Value-Based Cancer Care Issues


October 2011, Vol 2, No 6

The First NCQA-Recognized Medical Home in Oncology

John D. Sprandio, MD

Oncology

The patient-centered medical home (PCMH) model of care has proved successful in overcoming some of the fragmentation of primary care. Dr Sprandio and his colleagues have now demonstrated the value of applying the principles of the medical home to cancer care, with particular implications for oncologists and for payers and unique reimbursement dilemmas. [ Read More ]

Therapy-Associated Complications Significantly Increase Cost of Cancer Care

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—The cost of cancer therapies is a growing concern not only for patients but also for providers and payers. Addressing the cost burden for those involved in cancer care is becoming a priority that cannot be avoided with the growing role of targeted therapies in oncology.

Cost Nearly Doubles in Metastatic Breast Cancer

A study presented by Melissa Brammer, MD, Medical Director, Genentech, San Francisco, CA, shows that complications associated with treating cancer essentially double the cost of treating metastatic breast cancer.

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Value of Cost-Effectiveness Analyses for Clinical Practice Outlined by NICE

Value Propositions

The National Institute for Health and Clinical Excellence (NICE) has issued a report (Wonderling D, et al. Ann Intern Med. 2011;154:758-765) explaining the process and value of cost-effectiveness assessments and how these inform recommendations and decisions regarding clinical questions made by the UK National Clinical Guidelines Centre. The report dispels the following 3 myths regarding cost-effectiveness evaluations that further clarify the concept of value in medicine:

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How to Assess the Value of Clinical Interventions

Value Propositions

Another report in the same issue of the Annals of Internal Medicine focuses on the relevance of 3 concepts that can help in understanding the value of clinical interventions for those involved in clinical decisions (Owens DK, et al. Ann Intern Med. 2011;154:174-180). The authors define value as “an assessment of the benefit of an intervention relative to expenditures.”

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PET Imaging an Effective Tool for Tailoring Therapy in Advanced Lung Cancer

Value Propositions

Positron emission tomography (PET) is a promising approach for differentiating which patients with inoperable lung cancer will and will not benefit from additional treatment after standard chemotherapy/radiation therapy. Lead investigator Mitch Machtay, MD, Chairman of Radiation Oncology, Seidman Cancer Center, University Hospitals Case Western Medical Center, presented these results at the 2011 annual meeting of the American Society for Radiation Oncology (ASTRO), based on 251 patients with stage III lung cancer at 60 cancer centers around the country.

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US Patients Get New Cancer Drugs Faster than in Europe

Value Propositions

The US Food and Drug Administration (FDA) is often criticized for delaying treatments for patients, especially those with terminal illnesses such as advanced cancer. However, a new drug-to-drug comparison (Roberts SH, et al. Health Aff [Millwood]. 2011;30:1375-1381) of the 35 new cancer drugs approved by the FDA and the European Medicines Agency (EMA) between 2003 and 2010 shows that:

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Ginger Root Cost-Effective for Preventing Colon Cancer

Value Propositions

In a new study funded by the National Cancer Institute and the University of Michigan Clinical Research Center, inexpensive ginger supplements reduced markers of colon inflammation, indicating that ginger root may be beneficial in preventing colon cancer (Zick SM, et al. Cancer Prev Res [Phila]. 2011 Oct 11. Epub ahead of print). Colon inflammation is a precursor of colon cancer.

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Diagnosing Melanoma Early May Soon Be Easier: MelaFind Gets Approvable Letter

Value Propositions

On September 26, 2011, the FDA issued an approvable letter to Mela Sciences, the manufacturer of MelaFind, an investigational diagnostic device for early melanoma. This letter comes almost 1 year after the FDA rejected the device, requesting more clinical data. MelaFind is a noninvasive, multispectral computerized vision system that analyzes images of skin lesions. It is designed to differentiate nonulcerated, nonbleeding cutaneous malignant melanoma and high-grade lesions <2.2 cm from all other pigmented skin lesions. [ Read More ]

Companion Diagnostic for BRAF V600E Mutation

FDA Approvals, News & Updates

Along with vemurafenib the FDA concurrently approved the companion molecular diagnostic for this targeted therapy—the cobas 4800 BRAF V600 Mutation Test (Roche) for the diagnosis of BRAF V600E mutation in patients with melanoma. As a realtime polymerase chain-reaction test, it is 97.3% positive in detecting the mutation. (August 17, 2011)

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Brentuximab Indicated for 2 Types of Lymphomas

FDA Approvals, News & Updates

The FDA expedited the approval of brentuximab vedotin (Adcetris, Seattle Genetics) for the treatment of Hodgkin lymphoma, as well as for systemic anaplastic large-cell lymphoma (ALCL), a rare non-Hodgkin lymphoma that may manifest in several parts of the body, including the lymph nodes, skin, bones, soft tissue, lungs, and liver. Brentuximab is the first CD30-directed antibody-drug conjugate approved for systemic ALCL; it is also the first treatment ever approved for this rare disease.

