Medicare Part D
Spending, Beneficiary Out-of-Pocket Costs, and Efforts to Obtain Price Concessions for Certain High-Cost Drugs Gao ID: GAO-10-529T March 17, 2010The Centers for Medicare & Medicaid Services (CMS) allows Part D plans to utilize different tiers with different levels of cost sharing as a way of managing drug utilization and spending. One such tier, the specialty tier, is designed for high-cost drugs whose prices exceed a certain threshold set by CMS. Beneficiaries who use these drugs typically face higher out-of-pocket costs than beneficiaries who use only lower-cost drugs. This testimony is based on GAO's January 2010 report entitled Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier (GAO-10-242) in which GAO examined, among other things, (1) Part D spending on these drugs in 2007, the most recent year for which claims data were available; (2) how different cost-sharing structures could be expected to affect beneficiary out-of-pocket costs; (3) how negotiated drug prices could be expected to affect beneficiary out-of-pocket costs; and (4) information Part D plan sponsors reported on their ability to negotiate price concessions. For the second and third of these objectives, this testimony focuses on out-of-pocket costs for beneficiaries responsible for paying the full cost-sharing amounts required by their plans. GAO examined CMS data and interviewed officials from CMS and 8 of the 11 largest plan sponsors, based on enrollment in 2008. Seven of the 11 plan sponsors provided price concession data for a sample of 20 drugs for 2006 through 2008.
High-cost drugs eligible for a specialty tier commonly include immunosuppressant drugs, those used to treat cancer, and antiviral drugs. Specialty tier-eligible drugs accounted for 10 percent, or $5.6 billion, of the $54.4 billion in total prescription drug spending under Medicare Part D plans in 2007. Medicare beneficiaries who received a low-income subsidy (LIS) accounted for most of the spending on specialty tier-eligible drugs-- $4.0 billion, or 70 percent of the total. Among all beneficiaries who used at least one specialty tier-eligible drug in 2007, 55 percent reached the catastrophic coverage threshold, after which Medicare pays at least 80 percent of all drug costs. In contrast, only 8 percent of all Part D beneficiaries who filed claims but did not use any specialty tier-eligible drugs reached this threshold in 2007. Most beneficiaries are responsible for paying the full cost-sharing amounts required by their plans. For such beneficiaries who use a given specialty tier-eligible drug, different cost-sharing structures result in varying out-of-pocket costs only until they reach the catastrophic coverage threshold, which 31 percent of these beneficiaries did in 2007. After that point, beneficiaries' annual out-of-pocket costs for a given drug are likely to be similar regardless of their plans' cost-sharing structures. Variations in negotiated drug prices can also affect out-of-pocket costs for beneficiaries who are responsible for paying the full cost-sharing amounts required by their plans. Variations in negotiated prices can occur between drugs, across plans for the same drug, and from year to year. For example, the average negotiated price for the cancer drug Gleevec across our sample of plans increased by 46 percent between 2006 and 2009, from about $31,200 per year to about $45,500 per year. Correspondingly, the average out-of-pocket cost for a beneficiary taking Gleevec for the entire year could have been expected to rise from about $4,900 in 2006 to more than $6,300 in 2009. Plan sponsors reported having little leverage to negotiate price concessions from manufacturers for most specialty tier-eligible drugs. One reason for this limited leverage was that many of these drugs have few competitors on the market. Plan sponsors reported that they were more often able to negotiate price concessions for drugs with more competitors on the market--such as for drugs used to treat rheumatoid arthritis. Two additional reasons cited for limited negotiating leverage were CMS requirements that plans include all or most drugs from certain therapeutic classes on their formularies, limiting sponsors' ability to exclude drugs from their formularies in favor of competing drugs; and that the relatively limited share of total prescription drug utilization among Part D beneficiaries for some specialty tier-eligible drugs was insufficient to entice manufacturers to offer price concessions. CMS provided GAO with comments on a draft of the January 2010 report. CMS agreed with portions of GAO's findings and suggested additional information for GAO to include in the report, which GAO incorporated as appropriate.
