WASHINGTON -- Another quiet week in Washington was highlighted by an announcement of nearly $1 billion in Affordable Care Act (ACA)-related grants and the approval of a hemophilia drug.
HHS Announces Innovation Grants
The Department of Health and Human Services (HHS) plans to give out $840 million in grants over the next 4 years to 150,000 healthcare organizations that design strategies to improve quality while holding down costs, the agency announced Thursday. The program, a strategy of the ACA known as the Transforming Clinical Practice Initiative, will "encourage doctors to team with their peers and others to move from volume-driven systems to value-based, patient-centered, and coordinated healthcare services," the agency said in a press release.
Successful applicants -- which could include group practices, healthcare systems, and medical provider associations -- "will demonstrate the ability to achieve progress toward measurable goals, such as improving clinical outcomes, reducing unnecessary testing, achieving cost savings, and avoiding unnecessary hospitalizations."
"The administration is partnering with clinicians to find better ways to deliver care, pay providers, and distribute information to improve the quality of care we receive and spend our nation's dollars more wisely," HHS Secretary Sylvia Burwell said in the release. "We all have a stake in achieving these goals and delivering for patients, providers, and taxpayers alike."
New Factor VIII Replacement OK'd
A novel recombinant Factor VIII replacement drug was approved Friday by the FDA for patients with acquired hemophilia A, the agency said.
Called Obizur, the product mimics the porcine form of Factor VIII. As a result, it is less likely to be neutralized by autoantibodies targeting endogenous Factor VIII, which are responsible for acquired hemophilia A.
This rare autoimmune condition is thus distinct from hereditary forms of hemophilia A, the FDA explained, which are caused by genetic defects that interfere with normal Factor VIII production beginning at birth.
In about half of cases, acquired hemophilia A results from medical conditions such as pregnancy or malignancies or as a drug side effect. It appears to be spontaneous in the other half.
FDA Panel Backs Novel Biologic for Psoriasis
An FDA advisory committee voted 7-0 that the benefits of secukinumab in moderate-to-severe plaque psoriasis appear to outweigh the risks, supporting the drug's approval.
Panelists also indicated that an ultimate approval should include doses of 150 and 300 mg, even though the risk of infection was somewhat greater at the higher dose. In fact, most members of the Dermatologic and Ophthalmic Drugs Advisory Committee, meeting on Monday, indicated that the 300-mg dose would be optimal for most patients.
There also appeared to be a consensus that postmarketing studies should explore a 450-mg dose for patients weighing 90 kg (198 lbs) or more, since the existing data indicated that the effectiveness of fixed doses varied inversely with body weight. The clinical trials thus far did not examine doses higher than 300 mg.
Secukinumab is a monoclonal antibody that binds to interleukin (IL)-17A and blocks this inflammatory cytokine's interaction with its receptor, according to manufacturer Novartis.
ONC Director Leaves to Help With Ebola Effort
Karen DeSalvo, who headed HHS' Office of the National Coordinator (ONC) for Health Information Technology, will be leaving that office to head up the HHS effort on Ebola, HHS announced Thursday. DeSalvo will become the acting assistant secretary for health; that position also oversees the surgeon general's office.
Replacing DeSalvo as acting national coordinator will be Lisa Lewis. It is unclear whether DeSalvo will return to ONC once her work on Ebola is finished.
In another change at the ONC, deputy national coordinator Jacob Reider, MD, will be leaving in late November. "As some of you know, I have been commuting to D.C. from my home in Albany, N.Y., and committed to my family that 3 years would be the limit of such an arrangement," Reider wrote in a note to his staff, also on Thursday. "I'm a marathon runner -- so I have very good stamina -- but even marathons have a finish line!"
Next Week
Congress continues its pre-election recess next week, but the FDA will be busy.
On Monday, the FDA's Cardiovascular and Renal Drugs Advisory Committee will discuss a new drug application from Daiichi Sankyo for edoxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
On Monday and Tuesday, the agency will hold a workshop on female sexual dysfunction, to help it figure out how to regulate drugs to increase libido in women complaining of diminished desire.
And on Thursday and Friday, the FDA will convene a meeting on the development and regulation of abuse-deterrent formulations of opioid medications. This meeting appears to be very popular, as the FDA is already saying no more registrations will be accepted because the room is filled to capacity.