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H E A L T H T R A C K I N G M A R K E T W A T C H W E B E X C L U S I V E
28 July 2004
Generic Dispensing And Substitution In Mail And Retail Pharmacies
An in-depth look at some of the
market dynamics of pharmacy benefit managers.
By Marta Wosinska and Robert
S. Huckman
ABSTRACT:
Mail-order pharmacies
have lower aggregate generic-dispensing rates than their retail counterparts.
This fact has been used as evidence of self-dealing that could arise when a
pharmacy benefit manager (PBM) is both a plan administrator and a pharmacy owner.
Using the aggregate generic-dispensing rate, however, is problematic because
it confounds variation in performance with differences in demand. Controlling
for therapeutic mix alone explains 87 percent of the apparent difference in
aggregate dispensing rates. An alternative measureone that fully controls
for differences in price and indications across molecules within a categoryeliminates
the discrepancy in dispensing rates.
In 2003 the growth of mail-order pharmacy outpaced total prescription growth
by a factor of three. These types of mail operations, typically owned and operated
by pharmacy benefit managers (PBMs), are becoming formidable competitors to
retail pharmacies, with 5.5 percent of all prescriptions filled and a much higher
share of therapy days.1 In addition to the competition
for prescription revenue, retail pharmacies also face a loss of revenue from
items that customers might buy on the way to the prescription counter. Retail
pharmacies have responded to these new pressures in various ways, including
mergers and consolidations, providing the ninety-day fill quantities commonly
used by mail-order pharmacies, and introducing their own mail-order operations.
In this context, use of generic drugs became a sticking point between mail and
retail pharmacies because of the differences in their aggregate generic-dispensing
rates. This rate represents the percentage of claims for all drugswhether
or not they have generic equivalentsthat are dispensed as generics. In
aggregate, mail pharmacies owned by PBMs have a lower generic-dispensing rate
than retail pharmacies.2 Some have viewed this difference
as a reflection on pharmacy performance. In testimony before a committee of
the New Jersey State Assembly, John Davis of the National Community Pharmacists
Association noted, One reason for the underperformance by PBMs may be
that they receive significant rebates for not substituting equivalent cost saving
generics for higher priced brand name drugs.3
The generic-dispensing issue has surfaced in state legislatures, and it became
particularly salient in the debate over the role PBMs should play in the Medicare
drug program. The argument remains unresolved, but federal legislators have
asked the Federal Trade Commission (FTC) to look into the matter.4
Background
The combination of roles played by PBMs is the backbone of the conflict-of-interest
argument that certain observers have used to explain the discrepancy in the
generic-dispensing rate between retail and mail pharmacies. On the one hand,
PBMs manage their clients prescription benefits and receive fees for services
such as formulary management, adjudication of coverage eligibility, payment,
and formulary compliance. In addition, PBMs sometimes retain a percentage of
rebates and discounts that a pharmaceutical manufacturer may pay for listing
a brand-name drug on the clients formulary managed by the PBM or for increasing
the market share of that drug relative to those not listed on the clients
formulary. (Manufacturers generally do not pay rebates on drugs for which there
are generic substitutes, because in most cases there will be automatic generic
substitution.) On the other hand, PBMs operate mail-order pharmacies available
to contracting partiesalmost exclusively members of administered health
plans. They also negotiate discounts from retail pharmacies that join their
networks. Unlike retail pharmacies, however, PBMs negotiate the prices paid
by patients for prescriptions dispensed by mail. The combination of these roles
is the source of tension between mail and retail pharmacies.
Mail and retail pharmacies differ on several dimensions, many of which could
be labeled as convenience. Some of the most prevalent characteristics
include the number of days supplied, unit cost, delivery, and initial use obstacles.
Specifically, retail pharmacies commonly dispense thirty-day supplies, while
mail pharmacies dispense ninety-day supplies. In addition, mail copayment is
commonly twice the retail copayment even though the number of days supplied
is three times that of retail. Mail pharmacy prescriptions are sent to the patient,
which leads to differing fill-to-receive times between the two channels.
