volume 14, issue 4 - winter 2015 - oncologysupply ion€¦ · jan. 22-24, 2016 ash review orlando,...

Improving Access to Care

Takeda: Meeting Unmet Needs

Community-based Clinical Research

volume 14, issue 4 - winter 2015

ION Solutions’ Educational Programs

2016 Meeting Schedule

Meeting Date Meeting Name Location Venue

Jan. 22-24, 2016 ASH Review Orlando, FL Loews Portofino Bay

March 4-6, 2016 Oral Therapies Atlanta, GA Grand Hyatt Buckhead

Sept. 16-18, 2016 National Healthcare Practitioners New Orleans, LA Le Meridien

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

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

Table of Contentswinter 2015

6 Industry Insight

Takeda

An Interview with Liviu Niculescu, Vice President Global and U.S. Medical Affairs

10 Drug Review

Mylan

Oncology Drug Shortages: Past, Present and Future

18 Eye on ION

Clinical Research in the Community

By Brianna Simpson

22 What’s News at ION

4 | Oncologistics

Oncologistics | 5

volume 14, issue 4 - winter 2015

Whether it is ensuring patients have access to clinical trials or the optimal drug for their treatment, improving access to care remains an important topic. In this issue of Oncologistics, we explore efforts made by manufacturers and some of our own ION practices to improve access to and enhance patient care.

Takeda focuses on addressing unmet medical needs within blood cancers and solid tumors. Learn how the company strives to cure cancer on page six.

Since 2011, there has been a significant drop in the number of overall drug shortages in the U.S. On page 10, Mylan discusses the history of oncology drug shortages and possible solutions for the future.

The ability to provide patients with access to potentially

life changing clinical research is vital in shaping modern healthcare. Beginning on page 18, we introduce you to four ION Solutions member practices that are leaders in the community clinical research setting.

Thank you for your continued partnership. We are committed to offering you creative GPO contracting, educational events, practice advocacy and practice management tools. We look forward to continuing to do so in 2016.

Happy New Year!Mark Santos, PresidentION GPO

Editorial & Design staff:

· Chris Vorce Director, Marketing & Communications, ION Solutions

· Tricia Musslewhite Manager, Marketing & Communications, ION Solutions

· Connor Zetsche Coordinator, Marketing & Communications, ION Solutions

· Peter Kemp Graphic Designer, PKCreative

oncologisticsION Solutions article and advertising submissions:

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

Chris VorceManaging 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 Specialty Group. 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 Specialty Group company.

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

oneononewith Mark Santos

6 | Oncologistics

Industry Insight

TakedaAn Interview with Liviu Niculescu, Vice President Global and U.S. Medical Affairs

Industry-Sponsored Content

1. What programs does Takeda have in place to provide value to the community oncology setting?

We see community oncology centers as being at the forefront of the war on cancer, and so our commitment is to trying to understand and address the needs of community oncology healthcare practitioners and their patients. Takeda’s primary objective for community involvement, therefore, is to work with community hospitals and local patient networks to develop drugs that address unmet medical needs within blood cancers and solid tumors, and to help ensure that patients and providers have access to the most current information about these specific diseases and their treatments as they navigate the rapidly changing cancer treatment landscape.

Community sites are facing unprecedented pressures, and so developing therapeutics that work not only in academic and clinical trial settings, but also in community settings, is key to our focus. This is why we aim to include community sites in our clinical trials. We also include community physicians and nurses on our advisory boards, so that we have immediate access to their important perspectives.

In diseases such as multiple myeloma, where the incidence is relatively low, but the pressure to keep up with the scientific developments is very high, the need to make new information available to our community partners in a timely fashion is an ongoing goal. We try to understand which practices work so that we can better deliver, for

example, guidance on adverse event management or

provide patient adherence tools. Understanding the

anatomy of each practice also helps us partner with the

most appropriate group to achieve the right outcome.

Additionally, we have created long-standing relationships

with key patient advocacy groups who help us make a

lasting impact for patients. These relationships include

Multiple Myeloma Research Foundation (MMRF),

International Myeloma Foundation, and the Leukemia &

Lymphoma Society, among others. With each group, we

have established a successful collaborative relationship in

support of distinct educational programs and resources.

Multiple Myeloma Research Foundation (MMRF): Takeda is both an advocacy and research partner with the

MMRF. The MMRF established the CoMMpass Study – the

most comprehensive in multiple myeloma – with the goal

of enrolling 1,000 patients who would provide tissue

samples when first diagnosed and then each time there

was a change in their treatment. These tissue samples will

be genetically analyzed and shared along with resulting

treatment data among a team of researchers from more

than 100 cancer centers, including Takeda scientists.

The CoMMpass Study aims to dramatically advance the

understanding of the molecular basis of the disease

and how individual patients respond to therapies. In

September, the MMRF announced that it has reached a

pivotal milestone with full enrollment of 1,000 patients in

the first phase of the study.

