This Week in Managed Care: July 31, 2020

Top pharmaceutical executives refuse to attend Trump meeting after executive orders on costs, concerns about reopening schools, toll of COVID-19 split by party lines, background, and a review of 20 years of data concludes vaccines are "remarkably safe."

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

Trump Signs Executive Orders to Lower Drug Prices
This past Monday, top pharmaceutical executives were scheduled to meet with President Donald Trump at the White House to discuss drug pricing, but the meeting was canceled after Trump, beset with falling poll numbers amidst the COVID-19 pandemic, signed 4 executive orders last Friday aimed at lowering drug prices

The executive orders drew criticism from the drug industry who had initially thought the rule would be dropped ahead of Friday’s announcement.

One of the executive orders that would require health officials to release a plan linking Medicare payments for certain medicines to lower costs paid abroad was additionally criticized by some patient groups as they say the rule, which is known as the most-favored-nations rule, would curb innovation and reduce drug access.

On a call with the media last Friday, HHS Secretary Alex Azar said biologic and injectable drugs would not be an allowed import but said individuals would be able to re-import their own insulin from Canada. Under another part of the plan, the FDA would allow individuals to import drugs from countries with similar regulatory procedures.

The move was met with derision by Democrats, who last year passed a bill in the House of Representatives to allow Medicare to negotiate drug prices directly and cap out-of-pocket drug costs.

"Americans need lower drug prices now, not some day in the future that may never come. The president has had over a year to bring Congress together on a bipartisan plan to lower drug prices, but he has chosen to take the easy route of empty rhetoric instead," said Senate Finance Committee Ranking Member Ron Wyden in a statement.

For more on the executive orders, visit ajmc.com.
For more on drug industry reaction, visit ajmc.com.

Concerns About Reopening Schools, Toll of COVID-19 Split by Party Lines, Background
Last week, a new poll illustrated the disproportionate impact of the pandemic, both psychological ones and practical ones about the effect of school reopenings in the fall.

The July 2020 Kaiser Family Foundation Health Tracking Poll of US adults found a little more than half said pandemic anxieties are taking a toll on their mental health; most also feel that the worst fallout from COVID-19 is yet to come.

In addition, parents from communities of color and those with lower incomes have more worries than white and higher-income parents regarding reopening schools. Education, one of the key social determinants of health, has been highlighted in recent weeks as districts across the country announce a variety of attempts to reopen in the fall, including with remote instruction.

Overall, 60% of respondents think the worst of the pandemic has yet to come, up from 50% in May, as opposed to 1 in 5 adults who think that the worst of the outbreak has happened.

But the results also illustrate deep political divisions. Eight in 10 Democrats and a majority of independents think the worst of the pandemic has not yet arrived. That contrasts with 31% of Republicans who think the worst of the virus is over; 23% of Republicans believe that COVID-19 is or will be a major problem.

For more, visit ajmc.com.

Review of 20 Years of Data Concludes Vaccines Are "Remarkably Safe"
This week, findings from a comprehensive review of all safety-related label modifications of vaccines approved by the FDA between January 1996 and December 2015 indicated that vaccines are “remarkably safe” and confirmed population vaccination as a major public health strategy.

The retrospective cohort study, published in Annals of Internal Medicine, includes data from 57 vaccines against infectious diseases approved by the FDA within the 20-year window.

“Vaccination has greatly reduced morbidity, disability, and death from many infectious diseases,” the authors wrote. “The incidence of once common infections, such as measles, mumps, pertussis, rubella, and poliomyelitis, has decreased by more than 90%, and some diseases have been all but eliminated.”

However, vaccination rates have declined in recent years, “partly driven by reduced public trust and parental concerns over safety,” researchers said.

“If vaccines are perceived as unsafe, uptake in the population will decrease further, and the prevalence of infectious diseases and their associated morbidity and mortality will increase.”

For more on the review, visit ajmc.com.

FDA Gives Truvian Emergency OK for Rapid COVID-19 Antibody Test
This week, the FDA granted Truvian Sciences Emergency Use Authorization, or EUA, for its Easy Check COVID-19 antibody test. The company said it plans to produce the test “at mass scale” in the United States and immediately make it available to US health care providers.

Company officials said in a statement that the test exceeds EUA requirements, including a sensitivity rate of 98.44% a specificity of 98.9%. The cross-reactivity evaluation determined no cross-reactivity with HIV, influenza A and B, and several coronavirus strains.

In an interview The American Journal of Managed Care®, Jeff Hawkins, president and CEO of Truvian Sciences, spoke on availability and reimbursement of the tests.

“These tests are going to be made available through employers that will offer it routinely, through health care clinics, your primary care doctor, places like that,” said Hawkins. “So far, we're seeing that insurances are covering these antibody tests…In this pandemic, the insurance companies, both private and public payers like Medicare stepped up and right away started paying for testing.”

For more, visit ajmc.com.

Paper of the Week
And now, we bring you 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.

A November 2018 paper from authors at Mathematic in Princeton offered a hint of findings that would come later for highly touted strategies to address the needs of “superutilizers,” patients who have complex needs and use emergency care at much higher rates than most patients.

These strategies, which call for high levels of care coordination and meeting non-clinical needs, were pursued by Dr. Jeffrey Brenner and the Camden Coalition and repeated elsewhere. Our November 2018 paper found mixed results and showed that the models needed to be tested on a larger scale.

A paper on healthcare “hotspotting” in the New England Journal of Medicine that appeared in January cast doubt on whether these strategies save money, dealing a blow to the movement. But others say the process has to start further upstream.

Meanwhile, Dr Brenner, who had gone to work with United Healthcare, is returning to his roots in primary care in New Jersey.

For the paper, visit ajmc.com.

For all of us at AJMC, I’m Matthew Gavidia, thanks for joining us!