Finally, patients may not know how to fill an initial prescription through the
mail channel. For example, the health plan may send the patient a form that
must be submitted with the first prescription. Such hassles, coupled with time
delays, may prove too burdensome for some patients.
The conflict-of-interest argument builds on the mail delivery feature: With
several days to fill a mail-order prescription, mail pharmacies could use that
time to obtain the necessary physician permission to switch medications.5
This so-called therapeutic substitution is commonly used for formulary implementation.
For example, a pharmacist might inform the physician that the prescribed drug
has a high copayment because it is not listed on the patients formulary.
The pharmacist may then suggest formulary alternatives with lower copayments
for that patient. Physicians, who treat patients from multiple health plans
and thus multiple formularies, often are not aware of an individual patients
benefit structure and, therefore, may change the prescription as result of this
new benefit information. On the generic side, many of the calling programs are
aimed at getting physicians to reconsider their dispense as written
prescriptions. In states with generic substitution laws, the dispense
as written indication prevents the pharmacist from dispensing the generic
version of a brand-name product without obtaining permission from the prescribing
doctor.
Study Data And Methods
Five large PBMs provided data for this project: AdvancePCS, Caremark, Express
Scripts, Medco, and Prescription Solutions. The data set is based on the universe
of claims for integrated programsthat is, where the PBM manages both the
mail-service and the retail pharmacy benefit. As a result, the cohort of enrollees
is thus the same when retail and mail-service claims are compared. The data
exclude Medicaid and unfunded business. Unlike the private sector, state Medicaid
programs often impose mandatory generic substitution policies. Further, few
states use mail service in their fee-for-service Medicaid programs. Similarly,
PBM-owned mail pharmacies do not participate in the cash market, with the exception
of discount-card programs.
In the first six months of 2003, the five PBMs processed nearly 670 million
integrated program claims. The data used for this study are not individual claims
but rather the count of mail and retail claims for each state and drug subclass
during this period. Each PBM provided the number of prescription claims for
each of three types of drugs: generic, multiple-source brand-name (for which
generic alternatives exist), and single-source brand-name (for which no generic
alternative exists and which are usually covered by patents). The six-digit
Generic Product Identifier (GPI) classes we use are defined on a finer level
than therapeutic category. For example, the data are presented for statins rather
than all cholesterol-lowering drugs and for nonsedating antihistamines rather
than all antihistamines.
The therapeutic mix of drugs is more concentrated in the mail channel, with
the top ten categories accounting for more than 40 percent of all prescriptions
(Exhibit
1). Eight categories appear on both lists (mail and retail channels)all
for maintenance or episodic conditions (Exhibits
2 and 3).
The generic-dispensing rate is higher in retail in most categories, while the
generic-substitution ratethe number of generic claims divided by the total
number of claims for generic and multi-source drugsis higher for mail
in most of these categories.6
We began our analysis by comparing
the aggregate generic-dispensing rates for the mail and retail channels. This
rate is the number of generic claims as a percentage of all filled claims: generic,
single-source, and multiple-source. Arguments about self-dealing by mail pharmacies
have been based on comparisons using this measure.7
The aggregate generic-dispensing rate, however, does not provide an accurate comparison
of dispensing rates across channels. Because mail and retail pharmacies differ
in their characteristics, they attract patients with different needs and preferences.
If these preferences consistently map patients or situations to specific drug
characteristics, a much different therapeutic mix across the two pharmacy channels
will result. For example, because of greater days supplied, patients may be more
likely to choose the mail pharmacy for conditions that require long-term treatment.
Similarly, they will likely use the retail pharmacy for acute conditionsthe
acuity of an infection will greatly dampen willingness to wait for mail delivery
of a prescribed drug. Even a patient who uses the mail pharmacy to obtain medications
for hypertension may choose the retail pharmacy to fill a prescription for a seven-day
antibiotic treatment. In the latter situation, the higher number of days supplied
by mail (and thus a decreased frequency of refill) is of little value to the patient.
