Clinical

The FDA has several projects under its wings that can improve the regulatory aspect of drug development and healthcare overall.

Based on the results of the MINDACT trial, investigators have concluded that chemotherapy is unnecessary in women with early-stage breast cancer who have a high clinical and low genomic risk of disease recurrence.

What we're reading, August 25, 2016: Hillary Clinton proposes fund for public health crises; hospitals that treated victims of the Orlando Pulse nightclub shooting will not bill survivors; and 1 in 4 people admit to using leftover antibiotics.

Research at Massachusetts General Hospital has provided vital leads that can explain drug resistance observed in breast cancer.

A majority of hospitals that may be required to participate in the new Medicare cardiac bundled payment models would not experience losses or gains over $500,000 per year, according to a recent analysis by Avalere Health.

A new study by researchers at the Institute of Cancer Research has substantiated that hormone replacement using estrogen and progesterone increases the risk of breast cancer, especially with longer use.

A new report by the Harvey L. Neiman Health Policy Institute recommends a bundled payment model for breast cancer screening, with the objective of improved patient care and a more efficient use of healthcare resources.

Researchers from Tufts Medical Center analyzed findings from 26 studies to determine how drug exclusion policies affect patients and healthcare costs.

Factors such as insurance status and being married are significant determinants of survival compared with race/ethnicity, in patients with multiple myeloma who are less than 65 years of age.

Once smokers develop chronic obstructive pulmonary disease, quitting may not improve smokers’ lung function; thus, smokers should quit as early as possible to have the greatest chance of reversing lung damage.

This week, the top stories in managed care included Aetna's announcement that it was pulling back its participation on the Affordable Care Act exchanges, the annual meeting of the American Association of Diabetes Educators outlined how existing sites can help roll out the Diabetes Prevention Program nationwide, and hospital leaders gave their opinions on CMS' hospital readmission program.

This issue of Evidence-Based Oncology is dedicated to understanding the implications, scope, and opportunities within the realm of cost sharing in oncology.

Financial burden is a potential nonclinical adverse event in cancer patients. As patients, especially those in the lower income ranges and the middle class, struggle to meet their medical bills, the likelihood of them skipping doses or doctor’s visits is quite high.

Reducing barriers to hematopoetic stem cell (HPC) transplant is critical to supporting patients with one of the more than 70 blood cancers and other blood disorders (such as leukemia, lymphoma, and myloplastic dysplasia) for which a transplant may be the only therapy remaining with curative intent.

Young adult (YA) cancer survivors are hit the hardest in the wallet by their treatment. The average net worth of YAs who have received grants from The Samfund is a staggering —$35,000, while their counterparts in the general population is $68,000

Precision oncology, or the clinically and financially efficient use of genomically matched treatments and clinical trials, is evolving as a potentially important starting point for cancer care within successful alternative payment models.

A collaborative pilot that involves the California Department of Public Health, St. Joseph Health in Orange County, and UCSF Benioff Children’s Hospital in Oakland is studying whether near—real-time reporting of cancer diagnoses by pathologists, using standardized electronic forms, will permit providers to make more informed and timely treatment decisions.

The monoclonal antibody daratumumab (Darzalex) has been granted Breakthrough designation, the second for this drug, for use in combination with either lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy.

Results from the CheckMate 066 study found that the checkpoint inhibitor nivolumab, which has proven highly efficient in the treatment of melanoma, also performs well in improving the patient’s long-term quality of survival benefit in patients with advanced melanoma.

Loss-of-function mutations in Janus kinase 1 (JAK1) or Janus kinase 2 (JAK2), deletion of the wild-type allele of JAK1 or JAK2, and truncation in the antigen-presenting protein beta-2-microglobulin (B2M) gene have been found responsible for lack of response to interferon gamma in patients with melanoma.

Survival in patients with early-stage lung cancer, particularly those with adenocarcinomas, may be shortened by air pollution, according to a study published in the journal Thorax.

The key in making coverage decisions about the integration of immuno-oncology agents into payment plans is being able to identify the patients who are most likely to benefit while also considering the long-term need for the acceptance of innovation in cancer care when faced with economic constraints, said Michael Kolodziej, MD, national medical director for oncology strategy at Aetna.

A new health services study in JAMA Oncology evaluated the impact of clinical evidence on routine surveillance in ovarian cancer, and found none.

What we're reading, August 17, 2016: Walgreens looks to gamify medication adherence; Aetna warned the Department of Justice that if its merger wasn't approved, it would pull back from exchange participation; and the controversy behind numbers of medication error deaths.

One in 12 people who survive a common cancer will develop a second, unrelated malignancy, the most common of which was lung cancer.