volume 15, issue 3 - fall 2016

Registration will be available approximately 60 days prior to each event. To register, visit www.iononline.com. *Meeting dates subject to change.*

ION Solutions Educational Programs

2016-2017 Meeting Schedule

Meeting Date Meeting Name Location Venue

Nov. 4-6, 2016 ION National Salt Lake City, UT Grand America

January 20-22, 2017 ASH Review Orlando, FL Renaissance Sea World

March 10-12, 2017 Oral Therapies Meeting Fort Worth, TX Omni

All ION Solutions meeting materials are archived on iononline.com. Visit the website to view slides and videos from past meetings.

Oncologistics | 3

Build Referrals and Strengthen RevenuesBy Vicki Albrecht, Ph.D.

4 | Oncologistics

When independent community oncology practices thrive, both patients and physicians benefit. Community oncologists who are able to maintain their autonomy can determine not only the best treatment regimen for a particular patient but also the environment in which those patients are treated. Fortunately, multiple resources are available to help community oncologists maintain success by increasing awareness of their practice, providing the most innovative treatments to their patients and preparing for the future of oncology care. In this article, we’ll outline tactics that oncologists and practice managers can implement in the short-term to improve efficiency and find more time to spend with patients.

Increasing Patient Referrals

It is important to understand the driving forces behind patient referrals because new patients are the lifeblood of any practice. For many practices today, referrals from physicians are the source of many new patients. A few simple activities, such as maintaining an open line of communication, being transparent about pricing and keeping report turnaround times short can foster strong, ongoing relationships with referring physicians. Make it easy for referring physicians to work with you. Oncology practices that are known for streamlined service will naturally be more desirable partners. Engaging a referring physician’s office staff and sharing a clear value proposition about how your office can provide high-quality care will ensure your practice is foremost in mind.

Beyond solidifying the referral base, practices should find outlets through which they can share their approach to treatment and the value their practice provides to the community. The increasingly competitive oncology marketplace is a challenge but also a compelling reason to invest in marketing. Today, the most common marketing occurs through online channels. An important first step in online marketing can be a refreshed website, as the Web is where many patients look when evaluating where to receive care. The website should serve as the hub for a practice’s value proposition and incorporate the mission

statement and associated messaging. This will set the tone about what patients can expect from the practice during treatment. A website with a modern design and robust information can help highlight characteristics that, according to Xcenda market research, patients find most important in a practice. These include specializations within oncology, clinical trial experience and outcomes data—how successful is this oncologist at treating their type of cancer?

The practice website is only one online channel oncologists should use.

Social media is increasingly a resource for patients looking for information about a practice. Facebook, Twitter, LinkedIn and similar venues can be used to educate and engage with patients. In fact, social media can even be used to promote word-of-mouth referrals and add credibility to the practice.

Two-Way Communication Key to Web Marketing

Marketing online should be coupled with in-person interactions. A practice that is an active community partner will have the opportunity to improve its credibility in an authentic manner not found through online channels. Simple tactics to become an active community partner—such as

As more patients enter the

practice from increased referrals

and better marketing, physicians

and practice managers must

remain diligent in providing an

optimal patient experience while

continuing to maintain high-quality,

cost-effective care.

Oncologistics | 5

sponsoring events, supporting health initiatives or offering educational health programs—also can help increase awareness of a community practice. Serving on a board with other influential community members offers another avenue for practitioners to make connections. Over time, the reputation of the community practice will be tied not only to the quality medical care provided but also to regional events and programs that advance health and wellness in the general population.

Tracking referrals and increases in traffic will reveal how effectively these initiatives are working and shed light on where to invest marketing and awareness resources in the future. Technology solutions like InfoDive, a business intelligence solution that analyzes internal data and benchmarks against peers, can provide visibility into referral patterns. InfoDive provides practices with “heat maps” and demographic information to give practice managers and clinicians a deeper look into who they are reaching with their marketing efforts and from where patients are referred.

