Formulary Watch |

More research needed to quantify the impact of copay cards

COPAY CARDS and discount programs are an increasingly important part of many pharmaceutical brands’ marketing strategy. Yet as copay offset programs have grown more popular, they have become increasingly controversial, as indicated by lawsuits, regulatory changes and backlash from pharmacy benefit managers and health plans.

Long-term spironolactone use may improve heart function, but does not improve symptoms, quality of life for heart failure patients

In patients with heart failure with preserved ejection fraction, long-term treatment with spironolactone improved left ventricular diastolic function, but didn’t affect maximal exercise capacity, patient symptoms, or quality of life (QoL), according to a recent study in JAMA.

Humana, Boehringer Ingelheim form partnership to promote population health

Humana and Boehringer Ingelheim Pharmaceuticals have announced a multi-year collaboration to address key questions regarding treatment and healthcare costs for patients with chronic obstructive pulmonary disease (COPD), cardiovascular disease, and other disease states.

Diabetes drug canagliflozin receives FDA approval

Diabetes drug canagliflozin (Invokana, Janssen Pharmaceuticals) is the first drug approved by the FDA in a new class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.

Higher long-term mortality risk seen after young-adult stroke

Young adults who have had a stroke are at higher risk of long-term mortality compared with expected mortality, according to report published March 20 in the Journal of the American Medical Association.

New initiatives arise out of NECC compounding tragedy

The human toll of the New England Compounding Center (NECC) tragedy continues to grow as the death count is at 50 and the number of patients sickened now exceeds 722. These cases have been reported, and are being tracked by the Centers for Disease Control (CDC) in 20 states. The impact that this sequence of events has had, is having, and will continue to have on the practice of pharmacy nationwide is of unprecedented magnitude and is of the utmost concern to practicing pharmacists everywhere.

New molecular entities

Nesina: a new dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes as an adjunct to diet and exercise. Oseni: a fixed-dose combination of alogliptin and pioglitazone. Kazano: a fixed-dose combination of alogliptin and metformin HCl

Update on taxanes for prostate cancer

Recent advances in the treatment of metastatic castration-resistant prostate cancer CRPC) have led to new agents demonstrating overall survival (OS) advantages, including autologous cellular immunotherapy (sipuleucel-T), a new taxane (cabazitaxel), 2 therapies further targeting the androgen axis (abiraterone acetate and enzalutamide), and a bone-seeking alpha emitter (radium-223 chloride). This brief review discusses recent clinical trials utilizing the 2 FDA-approved taxanes that were presented at the 2013 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncologists (ASCO), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO).

Use of anti-TNF therapies for inflammatory diseases does not appear to increase risk of herpes zoster

Although patients with rheumatoid arthritis (RA) have a disproportionately higher incidence of herpes zoster, an analysis that included nearly 60,000 patients with RA and other inflammatory diseases found that those who initiated anti-tumor necrosis factor (TNF) therapies were not at higher risk of herpes zoster compared with patients who initiated nonbiologic treatment regimens, according to a study appearing in the March 6 issue of JAMA.

Review of the pharmacologic arsenal for the war on obesity

Obesity has become a highly prevalent chronic condition that is associated with significant morbidity and mortality. Studies have demonstrated that even as little as 5% to 10% of weight loss is associated with an improvement in cardiovascular risk factors and a reduction in the incidence of type 2 diabetes in high-risk patients. Prior to the recent approval of lorcaserin and extended-release phentermine/topiramate, there had been no new pharmacologic agents approved for the treatment of obesity for 13 years. This article reviews the pharmacologic treatment of obesity including past treatment options, lessons learned in recent years, current short- and long-term treatment options, and future direction. Formulary considerations of currently available agents are discussed.

CMS final Sunshine Act Transparency Rule: Managed care and hospital impacts

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released new regulations about the reporting of fees, meals, travel expenses, and other transfers of value for the implementation of the Physician Payment Sunshine Act (PPSA). These new regulations require that data on the payments and gifts that drug and medical device companies make to physicians will become available publicly in a searchable database beginning in September 2014.1

Liraglutide trial for obesity shows slight increase in weight loss with higher dose

Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.

FDA evaluates diabetes drugs for possible increased risk of pancreatitis, precancerous cellular changes of pancreas

Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.

