Is regeneron covered by insurance

If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.

Some early evidence suggests that mAb treatment can reduce the amount of the SARS-CoV-2 virus (which causes COVID-19) in a person's system. This amount is known as viral load. Having a lower viral load means you may have milder symptoms thereby decreasing the chance of you needing to stay in the hospital.

The FDA had granted Emergency Use Approvals (EUAs) for several mAb treatments: etesevimab and bamlanivimab (BAM/ETE), REGEN-COV (casirivimab and imdevimab), and sotrovimab. On Jan. 24, 2022, HHS and FDA announced that BAM/ETE and REGEN-COV are not currently authorized for use in the US because they are not considered effective against the Omicron variant. CDC estimates that Omicron is greater than 99 percent of new infections nationally. Sotrovimab is effective against Omicron and can still be used as treatment for people who test positive for COVID-19 to help prevent progression to severe disease in people at risk. Evusheld is another monoclonal antibody effective against omicron that is specifically for pre-exposure prophylaxis for people with immunocompromising conditions. On April 5, 2022, HHS and the FDA announced that Sotrovimab is not currently authorized in the US because they are not considered effective against the BA.2 variant.

Visit the FDA page Know Your Treatment Options for COVID-19 page to learn more.

How effective are mAb treatments?

Currently, mAb treatments for people with COVID-19 are only approved by the FDA for emergency use, but data show they are successful in reducing the chance of severe disease, hospitalization and death by 70 percent, and the treatment shortens the duration of symptoms by an average of four days.

No anaphylactic reactions or other serious adverse events have been reported.

Who benefits most from mAb treatments?

mAb treatment may help people who:

• Have a positive COVID-19 test, and had symptoms for 10 days or less
• Are at high risk of getting more serious symptoms
• Are not hospitalized or require supplemental oxygen

Children age 12 and older who weigh at least 88 pounds can be treated with monoclonal antibodies. Your doctor can help determine if monoclonal antibody treatment is appropriate for you or your child.

See the Understanding Your COVID-19 Treatment Options fact sheet to learn more.

How much will the treatment cost? Is it covered by insurance?

Because the federal government has purchased a supply of some monoclonal antibody treatments, there may be no cost to the patient for the monoclonal antibody product itself. Depending on your insurance coverage, you may or may not need to pay for a provider to administer the infusion. For many, infusion administration will have no cost. In particular:

• Medicare Medicaid, and Children’s Health Insurance Program (CHIP) are covering all infusion costs. Learn more about coverage of the treatment here.
• For patients covered under commercial insurance plans, costs of infusion may vary, but many large insurers are waiving all costs. Check with your health plan.
• If you do not have insurance, you should ask the treatment facility if there are charges.

Clinical trials

If you don’t qualify for mAb treatment, you still have options. There are clinical trials for people like you.

Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for COVID-19 and other conditions. For more information about joining a clinical trial, call 877-414-8106 or visit Combat COVID's clinical trials page.

On April 5, 2022, HHS and the FDA announced that Sotrovimab is not currently authorized in the US because they are not considered effective against the BA.2 variant.

The FDA had granted Emergency Use Approvals (EUAs) for several mAb treatments: etesevimab and bamlanivimab (BAM/ETE), REGEN-COV (casirivimab and imdevimab), and sotrovimab. On Jan. 24, 2022, HHS and FDA announced that BAM/ETE and REGEN-COV are not currently authorized for use in the US because they are not considered effective against the Omicron variant. CDC estimates that Omicron is greater than 99 percent of new infections nationally. Sotrovimab is effective against Omicron and can still be used as treatment for people who test positive for COVID-19 to help prevent progression to severe disease in people at risk. Evusheld is another monoclonal antibody effective against omicron that is specifically for pre-exposure prophylaxis for people with immunocompromising conditions.

Monoclonal antibody (mAb) treatments reduce hospitalizations and deaths among those affected by COVID-19. Expanding access to these treatments is integral to our focus on saving lives. DHEC and partner efforts have now guaranteed availability of monoclonal antibody treatments within 50 miles of every South Carolina resident, with most living within 25 miles of a treatment site.

South Carolina has 11,710 mAb treatments currently available for eligible residents. To date, 38,937 COVID-19 patients in South Carolina have been treated with monoclonal antibodies.

Recent shortages of monoclonal antibodies (mAb) for use in the treatment of patients with COVID-19 in South Carolina have been resolved at this time, and South Carolina now has sufficient supplies to provide for every resident who could benefit from these effective treatments. DHEC encourages healthcare facilities, providers, and eligible patients to take advantage of this treatment.

South Carolina currently has 11,534 mAb treatments available for eligible residents. To date, 32,686 COVID-19 patients in South Carolina have been treated with monoclonal antibodies.

News release: DHEC Encourages Use of Monoclonal Antibody Treatments for COVID-19

The federal government has informed each state that there is a national shortage of monoclonal antibodies. As a result, South Carolina will only receive 4,460 doses for this week's allocation to be distributed next week. In contrast, facilities across the state already have orders for 13,000 doses pending.

Due to the shortage, DHEC is determining the allocations for monoclonal antibody treatment sites in the state based on the amount the state will receive, sites' utilization rates, and access. We are quickly working on the details with the goal of assisting as many South Carolinians as we can with this successful treatment.

It is important to remember that monoclonal antibody treatment is not a substitute for COVID-19 vaccination. Those looking to protect themselves against COVID-19 are strongly encouraged to get fully vaccinated as soon as possible. Vaccines are safe, effective, and available for free at thousands of locations across the state.

In July 2021, the FDA authorized use of monoclonal antibodies as post-exposure prophylaxis (PEP) for people who are unvaccinated or vaccinated, have come into contact with the virus, and are at higher risk for severe COVID-19. Those at high risk include people who are older than 65, overweight (BMI greater than 25), have diabetes, chronic kidney, heart or lung disease, who are pregnant, or have weakened immune systems. The monoclonal antibodies can be given by intravenous (IV) infusion or a series of subcutaneous (SQ) shots. PEP can reduce the risk of infection of household contacts of infected people by as much as 81 percent. Monoclonal antibodies are safe, free, and highly effective but they need to be given within the first 10 days after symptoms developed or within 10 days of exposure if given as PEP.

Please see the map of locations below. mAb treatment must be recommended by a healthcare professional based on a person’s health history and how long they’ve had symptoms of COVID-19. A person can’t simply show up at one of these locations without a referral. Sites that had previously offered mAb may not being doing so now because only Sotrovimab is currently authorized as an mAb treatment.

Currently, there are 45 sites in South Carolina administering mAb treatments. DHEC continues to work with partners to expand the number of mAB infusion locations in the state, and is also reaching out to providers that offer home infusions to expand this treatment, at a doctor’s recommendation, to homebound people.