As more patients enter the practice from increased referrals and better marketing, physicians and practice managers must remain diligent in providing an optimal patient experience while continuing to maintain high-quality, cost-effective care. The ideal approach to creating efficiency is for physicians and practice managers to use data to identify areas for opportunity and/or improvement. If feasible, a great approach is to work with partners who blend oncology expertise with business intelligence tools and resources in order to identify tactics and resources that will help improve operations and ensure regular, reliable reimbursement.

There are a few key questions to ask when evaluating financial efficiencies:

■ How quickly are claims sent to the payer?

■ How quickly does the payer make payment?

■ How often are claims denied?

The answers to these questions may identify revenue cycle inefficiencies that take valuable time out of the clinician’s schedule. For each area of friction, practice managers or business coaches should start solving for trends rather than solving for each individual issue.

Reimbursement, however, is a two-way street. Keep in mind that patients also are affected by the changing reimbursement landscape and often are not aware of programs that can offer financial support. Practices can

engage reimbursement counselors to work directly with patients and physicians to help find appropriate access and financial support. Manufacturer support programs can be found through several outlets, including foundations and directly from specialty pharmacies where patients may receive their treatment. Providing tailored resources for patients to afford the costs associated with treatment can lower financial stress, remove the cost barrier and maintain practice health by ensuring appropriate payment.

The road ahead for community practices requires both the personalized care physicians are known for and business know-how. There are resources to help practices raise awareness of the value of community oncology, negotiate fair reimbursement and capture more revenue. Recently, a network of oncologists came together to share these types of resources under the name Innovation Cancer. Practices that join Innovation Cancer have access to business coaches, technology to support changes and marketing resources to build a practice’s reputation. The business coaches can evaluate a practice’s financial health, identify problem areas and help the practice implement a process to better support outstanding accounts receivable issues. The end benefit can be increased strength to secure patients and put more resources toward optimal care. ◾

Vicki Albrecht, Ph.D., is senior vice president and general manager of ION Solutions.

This article originally was published August 12, 2016, at http://www.onclive.com.

As an active community partner, the staff and patients of NSHOA Cancer Center participate in numerous events to raise funds for organizations throughout Long Island, N.Y.

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.

Copyright © 2016, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA 7/16 USO/IXA/16/0157

Now under contract with your GPOLearn more about NINLARO at NINLAROhcp.com.

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.

Depth of response in the NINLARO and placebo regimens• ORR*: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; and PR: 30% vs 33%, respectively

The NINLARO regimen demonstrated rapid responses

Median time to initial response (months)

1.9

1.1

Placebo+len+dex

NINLARO regimen

EXTEND EFFICACY. 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 progression-free survival vs the placebo regimen (placebo+lenalidomide+dexamethasone) (median: 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).

*ORR=CR+PR, including VGPR.ARs=adverse reactions; CR=complete response; ORRs=overall response rates; PR=partial response; VGPR=very good partial response.

IMPORTANT SAFETY INFORMATION FOR NINLARO

• 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.

WARNINGS 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 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.

INDICATION: 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.

WARNINGS AND PRECAUTIONS (continued)• 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.

• 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.

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.

• Lactation: Advise women to discontinue nursing while on NINLARO.

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

Please see adjacent Brief Summary.

REFERENCE: 1. Data on File 117, Takeda Pharmaceuticals International Co.

The NINLARO regimen represented a sustainable treatment for patients

Discontinuation rates of the full regimen due to ARs1

13% 11%NINLARO regimen

(n=360)Placebo+len+dex

(n=360)

Discontinuation rates were low and comparable with the NINLARO

and placebo regimens.

80% of patients continued at the starting dose of NINLARO without dose reduction1

Pooled hematologic adverse events and laboratory data• Incidence of thrombocytopenia in patients in the

NINLARO and placebo regimens: all grades, 78% and 54%; grades 3-4, 26% vs 11%, respectively

• Incidence of neutropenia: all grades, 67% vs 66%; grades 3-4, 26% vs 30%, respectively

†Represents a pooling of preferred terms.

