More than half of drugs approved in 2013 were specialty, according to FDA
NEW YORK — The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.
In total, 2013 saw the approval of 27 new drugs, down from 39 in 2012. Of the newly approved drugs, 14 were specialty drugs for serious disease states such as chronic viral infections, cancers, autoimmune diseases and genetic disorders. Meanwhile, two new drugs were approved for chronic obstructive pulmonary disease, and two were approved for Type 2 diabetes. Other new drugs were approved for such conditions as depression, epilepsy, athlete’s foot and menopause, among other conditions.
Highlights for the year include Gilead Sciences’ Sovaldi (sofosbuvir), part of a new generation of hepatitis C drugs that promises to greatly reduce the time required for treatment, while also carrying a high cost that could prompt pharmacy benefit managers like Express Scripts to start a "price war" in order to keep costs down. Another was Biogen Idec’s Tecfidera (dimethyl fumarate), a capsule for multiple sclerosis; according to some analysts, while injectable drugs for MS continue to dominate the market, orally administered drugs have been gaining on them, with Tecfidera in particular seeing a large increase in usage among patients.
Analysts have long forecast that specialty drugs would come to dominate new drug approvals as treatments for conditions like cardiovascular disease and psychiatric disorders become increasingly commoditized due to the growth of generics, which now account for about 84% of all prescriptions dispensed in the United States, according to IMS Health.
While the number of new drugs is a steep drop from 2012, it exceeds the annual total of new drugs approved between 2005 and 2010; in 2007, the FDA only approved 18 new drugs. In a report on the new drug approvals for 2012, the agency noted that despite a higher number of approvals that year and the year before, the number of applications for new drugs received by the agency had not seen a significant or consistent increase.
Walgreens offers month’s supply of drugs to patients enrolled in insurance marketplaces, but without ID numbers
DEERFIELD, Ill. — Patients who have enrolled in the new healthcare insurance marketplaces but haven’t received an identification number from their insurers can receive up to a 30-day supply of prescription drugs at no upfront cost at Walgreens, the retail pharmacy chain said.
Through the end of January, customers can take confirmation of their enrollment in the public health insurance marketplace to a Walgreens pharmacy, or the pharmacy staff can check to verify eligibility, and they can obtain up to a month’s supply of many branded or generic medications at no upfront cost.
"We understand that all the chains that come with healthcare reform may create some questions for newly enrolled individuals," Walgreens president of pharmacy, health and wellness Kermit Crawford said. "We are deeply committed to helping these patients get, stay and live well by helping them get their medications without interruption."
The chain said it was reaching out to insurance companies’ operations groups to request nightly eligibility file updates on health insurance marketplace plan enrollees to help ensure Walgreens pharmacy teams have the most up-to-date coverage information, as well as encouraging patients enrolled through the public marketplace to confirm coverage with their insurance companies. Pharmacy staff at Walgreens stores will individually review patient benefits and work with insurance companies directly to confirm benefit eligibility.
Mylan hires former Biocon executive to lead Indian marketing division
PITTSBURGH — Mylan has hired Rakesh Bamzai as its president for commercial and emerging markets in India, the drug maker said Thursday.
Mylan said Bamzai has more than 20 years of experience in the drug industry, having previously served as president of marketing at Biocon.
"We were extremely pleased when Rakesh asked to join our company," Mylan president Rajiv Malik said. "Many of us at Mylan have had a firsthand opportunity to work with Rakesh over the course of our strategic partnership with Biocon and have observed his strong business and marketing acumen, his strategic insight and outstanding leadership skills."