The search is on for a new HHS secretary, falling breast cancer death rates saved more than 300,000 lives, and FDA moves to broaden access to complex generic drugs.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Tom Price, MD, resigned as HHS secretary last Friday after more than a week of news stories about his preference for private charter flights. But reports say President Donald Trump was already frustrated with Price for failing to achieve a repeal of the Affordable Care Act, and he may look for someone who can reach a deal when he picks a replacement.
Leading candidates to replace Price are FDA Commissioner Scott Gottlieb, MD, CMS Administrator Seema Verma, and Veteran’s Affairs Secretary David Shulkin. All have been through confirmation, although Shulkin has recently received criticism over his own travel.
Breast Cancer Mortality Trends
October is breast cancer awareness month, and a new report from the American Cancer Society finds that death rates over the past generation have declined 39 percent.
Improvements in detection and treatment saved three hundred and twenty-two thousand lives between 1989 and 2015, the report found. However, disparities between black and white women are stark—death rates among black women are 42 percent higher.
Authors of the report found “a striking divergence in long-term breast cancer mortality trends between black and white women emerged in the early 1980s and continued to widen over the last several decades, but recent data suggest that the racial disparity may be stabilizing.”
Creating New Partnerships
Cancer care is changing and so is the nature of partnerships, according to Kim Woofter of the Advanced Centers for Cancer Care, who spoke recently with AJMC about the need for data in practices.
Access to Generics
This week, FDA announced a pair of strategies to give patients access to less expensive novel drugs. Both were announced in blog posts by Gottlieb, who has continued his agenda to promote manufacturing of generic drugs to lower drug costs.
The 2 new policies will:
Offer new guidance and boost communication for companies filing abbreviated new drug applications, which are needed for complex generic drugs.
Create new rules to make it easier for patients to get investigational drugs through the FDA’s expanded access program.
Finally, competition in the mealtime insulin market heated up this week after FDA approved one new treatment and updated the label for another.
On Friday, Novo Nordisk won approval for Fiasp, a faster-acting insulin that contains vitamin B3, which helps the body absorb it more quickly. Said Chief Medical Officer Todd Hobbs, MD, “Due to its fast onset and appearance in the bloodstream, Fiasp can be dosed at the beginning of a mealtime or within 20 minutes after the start of a meal.”
Then on Monday came word that FDA had updated the label for Afrezza, the inhaled insulin from MannKind, which has been popular with users but struggled to win favorable formulary placement.
The new label features a table outlining how the drug enters and exits the body quickly, which CEO Michael Castagna said will make it easier for MannKind to explain its advantages to doctors and patients. “We have removed the language that restricted our promotional activity.”