U.K. Set to Clear Use of New RA Tx
The United Kingdom's National Institute for Health and Clinical Excellence (NICE) recently recommended that Cimzia (certolizumab pegol) be available as a treatment option for adults with severe active rheumatoid arthritis. But the recommendation is still in draft form, and the NICE will hear appeals before it formally issues its guidance to the U.K.'s National Health Service. Under the recommendation, Cimzia would be used in combination with methotrexate for those patients who have had an inadequate response to disease-modifying antirheumatic drugs. The new treatment could also be used as monotherapy in cases where continued treatment with methotrexate is not appropriate. As part of an agreement with the U.K. Department of Health, Cimzia maker UCB Pharma has agreed to provide the drug for free to patients during the first 12 weeks of treatment.
Enbrel to Retain Hold of Top Spot
Enbrel (etanercept) is likely to maintain its position as the clinical standard and sales leader in RA treatment through 2018, according to an analysis from the market research firm Decision Resources Inc. One major factor is that rheumatologists don't want to prescribe drugs that may be less efficacious, even if they are less costly. As part of its new analysis, researchers at Decision Resources surveyed rheumatologists and found that their prescribing decisions are most affected by a drug's impact on reducing the signs and symptoms of RA at 1 year, and they see Enbrel as currently unmatched at inhibiting structural damage progression. “High price, intravenous delivery route, and the potential for harmful side effects are all drawbacks to current biologic agents used to treat TNF-alpha inhibitor-refractory patients,” Kyle Crowell, a Decision Resources analyst, said in a statement. “However, given a drug with incremental safety, delivery, and even cost advantages, physicians are still unwilling to compromise on efficacy,” according to Mr. Crowell.
Focus on Lupus Provider Education
Patient advocates, rheumatologists, and government officials recently met to discuss efforts to improve the diagnosis and treatment of lupus among minorities. At a meeting held in Atlanta in January, participants discussed how they could develop a national health care provider education initiative. About $1.6 million in government funding is available for projects that promote comprehensive lupus curricula in medical and nursing schools and among health professionals already in practice. A survey from the Lupus Foundation of America shows that, on average, a person will wait 3 years and visit four physicians before receiving an accurate diagnosis of lupus. The condition disproportionately affects women and minorities. More than 90% of individuals with lupus are women, and the condition is two to three times more likely among blacks, Hispanics, Asian Americans, and Native Americans than among whites, according to the Lupus Foundation of America.
Tobacco Act Gets Singed
A federal district court has struck down parts of the Family Smoking Prevention and Tobacco Control Act of 2009, saying that some of the landmark law violates tobacco makers' free speech rights. The U.S. District Court for the Western District of Kentucky ruled it unconstitutional for government to ban color and images in tobacco advertising. However, the court upheld provisions of the law requiring large, strongly worded warnings on tobacco packaging, prohibiting companies from making health claims about tobacco products without Food and Drug Administration review, and banning tobacco-branded events and merchandise, such as T-shirts. American Thoracic Society president Dr. J.R. Curtis said in a statement that the society is still “confident that the FDA will exercise its new authority to reduce tobacco use [in the United States] by stopping the efforts of big tobacco to market its dangerous products to minors, and by giving current smokers more motivation to stop smoking.”
Adverse Event Reports Are Limited
Little information is being made public about adverse events that occur in hospitals, even though public disclosure can help medical practitioners improve patient safety, according to a government report. The safety data in question are collected by organizations other than the hospitals. The Department of Health and Human Services Inspector General reviewed eight federally approved patient safety organizations and 17 systems that collect adverse event information for states. It found that only seven state systems passed along to providers adverse event analyses that led to changes in practice. The other states passed along reports without any analysis. A nationwide database of adverse events collected by the patient safety organizations won't be operational until at least 2011, according to the report.