We first controlled for differences across therapeutic classes. Given the mix
of therapeutic categories dispensed by mail pharmacies, we aimed to determine
whether the propensity to dispense generics is similar between the two channels.
Therefore, we applied the same therapeutic mix to both mail and retail pharmacies
to create normalized generic-dispensing rates. We calculated the normalized generic-dispensing
rate by weighting the generic-dispensing rate for each GPI in the retail channel
by the share of the mail channel attributable to that GPI. The difference between
the normalized rates is no longer influenced by the fact that the mail and retail
channels dispense a different mix of therapeutic categories. Instead, the normalized
generic-dispensing rate reflects differences in dispensing rates that occur within
individual GPIs, weighted by the volumes that mail pharmacies dispense for each
GPI.
This normalization only controls for differences across therapeutic categories;
however, drugs within a category may vary in their characteristics leading to
differing usage of individual molecules. Because of the perceived or real obstacles
in initial use of the mail channel, patients may use the retail channel for less
costly drugs and the mail channel for more costly therapies. This would apply
even for drugs within the same GPI. Other researchers have found that cost savings
are an important driver of channel choice. Jeffrey Johnson and colleagues found
that 88 percent of survey respondents chose the mail-service pharmacy because
of cost savings.8 In addition, drugs within the same
category may vary in their indications. For example, the single-source Serevent
is used solely as a maintenance drug, while Albuterol and its generic counterparts
can be used for both acute and maintenance conditions. As a result, patients use
the two channels differently for that category.
To resolve the problem of within-group variation, one could further disaggregate
the six-digit GPI codes. The next level of disaggregation is the eight-digit GPI,
which is defined at the molecule level. This level of disaggregation fully controls
for intermolecule differences in price, acuity, and length of treatment. Nonetheless,
it eliminates the possibility of therapeutic substitutionat this level,
molecules with single-source brands would, by definition, have a generic-dispensing
rate equal to zero. In this sense, it provides an upper bound for the impact of
demand effects on dispensing measures. For multisource molecules, the generic-dispensing
rate becomes equivalent to the generic-substitution rate, which is defined as
the number of generic claims divided by the total number of claims for generic
and multisource drugs.
Study Results
Exhibits
2 and 3
use data from the most-prescribed categories for mail and retail, respectively,
to illustrate the limitations associated with using the aggregate generic-dispensing
rate. The difference between aggregate dispensing rates for the most-prescribed
categories (29.29 percent in mail versus 39.65 percent in retail) is higher than
the gap for any individual category. This discrepancy between the aggregate and
category-specific rates is driven by the fact that, for example, the generic dispensing
rate for statins gets more than double the weight in the mail channel (8.13 percent)
versus the retail channel (3.78 percent). The difference in dispensing rates for
statins is thus magnified in the comparison of the aggregate rates.
Although we have noted
the limitations of the aggregate generic-dispensing rate above, we used it as
the starting point for our comparison of the mail and retail channels. We found
that when we considered all therapeutic categories, the aggregate generic-dispensing
rate for mail was 38.79 percent. The aggregate generic-dispensing rate for retail
is 48.51 percenta difference of 9.72 percentage points. (See Exhibit
4 for summary of this and other empirical results.)
Using the normalized generic-dispensing rates, we found that controlling for
differences in the mix of indications within the two channels greatly reduced
the gap in generic-dispensing rates to 1.26 percentage points. This result suggests
that 87 percent of the difference in the aggregate generic-dispensing rates
(more than 8.4 percentage points) can be explained by differences in therapeutic
mix across channels.
Finally, we considered the generic-substitution rate, which controls for the
possibility that a given drug category may contain a different mix of molecules
in the mail and retail channels. The generic-substitution rate excludes the
possibility for therapeutic substitution, but it provides an upper bound for
the demand effects that drive differential usage of mail and retail pharmacies.