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FDA Accelerates Approval of Crizotinib for NSCLC

FDA Approvals, News & Updates

Using a priority review, the FDA approved oral crizotinib (Xalkori, Pfizer) for the treatment of locally advanced or metastatic non–small-cell lung cancer (NSCLC) in patients with the anaplastic lymphoma kinase (ALK) genetic mutation, as detected by the companion test concurrently approved by the FDA. Approximately 3% to 5% of patients with NSCLC are ALK-positive.

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Value of Bevacizumab in Ovarian Cancer Got a Boost in a New Analysis

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—The indefinite use of bevacizumab (Avastin) in patients with re lapsed ovarian cancer got another boost at the 2011 European Multi disciplinary Cancer Congress, with a subanalysis of the phase 3 OCEANS trial showing consistent benefit across subgroups. The main finding of OCEANS, which was reported earlier at the 2011 American Society of Clinical Oncolo - gy annual meeting, was that the addition of bevacizumab to carboplatin (Paraplatin)/gemcitabine (Gemzar) in patients with advanced ovarian cancer reduced the risk of disease progress - ion by 52%.

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Positive Data Continue to Accrue for Crizotinib in ALK-Positive NSCLC

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—In patients with advanced non–small-cell lung cancer (NSCLC) and anaplastic lymphoma kinase (ALK) gene rearrangements, treatment with crizotinib (Xalkori) provided clinically meaningful antitumor activity, producing responses in 51% of patients, in the multicenter phase 2 PROFILE 1005 study reported at the 2011 European Multidisciplinary Can cer Congress.

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Everolimus-Exemestane Combination Prolongs Remission by 4 Months in Metastatic Breast Cancer

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—The use of everolimus (Afinitor) together with the aromatase inhibitor exemestane (Aromasin) more than halved the risk for disease progression in patients with advanced breast cancer, adding an average of 4 disease-free months, investigators reported at the 2011 European Society for Medical Oncology European Multidisciplinary Cancer Congress. [ Read More ]

New T-DM1 Reduces Disease Progression by 40% in Advanced Breast Cancer, with Low Toxicity

Caroline Helwick

ESMO 2011 Conference

Stockholm, Sweden—Trastuzumab emtansine (T-DM1), a novel monoclonal antibody–guided therapy for HER2- positive metastatic breast cancer, achieved almost a 40% reduction in the risk of disease progression compared with standard treatment with trastuzumab (Herceptin) and docetaxel (Taxotere), investigators reported at the 2011 European Multidisciplinary Cancer Congress.

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Genetic Diagnostic for ALK-Positive Status

FDA Approvals, News & Updates

The FDA also approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott) as a companion diagnostic test for the diagnosis of the ALK gene in patients with NSCLC to identify appropriate candidates for crizotinib therapy. The test uses fluorescence in situ hybridization to detect those rearrangements on the 2p23 chromosome. (August 26, 2011)

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ODAC Recommends Accelerated Approval for Iron Chelator Deferiprone

FDA Approvals, News & Updates

The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended accelerated approval of the iron chelator deferiprone (Ferriprox, ApoPharma) for patients with transfusional iron overload that is inadequately treated with deferoxamine (Desferal), the standard chelation therapy for patients with diseases such as thalassemia or sickle-cell disease, who must undergo multiple blood transfusions to survive.

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New Indications for Denosumab for Increasing Bone Density in Patients with Cancer

FDA Approvals, News & Updates

The FDA approved 2 new indications for denosumab (Prolia, Amgen) for treating patients at high risk for therapy-induced bone fracture. The first indication is for increasing bone mineral density (BMD) in men receiving an dro gen-deprivation therapy for nonmetastatic prostate cancer; the second is for increasing BMD in women receiving adjuvant aromatase inhibitor therapy for breast cancer.

The approval was based on 2 international randomized, placebo-controlled trials, one involving 1468 men with prostate cancer, the other including 252 women with breast cancer.

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Advances in the Management of Chronic Lymphocytic Leukemia

Phoebe Starr

NCCN Hematology Congress

New York, NY—Several advances have been made in the diagnosis and treatment of chronic lymphocytic leukemia (CLL), according to Susan O’Brien, MD, Chief, Acute Leukemia Section at M.D. Anderson Cancer Center, Houston. Treatment selection can now be guided by fluorescence in situ hybridization (FISH) testing for genetic abnormalities, and 2 new treatments in early-stage development hold promise for patients with a poor prognostic cytogenetic profile.

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US Preventive Services Task Force and the Future of Prostate Cancer Screening

Ross D. Margulies; Jayson Slotnik, JD, MPH

Health Policy

The decision this month (October 2011) by the US Preventive Services Task Force (USPSTF) to recommend against a prostate-specific antigen (PSA)-based screening for prostate cancer in healthy men1 has caused quite a stir both in and outside of medical circles, reminding many people of the task force’s 2009 recommendation against routine breast cancer screenings for women under age 50 years. [ Read More ]

AACR Urges Congress to Increase Funding for the NIH and NCI

Health Policy

In September 2011, the American Association of Cancer Research (AACR) issued a new report, “AACR Cancer Progress Report 2011” (www.aacr.org/Uploads/Document Re pository/2011CPR/2011_AACR_CPR_ Text_web.pdf) on the current state of cancer research and the implications of recent cuts in funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI). These cuts in NIH and NCI funding are already adversely affecting the progress made in cancer research in the United States.

