TOPS News

ALUNBRIG (brigatinib) Receives FDA Approval

Takeda Oncology is proud to announce the FDA approval of ALUNBRIGTM (brigatinib), a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Click here to read the complete announcement.
Prescribing information can be found here.

Posted 5/23/2017


Astellas Announces New XTANDI Data from the TERRAIN Trial

Astellas Pharma US, Inc. is pleased to announce new XTANDI data from the TERRAIN trial. The XTANDI Prescribing Information has been updated to reflect results from the TERRAIN trial, a phase 2, randomized, double-blind trial vs bicalutamide in metastatic castration-resistant prostate cancer. Please see the documents below for more information.

New trial data added toXTANDI Prescribing Information
Established efficacy from PREVAIL and new data from TERRAIN

November 14, 2016

 

Update on Prior Authorization for Injectable Outpatient Chemotherapy Services from UnitedHealthcare

Effective June 1, 2016, injectable outpatient chemotherapy services for UnitedHealthcare Community Plan members in Tennessee will require prior authorization.

If a UnitedHealthcare Community Plan member in Tennessee has received injectable chemotherapy drugs in an outpatient setting between March 1, 2016, and May 31, 2016, the care provider does not need to request prior authorization until a new chemotherapy drug is administered to the member.

For more information including a list of injectable drugs, please click here to read the full notice from UnitedHealthcare.

May 24, 2016

TOPS Congratulates Fellows Award Winners

During the TOPS Annual Conference on May 6, 2016, two fellows gave presentations and were presented with the TOPS Fellows Awards.

TOPS Fellows

From left to right, Sameer Nasir, MD, University of Tennessee, Gregg Shepard, MD, Tennessee Oncology Practice Society President, and Shruti Chaturvedi, MD, Vanderbilt University Medical Center.

May 9, 2016

TOPS Urges CMS to Withdraw Part B Drug Payment Model From Consideration

As many of you know, in early March, CMS proposed a program that would have a detrimental impact on our ability to provide high quality cancer care to our patients. The Medicare Part B Drug Payment Model proposes a sweeping change to Part B reimbursement, and may be implemented as early as this fall.

The state society recently sent a letter on behalf of members to our elected officials to oppose CMS’ ill-conceived proposal.

April 28, 2016

ACCC Expresses Strong Opposition to CMS Proposed Medicare Part B Payment Model Rule

Last week, TOPS joined with the Association of Community Cancer Centers (ACCC), American Society of Clinical Oncology (ASCO), the Community Oncology Alliance (COA), and approximately 100 other organizations in a letter to HHS Secretary Sylvia Burwell and Acting CMS Administrator Andy Slavitt expressing “strong concern” about the agency’s plans to put forward a proposed rule for the Medicare Part B Drug Payment Model and asking the agency not to proceed with the initiative.

The rule is scheduled to be published in the March 11 Federal Register. Comments on the proposed rule are due by May 9.

Read letter here. Read the ACCC press release here.

Read the CMS proposed rule here. Read CMS fact sheet here.

March 9, 2016

FDA Approves New Indication for Faslodex® (Fulvestrant)

AstraZeneca announced that the FDA has approved a new indication expanding the use of Faslodex®(fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.  

Faslodex has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

Read the full corporate announcement here.

March 8, 2016

FDA Approves Ninlaro in Combination Regimen for Previously Treated Multiple Myeloma Patients

On Nov. 20, 2015, the U.S. Food and Drug Administration (FDA) approved ixazomib (Ninlaro, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor.

Read the FDA announcement here.

Read the FDA press release here.

November 24, 2015

FDA Approves Lonsurf for Advanced Colorectal Cancer

The U.S. Food and Drug Administration (FDA) on Sept. 22, 2015, approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other treatments.

Read the FDA announcement here.

Read the FDA press release here.

