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Over the past year and a half, the COVID-19 pandemic has resulted in a shortage in several essential items — including rheumatology drugs. When the pandemic first started, the medication hydroxychloroquine was in short supply because it was touted as a treatment for use in certain hospitalized patients with COVID-19, though its emergency use authorization (EUA) was revoked in June 2020 after it wasn’t shown to be effective.
Now, the IL-6 inhibitor tocilizumab (Actemra) may be difficult for people with rheumatic conditions, such as rheumatoid arthritis, to access. According to the drug shortage database from the U.S. Food and Drug Administration (FDA), intravenous (IV) tocilizumab has been in shortage since August 2021.
This is likely the result of the FDA’s EUA on the drug in late June to treat hospitalized adults and pediatric COVID-19 patients who “receive systemic corticosteroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).”
This reallocation of Actemra has, unfortunately, impacted many members of the CreakyJoints and Global Healthy Living Foundation community.
“I was supposed to start my infusions, but because of the shortage I wasn’t able to,” Shirley R. shared on Instagram.
“[My area has] not had any since April and got a letter basically telling me that they have no idea when it will be available,” says Ana H.
Here is what you need to know about the shortage so you can talk to your health care team — including your doctor and pharmacist — to ensure you’re receiving proper treatment for your rheumatoid arthritis.
What Is Actemra?
Tocilizumab (Actemra) is a biologic medication used to treat adults with moderately to severely active rheumatoid arthritis, adults with giant cell arteritis (GCA), and children age 2 and older with polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA), per the American College of Rheumatology (ACR).
Actemra is known as an interleukin-6 (IL-6) blocker. IL-6 is an immune system protein that plays a role in inflammation. The medication works by blocking receptors for IL-6 on cells, which reduces the inflammation. This helps to decrease arthritis joint pain and swelling, and other symptoms caused by inflammation.
It can be given as an infusion (where an IV is put in your arm) at your doctor’s office, infusion clinic, or hospital — or it can be self-injected at home. The shortage of Actemra is primarily affecting the IV version, because that is the version used to treat COVID-19 patients.
The medication is administered at varying intervals, depending on your rheumatic condition, age, weight, whether it is injected or infused, and other factors. For adults with rheumatoid arthritis, the infusion is typically given every four weeks. As an injection for RA, it can be given weekly or every other week.
Actemra cannot be taken along with another biologic. It can be taken with methotrexate or other non-biologic drugs.
What to Know About the Actemra Shortage
Similar to people with rheumatoid arthritis and other conditions that tocilizumab treats, severely or critically ill COVID-19 patients can have an overactive immune system, according to the World Health Organization (WHO). Actemra blocks the IL-6 receptors that trigger this reaction. So, although Actemra does not directly target the coronavirus, it can address the body’s reaction to it.
Of course, increased demand for drugs can quickly lead to shortages. Actemra’s EUA status, combined with the surge in COVID-19 cases in the United States and around the world, has sparked a demand for the drug that very well may not have been part of the manufacturer’s projections.
“It’s a basic of any business practice that you don’t want to make more than you’re going to sell,” says Michael Ganio, PharmD, Senior Director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists. “Drug manufacturers look at their current sales and forecasting, and they determine how much production capacity they need for a monthly, quarterly, or annual cycle. The bottom line is, they’re not going to make excess.”
And if a drug company is already operating at capacity, there may not be much more it can do to increase output. Biologic medications like tocilizumab are complex and complicated to produce.
Genentech, the manufacturer of Actemra, released a statement in mid-August saying that the unprecedented surge in the global demand and supply limitations driven by Delta variant spikes has led to a worldwide shortage of Actemra for at least several weeks.
“The dramatic emergence of the COVID-19 Delta variant, as well as the unexpected slowing of vaccination rates in the U.S., has led to an overwhelmingly high incidence of COVID-19 hospitalizations in certain areas of the country,” according to the statement. “This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV — well-over 400 percent of pre-COVID levels over the last two weeks alone and it continues to increase.”
Although the company said it expected to receive scheduled replenishments by the end of August, it anticipates more shortages in the weeks and months ahead if the pandemic maintains its current pace of spread.
“There are so many variables, that it’s hard to assess where the shortages are at this point, but I think it’s somewhat local or regional,” says Marcus Snow, MD, Chair of the Committee on Rheumatologic Care at the American College of Rheumatology. “Personally, I’ve heard from colleagues who have shortages in Dallas. Here in Omaha, one of our local rheumatologists told me they were having trouble getting it.”
The Difference Between Actemra IV and Actemra Injections
Actemra can be administered in two ways: subcutaneous injection (under the skin) and intravenous (IV) infusion drip. Genentech stated in its release that it has a supply of subcutaneous Actemra, often used to treat rheumatoid arthritis and other inflammatory-related conditions, though the drug supply status is constantly evolving.
Currently, only Actemra IV has received EUA — not the injection form. However, the shortage in Actemra IV may have ripple effects.
“Once a product goes into shortage, usually what we see is any alternatives are going to follow shortly after,” says Dr. Ganio. “The emergency use authorization was issued for the intravenous form. However, there’s some information out there about using the injection to prepare an intravenous dose, which has increased the demand of the subcutaneous doses as well.”
