.1)]• Gastrointestinal Toxicities [see Warnings and Precautions (5.2)]• Peripheral Neuropathy [see Warnings and Precautions (5.3)]• Peripheral Edema [see Warnings and Precautions (5.4)]• Cutaneous Reactions [see Warnings and Precautions (5.5)]• Hepatotoxicity [see Warnings and Precautions (5.6)]

6.1 CLINICAL TRIALS EXPERIENCEBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with lenalidomide and dexamethasone (placebo regimen; N=360). The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

N=360

System Organ Class / Preferred Term N (%) N (%)

All Grade 3

Grade 4 All Grade

3Grade

4

Infections and infestationsUpper respiratory tract infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0

Nervous system disordersPeripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0

Gastrointestinal disordersDiarrheaConstipationNauseaVomiting

151 (42)122 (34)92 (26)79 (22)

22 (6)1 (< 1)6 (2)4 (1)

0000

130 (36)90 (25)74 (21)38 (11)

8 (2)1 (< 1)

02 (< 1)

0000

Skin and subcutaneous tissue disorders

Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0

Musculoskeletal and connective tissue disorders

Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0

General disorders and administration site conditions

Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0

Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0. *Represents a pooling of preferred terms

(Continued on next page)

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IXAZ17CDNY1359_Brief_Summary_Sept_2017_Update_r3.indd 1 9/20/17 4:53 PM

REFERENCES: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 28, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621-1634. Brief Summary (cont’d)

Table 5: Thrombocytopenia and Neutropenia (pooled adverse event and laboratory data)


N=360


N=360

N (%) N (%)

Any Grade Grade 3-4 Any Grade Grade 3-4

Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11)

Neutropenia 240 (67) 93 (26) 239 (66) 107 (30)

Herpes ZosterHerpes zoster was reported in 4% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the physician’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection compared to patients who did not receive prophylaxis (6%).Eye DisordersEye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen.The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. 7 DRUG INTERACTIONS7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort).8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy: Risk Summary: Based on its mechanism of action and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a pregnant woman. There are no human data available regarding the potential effect of NINLARO on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data: In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg.8.2 Lactation: No data are available regarding the presence of NINLARO or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because the potential for serious adverse reactions from NINLARO in breastfed infants is unknown, advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.8.3 Females and Males of Reproductive Potential: Contraception - Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because NINLARO is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered. Advise women using hormonal contraceptives to also use a barrier method of contraception. 8.4 Pediatric Use: Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric Use: Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified

differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment.8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. In the event of an overdose, monitor the patient for adverse reactions and provide appropriate supportive care.17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information).Dosing Instructions• Instruct patients to take NINLARO exactly as prescribed. • Advise patients to take NINLARO once a week on the same day and at

approximately the same time for the first three weeks of a four week cycle. • Advise patients to take NINLARO at least one hour before or at least two

hours after food. • Advise patients that NINLARO and dexamethasone should not be taken at the

same time, because dexamethasone should be taken with food and NINLARO should not be taken with food.

• Advise patients to swallow the capsule whole with water. The capsule should not be crushed, chewed or opened.

• Advise patients that direct contact with the capsule contents should be avoided. In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water.

• If a patient misses a dose, advise them to take the missed dose as long as the next scheduled dose is ≥ 72 hours away. Advise patients not to take a missed dose if it is within 72 hours of their next scheduled dose.

• If a patient vomits after taking a dose, advise them not to repeat the dose but resume dosing at the time of the next scheduled dose.

• Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO.

Thrombocytopenia: Advise patients that they may experience low platelet counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding and easy bruising.Gastrointestinal Toxicities: Advise patients they may experience diarrhea, constipation, nausea and vomiting and to contact their physician if these adverse reactions persist.Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs.Peripheral Edema: Advise patients to contact their physicians if they experience unusual swelling of their extremities or weight gain due to swelling.Cutaneous Reactions: Advise patients to contact their physicians if they experience new or worsening rashHepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal painOther Adverse Reactions: Advise patients to contact their physicians if they experience signs and symptoms of acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO and for 90 days following the final dose. Advise women using hormonal contraceptives to also use a barrier method of contraception. Advise patients to contact their physicians immediately if they or their female partner become pregnant during treatment or within 90 days of the final dose.Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking and before starting any new medications.

