WHO approves another $$$ COVID-19 drug!

The World Health Organization (WHO) has recommended a “new” drug to treat COVID-19: Baricitinib – Lilly’s Olumiant®.

In the United States this drug’s list price is as much as the median wage worker earns for some 140 hours labor, and that’s before taxes and other deductions.

A 30-day supply of tablets is $2,378.40.

Even with that price, while WHO claims that Baricitinib is “strongly recommended” for people with severe or critical COVID-19, it has limits.

WHO’s Guideline Development Group found “moderate certainty evidence that Baricitinib improved survival and reduced the need for ventilation, with no observed increase in adverse effects.”

“Moderate certainty” for more than two grand?

This recommendation is the eighth update of the agency’s guidelines on therapeutics and COVID-19, published in the British Medical Journal.

There is a dark side to this announcement.

Médecins Sans Frontières (MSF) wants to insure that patent protections “do not stand in the way of access to this treatment.”

The humanitarian organization reported that U.S. pharmaceutical company Eli Lilly has filed and obtained patents, including in Brazil, Russia, South Africa, and Indonesia. That blocks production of affordable versions of Baricitinib, MSF said.

Despite the fact that Baricitinib is already approved for other conditions like rheumatoid arthritis – and generic versions are already available in India and Bangladesh at much lower prices than those being charged by Eli Lilly – Baricitinib will not be widely available to treat COVID-19 as long as the company continues to block the generic production in most places,” MSF said..

An Indian manufacturer priced Baricitinib at $5.50 per treatment course of 4mg once per day for 14 days, and the lowest listed price in Bangladesh is $6.70. This is nearly 400 times less than Eli Lilly’s exorbitant listed price in July of $2,378 per treatment course.

The Food and Drug Administration has issued  guidelines:

INSTRUCTIONS FOR HEALTHCARE PROVIDERS

As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the “Fact Sheet for Patients, Parents and Caregivers” (and provide a copy of the Fact Sheet) prior to the patient receiving Baricitinib, including:

    • FDA has authorized the emergency use of Baricitinib to treat COVID-19 in hospitalized adults and pediatric patients 2 years or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extra corporeal membrane oxygenation (ECMO). This is not an FDA-approved use of Baricitinib.
    • The patient or parent/caregiver has the option to accept or refuse Baricitinib.
    • The significant known and potential risks and benefits of Baricitinib, and the extent to which such potential risks and benefits are unknown.
    • Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.

But nothing should stop profitable drug administration, so the FDA added:

If providing this information will delay the administration of Baricitinib to a degree that would endanger the lives of patients, the information must be provided to the patients as soon as practicable after Baricitinib is administered.

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