by Manasi Vaidya in New York

Eli Lilly’s Covid-19 monoclonal antibody (mAb) bamlanivimab is unlikely to face payer pushback, despite its broad label, after a recent FDA emergency use authorisation (EUA). Given the potential therapeutic and societal impact on stemming hospitalisations, bamlanivimab and other mAbs under FDA review can be considered cost-effective. Supply constraints may, however, create their own barriers to access.
There should not be any access issues given that clinicians have relatively more leeway in prescribing decisions when it comes to Covid-19. Given the potential to reduce hospitalisation costs and the pandemic’s negative societal impacts, bamlanivimab would likely be considered a valuable tool. The Centers for Medicare and Medicaid Services (CMS) has stated it will cover mAbs, underscoring that commercial payers will likely do the same.

Lilly will be supplying 300,000 vials of 700mg bamlanivimab to the US Government under a $375m contract, and will be providing it at a cost of $1,250 per vial, as per a 28 October press release and CEO note. Yet, supply constraints due to manufacturing mean a limited number of doses are currently available, which may create their own barriers to access, experts said.

Lilly’s market cap is $135.86bn. The company did not provide comment before deadline.

Broad label but unlikely for payers to create constraints

Bamlanivimab is intended to treat mild-to-moderate Covid-19 in patients who are 12 years and older at high risk for progressing to severe Covid-19 and/or hospitalisation. The FDA’s 9 November release further stated this high-risk population included those who are 65 years of age or older, or with certain chronic medical conditions.

Payer-stipulated prior authorisation to check for age or comorbidities is unlikely, said Jack Mycka, CEO, Medical Marketing Economics, Montclair, New Jersey. One thing to consider is that even though the label mentions those above 65 years of age, many people who are getting Covid-19 are in the 35–55 years of age range or even younger, said Anirban Basu, PhD, professor of Health Economics, University of Washington School of Pharmacy, Seattle. But if a physician determines a patient is a COVID-19 case, then treatment in general will be covered, said Randy Vogenberg, principal, Institute for Integrated Healthcare, Greenville, South Carolina. Payers will likely cover the mAb with physician attestation, said Debbie Warner, vice president, Commercial Health Division, Kantar Health, West Chester, Pennsylvania; that said, use will be stipulated according to the label, she noted.

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The CMS stated that the mAb will initially be given to healthcare providers at no charge, as per a 10 November note. Most government and private insurers have said they will charge little or no out-of-pocket patient costs, said Mycka. This passive payer attitude is underscored by the relative modest price of mAbs, said Mycka and Richard Manning, partner, Bates White Economic Consulting, Washington DC. Regeneron Pharmaceuticals‘ (NASDAQ:REGN) mAb REGN-COV2 is also under FDA review for its own EUA intended for patients with mild-to-moderate Covid-19 who are at risk for poor outcomes. Regeneron signed a USD 450m contract with the US government to supply the cocktail meant for 300,000 patients which news agencies have calculated to amount to USD 1,500/vial. A Regeneron spokesperson said REGN-COV2 does not have a commercial price yet.

mAbs could be cost-effective despite price

Since the virus has a serious impact on the elderly, bamlanivimab will be highly cost-effective for the intended population, said Manning. Since hospitals are overloaded, the cost of a single day’s stay would offset the USD 1,250 cost for the mAb, said Andrew Briggs, professor of Health Economics, London School of Hygiene and Tropical Medicine, UK. In a posthoc analysis of the 467 patients in the Phase II BLAZE-1 study (NCT04427501), hospitalisation among those who were aged 65 years or older and among those with a body mass index (BMI) of 35 or more was at 4% (4 of 95) in the bamlanivimab group and 15% (7 of 48) in the placebo group. While assessing its cost-effectiveness, one must consider not just reduced hospitalisation rates, but also the impact on overall healthcare savings, the prevention of loss of income and anxiety for caregivers, said Basu.

In the future, mAb prices could be discounted if Eli Lilly and Regeneron compete in the market and start offering discounts, said Mycka and Basu. Even if the two mAbs are different, the negotiated prices may be quite similar, said Basu. Moreover, once a vaccine is available and mAb therapeutic companies lose market share as more people get vaccinated, the competitive pressure will be higher, Basu added. Market evaluation for treatments will happen in terms of whether they were introduced before or after vaccines, agreed Mycka.

The traditional cost-effectiveness thresholds used to decide value-based price may be relaxed due to the pandemic, said Basu, adding the price ultimately paid by the payer would depend on the incremental therapeutic and societal value a treatment provides. However, as you move farther away from hospitalised Covid-19 cases, the value proposition for something that costs USD 1,250 becomes difficult, said Briggs.

Logistical constraints still a success caveat

Despite the mAb value proposition, supply chain constraints will be an issue given the limited number of doses to be available, experts said. Eli Lilly has stated that it will only be able to manufacture 1 million doses at the authorised 700mg dose by YE20. The first 300,000 doses of bamlanivimab will be provided by the US government free of charge to the patient, but the distribution channels will be different from nonpandemic times when a hospital would purchase the drug and then be billed, said Warner. Eli Lilly is shipping bamlanivimab to AmerisourceBergen, which will distribute it as directed by the US government’s allocation program, as per a 9 November press release.
Vogenberg noted the challenge in predicting national behavior around consumption, including the potential for a demand for mAbs, leading to potential shortages. The logistics will get more complicated with mAbs versus Gilead Sciences’ Veklury (remdesivir), as the former is meant for infected but nonhospitalised patients, said Mycka. Veklury, which has since been FDA-approved after initially receiving an EUA authorisation in May, is intended for high-risk hospitalised patients.

Since the mAbs are delivered through an infusion, the logistics involved in a patient getting to a facility to receive it, which may not be possible for all, also need to be considered, said Basu. However, Manning said getting an infusion may not be as challenging as anticipated. While infusions are not traditionally given at primary or urgent care offices, it could be possible to do so, he added.

Manasi Vaidya is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.