Please see full Prescribing Information for NINLARO at NINLARO-hcp.com.

All trademarks are the property of their respective owners. ©2017 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved.

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BRIEF SUMMARY OF PRESCRIBING INFORMATIONNINLARO (ixazomib) capsules, for oral use

1 INDICATIONNINLARO (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

5 WARNINGS AND PRECAUTIONS5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment. Less than 1% of patients in both regimens had a platelet count ≤ 5000/mm3 during treatment. Discontinuations due to thrombocytopenia were similar in both regimens (< 1% of patients in the NINLARO regimen and 2% of patients in the placebo regimen discontinued one or more of the three drugs).The rate of platelet transfusions was 6% in the NINLARO regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. Consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, have been reported with NINLARO, occasionally requiring use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea was reported in 42% of patients in the NINLARO regimen and 36% in the placebo regimen, constipation in 34% and 25%, respectively, nausea in 26% and 21%, respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at 2% in both regimens; there were no Grade 4 or serious adverse reactions. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Patients should be monitored for symptoms of neuropathy. Patients experiencing new or worsening peripheral neuropathy may require dose modification.5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen).Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral edema reported. There were no discontinuations reported due to peripheral edema. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 7% in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% in the placebo regimen). Grade 3 rash was reported in 3% of patients in the NINLARO regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type of rash reported in both regimens included maculo-papular and macular rash. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose.

Females of reproductive potential should be advised to avoid becoming pregnant while being treated with NINLARO. If NINLARO is used during pregnancy or if the patient becomes pregnant while taking NINLARO, the patient should be apprised of the potential hazard to the fetus. Advise females of reproductive potential that they must use effective contraception during treatment with NINLARO and for 90 days following the final dose. Women using hormonal contraceptives should also use a barrier method of contraception.

6 ADVERSE REACTIONSThe following adverse reactions are described in detail in other sections of the prescribing information:• Thrombocytopenia [see Warnings and Precautions (5.1)]• Gastrointestinal Toxicities [see Warnings and Precautions (5.2)]• Peripheral Neuropathy [see Warnings and Precautions (5.3)]• Peripheral Edema [see Warnings and Precautions (5.4)]• Cutaneous Reactions [see Warnings and Precautions (5.5)]• Hepatotoxicity [see Warnings and Precautions (5.6)]

6.1 CLINICAL TRIALS EXPERIENCEBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with lenalidomide and dexamethasone (placebo regimen; N=360). The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)


N=360


N=360

System Organ Class / Preferred Term N (%) N (%)

All Grade 3

Grade 4 All Grade

3Grade

4

Infections and infestationsUpper respiratory tract infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0

Nervous system disordersPeripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0

Gastrointestinal disordersDiarrheaConstipationNauseaVomiting

151 (42)122 (34)92 (26)79 (22)

22 (6)1 (< 1)6 (2)4 (1)

0000

130 (36)90 (25)74 (21)38 (11)

8 (2)1 (< 1)

02 (< 1)

0000

Skin and subcutaneous tissue disorders

Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0

Musculoskeletal and connective tissue disorders

Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0

General disorders and administration site conditions

Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0

Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0. *Represents a pooling of preferred terms

(Continued on next page)

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REFERENCES: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed March 28, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621-1634. Brief Summary (cont’d)

Table 5: Thrombocytopenia and Neutropenia (pooled adverse event and laboratory data)


N=360


N=360

N (%) N (%)

Any Grade Grade 3-4 Any Grade Grade 3-4

Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11)

Neutropenia 240 (67) 93 (26) 239 (66) 107 (30)

