Study: Lack of compliance increases medical costs
Patients with diabetes and high cholesterol can save the health care system millions of dollars by properly taking their medication, according to a new study from Medco Health Solutions in Franklin Lakes, NJ.
Although prescription drug costs have escalated 12%-16% annually, the costs and risks of hospitalization far outweigh the costs of using medications as directed, according to the study "Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost," published in the June issue of Medical Care, a journal published by the American Public Health Association. The study was based on a sample of more than 137,000 patients younger than age 65 with diabetes, high cholesterol, hypertension, or congestive heart failure.
The study found that the least compliant diabetes patients were more than twice as likely to be hospitalized compared to those who were most compliant, and their total health care costs were nearly double, too. The authors note that people who use their diabetes medications as directed are less likely to develop the short-term and long-term health problems that can require expensive care.
The hospitalization risk of the most compliant patients with cholesterol problems is 12% vs. 15% in the least compliant group. However, the total health care cost is $3,924 for the most compliant group, compared with $6,888 in the least compliant group.
The study also looked at medical expenses that included cases in which patients have more than one ailment. The least compliant group of diabetics had on average $16,498 in total medical and drug costs, compared with $8,886 for the most compliant group. Among patients with high blood cholesterol, the total medical and drug costs were $10,916 in the least compliant group vs. $6,752 in the most compliant category.
FDA announces efavirenz labeling changes
Bristol-Myers Squibb and the FDA have notified health care professionals of revisions to the prescribing information for efavirenz (Sustiva), which is indicated in the treatment of HIV-1 infection. The revisions are a result of four retrospective reports of neural tube defects in infants born to women with first trimester exposure to efavirenz, including three cases of meningomyelocele and one Dandy Walker syndrome. As efavirenz may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving efavirenz. An antiretroviral pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to efavirenz.
For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Sustiva.
Closely watched TB drug enters clinical trial
A new drug candidate that may be effective against both actively dividing and slow-growing Mycobacterium tuberculosis has begun testing in humans, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced. The novel antibiotic, PA-824, may shorten the time needed to treat tuberculosis (TB). In partnership with the nonprofit New York-based Global Alliance for TB Drug Development (TB Alliance), NIAID contributed to the drug candidate’s preclinical safety and efficacy testing in animal models. Now, a clinical trial to assess PA-824’s safety, sponsored by the TB Alliance, has opened at a medical clinic in Lincoln, NE.
In addition to activity against both actively dividing and slow-growing Mycobacterium tuberculosis, PA-824 shows evidence of being active against both drug-sensitive and multidrug-resistant TB, too. Also, in animal testing, single doses of the compound administered orally traveled rapidly to such target organs as the lung and spleen.
Finally, PA-824’s apparent lack of interaction with certain liver enzymes means it may be safe for use by people coinfected by HIV and TB.
Currently, such individuals may experience adverse effects when taking both rifampin (to treat TB) and antiretroviral drugs (to treat HIV).
FDA limits gefitinib patient population
The FDA has approved new labeling for gefitinib (Iressa), which limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib treatment. The FDA has agreed to AstraZeneca’s proposal to limit distribution of this drug under a risk management plan called the Iressa Access Program, to the following patient populations:
- patients currently receiving and benefiting from gefitinib;
- patients who have previously received and benefited from gefitinib;
- previously enrolled patients or new patients in non-Investigational New Drug (IND) clinical trials approved by an IRB prior to June 17.
New patients may also be able to obtain gefitinib if AstraZeneca decides to make it available under IND and the patients meet the criteria for enrollment under the IND.
Gefitinib, an orally administered epidermal growth factor receptor tyrosine kinase inhibitor, was approved for marketing in May 2003 for patients with nonsmall cell lung cancer under Subpart H-accelerated approval regulations that allow products to be approved on the basis of a surrogate endpoint for clinical efficacy. The approved indication was for the treatment of patients who were refractory to established cancer treatments (both a platinum drug and docetaxel). However, since the initial approval of Iressa, erlotinib (Tarceva) has been approved for treatment of this same group. Erlotinib was approved based on improved overall survival.
The FDA has carefully reviewed data from two failed clinical studies of gefitinib. The first trial enrolled patients with regionally advanced or metastatic NSCLC who had failed one or two prior treatment regimens. In this large study, 1,692 patients were given either gefitinib or placebo. There was no significant survival benefit in the overall study population or in patients who had high levels of a surface marker called EGFR. In contrast, the presence of EGFR at high levels appears to predict a good response to erlotinib.
In the second trial in patients with Stage III NSCLC, after completion of induction and consolidation chemotherapy and radiation therapy, patients were given either gefitinib or placebo maintenance therapy. No gefitinib survival benefit could be demonstrated.
The FDA is not considering market withdrawal of gefitinib at this time.
FDA, Qualitest recall insulin syringes
Qualitest Pharmaceuticals and the FDA have notified health care professionals and consumers of a voluntary nationwide recall of AccuSure Insulin Syringes 1 cc, 28 Gauge ½ Inch, distributed between October 2004 and June 2005. There may be 1 cc syringes that are mislabeled as ½ cc syringes on the plastic inner wrap holding 10 individual syringes, which could potentially result in confusion by the patient or caregiver, resulting in an incorrect dose or amount being administered.
For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#accusure.
Patients with diabetes and high cholesterol can save the health care system millions of dollars by properly taking their medication, according to a new study from Medco Health Solutions in Franklin Lakes, NJ.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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