Independents providing LTC could face challenges under newly proposed CMS regulations
ALEXANDRIA, Va. — According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.
"In response to inadequate data and the alleged wrongdoing by one national, LTC pharmacy corporation, CMS has suggested requiring all LTC facilities to contract solely with consultant pharmacists who have no affiliations to any in-facility LTC pharmacy, pharmaceutical manufacturer or drug wholesaler," the association stated.
A November 2011 survey of NCPA members supported the concerns expressed in NCPA’s comments. Namely, respondents indicated that 80% of the LTC facilities that they serve are in rural areas. Further, most pharmacists surveyed said that, in the communities that their LTC pharmacies serve, there already is a shortage of consultant pharmacists, which NCPA argued would become worse under CMS’ proposal.
In addition, the overwhelming majority of respondents asserted that CMS’ proposed requirement would be detrimental to LTC facilities’ efficiencies, continuity of care, timeliness of care and services, as well as communication between healthcare providers.
If CMS ultimately decides to implement such changes, the agency should delay the effective date past the proposed Jan. 1, 2013, date, NCPA added. That’s because another significant regulatory requirement — that LTC pharmacies dispense certain high-cost drugs in shorter, 14-day (or less) cycles — also is set to take effect on that date.
Genzyme reports lackluster results in MS drug trial
CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.
Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.
Teriflunomide in doses of 7 mg and 14 mg did not show superiority over Rebif on risk of treatment failure, defined as a disease relapse or permanent discontinuation of treatment for any reason. Among patients receiving the 7-mg dose, 48.6% did not show risk of treatment failure, compared with 37.8% of those taking the 14-mg dose, and 42.3% of those taking Rebif.
Estimated annual relapse rates were higher among patients taking teriflunomide in the 7-mg dose than among those taking the 14-mg dose or Rebif, while patients taking Rebif showed higher rates of permanent treatment discontinuation than those taking teriflunomide.
Merck’s Isentress approved for children, adolescents
SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.
The FDA announced the approval of Merck’s Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.
"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.