What We're Reading: FDA Breast Implant Warnings; Arizona Delays Medicaid Work Requirement; Amgen Lowers Price of Evolocumab

October 24, 2019
AJMC Staff
AJMC Staff

The FDA proposed new warnings on breast implants, requiring manufacturers to detail complications; Arizona suspends implementation of Medicaid work requirements; Amgen will lower the list price of evolocumab by 60%.

FDA Calls for New Warnings Attributed to Breast Implants

Arizona Suspends Medicaid Work Requirement

Amgen Lowers List Price of Evolocumab by 60%

Yesterday, the FDA proposed that manufacturers detail possible complications from breast implants, including rare cancers, related symptoms, and the need for additional surgeries, according to The Washington Post. The move comes amid pressure from women who have reported harm from their breast implants. Among the recommendations, a boxed warning from manufacturers, said the FDA, is of the utmost priority. These warnings will clearly spell out implants' risks, as well as the facts that they are not lifetime devices and their risks increase over time. Cancers, such as a rare form of lymphoma, were linked to breast implants, and there have also been reports of fatigue, muscle aches, and joint pain.Arizona has chosen to suspend plans to require approximately 120,000 people to work, volunteer, or go to school to receive Medicaid benefits, according to the Arizona Capital Times. Arizona’s Medicaid program, the Arizona Healthcare Cost Containment System, provided a notice on its website stating, “implementation is being temporarily delayed, as court cases in other states play out, to avoid disruptions and protect Arizona’s most vulnerable members.” The decision provides another setback to efforts by the Trump administration to place work requirements on those seeking Medicaid benefits.Amgen announced today that it will make evolocumab, sold as Repatha, available in the United States at a 60% reduced list price, effective December 31, 2019. Evolocumab, a biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, will carry a list price of $5850 per year, allowing greater affordability by reducing patient copays, especially for Medicare beneficiaries. Amgen noted that the decision reflects its active participation in the American Heart Association’s Value in Healthcare Initiative, as well as its support of the Trump administration’s goal to lower the price of drugs for US consumers.