GAO-10-529T, Medicare Part D: Spending, Beneficiary Out-of-Pocket Costs, and Efforts to Obtain Price Concessions for Certain High-Cost Drugs
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Testimony:
Before the Special Committee on Aging, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 2:30 p.m. EDT:
Wednesday, March 17, 2010:
Medicare Part D:
Spending, Beneficiary Out-of-Pocket Costs, and Efforts to Obtain Price
Concessions for Certain High-Cost Drugs:
Statement of John E. Dicken:
Director, Health Care:
GAO-10-529T:
GAO Highlights:
Highlights of GAO-10-529T, a testimony before the Special Committee on
Aging, U.S. Senate.
Why GAO Did This Study:
The Centers for Medicare & Medicaid Services (CMS) allows Part D plans
to utilize different tiers with different levels of cost sharing as a
way of managing drug utilization and spending. One such tier, the
specialty tier, is designed for high-cost drugs whose prices exceed a
certain threshold set by CMS. Beneficiaries who use these drugs
typically face higher out-of-pocket costs than beneficiaries who use
only lower-cost drugs.
This testimony is based on GAO‘s January 2010 report entitled Medicare
Part D: Spending, Beneficiary Cost Sharing, and Cost-Containment
Efforts for High-Cost Drugs Eligible for a Specialty Tier (GAO-10-242)
in which GAO examined, among other things, (1) Part D spending on
these drugs in 2007, the most recent year for which claims data were
available; (2) how different cost-sharing structures could be expected
to affect beneficiary out-of-pocket costs; (3) how negotiated drug
prices could be expected to affect beneficiary out-of-pocket costs;
and (4) information Part D plan sponsors reported on their ability to
negotiate price concessions. For the second and third of these
objectives, this testimony focuses on out-of-pocket costs for
beneficiaries responsible for paying the full cost-sharing amounts
required by their plans. GAO examined CMS data and interviewed
officials from CMS and 8 of the 11 largest plan sponsors, based on
enrollment in 2008. Seven of the 11 plan sponsors provided price
concession data for a sample of 20 drugs for 2006 through 2008.
What GAO Found:
High-cost drugs eligible for a specialty tier commonly include
immunosuppressant drugs, those used to treat cancer, and antiviral
drugs. Specialty tier-eligible drugs accounted for 10 percent, or $5.6
billion, of the $54.4 billion in total prescription drug spending
under Medicare Part D plans in 2007. Medicare beneficiaries who
received a low-income subsidy (LIS) accounted for most of the spending
on specialty tier-eligible drugs”$4.0 billion, or 70 percent of the
total. Among all beneficiaries who used at least one specialty tier-
eligible drug in 2007, 55 percent reached the catastrophic coverage
threshold, after which Medicare pays at least 80 percent of all drug
costs. In contrast, only 8 percent of all Part D beneficiaries who
filed claims but did not use any specialty tier-eligible drugs reached
this threshold in 2007.
Most beneficiaries are responsible for paying the full cost-sharing
amounts required by their plans. For such beneficiaries who use a
given specialty tier-eligible drug, different cost-sharing structures
result in varying out-of-pocket costs only until they reach the
catastrophic coverage threshold, which 31 percent of these
beneficiaries did in 2007. After that point, beneficiaries‘ annual out-
of-pocket costs for a given drug are likely to be similar regardless
of their plans‘ cost-sharing structures.
Variations in negotiated drug prices can also affect out-of-pocket
costs for beneficiaries who are responsible for paying the full cost-
sharing amounts required by their plans. Variations in negotiated
prices can occur between drugs, across plans for the same drug, and
from year to year. For example, the average negotiated price for the
cancer drug Gleevec across our sample of plans increased by 46 percent
between 2006 and 2009, from about $31,200 per year to about $45,500
per year. Correspondingly, the average out-of-pocket cost for a
beneficiary taking Gleevec for the entire year could have been
expected to rise from about $4,900 in 2006 to more than $6,300 in 2009.