What to Do If You Have Trouble Getting Actemra
You may understandably be eager to find out if you can depend on your current supply of Actemra or have access to it at your doctor’s office or infusion clinic.
“As the days and weeks go by, there’s a lot of anxiety that at any moment, things could change and patients’ medications that they depend upon might no longer be available,” says Jeffrey Sparks, MD, MMSc, Assistant Professor of Medicine at Harvard Medical School and a rheumatologist at Brigham and Women’s Hospital in Boston.
Unless you speak to your rheumatologist office regularly, you may not know until your pharmacy or an IV clinic says your drug is not available.
“The best thing you can do is to stay in close contact with your rheumatologist,” says Dr. Snow. “As things change, Genentech has indicated they will be ramping up production, which will help the situation. But in the end, it comes down to your rheumatologist and where you’re getting your infusion.”
If you have concerns about an upcoming dose or refill, you should call your pharmacy or infusion site to confirm that it is available.
In general, experts agree that the tide is constantly changing when it comes to the supply of this drug, so it’s important to be prepared.
“I would encourage all patients on Actemra — and in particular, those with IV Actemra — to reach out to their physician to map out a contingency plan for what to do,” says Dr. Sparks.
Again, it is important to consult with your health care team before making any adjustments to your treatment plan. They know your disease and your body best, and will be able to help you make the best choice.
If you are having difficulty accessing this medication, here are some options to consider with your doctor.
Switch From IV to Injection
As a first remedy, your doctor may switch your Actemra IV to an injection dose. There are no major risks associated with this, though it’s important to work closely with your doctor and to report any side effects or changes in symptoms that you experience.
According to ACR guidance, “when the IV formulation of tocilizumab is not available, we support the substitution of the subcutaneous form in place of the IV formulation with no increased cost to the patient.”
Of course, how much you end up needing to pay for that injection will depend on your insurance.
“Patients whose insurance coverage prefers the IV formulation could be stuck with a big bill if they want to stay on Actemra but have to switch to the subcutaneous version,” says Dr. Sparks.
Adjust the Timing
Your doctor may adjust the frequency of your Actemra treatment in anticipation of shortages. This was the case for CreakyJoints community member Shelley, who wrote on Instagram that, “my infusions were every four weeks and have now been told it’s every six weeks as there is such a huge shortage.” This may be appropriate for people whose disease activity is under good control and spreading out the medication doses may be less likely to cause an increase in the risk of having a flare.
Transition to a New Biologic
The ACR notes that if a treatment regimen must be changed because of a shortage, every effort should be made to ensure the new treatment has a similar mechanism of action. In this case your doctor may recommend switching to another IL-6 inhibitor, like sarilumab (Kevzara).
Experts are not currently seeing a shortage of sarilumab, but it could be at risk of short supply, too, as it is also being studied for the treatment of COVID-19. Like Actemra, it has been found to suppress the overreaction of the immune system in severely ill patients, per the WHO.
“It’s possible that we’ll see a shortage of sarilumab as well,” says Dr. Ganio. “I have not seen any reports of one yet, but as hospitalizations and severely ill COVID-19 patients who require ventilation increase, it’s possible that demand will go up and hospitals will start using sarilumab in addition to tocilizumab.”
Switching from Actemra to another type of medication may not be easy, depending on your personal history.
“Other medications are not that easy of a solution, because many patients ended up on Actemra because other options did not work,” says Dr. Sparks. “Even though rheumatoid arthritis in theory has many other options, in practicality, a lot of those options have already been crossed off the list.”
If you’re feeling anxious about potential shortages, keep in mind that you’re not alone — and that being prepared may be your best defense.
“We’re all in this together, and I think everyone really wants all the patients to be treated adequately,” says Dr. Sparks. “Certainly our hope is that in a very short time frame, there’s a supply that replenishes so every patient who needs the drug can get it.”
The bottom line: The best thing you can do when your drug is in short supply is talk to your doctor as soon as possible. Being prepared will help you to better manage the shifting tides of drug access during the COVID-19 pandemic, and allow you to stay on top of your treatment.
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Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19. U.S. Food & Drug Administration. June 24, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19.
Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Tocilizumab Injection. FDA Drug Shortages. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Tocilizumab%20Injection&st=c&tab=tabs-1.
Interview with Jeffrey Sparks, MD, MMSc, Assistant Professor of Medicine at Harvard Medical School and a rheumatologist at Brigham and Women’s Hospital in Boston
Interview with Marcus Snow, MD, Chair of the Committee on Rheumatologic Care at the American College of Rheumatology
Interview with Michael Ganio, PharmD, Senior Director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists
Tocilizumab (Actemra). American College of Rheumatology. December 2020. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Tocilizumab-Actemra.
Update on Actemra (Tocilizumab) Supply in the U.S. Genentech. August 20, 2021. https://www.gene.com/media/statements/ps_081621.
WHO recommends life-saving interleukin-6 receptor blockers for COVID-19 and urges producers to join efforts to rapidly increase access. World Health Organization. July 6, 2021. https://www.who.int/news/item/06-07-2021-who-recommends-life-saving-interleukin-6-receptor-blockers-for-covid-19-and-urges-producers-to-join-efforts-to-rapidly-increase-access.