Oncologistics | 7

Liviu Niculescu

8 | Oncologistics

International Myeloma Foundation (IMF): Emphasizing education, advocacy and support, Takeda supports “Patient and Family Seminars,” which are local market meetings that empower patients and provide invaluable information to the multiple myeloma community. The seminar is structured as a two-day format, including a full day “interactive” seminar with world-renowned multiple myeloma experts covering a broad range of topics, including treatment advances, novel therapies, supportive care and clinical trials. The data gathered from the interactive session provides invaluable information on treatment trends and patients’ perspectives on the treatment journey and clinical trials, among other important insights. The seminar also features a dedicated session featuring esteemed faculty on the topic of targeted therapies. The average attendance of the Patient & Family Seminar is 150-250 people.

Leukemia & Lymphoma Society (LLS): Takeda supports the “Light the Night” fundraising effort that benefits the LLS and their funding of research to find cures for blood

cancers while also raising awareness of the illnesses, treatment options and the need for further research and medical advancements. Every fall, participants in nearly 200 communities across North America participate in fundraising walks; joining together and carrying illuminated lanterns to take steps to end cancer. Light the Night raises funds through these “walk teams” as well as donation capabilities at retail outlets nationwide.

2. What differentiates Takeda in the oncology marketplace? What are your primary objectives in this setting?

Takeda’s legacy in advancing the science of cancer care extends more than 25 years, with more than 15 years of experience leading the advancements in multiple myeloma. Our leadership in advancing the treatment of multiple myeloma is evidenced through the development of VELCADE (bortezomib), which was approved in 2003, and NINLARO (ixazomib), approved in 2015, as well as a broad research and clinical program with five phase 3 trials and

Industry Insight

Oncologistics | 9

We see community oncology

as being at the forefront of

the war on cancer, and so our

commitment is to trying to

understand and address the

needs of community oncology

healthcare practitioners and

their patients.

numerous smaller clinical trials with ixazomib, studying it in various treatment settings for multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Many community sites are included in this clinical program and have contributed significantly to these studies.

Our deep commitment to patients with multiple myeloma and other blood cancers and our long history of scientific investigation into these diseases have helped Takeda establish a strong understanding of these specific diseases and the unmet needs of patients who are affected by them. This knowledge has allowed us to now translate that understanding into other diseases as we advance our pipeline to hopefully benefit more patients.

3. What are Takeda’s long-term goals for its oncology business?

From our research studies and partnerships to our patient support programs and corporate commitments, our mission begins and ends every day with striving to improve the lives of people with cancer. Takeda aspires to cure cancer by delivering novel therapies to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. We aim to do this by combining the power of leading scientific minds with our agile and entrepreneurial spirit and continuing to focus on cancers where there remains an unmet medical need.

We continue to focus on developing first-in-class novel cancer medicines and best-in-class new combination cancer therapeutics that offer potentially life-changing benefits to patients and demonstrate meaningful market differentiation.

That said, at our core, Takeda strives to support cancer patients in their journey, which goes beyond the science in helping ensure that the people who are fighting cancer have access to the treatments they need.

4. Can you talk about any patient assistance you offer?

Takeda is committed to helping patients gain access to our medicines whenever possible. Our program provides access and coverage support and other useful information

to help patients during their treatment. In fact, Takeda has offered regular assistance to multiple myeloma patients for nearly 15 years since VELCADE’s approval in 2003 and now, Takeda has created a robust suite of support services to help patients access NINLARO. We are committed to these programs and will continue our work to help patients gain access to the treatments they need.

5. Can you tell us about your pipeline?

Takeda’s research and development focus is on cancers where there remains an unmet need, and specifically investigating the disease pathways or processes that cancer cells depend on to survive. We have over 15 drug candidates in our pipeline in various stages of clinical development.

6. Ten years from now, what do you hope to be able to say about Takeda’s contribution to the cancer care portfolio?

Our aspiration is to cure cancer, and that will remain our focus until it is achieved. We recognize that this is a bold goal and we will need the help of many other research and clinical partners, including those within the community hospital setting. We expect a growing involvement with the community medical teams to gain a deeper understating of not only the biology and treatment of the disease, but also of the practicalities of delivering care. ◾

Takeda

10 | Oncologistics


Drug ReviewIndustry-Sponsored Content

Oncologistics | 11


Oncology drug shortages are deeply frustrating for oncology clinics, hospitals and oncology practices, and other members of the healthcare team as they try to provide exceptional patient care. Shortages can also be devastating to patients who may not have access to the optimal drug for their treatment regimen, prompting delays in care or the need to switch to an agent that might be less effective or more toxic.

“Several years ago, we would hear about patients who couldn’t get their infusions because centers didn’t have enough product,” says Erin Fox, PharmD, who helps track drug shortages as Director of the Drug Information Service at the University of Utah. “It was extremely frustrating and scary for patients, and it put oncologists in the very bad position of deciding who would get the last vial of a treatment.”