Nonhematologic ARs occurring in ≥5% of patients with a ≥5% di� erence between the NINLARO regimen (n=360) and the placebo regimen (n=360)• All grades, grade 3 (respectively): upper respiratory

(19%, <1% vs 14%, <1%), peripheral neuropathies† (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash† (19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%)

• Grade 4 ARs occurring in ≥5% of patients with a ≥5% di± erence between the 2 regimens were 0%

IXAZ16CDNY5936_ION_JA_Sept2016_r4.indd All Pages 8/1/16 2:10 PM

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.

Copyright © 2016, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA 7/16 USO/IXA/16/0157

Now under contract with your GPOLearn more about NINLARO at NINLAROhcp.com.

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.

Depth of response in the NINLARO and placebo regimens• ORR*: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; and PR: 30% vs 33%, respectively

The NINLARO regimen demonstrated rapid responses

Median time to initial response (months)

1.9

1.1

Placebo+len+dex

NINLARO regimen

EXTEND EFFICACY. 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 progression-free survival vs the placebo regimen (placebo+lenalidomide+dexamethasone) (median: 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).

*ORR=CR+PR, including VGPR.ARs=adverse reactions; CR=complete response; ORRs=overall response rates; PR=partial response; VGPR=very good partial response.

IMPORTANT SAFETY INFORMATION FOR NINLARO

• 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.

WARNINGS 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 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.

INDICATION: 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.

WARNINGS AND PRECAUTIONS (continued)• 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.

• 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.

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.

• Lactation: Advise women to discontinue nursing while on NINLARO.

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

Please see adjacent Brief Summary.

REFERENCE: 1. Data on File 117, Takeda Pharmaceuticals International Co.

The NINLARO regimen represented a sustainable treatment for patients

Discontinuation rates of the full regimen due to ARs1

13% 11%NINLARO regimen

(n=360)Placebo+len+dex

(n=360)

Discontinuation rates were low and comparable with the NINLARO

and placebo regimens.

80% of patients continued at the starting dose of NINLARO without dose reduction1

Pooled hematologic adverse events and laboratory data• Incidence of thrombocytopenia in patients in the

NINLARO and placebo regimens: all grades, 78% and 54%; grades 3-4, 26% vs 11%, respectively

• Incidence of neutropenia: all grades, 67% vs 66%; grades 3-4, 26% vs 30%, respectively

†Represents a pooling of preferred terms.

Nonhematologic ARs occurring in ≥5% of patients with a ≥5% di� erence between the NINLARO regimen (n=360) and the placebo regimen (n=360)• All grades, grade 3 (respectively): upper respiratory

(19%, <1% vs 14%, <1%), peripheral neuropathies† (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash† (19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%)

• Grade 4 ARs occurring in ≥5% of patients with a ≥5% di± erence between the 2 regimens were 0%

IXAZ16CDNY5936_ION_JA_Sept2016_r4.indd All Pages 8/1/16 2:10 PM

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.

Copyright © 2016, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA 7/16 USO/IXA/16/0157

Now under contract with your GPOLearn more about NINLARO at NINLAROhcp.com.

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.

Depth of response in the NINLARO and placebo regimens• ORR*: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; and PR: 30% vs 33%, respectively

The NINLARO regimen demonstrated rapid responses

Median time to initial response (months)

1.9

1.1

Placebo+len+dex

NINLARO regimen

EXTEND EFFICACY. 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 progression-free survival vs the placebo regimen (placebo+lenalidomide+dexamethasone) (median: 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).

*ORR=CR+PR, including VGPR.ARs=adverse reactions; CR=complete response; ORRs=overall response rates; PR=partial response; VGPR=very good partial response.

IMPORTANT SAFETY INFORMATION FOR NINLARO

• 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.

WARNINGS 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 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.

INDICATION: 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.

WARNINGS AND PRECAUTIONS (continued)• 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.

• 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.

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.

• Lactation: Advise women to discontinue nursing while on NINLARO.

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

Please see adjacent Brief Summary.

REFERENCE: 1. Data on File 117, Takeda Pharmaceuticals International Co.

The NINLARO regimen represented a sustainable treatment for patients

Discontinuation rates of the full regimen due to ARs1

13% 11%NINLARO regimen

(n=360)Placebo+len+dex

(n=360)

Discontinuation rates were low and comparable with the NINLARO

and placebo regimens.

