OTC Allergy Drug Use Increases: A Symptom With Multiple Causes
This article was originally published in The Pink Sheet
Executive Summary
CHPA says growing use of allergy OTCs from 2009 through 2015 in the US is a sign of more consumers prioritizing self-care over using health care services, but allergy specialists say their patients often have to start with an OTC even when they have a prescription.
US OTC switches of three intranasal corticosteroids and an oral antihistamine ingredient since 2007 are pushing an increase in consumer use of nonprescription allergy treatments and a decrease in Rx drug use, says the Consumer Healthcare Products Association.
While the industry trade group says growing use of allergy OTCs from 2009 through 2015 is a sign of more consumers prioritizing self-care over using health care services, allergy specialists said in interviews that their patients often have to start treatment with an OTC. That’s because with most allergy ingredients available OTC, insurers often require patients to try a nonprescription version of an ingredient before an Rx product is covered.
“I don’t have any patients who could walk into a pharmacy right now and have their insurance cover paying for an allergy drug prescription without trying an OTC drug first,” said Rajan Merchant, an allergy, asthma and immunology specialist with Dignity Health in in Sacramento, Calif.
On the other hand, consumers relying on an OTC product before consulting a doctor could be wrong about their allergy type and could choose the wrong ingredient for their symptoms, say Merchant and Julie McNairn, another specialist suggested by the American Academy of Allergy, Asthma & Immunology to offer insight on allergy treatments.
“I don’t think most consumers realize what the ingredients are,” said McNairn, an allergist and immunologist with Allergy and Asthma Associates in Ithaca, N.Y.
According to results of a July 2016 survey CHPA commissioned, the percentage of allergy sufferers using only OTC drug remedies for allergies has increased from 53% in 2009 to 60% in 2015. At the same time, the percentage who receive a health care provider's treatment for allergies decreased from 31% in 2009 to 28% in 2015, Nielsen Homescan data included in the survey show.
Consumers' Allergy Rates And How They Respond
The Consumer Healthcare Product Association's survey conducted with Nielsen Homescan looked not only at the percentage of consumers reporting allergies during 2009-2015, but also asked how they treated the conditions, including whether they used health care services.
CHPA and Nielsen Homescan survey
“The implication here is that allergy sufferers in some cases are increasingly self-treating their symptoms,” CHPA says in its report on the survey, which also included information from IMS Health on consumers’ spending on Rx drugs and health care services and from questions asked of 2,000 consumers.
Target Market Grows, Too
The survey also shows that the number of consumers who say they have allergies has edged up, from 26.9% in 2009 to 27.8% in 2015. CHPA says that taking into account population growth and the survey results, it projects 9.7m more consumers had allergies in 2015 than had them five years earlier.
With more consumers reporting they have allergies, the number using OTC remedies will correspondingly increase.
The survey also stated, Merchant pointed out, that almost half of the respondents said they asked a doctor and 23% said they asked a pharmacist to recommend an OTC allergy drug.
“More than half the patients still are asking for advice,” said Merchant, who also is a clinician and a clinical researcher Woodland Medical Group.
And when physicians determine that a patient needs a treatment for allergies, their first step is prescribing the appropriate Rx ingredient, he added. “We haven’t changed our treatment guidelines.”
McNairn observed that unless their patients inform them, physicians don’t know how they react to OTC allergy drugs, which, although safe, still could cause potentially harmful side effects, or whether a certain ingredient is effective.
“That’s the disservice that’s going on here,” she said.
Although nonprescription allergy drugs have histories of safe use, one criteria for a drug to be available OTC is an indication for a self-limiting condition, Merchant said. “Allergies are not necessarily considered self-limiting,” he said.
'Burden' Similar Across Remedy Types
Consumers reporting using only OTC or only Rx drugs to treat their allergies also reported similar financial burden levels.
CHPA and Nielsen Homescan survey
The first intranasal corticosteroid approved as an OTC, Sanofi’s Nasacort Allergy 24HR, prompted concerns about growth suppression in children and inadequate long-term use data to garner a positive recommendation from FDA’s Nonprescription Drugs Advisory Committee in 2013. (Also see "Nasacort AQ Switch Gets NDAC Nod Despite Pediatric Use Concerns" - Pink Sheet, 5 Aug, 2013.)
