Value-Based Cancer Care Issues


October 2012, Vol 3, No 7

Updated Data Confirm Survival Benefits with T-DM1 in Breast Cancer and with Regorafenib in Colon Cancer

Phoebe Starr

ESMO 2012 Conference

Vienna, Austria—The updated analyses of 2 major studies of drugs that were recently approved by the US Food and Drug Administration (FDA) confirm the benefits of tras­tuzumab emtansine (T-DM1) in patients with advanced HER2-positive breast cancer and of regorafenib (Stivarga) in patients with metastatic colorectal cancer (mCRC). Both studies were presented at the 2012 European Society for Medical On­cology (ESMO) Congress. Regora­fenib was approved by the FDA for the treatment of mCRC during the ESMO meeting (see article here).

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Many Emerging Biomarkers, but Few Are Clinically Applicable

Caroline Helwick

AVBCC Annual Conference

Houston, TX—Despite much talk about biomarkers and a field that is exploding, only a few biomarkers can be reliably and routinely used to improve patient care at this time, according to Peter G. Ellis, MD, Deputy Director of Clinical Services, Associate Chief Medical Officer, University of Pittsburgh Medical Center Cancer Centers.

A biomarker is any measure (ie, gene mutation, staining pattern, gene expression microarray) that can be associated with a clinically distinct prognosis, diagnosis, or response to a specific therapy.

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Indirect Costs of Metastatic Breast Cancer Are Substantial

Caroline Helwick

Breast Cancer Symposium

San Francisco, CA—The indirect costs of metastatic breast cancer are substantial and are much higher than the costs of early breast cancer, according to what may be the first study to compare costs related to lost productivity in the population with breast cancer.

The study was reported at the 2012 Breast Cancer Symposium by Yin Wan, MS, of Pharmerit International, Bethesda, MD. The senior research-
er was Lee Schwartzberg, MD, Medi­­cal Director of the West Clinic in Memphis, TN.

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FDA Approves Neutroval for Severe Neutropenia

FDA Approvals, News & Updates

The FDA approved tbo-filgrastim (Neutro­val; Sicor Biotech UAB, a member of Teva Corporation) to reduce the duration of severe neutropenia in pa­tients with cancer receiving chemo­therapy.

Tbo-filgrastim is a short-acting re­com­binant human granulocyte colony-stimulating factor that is indicated for use in patients with cancer, except blood or bone marrow cancers, who are receiving chemotherapies that cause febrile neutropenia. Tbo-filgrastim is administered as a subcutaneous in­jection, 5 mcg/kg, 24 hours after chemotherapy treatment.

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Marqibo New Option for Acute Lymphoblastic Leukemia

FDA Approvals, News & Updates

The FDA accelerated the approval of vincristine sulfate liposome injection (Marqibo; Talon Therapeutics) for the treatment of patients with Philadelphia chromosome–negative acute lympho­blastic leukemia (ALL), a rare type of leukemia, with a second or greater relapse after treatment with ≥2 anti­leukemia therapies. The drug is designated as an orphan product.

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Enzalutamide Prolongs Overall Survival after Chemotherapy in Prostate Cancer

In the Literature

The once-daily oral androgen-receptor–signaling inhibitor enzalutamide (Xtandi) differs from current antiandrogen therapies by its ability to inhibit nuclear translocation of the androgen receptor, its DNA binding activity, and its coactivator recruitment, in addition to other clinical benefits in the context of prostate cancer. This novel agent is administered without the need for concomitant prednisone, which has been postulated to activate androgen-receptor signaling. [ Read More ]

Adding Cetuximab to Chemotherapy Improves Outcomes in Patients with KRAS G13D Mutation

In the Literature

Although epidermal growth factor receptor (EGFR) monoclonal antibodies were initially indicated for the treatment of EGFR-expressing meta­static colorectal cancer (mCRC), studies conducted in patients with mCRC have failed to show benefits of the EGFR monoclonal antibodies cetuximab (Erbitux) and panitumumab (Vectibix) for patients with KRAS mutations. However, approximately 40% of patients with CRC have one of the KRAS gene mutations, with the most frequent mutations seen with G12D (13%), G12V (9%), or G13D (8%). [ Read More ]

Soy Isoflavone Intake Significantly Reduces Risk of Breast Cancer Recurrence, May Improve Survival

In the Literature

It has been suggested in previous studies that soy isoflavones have anticancer properties; however, it is also known that soy-based foods possess estrogen-like properties and can therefore present complications rather than benefits for patients with breast cancer, potentially even playing a role in the genesis of breast cancer or its progression. Now 2 new studies indicate that daily consumption of soy-based foods may confer benefits for patients with breast cancer.

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Head-to-Head Comparison: Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma

Caroline Helwick

ESMO 2012 Conference

Vienna, Austria—In a head-to-head comparison of 2 treatments for meta­static renal-cell carcinoma (mRCC), pazopanib (Votrient) showed similar efficacy to sunitinib (Sutent), with a 1-month survival advantage for sunitinib, which was associated with fewer side effects and an increased quality of life (QOL), suggested Robert J. Motzer, MD, Professor of Medicine, Weill Medical College of Cornell University, and an attending physician at Memorial Sloan-Kettering Cancer Center, New York. [ Read More ]

ESMO Theme: Personalized (“Precision”) Oncology Care Marches Forward

Caroline Helwick

Personalized Medicine

Vienna, Austria—“One of our themes at the 2012 ESMO Congress is personalized oncology,” European Society for Medical Oncology (ESMO) Presi­dent Martine J. Piccart-Gebhart, MD, PhD, Professor of Oncology at the Université Libre de Bruxelles and Director of the Medicine Department at Jules Bordet Institute, Brussels, Belgium, said at a press briefing at the meeting. She noted that the numerous presentations on targeted therapy and diagnostics at ESMO are evidence that the field is rapidly moving forward.

