Value-Based Cancer Care Issues

July 2016, Vol 7, No 6

Cost of Drugs and Affordability Don’t Always Jibe

Phoebe Starr

Value in Oncology

An international collaborative pilot study found large differences by country in retail prices for 23 cancer drugs, with the highest retail prices in the United States and the lowest in India and South Africa. Higher prices, however, did not mean that the drugs were less affordable, according to lead investigator Daniel Goldstein, MD, Rabin Medical Center, Petach Tikvah, Israel, who presented the results at the 2016 ASCO annual meeting. [ Read More ]

Liquid Biopsies Show High Correlation with Tissue Biopsy for Genetic Mutations

Wayne Kuznar

Personalized Medicine

With the exception of resistance mutations, somatic alterations in circulating tumor (ct) DNA (ie, a liquid biopsy) are consistent with alterations found in tissue biopsies of patients with advanced solid tumors, said Philip C. Mack, PhD, Director of Molecular Pharmacology, University of California Davis Comprehensive Cancer Center, Sacramento, at the 2016 American Society of Clinical Oncology (ASCO) annual meeting. [ Read More ]

Opportunities for Shared Decision-Making in Clinical Practice

Chase Doyle

Value in Oncology

The National Academy of Medicine recommends a shared decision-making approach when discussing medical treatments; however, an overview of evidence presented by Terrance Lynn Albrecht, PhD, Associate Center Director, Population Sciences, Karmanos Cancer Institute, and Chief of Oncology, Wayne State University School of Medicine, Detroit, at the 2016 American Society of Clinical Oncology annual meeting suggests that clinicians are not very effective in following this recommendation. [ Read More ]

Adding Daratumumab to the Treatment Regimen Improves Progression-Free Survival in Patients with Multiple Myeloma

Jessica Miller

Multiple Myeloma

Daratumumab in combination with lenalidomide and dexamethasone achieved a 63% reduction in progression-free survival (PFS) compared with lenalidomide and dexamethasone alone in patients with multiple myeloma who had received at least 1 previous line of therapy, according to study results presented at the 2016 European Hematology Association Annual Congress meeting. [ Read More ]

Incorporating Patient and Employer Perspectives into Value-Based Cancer Therapy Decision-Making

Joseph P. Fulginiti, PharmD; Melissa S. Pavilack, PharmD

Employers’ Perspective

“Value” in healthcare has been defined as outcomes relative to cost. Determining the value of a healthcare benefit remains difficult and complex for many stakeholders. With the increasing cost of cancer therapies, value has become an important topic of conversation for patients, healthcare providers, self-funded plan sponsors (employers), and payers. [ Read More ]

FDA Streamlines Expanded Access Application for Patients to Get Investigational Drugs

Nick Bryant

Health Policy

The Individual Patient Expanded Access Application, which is designed to streamline the application procedure for individual patients who apply for expanded access to investigational therapeutics, including expanded access to drugs that are not in clinical trials, was recently updated by the FDA. Form FDA 3926 authorizes expanded access to investigational drugs for patients with serious or life-threatening conditions who have no therapeutic options. [ Read More ]

Adjuvant Chemoradiotherapy May Provide Benefit in Locally Advanced Bladder Cancer

Phoebe Starr

Genitourinary Cancers

In the United States, the standard of care for locally advanced bladder cancer after radical cystectomy is to “consider” adjuvant chemotherapy and ad­juvant radiation. Results of a 3-arm randomized clinical trial showed that adjuvant radiation therapy alone or combined with chemotherapy (ie, chemoradiotherapy) did not significantly improve disease-free survival compared with adjuvant chemotherapy alone. However, the findings hint at benefits for chemoradiotherapy that should be studied further. Brian Baumann, MD, a radiation oncology resident at the University of Pennsylvania, Philadelphia, presented the findings at the 2016 Genitourinary Cancers Symposium. [ Read More ]

FDA Advisors Vote Against Duchenne Muscular Dystrophy Drug, Reject Value of Hope for Patients

Robert Goldberg, PhD

Patient Advocacy

On April 25, 2016, an FDA advisory committee voted not to recommend the approval of eteplirsen, an experimental drug that targets one of many genetic mutations causing Duchenne muscular dystrophy (DMD), a deadly degenerative disease that has no cure. After agreeing to study the real-world effects of eteplir­sen, the FDA advisory committee rejected findings that patients who have been taking eteplirsen since 2011 were still able to walk because the clinical data did not meet the FDA requirements for a well-controlled study. [ Read More ]

New Biomarker Holds Promise to Discriminate Between High-Grade and Low-Grade Prostate Cancer

Wayne Kuznar

Personalized Medicine

When combined with other clinically relevant parameters, a novel protein biomarker called IsoPSA can improve selection of patients with prostate cancer for biopsy. IsoPSA holds promise for improved diagnostic accuracy, said Eric A. Klein, MD, Chairman, Glickman Urological and Kidney Institute, Cleveland Clinic, OH, at the 2016 American Urological Association annual meeting. [ Read More ]

Cologuard: Stool DNA Test Performs Well in Community-Based Setting Among Medicare Beneficiaries

Charles Bankhead

Colorectal Cancer

The multitarget stool DNA test, a noninvasive screening tool for colorectal cancer (CRC), demonstrated potential for identifying cancer and advanced adenomas in community-based individuals who had previously not followed national screening recommendations, reported Mark Prince, MD, MBA, Director of Gastroenterology, USMD Health System, Arlington, TX, at the 2016 American Association for Cancer Research annual meeting. [ Read More ]

USPSTF Issues New Colorectal Cancer Screening Recommendations

Jessica Miller

Colorectal Cancer

New recommendations issued by the US Preventive Services Task Force (USPSTF) focus on increasing colorectal cancer screening, which, according to the task force, is “a substantially underused preventive health strategy.” Previous USPSTF guidelines recommended specific screening approaches, including colonoscopy, fecal occult blood testing, or sigmoidoscopy, for adults aged 50 through 75 years. [ Read More ]

Defitelio (Defibrotide Sodium): First Drug Approved for Patients with Hepatic Veno-Occlusive Disease

Laura Morgan

Drug Updates

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, is a rare and life-threatening liver condition that is characterized by rapid weight gain, ascites, painful hepatomegaly, and jaundice. It is often observed in patients after allogeneic or autologous hematopoietic stem-cell transplantation (HSCT), and has also been reported during the treatment of Wilms tumor, rhabdomyosarcoma associated with actinomycin D, and acute lymphoblastic leukemia. [ Read More ]