Overkill: High Cost Drugs for Common Condition

When I think of specialty medications, I think of medications used to treat disease states that have traditionally been hard or impossible to provide treatment for. The advances in some of these disease states has been astounding in my mind. Take for example the treatments we now have available for hepatitis C that cure the infection for all but a few with only an 8 or 12 week therapy course. These treatments have come as a shock to the budgets of payers, but most tolerate the cost as they understand the benefits that come from it. Advances like these are starting to become the expectation as we look at the pipeline of specialty medications. We want to see therapies for hard to treat diseases that provide results we have not see with traditional medications.

I was therefore more than a little surprised when I first heard mention of pipeline development of a monoclonal antibody for the treatment of atopic dermatitis. As soon as the words monoclonal antibody are mentioned we have a pretty good idea that a price tag reaching into thousands of dollars per month will be attached. I could not see a need for attaching such a price tag to the treatment of a skin condition as common as eczema. In my experience to that point of time with patients with atopic dermatitis, standard treatments starting with moisturizing, phototherapy, and topical corticosteroids if needed had almost always been effective. Needing to move beyond that to a second line treatment like a topical calcineurin inhibitor was rare. Thinking of the potential financial costs to society of a biologic therapy for a condition like atopic dermatitis made me worry that a new trend would develop of creating specialty medications for diseases that did not need them.

As time has gone on, and I have been able to learn more about severe cases of atopic dermatitis, my initial level of worry has decreased some. I am now aware of patient cases where atopic dermatitis covers a majority of their body. Some have tried every therapy we know of to treat the condition including systemic corticosteroids, oral methotrexate, and oral cyclosporine all without finding much relief. Some of these patients live each day with the constant itching, oozing, and crusting this condition causes. Most have also experienced at least some level of embarrassment at the appearance of their skin. For a patient like this, the thought of a new treatment option must provide welcome optimism that they can find relief from their symptoms.

Within the last few months we have seen the first drug in this class, Dupixent (dupilumab), receive FDA approval and begin marketing in the United States. Dupixent works differently from biologics used to treat similar conditions like plaque psoriasis by being the first drug to inhibit both IL-4 and IL-13. The clinical studies were promising as they showed statistically and, in my opinion, clinically significant improvement in outcomes over placebo or placebo plus topical corticosteroid. I was not surprised to see a launch price for Dupixent of $37,000 annually, but seeing the price in writing did cause some of my worry to sneak back in. According to the National Eczema Association, the prevalence of adult atopic dermatitis hovers nears 10%. For a theoretical moderately sized payer population, with 5000 adult members, this means there are potentially 500 members with atopic dermatitis. If even only 50 of those members end up qualifying for treatment by having moderate to severe disease, the annual listed price tag for the health plan could be north of $1,800,000—Ouch! While we know the actual price tag will be lower depending on PBM/pharmacy pricing and potential rebates, the impact could still be financially painful.

Considering this potential budget impact of using a biologic medication to treat atopic dermatitis, I expect payers will work to make sure the medication is only approved for coverage for members that can demonstrate actual need for it. As with most specialty medications, I foresee extra scrutiny given to requests for coverage of this medication and any others that may follow. I think it is conceivable that payers will require a certain percentage or certain areas of the body to be affected by atopic dermatitis. There will also likely be requirements for the member to have tried and failed therapy on multiple preferred treatments from different classes of medication to ensure a more cost effective option will not provide the needed relief. I support these types of requirements in order to protect the financial resources available for health care spending.

We may continue to see development of other biologics for the treatment of atopic dermatitis or drugs currently on the market may file for an additional indication to treat atopic dermatitis. While these will provide options and optimism for patients who have reached the end of the current options for treatment, we will need to be diligent to make sure spending does not get out of hand for those who do not have a true need.