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New Challenges to Old Standards in the Treatment of Rhinitis
Anticholinergics
Ipratropium bromide, another safe medication with few side
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A
Comparison of Selected
Product Indications
ef~ects, is useful in treating rhinorrhea but will not address allergic symptoms. lpratropium bromide is a quaternary amine that
minimally crosses the nasal and gastrointestinal membrane,
Seasonal Allergic
Nonallergic
Rhinitis
Rhinitis
reducing systemic antichoJinergic effects. 15. 16 Although it can be
Clarilin
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combined ,vith nasal steroids to treat rhinitis, iprmropium bromide is not very effective for vasomotor rhinitis.
Allegra
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Z yrtec
V
Astelin
V
V
V
V
Flonase
V
V
Nasacort
V
Nasonex
V
Rhinocort
V
Rhinocort AQ
V
Vancenase AQ
V
Decongestants
Topical decongestants like pseudoephedrine are systemic medications that may alleviate nasal congestion. However, they may
have adverse effects, such as loss
of appetite, anxiety, nervous-
ness, and insomnia. Patiellls who have an arrhythmia, angina,
hypenension, or hyperthyroidism are not good candidates for
these medications because they can aggravate these conditions.
The Food and Drug Administration (FDA) recently issued a
recall for all products cOlllaining phenylpropanolamine (PPA)
due to safety concerns.
Topical decongestants Jike oxymetazoJine can be effective in
treating rhinitis-induced congestion but only for fewer than
four days. Longer use may lead to rhinitis medicamentosa or
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"rebound" congestion.
Intranasal Corticosteroids
Beconase
AQ
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V
V
Note: C!witin, Nasonex, and \lancenase are trademarks
Allegra and Nasacon
oj Schering-Plough.
oj Aventis.
Rhinocol'/ is an AstraZeneca
trademarll. Bccona.le and F!onase are trademarl1s of G!cLxoSmithKline and Zyrtcc
1.1 a
Beclomethasone dipropionate, budesonide, and Oucticasone are
all nasal conicosteroids that have been approved for treatment
of seasonal allergic rhinitis and perennial nonallergic rhinitis.
W'C trademarks
PJizertrademarl1.
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Target Drugs
/'
Their localized anti-inOammatory activity and minimal systemic absorption make them very effective. Side effects include
nasal irritation and nasal bleeding. Because they are steroids,
Antihistamines
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there is some .concern about growth suppression in children.
Current FDA guidelines require that children younger than 12
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Antihistamines
Antihistamines
Nasal'Steroids
Antihistamine options include either first- or second-generation
oral antihistamines and a nasal antihistamine. Because first-gen-
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eration oral antihistamines, such as diphenhydramine and
hydroxyzine, are considered strong sedatives, they are usually not
first-line choices for most patiellls. Loratadine and fexofenadine,
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both second-generation
oral antihistamines, are effective in
reducing sneezing, itching, and rhinorrhea, but they have mini-
Oral Solids
Zyrtec (celirizine)
Allegra (fexofenacline)
who receive either nasal or inhaled steroids be measured regularly using a stadiometer. '"
.
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Claritin (loratacline)
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Nasal Spray
Astelin (azelasline)
Nasalicle, Nasarel (nunisolicle)
Beconase, Beconase AQ, Beconase
AQ DS, Vancenase,
Vancenase AQ (beclomethasone)
Nasacort, Nasacort
AQ (triamcinolone)
.
Rhinocorl, Rhinocort AQ (buclesonicle)
.
Flonase (nuticasone)
.
Nasonex (mometasone)
mal effects on nasal congestion and postnasal drip. Therefore,
they may be prescribed in combination with other medications.;
Like second-generation oral antihistamines, the nasal antihistamine azelastine has an onset of action within three hours. It is the
only second-generation antihistamine to be approved to treat seasonal allergic rhinitis in adults and children age 5 and over, as well
as nonallergic vasomotor rhinitis in adults and children age 12 and
over. It is effective in treating the symptoms of rhinitis, including
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The most common side
effects are bitter taste, headache, somnolence, and nasal burning.
