Formulary Watch

As organizations and politicians continue to sound the alarm that drug prices are rising, another new report confirmed the trend. Total spending on medicines in the US reached $310 billion in 2015 on an estimated net price basis, up 8.5 percent from the previous year, according to a new report from the IMS Institute for Healthcare Informatics.

FDA advisory committee recently voted to recommend approval of obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis (PBC). If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

FDA recently approved venetoclax (Venclexta, AbbVie and Genentech) to treat chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least 1 prior therapy

While FDA’s approval last week of infliximab-dyyb (Inflectra, Celltrion and Hospira), a biosimilar to Remicade (Janssen Biotech) for rheumatoid arthritis, Chron’s disease and other conditions is positive, FDA’s approval pace for biosimilars is too slow, according to a pharmacy benefit manager (PBM).

Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, according to FDA’s new Drug Safety Communication.

Soon after FDA expanded access to the “abortion pill” or mifepristone (Mifeprex, Danco Laboratories), some states may be combating the decision.

FDA recently approved reslizumab (Cinqair, Teva Pharmaceuticals), an injectable used with other asthma medicines for the maintenance treatment of severe asthma. Here are the top 5 facts to know about Cinqair.

FDA recently approved the first generic version of Nasonex nasal spray (mometasone furoate monohydrate, Apotex Corp).

Diabetes prevention program found to improve quality and reduces healthcare costs. It will now be covered by Medicare in 2017.

FDA approved ixekizumab (Taltz, Eli Lilly and Co.) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

FDA this week approved obiltoxaximab injection, (Anthim, Elusys Therapeutics), to treat inhalational anthrax.

FDA issued a draft guidance to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF), while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

FDA has extended approval of crizotinib (Xalkori, Pfizer) for the treatment of certain patients with non-small cell lung cancer (NSCLC).

A month after FDA announced several measures aimed at curbing opioid abuse, the agency said it would require a new boxed warning addressing the serious risk of misuse, abuse, addiction, overdose and death on immediate-release (IR) opioid pain medications.

The new partnership between Walgreens Boots Alliance and OptumRx may signal that Walgreens is not looking to buy another PBM.

Spending on brand name drugs spiked 16.2% in 2015 and 98.2% since 2011, according to a new report from pharmacy benefit manager (PBM) Express Scripts. Plus, a third of branded products experienced price increases greater than 20% in 2015, according to Express Scripts’ annual Drug Trend Report.

FDA recently approved Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment of hemophilia B. Here are the top 6 facts to know about Idelvion.

The Centers for Disease Control and Prevention (CDC) issued new voluntary guidelines this week for prescribing opioid medications for chronic pain, excluding cancer, palliative, and end-of-life care.

US hospitals using rivaroxaban (Xarelto, Janssen Pharmaceuticals) instead of warfarin (Coumadin, Bristol-Myers Squibb) to treat patients diagnosed with a venous thromboembolism (VTE) may save nearly $2,000 per patient and shorten a patient’s hospital stay by approximately 1.5 days, according to a new study.

FDA has approved expanded indication for the use of fulvestrant (Faslodex, AstraZeneca) in combination with another therapy in the treatment of metastatic breast cancer.

While FDA just approved the first generic version of sildenafil citrate (Viagra, Pfizer), the new product won’t be on the market until late 2017.

The use of insulin management software in hospital emergency departments can decrease hospital admissions for diabetic ketoacidosis (DKA) by 45%, according to a new study.

FDA has approved Odefsey (Gilead Sciences, Inc.) for the treatment of HIV-1 infection in certain patients. Here are the top 7 facts to know about Odefsey.

While FDA recently approved ibrutinib (Imbruvica, Janssen Biotech, Inc. and Pharmacyclics LLC) to treat patients with chronic lymphocytic leukemia (CLL), United Kingdom’s National Institute of Health and Care Excellence (NICE) will not yet recommend the medication.

New data from Novo Nordisk will help its Victoza (liraglutide) for type 2 diabetes better compete against Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin). Victoza significantly reduced the combined incidence of heart attack, stroke and cardiovascular death in high-risk Type 2 diabetes patients, according to Novo Nordisk

While many Americans and legislators have complained about the rising cost of medications in recent years, seniors are likely impacted more than the population at large. The average retail price among 622 prescription medications widely used by seniors doubled from 2006 to 2013, to reach more than $11,000, according to the American Association of Retired Persons’ (AARP)’s updated “Rx Price Watch” report.

Stroke patients were more adherent to mail order prescriptions versus picking up their medications at retail pharmacies, according to new research presented at the recent International Stroke Conference in Los Angeles, Calif.

FDA has approved tofacitinib citrate extended-release (Xeljanz XR, Pfizer) tablets for the treatment of moderate to severe rheumatoid arthritis (RA).