February 2012

Pharmaceutical Companies Losing Patent Exclusivities

Since the US Food and Drug Administration approved Lipitor (atorvastatin) in the late 1990s, Pfizer, Inc, could rely on the cholesterol-lowering drug to generate billions in revenue. The product became the best-selling drug in history, providing a significant advantage for the company as it endured the industry’s cyclical nature.

No longer.



Lawmakers Introduce Bills to Reduce Drug Costs

With prescription drug prices rising and governments facing dire financial situations, elected officials have recently proposed legislation that would lower drug prices. However, the plans are not always popular with the pharmaceutical industry, leading to acrimony between the constituencies over the validity of each other’s claims.



Supreme Court to Address Healthcare Reform Law

The Supreme Court will soon weigh in on the healthcare reform law and its constitutionality by reviewing 2 key provisions of the Patient Protection and Affordable Care Act (ACA): the individual mandate and the Medicaid expansion.

A new brief from the Henry J. Kaiser Family Foundation reviews the 2 cases the Supreme Court plans to consider, the arguments of each case, and the possible implications of the court’s decision.



Rivaroxaban Treatment for Patients with a Recent Acute Coronary Syndrome

Standard medical therapy following an acute coronary syndrome includes long-term antiplatelet therapy with aspirin and an adenosine diphosphate receptor inhibitor. Despite this therapy, patients remain at risk for recurrent cardiovascular events, due perhaps to excess thrombin generation that persists beyond the acute presentation in such patients. The risk of recurrent cardiovascular events has brought attention to the role of oral anticoagulants following an acute coronary syndrome.



Awareness of Glaucoma Lacking

Of the 60 million people worldwide and 2.2 million in the United States who have glaucoma, approximately half do not know they suffer from the group of diseases, according to the Glaucoma Research Foundation (GRF).

To publicize glaucoma, the GRF created a campaign calling January National Glaucoma Awareness month. During the month, organizations such as GRF and the National Eye Institute (NEI) highlighted research and educational programs, and stressed that vision loss is beest prevented through early detection and treatment.



SBP and Risk of Recurrent Stroke

In persons with a prior stroke, national guidelines suggest maintaining a normal blood pressure (BP), defined as systolic BP (SBP) of <120 mm Hg and a diastolic BP of <80 mm Hg. According to researchers, data specifically addressing the role of BP levels within the normal range for vascular risk reduction after stroke are limited. Recent studies have shown that there is no benefit in achieving more aggressive SBP targets in high-risk patients with diabetes.



ABVD Chemotherapy without Radiation Associated with Increased Survival in Hodgkin’s Lymphoma

A randomized study has found that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy was associated with a higher rate of 12-year overall survival than subtotal nodal radiation therapy, with or without ABVD, in patients with stage IA or IIA nonbulky Hodgkin’s lymphoma. The findings were published online in the New England Journal of Medicine [10.1056/NEJMoa11111961].



Bivalirudin Compared with Abciximab plus Heparin for Non-STEMI

High-risk patients who have an acute coronary syndrome are often treated with an invasive strategy of coronary angiography. Identifying the most appropriate adjunctive antithrombotic therapy prior to, during, and following percutaneous coronary intervention (PCI) has been the subject of research for the past 30 years.



Prophylaxis with Apixaban for Acutely Ill Patients

A double-blind study evaluating the safety and efficacy of extended prophylaxis with apixaban for venous thromboembolism in acutely ill patients found that the extended treatment was not superior to short-term prophylaxis with enoxaparin; however, it was associated with significantly more major bleeding events. These findings and others from the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial were published online in the New England Journal of Medicine [10.1056/NEJMoa1110899].



Routine Use of Aspirin for Primary Prevention of Cardiovascular Events

The use of aspirin for primary prevention of cardiovascular events was not shown to be beneficial for preventing fatal myocardial infarction (MI), stroke, or death related to cardiovascular disease (CVD) or cancer, according to results of a recent study reported online in Archives of Internal Medicine [doi:10.1001/archinternmed.2011.628]. Significant reductions in nonfatal MI, however, were observed.



Race Influences Risk of Emergency Diverticulitis Surgery

A study published in Archives of Surgery [2011;146(11):1272-1276] has reported that black patients were more likely to undergo emergency surgery for diverticulitis and had a higher in-hospital mortality risk compared with white counterparts.