Herpes ZosterHerpes zoster was reported in 4% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the physician’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection compared to patients who did not receive prophylaxis (6%).Eye DisordersEye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen.The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. 7 DRUG INTERACTIONS7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort).8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy: Risk Summary: Based on its mechanism of action and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a pregnant woman. There are no human data available regarding the potential effect of NINLARO on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data: In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg.8.2 Lactation: No data are available regarding the presence of NINLARO or its metabolites in human milk, the effects of the drug on the breast fed infant, or the effects of the drug on milk production. Because the potential for serious adverse reactions from NINLARO in breastfed infants is unknown, advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.8.3 Females and Males of Reproductive Potential: Contraception - Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Dexamethasone is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters. Because NINLARO is administered with dexamethasone, the risk for reduced efficacy of contraceptives needs to be considered. Advise women using hormonal contraceptives to also use a barrier method of contraception. 8.4 Pediatric Use: Safety and effectiveness have not been established in pediatric patients.8.5 Geriatric Use: Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified

differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment.8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. In the event of an overdose, monitor the patient for adverse reactions and provide appropriate supportive care.17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information).Dosing Instructions• Instruct patients to take NINLARO exactly as prescribed. • Advise patients to take NINLARO once a week on the same day and at

approximately the same time for the first three weeks of a four week cycle. • Advise patients to take NINLARO at least one hour before or at least two

hours after food. • Advise patients that NINLARO and dexamethasone should not be taken at the

same time, because dexamethasone should be taken with food and NINLARO should not be taken with food.

• Advise patients to swallow the capsule whole with water. The capsule should not be crushed, chewed or opened.

• Advise patients that direct contact with the capsule contents should be avoided. In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water.

• If a patient misses a dose, advise them to take the missed dose as long as the next scheduled dose is ≥ 72 hours away. Advise patients not to take a missed dose if it is within 72 hours of their next scheduled dose.

• If a patient vomits after taking a dose, advise them not to repeat the dose but resume dosing at the time of the next scheduled dose.

• Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO.

Thrombocytopenia: Advise patients that they may experience low platelet counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding and easy bruising.Gastrointestinal Toxicities: Advise patients they may experience diarrhea, constipation, nausea and vomiting and to contact their physician if these adverse reactions persist.Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs.Peripheral Edema: Advise patients to contact their physicians if they experience unusual swelling of their extremities or weight gain due to swelling.Cutaneous Reactions: Advise patients to contact their physicians if they experience new or worsening rashHepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal painOther Adverse Reactions: Advise patients to contact their physicians if they experience signs and symptoms of acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO and for 90 days following the final dose. Advise women using hormonal contraceptives to also use a barrier method of contraception. Advise patients to contact their physicians immediately if they or their female partner become pregnant during treatment or within 90 days of the final dose.Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking and before starting any new medications.

Please see full Prescribing Information for NINLARO at NINLARO-hcp.com.

All trademarks are the property of their respective owners. ©2017 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved.

SEPT 2017 USO/IXA/15/0123(4)

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14 | Oncologistics

The Burnout Epidemic

Unhealthy stress and burnout – the physical, emotional and mental exhaustion caused by long-term involvement in emotionally demanding situations1 – is an epidemic among physicians, nurses, physician assistants and office staff in medical practices across the country. Several studies2,3 show oncologists suffer from a higher rate of burnout than other specialties, with nearly 50 percent exhibiting physical, emotional and behavioral signs and symptoms. Likewise, oncology nurses and physician assistants working in oncology practices report similarly high levels.

Think back to when you started in practice; on that first day you were likely hopeful, excited and ready to try something new. But cancer care is a tough business, and today you might find that years of dealing with unwieldy EMRs, overwhelming paperwork, financial and regulatory pressures, long hours, challenging patient situations and grieving families has taken its toll. If you now find yourself exhausted, unexcited and emotionally detached from your colleagues, your family and your patients, chances are that you too are suffering from some degree of burnout.

The Multi-Faceted Impact

Consequences of long-term burnout include “chronic health conditions, emotional exhaustion, cynicism, a low sense of professional accomplishment, diminished quality of care and increased likelihood of early retirement.4“ Importantly, however, burnout affects not only the person experiencing it, but the people with whom they interact in pervasive, insidious ways. Let’s explore a few examples of this phenomenon.

Personal Relationships – Unaddressed burnout impairs one’s capacity to problem solve and actually amplifies problems – making them feel somehow insurmountable. Of course, what bothers us at work often follows us home, in turn, making it difficult or exhausting to have positive interactions with the people who matter most in our lives, such as partners, children and friends. Over time, the inability to be present, interested and interesting can erode cherished relationships that make up our personal support network.

