Clinical

Patient access, supply chain, adherence, and comorbidities are only a few of the challenges associated with oral anticancer agents, which are included distributed by specialty pharmacies.

A one-minute look at managed care news during the week of April 27, 2015, including more good news for the much-anticipated PCSK9 inhibitors and growth in the individual insurance market enrollment.

The debate over including patient reported outcomes on oncology drug labels continues. The FDA expects well-defined and validated measurement tools and the patient community wants patient experiences to find their way to the label.

Co-sponsored by Republican Fred Upton and Democrat Diana DeGette, the bill, in the works for month, aims to speed the pace of drug cures by removing unnecessary barriers from the regulatory process.

Pharmacy benefit manager Express Scripts Holding Co, which has aggressively negotiated lower costs of new hepatitis C drugs, on Wednesday said a new "focus area" will be subduing costs of a growing wave of pricey biotech cancer drugs.

A review of clinical registries determined data collection on patient outcomes are substandard and the information is not useful for patients, physicians, and policy makers, according to a paper published in the Journal for Healthcare Quality.

Today's call for Medicare to cover the Diabetes Prevention Program is part of a broader effort by advocacy groups and the AMA to identify those with prediabetes and intervene before people develop full-blown diabetes.

The study, "Medicine Use and Spending Shifts: A Review of the Use of Medicines in the U.S. in 2014," found that total dollars spent on medications in the country rose 13.1%, up from a 3.2% increase in 2013.

Amgen might be the latest entrant in the immunotherapy realm if the FDA heeds the advice of an independent advisory panel, recommending Amgen's anticancer viral therapy, T-Vec, for melanoma treatment.

The authors conducting the research attribute the higer cost in part to more frequent adverse events and hospital-based healthcare within 30 days of their surgical procedure.

A press release by Bristol-Myers Squibb announced their filing of a supplemental Biologics License Application for Opdivo (nivolumab) in the treatment of previously untreated individuals with advanced melanoma.

The study, called the the SLIMM-T2D (Surgery or Lifestyle with Intensive Medical Management in Treatment of Type 2 Diabetes) trial, was published in the Journal of Clinical Endocrinology & Metabolism and observed similar improvements in blood sugar control a year after gastric band surgery or being on a group-based weight management program.

The consortium, called CANCER-ID, is a partnership between 33 organizations across 13 European nations focused on establishing the clinical utility of liquid biopsies in patients with NSCLC and HER2-resistant breast cancer.

Studies have shown that embedding behavioral health services into the primary care practice produces better health outcomes for patients with diabetes, while reducing indications of depression. The challenge is figuring out how to make the transition to new payment models that reward such care.

Opioid-dependent patients treated at an emergency department (ED) who were given buprenorphine were more likely to engage in addiction treatment to reduce their opioid use, according to a study published in JAMA.

Published in the Journal of the National Cancer Institute, results showed that women who had previously breastfed their babies had a 30% overall decreased risk of their breast cancer recurring.

While lawmakers, payers, and patient advocates are raising a voice against the sky-rocketing costs of the newer breakthorugh agents in cancer, the drug developers can boast a strong start to the year with big sales figures.

A review of 24 trials covering more than 10,000 patients confirmed earlier findings that PCSK9 inhibitors dramatically reduce cholesterol and risk of heart attacks. But an editorial that appeared alongside the meta-analysis in Annals of Internal Medicine said long-term studies are needed on this new drug class.

Published early online in Cancer, the findings suggest that the expansion of coverage through the Affordable Care Act may disproportionally benefit certain patient populations.

The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.

More pharmaceutical companies are buying drugs that they see as undervalued, then raising the prices. It is one of a number of industry tactics, driving up the cost of drugs.

A treatment approved for the most common form of hepatitis C in the US was also highly effective in less widespread variants, researchers reported at the European Association for the Study of the Liver annual meeting.

The study found that despite an increase in the armamentarium of drugs to treat multiple sclerosis, the cost of the drugs has skyrocketed and not dropped.

While brachytherapy improved progression-free survival in men with prostate cancer, compared with traditional readiotherapy, the study found that overall survival was not very different between the 2 groups.

Remote monitoring for heart failure patients resulted in fewer hospitalizations and deaths than a similar group of patients receiving usual care during a 4-month study, but the benefits didn't last beyond the study period.