nasal congestion and postnasal dJip.;
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Evaluating Utilization Patterns
Medication costs for treatment of rhinitis continue to rise, in some
cases quite shaqJI)' For example, in 1998, the cost of
March/April 200\
prescribed
Supplement to the Journal of Managed Care Pharmacy
7
New Challenges to Old Standards in the Treatment of Rhinitis
more than 25%. Similarly, the PM PY cost for intranasal steroids
providers, 64%; a1lergists, 14%; ear, nose, and throat (ENT)
specialists, 7%; pulmonary specialists, 2%; and other physicians, such as cardiologists, surgeons, and neurologists, 13%.
jumped from $3.59 PMPY in 1998 to $4.56 PMPY in 1999."'.21
A patient analysis conducted in 2000 by Nelda Johnson and
Combination Therapy
antihistamines was $8.33 per health care plan member per year
(PMPY). One year later, this figure rose to $10.51, an increase of
technology-based
Of the patients studied, 11 % were started on combination thera-
information management company, was supported by Wallace
laboratories to explore several managed health care prescrip-
py, usually antihistamine and a nasal steroid. Drugs were sometimes added to a treatment plan after an initial single-drug start. In
a1l, 39% of patients in the study used two or more classes of medications during the one year fo1low-up peIiod, perhaps as a result
Omar Shoheiber of Tricore Technology, Inc.,
a
tion-utilization and diagnostic indicators:
\Vhat are the prescription patterns?
What medical diagnoses are associated with prescriptions for
second-generation antihistamines and nasal steroids?
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What are the resource-utilization patterns?
The retrospective database analysis used medical and pharmacy claims for three different health plans, each with a minimum of 100,000 members. One was located in the northeast, one
in the north central, and one in the western part of the United
States. Candidates for the study were plan members who had
been continuous1y enrolled for at least 12 months with both medical and pharmacy coverage and who had received at least two of
the target drugs. The target drugs are listed in Table 5 on page 7.
Of a starting sample population of 44,989 patients who had
received one of the drugs, 19,325 patients were se1ected who
had received more than one prescription for a target drug, inclicating either a refi1l or another therapeutic option, and had been
continuously enrolled in the health plan for 12 months or more.
of treatment failure.
Allergists were most likely to recommend combination care
from the stan. Among plimaty care, allergy, ENT, and pulmonaty
care physicians, a1lergists prescribed initial combination therapy
20% of the time-about twice as often as plimary care physicians.
Primary care physicians favored initial antihistamine therapy,
choosing one of the target antihistamines 56% of the time. Initial
therapy with nasa1 steroids was the first choice of both ENT spepulmon010gists (see Table 6, below).
cialists and
The cost and number of prescriptions per person were greater
than the study averages for the group receiving initial combination
therapy: $188 PMPY, compared with the study average of $175.
Similarly, the average number of prescriptions for combination
therapy was 4.9 prescriptions compared to a study average of 4.5.
Medical Claims Analysis
The mean age of patients was 35 years; 55% were female.
Examining the medical rather than phannacy claims for these
19,325 patients produced further insights. Of the qualified patients
Targeted Options
(those continuously enrolled for more than one year who had prescriptions for one of the target drugs) medical claims showed that
on1y 40% had one of the target diagnoses.
The two categories of medication included were antihistamines
(oral and nasal) (62%) and nasal steroids (38%). The average
number of prescriptions for all target drugs was 4.5 prescriptions PMPY, at an average annual cost of $175 per person.
Diagnoses analyzed, identified by lCD-9 codes, were a11ergic
rhinitis, chronic rhinitis, acute sinusitis, chronic sinusitis, acute
nasopharyngitis (common cold), and other diseases of the nasa1
Among patients with a target primary diagnosis, the study
authors identified some startling patterns in correlated therapies
observab1e within 30 days of the diagnosis date. Pure antihistamines were prescribed 41% of the time in response to a diag-
cavity and sinuses.
are not indicated. Allergic rhinitis pátiems received antihista-
The population was also analyzed according to the type of
physician prescribing the target medication: primary care
mine therapy 50% of the time, and combination therapy 29% of
the time. It is unknown what proportion of the patients actual-
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nosis of acute
Initial Therapy by Physician Specialty
Physician Specialty
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sinusitis-a condition for which antihistamines
Initial Therapy
Nasal Steroids
Antihistamines
Combination
Primary Care
33%
56%
11%
Allergist
36%
44%
20%
Ear, nose, ancllhroal CENT)
60%
30%
10%
Pulmonary
53%
39%
9%
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March/April 200 I
Vol. 7,
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New Challenges to Old Standards in the Treatment of Rhinitis
11'had mixed or pure (with no allergic components or etiology)
nonallergic rhinitis. More than 60% of patients with common
colds (diagnosis: acute nasopharyngitis) were given one of the
targeted antihistamines.
