Actemra Unfit For Use Against Giant Cell Arthritis, UK Regulators Rule

Regulators in the United Kingdom indicate that the potential side effects of Actemra make the drug unfit for use in the treatment of giant cell arthritis, indicating that this additional use for the rheumatoid arthritis drug would not be cost effective. 

The U.K.’s drug and health agency, the National Institute For Health and Care Excellence (NICE), released the decision in an Appraisal consultation document last month.

The decision came after a clinical trial showed a number of adverse events linked to Actemra’s use in giant cell arthritis cases, though NICE indicates that the cost of the drug versus the quality of life years gained was the main motivation for its decision.

Actemra (tocilizumab) is a new-generation rheumatoid arthritis drug introduced by Roche in 2010, which is a second-line medication primarily prescribed to treat severe cases of rheumatoid arthritis that may not have responded to other drugs. However, in May 2017, the drug maker obtained expanded approval of Actemra injections for giant cell arthritis.

In Europe and the U.K, it is sold under the brand name RoActemra.

In its decision, NICE noted that giant cell arthritis is usually treated with high doses of corticosteroids, which are reduced over time. The side effects of corticosteroid use can include skin problems, weight gain, diabetes and osteoporosis.

“Clinical trial results show that after having tocilizumab plus corticosteroids for 1 year, more people are able to sustain a remission and need lower doses of corticosteroids compared with people having corticosteroids alone,” the appraisal states. “Including the committee’s preferred assumptions, the most likely cost effectiveness estimate for tocilizumab is at least £65,800 per quality adjusted life year gained. This is much higher than the range normally considered to be a cost-effective use of (U.K. National Health Service) resources.”

NICE also noted that there were significant uncertainties in how long patients would have to take Actemra and what the benefits would be long-term.

Actemra has become a blockbuster treatment for Roche, generating over $1.6 billion in annual sales, since it was widely thought by many doctors that it does not carry some of the same health risks associated with competing rheumatoid arthritis drugs, such as Humira, Remicade and Enbrel. However, concerns have emerged in recent months about potential Actemra health risks, after an independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis.

In July, the findings of phase III clinical trials for the use of Actemra for giant cell arthritis showed that it had benefits for patients, but also revealed that 15% suffered adverse side effects.

Adding to the Actemra problems for Roche, another study published in July in the medical journal Rheumatology found that individuals with a specific type of rheumatoid arthritis (RA), known as anti-citrullinated protein antibody (ACPA) negative, face a higher risk of infections than those with ACPA-positive rheumatoid arthritis.

Unlike other competing rheumatoid arthritis drugs, Actemra warnings do not include information about certain health risks linked to competing treatments, such as Humira, Remicade and Enbrel. Therefore, many doctors and consumers are under the impression that Actemra is safer. However, recent reports suggest that users may face the same, or higher risks.

A recent independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010. As a result, some are calling for Actemra warnings to be added, which may cut into sales.

A number of product liability lawyers are now reviewing potential Actemra lawsuits, indicating that evidence suggests that Roche knew or should have known that the drug carried similar risks to other rheumatoid arthritis drugs, but withheld information from the label to create a false impression that their drug was safer.