Formulary Watch |

FDA approves bortezomib for injection for previously untreated patients with mantle cell lymphoma

FDA approved bortezomib (Velcade, Millennium: The Takeda Oncology Company) for injection for use in previously untreated patients with mantle cell lymphoma (MCL), making it the first treatment in the United States to be approved for previously untreated patients with MCL.

Enterovirus D68: 5 ways formulary managers can help

In recent months, the incidence of enterovirus D68 (EV-D68) infection has markedly increased across the United States, notably affecting young pediatric patients. Hospitalizations of children with severe respiratory illness associated with this non-polio enterovirus have concurrently risen.1,2

FDA’s new hep C approval: A step closer to a cure?

FDA’s approval of ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults, may signal that industry is at the forefront of a cure for hepatitis C, according to one industry expert.

Flu vaccine: What you need to know

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices recommends that everybody aged 6 months and older receive an annual flu vaccine.

FDA fast tracks ALS drug

FDA has designated new ALS stem cell therapy from BrainStorm Cell Therapeutics as a “fast-track” product.

FDA drug approvals - October 2014

FDA actions in brief, fast-track designations, priority review.

FDA approves first drug-coated balloon catheter

FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.

Drugs in Perspective: Zykadia (ceritinib)

Zykadia (ceritinib) is a tyrosine kinase inhibitor that was approved by FDA on April 29, 2014, as a medication for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.

Metformin linked to low levels of thyroid-stimulating hormone levels in hypothyroidism

Low thyroid stimulating hormone (TSH) can be observed in patients with treated hypothyroidism initiating metformin, especially between 90 and 180 days of use, according to a study published September 22 in the CMJA.

Specialty drugs: A good value, despite high costs

Specialty drugs’ high prices raise questions about whether their cost is worth the clinical benefits they provide, according to a recent study in Health Affairs.

Dallas Ebola victim dies

Responding to requests from treating physicians, FDA has okayed brincidofovir for Emergency Investigational New Drug Applications (EIND), allowing it to be used in the treatment of the Ebola virus disease.

Bristol-Myers Squibb withdraws potential hep C combo therapy

Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

Studies: Evolocumab shows promise in reducing LDL cholesterol in patients with genetic disorders that cause high cholesterol

Recent data from 2 phase 3 studies showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH).

Cost, use of opioid dependence treatment are increasing, spurring need for care management programs

Understanding the patterns and costs associated with opioid dependence treatments is important when developing and improving care management programs for plan members, according to 2 studies by pharmacy benefit manager Prime Therapeutics LLC (Prime).

Recent drug pricing trends – What do these mean for your formulary?

Earlier this year, IMS Health released a report indicating that overall drug spend in the United States increased by 3.2% in 2013.1 That increase stands in contrast to the 1% decline in drug spend in 2012.1 IMS noted that primary drivers of the increase include fewer patent expirations, drug price increases, expensive new drug therapies, and greater use of the healthcare system. Considering these drivers, all indications are that drug spend will continue to increase in the years to come.

Humira approved for treating polyarticular juvenile idiopathic arthritis patients aged 2 and older

FDA has extended the indication for adalimumbab (Humira, AbbVie) to include the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients aged 2 years and older.

5 ways formulary managers can brace for Ebola

In recent months, the CDC has cautioned that individuals with Ebola virus disease (EVD) in West Africa may travel to the United States, exhibit signs and symptoms of EVD, and present to US facilities.1,2 Now, the first case of a patient presenting with EVD to a US hospital has been reported and some others identified as being in contact with this patient are at risk.3

Study to measure impact of MTM on outcomes for IBD patients

The effectiveness of an inflammatory bowel disease (IBD) medication therapy management (MTM) patient fulfillment model and its impact on adherence compared to standard care will be evaluated in a new study.

Distribution changes for top cancer drugs cause hospitals to protest

Genentech has announced a major change in the distribution process for their 3 top cancer drugs: Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab). Now, distribution of the drugs to hospitals and clinics will be restricted to authorized specialty distributors.

Investigational ACL inhibitor shows promise in lowering LDL cholesterol

ACL inhibitor ETC-1002 (Esperion) met its primary end point of greater LDL-cholesterol lowering from baseline with ETC-1002 compared with ezetimibe, according to a study.

New data examines step-wise withdrawal of inhaled corticosteroids in COPD

In patients with severe to very severe COPD and a history of exacerbation, the risk of moderate or severe exacerbations during 1 year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids (ICS) and those who discontinued ICS therapy in a step-wise manner, as long as patients continued to receive maintenance treatment with long-acting bronchodilators (tiotropium and a long-acting beta agonist [LABA]), according to data presented at the European Respiratory Society (ERS) International Congress 2014 and also published in The New England Journal of Medicine.

In cancer patients, rivaroxaban reduced VTE recurrence, major bleeding

In patients with active cancer who experienced venous thromboembolism (VTE), rivaroxaban (Xarelto) was as effective as standard of care, with lower rates of major bleeding, according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

First long-term treatment for DME approved by FDA

FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.

Pertuzumab regimen extends lives in HER2-positive breast cancer

Adding pertuzumab (Perjeta, Roche) to trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy extended the lives (overall survival; OS) of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy (median OS: 56.5 vs. 40.8 months), according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

FDA approves subcutaneous injection for opioid-induced constipation in chronic non-cancer pain

FDA approved methylnaltrexone bromide (Relistor, Salix Pharmaceuticals and Progenics Pharmaceuticals) subcutaneous injection, 12 mg/0.6 mL, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.

FDA: Slightly elevated risk of cardiovascular, cerebrovascular issues with Xolair

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

FDA approves updated label changes for Chantix

FDA has approved updated label changes for the smoking cessation drug, varenicline (Chantix, Pfizer).

Humira receives FDA approval for treating pediatric patients with Crohn’s disease

FDA has approved adalimubab (Humira, AbbVie) to treat pediatric patients with moderate to severe Crohn’s disease.

Pulmonary Fibrosis patient survey highlights quality of life issues

The Pulmonary Fibrosis Foundation (PFF) submitted survey data from more than 1,100 patients and families suffering from pulmonary fibrosis (PF) to the U.S. Food and Drug Administration (FDA). Read more about the survey data to better understand the unique needs of patients and families with IPF.

Otezla approved for plaque psoriasis

FDA has approved Otezla (apremilast, Celgene) for treating moderate-to-severe plaque psoriasis in patients who are considered candidates for systemic therapy or phototherapy.