October 8, 2015

New Clinical Trials Resource

To raise awareness and advance cancer treatment and science, the American Cancer Society and Genentech have teamed up to provide About Clinical Trials (ACT).

ACT is a series of unbiased videos and patient resources. Study participants, clinicians, thought leaders, nurses, and others share their experience in order to educate and inspire patients, caregivers, and physicians to act by considering enrollment in cancer clinical trials. Society Chief Medical Officer Otis W. Brawley, MD, is featured.

Go to LearnAboutClincialTrials.org to learn more about clinical trials and access resources to help patients make educated decisions about their treatment, including the American Cancer Society's Clinical Trials Matching Service. Constituents may also call the American Cancer Society National Call Information Center (NCIC) at 800.227.2345 to receive a free patient kit, which contains an educational brochure with a DVD and USB drive, and also directs inquiries to the Clinical Trials Matching Service.

August 25, 2015

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Immuno-Oncology Coverage & Reimbursement Webinar

August 27 at Noon, EST, join Niesha Griffith, RPh, MS, FASHP, Administrator of Oncology Pharmacy and Infusion Services at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University and Bill McGivney, PhD, Principal of McGivney Global Advisers for a complimentary webinar to discuss the intricate coverage and reimbursement issues related to immuno-oncology agents. Brought to you by the Institute for Clinical Immuno-Oncology (ICLIO) An Institute of ACCC.

Discussion will include:
-Determination of coverage and reimbursement for I-O agents
-Compendia review
-Present coverage for I-O agents
-Impact of new Oncology Value Metrics
-Institutional considerations and needs
-Assurance of explicit, timely, and clear coverage policies
-Reimbursement issues in contracting, pilot projects etc.

Click here to register.

August 14, 2015

 

Webinar on Immunotherapy and Advanced Melanoma

ACCC members are invited to join Dr. Michael Postow for an interactive webinar on the role of immunotherapy in treating patients with advanced melanoma. As part of the Principles and Application of Immunotherapy of Cancer series, this free, CME/ANCC/APCE-certified webinar will be held this Friday, May 22, from 7:30 am - 8:30 am ET.

Topics include:

View the agenda and register for the May 22 webcast today! Please share this webinar with all members of your team who provide care for patients with melanoma.

Your cancer program can host a private webinar on integrating immunotherapy into the treatment of melanoma or lung cancer, at no charge. Email Lorna Lucas or call 866.690.9902 for more information.

May 20, 2015

 

Pictures from TOPS 2015 Annual Membership Conference

The Annual Membership Conference was another successful TOPS event! Thank you to all our speakers and attendees for making this a great meeting! We look forward to seeing you at future TOPS meetings.

Smith and Sheppard

TOPS President Gregg Shepard, MD, recognizing Past President Clyde Smith, MD, for his services.

fellows

TOPS Fellows Award winners: Valerie M. Jansen, MD, PhD, Vanderbilt University Medical Center, and George Yaghmour, MD, University of Tennessee.

May 18, 2015

 

TOPS Joins Health Care Payment Learning and Action Network

The Association of Community Cancer Centers (ACCC), on behalf of TOPS, has joined HHS' Health Care Payment Learning and Action Network, a collaborative network of payers, employers, providers, patients, states, and consumer groups, who will work together to generate knowledge, capture best practices, disseminate information, and apply lessons learned that support the increased adoption of value-based payments in Medicare.

The network was created in tandem with HHS Secretary Burwell's January announcement that set tangible goals to shift Medicare payments towards value-based payments.

April 3, 2015

 

FDA Expands Indication for Revlimid Plus Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma

On Feb. 18, 2015, Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma.

Read company press release here.

