A rep recently came to my office with brochures announcing another biologic for dermatologic disorders new to the market. It retails for about $78,000 per year, but they told my staff that the company assists patients, even those on Medicaid, to obtain the medication. So, I start questioning: How effective is this new drug? Is it better than other options? Is it worth the price for my patient(s)?
This scenario is one that all physicians can relate to as new pharmaceuticals make their way to our offices. What does this mean for physicians and their patients?
Over the past 20 years as a dermatologist, I have witnessed the tremendous growth of two new classes of drugs for potential use in treating a selection of dermatologic disorders: biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors. These medications are FDA-approved in the United States for psoriasis, atopic dermatitis, hidradenitis suppurativa, alopecia areata, and several other conditions. There are currently 14 bDMARDs and six JAK inhibitors competing in the marketplace for relatively few skin conditions. Every few months another one seems to enter the pipeline, leaving it to clinicians to educate themselves about the evidence base and the potential benefits or harms these new and novel drugs may place on their patients.
When indicated, many of these new drugs are effective and for the most part safe, but it is hard for practitioners – generalists or specialists – to decide between them.
A recent letter published in the Journal of the American Academy of Dermatology highlighted two concerns about new drugs that call their immediate benefit into question: (1) clinical studies evaluating the safety and efficacy of new drugs do not need to demonstrate evidence of comparative efficacy with older drugs and other bDMARDs and JAK inhibitors to receive FDA approval, and (2) most commentaries and editorials (commentorials) about newer drugs are written by authors with conflicts of interest.
Also concerning, scientific articles about bDMARDs and JAK inhibitors are sometimes written by physicians who benefit financially from the clinical studies they participate in. These opinion leaders often give lectures at conferences and are interviewed by the media with little, if any, attention to conflicts of interest. With transparency about potential biases being a fundamental prerequisite for scientific evaluation, how does a clinician decide which medications are best for their patients?
For a dermatologist in this context, which bDMARD or JAK inhibitor is best for a patient with significant psoriasis, atopic dermatitis, hidradenitis suppurativa, or alopecia areata? As a clinician who has been following these drugs for years, I still find this difficult and challenging.
For example, I don’t see an enormous clinical difference between etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), or a host of others for patients with widespread psoriasis. However, efficacy is not the only consideration. If a newer, expensive drug is not fully covered by insurance, it limits access. An article in the New York Times discussed the difficulties many patients face in getting these drugs covered by insurance plans. For one patient, dupilumab for atopic dermatitis was not covered by his insurance and the out-of-pocket costs would be about $36,000. This patient was able to find a dermatologist who had participated in clinical research for the drug and had samples they could provide. Even though the office did not accept insurance and each office visit cost $325, the free samples saved the patient over $25,000 per year.
I couldn’t help but wonder:
- Would one of the older medications have worked just as well for this patient?
- How do other patients without the means to investigate which clinicians are involved in clinical trials, travel to their offices, and pay for office visits outside their insurance plans manage?
Physicians and patients need impartial, unbiased information to navigate the constantly changing landscape of bDMARD and JAK inhibitor therapies. One of the first places I start when investigating a new drug is the Center for Medicare Studies, which posts financial information given to physicians and ancillary practitioners for pharmaceutical-related research and communications in the United States. The OpenPayments website allows us to consider potential conflicts of interest. For researchers or authors outside the United States, this becomes difficult, and sometimes impossible, to determine. But the benefits to our patients will be substantial.