Plan sponsors reported having little leverage to negotiate price
concessions from manufacturers for most specialty tier-eligible drugs.
One reason for this limited leverage was that many of these drugs have
few competitors on the market. Plan sponsors reported that they were
more often able to negotiate price concessions for drugs with more
competitors on the market”such as for drugs used to treat rheumatoid
arthritis. Two additional reasons cited for limited negotiating
leverage were CMS requirements that plans include all or most drugs
from certain therapeutic classes on their formularies, limiting
sponsors‘ ability to exclude drugs from their formularies in favor of
competing drugs; and that the relatively limited share of total
prescription drug utilization among Part D beneficiaries for some
specialty tier-eligible drugs was insufficient to entice manufacturers
to offer price concessions.
CMS provided GAO with comments on a draft of the January 2010 report.
CMS agreed with portions of GAO‘s findings and suggested additional
information for GAO to include in the report, which GAO incorporated
as appropriate.
View [hyperlink, http://www.gao.gov/products/GAO-10-529T] or key
components. For more information, contact John E. Dicken at (202) 512-
7114 or DickenJ@gao.gov.
[End of section]
Mr. Chairman and Members of the Committee:
I am pleased to be here today to discuss high-cost drugs covered under
Medicare Part D and to provide highlights from our January 2010 report
entitled Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-
Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier.
[Footnote 1] Medicare Part D is the outpatient prescription drug
benefit offered by Medicare, the federal health insurance program
which serves about 45 million elderly and disabled individuals. Some
drugs covered by Part D have particularly high costs--sometimes
exceeding tens of thousands of dollars per year--and beneficiaries who
take these drugs often face high annual out-of-pocket costs.
Under Part D, coverage and beneficiary cost sharing can vary. Medicare
beneficiaries obtain Part D drug coverage by choosing from multiple
competing plans offered by plan sponsors--often private insurers--that
contract with the Centers for Medicare & Medicaid Services (CMS) in
order to offer the prescription drug benefit. As of February 2010, CMS
reported that 27.6 million beneficiaries were enrolled in Part D
plans. Part D plan sponsors can offer a range of plans with either a
defined standard benefit or an actuarially equivalent alternative, or
plans with enhanced benefits. Plans can vary in the coverage provided,
monthly premiums, and cost-sharing structure such as copayments and
coinsurance.[Footnote 2] Most Part D beneficiaries--approximately 18
million--are responsible for paying the full premium and cost-sharing
amounts required by their plans. Part D provides premium and cost-
sharing assistance through its low-income subsidy (LIS) for other
beneficiaries who meet certain income and asset requirements.
Plan sponsors can assign covered drugs to distinct tiers, such as
separate tiers for generic and brand-name drugs. These tiers often
have increasing levels of cost sharing in order to encourage
beneficiaries to utilize less costly drugs such as generics. CMS also
allows Part D plans to establish a "specialty tier" for high-cost
drugs when the total cost for a drug--as determined through
negotiations between the plan and pharmacies--exceeds a certain
threshold, set by CMS at $500 per month for 2007 and $600 per month
for 2008 through 2010. Drugs eligible to be placed on specialty tiers
are among the most expensive drugs on the market. They are used by a
small proportion of beneficiaries and commonly include
immunosuppressant drugs, those used to treat cancer, and antiviral
drugs. Plan sponsors may be able to manage spending on these high-cost
drugs by negotiating price concessions with manufacturers or price
discounts with pharmacies.[Footnote 3]
My statement today is based upon our January 2010 report, in which we
examined, among other things, (1) spending under Medicare Part D on
specialty tier-eligible drugs covered in 2007, the most recent year
for which claims data were available when we conducted our study; (2)
how the different cost-sharing structures used by Part D plans for
specialty tier-eligible drugs could be expected to affect beneficiary
out-of-pocket costs; (3) how prices negotiated with pharmacies for
specialty tier-eligible drugs could be expected to affect beneficiary
out-of-pocket costs; and (4) the ability of Part D plans to negotiate
price concessions from manufacturers for specialty tier-eligible
drugs. For the second and third of these objectives, my statement
today focuses primarily on out-of-pocket costs for most beneficiaries--
those who are responsible for paying the full cost-sharing amounts
required by their plans. Details on out-of-pocket costs for LIS
beneficiaries, which are subsidized by Medicare, can be found in our
January 2010 report.