80% of patients continued at the starting dose of NINLARO without dose reduction1

Pooled hematologic adverse events and laboratory data• Incidence of thrombocytopenia in patients in the

NINLARO and placebo regimens: all grades, 78% and 54%; grades 3-4, 26% vs 11%, respectively

• Incidence of neutropenia: all grades, 67% vs 66%; grades 3-4, 26% vs 30%, respectively

†Represents a pooling of preferred terms.

Nonhematologic ARs occurring in ≥5% of patients with a ≥5% di� erence between the NINLARO regimen (n=360) and the placebo regimen (n=360)• All grades, grade 3 (respectively): upper respiratory

(19%, <1% vs 14%, <1%), peripheral neuropathies† (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash† (19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%)

• Grade 4 ARs occurring in ≥5% of patients with a ≥5% di± erence between the 2 regimens were 0%

IXAZ16CDNY5936_ION_JA_Sept2016_r4.indd All Pages 8/1/16 2:10 PM

Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.

Copyright © 2016, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA 7/16 USO/IXA/16/0157

Now under contract with your GPOLearn more about NINLARO at NINLAROhcp.com.

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.

Depth of response in the NINLARO and placebo regimens• ORR*: 78% vs 72%; CR: 12% vs 7%; VGPR+CR: 48% vs 39%; and PR: 30% vs 33%, respectively

The NINLARO regimen demonstrated rapid responses

Median time to initial response (months)

1.9

1.1

Placebo+len+dex

NINLARO regimen

EXTEND EFFICACY. 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 progression-free survival vs the placebo regimen (placebo+lenalidomide+dexamethasone) (median: 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).

*ORR=CR+PR, including VGPR.ARs=adverse reactions; CR=complete response; ORRs=overall response rates; PR=partial response; VGPR=very good partial response.

IMPORTANT SAFETY INFORMATION FOR NINLARO

• 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.

WARNINGS 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 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.

INDICATION: 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.

WARNINGS AND PRECAUTIONS (continued)• 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.

• 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.

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.

• Lactation: Advise women to discontinue nursing while on NINLARO.

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

Please see adjacent Brief Summary.

REFERENCE: 1. Data on File 117, Takeda Pharmaceuticals International Co.

The NINLARO regimen represented a sustainable treatment for patients

Discontinuation rates of the full regimen due to ARs1

13% 11%NINLARO regimen

(n=360)Placebo+len+dex

(n=360)

Discontinuation rates were low and comparable with the NINLARO

and placebo regimens.

80% of patients continued at the starting dose of NINLARO without dose reduction1

Pooled hematologic adverse events and laboratory data• Incidence of thrombocytopenia in patients in the

NINLARO and placebo regimens: all grades, 78% and 54%; grades 3-4, 26% vs 11%, respectively

• Incidence of neutropenia: all grades, 67% vs 66%; grades 3-4, 26% vs 30%, respectively

†Represents a pooling of preferred terms.

Nonhematologic ARs occurring in ≥5% of patients with a ≥5% di� erence between the NINLARO regimen (n=360) and the placebo regimen (n=360)• All grades, grade 3 (respectively): upper respiratory

(19%, <1% vs 14%, <1%), peripheral neuropathies† (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash† (19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%)

• Grade 4 ARs occurring in ≥5% of patients with a ≥5% di± erence between the 2 regimens were 0%

IXAZ16CDNY5936_ION_JA_Sept2016_r4.indd All Pages 8/1/16 2:10 PM

8 | Oncologistics

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.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)

Oncologistics | 9

Brief Summary (cont’d)

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

NINLARO + Lenalidomide and Dexamethasone

N=360

Placebo + Lenalidomide and Dexamethasone

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)

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: Women should avoid becoming pregnant while being treated with NINLARO.Risk Summary: 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 than 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: It is not known whether NINLARO or its metabolites are present in human milk. Many drugs are present in human milk and as a result, there could be a potential for adverse events in nursing infants. Advise women to discontinue nursing.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. Infertility - Fertility studies were not conducted with NINLARO; however there were no effects on reproductive organs in either males or females in nonclinical studies in rats and dogs.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 dialysis.10 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 rash.Hepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal pain.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 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.

NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

©2016 Millennium Pharmaceuticals, Inc.20160209 v2 USO/IXA/15/0123(2)

10 | Oncologistics

USP 800 What We Know Today

Both federal and state governments are looking at measures to more tightly regulate the practice of sterile compounding, one of which is through adoption of USP 800.

ION Solutions believes that the implementation of USP 800, as currently written, poses distinct barriers to the ability of patients to obtain treatment from their physicians.

ION Solutions also believes that community oncology should be exempt from USP 800, as the FDA excludes the following from the definition of compounding:

“Compounding does not include mixing, reconstituting or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.”

In those states that have considered implementation of USP 800 as written, despite the above guidance from the FDA, education and lobbying efforts have helped physicians obtain key relief from USP 800 oversight. This relief has enabled them to continue to prepare certain medications for administration to their patients, which would otherwise meet the definition of sterile compounding and fall under USP 800.

Our recommendation is to work with your local and state governmental agencies to ensure your patients’ access to treatment does not become subject to the otherwise burdensome requirements of USP 800.

There are a number of things you can do to get involved:

■ Contact the agency who has responsibility for oversight of your practice (i.e. Board of Medicine)

■ Contact the agency that is contemplating the adoption of any new sterile compounding regulations. Those agencies may extend from the Board of Medicine or Pharmacy, the state OSHA agency or possibly down to the local county board of health.

■ If the overseeing agency intends to adopt new sterile compounding regulations, initiate a dialogue on how the contemplated sterile compounding regulations negatively impacts patient access to obtaining needed treatment, and how you may gain an exemption from the requirements.

■ Reach out to your state legislative representatives so that they can advocate on your behalf.

Also, note that USP itself isn’t a governmental body. In order for compliance to be mandatory, a federal/state legislature or agency must adopt the relevant USP standard.

Getting involved in advocacy by helping to educate the relevant governmental entities on the impact of any proposed new sterile compounding laws/regulations has proved to be community oncology’s best course of action.

Contact your ION strategic accounts manager (SAM) for more information on what you can do to get involved.

What’s News at ION

SON Dashboard Provides Analytics Insight for In-Office Dispensing Programs

ION Solutions Specialty Oncology Network (SON) members now have access to the SON Dashboard, an innovative tool designed to give community oncologists the information they need to manage the operational flow of dispensing, adapt to dispensing trends and enhance patient care.

With the SON Dashboard you can:

■ Monitor key metrics to improve operations and profitability

■ Evaluate and improve practice workflow to increase capture rates

■ Assess specialty percentage by payer

■ Understand prescription retention

■ Manage compliance to contracts

■ Identify Medicare and commercial dispenses

To learn how to add the SON Dashboard to your dispensing program, talk to your clinical practice consultant. If you would like to learn more about SON, the leader in the oral dispensing space with 255 dispensing sites, talk to your SAM or email SON@iononline.com.

Preparing your Practice for MIPS

With MACRA and the quality-based reimbursement measures proposed to go into effect on Jan. 1 for nearly all physicians who accept Medicare, practices need to become familiar with what is to come.

CMS says that most physician practices will have to choose the MIPS pathway (Merit-Based Incentive Payment System) in order to be reimbursed for Medicare patients.

Is your practice prepared? Some of the general considerations practices should address (as outlined by the AMA and ASCO):

■ You are exempt from MIPS participation if you have $10,000 or less in Medicare charges and 100 or fewer Medicare patients annually or you are in your first year of Medicare Part B participation

■ If you are not already participating in a patient clinical data registry, contact your specialty society about participating in theirs—data registries can streamline reporting

■ Be sure your practice is reporting for the Physician Quality Reporting System (PQRS) and Meaningful Use (MU)

■ Physicians in a practice of more than one eligible clinician should decide whether to report individually or as a group

■ Review your Quality and Resource Use Report (QRUR), which determines your Value-Based Payment Modifier (Value Modifier) score (See page 12)

Even with information from different medical societies, the ever-changing rules and acronyms can be difficult to understand. With PQRS, MU and the Value Modifier all merged into MIPS, practices need to understand the changes.

