This Week in Managed Care: June 19, 2020

US releases more details about COVID-19 vaccine process, CDC tries to reinforce social distancing guidance amid nationwide reopening, and AJMC^® recaps the American Diabetes Association 2020 Virtual Scientific Sessions.

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

US Releases More Details About COVID-19 Vaccine Process

This week, the United States, through its Operation Warp Speed, or OWS, project to rapidly develop and deploy a vaccine for COVID-19, intends to provide the vaccine for free to elderly patients and other vulnerable populations if they cannot afford it, according to senior administration officials associated with OWS.

On a media call to explain more about the project, the officials also said that although they have no agreements with payers, they have had conversations with insurers who have expressed interest in providing the vaccine for no co-pay.

In response to a question about the cost of a vaccine, one of the officials said, “For any American who is a vulnerable who cannot afford the vaccine, and desires a vaccine, we will provide it for free.”

Asked later about how HHS would determine vulnerability and affordability, an official responded via email to AJMC^® by saying, “HHS is in the process of determining eligibility for a no-cost vaccine, predicated on the successful vaccines that emerge from the OWS process… In regards to defining ‘vulnerable’ populations, OWS follows HHS protocol to determine at-risk populations based on data earned from experience with COVID-19.”

However, the nation’s lobbying organization for insurers indicated any vaccines for COVID-19 would be covered in accordance with other vaccination policies.

For more, visit ajmc.com.

With States Reopening, CDC Tries to Reinforce Social Distancing Guidance

Last Friday, the CDC released guidance for the public seeking to reengage in socializing or large events while continuing to recommend that people use social distancing, hand washing, and face masks in order to decrease the number of cases of COVID-19.

The highest degree of risk, the CDC report said, would be large indoor events with many people close together, with no social distancing and for which they travel long distances to attend.

During a call with the media, CDC Director Dr Robert E. Redfield called the recommendations “common sense suggestions” that can be adapted to local levels of transmission.

The new advice comes as President Donald Trump seeks to hold an indoor re-election rally for his presidential campaign in Tulsa, Oklahoma, on June 20th. To attend, the campaign is requiring attendees to sign a waiver not to sue if they contract the virus.

For more, visit ajmc.com.

Recap of ADA 2020 Coverage

This week, the American Diabetes Association presented its 2020 Scientific Sessions in a virtual format.

AJMC.com provided full coverage of the virtual meeting, which took place June 12th to the 16th.

Highlights included:

• An exclusive interview with Dr Robert Gabbay on insulin cost caps for some Medicare beneficiaries
• Expert says COVID-19 is changing the A1C vs time-in-range debate
• And real-world data suggest starting insulin and glucagon-like peptide-1 receptor agonists at the same time brings better glycemic control

For full conference coverage, visit ajmc.com.

Panel Rules Drug Makers Do Not Have to Disclose Prices in TV Ads

This week, a Washington DC Circuit panel upheld a federal judge’s decision to halt a Trump administration initiative that would have required drugmakers to reveal the sticker price of their drugs in television ads.

The panel ruled unanimously in favor of pharmaceutical companies who challenged the rule by HHS a year ago, including plaintiffs Merck, Eli Lilly, and Amgen.

“The Department acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs,” wrote US Circuit Judge Patricia Millett.

For more, visit ajmc.com.

FDA Approves Second Biomarker-Based Indication for Pembrolizumab

In drug-related news, the FDA granted accelerated approval this week to the second biomarker-based indication for Merck’s pembrolizumab, sold as Keytruda.

“Not only does this approval mean that clinicians will be able to identify more patients who could benefit from this treatment option, but it’s an important milestone in the shift toward making biomarker-driven, tumor agnostic therapies available to patients, which is possible through an FDA-approved companion diagnostic,” said Dr Brian Alexander, chief medical officer of Foundation Medicine.

Pembrolizumab, an anti-PD-1 therapy, is now indicated for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high solid tumors that progressed after previous treatment and for which there are no satisfactory alternative treatments.

The accelerated approval is based on tumor response rate and durability of response evidenced in a prospectively-planned retrospective analysis of 10 cohorts of patients enrolled in the KEYNOTE-158 trial.

For more, visit ajmc.com.

Paper of the Week

And now, our paper of the week, which looks back at some of the most important papers over the past 25 years of The American Journal of Managed Care^® and why they matter today.

Long-term effectiveness of the Diabetes Prevention Program received attention at this week’s ADA Scientific Sessions, but it’s not the first time the program has received an interim report card.

A 10-year lookback at the program, including its effect on healthcare spending, appeared in The American Journal of Managed Care^® in 2013. At that time, the original DPP Research Group found that the relative risk reduction was still 49% among the those in the lifestyle group and 21% in the metformin group compared with placebo. The researchers also found that enrolling in the lifestyle program saved money in the long run.

For the paper, visit ajmc.com.

For all of us at AJMC^®, I’m Matthew Gavidia.