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FDA could do a better job sharing numbers on costly new eczema drug

Rating

4 Star

FDA approves new eczema drug Dupixent

Our Review Summary

This news release from the FDA announces the agency’s approval of a new drug, dupilumab (to be marketed as Dupixent), for treating eczema, or atopic dermatitis. It briefly describes the type of clinical trials leading to the approval and identifies the possible harms that might arise from use of this injectable drug. It omits, however, any measurements showing how effective the drug is, referring to benefits only in general terms.

 

Why This Matters

Some estimates suggest as many as 18 million Americans suffer from moderate-to-severe eczema — and for them it is a miserable disease. A new medication that is potentially effective against this condition would therefore be welcomed. But the enormous cost of this drug, similar to others aimed at thwarting eczema, might play a major role in patient access to the treatment.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Applicable

The FDA evaluates drugs without considering costs, which is why they are not discussed in this news release. We rate this one Not Applicable. We hope the FDA will also begin commenting on the projected cost of a drug and its cost-effectiveness.

In this case, costs are very steep. An NBC.com story on the approval which we also reviewed, predicts the drug will cost $37,000 annually. It’s unknown if Dupixent will be covered by health insurance.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

In terms of benefits, the release offers the following: “Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.” But readers are left to interpret on their own what “greater response” and “a reduction in itch” mean.

The release would have been better if it had told readers how the improvement was measured and how many patients experienced improvement rather than using the term “overall.”

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release gets an acceptable rating in this category since it mentions that the drug can cause serious allergic reactions and eye problems including conjunctivitis (pinkeye) and keratitis (inflammation of the cornea). It also cautions that people with asthma shouldn’t use the drug since it hasn’t been tested for safety in these patients.

The release should also have noted that regulators don’t know if there are any long-term harms associated with Dupixent use. None of the trials exceeded 16 weeks.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release describes who was studied and for how long, and offers a bare-bones description of the types of studies: “The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s).”

The FDA doesn’t provide a link to the studies or their titles and where they were published. The release would be more complete had that information been included. It would help journalists and people with eczema and would be a significant improvement to FDA releases.

Does the news release commit disease-mongering?

Satisfactory

The release does not engage in disease-mongering. Instead it offers a clear description of what eczema is and what causes the condition.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

There is no mention of who funded the research leading to the FDA approval, although many readers will assume it was supported by the manufacturer Regeneron.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release gets a borderline satisfactory for mentioning topical corticosteroids as an alternative treatment for eczema but neglects to mention that other pharmaceuticals are also now available for treating it.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Whether or not this medication will be covered by insurance is a huge concern. Its high cost will affect how many people can access this new drug. Its availability should have been addressed in the release.

Does the news release establish the true novelty of the approach?

Satisfactory

It’s newsworthy whenever the FDA approves a new drug. This appears to be the first biologic, injectable treatment for eczema.

Total Score: 6 of 9 Satisfactory

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