FDA approves Avion Pharmaceuticals’ Balcoltra
The Food and Drug Administration has approved Avion Pharmaceuticals’ Balcoltra oral contraceptive. The Atlanta-based maker of Prenate prescription prenatal vitamins said that this approval was its first for a new drug it had developed internally.
Balcoltra combines 0.1-mg levonorgestrel tablets, 20-mcg ethinyl estradiol tablets and 36.5-mg ferrous bisglycinate tablets — which the company said was a unique combination on the market.
“Avion is excited to offer our women’s health community this oral contraceptive formulation that fills a gap in the current branded options available to women,” Avion CEO Art Deas said. “The validity of data related to safety and efficacy for Balcoltra also provides another viable prescribing option for our prescribing community.”
The company said it plans to launch Balcoltra in the spring.
“Avion has always focused on creating a meaningful and long-term supporting role for our women’s healthcare prescribers,” Avion president Mike Sullivan said. “The Balcoltra approval and forthcoming launch is a monumental event for Avion, allowing us to solidify our commitment to the women’s healthcare community.”
CVS Health adds rheumatoid arthritis to Transform Care offerings
In a move it said was aimed at helping its pharmacy benefits management clients control high specialty drug costs and improve patient outcomes, CVS Health has introduced the Transform Rheumatoid Arthritis Care program.
Part of the Woonsocket, R.I.-based company’s suite of personalized and condition-specific Transform Care offerings, CVS Health said Transform RA Care is designed to leverage pharmacy network and utilization management tools to encourage use of lower-cost therapies. It also uses outcomes-based contracts that tie reimbursement to how well a drug meets targets. A drug’s inability to meet outcome targets might result in a manufacturer having to provide additional value
“Rheumatoid arthritis is a complex condition and is one of the top drivers of specialty drug trend for our PBM clients,” CVS Health executive vice president and chief medical officer Troyen Brennan said. “By leveraging our integrated pharmacy care model, we can provide highly personalized, whole-patient support through our specialty pharmacy and embedded AccordantCare nurses, while harnessing the power of our PBM’s tools to encourage appropriate use of and adherence to lower cost therapies.”
Among the PBM tools the company said is part of Transform RA Care is the use of an indication-based formulary for autoimmune drugs. CVS Health said that this approach chooses a drug’s formulary placement based on a patient’s diagnosis, rather than the therapy’s class.
“Treating Rheumatoid Arthritis costs the U.S. health care system $19 billion a year. Both spend and trend have also been rising for the autoimmune category in recent years and market analysts expect this category to be the fastest-growing drug class over the next five years,” CVS Specialty executive vice president Alan Lotvin said. “Our program is unique in that we can pull together resources enabled by our integrated pharmacy care model to deliver both a truly member-focused clinical management program while also helping to manage the rising costs within the autoimmune category through new approaches to contracting and formulary management.”
CVS Health said PBM members who enroll in Transform RA Care also will continue to receive personalized care and expertise from its RA Care Team, which includes specialty-trained pharmacists and Accordant nurses. The care team offers clinical assessments, benefit verification, medication dispensing and distribution and other support services that include symptom and side effect management and care coordination, as well as education and coaching.
CVS Health noted that clients enrolled in Transform RA Care could expect savings of up to 5% on their annual spending on RA drugs — as much as $500,000 for a client that manages 100,000 lives.
Greenstone launches authorized generic of Silvadene Cream
Pfizer subsidiary Greenstone has introduced its authorized generic of Silvadene Cream (silver sulfadiazine cream, 1%). The drug is indicated as an adjunct to prevent and treat wound sepsis in patients with first- and second-degree burns.
Greenstone’s generic will be available in 50- and 85-g tubes, as well as in 50- and 400-g jars.