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PARP Inhibitor Olaparib a Promising Treatment for Ovarian Cancer

In the Literature

In phase 1 and 2 clinical trials, olaparib, a small-molecule poly(ADPribose) polymerase (PARP) inhibitor, has demonstrated objective responses in women with breast or ovarian cancer and BRCA1 and BRCA2 mutations. Results of a new study show that olaparib may be a promising therapy for women with aggressive ovarian cancer (Gelmon KA, et al. Lancet Oncol. 2011;12:852-861).

[ Read More ]

Nilotinib Sustains 24-Month Superiority to Imatinib in CML

In the Literature

The BCR-ABL inhibitor nilotinib (Tasigna) was developed as a selective treatment for patients with chronic myeloid leukemia (CML) who are not responding appropriately to imatinib (Gleevec) therapy. Previous results from the Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd) study showed 12-month superior efficacy for nilotinib over imatinib in patients with newly diagnosed Philadelphia chromosome– positive (Ph+) CML in the chronic phase. [ Read More ]

Noise-Canceling Information

Ron Ribitzky, MD

Oncology

New discoveries in diagnosis, treatment, and prevention of cancer abound, but what is just “noise”? What is in oncology that is interesting, intriguing, inspiring, yet still just “noise,” because the path to action “here and now” is missing, or not obvious? [ Read More ]

Novel HDAC Inhibitor Improves Outcomes in Patients with Estrogen-Sensitive Breast Cancer

Audrey Andrews

Uncategorized

San Francisco, CA—A novel histone deacetylase (HDAC) inhibitor, when added to the aromatase inhibitor exemestane (Aromasin), appears to restore sensitivity to the endocrine agent by significantly delaying recurrences and creating an increased survival trend.

The findings come from the Entinostat Combinations Overcoming Resistance (ENCORE 301) study presented at the 2011 Breast Cancer Symposium by Denise Yardley, MD, Sarah Cannon Research Institute and Tennessee Oncology, Nashville.

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Breast Cancer Treatment Still Under Par for Patients Covered by Medicaid

Audrey Andrews

Breast Cancer Symposium

San Francisco, CA—Several studies presented at the 2011 Breast Cancer Symposium shed light on the quality of breast cancer care received by women who are uninsured or receiving Medicaid.

In a study conducted at Rollins School of Public Health of Emory University, Atlanta, researchers investigated the quality of breast cancer treatment in patients enrolled under Medicaid and the Breast and Cervical Cancer Prevention and Treatment Act (BCCPTA) of 2000 in Georgia.

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Targeted Radiation Therapy Gaining Momentum

Caroline Helwick

Breast Cancer Symposium

San Francisco, CA—Accelerated partial breast irradiation using brachytherapy (APBIb) for breast cancer has been rapidly adopted in the United States, although its use varies by region, race, and ethnicity. Jona A. Hattangadi, MD, Harvard Radiation Oncology Program, Boston, reported the findings at the 2011 ASCO Breast Cancer Symposium, which was sponsored by 6 breast, oncology, and surgical societies.

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Survivorship Programs an Emerging Need, But Are They Cost-Effective?

Caroline Helwick

Survivorship Care

The population of cancer survivors is rapidly growing. More than 12 million Americans are alive after a cancer diagnosis: most are living at least 5 years and 16% are alive 20 years after diagnosis.

This growing population of cancer survivors is at risk for many comorbidities, especially as they age. A study of 10,397 childhood cancer survivors showed that group is 8 times more likely to have a severe or life-threatening condition than their siblings (Oeffinger K, et al. N Engl J Med. 2006; 355:1572-1582).

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Concurrent Chemotherapy and Radiation Therapy Extends Survival in NSCLC

In the Literature

The concurrent use of chemotherapy and thoracic radiotherapy (TRT) confers a greater survival benefit in patients with stage III non–small-cell lung cancer (NSCLC) than a sequential use of these therapies, based on results from a phase 3 clinical study (Curran WJ, et al. J Natl Cancer Inst. 2011;103: 1452-1460).

This study compared standard therapy (ie, chemotherapy followed by radiation) with 2 regimens of concurrent chemoradiation in 610 patients with inoperable stage II or III NSCLC enrolled from 153 centers in the United States and Canada.

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Recent Ruling on Genetic Patents Leaves Many Questions

Rosemary Frei, MSc

Health Policy

On July 29, 2011, a 3-judge panel from the US Court of Appeals for the Federal Circuit invalidated some patents held by Myriad Genetics and the University of Utah Research Foundation for methods of analyzing individuals’ gene sequences for the presence of BRCA1 and BRCA2 mutations, but upheld other related patents in a reversal of a lower court ruling. The decision has left the door open to many questions.

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