Team – Burnout shuts down our interest in giving and receiving input, ideas or help – which can undermine team communication and collaboration. Even if a team is deliberately trying to support a burned-out team member, that person will likely be unable to receive their help or engage effectively. Gradually, this behavior negatively affects morale, employee engagement and the collective ability to innovate.

Practice – Burnout is directly correlated to turnover and lower productivity5, (impacting productivity by as much as 31 percent6). Given that the cost to replace an oncologist is between $500,000 and $1 million7, and the cost of replacing a nurse is about $100,000, burnout-related turnover exacts an enormous financial toll on practices. Increasing reimbursement pressures, as well as rising labor and drug costs, mean practices can ill afford the cost of burnout.

Patients – Some of the most troubling consequences burned out physicians and clinical and administrative staff produce involve patients and their families. Not only do practices with high levels of burnout have lower patient satisfaction scores; but lower levels of collegiality and coordination from those in burnout can compromise patient safety as well.8

Burnout Is Systemic – But There Is Hope

Burnout creates a negative spiral both personally and professionally and is a complex, systemic issue requiring improvement of external factors (such as inefficient work processes, long work hours, heavy workloads, etc.) as well as internal factors (such as the innate ability to reduce stress, enhance personal resilience and cultivate greater well-being in the face of challenging, external forces).

Fortunately, organizations such as the National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience are curating available research, facilitating knowledge sharing and spurring action. Also, innovative programs

The Effect of Burnout on Oncology PracticesBy Gordon Kuntz

16 | Oncologistics

are available today that are proven to measurably reduce burnout, increase resilience and well-being and improve key performance measures, including engagement and patient satisfaction.

Burnout is pervasive in oncology. You and everyone else in your practice are susceptible, but prevention and remediation are possible. The important thing is to do something about it instead of suffering its worsening personal and professional effects.

So, what is the solution? There are any number of actions recommended to help individuals and organizations combat burnout – from drinking more water and increasing exercise, to journaling and taking more time off. All are great, but none of these will reduce burnout more than temporarily. The antidote to burnout is, in fact, happiness. Not skip-down-the-hall-whistling-a-tune happiness, but the type of happiness based on a person’s innate ability to locate and cultivate serenity and excitement about life regardless of outside forces. To truly address the burnout epidemic in oncology, each and every physician, nurse and staff

1. Ayala Pines, PhD, Elliot Aronson, PhD, Ditsa Kafry. Burnout: from tedium to personal growth. Free Press, 1981.

2. Meg Barbor, MPH “Physician Burnout in the Oncology Practice Setting” Oncology Practice Management. May 2017, Vol 7, No 5.

3. “Burnout levels reach ‘tipping point’ among oncologists” HemOnc Today, February 25, 2017.

4. Ibid.

5. Ibid.

6. Global Wellness Summit. “2018 Wellness Trends, from Global Wellness Summit”. www.globalwellnesssummit.com. 2018.

7. Tait Shanafelt, MD; Joel Goh, PhD; Christine Sinsky, MD. “The Business Case for Investing in Physician Well-being” JAMA Internal Medicine. September 25, 2017.

8. “Burnout levels reach ‘tipping point’ among oncologists” HemOnc Today, February 25, 2017.

person in each and every practice, must develop innate new habits that reduce stress, increase happiness and optimize emotional, physical and behavioral well-being. The byproducts of gaining these new habits are many, including, increased personal resilience, sustainability and innovation, as well as improved collaboration, engagement and communication.

We have, over our lifetimes, trained ourselves to merely cope with repetitive stress, and our coping methods have left us burned out, unhappy and living in survival mode. Fortunately, with practice, we can train ourselves to relocate and amplify our innate serenity and excitement, and in doing so, recover from burnout and emerge as healthy, happy and productive human beings able to thrive in oncology and in life.

As the weight of burnout lifts, it is possible to feel like yourself again and to return joy to your practice, your patients, your loved ones, and yourself.

Gordon Kuntz serves as COO of Experience Happiness.

