This spring, two more Rx products for allergic rhinitis went over-the-counter (OTC) – Xyzal and Flonase Sensimist (known as Veramyst as an Rx product). It seems like yesterday when the initial second-generation antihistamines – Claritin, Allegra and Zyrtec – went OTC. In fact, the push to make these treatments available over the counter began in 1998 when Wellpoint filed a petition with the FDA asking they be sold without a prescription. The FDA approved the OTC switch of these antihistamines in November 2002. Next came intranasal corticosteroids, with Nasacort AQ receiving the okay from the FDA to go OTC in 2013. And the floodgates opened.
So, what’s happened to patients since these allergic rhinitis medications went OTC? How has it affected you, the allergist? Do you think it reduced the number of patients seeing you for nasal allergies? Are the allergy patients you are seeing now more severely affected then before the switches? Are your patients satisfied with the relief and cost from using these OTC allergy medicines? Well, a recent survey gives us some insight into the consumer’s thoughts about OTC allergy medications. I thought you might be interested in some of the results.
The survey is entitled “Assessing Consumer Benefits of Allergy Rx-to-OTC Switches.” It was commissioned by CHPA. What you ask is CHPA? It’s the Consumer Healthcare Products Association, the major trade organization of companies that manufacture and market OTC medications. Basically, it’s the OTC equivalent of PhRMA, the trade organization for manufactures of Rx medications.
The Nielsen Corporation conducted the polling of 2,000 adult allergy sufferers. Data was compared to results from a 2010 Nielsen Ailment Survey. Physician visits and number of prescriptions were obtained from IMS Health data (Unfortunately, we don’t know what percentage of physician visits were to allergists). Let’s look at some of the results that I think you may find interesting.
First, they found from their analysis that, 27.8% of the adult U.S. population in 2015 suffered with allergies, which was an increase of about 2% from data from 2010. Not surprising to us as allergists was that April and May were the most severe months for sufferers. During these two months, 76% said they experience allergy symptoms. A smaller seasonal spike occurs in the fall, during September specifically, when 64% of allergy sufferers stated they have symptoms. November through February was the mildest period for allergies, as only one third of sufferers say they experience symptoms during these months. Similar peaks and troughs were seen for health care provider visits. There were approximately 22% more allergy related visits in April than in the average month, and 18% above average in May. The fewest allergy-related visits were found in December, January and February.
When examining how allergy sufferers rated their severity of symptoms, there has been little change over the past six years. 37% of allergy patients rated their symptoms as mild, 51% as moderate and 11% as severe. It was the severe patients who were the least engaged as far as using OTC products and more likely to be on a prescription. In fact, the survey found 27.5% of allergy sufferers visited a health care provider for this problem in 2015. This was down from 30.9% in 2009, but leveled off since 2013. These observations suggest to me that there are still a large number of patients needing physician care for their allergies.
The survey found there has been a clear shift to OTC products. In 2015, health care providers wrote approximately 31% fewer allergy prescriptions when compared to 2010. No doubt, part of this was due to fewer visits to the health care provider, but I believe much of this was related to higher co-pays for generic corticosteroid and antihistamine nasal sprays. It could also be related to the need for prior authorizations or lack of insurance coverage for combination corticosteroid/antihistamine nasal sprays.
The reduced number of allergy-related health care provider visits and the decline in allergy Rx did not mean the health care provider’s influence was not important -–quite the opposite, actually. When asked how they chose a specific allergy OTC product, almost half stated that a health care provider recommendation was an influence.
Other thought-provoking nuggets gleaned from this survey are the additional ailments allergy sufferers experienced which may lead them to seek medical care. The findings showed that almost half had sinus congestion and pain, over one-third suffered from sleeping difficulty and heartburn, and over one in five were also dealing with asthma and chronic pain. So, in addition to 25% of allergy patients needing physician care, we need to add all these other conditions for which the allergy sufferer may seek a physician’s help.
In conclusion, there are many ways to look at this data. The way I interpret it is there is still the need for the allergist in treating the patient with severe nasal allergies and co-morbidities associated with it. The Rx to OTC switches have not resulted in the demise of the allergist in rhinitis management. And if this survey is correct in showing a growth in numbers suffering from allergies, chances are you are going to see an increase in the number of patients needing your help.
Michael Blaiss, MD, FACAAI, Executive Medical Director