Value-Based Cancer Care Issues


June 2013, Vol 4, No 5

Genomic Sequencing Assay Potentially a Game Changer

Caroline Helwick

AVBCC 2013 3rd Annual Conference

Hollywood, FL—Genomic profiling of individual tumors represents a paradigm shift in oncology and holds great promise for patients, according to Gary Palmer, MD, JD, MBA, MPH, Senior Vice President, Medical Affairs and Commercial Development, Foun­dation Medicine, who described this new genomic assay at the Third Annual Conference of the Association for Value-Based Cancer Care.
Before his position with Foundation Medicine, Dr Palmer led the development of the Oncotype DX Breast Cancer Assay for Genomic Health.

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Variations in Cancer Treatment Raise Average Cost of Care by $25,000 per Patient

Wayne Kuznar

ASCO Annual Meeting

Chicago, IL—Inappropriate deviation from evidence-based standards of care for cancer raises costs in excess of $25,000 per patient, stated Arlene A. Forastiere, MD, Senior Vice President of Medical Affairs at eviti, Inc, Philadelphia, PA, in a poster presented at the 2013 American Society of Clinical Oncology annual meeting.

In Dr Forastiere’s review of oncology treatment plans for 2544 patients, approximately 25% of the patients had treatment plans that did not conform to evidence-based standards.

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Pazopanib: First Positive Maintenance Trial in Ovarian Cancer

Phoebe Starr

ASCO Annual Meeting

Chicago, IL—Previous trials of maintenance therapy for patients with ovarian cancer have failed to show improved survival. A study presented at the 2013 American Society of Clinical Oncology annual meeting is the first successful phase 3 trial in this setting, showing that the targeted therapy pazopanib (Votrient) extended progression-free survival (PFS) by a median of 5.6 months in women with ovarian cancer. Women enrolled in the trial were free of disease after initial treatment with surgery and chemotherapy.

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Popularizing Cancer as a Topic of Public Discourse

Craig Deligdish, MD

From the Editor

Chief Medical Officer, Oncology Resource Networks, and Editor-In-Chief, Value-Based Cancer Care

With the Third Annual Con­ference of the Associ­ation for Value-Based Cancer Care (AVBCC) held in May in Florida and the 2013 Annual Meeting of the American Society of Clinical Oncology concluding in June in Chicago, it is tempting to consider which of the many presentations, abstracts, and reports were most impactful or will have the greatest influence on how oncologists think about, diagnose, and treat patients with cancer.

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Genetic Testing a Potential Game Changer in the Approach to Endometrial Cancer

Value Propositions

Researchers have analyzed the genetic makeup of hundreds of endometrial tumors that may lead to targeted therapies for subpopulations of patients with this deadly cancer. Endometrial cancer, which affects the lining of the uterus, is the fourth most common cancer among women in the United States. Although most of the patients with type I endometrial cancer are cured, patients with type II endometrial cancer have few treatment options.

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21st Century Oncology Administering First Commercial Dose of Xofigo for Advanced Prostate Cancer

Value Propositions

Only 9 days after the US Food and Drug Administration (FDA) approved radium RA 223 dichloride (Xofigo) for the treatment of patients with meta­static castration-resistant prostate cancer (CRPC) on May 15, 2013, which was 3 months ahead of the scheduled FDA review, the first worldwide commercial dose of this new therapy was administered to a patient with advanced CRPC. This event was made possible by a joint effort between 3 urology clinics in Myrtle Beach, SC, that constitute a division of 21st Century Oncology.

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Disease Burden, Not Inefficiency in Care, Explains the Lion Share of Geographical Differences in Medicare Costs

Value Propositions

A novel study offers a new explanation for the geographical differences seen in Medicare costs across the nation. Unlike the explanation offered mainly by the Dartmouth Atlas of Health Care and other research attributing geographical variations in care to waste and inefficiency in the delivery of healthcare, “our results suggest that the portion of the geographic variation that can be explained by patient health is much greater than previously estimated, leaving less of the geographic variation potentially attributable to inefficiency,” wrote James D. [ Read More ]

Pathways Creating More and More Value

AVBCC 2013 3rd Annual Conference

Hollywood, FL—Pathways continue to be refined toward value-based care, adapting to the challenges of a rapidly shifting oncology landscape, as 2 speakers at the Third Annual Conference of the Association for Value-Based Cancer Care described.