Experience Happiness helps people and organizations thrive through happiness. We offer The Happiness Practice™ (THP) to empower leaders to proactively cultivate individual and organizational happiness while measuring Return On Happiness™ (ROH™) at individual, team, and organizational levels. THP is a transformative life practice proven to simultaneously reduce stress/burnout, increase happiness, and build engaged, high-performance cultures of wellbeing that are strategically empowered to attract, retain and optimize talent.

For more information, please contact Gordon Kuntz at 651-336-4636 or [email protected].

Oncologistics | 17

MIPS TipsInformation to help your practice successfully meet all MIPS measures

New Budget Bill Excludes Medicare Part B Drug Cost from MIPS Payment Adjustments

Recently, the Bipartisan Budget Act of 2018 was passed by Congress and signed by President Trump. The bill had many high-profile issues like extending the Children’s Health Insurance Program (CHIP) for a total of 10 years. But most importantly, the new bill significantly impacts medical practices when it comes to reporting and reimbursement under MIPS – many changes at the urging of the American Society of Clinical Oncology (ASCO) as well as other specialty societies.

Several changes were made to the Medicare Access and CHIP Reauthorization Act (MACRA) that are specific to the Merit-based Incentive Payment System (MIPS):

◾ Originally, 2019 was to be the post-transition year for MIPS; it now will begin in 2022.

◾ Thresholds in 2022 must be the mean or median of the historical national MIPS scores.

◾ Medicare Part B drug costs are excluded from MIPS payment adjustments and from the low-volume threshold determination; payment adjustments will now only apply to ‘covered professional services.’ This change will also have an impact on the eligibility status for more clinicians who meet the low-volume threshold - more will be excluded from MIPS participation. Performance thresholds will have a ‘gradual and incremental transition’ into the first post-transition year of 2022.

◾ The Cost category of MIPS now allows for reweighting of the category - not to be less than 10 percent or more than 30 percent for the years of 2019-2021. Cost must be weighted to 30 percent in 2022. The Advancing Care Information and Improvement Activities categories remain the same - no changes.

This Act solidifies the fact that the Centers for Medicare and Medicaid Services (CMS) is reinforcing the move from fee for service into a value-based care program. Additionally, the extension of the transition years will make it a little easier for physicians to successfully meet the MIPS requirements. The other option would be for clinicians to move into an Alternative Payment Model (APM) which can be more challenging for practices.

What this ultimately means for practices is that MIPS is not going away. These changes only confirm CMS’ commitment to improving the quality of care for patients. With Eligible Clinicians’ scores being available for patients to view in the fourth quarter of 2018 on the Physician Compare website, there is a reputational impact for physicians as well as the penalties for non-participation. Those percentages have not changed:

◾ -5% for 2018 (adjustment will impact the 2020 payment year)

◾ -7% for 2019 (adjustment will impact the 2021 payment year)

◾ -9% for 2020 and beyond

As regulations and guidelines continue to evolve, the success of each Eligible Clinician in your practice is dependent upon staying updated and current. The thresholds and intricate details will continue to develop and be modified, which will require practices to have a dedicated resource available that can communicate these changes to the practice.

18 | Oncologistics

How will Topped Out Measures Affect Your Practice?

Your practice has finalized your reporting of the MIPS measures for last year and set your quality measures for reporting for this year. Many practices are reviewing their numbers monthly or at least quarterly to make those course corrections to potentially maximize their reimbursements under the Quality Payment Program.

Starting this year, you may not be able to receive the maximum number of points on some measures as they are “topped out” by CMS. According to CMS, “A measure may be considered topped out if meaningful distinctions and improvement in performance can no longer be made. ”1 Specifically, a process measure, which make up about half of all measures, would be topped out if median performance is 95 percent or higher or 5 percent or lower if it is scored inversely.

