COVID-19

Perspectives on Remdesivir’s $3,120 Price Tag

August 6, 2020

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

Gilead Sciences, Inc. revealed that for promising COVID-19 treatment remdesivir, it will charge $2,340 for a typical five-day, six-vial treatment course for people covered by U.S. government health programs and $3,120 for those covered by private insurance, AIS Health reported.

In an open letter, Gilead CEO Daniel O’Day argued that Gilead priced remdesivir “well below” its estimated value, considering it can save the U.S. health care system approximately $12,000 per patient by reducing the length of COVID-19 patients’ hospital stays.

But not everyone is convinced by that argument.

“So they’re saying by shortening hospital stays, the system is going to save all these monies, but I always ask the question, ‘Why is it that the drug company should get to pocket all or some substantial portion of that savings?'” says Jack Hoadley, Ph.D., a research professor emeritus at Georgetown University’s Health Policy Institute. “That’s a savings we should accumulate for consumers, for payers [and] everybody else.”

Hoadley is not alone in those views. The advocacy group Patients for Affordable Drugs, in a June 29 statement, wrote that “Gilead’s price for remdesivir shows once again that we can’t trust Big Pharma to act responsibly — even in the face of a global pandemic.”

The U.S. government helped fund the development of remdesivir, and dexamethasone — a generic steroid — is priced at less than $1 per day even though it ‘showed promise for combating severe COVID-19 cases and reducing potential mortality rates,” the organization said.

The Institute for Clinical and Economic Review (ICER) also brought up dexamethasone in its statement. The U.S. price range of $2,340 to $3,120 is “is largely in line with ICER’s independent assessment suggesting that a price of approximately $2,800 would be reasonable in proportion to the added benefits for patients and the cost offsets in the health system now that dexamethasone is rapidly becoming standard of care,” wrote ICER President Steven D. Pearson, M.D.

Leerink analyst Geoffrey Porges, in a June 29 note to investors, pointed out that the U.S. commercial price set for remdesivir was below his firm’s expectations. Still, “we believe the disclosed [remdesivir] pricing is reasonable, and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency,” Porges wrote.

Radar On Market Access: Manufacturers, Payers Wait on Federal COVID-19 Vaccine Distribution Plan

July 28, 2020

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

As the many COVID-19 vaccines under development barrel toward clinical trials for safety and efficacy, questions remain about how they will be distributed when they become available, AIS Health reported.

In a hearing held by a subcommittee of the House Energy & Commerce committee, pharmaceutical executives said they would rely on guidance from the Trump administration and the Centers for Disease Control and Prevention (CDC) to distribute vaccine doses.

Those guidelines will be important to insurers, as vaccine doses aren’t likely to be available to everyone immediately, according to Mike Schneider, a principal at Avalere Health. Though some firms have already begun manufacturing doses of their vaccine in parallel to testing, the immediate availability of hundreds of millions of doses at the time of FDA approval would be unprecedented.

Schneider notes that multiple vaccines may be available at the same time, and one may offer greater protection from COVID-19 than others. Protocols will need to be developed to determine which patients will be first in line for the most effective vaccine. Schneider says that plans need to start thinking about their internal guidelines now.

He adds that PBMs, which often have the most robust data about a patient’s drug regimen and immunization status, will be essential to tracking who has been vaccinated and screened.

Schneider says that plans are unlikely to favor one vaccine over another in their formularies. For example, Prime Therapeutics, a PBM owned by Blue Cross and Blue Shield affiliates, says it is committed to obtaining a supply of COVID-19 vaccine as soon as possible, seemingly regardless of who manufactures it.

A July 20 analysis prepared by health care investment bank SVB Leerink LLC takes a different view of the shape of the initial vaccine market than Schneider’s prediction of scarcity, arguing that the sheer volume of development efforts makes more than one breakout product likely.

In any case, Schneider predicts that the initial rollout will be unusual when compared with other vaccine distribution.

“This won’t just be going to your pharmacy and your pharmacist gives you a vaccine, like the flu vaccine,” Schneider says. He suspects that rollout will involve specialized facilities that combine rapid screening with inoculations at the same site.

Perspectives on Trump Admin’s COVID-19 Testing Payment Guidance

July 23, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: Despite Coronavirus Surge, UnitedHealth Expects Care Utilization to Rebound This Year

July 23, 2020

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

With COVID-19 cases and deaths surging in some U.S. states, it has become clear that the nation won’t be back to normal anytime soon. Still, the country’s largest health insurer is betting that health care utilization, and the costs associated with it, will return to something close to typical levels in the second half of the year, AIS Health reported.