An American Academy of Allergy, Asthma & Immunology task force in 2006 advocated against switching intranasal corticosteroids due to their potential for overuse, complications from adverse effects and serious associated risks including bone resorption – by which bones begin to lose substance – as well as growth suppression and ocular effects such as glaucoma and cataracts. (Also see "Steroid Nasal Sprays Not Suitable For Rx-to-OTC Switch – Task Force" - Pink Sheet, 22 May, 2006.)
Costs Influence Satisfaction
From its questions for consumers, the survey showed that among those who only take OTCs to treat allergies, 87% said they are satisfied, the highest satisfaction rate among groups that respond differently to the conditions. Respondents who take both an Rx and OTC concurrently to treat allergies expressed the lowest satisfaction with their medication options, 81%.
“This could be likely due to the level of severity of their allergies, or possibly the costs associated with managing their symptoms,” CHPA suggests.
As consumers have fewer doctor visits, they also are lowering their overall spending on allergy treatments. Consumers treating with OTCs only discuss their allergies with their doctor or other health care professional an average of 1.5 times per year, spending about $37.56 in co-pays for allergy-related health care services.
Consumers opting for Rx-only allergy treatment see a doctor for the condition an average of 2.2 times per year, spending $55.09 in co-pays, and those using both Rx and OTC drugs seeks health care an average of 6 per year, accounting for $150.24 in co-pays.
3 Corticosteroids, 1 Antihistamine
The four ingredients with allergy indications moved from Rx to OTC in the US and noted in the survey report comprise three intranasal corticosteroids, each a consumer products sales driver for its marketer, and an oral antihistamine that also is a key consumer brand for its marketer.
The antihistamine is cetirizine, approved for OTC in 2007 through Johnson & Johnson’s switch application for its Zyrtec product and launched 2008, though private label versions from Perrigo Co. PLC reached store shelves before the brand. (Also see "Zyrtec Launch Brings Big Boost To Johnson & Johnson, But Competition Grows" - Pink Sheet, 21 Apr, 2008.)
The first intranasal corticosteroid ingredient available OTC was approved in 2013 through Sanofi’s proposal for triamcinolone acetonide, which it markets nonprescription as Nasacortrx Allergy 24HR. (Also see "Sanofi’s Nasacort First-In-Class Switch Receives FDA Approval" - Pink Sheet, 11 Oct, 2013.)
GlaxoSmithKline PLC was second to the OTC intranasal corticosteroid market with fluticasone propionate, available in its Flonase Allergy Relief product approved in 2014. (Also see "Flonase Allergy Relief Exclusivity Sliced Up By Label Carve-Out" - Pink Sheet, 10 Feb, 2015.)
Under license from AstraZeneca PLC,J&J markets the third ingredient in the category, budesonide, available in Rhinocort Allergy 24HR since approval in 2015. (Also see "Rhinocort Switch Makes Three In OTC Intranasal Corticosteroid Market" - Pink Sheet, 26 Mar, 2015.)
Costs likely are the key influence on consumers using OTC allergy drugs without also seeking a doctor’s diagnosis, McNairn observed.
“It’s ultimately a cost issue and an access issue,” she said. “The insurance programs are covering fewer and fewer prescription allergy drugs.”
Dual Usage Steady
The survey showed that of consumers with allergies, more than 90% of take some type of medication to manage their symptoms. CHPA says consumers have adjusted their behaviors as more OTC allergy drugs are available, with 66% in 2009 and 75% in 2015 purchasing an OTC either on its own or in conjunction with an Rx product.
However, with more consumers opting for OTC-only treatment, as the overall number using some type of allergy product increased, the percentage who take both an Rx and an OTC medication stayed relatively flat, 13% to 15%, over the five-year period analyzed.
The data also showed consumers’ level of engagement with OTCs depends on the severity of symptoms. Households most engaged with the OTC products report moderate allergies, while the least engaged with the products have severe allergies, implying that the more severe an allergy, the more likely a prescription drug will be needed.
The survey’s Nielsen Homescan component also found changes in spending on allergy OTCs, from around $33 for an average household on 2.9 trips to retail outlets in 2009 to $39 on the same number of trips in 2016.
From the editors of the Tan Sheet.