In 2011, a shortage of over 250 drugs including cytarabine and other agents used in cancer brought the issue of drug shortages into the wider public eye.1,2,3 It was also the first time the U.S. had experienced a widespread shortage of

drugs essential for cancer care.4

The crisis sparked an executive order resulting in the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) 2012, granting the FDA the authority to require advanced warning from manufacturers regarding potential drug shortages.3-6

It’s a change that seems to have helped alleviate concerns. Since 2011, there has been a significant drop in the number of overall drug shortages in the U.S. In 2014, only 44 shortages were reported, compared to 251 in 20117, and the effects have been felt in the oncology drug market.

“Right now, one of the bright spots is that the oncology drug shortage is much improved compared to several years ago,” says Dr. Fox.

Better communication between the FDA and industry has helped avert an impressive number of shortages. Also playing a role has been resolution of quality problems that have affected production at some manufacturing sites, hand in hand with an increased focus on quality by manufacturers.

“The combination of industry working to improve quality and FDA helping to prevent shortages has been key,” notes Dr. Fox.

Matthew Erick is President of Mylan’s Institutional business in the U.S. Mylan manufactures and distributes a broad portfolio of injectable medicines, including oncology products in the U.S. and around the world. In fact, over the past five years, Mylan has grown

Coalescing around a plan to address distribution may be one way to help avert future shortages.

Source: U.S. Food and Drug Administration. 2014.

251 191165

282213

170145

10162

183

11784

4435

4430

Shortages Reported Shortages Averted

All Forms

2011

2012

2013

2014 Injectables

Drug Shortages in the U.S., 2011-2014

12 | Oncologistics

its U.S. oncology portfolio from two cancer therapies to more than 20 approved products, with additional cancer and supportive care therapies in the pipeline. The company plans to double the size of its existing injectables portfolio by 2018. Erick agrees that better communication between the FDA and manufacturers has had a large impact.

“Industry and the FDA have improved communication with each other about the issue of shortages,” he says. “That level of interaction and transparency is part of what was missing in the past. The more we can communicate and prepare for potential shortages, the more we can reduce the impact on patients and families.”

Even with improved communication, addressing a drug shortage is a huge challenge for manufacturers. Given the complexity of some molecules, it can be difficult to ramp up quickly for an increase in production. In addition, most manufacturers are operating at capacity. To step in and address a shortage, a manufacturer might have to reduce or stop production of a different product on the manufacturing line or even dedicate an entire plant so that they can produce the drug in shortage.

“Any time you step in to alleviate a shortage, whether by increasing production of an existing drug or manufacturing a drug you haven’t made before, you need to consider a broad set of priorities,” says Erick. “You want to make sure you are trading off the right thing at the right time, and not shorting one product while addressing a shortage of another. It’s a tremendous balancing act.”

A recent shortage of a frequently prescribed cancer therapy used to treat a variety of conditions, including pediatric cancer, highlights the impact of drug shortages. Mylan recognized the critical importance of this product8

and to address that shortage, the company

redirected their production capacity

specifically towards the pediatric product,

which required shifting away from

producing the drug for adults who might

use the product in a variety of indications.

The company also realigned shipping to

deliver directly to the pediatric hospitals

where it was needed most.

Although recent changes have been

positive overall, there are still many

opportunities for improvement as the

current system of preparing for and

dealing with drug shortages in the U.S.

evolves.

“We are really at a starting point,” says

Erick. “Manufacturers are communicating

back to the FDA about potential shortages,

but there is also an opportunity with

healthcare associations to improve

communication and alignment on

manufacturing and distribution.”

Erick notes, problems can arise with

oversupply if a manufacturer who steps

in to help deal with a shortage isn’t given

enough notice that another manufacturer

has come back online. Distribution is

another area where Erick sees room for

improvement. Today, manufacturers are doing a good job

of communicating needs and working with the FDA to

help prevent shortages, but they may need to work harder

to close the distribution gap and make sure products are

going where they are most needed.

“There is a huge opportunity for everyone to make sure an

appropriate balance of product is going to the appropriate

treatment centers,” says Erick. “How do we make sure the

right product goes to the right place at the right time for

the right patients? This is a question that has not yet been

fully addressed.”

Drug Review

Erin Fox, PharmD

Matthew Erick, President of Mylan’s Institutional business in the U.S.

Oncologistics | 13

Currently, some manufacturers like Mylan might ship product directly to make sure needs are met, but not all manufacturers have a business structure that can support that ability.

“There needs to be a standard,” says Erick. “We have made progress in closing the communication gap with the FDA, but we now have to better address manufacturing and distribution to continue to ensure that patients have the course of therapy when and where they need it.”

Coalescing around a plan to address distribution may be one way to help avert future shortages. Other proposed solutions range from offering manufacturers incentives for building in backup capacity for their plants to changing drug labeling laws so that purchasers can see who has manufactured a product and choose who they’d like to buy from—potentially providing more transparency into the quality of a given product. The International Society for Pharmaceutical Engineering (ISPE) has been working for several years on a drug shortage prevention program, and

organizations like American Society of Clinical Oncology (ASCO), American Society of Health System Pharmacists (ASHP), healthcare organizations and others have also spent much time focusing on the issue.

