FDA Issues Warning on Do-It-Yourself Artificial Pancreas
May 19, 2019 – Mary Caffrey
May 18, 2019 – Samantha DiGrande
May 18, 2019 – Laura Joszt
May 18, 2019 – Wallace Stephens
May 18, 2019 – Allison Inserro
May 18, 2019 – Wallace Stephens
First-in-Human Study of Dual Inhibitor Licogliflozin Showed Significant Weight Loss in Obese Patients
May 17, 2019 – Mary Caffrey
May 17, 2019 – Samantha DiGrande
May 17, 2019 – Allison Inserro
May 17, 2019 – Samantha DiGrande
This Week in Managed Care: March 1, 2019
This week, the top managed care news included pharmaceutical executives appearing before a Senate drug pricing hearing; HHS finalizing a Title X rule change; and an analysis that found travel and wait times for healthcare services come with a high price.
Senators grill pharma executives on drug prices, HHS issues new rules for family planning funds, and going to the doctor costs Americans billions in lost time. Welcome to This Week in Managed Care, I’m Jaime Rosenberg.
Pharma CEOs Testify at Drug Pricing Hearing
Chief executive officers (CEOs) from 7 leading pharmaceutical companies appeared before the Senate Finance Committee for a hearing on the cost of prescription drug prices. Finance Chairman Senator Chuck Grassley, R-Iowa, had vowed in January to bring in the executives and get to the bottom of price increases, especially those for insulin.
Said Grassley: “There is no question that researchers and doctors have developed treatments and cures for disease where there was no such cures or treatments. Such innovations take time and money...but we’re all trying to understand the sticker shock that many drugs generate.”
The executives, who included Ken Frazier of Merck and Olivier Brandicourt of Sanofi, pointed at the rebate system as a culprit and called for promoting biosimilars and allowing patients to share in the savings from rebates.
But Senator Ron Wyden, D-Oregon, wanted the companies to take action themselves. He said, “I’ve heard a lot of happy talk this morning, but what people are taking away from this hearing … no firm commitments have been made to lower list prices.”
Robert Gonzalez, chairman and CEO of AbbVie, the maker of Humira, the world’s top-selling drug, was asked if the company still makes a profit when it sells the drug at a lower price in Germany and France, where Humira costs much less than it does in the United States.
Gonzalez replied: “If a market the size of the US were to collapse, AbbVie wouldn’t be able to invest the amount it does in [research and development].”
For full coverage, visit ajmc.com.
HHS Finalizes Title X Rule Change
HHS last week finalized a rule change for Title X, the decades-old family planning program for the poor, and will no longer allow programs that offer abortion to receive any federal funds for other services. The change, combined with an earlier directive that opened funding to faith-based groups, is expected to redirect most of the $286 million program and remove all funding from Planned Parenthood, which will lose $60 million.
A statement from HHS read: “The final rule ensures compliance with statutory program integrity provisions governing the program and, in particular, the statutory prohibition on funding programs where abortion is a method of family planning. The final rule amends the Title X regulation, which had not been substantially updated in nearly 2 decades, and makes notable improvements designed to increase the number of patients served and improve the quality of their care.”
Critics of the change have called it a “gag rule” because Title X recipients would not be allowed to make referrals for abortion services, even if patients request them. The president of the American Medical Association said the change would make it impossible for doctors to discuss all available options with patients and would thus violate the Code of Medical Ethics.
Said Barbara McAneny, MD: “Title X is popular, successful, and has had bipartisan support for decades. Our country is at a 30-year low for unintended pregnancy and an historic low for pregnancy among teenagers — largely because of expanded access to birth control. We should not be walking back from that progress.”
For more visit ajmc.com.
HPV Vaccine Cuts Cervical Cancer Rates
Cervical cancer rates are falling thanks to a vaccine to protect women from HPV, according to a new study reported this week. The journal of Cancer Epidemiology, Biomarkers and Prevention, a publication of the American Association of Cancer Research published data that showed prevalence of the most dangerous strains of human papillomavirus—the same ones that cause most cancers—had fallen in archived tissue samples that were collected between 2008 and 2014 among women aged 18 to 39 years.
The researchers from the CDC found that the vaccine appears to be producing herd protection among women who have not received it. Public health campaigns have emphasized the need to get all children vaccinated between 11 and 12 years old.
The researchers wrote: “This is clear evidence that the HPV vaccine is working to prevent cervical disease in young women in the United States.”
The Cost of Traveling, Wait Times for Healthcare Services
Traveling to the doctor and sitting in the waiting room has a high price tag: nearly $90 billion a year. The analysis from Altarum is based on data from the Bureau of Labor Statistics American Time Use Survey and included data from 2006 to 2017.
On average, Americans spend 34 minutes traveling to healthcare services and 11 minutes waiting.
The report states: “Time traveling and waiting for care likely adds little, if any, additional value to one’s health or wellbeing (and in fact is likely a significant burden in receiving adequate care); therefore, the opportunity cost of waiting and traveling for care is important to quantify.”
For more, visit ajmc.com.
Coverage of the American Academy of Allergy, Asthma, and Immunology
Finally, AJMC reported this weekend on proceedings from the American Academy of Allergy, Asthma, and Immunology, which held its annual meeting in San Francisco, California. Among the highlights:
- Researchers released results on sesame allergy in an effort to convince FDA to include it in food labeling requirements
- Most patients in peanut immunotherapy trials were still eating peanut daily during a follow-up study
- Results from an egg oral immunotherapy trial may produce biomarkers to show which children will respond to this treatment
For all of us at the Managed Markets News Network, I’m Jaime Rosenberg. Thanks for joining us.