To do the work for our report, we examined CMS's Prescription Drug
Event (PDE) claims data from 2007 for Medicare Advantage prescription
drug (MA-PD) plans and stand-alone prescription drug plans (PDP) to
determine spending on drugs eligible to be placed on a Part D plan's
specialty tier. For our purposes, we considered specialty tier-
eligible drugs to be all drugs with claims reimbursed under Part D
with a median negotiated cost of at least $500 for a 30-day supply
(i.e., where at least half of the claims for these drugs in 2007 met
or exceeded the CMS cost threshold of $500 per month). We analyzed the
effect of typical cost-sharing structures on beneficiary out-of-pocket
costs. We also chose a judgmental sample of 20 specialty tier-eligible
drugs and a sample of 36 high-enrollment MA-PD and PDP plans from six
counties based on enrollment as of March 2008. We used CMS negotiated
price data[Footnote 4] and CMS estimates of beneficiary out-of-pocket
costs for our sample of drugs in 35 of the 36 selected plans[Footnote
5] to analyze how negotiated drug prices could be expected to affect
beneficiary out-of-pocket costs from 2006 through 2009. The results of
this analysis cannot be generalized beyond our judgmental sample of
drugs and selected plans. We conducted interviews with representatives
from 8 of the 11 largest MA-PD and PDP plan sponsors based on 2008
enrollment data from CMS. In addition, 7 of the plan sponsors we
interviewed provided price concession data for our sample of 20
specialty tier-eligible drugs for 2006 through 2008. These 7 plan
sponsors represented 51 percent of all MA-PD enrollment and 67 percent
of all PDP enrollment in 2008. We determined that the data we used for
our report were sufficiently reliable for our purposes. We conducted
the work for our report from March 2009 through December 2009 in
accordance with all sections of GAO's quality assurance framework that
are relevant to our objectives. The framework requires that we plan
and perform the engagement to obtain sufficient and appropriate
evidence to meet our stated objectives and to discuss any limitations
in our work. We believe that the information and data obtained, and
the analysis conducted, provide a reasonable basis for any findings
and conclusions in this product. A detailed explanation of our
methodology is included in our January 2010 report.
Background:
Under the defined standard benefit in 2009, beneficiaries subject to
full cost-sharing amounts paid out-of-pocket costs during the initial
coverage period that included a deductible equal to the first $295 in
drug costs, followed by 25 percent coinsurance for all drugs until
total drug costs reached $2,700, with beneficiary out-of-pocket costs
accounting for $896.25 of that total. (See fig. 1.) This initial
coverage period is followed by a coverage gap--the so-called doughnut
hole--in which these beneficiaries paid 100 percent of their drug
costs. In 2009, the coverage gap lasted until total drug costs--
including the costs accrued during the initial coverage period--
reached $6,153.75, with beneficiary out-of-pocket drug costs
accounting for $4,350 of that total. This point is referred to as the
catastrophic coverage threshold.[Footnote 6] After reaching the
catastrophic coverage threshold, beneficiaries taking a specialty tier-
eligible drug paid 5 percent of total drug costs for each prescription
for the remainder of the year.[Footnote 7]
Figure 1: Medicare Part D Cost-Sharing Structure for Specialty Tier-
Eligible Drugs under the Defined Standard Benefit, 2009:
[Refer to PDF for image: illustration]
Initial coverage period:
Beneficiary paid $295 deductible;
Plan paid 75 percent of drug costs;
Beneficiary paid 25 percent of drug costs;
$2,700 in total drug costs (Beneficiary paid $896.25 out of pocket).
