“Getting new therapeutics like this to patients has the potential to save thousands of lives and significantly reduce the disease’s burden on our health care system,” HHS Secretary Alex Azar said at a news conference.
Currently, there are over 80,000 doses available for allocation and distribution, Azar said. Lilly told CNN that at the beginning of the first quarter of 2021 it expects the supply of the antibody therapy will “increase substantially.”
For now, with the limited number of doses, states that have a larger share of the country’s total number of confirmed Covid-19 patients, as well as those regions with a larger total of confirmed hospitalized patients, will be given priority.
While treatments are badly needed, Goldstein said, doctors still don’t have a lot of detail.
“We don’t like to practice medicine by press release,” Goldstein told CNN. News releases may reassure investors, he said, but they leave doctors with too many questions.
He said with the details he’s heard about the monoclonal antibody rollout feels like “remdesivir all over again.”
“With remdesivir, we were given no instruction over who would benefit from the medication, how to best distribute a very limited resource, how to make sure that we were doing the right follow up to see if it was effective,” Goldstein said.
“In the end, we have to make a lot of decisions on our own without data and we’ll be worried, who best to give this very limited resource to so that we can prevent the most amount of harm?” Goldstein said.
Government official: ‘There’ll be challenges’
Goldstein said he also thinks the logistics are “going to be a nightmare.”
Patients get the treatment through an infusion that takes an hour and needs to be done at a health care facility that has access to emergency treatment in case there are problems. The patient then needs to stay for another hour for observation.
Goldstein is concerned these treatments could strain the health care system and would also likely exclude patients treated by rural and safety net hospital systems that don’t have the capacity for large-scale infusion operations.
Federal officials said this week the distribution of these treatments won’t be easy.
“We anticipate that initially, there’ll be challenges for the health care system in administering IV infusions to infected patients,” Dr. Janet Woodcock, the head of therapeutics for Operation Warp Speed, said at a briefing Tuesday. She said the government and Lilly have distributed a playbook to help health care providers think through the challenges, and figure out the best way to set up infusion centers.
“We believe there will be multiple solutions to these challenges depending on the setting and we look forward to working with the healthcare system in rising to this challenge,” Woodcock said.
President Trump said in October that these treatments would be free. HHS said Tuesday there would be no charge for the Lilly treatment itself, but there will be a cost for its administration. The Centers for Medicare and Medicaid Services said it would pay that cost for its beneficiaries — about $300 a treatment.
That payment structure could worsen the inequities in the health care system, Goldstein said.
Billed through outpatient clinics and centers, patients without insurance have had “relatively limited reimbursement” from the government, Goldstein said.
Many clinics and medical centers are not eligible for federal programs that would pick up costs, “leaving the exorbitant outpatient cost burden on the patient,” the editorial said.
With nearly 8 million residents losing their employee-sponsored health insurance due to the pandemic,the editorial said, it could worsen “disparities in insurance coverage for Black and Latinx people” and leave the communities with the highest rates of infection “unable to afford the best possible treatment.”
Following up after treatment
The editorial’s final concern is that there is no obligation for doctors to document how well the therapy works.
“You know, you would think if we’re going to do this again with monoclonal antibodies from the get-go, we should be creating a registration so we’d get a national look at all the outcomes of all the people who receive the infusion to prove to ourselves that this is actually effective.”
“But we can do this better,” he said. “We know that we can do this better and we should be doing it better.”