FDA report highlights savings from 2017 approvals
The Food and Drug Administration has released a report focusing on the savings that generic approvals brought the healthcare system in 2017. The report is the first of its kind from the FDA’s Office of Generic Drugs, and notes that the FDA fully approved 843 Abbreviated New Drug Applications, issuing tentative approval to a further 184 ANDAs.
The agency’s report estimates that savings from 2017 approvals through February 2018 totaled $11.8 billion, with $8.8 billion in savings through December 2017. Further, the report estimates that in one full year after each generic approval from last year, the savings will be $16 billion.
To reach its estimates, the FDA created a dataset using the 2017 ANDA approvals in the FDA’s Orange book, the NDC numbers of the approvals from various sources, a defined market parameter and monthly sales of all products with the same ingredients/route/dosage form as the 2017 approvals, including the branded drug and previously approved ANDAs. The agency noted that the sales data it looked at did not reflect rebates, discounts or off-invoice adjustments and that it measured market impact following approval rather than marketing. It also did not look at the impact of tentatively approved drugs because of delays that occur before full approval and exclusivity issues.
“FDA approved a record number of generic drug applications in 2017,” the report says. “Since its inception in 1984, the generic drug approval pathway has played a critical role in increasing access to safe, high-quality, and affordable medicines for the American public.”
FDA approves Alembic’s generic Wellbutrin
The Food and Drug Administration has approved Alembic Pharmaceuticals’ generic Wellbutrin (bupropion HCL) tablets. The drug is indicated to treat major depressive disorder.
Alembic’s generic Wellbutrin will be available in 75- and 100-mg dosage strengths. The product’s market size for the 12 months ended December 2017 was $37 million, according to IQVIA data.
Express Scripts, MedAvail pilot Rx kiosks
Pharmacy tech company MedAvail is bringing a new pharmacy convenience pilot to Arizona, backed by a strategic investment from Express Scripts. The companies are rolling out MedAvail’s MedCenter self-service pharmacy kiosks in Phoenix and Tucson, offering securely dispensed chronic and acute prescriptions, as well as OTC medications 24/7.
“Technology — and a culture shift — allow us the opportunity to evolve and simplify healthcare services to better accommodate our busy schedules, which in turn can lead to better adherence and outcomes,” said Glen Stettin, chief innovation officer at Express Scripts. “Through our work with MedAvail’s prescription dispensing technology, we are examining how MedCenter, MedAvail’s self-service, pharmacist-supported, kiosk pharmacies can provide patients with safe and cost-effective pharmacy care close to where they live, work or get their medical care.”
The kiosks, which are supervised by pharmcists, can dispense a prescription in under 90 seconds and can accept either electronic or handwritten prescriptions. Pharmacists carry out such functions as reviewing patient medical history and allergies, as well as potential interaction with other medications being taken. They also provide medication counseling to address patient concerns, the companies said.
“This consumer experience can do for pharmacy care what the ATM did for personal banking – enable greater access and efficiency, especially during times of immediate need, while streamlining the experience for those consumers who need expert counsel and support from a pharmacist,” Stettin said. “We believe this technology, when deployed on a larger scale, could have the potential to bring pharmacy dispensing to employer sites, hospital emergency rooms, community clinics and university campuses.”
Express Scripts also sees potential for MedCenters to open up opportunities for pharmacists.
“This technology also could help community pharmacists increase their community presence and the efficiency of their operations, relieve congestion at retail pharmacy counters, extend a pharmacy’s hours of operation, and allow pharmacists to focus on their important role in providing clinical care to patients,” he said.
There currently are six MedCenters available in Phoenix and Tuscon at such locations as grocery stores, pharmacies and medical clinics. The companies plan to have 15 kiosks in place by the end of 2018. Patients in the Inside Rx prescription savings program can choose to fill their prescriptions at one of the MedCenters. In addition to the pilot, the companies said they planned to expand MedCenters to several states, including Illinois.