Coverage gap:
Beneficiary paid 100 percent of drug costs;
$6,153.75 in total drug costs (Beneficiary paid $4,350 out of pocket).
Catastrophic coverage period:
Medicare paid 80 percent of drug costs;
Plan paid 15 percent of drug costs;
Beneficiary paid 5 percent of drug costs[A].
Source: GAO analysis of CMS data.
Note: LIS beneficiaries paid lower amounts in all phases of the
benefit, while Medicare paid the remainder of beneficiaries' out-of-
pocket costs.
[A] Because of the high cost of specialty tier-eligible drugs, the
beneficiary always paid 5 percent of drug costs during the
catastrophic coverage period.
[End of figure]
In addition to cost sharing for prescription drugs, many Part D plans
also charge a monthly premium. In 2009, premiums across all Part D
plans averaged about $31 per month, an increase of 24 percent from
2008.[Footnote 8] Beneficiaries are responsible for paying these
premiums except in the case of LIS beneficiaries, whose premiums are
subsidized by Medicare.
In 2007, Specialty Tier-Eligible Drugs Accounted for 10 Percent of
Part D Spending:
We found that specialty tier-eligible drugs accounted for about 10
percent, or $5.6 billion, of the $54.4 billion in total prescription
drug spending under Part D MA-PD and PDP plans in 2007.[Footnote 9]
Prescriptions for LIS beneficiaries accounted for about 70 percent, or
about $4.0 billion, of the $5.6 billion spent on specialty tier-
eligible drugs under MA-PD and PDP plans that year. (See figure 2.)
The fact that spending on specialty tier-eligible drugs in 2007 was
largely accounted for by LIS beneficiaries is noteworthy because their
cost sharing is largely paid by Medicare.
Figure 2: Spending on Specialty Tier-Eligible Drugs under Part D MA-PD
and PDP Plans, 2007:
[Refer to PDF for image: illustration]
Specialty tier-eligible drugs:
$5.6 billion in spending (10% of total Part D drug spending).
LIS beneficiaries:
$4.0 billion in spending (70% of specialty tier-eligible spending):
Paid by Medicare: $3.11 billion (79%);
Paid by Plans: $0.84 billion (21%);
Paid by Beneficiaries: $0.01 billion (0.2%).
Non-LIS beneficiaries:
$1.7 billion[A] in spending (30% of specialty tier-eligible spending):
Paid by Medicare: $0.70 billion (42%);
Paid by Plans: $0.63 billion (38%);
Paid by Beneficiaries: $0.33 billion (20%).
Source: GAO analysis of CMS data.
[A] Totals do not add to $5.6 billion due to rounding.
[End of figure]
While only 8 percent of Part D beneficiaries in MA-PD and PDP plans
who filed claims but did not use any specialty tier-eligible drugs
reached the catastrophic coverage threshold of the Part D benefit in
2007, 55 percent of beneficiaries who used at least one specialty tier-
eligible drug reached the threshold. Specifically, among those
beneficiaries who used at least one specialty tier-eligible drug in
2007, 31 percent of beneficiaries responsible for paying the full cost
sharing required by their plans and 67 percent of beneficiaries whose
costs were subsidized by Medicare through the LIS reached the
catastrophic coverage threshold. Most (62 percent) of the $5.6 billion
in total Part D spending on specialty tier-eligible drugs under MA-PD
and PDP plans occurred after beneficiaries reached the catastrophic
coverage phase of the Part D benefit.
