CVS Caremark’s Reid reiterates support of biogeneric drugs in the Affordable Care Act
WOONSOCKET, R.I. In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy operations, Scott Reid, reiterated the company’s support that the FDA implement regulations necessary to approve biogeneric drugs under the Affordable Care Act.
“Every day, CVS Caremark supports patients who depend on specialty and other biotech drugs to provide critical treatment for their serious, chronic conditions, and we have long advocated for the creation of an FDA pathway for approval of biogeneric options,” Reid said. “The availability of biogenerics will not only help health plans, employers and federal programs manage their drug spend, but, more importantly, it will help make these extremely expensive medicines more affordable for patients.”
Reid’s comments, which were made during a public hearing at the FDA’s headquarters in Silver Spring, Md., also touched on ensuring that pharmacovigilance programs for biosimilar and interchangeable products are consistent with programs for the innovator products, and that additive burdens that could inhibit patient access are not imposed on pharmacies at the front lines of managing these programs. He also urged the FDA to work with the Centers for Medicare and Medicaid Services to establish a regulatory process that not only allows for interachangeability of biologics but also aligns reimbursement incentives for payers, patients and providers to choose a biogeneric.
FDA approves new treatment for bacterial infections
NEW YORK The Food and Drug Administration has approved a new treatment for bacterial infections made by Forest Labs, Forest said.
The drug maker announced the approval of Teflaro (ceftaroline fosamil) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection, also known as ABSSSI, caused by bacteria that include methicillin-resistant Staphylococcus aureaus.
“Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and [ABSSSI], and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications,” said Dirk Thye, president of Forest subsidiary Cerexa.
Forest said it plans to make Teflaro available to wholesalers by January.
Adding to its clout in specialty care, McKesson wins bid for U.S. Oncology
SAN FRANCISCO In a big boost to its growing specialty pharmacy operation, drug-distribution and health services giant McKesson today revealed it has bought U.S. Oncology for $2.16 billion in cash and assumed debt.
Both companies said the deal should close by the end of McKesson’s third quarter on Dec. 31. When finalized, said company officials, it will merge McKesson’s strengths in healthcare services and information technology with U.S. Oncology’s expertise in clinical care, along with what it calls “the largest community-based cancer treatment and research network in America.” The combined organization, said McKesson, “will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.”
Following the merger, McKesson’s combined Specialty Care Solutions business will be led by U.S. Oncology CEO Bruce Broussard, who will report to McKesson executive VP and group president Paul Julian. The new operation will be based in The Woodlands, Texas, with additional offices in McKesson’s home city of San Francisco and other locations throughout the country.
It will deliver, in McKesson’s words, “a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts.”
The new organization will initially serve a base of some 3,000 oncologists, spurring what the company said will be accelerated investments in integrated systems and clinical programs to boost productivity, efficient delivery of care and improved patient outcomes.
“For U.S. Oncology customers, they’re going to get a world-class distributor,” said McKesson chairman and CEO John Hammergren. “And for McKesson customers, they’re going to get a world-class oncology operations company.”
Hammergren called the acquisition “the next step in our involvement in oncology.”
“Clearly U.S. Oncology has a significant amount of technology, and has the world’s leading physicians using the world’s state-of-the-art thinking around clinical care,” he added. “They’ve driven efficiency in their practices, but perhaps more importantly, they’ve been leading the practice of health care from an oncology perspective.”
McKesson’s acquisition of the cancer-care giant will accelerate the consolidation of the specialty pharmacy market, predicted Adam Fein, PhD, founder and president of Pembroke Consulting. “After the U.S. Oncology acquisition, McKesson and AmerisourceBergen will now represent almost 80% of all specialty pharmaceutical distribution, which is the primary channel to market for office or clinic-based physicians,” Fein noted today.