AdventRx’s application for Exelbine accepted by FDA
SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.
The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.
The company described itself as developing existing cancer drugs to improve their performance by addressing limitations associated with their safety and use. “We are pleased to have reached this important milestone and look forward to working with the FDA on moving Exelbine toward approval in 2011,” AdventRx CEO Brian Culley said.
Adherence among chronic disease patients can lead to big savings
WOONSOCKET, R.I. — Patients with one or more out of four chronic diseases studied who take their medications as prescribed may save the healthcare system as much as $7,800 per patient annually, according to findings of a new CVS Caremark study analyzing annual pharmacy and medical costs over a three-year period.
The study findings revealed robust reductions in emergency department visits and in-patient hospital days from medication adherence. By avoiding those costly events, there were substantial savings in overall healthcare costs. The study, "Medication Adherence Leads to Lower Health Care Use and Costs Despite Increased Drug Spending," was released today in the January issue of Health Affairs.
Company researchers analyzed pharmacy and medical claims data of 135,000 patients with congestive heart failure, diabetes, hypertension and dyslipidemia to determine the direct effect of adherence on costs, according to Troyen Brennan, EVP and chief medical officer of CVS Caremark and a study author.
"There have been many studies through the years that suggest adherence can save on healthcare costs, but the issue has not been central to healthcare cost discussions because those studies did not establish a causal link. We took the research further, and what we found is that although adherent patients spend more on medications — as much as $1,000 more annually — across the board, they spend significantly less for their overall healthcare costs," Brennan stated.
The annual per person savings for chronically ill patients who were adherent to medications, compared with those who were not, amounted to $7,823 for those with congestive heart failure, $3,756 for diabetes, $3,908 for hypertension and $1,258 for dyslipidemia or high cholesterol. Brennan said CVS Caremark plans to share the study with healthcare regulators and federal legislators as they consider policies to reduce healthcare costs.
The study population included patients in the CVS Caremark book of business with congestive heart failure (16,353), diabetes (42,080), hypertension (112,757) and dyslipidemia (53,401).
Among the disease-specific findings are:
People with congestive heart failure spent $39,076 on average annually and had an average of 11.9 days in the hospital. Those with congestive heart failure were older, averaging 77 years of age;
Diabetes costs per patient on average were $17,955 annually, and these patients had an average of 4.26 days in the hospital;
Hypertension patients spent $14,813 on average annually and had 3.29 days on average in the hospital; and
The annual spend for a person being treated for dyslipidemia was $12,688 on average. Hospital stays for these patients were 2.24 days on average.
Pharmacy costs for the patients ranged from $2,867 to $3,780 per year.
The researchers also found that adherence effects were more pronounced in elderly patients 65 years and older. They stated that changes in the recently passed health-reform law for Medicare, which reduced prescription costs for beneficiaries by eliminating the doughnut hole and providing for therapy management and wellness programs, "were prudent." They recommended policy analysts take a harder look at how adherence programs and incentives might bend the healthcare cost curve downward.
"No matter what the intervention, the researchers agreed that actively encouraging medication adherence for chronic disease should be a top priority," noted M. Christopher Roebuck, director of strategic research for CVS Caremark and lead author of the study. "Despite higher pharmacy spending, the reduction in hospitalizations and emergency room use resulted in substantial savings."
Genentech granted supplemental approval for Actemra
SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.
The FDA approved Actemra (tocilizumab) for the inhibition and slowing of structural joint damage, improvement of physical function and achievement of clinical response in patients with moderate to severe rheumatoid arthritis. The drug originally was approved as a treatment for RA last year.
“This FDA approval further supports the efficacy of Actemra and follows a similar approval in the [European Union],” Genentech chief medical officer and head of global product development Hal Barron said. “For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals.”