1I:IIIClII:I=-_ 12-Month Prescription and
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$250
Cost of Care-Medical and Pharmacological
The medical claims also showed that, most of the time (59%),
patients visited their primary care physicians for treatment of
their rhinitis symptoms. On average the number of office visits
resulting in one of the target diagnoses as a primary diagnosis
was 0.6 visits per patient per year, at an average annual medical
charge of $19 per patient per year (PPPY).
Taking both medical and phannacy eXlJenditures into account,
the greatest total cost per patient per year was associated with combination therapy at $210, followed by oral antihistamines at $202,
and nasal steroids at $177 PPPY. Treatment with nasal antihistamines had the lowest cost, $131 (see Figure 1, right).
The data demonstrate that allergic rhinitis is treated mainly
in the primary care setting. Up to 39% of patients are treated
with multiple products. About 60% did not have a diagnosis
matching one of the primary diagnoses studied. The absence of
such diagnosis coupled with the significant use of multiple
_The
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Prescription Costs
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Diagnosis Costs
$200
$177
$210
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$150
$131
$100
..
$188
$188
Oral
Combination
$151
$103
$50
$0
Nasal
Nasal Steroids
Antihistamines
products suggests that physicians may be treating empirically.
Whether these products are targeting the underlying causes of
rhinitis is questionable.
Diagnosis Costs
Antihistamines
Approaching Ideal Treatment
A process in
Primary Care Physician's Perspective
According to the reference study conducted by Tricore, only 40%
of patients receiving prescriptions for rhinitis had a related diagnosis. Physicians today, especially primary care physicians, are
experiencing greater demands on their time and may need to see
more patients in a day and take care o[ patient complaints quickly without benefit o[ a complete histOlY and exam. To provide
some relief [or their patients, physicians may choose an antihistamine, knowing that about half the time it will work.
Patients come .to physicians anned with in[ormation from
direct-to-consumer marketing, the popular press, or the Internet.
They are requesting particular rhinitis medications by name to
treat their rhinitis symptoms. This therapeutic category is one o[
those most aggressively targeted by direct-to-consumer advertising. Patients [urther believe they have researched the topic well
enough to know exactly what they need. According to the 2000
Novartis pharmacy benefit report, prescriptions in the category
grew by over 30% in 1999.
When physicians empirically choose an antihistamine treat-
ment, the outcomes can be predicted based on the nature of the
patient's rhinitis symptoms. For the 43% of patients whose symptoms are purely allergic, antihistamine therapy will probably
improve symptoms. For the 57% of patients whose symptoms are
either purely nonallergic or mixed, antihistamine therapy wi11 be
only partially effective or ineffective (see Figure 2, page 10).
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No.2
which less than half the patients treated get relief
after their initial visits is not satisfactory. Physicians need a
process that will bring greater patient satisfaction, yield better
results in
a
shorter time, and be more cost effective.
As early as possible, patients who present with rhinitis symp-
toms should have their symptoms categorized as pure allergic,
pure nonallergic, or mixed. Patients whose symptoms are purely allergic can be tested [or potential allergens, be treated for
their symptoms, and learn to remove or avoid those allergens.
The remaining patients can then have their symptoms treated
with an effective medication while causes are investigated (see
Figure 3, page 10).
A
Diagnostic Tool
For this ideal treatment approach to work, physicians must be
able to establish a diagnosis quickly; they need a tool or a technique that integrates the patient into the proce'ss, one that
would help patients understand the causes of their symptoms
and guide their expectations about treatment.
Dr. Phillip Lieberman, clinical professor o[ medicine at the
University of Tennessee School ofMeclicine, has developed a simple, self-administerecl screening tool designed to help patients
and physicians identify rhinitis etiology (see Figure 4, page 11).
The patient can complete the evaluation independent of the
physician. With the data presented by the patient, the physician
can easily conduct a focused patient assessment and choose the
March/April 2001
Supplement to the Journal of Managed Care Pharmacy
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