“The number one thing oncologists and other physicians are concerned with is reliability – making sure that a reliable supply of product is there for preferred clinical pathways is key. That need is understood, but the “how” still needs to be borne out,” notes Erick.

This work is warranted, as any drug shortage can have potentially serious outcomes on a variety of patients.

“The most concerning shortages right now are antibiotics used in hospitals,” says Dr. Fox. “These types of shortages can have a large impact on cancer patients if they get sick.”

Overall, however, the changes since 2011 have been largely positive, and drug shortages are fewer and farther in between, including shortages of oncology drugs. Improving the system further will take time and involve addressing a number of complex issues, but collaboration among different organizations and stakeholders remains critical to coming up with viable solutions.

“It’s something many people are thinking about and working on,” says Dr. Fox. ◾ 12345678

1 Link MP, Hagerty K, Kantarjian HM. Chemotherapy drug shortages in the United States: genesis and potential solutions. J Clin Oncol. 2012;30(7):692-4.

2 Ventola CL. The drug shortage crisis in the United States: Causes, impact, and management strategies. Pharm Therapeut. 2011;36(11):740-757.

3 U.S. Food and Drug Administration. Report to Congress: Second Annual Report on Drug Shortages for Calendar Year 2014. Accessed Nov 12, 2015. Available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM443917.pdf.

4 Gatesman ML, Smith TJ. The shortage of essential chemotherapy drugs in the United States. N Engl J Med. 2011;365(18):1653-5.

5 The White House. Executive Order 13588 - Reducing Prescription Drug Shortages (October 31, 2011). Accessed Nov. 12, 2015. Available at: https://www.white-house.gov/the-press-office/2011/10/31/executive-order-13588-reducing-prescrip-tion-drug-shortages

6 U.S. Food and Drug Administration. Strategic Plan for Preventing and Mitigating Drug Shortages (October 2013). Accessed Nov 12, 2015. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf.

7 U.S. Food and Drug Administration. Drug Shortages [Infographic]. Accessed Nov 12, 2015. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM441583.pdf.

8 Mylan Actively Addressing Shortage of Preservative-Free Methotrexate Injection. Available at: http://newsroom.mylan.com/index.php?s=2429&item=122598

Mylan Institutional provided support and content.


http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM443917.pdf

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM443917.pdf

https://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-13588-reducing-prescription-drug-shortages



http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf




http://newsroom.mylan.com/index.php?s=2429&item=122598

PROGRESSIONHOLD BACK

INDICATIONSomatuline® Depot (lanreotide) Injection 120 mg is indicated for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

IMPORTANT SAFETY INFORMATIONContraindications:Somatuline Depot is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S. IPSEN CARES is a trademark of Ipsen S.A.S. ©2015 Ipsen Biopharmaceuticals, Inc. April 2015. NET00124

In patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastrointestinal and pancreatic neuroendocrine tumors (NETs)

Time (Months)

100

90

80

70

60

50

40

30

20

10

00 3 6 9 12 15 18 2421

Hazard ratio=0.4795% CI: 0.30-0.73

Somatuline Depot (n=101)Placebo (n=103)

Median PFS for placebo: 16.6 months95% CI: 11.2-22.1

Pro

gres

sion

-Fre

e S

urvi

val P

roba

bilit

y (%

)

Median PFS for Somatuline Depot not yet reached at 22 months

SIGNIFICANTLY IMPROVED PROGRESSION-FREE SURVIVAL (PFS)1

Study design: Randomized, double-blind, placebo-controlled, multicenter, 96-week study of Somatuline Depot 120 mg vs placebo administered every 28 days. Patients had unresectable, well- or moderately differentiated, nonfunctioning,locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Primary endpoint was time to disease progression or death.

Somatuline Depotvs placebo

reduced risk of progression or

death by

53%

Warnings and Precautions:� Cholelithiasis and Gallbladder Sludge: Somatuline Depot may reduce gallbladder motility and lead

to gallstone formation. Periodic monitoring may be needed.

� Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline Depot, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Blood glucose levels should be monitored when Somatuline Depot treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly. To learn more, visit SomatulineDepot.comReference: 1. Somatuline Depot (lanreotide) Injection [Prescribing Information].

Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; December 2014.

IMPORTANT SAFETY INFORMATION (Continued)Warnings and Precautions (Continued):� Cardiac Abnormalities: Somatuline Depot may decrease heart rate. In 81 patients with baseline heart rates of

≥60 beats per minute (bpm) treated with Somatuline Depot in the GEP-NETs clinical trial, the incidence of heart rate <60 bpm was 23% (19/81) with Somatuline Depot vs 16% (15/94) with placebo; 10 patients (12%) had documented heart rates <60 bpm on more than one visit. The incidence of documented episodes of heart rate <50 bpm or bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia. In patients without underlying cardiac disease, Somatuline Depot may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.

� Drug Interactions: The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels.