At its lowest point in April, inpatient care volume — including care for COVID-19 patients — was about three quarters less than normal, UnitedHealth Group Chief Financial Officer John Rex said during a July 15 conference call to discuss the company’s second-quarter earnings. At that same low point, utilization of outpatient and physician services fell to roughly 60% of normal levels. But in June, UnitedHealth saw inpatient volume recover to nearly 95% of baseline, and as June turned to July, outpatient and physician services were “tracking above 90%,” Rex said. “These national trends have continued thus far in July, even as certain states are seeing short-term deferral of services where there are elevated levels of infection and hospitalization,” he added.

Indeed, the company predicts that overall, “utilization’s going to come back during the second half of the year,” UnitedHealthcare CEO Dirk McMahon said.

In a note to investors, Citi analyst Ralph Giacobbe observed that the executives’ comments about health care utilization returning to normal were “surprising to us.”

“Ultimately we believe healthcare cost trends will remain muted, and as we look out over the next 12+ months we see those trends driving upside, and lower headline risk post-election driving multiples higher,” Giacobbe added.

In the second quarter, UnitedHealth’s adjusted earnings per share of $7.12 easily beat the consensus estimate of $5.28, and the firm nearly doubled its adjusted EPS compared with the second quarter of 2019. UnitedHealth also maintained its 2020 EPS outlook of $15.45 to $15.75 ($16.25 to $16.55 on an adjusted basis).

Meanwhile, job losses tied to the COVID-19 pandemic and ensuing recession led to a decline in revenue and enrollment for UnitedHealth’s commercial insurance business. But revenue rose on the government business side as Medicare and Medicaid enrollment grew “by nearly 600,000 additional people served year to date,” per the company’s earnings release.

Radar On Market Access: Trump Admin’s COVID-19 Testing Payment Guidance Stirs Debate

July 21, 2020

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

Weeks after the Trump administration released guidance saying private health insurers don’t have to pay for COVID-19 testing conducted for the purposes of workplace safety or public health surveillance, questions and controversy are still simmering about the implications of that edict, AIS Health reported.

“With COVID-19 cases skyrocketing and our testing capacity nowhere near where it needs to be, it is unacceptable that this Administration’s priority seems to be giving insurance companies loopholes instead of getting people the free testing they need,” wrote Frank Pallone Jr. (D-N.Y.), Bobby Scott (D-Va.), Richard Neal (D-Mass.), Patty Murray (D-Wash.) and Ron Wyden (D-Ore.) in a recent letter to HHS, the Dept. of Labor and the Treasury Dept.

James Gelfand, senior vice president of health policy at the ERISA Industry Committee (ERIC), tells AIS Health that he’s fielded concerns that since insurers aren’t paying for back-to-work testing, workers might have to. But in reality, many of the large, self-insured businesses that ERIC represents “are starting to reopen and relaunch back up to full capacity, but most of them are not using a robust testing regime to do so.” The reason, he says, is that diagnostic tests “are essentially taking a snapshot of a moment in time with sometimes a 10-day lag time,” so they’re not very helpful to employees who need to know right away if they’re safe to go back to work.

Steve Wojcik, vice president of public policy at the Business Group on Health, says he sees the logic behind not forcing health insurers to pay for back-to-work testing.

“If there is a medical reason…to get tested, and a doctor is recommending it, then the health plan would cover it, but if testing is part of return to work, some employers may be incorporating testing [costs] into their return-to-work plans,” he points out.

According to Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy, a separate problem is the fact that private insurers are required to pay for out-of-network COVID-19 testing at whatever cash price that a lab or provider lists on a public website. Because those prices aren’t necessarily constrained by prevailing market rates, that can “put a lot of upward pressure on insurance reimbursement for tests,” she says.

Trends That Matter for Racial Disparities in MA Plans

July 16, 2020

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

As protests erupt across the U.S. calling for racial justice and police reforms, the COVID-19 pandemic continues to bring to light many of the racial disparities in health care, putting pressure on policymakers and the industry to take a hard look at health and access inequities, AIS Health reported.

Meanwhile, CMS’s Office of Minority Research in April released a stratified report highlighting the racial and ethnic differences in health care experiences and care of Medicare Advantage (MA) enrollees. The data showed that black members enrolled in MA plans in 2018 received worse clinical care than white enrollees on 20 out of 44 measures, similar care for 20 and better care for four. And all minority populations reported experiences with care that were either worse than or similar to the experiences reported by white enrollees, including the experience measure for getting appointments and care quickly.

Not getting the proper care when it’s needed is a reflection of the provider network, says John Gorman, chairman and CEO of Nightingale Partners LLC. “And then when you look at the clinical measures where there’s huge racial disparities, all of those tie back to a lack of culturally competent physicians serving these populations in a manner that speaks to the way that they need to access health care,” he observes.