Risk of Diabetes Correlates with Duration of Obesity

The degree and duration of obesity, expressed as excess body mass index (BMI)-years, increases the risk of developing type 2 diabetes more than BMI alone, but race and young age also are risk factors, according to the results of a longitudinal analysis [Arch Pediatr Adolesc Med. 2012;166(1):42-48].



Post–Myocardial-Infarction Medications with No Copayments

Patients in the United States with acute myocardial infarction are most often prescribed a medication regimen at discharge from the hospital. However, gaps in care can occur following discharge, due mainly to either a failure to fill the initial prescription or increasingly poor adherence over time.

Underuse of medication occurs due to various factors, among them out-of-pocket costs. One third of Americans report underuse or discontinuation of medications because of out-of-pocket costs. Among patients with insurance, adherence rates correlate with the comprehensiveness of coverage.



Implementing the Summary of Benefits and Coverage Provision of the ACA

The Patient Protection and Affordable Care Act of 2010 (ACA) includes a provision requiring private individual and group health plans to provide all applicants and enrollees with a uniform summary of benefits and coverage (SBC). The provision is meant to help consumers compare health insurance options prior to enrollment and understand their coverage when they enroll. The SBC provision applies to all health plans, both individual and group, and takes effect March 23, 2012.



Alternative Benefit Design for Medicare

Restructuring the Medicare benefit design and placing a limit on beneficiary cost-sharing for Medicare-covered services in 2013 could lead to savings for Medicare and a minority of beneficiaries with high medical spending, but it could also mean higher costs for the majority of beneficiaries with modest medical spending, according to Restructuring Medicare’s Benefit Design: Implications for Beneficiaries and Spending, a new analysis from the Henry J. Kaiser Family Foundation.



AMCP Comments on Proposed CMS Changes to Part D Reporting Requirements

Future changes to Part D Reporting Requirements proposed by the Centers for Medicare & Medicaid Services (CMS) for contract year 2013 may pose new challenges to Part D plan sponsors if enacted. Responding to a request by CMS for comments on the proposed changes, the Academy of Managed Care Pharmacy (AMCP) issued a letter to CMS in January 2012 responding to a number of potentially problematic issues particularly in 2 areas: Long-Term Care (LTC) Utilization and Waste (or currently referred to as Unused Drugs in Long-Term Care) and medication therapy management (MTM) programs.



Staff Morale Is Correlated with Perceived PCMH Characteristics

Healthcare providers and staff who perceived more patient-centered medical home (PCMH) characteristics at their workplace were more likely to report higher morale, according to the results of a recent study. The findings from the study were recently published in the Archives of Internal Medicine [2012;172(1):23-31].

Although previous research has been conducted to assess whether PCMHs improve patient outcomes, according to the authors of this latest study, little research has been done to examine the effects of the PCMH on staff satisfaction and work environment.



ACR Recommendations for Treating Rheumatoid Arthritis

Chicago—New recommendations for the treatment of rheumatoid arthritis (RA) are near completion and will provide evidence-based recommendations on a number of issues related to the use of biologics and traditional disease-modifying antirheumatic drugs (DMARDs).These include indications for the use of each class of medications, switching agents (with particular emphasis on biologics), tuberculosis screening, vaccinations, and the use of biologics in high-risk patients.



Earlier Onset Knee Osteoarthritis Impacts Healthcare System

Chicago—New data highlight the increasing number of people in the United States newly diagnosed with knee osteoarthritis (OA), particularly younger people, and the additional burden it is estimated this will place on the US healthcare system due to the increased need for total knee replacements, among other factors.



3-Year Analysis of Patients Treated with Golimumab

Chicago—In patients with anemia of inflammation due to chronic rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PSA), treatment with golimumab was associated with greater improvements in hemoglobin at 6 months compared with placebo. In addition, a greater proportion of golimumab-treated patients achieved normal hemoglobin at 6 months, and patients who continued golimumab treatment maintained normal hemoglobin levels through 3 years.



Subcutaneous versus Intravenous Abatacept in Rheumatoid Arthritis

Chicago—The efficacy and safety of subcutaneous (SC) abatacept to treat rheumatoid arthritis (RA) was maintained over 24 months, according to investigators of a recent open-label long-term extension study that looked at 24-month follow-up from the ACQUIRE (Abatacept Comparison of Subcutaneous versus Intravenous in Inadequate Responders to Methotrexate) trial.