Adverse Reactions:In the GEP-NET pivotal trial, the most common adverse reactions (incidence >10% and more common than placebo) in patients treated with Somatuline Depot vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).

You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.

SOMATULINE DEPOT SIGNIFICANTLY EXTENDED PFS IN LOCALLY ADVANCED OR METASTATIC GEP-NETs1

Please see Brief Summary of full Prescribing Information on the following page.

A 53% REDUCTION IN THE RISK OF DISEASE PROGRESSION OR DEATH VS PLACEBO1

Patient support is available through IPSEN CARES™: (866) 435-5677 (8 AM to 8 PM ET)

1 of 2

This fi le has been prepared by

Pub: Oncologistics Trim: 17” x 11”Color: 4/C Bleed: 17.5” x 11.25”LPI: Live: 16” x 10.5”Material Due Date: Job: IPSO15105

SOMATULINE DEPOT® (lanreotide) Injection 120 mg

Brief Summary of Prescribing Information

1 INDICATIONSOMATULINE DEPOT Injection 120 mg is indicated for the treatment of patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

4 CONTRAINDICATIONSSOMATULINE DEPOT is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

5 WARNINGS AND PRECAUTIONS5.1 Cholelithiasis and Gallbladder Sludge Lanreotide may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically [see Adverse Reactions (6.1)].

5.2 Hyperglycemia and HypoglycemiaPharmacological studies in animals and humans show that lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Hence, patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when lanreotide treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly [see Adverse Reactions (6.1)].

5.3 Thyroid Function AbnormalitiesSlight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare (<1%). Thyroid function tests are recommended where clinically indicated.

5.4 Cardiovascular AbnormalitiesIn patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to SOMATULINE DEPOT treatment, sinus bradycardia may occur. Care should be taken when initiating treatment with SOMATULINE DEPOT in patients with bradycardia.

In patients with baseline heart rates of ≥ 60 beats per minute (bpm) treated with SOMATULINE DEPOT in the GEP-NETs clinical trial, the incidence of heart rate < 60 bpm was 23% as compared to 16 % of placebo-treated patients; 12% of patients had documented heart rates < 60 bpm on more than one visit. The incidence of documented episodes of heart rate < 50 bpm as well as the incidence of bradycardia reported as an adverse event was 1% in each treatment group. Initiate appropriate medical management in patients who develop symptomatic bradycardia.

5.5 Drug InteractionsThe pharmacological gastrointestinal effects of SOMATULINE DEPOT may reduce the intestinal absorption of concomitant drugs.

Lanreotide may decrease the relative bioavailability of cyclosporine. Concomitant-administration of SOMATULINE DEPOT and cyclosporine may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels [see Drug Interactions (7.2)].

6 ADVERSE REACTIONS6.1 Clinical Studies ExperienceThe safety of SOMATULINE DEPOT 120mg for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) was evaluated in Study 3, a double-blind, placebo-controlled trial. Patients in Study 3 were randomized to receive SOMATULINE DEPOT (N=101) or placebo (N=103) administered by deep subcutaneous injection once every 4 weeks. Patients treated with SOMATULINE DEPOT had a median age of 64 years (range 30-83 years), 53% were men and 96% were Caucasian. Eighty-one percent of patients (83/101) in the SOMATULINE DEPOT arm and eighty-two percent of patients (82/103) in the placebo arm did not have disease progression within 6 months of enrollment and had not received prior therapy for GEP-NETs. The rates of discontinuation due to treatment-emergent adverse reactions were 5% (5/101 patients) in the SOMATULINE DEPOT arm and 3% (3/103 patients) in the placebo arm.

Table 1: Adverse Reactions Occurring in >5% in SOMATULINE DEPOT- Treated Patients and Occurring More Commonly Than Placebo-Treated Patients (>5% higher incidence) in Study 3

SOMATULINE DEPOTAdverse 120 mg PlaceboReaction (N=101) (N=103) Any Severe Any Severe (%) † (%) (%) † (%)

Any Adverse 88 26 90 31ReactionsAbdominal 34* 6* 24* 4pain1

Musculoskeletal 19* 2* 13 2pain2

Vomiting 19* 2* 9* 2*Headache 16 0 11 1Injection site 15 0 7 0reaction3

Hyperglycemia4 14* 0 5 0Hypertension5 14* 1* 5 0Cholelithiasis 14* 1* 7 0Dizziness 9 0 2* 0Depression6 7 0 1 0Dyspnea 6 0 1 01 Includes preferred terms of abdominal pain, abdominal pain upper/lower,

abdominal discomfort2 Includes preferred terms of myalgia, musculoskeletal discomfort,

musculoskeletal pain, back pain3 Includes preferred terms of infusion site extravasation, injection site

discomfort, injection site granuloma, injections site hematoma, injection site hemorrhage, injection site induration, injection site mass, injections site nodule, injection site pain, injection site pruritus, injection site rash, injection site reaction, injection site swelling.