The generic-substitution rate tends to be very high (on the order of 90 percent)
because most states have generic-substitution laws that require a pharmacist
to dispense the generic version of a prescribed multisource drug unless the
physician specifies otherwise. If the state does not require automatic generic
substitution, then the pharmacist has the option to intervene and ask for the
physicians permission to dispense a generic. The additional fill-to-receive
time in the mail channel presumably makes this type of intervention more likely.
We found that the aggregate mail generic-substitution rate of 92.99 percent
was higher than the retail generic-substitution rate by 0.19 percentage points.
Once we normalized the generic-substitution rate for the retail channel using
the mix of the mail channel, this difference increased slightly to 0.97 percentage
points.
Discussion
Many therapeutic categories for chronic conditions are relatively new and, as
a result, do not face generic competition. At the same time, many acute conditions
are treated with older drugs that solely because of their age have more generic
competitors and, in turn, higher generic-dispensing rates. This phenomenon is
responsible for 87 percent of the difference in aggregate generic-dispensing
rates.
Our earlier discussion suggests that there could be demand-side explanations
for the differences in within-category generic-dispensing rates. As result,
the 1.26-percentage-point difference in generic-dispensing rates cannot be attributed
to therapeutic substitution alone. The results from generic-substitution rates
and the consequences of price incentives faced by patients provide compelling,
although not conclusive, evidence that the difference is driven by demand.
Generic-substitution rates are higher in the mail channel (Exhibit
4). The higher rates may be driven by therapeutic substitution, but in the
opposite direction than that suggested by the conflict-of-interest argument.
In states with no generic-substitution laws, the pharmacist may contact the
physician to ask for permission to dispense a generic druga price-based
intervention that is a standard part of a pharmacists interaction with
a physician. Alternatively, the pharmacist may call the physician to reconsider
prescriptions marked dispense as written. Given that mail pharmacies
have several days to fill a mail-order prescription, such intervention is more
likely to take place in the mail channel, thereby yielding higher generic-substitution
rates. Unless mail pharmacies have two conflicting therapeutic substitution
policiesone that encourages greater use of generics and the other that
encourages greater use of single-source drugsour empirical results suggest
that therapeutic substitution away from generic drugs does not explain the discrepancy
in generic-dispensing rates.
While the generic-substitution measure provides an upper bound for the demand
effects that drive differential use of mail and retail pharmacies, the isolated
impact of prices on differential use of mail and retail pharmacies warrants
further discussion. Consider the following example. Suppose Johns pharmacy
benefits follow the 10-25-45 copayment structure: He pays $10 for generics,
$25 for brand-name drugs listed on the formulary (second tier), and $45 for
unlisted brand-name drugs (third tier), all if he obtains a maximum thirty-day
supply from a retail pharmacy. If John uses the mail pharmacy, he can obtain
a ninety-day supply for twice the price (that is, his mail benefit structure
is 20-50-90).
Now suppose Johns physician prescribes a generic drug. If John fills the
prescription through a mail pharmacy, he can save $40 per year (twelve fills
at $10 each, versus four fills at $20 each). If, however, his doctor prescribes
a brand that is on the formulary for his plan, John would save $100 (twelve
fills at $25 each, versus four fills at $50 each). Finally, suppose Johns
doctor prescribes a brand-name product that is not listed on the formulary.
Then John has a much greater incentive to use the mail pharmacy. His yearly
savings come out to $180 (twelve fills at $45 each versus four fills at $90
each). We note, however, that if the benefit structure for the mail channel
had a greater penalty for using nonformulary brands, the incentive to use the
mail channel for nonformulary brands would be reduced.9
Although the benefit structure will differ across patients, the tiered structure
of copayments will necessarily result in greater financial savings for more
expensive drugs. Because patients taking such drugs have greater financial incentives
to choose mail over retail, they will be more willing to take the time and effort
to learn how to use the mail pharmacy. As a result, mail pharmacies are likely
to have a disproportionate share of single-source (brand-name) drugs for a given
therapeutic category or even subcategory, such as statins.
