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.
This two-day program will cover evidence-based guidelines, recommendations and recent advances regarding therapeutic options for patients with benign and malignant hematologic disorders. At the end of the course, physicians will leave with a deeper understanding of the pathogenesis, diagnostic evaluation and therapeutic modalities available for common benign and malignant hematologic disorders.
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.
Charles F. Miller, MD (Board Member, HSCO, on right), and Senator Mazie K. Hirono (D-HI, middle) pictured above at an April meeting at the Senator's office.
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.
The U.S. approval follows the recent marketing authorization of Gilotrif in this patientpopulation by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.
Read the corporate press release here.
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.
The Hawaii Society of Clinical Oncology (HSCO) collaborated with the Association of Community Cancer Centers (ACCC) on a project to understand the unique cultural, economic, and demographic needs of Asian American and Pacific Islander (AAPI) lung cancer patients, in order to improve the diagnosis and treatment of this vulnerable patient population. Through a survey and focus groups, the initiative identified key issues providers face when treating AAPI patients. Read our newly released white paper.
Funding and support for this initiative was provided by Boehringer Ingelheim.
On March 4, 2016, the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).
Learn more here.
HSCO is pleased to announce that our board member Laeton J. Pang, MD, MPH, FACR, was recently invited to join the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Dr. Pang's nomination was supported by the HSCO board and we wish him all the best. Congratulations Dr. Pang!
Learn more about MEDCAC here.
Laeton J. Pang, MD, MPH, FACR (Board Member, HSCO), and Congressman Mark Takai (Hawaii First District) pictured above at ACCC Capitol Hill Day, March 2, 2016.
Last week, HSCO 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.
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.
Don't miss Comprehensive Oncology Update, an educational program conducted by the Seattle Cancer Care Alliance (SCCA), from April 16–17, 2016, in Honolulu, HI.
This two-day program will incorporate data supporting guideline-based recommendations and recent advances regarding therapeutic options in patients with malignant solid tumors. At the end of the course, physicians will leave with a deeper understanding of the pathogenesis, diagnostic evaluation, and therapeutic modalities available for common solid tumor malignancies. Please see the course brochure for more information about this course.
Registration is free of charge. Email this registration form to firstname.lastname@example.org to register for this course. Please contact the Seattle Cancer Care Alliance at 206.288.1066 or email email@example.com with questions.
Below please find the following materials from the recent meeting:
EHR Incentive Programs for Eligible Professionals: What You Need to Know for 2015 Tipsheet
Payment Adjustments & Hardship Exceptions Tipsheet for Eligible Professionals
Hawaii Contractor Advisory Committee
Benign Skin Lesion Removal (Excludes Actinic Keratosis, and Mohs)
Intensity Modulated Radiation Therapy (IMRT)
MolDX: HLA-DQB1*06:02 Testing for Narcolepsy
MolDX: Chromosome 1p/19q Deletion Analysis
Total Hip Arthroplasty
Total Knee Arthroplasty
Treatment of Males with Low Testosterone
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.
The following 6 draft LCDs for discussion:
Boehringer Ingelheim announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition. Click here for the full press release.
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 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
-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.
The 16-page booklet "A Guide to Advance Care Planning: Making Life Decisions" by Kōkua Mau has been reprinted and is now available for download.
Now available with updated wording, the new booklet reflects 2014 changes to POLST which added APRNs as signers. The booklet also lists organizations and resources as well as answers to common patient questions about palliative care.
Register to attend Clinical Advances in the Art and Science of Care, a virtual conference hosted by the National Hospice and Palliative Care Organization (NHPCO), the American Academy of Hospice and Palliative Medicine (AAHPM), and the Hospice and Palliative Nurses Association (HPNA) July 21, 22, & 23.
Please register by Monday, July 13 to make sure you get access to the conference handouts. This is a great chance to earn continuing education credits from national experts without having to leave home.
Registration is free! Seating is limited, sign up today. Register here now.
Below please find the following materials for the upcoming meeting:
The next Ask the Contractor Teleconference will be July 23, 2015. Conference number: 800-553-5260.
Dr. Charles F. Miller (Past-President, HSCO), Congressman Mark Takai (Hawaii First District), and Terry Hamlin (Director, State Initiatives, ASCO) pictured above at ASCO Hill Day in April.
Join The Hawaii Comprehensive Cancer Control Coalition and their partners at the Pomaikai Ballrooms in Honolulu on June 11! This conference, for cancer survivors and caregivers will focus on key issues related to survivorship. Register online or click here to download a registration form.
Download the conference brochure for the complete agenda and more information.
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.
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.
The Association of Community Cancer Centers (ACCC), on behalf of HSCO, 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.
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.
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 firstname.lastname@example.org.