4 Includes preferred terms of diabetes mellitus, glucose tolerance impaired, hyperglycemia, type 2 diabetes mellitus

5 Includes preferred terms of hypertension, hypertensive crisis6 Includes preferred terms of depression, depressed mood* Includes one or more serious adverse events (SAEs) defined as any

event that results in death, is life threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability, results in congenital anomaly/birth defect, or may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed.

† Defined as hazardous to well-being, significant impairment of function or incapacitation

6.2 ImmunogenicityIn Study 3, development of anti-lanreotide antibodies was assessed using a radioimmunoprecipitation assay. In patients with GEP NETs receiving SOMATULINE DEPOT, the incidence of anti-lanreotide antibodies was 3.7% (3 of 82) at 24 weeks, 10.4% (7 of 67) at 48 weeks, 10.5% (6 of 57) at 72 weeks, and 9.5% (8 of 84) at 96 weeks. Assessment for neutralizing antibodies was not conducted.The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence ofantibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SOMATULINE DEPOT with the incidence of antibodies to other products may be misleading.

6.3 Postmarketing ExperienceThe profile of reported adverse reactions for SOMATULINE DEPOT was consistent with that observed for treatment-related adverse reactions inthe clinical studies. Those reported most frequently being gastrointestinal disorders (abdominal pain, diarrhea, and steatorrhea), hepatobiliary disorders (cholecystitis), and general disorders and administration site conditions (injection site reactions). Occasional cases of pancreatitis have also been observed.Allergic reactions associated with lanreotide (including angioedema and anaphylaxis) have been reported.

7 DRUG INTERACTIONS7.1 Insulin and Oral Hypoglycemic DrugsLanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when lanreotide treatment is initiated or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.

7.2 CyclosporineConcomitant administration of cyclosporine with lanreotide may decrease the relative bioavailability of cyclosporine and, therefore, may necessitate adjustment of cyclosporine dose to maintain therapeutic levels.

7.3 Other Concomitant Drug TherapyThe pharmacological gastrointestinal effects of SOMATULINE DEPOT may reduce the intestinal absorption of concomitant drugs. Limited published data indicate that concomitant administration of a somatostatin analog and bromocriptine may increase the availability of bromocriptine.

Concomitant administration of bradycardia-inducing drugs (e.g., beta- blockers) may have an additive effect on the reduction of heart rate associated with lanreotide. Dose adjustments of concomitant medication may be necessary. Vitamin K absorption was not affected when concomitantly administered with lanreotide.

7.4 Drug Metabolism InteractionsThe limited published data available indicate that somatostatin analogs may decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that lanreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g. quinidine, terfenadine) should therefore be used with caution. Drugs metabolized by the liver may be metabolized more slowly during lanreotide treatment and dose reductions of the concomitantly administered medications should be considered.

8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category CLanreotide has been shown to have an embryocidal effect in rats and rabbits. There are no adequate and well-controlled studies in pregnant women. SOMATULINE DEPOT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproductive studies in pregnant rats given 30 mg/kg by subcutaneous injection every 2 weeks (five times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival. Studies in pregnant rabbits given subcutaneous injections of 0.45 mg/kg/day (two times the human therapeutic exposures at the maximum recommended dose of 120 mg, based on comparisons of relative body surface area) shows decreased fetal survival and increased fetal skeletal/soft tissue abnormalities.

8.3 Nursing MothersIt is not known whether lanreotide is excreted in human milk. Many drugs are excreted in human milk. As a result of serious adverse reactions from SOMATULINE DEPOT in animals and, potentially, in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, after taking into account the importance of the drug to the mother.

8.4 Pediatric UseSafety and effectiveness in pediatric patients have not been established.

8.5 Geriatric UseThe GEP-NETs clinical trial did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently fromyounger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. No dose adjustment required.

8.6 Renal Impairment No effect was observed in total clearance of lanreotide in patients with mild to moderate renal impairment receiving SOMATULINE DEPOT 120 mg. Patients with severe renal impairment were not studied.

8.7 Hepatic ImpairmentSOMATULINE DEPOT has not been studied in patients with hepatic impairment.

10 OverdosageIf overdose occurs, symptomatic management is indicated.Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at phone number 1-800-222-1222.

17 Patient Counseling InformationAdvise the patient to read the FDA-approved patient labeling (Patient Information).Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms, or if any known symptom persists or worsens.Advise patients experiencing dizziness not to drive or operate machinery.

Manufactured by: Ipsen Pharma BiotechSignes, France Distributed by: Ipsen Biopharmaceuticals, Inc.Basking Ridge, NJ 07920

©2015 Ipsen Biopharmaceuticals, Inc.

RX ONLYNET00107b

2 of 2

This file has been prepared by

Pub: Oncologistics Trim: 8.5” x 11”Color: 1/C Bleed: N/A

LPI: Live: 8” x 10.5”Material Due Date: Job: IPSO15105

18 | Oncologistics

Clinical Research in the CommunityION Practices Bring Treatment Options to Patients

By Brianna Simpson

Eye on ION

Oncologistics | 19

The ability to provide patients with access to potentially life changing clinical research is vital in shaping modern healthcare. Community-based oncologists have a special advantage in this area by offering patients an environment for research in their own communities, close to their support systems, making them capable of contributing to improved patient results and a reduction in cancer discrepancies.