TNF Antagonists and Cardiovascular Disease Risk

Chicago—Data from a large epidemiologic study presented at the ACR meeting suggest a trend toward reduced cardiovascular disease (CVD) risk among patients with rheumatoid arthritis (RA) during the first 6 months of initiating treatment with tumor necrosis factor (TNF) antagonists.



Anti-TNF Therapy and Solid Cancer Risk

Chicago—Patients treated with anti–tumor necrosis factor (TNF) therapy for rheumatoid arthritis (RA) are not at increased risk of solid cancers compared with patients receiving nonbiologic disease-modifying antirheumatic drugs (DMARDs), investigators reported in a study presented in an oral abstract session and at a news conference at the ACR meeting.



Serious Infections in Patients with Autoimmune Diseases

Chicago—The risk of serious infection was not significantly increased in patients with autoimmune diseases initiating treatment with tumor necrosis factor (TNF) antagonists compared with those treated with nonbiologic disease regimens, even in older and low-income people, according to a study presented at the ACR meeting. The investigators retrospectively examined the incidence of serious infections in patients with autoimmune diseases during the first 12 months after initiation of TNF antagonists or nonbiologic regimens.



Cost-Effectiveness and Survival of HRPC Treatments

New Orleans—To determine survival benefits for patients with hormone-refractory prostate cancer (HRPC), researchers conducted a cost-effectiveness analysis that looked at the comparative economics of treating HRPC with sipuleucel-T and docetaxel with prednisone. The findings suggested that sipuleucel-T is not a cost-effective option; however, it is an appropriate treatment strategy when healthcare providers are willing to pay the $34,912 per additional life-month gained over docetaxel plus prednisone.



Length of Hospital Stay Associated with Dabigatran and Warfarin

New Orleans—A retrospective cohort study found that patients with atrial fibrillation (AF) who took dabigatran did not have a significant reduction in length of stay in a hospital compared with those who took warfarin. However, the authors found that a hospital would save $766 per patient treated with dabigatran compared with warfarin due to the fewer days spent hospitalized.

Results were presented at the ASHP meeting in a poster titled Pharmacoeconomic Evaluation of Dabigatran Compared to Warfarin for Stroke Prophylaxis in Atrial Fibrillation.



Cost Comparison of Fulvestrant Regimens

New Orleans—A study comparing the cost of fulvestrant 250 mg and 500 mg found that 250 mg appears to be a cost-effective option in treating postmenopausal women with breast cancer, considering an incremental cost-effectiveness ratio (ICER) of $10,972 for the 500-mg regimen. As a result, third-party payers may prefer the 250-mg regimen over the 500-mg regimen. Overall, the cost of either drug is dependent on willingness to pay by third-party payers.



Treating Osteoporosis in Postmenopausal Women

New Orleans—According to an analysis of clinical trials, bazedoxifene is effective as a second-line therapy for postmenopausal women who have osteoporosis, although the drug is not cost-effective compared with raloxifene. Bazedoxifene and raloxifene are selective estrogen receptor modulators (SERMs), and raloxifene is the only SERM approved by the US Food and Drug Administration (FDA) to treat osteoporosis.



HPV Vaccination among Teens

Human papillomavirus (HPV) is the most prevalent sexually transmitted infection (STI) in the United States. HPV has a prevalence of 29.5% in sexually experienced girls 14 to 19 years of age. Sequelae of HPV infection may include genital warts, cervical dysplasia, and, with long-term viral persistence, cervical cancer. In 2006, the US Food and Drug Administration licensed the first prophylactic HPV vaccine.



Genital Herpes Vaccine Only Protects against One Strain of Virus

An investigational vaccine for genital herpes was effective in protecting some women against genital disease and infection from herpes simplex type 1 (HSV-1) but not from herpes simplex type 2 (HSV-2). Although the results are puzzling since 2 earlier studies of an HSV-2 glycoprotein D–based subunit (gD-2) vaccine in discordant couples showed efficacy against HSV-2, the investigators of the current study said the findings showed progress toward a genital herpes vaccine [N Engl J Med. 2012;366(1):34-43].



Vemurafenib Accelerates Secondary Skin Cancer in Some Patients

Although vemurafenib improves outcomes in patients with advanced melanoma that harbors a BRAF gene mutation, the drug also accelerates the development of squamous-cell carcinomas and keratoacanthomas in some patients. Results that show a skin cancer drug that causes secondary skin cancers was unexpected, according to the researchers [N Engl J Med. 2012;366(3):207-215].