Reduced rate of COPD-related hospitalizations seen with long-term ICS/LABA combination therapy

Long-term treatment with fixed-combination budesonide/formoterol (Symbicort Turbuhaler, AstraZeneca) was associated with fewer healthcare utilization-defined exacerbations and hospitalizations than fluticasone/salmeterol in patients with moderate and severe chronic obstructive pulmonary disease (COPD), according to a study published online in the Journal of Internal Medicine.

Pipeline Preview

Complete response letters; recommendation for approval; fast-track designations; orphan drug designations; first-time generic approvals; FDA actions in brief

Tivozanib, sorafenib found to extend survival in advanced renal cell carcinoma patients

Tivozanib and sorafenib extended survival in advanced renal cell carcinoma (RCC) patients with no statistical difference, according to the phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st Line Advanced RCC) trial data, presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), in Orlando, Fla., in February.

FDA approves AcipHex Sprinkle for young children

FDA has approved rabeprazole sodium (AcipHex Sprinkle, Eisai) Delayed-Release capsules 5 mg and 10 mg for the treatment of gastroesophageal reflux disease (GERD) in children ages 1 to 11 years of age for up to 12 weeks.

Biogen receives FDA approval for new MS treatment

FDA approved dimethyl fumarate (Tecfidera, Biogen Idec) capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS), including the most common form, relapsing-remitting multiple sclerosis (RRMS), according to an FDA statement on March 27.

FDA approves time-saving antibacterial drug for cystic fibrosis patients

FDA approved tobramycin inhalation powder (TOBI Podhaler, Novartis) for the management of cystic fibrosis patients with Pseudomonas aeruginosa), a bacterium that causes lung infections.

When it comes to safe and reliable biological medicines, manufacturing matters

Managed care and hospital decision-makers should consider that biological drugs are different from traditional drugs in terms of their complexity and there is potential for problems to arise when manufacturing is not strictly controlled. Furthermore, biological medicines are more difficult to characterize, produce, and reproduce than most traditional pharmaceuticals. This, in turn, can affect the medicine’s quality, safety, or efficacy, and can ultimately impact the reliability of supply, according to a presentation at the Hematology/Oncology Pharmacy Association’s annual conference in Los Angeles, in March.

Liraglutide trial for obesity shows slight increase in weight loss with higher dose

Patients with type 2 diabetes achieved 6% weight loss with liraglutide 3 mg in a phase 3a obesity trial, according to Novo Nordisk.

AMCP calls on Congress for prohibition of generic exclusion agreements

The Academy of Managed Care Pharmacy (AMCP) is urging US House leaders to consider a number of proposals to rein in federal spending on healthcare without compromising the popular programs of Medicare and Medicaid.

New Jersey compounding pharmacy recalls all products, fearing mold contamination

Med Prep Consulting, Inc., a compounding pharmacy in Tinton Falls, NJ, is voluntarily recalling all lots of compounded products from its facility for fear of mold contamination, according to an FDA press release.

FDA evaluates diabetes drugs for possible increased risk of pancreatitis, precancerous cellular changes of pancreas

Diabetes drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto) are being evaluated by FDA for a potential link to pancreatitis and precancerous changes of the pancreas.

FDA approves Lymphoseek Injection for use in lymphatic mapping

FDA approved (technetium Tc 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Niacin ER not recommended for patients at risk for cardiovascular outcomes

The use of extended-release niacin as an adjunct to statins does not reduce the risk of a heart attack or stroke in patients with pre-existing cardiovascular disease, according to researchers who led the HPS2-THRIVE study. The results of the study were reported at the American College of Cardiology conference in San Francisco on March 9.

FDA panel recommends strains for 2013-2014 flu vaccine

Medication management care transition guide available

After receiving input from more than 80 institutions across the United States, the American Society of Health Systems Pharmacists (ASHP) and the American Pharmacists Association (APhA) developed a new medication management care transition guide.

Certain patients at risk for arrhythmias with azithromycin use, FDA warns

FDA is warning the public that azithromycin (Zithromax or Zmax; Pfizer) can cause abnormal changes in the electrical activity of the heart that may lead to potentially fatal cardiac arrhythmias.

Survey reveals healthcare provider trust in OTC medications

Almost 98% of primary care physicians (PCPs), nurse practitioners, and pharmacists trust and recommend over-the-counter (OTC) medicines to their patients, according to a new survey released by the Consumer Healthcare Products Association (CHPA).