CMS has already chosen measures for 2018 that will cap the maximum of points to seven, instead of the standard 10 points. If your practice used the following measures in 2017, they will now be capped at the maximum of seven points for 2018 performance. The measures include:

◾ Perioperative Care: Selection of Prophylactic Antibiotic-First or Second-Generation Cephalosporin (Quality Measure ID: 21)

◾ Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients) (Quality Measure ID: 23)

◾ Chronic Obstructive Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy (Quality Measure ID: 52)

◾ Melanoma: Overutilization of Imaging Studies in Melanoma (Quality Measure ID: 224)

◾ Image Confirmation of Successful Excision of Image Localized Breast Lesion (Quality Measure ID: 262)

◾ Optimizing Patient Exposure to Ionizing Radiation: Utilization of a Standardized Nomenclature for Computerized Tomography (CT) Imaging Description (Quality Measure ID: 359)

What does this mean for the future?

CMS will continue to look at Quality measures to identify those that provide little room for improvement for the majority of MIPS eligible clinicians. As those measures are identified, they will be capped and eventually phased out as measures over a four-year phasing out timeline. If a measure has benchmarks that have been topped out for at least two or more consecutive years, the measure will be adjusted to receive the maximum of seven points on the third year, then be phased out by the fourth year. The benchmarks for measures can also vary depending on the submission method (i.e., claims vs. qualified registry).

Make sure your practice reviews measures annually to determine if you are collecting data for potential topped out measures. Your practice will need to look to report on measures that show meaningful improvement in care for you to receive your highest reimbursements possible.

1. https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/QPP-Year-2-Final-Rule-NPC-Slides.pdf

Oncologistics | 19

Checklist for MIPS Reporting: Helping Your Practice Organize for a Potential Audit

With gathering the data and preparing submissions for MIPS reporting for the 2018 Quality Payment Program, practices need to document their submissions and supporting records in case of a CMS or ONC audit. According to a recent presentation held by CMS, the presenter noted: “… providers should retain copies of medical records, charts, reports, and any electronic data utilized, to determine which measures and activities were applicable and appropriate for their scope of practice, and patient population for reporting under MIPS for up to 10 years after the conclusion of the performance period, to prepare for verification in the event that you’re selected for an audit.”

“This record-retention timeframe aligns with the record-retention timeframes already in place for APMs, either established in regulation or included in participation agreements. CMS may request any records or data retained for the purposes of MIPS for up to six years and three months. And we will provide audit specifications through subreg guidance. MIPS-eligible clinicians or groups selected for data validation audits will be provided instructions and examples of documents required.”1

ION Solutions’ Quality Reporting Engagement Group has created a checklist to help those practices keep track of what they need for MIPS reporting. The checklist is a helpful overview and will assist a practice in being prepared in the event of an audit. Visit iononline.com to download a copy.

ION Solutions’ Quality Reporting Engagement Group can help practices understand their scores and find opportunities for work flow improvements so that a practice can be successful with MIPS reporting. For more information, send an email to [email protected] or call 877-570-8721 x2.

1. Merit-Based Incentive Payment System (MIPS) Overview: Understanding Advancing Care Information (ACI) & Improvement Activities; CMS Presentation, December 13, 2017, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MIPS-ACI-and-IA-transcript.pdf

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Oncologistics | 21

What’s News at ION

Where Practices Should Focus in 2018In February, an article written by Barry Fortner, Ph.D., Senior Vice President and President of Specialty Physician Services at AmerisourceBergen, was published in Physicians Practice. The article identifies the four key areas in which practices should invest time and resources to be successful in 2018:

◾ For a medical practice to gain financial and operational control of its drug inventory it needs an inventory management system.

◾ To be successful with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program practices need to dedicate an in-house Merit-based Incentive Payment System (MIPS) expert or work with an external partner.

◾ Partnerships that can connect practices to clinical trials and research opportunities will help patients access cutting-edge care.

◾ In-office dispensing enables providers to play a greater role in their patients’ pharmaceutical care, resulting in a positive impact on patient outcomes and provider measurement under a value-based care model.

ION Solutions has experts and programs to help your practice address these four areas. To learn more, talk to your Strategic Account Manager. To read the full article, visit www.physicianspractice.com/operations/4-areas-practices-focus-2018.

“We’ve identified four key areas in

which practices should invest time and

resources to be successful: inventory

management, the Medicare Access

and CHIP Reauthorization Act of 2015

(MACRA) Quality Payment Program,

clinical research, and physician

dispensing.”