The research conducted in the community setting has many benefits to oncologists as well, including access to a larger and more diverse patient population. Researchers also gain exposure to available experimental therapies and current treatment options.

ION Solutions member practices are leaders in the community clinical research setting among their peers. One of the main rea-sons for the success of these practices is diversification of services.

Gabrail Cancer Center

The Gabrail Cancer Center (GCC) of Canton, Ohio, an ION practice, is among the frontrunners in community oncology clinical research. GCC embarked on Phases I, II and III of meaningful clinical research in 1998, and since then has expanded to launch the Sargon Research Program to help their peers do the same.

“GCC regularly gets patients referred from area academic centers for clinical trials,” says Dr. Nash Gabrail. “Being at the tip of the bayonet in clinical research has made our practice the place to go for a second opinion, yet another source of a stream for patient referral.”

The results of the GCC success are evident. More than 85 percent of patients at GCC are enrolled in a clinical trial at one stage or another in their treatment course, with more than 45 percent of patients enrolled in more than one study sequentially. Gabrail credits clinical research as a critical element in the economic viability of the practice.

South Texas Accelerated Research Therapeutics

Another example of ION practices breaking barriers in

clinical research is found in The Cancer and Hematology

Centers of Western Michigan and their partnership with

San Antonio-based START (South Texas Accelerated

Research Therapeutics) to open one of the first

comprehensive Phase I oncology clinical trials program

in Western Michigan, which operates under the START

banner.

START directs the clinical trials of novel anticancer agents

using a high quality and innovative information technology

infrastructure to ensure accurate and rapid clinical trials in

a setting that emphasizes personalized and compassionate

clinical care. The superior team of clinical and research

support staff have extensive experience in oncology drug

development and patient care. With headquarters in San

Antonio at ION member practice South Texas Oncology and

Hematology, START conducts the world’s largest Phase I

medical oncology program.

START Midwest is START’s second U.S.-based site, led by

Drs. Nehal Lakhani and Timothy O’Rourke. START Midwest

began accepting patients for clinical trials on Dec. 10,

2015. Operating through one of the Midwest’s largest and

most prestigious cancer practices, the new site will bring

the latest treatment options to cancer patients throughout

the Midwest and help accelerate cancer drug development

worldwide.

START’s researchers are among the rare individuals who

can claim a direct, hands-on involvement with the clinical

development of more than 19 anticancer drugs that, in the

past 18 years, have obtained FDA approval and are now

considered a part of standard of care.

The patient-centered care provided by community-based practices is a critical element to the accomplishments clinical research can achieve, and an important thing to consider moving forward in cancer care.

Clinical Research in the Community

20 | Oncologistics

The Center for Cancer and Blood Disorders

Also in the ION practice family is the all-encompassing cancer facility, The Center for Cancer and Blood Disorders in Fort Worth, Texas. The Center gives patients the opportunity to access the latest innovative therapies in clinical trials and the highest level of sophistication in comprehensive patient management. Under the research leadership of Dr. Ray Page, The Center has participated in almost 200 critical clinical trials involving several experimental drugs that have now achieved FDA approval for standard use of care.

In the past few years, The Center has been prestigiously established as one of the seven worldwide strategic sites of the Sarah Cannon Research Institute. SCRI has the most robust community oncology clinical trial program in the world, reaching more than 100,000 diagnosed annually. The SCRI is known for its outstanding physician leadership at the forefront of new drug development.

ION member practices are changing the way clinical research is affecting patients. Through innovative technology and personable staff members, oncologists are able to see clear results in the success that their research brings. The patient-centered care provided by community-based practices is a critical element to the accomplishments clinical research can achieve, and an important thing to consider moving forward in cancer care.

With a greater amount of community oncologists engaging in research, there will be a more diverse patient arena to access. Through the expanded opportunity to reach individuals, community-centered research has the potential to help patients become more involved in their own healthcare on a larger scale, increasing further positive opportunities for oncologists. ◾

Brianna Simpson is coordinator, marketing and communications, at ION Solutions.

Eye on ION

To learn more about our test offerings, please visit

www.integratedoncology.com.

Because Knowledge is a Powerful Tool.

Prosigna® is a registered trademark of NanoString Technologies, Inc. ©2015 Laboratory Corporation of America® Holdings. All rights reserved.

onc-883-v1-1015

• Expanded RAS and RAF Predictive Testing for Colorectal Cancer

• Lynch Syndrome Tumor and Germline Testing

• IntelliGEN® Next Generation Sequencing Therapeutic Panel

• Prosigna® Breast Cancer Prognostic Gene Signature Assay

• Reveal® SNP Array for Hematologic Malignancies

Comprehensive Diagnostic and Predictive Molecular Pathology Services including:

onc_883_v1_0915.indd 1 9/22/15 12:16 PM

To learn more about our test offerings, please visit

www.integratedoncology.com.

