Drug pipeline developments: Alopecia areata and atopic dermatitis

More than 6.8 million Americans have, had or will develop alopecia areata at some point in their lives, according to the National Alopecia Areata Foundation (NAAF). Alopecia areata is an autoimmune skin disease resulting in the loss of hair on the scalp and elsewhere on the body. The dermatologic condition occurs in both males and females of all ages, but onset often occurs in childhood.

Alopecia areata differs from male/female pattern baldness in that it is driven by an underlying autoimmune disorder, whereby male/female pattern baldness is determined by imbalanced sex hormones (e.g., estrogen, progesterone and testosterone) and excess inflammation.

WongEczema refers to a group of dermatological conditions characterized by skin inflammation. Atopic dermatitis is one type of chronic eczema that produces symptoms such as dry, scaly skin, redness, itching and rash. According to the National Eczema Association (NEA), approximately 31.6 million Americans are diagnosed with eczema, and at least 17.8 million of those have moderate-to-severe eczema, or atopic dermatitis. Like alopecia, atopic dermatitis usually begins in childhood, often in the first six months of life.

Hair loss and skin problems are not the only detriments associated with alopecia and atopic dermatitis. Individuals with these conditions may suffer from other comorbidities, including allergic rhinitis, asthma, food allergies, eye disease, obesity, anemia, and some psychiatric or mood disorders, according to Farrah Wong, PharmD, director of pipeline and drug surveillance at OptumRx.

Current treatments

According to the American Academy of Dermatology, there is no cure for alopecia areata; hair often re-grows on its own but treatment can help the hair re-grow more quickly. Current treatments include systemic or topical corticosteroids, topical minoxidil, and topical anthralin.

As with alopecia, treatment cannot cure atopic dermatitis but it can help control symptoms. Current treatments include over-the-counter (OTC) moisturizers, systemic or topical corticosteroids, and topical calcineurin inhibitors (TCIs), nonsteroidal medications that are applied to the parts of the affected skin. Once absorbed in the skin, TCIs work by stopping a piece of the immune system from “switching on,” preventing it from causing certain eczema symptoms such as redness and itch.

TCIs, including tacrolimus and pimecrolimus, are generally reserved for after topical prescription corticosteroids have failed in patients with atopic dermatitis, according to Craig Mattson, RPh, senior director of formulary development at Prime Therapeutics.

At Prime Therapeutics, Mattson says that most plans do not pay for OTC drugs, nor do they pay for drugs whose use are primarily cosmetic.

Rosier“The categorization and definitions as ‘cosmetic’ or ‘discretionary’ vary from plan sponsor to plan sponsor and insurer to insurer,” says Nadina Rosier, health and group benefits practice leader at Willis Towers Watson. “Most plan sponsors generally cover legend products or non-OTC treatments of dermatological conditions, but may require pre-certification or prior authorization coupled with quantity limits to ensure the drugs are used appropriately.”

OTC products generally have been excluded from plan sponsor coverage in this therapeutic class, explains Rosier. One example of a generally excluded product labeled as “cosmetic” is topical minoxidil, or Rogaine, used for alopecia areata.

It should be noted however that some of these products such as minoxidil have not been tested and may not be recommended in those under the age of 18 years.

Internal server error