Rate review under the Patient Protection and Affordable Care Act will take effect September 1, and many states still have a great deal of groundwork to do. States will have the primary responsibility for reviewing rate increases, while the Department of Health and Human Services will serve in a backup role.
An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.
A 56-week phase 3 data for orphan drug lomitapide are consistent with 26-week data, showing that the drug significantly reduced low density lipoprotein cholesterol levels in patients with homozygous familial hypercholesterolemia, according to the drug?s manufacturer Aegerion Pharmaceuticals.
Lacosamide (Vimpat, UCB) appears both cost- and utility-effective as an add-on therapy for adults with uncontrolled partial-onset seizure, according to a pharmacoeconomics analysis that was recently presented at the International Society for Pharmacoeconomics Research.
Dietary calcium intake above 750 mg does not provide added benefit against risk of fractures or osteoporosis, according to the results of a large prospective longitudinal cohort study reported in the May 24 issue of the British Medical Journal.
Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.
FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.
An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.
Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health (Add Health) published online May 23 in Epidemiology.
FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.
An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.
Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine.
FDA approved fidaxomicin (Dificid, Optimer Pharmaceuticals) tablets for the treatment of Clostridium difficile-associated diarrhea.
There is no clear difference in benefit between drug classes when adding an antihyperglycemic as a third agent to the treatment of patients with type 2 diabetes who are already receiving metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of Annals of Internal Medicine.
Comparative effectiveness research will take a more prominent role in payer policies and programs, as the Patient-Centered Outcomes Research Institute will increase CER and CER will be used by Medicare and managed care organizations in development of clinical policies and programs, according to a recent audio conference.
The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.
Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.
FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.
The pipeline continues to decline from 4 to 5 years ago where smaller molecules led the way, according to a current state of the pharmaceutical pipeline presentation at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis.
Chronic hepatitis C virus affects more than 170 million people worldwide and is the most common chronic blood-borne infection in the United States. Telaprevir is a member of a new class of specifically targeted antiviral therapies for HCV.
New molecular entity: Gabapentin enacarbil extended-release tablets was approved by FDA as treatment for moderate-to-severe restless legs syndrome in adults.
Multiple sclerosis is the most common disabling neurologic disease afflicting young adults in the United States. Since the majority of MS patients have normal or near-normal life expectancy, the clinical and economic burden is substantial, with disability typically worsening over time. Disease-modifying therapies have been shown to decrease and postpone long-term disability by lowering the relapse rate, extending the remission phase, and reducing the accumulation of new magnetic resonance imaging lesions and related neurologic deficits.
Within the next 5 years, approximately $100 billion will be lost on previous blockbuster brands that will lose patent protection.
Recent FDA action (through May 2011) related to Augment Bone Graft, crizotinib, DP-b99 development program, regorafenib, MCD-386CR, liver cell infusion of donated human liver cells
New biologic: Belimumab intravenous injection is a B-lymphocyte stimulator-specific inhibitor approved by FDA to treat systemic lupus erythematosus.
Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension
Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev
Be nimble in product design and prepare for essential benefits and the Basic Health Plan program.
The Federal Health IT Strategic Plan is an initiative of the Office of the National Coordinator for Health Information Technology, which aims to further its goal of working with the private sector to improve quality.
Comparative effectiveness research will take a more prominent role in payer policies as the Patient-Centered Outcomes Research Institute drives research efforts.