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Is Personalized Cancer Care Affordable?

Caroline Helwick

Personalized Medicine

Vienna, Austria—“Is personalized cancer care affordable?” asked Richard Sullivan, MD, PhD, Director of Kings Health Partners Institute of Cancer Policy and Global Health in the United Kingdom, in an invited presentation at the 2012 European Society for Medical Oncology Congress.

The short answer he gave was “no,” barring seismic shifts not only in the oncology landscape but also in the larger societal picture. He described 3 trends that will be disastrous for controlling the cost of care.

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An Underappreciated Cause of Cancer Death: Disparities in Treatment

Caroline Helwick

Breast Cancer Symposium

San Francisco, CA—When cancer treatment is equal among patients, the outcomes are equal as well, “but there is not equal treatment” within the US population with cancer, according to Otis W. Brawley, MD, Chief Medical and Scientific Officer of the American Cancer Society, and Professor of Hematology, Medical Oncology, Med­icine, and Epidemiology at Emory University, Atlanta.

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More Evidence Supports the Anticancer Effect of Metformin

Charles Bankhead

Breast Cancer Symposium

San Francisco, CA—Women with diabetes taking metformin had a significantly lower risk of breast cancer, an association that appeared to grow stronger with increasing duration of follow-up, results of a recent meta-analysis showed.

Overall, metformin users had a 17% lower risk of breast cancer compared with women who did not use the drug, including diabetic women who were taking other hypoglycemic agents. The reduction in risk increased to 25% among women who took metformin for >3 years and to 32% when follow-up started before 1997.

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The IOM Considers the Economics of Genome-Based Targeted Drug Development

Value Propositions

The Institute of Medicine (IOM) recently held a roundtable discussion on the status of genome-based drug development. In its summary of the meeting, the IOM stated, “The number of new drug approvals has remained steady for the last 50 years while spending on health-related research and development has tripled since 1990. This trajectory is not economically sustainable for the businesses involved, and, in response, many companies are turning toward collaborative models of drug development. [ Read More ]

Health Plans Need Policies for Dealing with Off-Label Drug Use

Caroline Helwick

AVBCC Annual Conference

Houston, TX—To eliminate coverage inconsistencies and enhance relationships with providers, health plans should have specific policies for dealing with off-label use of oncologic drugs, said Kristen M. Reimers, RPh, Specialty Pharmacy Director and Clinical Operations Manager for Excellus Health Plans.

At the Second Annual Association for Value-Based Cancer Care Con­ference, Ms Reimers described the rationale for and the process of development and benefits of the off-label drug policy that she helped to develop at Excellus.

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Evolving Strategies for Cost-Effective Cancer Management

AVBCC Annual Conference

Houston, TX—A wealth of new agents and abundant clinical trial data supporting their use have led to multiple “acceptable” evidence-based options for treating tumors. This can make the “real-life” care of patients with cancer confusing with regard to disease outcomes and in the assessment of value propositions related to treatment, ac­cording to Atheer A. Kaddis, PharmD, Senior Vice President of Managed Markets, Diplomat Specialty Pharm­acy, Flint, MI.

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Companion Drug Testing Is Becoming Critical to Pharmacy Benefits Management

Caroline Helwick

AVBCC Annual Conference

Houston, TX—With the onslaught of drugs that will target genetic subsets of patients, companion diagnostic testing will become vitally important, said Jane F. Barlow, MD, MPH, MBA, Vice President of Clinical Innovation, Medco Health Solutions (now Express Scripts), New York, who spoke on personalized medicine during the 2012 Annual Conference of the Association for Value-Based Cancer Care.

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Integrative Medicine Cuts Inpatient Costs in Oncology Care Unit

Rosemary Frei, MSc

Economics of Cancer Care

Albuquerque, NM—Using yoga and other integrative medicine and complementary therapies can cut oncology-related inpatient costs by more than $150 per day as a result of the reduced need for pain medications, anxiolytics, and antiemetics, according to a recent study conducted at the Beth Israel Medical Center in New York City; this daily reduction adds up to nearly $1 million annually when the savings are extrapolated to a 24-bed oncology unit in the hospital.

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First Analysis of Medicare Costs Associated with Head and Neck Cancers

Economics of Cancer Care

Toronto, Canada—The first-ever analysis of Medicare payments for head and neck tumors shows that comorbidities and treatment choices are the primary drivers of the costs of each type of cancer; the study results were presented at the 2012 International Conference on Head and Neck Cancer. Consequently, the total 5-year cumulative costs per oral-cavity cancer case are approximately $72,000 and approximately $91,000 for oropharyngeal cancer.

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Pertuzumab a New Therapeutic Option for Patients with HER2-Positive Metastatic Breast Cancer

Alice Goodman

Drug Updates

Breast cancer is the most common cancer and the second leading cause of cancer death among women worldwide.1 In the United States, an estimated 230,480 new cases of invasive breast cancer, as well as an additional 57,650 cases of carcinoma in situ, were expected to be diagnosed in 2011. Approximately 39,500 deaths from breast cancer were expected to occur in 2011.2

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