FDA approves expanded use of Omnitrope
PRINCETON, N.J. The Food and Drug Administrations has approved two new uses for what remains, thus far, the only biosimilar on the U.S. market.
Sandoz, the generics arm of Swiss drug maker Novartis, said Monday that the FDA had approved Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Prader-Willi syndrome and for those who are small for gestational age.
The company also announced changes to OmniSource, a support program for patients taking the drug, replacing the Sandoz Access program with what it called a more extensive range of programs, higher-value reimbursement and expanded insurance features. Sandoz said, for example, that patients could save up to $3,000 per year in out-of-pocket costs for Omnitrope prescriptions through the “Save As You Grow” program.
The FDA originally approved Omnitrope in May 2006 under a section of the Federal Food, Drug and Cosmetic Act for children with growth failure and as a replacement therapy for adults with growth hormone deficiency. The drug was launched in the United States in January 2007. Omnitrope is a biosimilar of Pfizer’s Genotropin.
NCL: Patients concerned about therapeutic substitution
WASHINGTON Nearly 75% of consumers would feel “very concerned” if a drug they used was switched to another drug designed to treat the same condition without their doctors’ knowledge, according to a new survey by the National Consumers League. One-in-5 said they still would be concerned if their doctors knew.
The practice, known as therapeutic substitution, has become common among insurance companies as healthcare costs have increased. The practice involves switching a medication that is not chemically equivalent or simply a generic version, but belongs to the same class as what the patient already takes.
“Consumers are justifiably concerned about the practice of therapeutic substitution, how it’s done and who’s involved,” NCL executive director Sally Greenberg said. “For some conditions and treatments, it may make good financial and medical sense to swap out one prescription for another. But, as consumers reported in our survey, it’s essential for them to be part of the process, to know their doctor is aware and supportive of the switch and to feel confident that their health and treatment – not financial incentives – are top priority.”
Independents will gain clout with NCPA-CDC alliance
WHAT IT MEANS AND WHY IT’S IMPORTANT The partnership between the National Community Pharmacists Association and Chain Drug Consortium brings together one of the largest pharmacy trade groups in the country with one of the largest purchasing organizations.
(THE NEWS: NCPA, CDC buying group forge new ties. For the full story, click here)
This means the amount of clout that the NCPA has on Capitol Hill will combine with the CDC’s purchasing and marketing abilities to help bolster independents, a segment of the pharmacy industry that often has struggled in comparison with the big national chains.
For the NCPA, it also might be a way to attract new members. The CDC’s membership includes a number of regional chains around the country that still may qualify for NCPA membership and often face many of the same challenges as independents, especially considering the difficulties that the group often has had in finding new members and the number of independent pharmacies that have been forced to close down over the years.