- BARRY FORTNER, PhD, SVP AND PRESIDENT OF

SPECIALTY PHYSICIAN SERVICES

Negotiating with Payers: How Does your Practice Manage Contracts and Maximize Them

Negotiating with payers can have a significant impact on the financial success of your practice. Have you reviewed your contracts and taken opportunities to highlight your accomplishments in patient satisfaction and improved outcomes?

Understand the Details in Your Payer Contracts

A simple table graph can help you keep track of payer contracts and when you start negotiations. In the graph, note the payers’ contract elements for: renewal date, fee schedule revision, termination, timely filing, refund request, denials rate, fee scheduling rating, credentialing and reimbursement performance. It is also helpful to have in the same table the payer mix by charge percentage and payment percentage.

As you review your payer contracts, make sure you compare the actual reimbursement to what Medicare would have paid for the same service. Influencing factors in this comparison could include: contract rates or RVU year, modifier adjustments, denials, patient write-offs, payer adjudication flaws, GPCI adjustments and coding errors or unbundling.

Armed with data, your practice will be ready when it comes time to begin negotiations for renewal of payer contracts.

Appreciating Your Practice’s Strengths and Weaknesses

Understanding your strengths and weaknesses is of utmost importance when you begin negotiations of payer contracts.

Some important points to consider include:

◾ Do you have good patient satisfaction data, as well as outcomes data and metrics to share?

◾ Does your practice have competition from other providers of the same specialty? And do you know who they are?

◾ Do you offer services that maximize convenience for patients, like laboratory, imaging and/or oral pharmacy dispensing?

◾ And, are you willing, if asked, to pilot quality incentives in your practice?

Having an accurate and unbiased approach to your strengths, and weaknesses, will best prepare you to negotiate the best possible contract with your payers.

But before you start that negotiation process, you also need to gather data for your payers. It is important that they understand your business model, so developing a relationship is key. They should appreciate what measures you take to increase patient satisfaction and outcomes. Communication is vital – you should focus on patient care and keep in touch with your provider reps and medical directors at least quarterly. If you have the opportunity, invite them to tour your practice and hear of the challenges you face with reimbursements.

At the same time, gather your own data, like patient satisfaction scores, quality scores, favorable Physician Quality Reporting System (PQRS) data and patient testimonials. Identify measures used in the HEDIS tool (Health Effectiveness Data and Information Set) that is used by health plans to evaluate their performance on dimensions of care and service. Your practice can help the payer meet or exceed their own requirements.

For more help with payer contract negotiations, send an email to [email protected].

Shrinking margins have pushed independent specialty practices

to place even greater focus on operational efficiency. In response,

successful practices have turned to their GPO and distribution

pa r t ne r for c u s tom i z ed i nve ntor y m a n age me nt , a s we l l a s

integrated technologies and business consulting, to increase time

with patients. Improving cash f low takes a streamlined workflow.

It takes AmerisourceBergen. ItTakesAmerisourceBergen.com

SPECIALTY DISTRIBUTION \ GPO SERVICES \ TECHNOLOGY AND BUSINESS CONSULTING \ SPECIALTY PHARMACY

33684-16-516516_ABC_EPC-SP_Workflow_8.5x11_4C_r0.indd 1 7/11/16 12:00 PM

Oncologistics | 23

Shrinking margins have pushed independent specialty practices

to place even greater focus on operational efficiency. In response,

successful practices have turned to their GPO and distribution

pa r t ne r for c u s tom i z ed i nve ntor y m a n age me nt , a s we l l a s

integrated technologies and business consulting, to increase time

with patients. Improving cash f low takes a streamlined workflow.

It takes AmerisourceBergen. ItTakesAmerisourceBergen.com

SPECIALTY DISTRIBUTION \ GPO SERVICES \ TECHNOLOGY AND BUSINESS CONSULTING \ SPECIALTY PHARMACY

33684-16-516516_ABC_EPC-SP_Workflow_8.5x11_4C_r0.indd 1 7/11/16 12:00 PM

The Effect of Burnout on Oncology Practices...shift from traditional randomized clinical trials to pragmatic clinical trials conducted in real-world settings. There has also been an

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