Because Knowledge is a Powerful Tool.

Prosigna® is a registered trademark of NanoString Technologies, Inc. ©2015 Laboratory Corporation of America® Holdings. All rights reserved.

onc-883-v1-1015

• Expanded RAS and RAF Predictive Testing for Colorectal Cancer

• Lynch Syndrome Tumor and Germline Testing

• IntelliGEN® Next Generation Sequencing Therapeutic Panel

• Prosigna® Breast Cancer Prognostic Gene Signature Assay

• Reveal® SNP Array for Hematologic Malignancies

Comprehensive Diagnostic and Predictive Molecular Pathology Services including:

onc_883_v1_0915.indd 1 9/22/15 12:16 PM

22 | Oncologistics

What’s News at ION

AmerisourceBergen Introduces CareFront to Support Patients During Cancer CareIn December 2015, AmerisourceBergen launched CareFront, a first-of-its-kind population health management program focused on the needs of patients diagnosed with cancer. Designed to be built into existing employer benefit packages, CareFront connects newly diagnosed cancer patients with resources for their care and explains how to avoid unnecessary medical costs. The program also offers tools to help patients understand their treatment options and financially rewards participants for enhancing the quality of their care.

“Cancer continues to be among the most expensive diseases individuals and families may encounter. By optimizing the quality of care, we can also reduce the overall costs of cancer care and minimize the negative

impact on patients,” said Barry Fortner, president of ION Solutions, an AmerisourceBergen company. “Supporting patients as they navigate oncology care has

long been an important focus area for AmerisourceBergen. We are proud to launch CareFront as a comprehensive patient engagement strategy that helps participants control costs and evaluate diverse choices for their site of care.”

Approximately 200 ION Solutions member practices are listed in the CareFront directory. Thank you for making this valuable program a reality for patients. To learn more about how CareFront can benefit your practice or to list your practice in the directory, send an email to [email protected]. ◾

Shaping Healthcare Delivery AwardDuring AmerisourceBergen’s annual manufacturer summit, ThinkLive 2015, AmerisourceBergen recognized ION Solutions member practice Florida Cancer Specialists & Research Institute with the “Shaping Healthcare Delivery” award, which celebrates a customer that is making a positive impact on healthcare delivery and helping to shape the industry in innovative ways. Founded in 1984, Florida Cancer Specialists & Research Institute is the largest independent medical oncology/hematology practice in the U.S. With more than 180 physicians, 130 nurse practitioners and physician assistants and more than 90 locations, everyone at Florida Cancer is committed to providing world-class cancer care in community-based settings close to home.

“At Florida Cancer Specialists & Research Institute, everything we do starts with considering the patient experience first,” said Brad Prechtl, Chief Executive Officer. “Receiving the 2015 Shaping Healthcare Delivery award is a true testament to our staff and the patients they care for every day, and we couldn’t be more proud.” ◾

“In order for us to deliver the best care to our patients, we need to work with a distributor that keeps patients’ needs top of mind. AmerisourceBergen is exactly that type of trusted partner,” said Dr. William Harwin, President and Managing Partner of Florida Cancer Specialists. “We’ve collaborated with AmerisourceBergen’s ION Solutions and Oncology Supply for many years, and we value their commitment to independent physicians and practices. We’re honored to be their 2015 Shaping Healthcare Delivery award winner.”

community counts practice effectiveness

web series

As part of Community Counts, ION Solutions is hosting a

Webcast Series where members can receive valuable

information and insight on a number of vital topics, such as

preparing for the ICD-10 change, quality care models and

the �nal rule for the 2016 Medicare Physician Fee Schedule.

events are as follows:

January 14

February 18

March 10

All events will be held at 3 p.m. EST, and ION Solutions members can register here:

Business Intelligence with InfoDive

NOW OFFERING GUIDELINES-BASED PANELS FOR HEREDITARY BREAST, GYNECOLOGIC, AND COLON CANCER

We’re making genetic testing even more accessible by offering more genes than ever while keeping our commitment to high-quality, affordable genetic testing. With every test, we offer:

n Affordable, transparent pricingn Faster time to answersn Flexible test optionsn Deeper genetic insightsn Quality and confidencen Support every step of the way

We also offer a Clinical Consult program to help clinicians choose the right tests and interpret results.

Join us in our mission to battle cancer and bring genetic testing into mainstream medical practice to improve healthcare for billions of people.

[email protected]

© 2015 Invitae Corporation. All Rights Reserved.

Visit invitae.com/guidelines to view our new

guidelines-based panels.

Hundreds of new genes. Dramatically expanded test menu. Same mission.

Ad, Print, Oncologistics Dec 2015.indd 1 11/19/2015 12:43:47 PM

Oncologistics | 25

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.

volume 14, issue 4 - winter 2015 - oncologysupply ion€¦ · jan. 22-24, 2016 ash review orlando,...

Documents