ION Solutions will be offering more information on how practices can submit quality data and does offer assistance looking at current practice processes to help achieve those quality measures, as well as assistance in reporting for the proposed MACRA program.

To view our webinar series, Preparing Your Practice for MIPS, visit www.iononline.com, click on Meetings and Webcasts and go to the Webcast Archives.

12 | Oncologistics

Accessing your QRUR

What is a QRUR?

CMS established the Quality and Resource Use Report (QRUR) to provide physicians with comparative information about the quality and cost of care for their Medicare patients. Information in the reports comes from PQRS and claims data and are compared across similar specialties on data provided in the previous year.

Through its Physician Feedback Program, CMS produces QRURs for all solo physicians and physician groups that have billed Medicare Part B FFS during the reporting year. The QRUR includes information regarding performance on quality and cost of care measures delivered to patients. It is a part of CMS’ effort to move physician payment toward a system that rewards value over volume.

The QRUR analyzes performance at the Tax Identification Number (TIN) level. The report includes performance information from measures reported through the Physician Quality Reporting System (PQRS) and uses Medicare claims to calculate additional quality outcome measures and cost measures. Data in the QRUR is used to calculate your Value Modifier and subsequent payment adjustments (positive, negative, or neutral).

In September, CMS made available the 2015 QRURs and the information shown in them determine how CMS calculates the 2017 Value Modifier with downward, upward or neutral adjustments (for 10 or more eligible professionals in a practice only). For those practices with nine or fewer EPs, a neutral or upward adjustment will be made, as long as PQRS is reported successfully. The annual QRUR provides comprehensive information from the reporting period (January–December).

CMS provides QRURs as a means to help physicians and groups understand the care they deliver to Medicare beneficiaries and identify opportunities for improvement in that care. Reviewing your practice’s QRUR gives you information that can help your practice maximize payments now and in the future. It is CMS’ hope that practices take the information from the report to see practice care patterns and see actionable items that will help your practice improve care and reduce costs at the same time.

There are two reports each year—a mid-year QRUR, which is informational only, and the annual QRUR, which used information from January–December along with the CMS-calculated quality and cost measures.

How do I see my QRUR?

QRURs are available at the TIN level and accessed via the CMS Enterprise Portal (portal.cms.gov) by authorized individuals of solo or group practices. Each TIN needs a designated “Security Official,” or in the case of solo practices an “Individual Practitioner.” This role is acquired through the CMS Enterprise Identity Management (EIDM) system.

The process to access a QRUR can be difficult to navigate. CMS offers a quick reference guide with screenshots that walks you through the process. You may contact the QualityNet Help Desk at qnetsupport@hcqis.org or 866-288-8912 for assistance with EIDM accounts.

We Support the Health of your PracticeWith the Same Dedication that You Support Your Patients

Your number one priority is the health of your patients. With the changing healthcare landscape, our number one priority is the business health of your practice.

Dedicated exclusively to the viability of community oncology, ION Solutions provides contracting, technology, education and advocacy support that ensures you have the tools to run your practice both ef�ciently and effectively. With the practice support of ION Solutions, you can navigate this changing environment and focus on providing quality care for your patients.

To learn how ION Solutions enables community oncology practices to improve operational ef�ciency, �nancial performance and quality of care, contact your Strategic Account Manager or visit IONonline.com.

To experience ION Solutions advocacy support, visit ourcommunitycounts.org.

We Support the Health of your PracticeWith the Same Dedication that You Support Your Patients

Your number one priority is the health of your patients. With the changing healthcare landscape, our number one priority is the business health of your practice.

Dedicated exclusively to the viability of community oncology, ION Solutions provides contracting, technology, education and advocacy support that ensures you have the tools to run your practice both ef�ciently and effectively. With the practice support of ION Solutions, you can navigate this changing environment and focus on providing quality care for your patients.

To learn how ION Solutions enables community oncology practices to improve operational ef�ciency, �nancial performance and quality of care, contact your Strategic Account Manager or visit IONonline.com.

To experience ION Solutions advocacy support, visit ourcommunitycounts.org.

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