To test the impact of price incentives on demand for mail order, one would need
to estimate the probability of channel choice as a function of price differentials.
One may argue, however, that these price differentials would not be fully exogenous
because the PBM has more influence over the mail pharmacy copayment than an
individual retail pharmacy does over the retail copayment. Unfortunately, finding
proper instruments to adjust for this could be difficult.
Conclusion
The fact that mail pharmacies have lower generic-dispensing rates than their
retail counterparts has been used as evidence of self-dealing that could arise
when a PBM is both a plan administrator and a pharmacy owner. Our analysis found
that the difference in aggregate generic-dispensing rates between mail and retail
pharmacies confounds variation in performance with differences in demand. Using
the universe of claims for third-party clients of five large PBMs, we found
that 87 percent of the difference in the aggregate generic-dispensing rate is
driven by differences in therapeutic mix.
Although our data do not allow us to fully control for all potential demand-side
factors, such as differences in price, acuity, and length of treatment, we provide
evidence that even category-specific generic-dispensing rates are influenced
by these differences. In particular, the generic-substitution rate, which fully
controls for intermolecule differences, eliminates the discrepancy in dispensing
rates. These results underscore the fact that it is impossible to make definitive
judgments about pharmacy performance based on the generic-dispensing measure.
As a result, addressing the proposed conflict of interest ultimately requires
direct analysis of whether the monetary benefits from rebates outweigh the cost
of interventions for therapeutic substitution and the obligations PBMs have
to their clients.
This project was funded by the Division of Research at the Harvard Business
School. The authors thank Donald Metz and two anonymous reviewers for their
insightful comments.
NOTES
1. IMS Health. The discrepancy between the two percentages is
driven by the fact that prescriptions filled through mail pharmacies typically
dispense ninety-day supplies of medication, while retail pharmacies typically
dispense thirty-day supplies.
2. J. Langenfeld and R. Maness, The Cost of PBM Self-Dealing
under a Medicare Prescription Drug Benefit, 9 September 2003, www.ncpanet.org/assets/Federal_Bills_Pending_Legislation/asset_upload_file222_2891.pdf
(2 March 2004).
3. Public Hearing before Assembly Health and Human Services
Committee: Assembly Bill No. 2337, 8 August 2002, www.njleg.state.nj.us/legislativepub/pubhear/080802rs.pdf,
p. 45 (2 March 2004).
4. The Medicare Prescription Drug, Improvement, and Modernization
Act of 2003, P.L. 108-173, Section 110.
5. Langenfeld and Maness, The Cost of PBM Self-Dealing.
6. It should be noted that there were no generics in the nonsedating
antihistamine categories until November 2003, when Claritin lost its patent.
The generic-dispensing and -substitution rates reflect dispensing of over-the-counter
(OTC) medications such as Tavist, which are covered by select plans.
7. Langenfeld and Maness, The Cost of PBM Self-Dealing;
and Public Hearing before Assembly Health and Human Services Committee.
8. J. Johnson at al., A Comparison of Satisfaction with
Mail versus Traditional Pharmacy Services, Journal of Managed Care
Pharmacy 3, no. 3 (1997): 327337.
9. For example, suppose that Johns benefit structure for
the mail channel moved from 20-50-90 to 20-50-135. That is, he pays twice the
retail copayment for generics and listed brands and three times the retail copayment
for unlisted brands. He now saves no money by using mail for unlisted brands
(twelve fills at $45 each for retail, versus four fills at $135 each for mail).
Marta Wosinska (mwosinska{at}hbs.edu) is
an assistant professor of business administration, Harvard Business School,
in Boston, Massachusetts. Robert Huckman is also an assistant professor of business
administration there and is a faculty research fellow at the National Bureau
of Economic Research.
DOI: 10.1377/hlthaff.W4.409
©2004 Project HOPEThe People-to-People Health Foundation, Inc.
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