Michael A. Kolodziej, MD, National Medical Director for Oncology Strategies at Aetna, Hartford, CT, and Marcus A. Neubauer, MD, Medical Director, Oncology Services, US Oncology/McKesson Specialty Health, TX, first discussed market pressures and the need to control costs.

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FDA Expedites Approval of Xofigo for Metastatic, Castration-Resistant Prostate Cancer

FDA Approvals, News & Updates

Radium Ra 223 dichloride (Xofigo; Bayer Pharmaceuticals) was approved by the US Food and Drug Admini­s­tration (FDA) for men with metastatic, castration-resistant prostate cancer (CRPC) that has spread to bones but not to other organs. Ra 223 dichloride is an alpha particle-emitting radioactive therapy that is used to lower the testosterone levels for patients whose cancer has spread after medical or surgical therapy.

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Mekinist and Tafinlar Approved for Advanced Melanoma with BRAF Mutations

FDA Approvals, News & Updates

On the same day, the FDA approved 2 targeted oral therapies for patients with melanoma. The 2 therapies were both developed by Glaxo­SmithKline and are targeting similar, but not the same, populations of patients with melanoma and a BRAF mutation. Both drugs were approved concurrently with the FDA approval of a companion diagnostic assay THxID BRAF (manufactured by bioMérieux) for the detection of BRAF V600E and BRAF V600K mutations.

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The Cost of Cancer Care: We Must Incorporate Value and Quality of Life into the Mix

Caroline Helwick

AVBCC 2013 3rd Annual Conference

Hollywood, FL—The cost of cancer care or cancer cure means different things to different stakeholders. Finding a consistent definition may be impossible, but in today’s environment “it is probably unfair to focus on costs without incorporating value,” said John E. Hennessy, MBA, CMPE, Vice President, Operations Midwest Division Oncology, Sarah Cannon Cancer Center, Nashville, TN, who spoke at the Third Annual Conference of the Association for Value-Based Cancer Care. The types of costs in cancer care include:

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Oncology Practices Need to Transform the Way They Deliver Cancer Care

Caroline Helwick

AVBCC 2013 3rd Annual Conference

Hollywood, FL—Oncology practices need to transform the way they deliver cancer care, said John D. Sprandio, MD, FACP, Chief of Oncology at Delaware County Memorial Hospital in Drexel Hill, PA, and Medical Director of ION Solutions.

“According to Darwin, it’s not the strongest of a species that survives; the species that survives is the one that is adaptable to change,” Dr Sprandio said. “Practices and programs need to plan their response.”

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The Changing Landscape of Oncology

Caroline Helwick

AVBCC 2013 3rd Annual Conference

Hollywood, FL—At the Third Annual Conference of the Association for Value-Based Cancer Care, 2 oncologists representing opposite corners of the oncology care landscape discussed the current trends in the delivery of patient care, and the challenges that are facing oncologists.

Robert W. Carlson, MD, the new Chief Executive Officer of the National Comprehensive Cancer Network (NCCN), called the new delivery
models and processes in oncology “the tip of the iceberg.”

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FDA Expected to Approve Surrogate End Point for Neoadjuvant Breast Cancer Trials

Caroline Helwick

ASCO Annual Meeting

Chicago, IL—For years, the cancer research community has pushed for the use of surrogate end points in clinical trials as a means of hastening the drug approval process. These efforts will soon bear fruit, with the anticipated release by the US Food and Drug Administration (FDA) of its final guidance to drug manufacturers for accelerated drug approval for neoadjuvant breast cancer therapies. At the 2013 American Society of Clinical Oncology (ASCO) annual meeting, the speakers discussed the potential implications for researchers, providers, and patients.

