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Little more than one week before
its US exclusivity expired on December 19, 2002, the leading
prescription antihistamine, Schering-Plough's Claritin
(loratadine), finally became available over-the-counter
in the United States.
Claritin has been sold OTC
in most countries for many years. In the US, however, the
OTC allergy market has been dominated by older, sedating
antihistamines, led by Pfizer's Benadryl (diphenhydramine).
This is despite the fact that the newer products are agreed
to be safer: for example, a USA Today investigation
in 2000 estimated that there were 600 automobile fatalities
in the US each year due to the sedating effects of OTC antihistamines.
One major reason for keeping
Claritin and its peers prescription-only was profit, and
it is no coincidence that Schering-Plough had avoided OTC
sale of its leading drug in the US until the end of its
exclusivity began to loom. In 2001, the Claritin range accounted
for approximately one-third of the company's revenues, and
were the pharmaceutical products most heavily promoted to
consumers.
US market development
The first effective antihistamine
was discovered in 1944, and diphenhydramine was introduced
the following year. As Benadryl, it was still the leading
OTC antihistamine in the US in 2002; it went from prescription-only
to OTC in 1981. Others include Schering-Plough's Chlor-Trimeton
(chlorpheniramine), which went OTC in 1976. The main drawback
of these older products is that they affect the central
nervous system, causing sleepiness and impaired reactions,
and their anticholinergic activity can also lead to dry
mouth and urine retention.
Hoechst Marion Roussel
(now Aventis) launched the first non-sedating antihistamine,
Seldane (terfenadine), in the US in 1985. It was
being considered for OTC sale when reports arose of dangerous
cardiovascular side-effects and it was withdrawn, as was
Johnson & Johnson's Hismanal (astemizole). Aventis
then linked up with 'improved chemical entity' specialist
Sepracor,
and introduced a safer version, Allegra (fexofenadine),
in 1996. Claritin was launched in 1993 and the leading trio
in the R6A systemic antihistamine class was completed with
the introduction of Zyrtec (cetirizine), developed
by UCB, by Pfizer in 1996. Unlike Allegra and Claritin,
Zyrtec causes a very slight degree of sedation.
US antihistamine
(R6A) market share
12 months to September 2002
Source: MIDAS
Claritin rapidly became the
top-selling systemic antihistamine in the US. According
to IMS data, Claritin, Allegra and Zyrtec had combined US
sales of over $3.3 billion in the 12 months to September
2002. By comparison, Benadryl, the OTC leader with over
40% of the market, had sales of less than $55 million in
the same period, according to IMS data.
While health insurers like
Wellpoint had asked the FDA to move the newer antihistamines
OTC, saving them millions of dollars, there was no action
from either the agency or Schering-Plough until early 2002
- though an FDA panel had deemed them safe for OTC sale
in May 2001. In February, US Health and Human Services Secretary
Tommy Thompson said he was considering OTC status for the
three leading products, despite opposition from their manufacturers
- conscious of the lower profits from non-prescription products.
Making the best of it
In August 2002, Schering-Plough
lost a Claritin patent case that could have seen the drug's
US exclusivity extended into 2004; it had sued a number
of companies that had filed applications to market generic
copies. In January 2002, it had finally introduced Clarinex
(desloratadine), an active metabolite of Claritin designed
to work faster and for longer than Claritin. Delays in the
approval of Clarinex, however, left Schering-Plough little
time to convert Claritin users to the newer product before
the loss of exclusivity at the end of the year - though
it did price Clarinex lower as an incentive.
Shortly after its legal defeat,
Schering-Plough made a U-turn on its long-held stance that
Claritin should not be sold OTC, and made an application
to the FDA to transform its cash cow into a non-prescription
product. In November 2002, this was approved, for all five
Claritin presentations in their original prescription strengths
(though its use in hives was yet to be finalized):
- Claritin Tablets (once-daily)
- Claritin RediTabs (orally
disintegrating once-daily tablets)
- Claritin-D 24 Hour (once-daily
tablets plus decongestant)
- Claritin-D 12 Hour (twice-daily
tablets plus decongestant)
- Claritin Syrup (liquid formulation
for children over two years of age)
Massive savings for insurers...
Merck & Co's pharmacy benefits
manager Medco Health Solutions said the move would save
health plans and employers up to $500 million. In 2002,
its clients spent approximately $1.3 billion on non-sedating
antihistamines, including over $600 million on Claritin.
It is working with its clients to help them save up to 30%
of their costs in the category.
The OTC availability will affect
both Claritin and its competitors: insurers are less likely
to cover Allegra, Clarinex and Zyrtec if patients can buy
their own Claritin - or a generic copy - OTC instead. They
will probably only be approved for patients in whom Claritin
causes side-effects or shows little effectiveness, and charged
at the highest co-payment rate.
This led to criticism from
the American College of Allergy, Asthma and Immunology,
whose President said, "The decisions are being made in the
boardroom and not in the exam room as to what's in the patient's
best interest." The ACAAI was also concerned that cost would
force some allergy sufferers to use older, less safe productsl;
moreover, they believe some patients will seek medical advice
and care later than normal, when their disease is more advanced
and the risk of co-morbidities, such as asthma, has increased.
...but not necessarily for
consumers
Some patients will actually
be worse off: one month's supply of Claritin cost $80-95
on prescription, but much of this was covered by the insurer.
Schering-Plough cut the cost up to 75% for OTC sale, to
92 cents up to $1.17 a pill, but patients who paid less
than approximately $30 a month in co-payments to their insurer
(and many paid only $5-20) will therefore have to pay more
for a month's supply.
Joining OTC Claritin will be
generic versions of loratadine, including one from Johnson
& Johnson and another, branded as Alavert, from
Wyeth. When it approved the OTC switch for branded Claritin,
the FDA also said any generic copies would only be sold
OTC as well. Wyeth plans to launch Alavert on December 20,
though Schering-Plough is still appealing the August patent
ruling. Wyeth had not given any guidelines on pricing, but
Schering-Plough's annual revenues from Claritin are expected
to drop to the region of $400 million.
The FDA is still considering
OTC status for Allegra and Zyrtec (and Clarinex, thanks
to an April 2002 petition from Wellpoint), but Aventis is
confident that Allegra can withstand competition from OTC/generic
Claritin. It has teamed up with Cima to create a fast-dissolve
version of Allegra, and is working on extending the product's
uses. Pfizer too believes consumers will be loyal to Benadryl.
Nevertheless, the availability of OTC Claritin represents
a seismic shift in the US antihistamine market, and could
provide an interesting model for further switches, such
as the proton pump inhibitors (e.g. Prilosec) for
heartburn.
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