March 8, 2015

 

Opportunity to Host Immunotherapy Webinars

Principles and Application in Immunotherapy of Cancer is a CME/ANCC/ACPE certified education series designed for multidisciplinary oncology care teams. Presented in an interactive webinar format, the series will provide a full overview of the core principles of immunotherapy and a review of issues related to the clinical application of these therapies in Melanoma and Lung Cancer from the convenience of your own office. Cancer practices can choose to participate in one or both of these 60-minute tumor-specific tracks. The series has been developed by a faculty committee composed of 1 physician expert and 1 nurse practitioner along with input from 10 additional presenting faculty.

This private webcast provides your practice with exclusive access. The format is designed so that your team members can learn and connect directly with expert faculty well versed in immunotherapy principles and clinical application. The opportunity is available at no cost to participating practices.

This series is jointly provided by Postgraduate Institute for Medicine and Clinical Care Options, LLC, in partnership with ACCC.

If your cancer practice is interested in participating, or if you would like more information, please contact me at directly at llucas@accc-cancer.org.

February 3, 2015

 

FDA Expands Approved Use of Imbruvica for CLL

On July 28, 2014, the U.S. Food and Drug Administration (FDA) expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.

The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.

Read the FDA press release here.

August 15, 2014

 

Webinars Offer Overview of Claims and Coding for Xofigo®

Sign up today for an informational webinar on claims and coding for Xofigo®. Presenters will provide information on payer requirements for the coding and billing of Xofigo®, as well as considerations for claims submission and appeal.

The presenters will also provide an update on:

To reserve your space, please visit www.regonline.com/XofigoWebinars to
register. Download this brochure for the full schedule of webinars and more information.

July 31, 2014

 

Rep. Chuck Fleischmann Participates in Special Order to Honor ASCO

Rep. Chuck Fleischmann (R-TN), participated in a recent Special Order held by the US House of Representatives in honor of ASCO celebrating its 50th anniversary.

On Thursday May 8th, Rep. Fleischmann and several other members of Congress met on the House floor and highlighted critical advancements in cancer care over the last 50 years and the impact of ASCO’s work on driving progress and innovation.

Rep. Fleischmann was joined by Rep. Lance (R-NJ), Rep. Higgins (D-NY), and Rep. Lee (D-TX) in the Special Order. You can watch the Special Order to honor ASCO’s 50th Anniversary on CSPAN, read ASCO's statement, and the ASCO in Action article for more information.

May 20, 2014

 

FDA Approves Imbruvica for Treatment of CLL

Pharmacyclics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Imbruvica™ (ibrutinib) as a single agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. Imbruvica is the first oncedaily, single-agent, oral kinase inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Read the full press release here.

April 21, 2014

 

New CMS HCPCS code for Neupogen® (filgrastim)

On November 29, 2013, CMS released the Healthcare Common Procedure Coding System (HCPCS) code set updates that will be effective January 1, 2014.

For the full Prescribing Information on Neupogen® (filgrastim), please go to:
http://www.neupogen.com

December 16, 2013

 

Announcing the 2014 TOPS Board of Directors

Please join us in congratulating the new 2014 Tennessee Oncology Practice Society (TOPS) Board of Directors:

President
Clyde E. Smith, MD
Kirkland Cancer Center an affiliate of
Medical Plaza
Jackson

President-Elect
Gregg Shepard, MD
Tennessee Oncology, PLLC
Nashville

Secretary/Treasurer
W. Charles Penley, MD
Tennessee Oncology, PLLC
Nashville

Immediate Past President
Larry L. Schlabach, MD
University Oncology & Hematology Associates
Chattanooga

Board Members
Jill Gilbert, MD
Vanderbilt Ingram Cancer Center
Nashville

Anthony A. Meluch, MD
Tennessee Oncology, PLLC
Nashville

Benton M. Wheeler, MD
The West Clinic, PC
Memphis

Practice Administrator Ex Officios
Jamison D. Chandler
The West Clinic, PC
Memphis

Patti Garner
Tennessee Oncology, PLLC
Nashville

Gina Geren, BA, MT
Tennessee Oncology, PLLC
Chattanooga

November 25, 2013

 

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