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Rituximab Maintenance Prolongs PFS in Patients with Relapsed Lymphoma

In the Literature

The majority of patients with follicular lymphoma will relapse after initial response to therapy. A high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) strategy has been shown to improve outcomes in patients with recurrent disease. The benefit of rituximab (Rituxan) maintenance has been shown in patients with relapsed follicular lymphoma in the first-line and salvage settings but not in the setting of second-line maintenance after HDC-ASCT. [ Read More ]

Crizotinib Superior to Standard Chemotherapy in Patients with ALK-Positive Lung Cancer

In the Literature

Crizotinib (Xalkori), an inhibitor of the anaplastic lymphoma kinase (ALK) gene, has shown significant response rates in patients with advanced non–small-cell lung cancer (NSCLC) and the ALK rearrangement. One study in patients with ALK-positive advanced NSCLC showed a 60% objective response rate and a median PFS of 8.1 months with crizotinib; in a second study, the PFS was 9.7 months with crizotinib. A new study compared the response rates of crizotinib versus standard chemotherapy in patients with ALK-positive advanced NSCLC (Shaw AT, et al. N Engl J Med. [ Read More ]

Prostate Cancer Risk Doubles in Men with Lynch Syndrome

In the Literature

Lynch syndrome (LS) is an inherited syndrome of predisposition to cancer with an increased risk for colorectal cancer ranging from 30% to 80%. Prostate cancer has been described as a component tumor of LS, but the lifetime risk of prostate cancer in patients with LS has not been quantified because of inherent difficulties. In a new analysis, researchers have used genetic data to define the risk of prostate cancer in men with LS (Raymond VM, et al. J Clin Oncol. 2013;31:1713-1718).

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Immunotherapies Take Center Stage in Melanoma

Audrey Andrews

ASCO Annual Meeting

Chicago, IL—Data continue to build for the application of immunotherapy for patients with metastatic melanoma. At the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO), several sessions were devoted to recent advances in melanoma, focusing on new ways to boost the activity of current therapies, introducing a new class of immunotherapy in development, and a new form of immunotherapy—an oncolytic vaccine.

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Use of High-Cost Tests for Lung Cancer Surveillance Rising

Wayne Kuznar

Economics of Cancer Care

Chicago, IL—The use of costly diagnostic imaging of uncertain value is increasing rapidly for patients with localized non–small-cell lung cancer (NSCLC), according to data from the Surveillance, Epidemiology and End Results (SEER)-Medicare database. Frequent surveillance imaging was found for white patients and for those with higher socioeconomic status, despite lack of evidence for its value and its high cost, said Jason D. [ Read More ]

Single, Older Women Less Likely to Receive Guideline- Recommended Treatment for Breast Cancer in Rural Georgia

Neil Canavan

Economics of Cancer Care

New Orleans, LA—Researchers looking at whether guideline-directed adjuvant treatments for breast cancer were actually being administered in rural areas of the United States found that only 41% of the patients in this study received all of the suggested treatment modalities for breast cancer. Being single and advancing in age were negative predictors for receiving guideline-based care.

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Urologists’ Prescribing of Gonadotropin-Releasing Hormone Agonists for Prostate Cancer Vary by Practice Affiliation

Neil Canavan

Economics of Cancer Care

New Orleans, LA—An analysis comparing the prescribing habits of urology practices shows that, despite treatment guideline recommendations to the contrary, gonadotropin-releasing hormone (GnRH) agonists, which are only indicated for the palliative treatment of advanced prostate cancer, are routinely prescribed for patients with localized, low- or intermediate-grade prostate cancer, particularly by urologists who have no practice affiliation with a medical school.

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Companion Diagnostics Information Not Easily Obtained

Charles Bankhead

Personalized Medicine

San Diego, CA—Getting technical information about companion diagnostic tests required to make formulary decisions about oncology drugs may not be easy, according to a small telephone survey conducted by Aashish Surti, PharmD can­didate, and Iris Tam, PharmD, Di­rector, Managed Care Med­i­­cal Com­mu­n­i­­cations, Genentech. They reported their survey results in a poster presented at the 2013 Academy of Man­aged Care Pharmacy (AMCP) meeting.

