Assessing the clinical utility of diagnostic testing has always been a complicated undertaking. And as new genetic tests enter the equation, that complexity will only increase. To examine the issues surrounding clinical utility, I’d like to share a quick story.
FDA drug approvals, breakthrough designations, fast-track designations, priority review
FDA is holding a public workshop on its proposed prescription drug tracking system on May 8-9.
Patients who use statins are consuming more calories and fats than a decade earlier, increasing the risk of obesity, diabetes, and cardiovascular disease, according to a study published online in JAMA Internal Medicine.
Pfizer said it offered to buy AstraZeneca for approximately $100 billion. If the deal materializes, it would represent the biggest-ever foreign takeover of a British business and allow Pfizer to pay a lower corporate tax rate of 20%, according to some reports.
The biggest challenge in tackling opioid abuse is lack of awareness and understanding of addictive diseases generally and specifically opioid use disorders, as well as misinformation and negative perceptions of medication-assisted therapies (MATs), according to a recent opinion article published in the New England Journal of Medicine.
Pharmacists who contacted high-risk patients within 72 hours of discharge from Massachusetts General Hospital, Boston, found more than half of the patients had medication-related issues. In a different group of high-risk patients who had received inpatient interventions, 35% of patients were found to have issues after a pharmacist reviewed their medications just prior to discharge, according to Laura Carr, PharmD.
Pharmacist-led care with prescribing authority substantially improved risk factors at 6 months among stroke survivors than nurse case managers who monitored patients and provided feedback to their primary care physicians, according to a report published in the Canadian Medical Association’s journal, CMAJ.
FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.
FDA approved ramucirumab (Cyramza, Eli Lilly) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.
Community factors may be linked to hospital readmission rates, according to a study published in Health Services Research.
FDA is requiring that drug labels for injectable corticosteroids used to treat neck and back pain must be updated to include a warning of rare but serious adverse events, including vision loss, stroke, paralysis, and death, according to a recent FDA drug safety communication.
Implementation of a quality initiative has been linked to improvement in the time to treatment and a lower risk of in-hospital death, intracranial hemorrhage (bleeding in the brain), and an increase in the portion of patients discharged to their home, according to a study in the April 23/30 issue of JAMA.
Managed care organizations (MCOs) experienced a 1.7% drug overall trend, a 10.5% reduction from 2012 to 2013, according to Catamaran’s 2013 Drug Trend data. In 2012, MCO trend was 1.9%.
FDA approved albiglutide (Tanzeum, GlaxoSmithKline), a once-weekly subcutaneous injectable for the treatment of adults with type 2 diabetes. It helps to improve glycemic control, along with diet and exercise.
Despite strong FDA warnings against its use in adolescents, a new study suggests that codeine is prescribed for children during at least 500,000 emergency room (ER) visits each year.
FDA approved Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults aged 18 years through 65 years.
FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.
As specialty drugs become the standard of care for many complex diseases, they present unique challenges to payers, according to the 10th edition of the EMD Serono Specialty Digest. Specialty drugs can be delivered through various routes of administration (subcutaneous injection, intravenous, intramuscular injection, oral), all of which may have unique coverage criteria, patient cost share, clinical management, and patient access.
Antipsychotic drugs are increasingly being prescribed to treat attention-deficit/hyperactivity disorder (ADHD) in children and teens in foster care, according to a study published in the Journal of Child and Adolescent Psychopharmacology.
FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.
The global insulin delivery devices market value is projected to increase from $8.78 billion in 2012 to $13.8 billion by 2019, according to a new report.
Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, but more work is needed to improve patient safety, according to 2 reports released by the Centers for Disease Control and Prevention (CDC).
Low-risk Medicare patients entering home healthcare and receiving a telephonic medication therapy management (MTM) consultation by a pharmacist were three times less likely to be hospitalized within the next 2 months, while those at greater risk saw no benefit, according to a study in Health Services Research.
Antidiabetic drugs are considered to be first-line treatment options for individuals with type 1 and type 2 diabetes mellitus. It is estimated that type 2 diabetes affects about 24 million persons in the United States. Over time high blood levels can lead to complications such as heart disease, kidney damage, or blindness.1 When it comes to the treatment of type 2 diabetes individuals have the option of using oral hypoglycemic agents, compared to individuals with type 1 diabetes that requires insulin therapy.
