An Overview of Vitiligo: Prevalence, Comorbidities, and Available Therapies

In this interview with First Report Managed Care, Gary Owens, MD, president of Gary Owens Associates, reviews the prevalence and burden of vitiligo, as well as coverage considerations for a range of treatment options. 

How prevalent is vitiligo in the United States?

Although we do not have the greatest epidemiologic data, the estimate is somewhere from 0.5% to 2% of the US population may have vitiligo. If you translate that, it is somewhere between about 1.3 and 2.8 million people with vitiligo. 

Vitiligo is a disease that develops at a relatively young age. About 75% of people report their first symptom or first noticeable spots of vitiligo before the age of 20, and up to three-quarters report by the time they are 30.

What is the burden of disease associated with vitiligo?

Vitiligo is an interesting disease because it is a change in skin pigmentation. One might look at that and say, "Well, how important is that disease?" But if you really think about it, nonsegmental vitiligo often appears in very visible areas of the skin—the face, the arms, and other areas which can be quite noticeable, especially in people of color.

A global survey of these patients showed there is quite a gap between the onset of vitiligo and the diagnosis. Very often, that can be 1 or 2 years. In fact, up to one-third of patients report they were not properly diagnosed initially, and almost half of patients were told, "Well, it's vitiligo. It's harmless. There's really nothing that can be done about that."

Although stated as harmless, we now know vitiligo is a chronic autoimmune condition. It is an autoimmune condition affecting the production of pigment in the melanocytes of the skin. Because it is autoimmune, like many other autoimmune conditions, vitiligo tends to have association with other autoimmune diseases. Up to 15% of people with vitiligo may have 1 or more other autoimmune diseases, with hypothyroidism being the most common in about 10% or 11% of patients. But some people with vitiligo have rheumatoid arthritis, inflammatory bowel disease, lupus, and even multiple sclerosis. 

Then there are some issues with body image, mental health issues, issues like depression and feelings of social isolation. While it is certainly not a life-threatening disease, vitiligo is an autoimmune disease and can have significant psychosocial consequences.

Can you please review some of the treatment options that are available for this patient population?

Until recently, the treatment options were not that great. It is probably understandable, in that survey, that about 50% of patients were told by their health care provider, typically their primary care physician, there is not much to do about it. But there are treatments.

Dermatologists use topical corticosteroids as a treatment. Also, topical calcineurin inhibitors have been used with varying degrees of success. Light therapy is another therapeutic option, including various forms of UVA and UVB therapy. There is even surgical therapy with grafting, although that is considered a treatment of last resort and is only used for severe cases. 

More recently we have seen the investigation, recent approval and use of one JAK inhibitor, topical ruxolitinib, for the treatment of vitiligo. Ruxolitinib has expanded the treatment armamentarium, with several other JAK inhibitors now being studied in topical forms for vitiligo. So, the treatments available to these patients has expanded recently.

Payer coverage of vitiligo treatments varies. Given the range of therapeutic modalities, and since the landscape for biologics is not that big yet, what do you think are the most important outcomes for payers to keep in mind when they approach coverage?

The reality is when things like topical corticosteroids and topical calcineurin inhibitors, most of which have generic versions were used off-label, payers covered these treatments because there were no prior authorization criteria or diagnostic requirements to fill a prescription for them.

Fast forward, and we now have a topical JAK inhibitor, ruxolitinib, and most payers have developed some sort of prior authorization criteria. In fact, a recent study looked at payer coverage across 100 million lives, and about 50% of those payers had a single-step edit through either a topical corticosteroid or a topical calcineurin inhibitor. The other 50% had a double-step edit through both a topical corticosteroid and a topical calcineurin inhibitor.

Payers are managing access to the JAK inhibitor, but typically with drugs they were already paying for. For the most part, when you look at payer policies, they do not consider the treatment of vitiligo to be purely a cosmetic and therefore excluded treatment. 

Is there anything else you want to add to this conversation?

I think there is a robust pipeline. There are a couple more topical JAK inhibitors being studied in phase 2 trials, including povorcitinib and adalimumab, which is a monoclonal antibody in very early clinical trials. Additionally, some other existing JAK inhibitors are being studied for things like vitiligo and alopecia areata. 

For payers, I think it is important to recognize there are going to be more treatment options in this space, and maybe some opportunities for looking at comparative effectiveness. There may even be potential for having a preferred agent in the therapeutic armamentarium. But that is the future. 

Right now, we have topical corticosteroids, calcineurin inhibitors, JAK inhibitors, and then the more advanced options, which are used much less often, like light therapy and surgical treatment.