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Patient-Reported Outcomes More Common in EU Labeling than FDA Labeling of Drug Approved for Lung Cancer

Neil Canavan

Economics of Cancer Care

New Orleans, LA—A study comparing patient-reported outcomes (PROs) labeling claims in Europe and in the United States showed that the European Medicines Agency (EMA) is more proactive in considering patient-generated feedback in their drug labeling decisions—this despite the US Food and Drug Administration (FDA)’s 2009 guidance that emphasized the importance of gathering and disseminating such data.

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Kadcyla (Ado-Trastuzumab Emtansine): First Antibody-Drug Conjugate Approved for the Treatment of HER2-Positive Metastatic Breast Cancer

Lisa A. Raedler, PhD, RPh

Drug Updates

Approximately 25% of women who are diagnosed with breast cancer have HER2-positive tumors. The HER2 gene, which resides on chromosome 17, directs tumor cells to manufacture HER2 protein. This protein is a cell-surface receptor that compels the tumor cell to grow and to divide more frequently than normal, making HER2-positive breast cancer an aggressive phenotype.

Before the advent of HER2-directed therapies, patients diagnosed with HER2-positive disease had significantly shorter disease-free survival compared with patients with other breast cancer subtypes.1

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New Guideline Emphasizes Sequenced Therapy for Castration-Resistant Prostate Cancer

Charles Bankhead

Prostate Cancer

San Diego, CA—Evidence-based drug sequencing should form the basis of treatment for castration-resistant prostate cancer (CRPC), according to a new guideline from the American Urolo­gical Association (AUA) released at the 2013 AUA annual meeting.

Organized into strategies for 6 types of patients with CRPC (“index patients”), the guideline emphasizes thera­pies that have demonstrated efficacy in the specific index patient.

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Meridian Cancer Care’s Multidisciplinary Approach to Patient Care

Mark J. Krasna, MD

Cancer Center Profile

Corporate Medical Director of Oncology, Meridian Cancer Care, NJ

From the beginning, decisions about cancer treatment can be overwhelming. To help patients get back to the life and the people they love, Meridian Cancer Care offers every medical advantage. Medical collaboration is critical in the treatment of cancer. At Meridian Health, surgeons, medical oncologists, radiation oncologists, and other specialists work together to provide the best treatment plan for patients with cancer.

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SGX942 Receives Fast Track Designation for Oral Mucositis

FDA Approvals, News & Updates

The FDA has granted a fast track designation for the development of SGX942 (Soligenix) for the treatment of oral mucositis associated with radiation and/or chemotherapy used in patients with head and neck cancer. SGX942 is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Extensive in vivo preclinical studies have demonstrated a significant reduction in tissue damage associated with chemotherapy, radiation, trauma, and inflammation. (June 2, 2013)

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FDA Requests More Data for Tivozanib

FDA Approvals, News & Updates

The FDA denied the approval of a New Drug Application for tivozanib, which was submitted by its manu­facturer (Aveo Pharmaceuticals/Astellas), for the treatment of renal-cell carcinoma. In its Complete Response letter to the company, the FDA noted that the survival results from the TIVO-1 clinical trial were inconsistent, which made the results “uninterpretable and inconclusive.” The FDA requested that the company provide new survival data from new clinical trials. Tivozanib is currently in phase 2 clinical trials for the treatment of colo­rectal cancer. [ Read More ]

Off-Label Drug Use in Oncology Accounts for 18% of Spending

Caroline Helwick

Economics of Cancer Care

Chicago, IL—An examination of the Surveillance, Epidemiology and End Results (SEER)-Medicare database from 1998 to 2008 revealed that a significant number of patients with cancer receive drugs that are neither indicated by the US Food and Drug Administration (FDA) for the specific condition nor endorsed by the National Comprehensive Cancer Network (NCCN) compendia—and 18% of the spending on cancer drugs is for off-label drug use.

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