Differences in Plans' Cost-Sharing Structures Result in Out-of-Pocket
Costs for Most Beneficiaries That Vary Initially and Then Become
Similar:
For most beneficiaries--those who are responsible for paying the full
cost-sharing amounts required by their plans--who use a given
specialty tier-eligible drug, different cost-sharing structures can be
expected to result in varying out-of-pocket costs during the benefit's
initial coverage period.[Footnote 10] However, as long as
beneficiaries reach the catastrophic coverage threshold in a calendar
year--as 31 percent of beneficiaries who used at least one specialty
tier-eligible drug and who were responsible for the full cost-sharing
amounts did in 2007--their annual out-of-pocket costs for that drug
are likely to be similar regardless of their plans' cost-sharing
structures.
During the initial coverage period, the estimated out-of-pocket costs
for these beneficiaries for a given specialty tier-eligible drug are
likely to vary, because some Part D plans may place the drug on a tier
with coinsurance while other plans may require a flat copayment for
the drug. For example, estimated 2009 out-of-pocket costs during the
initial coverage period, excluding any deductibles, for a drug with a
monthly negotiated price of $1,100 would range from $25 per month for
a plan with a flat $25 monthly copayment to $363 per month for a plan
with a 33 percent coinsurance rate.[Footnote 11]
However, even if beneficiaries pay different out-of-pocket costs
during the initial coverage period, their out-of-pocket costs become
similar due to the coverage gap and the fixed catastrophic coverage
threshold ($4,350 in out-of-pocket costs in 2009). (See fig. 3.) There
are several reasons for this. First, beneficiaries taking equally
priced drugs will reach the coverage gap at the same time--even with
different cost-sharing structures--because entry into the coverage gap
is based on total drug costs paid by the beneficiary and the plan,
rather than on out-of-pocket costs paid by the beneficiary. Since
specialty tier-eligible drugs have high total drug costs,
beneficiaries will typically reach the coverage gap within 3 months in
the same calendar year. Second, during the coverage gap, beneficiaries
typically pay 100 percent of their total drug costs until they reach
the catastrophic coverage threshold. This threshold ($4,350 in out-of-
pocket costs) includes costs paid by the beneficiary during the
initial coverage period. Therefore, beneficiaries who paid higher out-
of-pocket costs in the initial coverage period had less to pay in the
coverage gap before they reached the threshold. Conversely,
beneficiaries who paid lower out-of-pocket costs in the initial
coverage period had more to pay in the coverage gap before they
reached the same threshold of $4,350 in out-of-pocket costs. Third,
after reaching the threshold, beneficiaries' out-of-pocket costs
become similar because they typically pay 5 percent of the drug's
negotiated price for the remainder of the calendar year.[Footnote 12]
Figure 3: Cumulative Beneficiary Out-of-Pocket Costs under Different
Cost-Sharing Structures for a Drug with a Negotiated Price of $1,100
per Month, for Beneficiaries Responsible for Full Cost-Sharing Amounts:
[Refer to PDF for image: multiple line graph]
Catastrophic coverage threshold ($4,350 out of pocket).
Number of months the beneficiary filled a prescription for the drug in
2009: 1;
$50 copayment: $345;
25 percent coinsurance: $496;
33 percent coinsurance: $561.
Number of months the beneficiary filled a prescription for the drug in
2009: 2;
$50 copayment: $395;
25 percent coinsurance: $771;
33 percent coinsurance: $924.
Number of months the beneficiary filled a prescription for the drug in
2009: 3;
$50 copayment: $1,045;
25 percent coinsurance: $1,496;
33 percent coinsurance: $1,689.
Number of months the beneficiary filled a prescription for the drug in
2009: 4;
$50 copayment: $2,145;
25 percent coinsurance: $2,596;
33 percent coinsurance: $2,789.
Number of months the beneficiary filled a prescription for the drug in
2009: 5;
$50 copayment: $3,245;
25 percent coinsurance: $3,696;
33 percent coinsurance: $3,889.
Out-of-pocket costs become similar once beneficiaries reach the
catastrophic coverage threshold.
Number of months the beneficiary filled a prescription for the drug in
2009: 6;
$50 copayment: $4,345;
25 percent coinsurance: $4,372;
33 percent coinsurance: $4,382.
Number of months the beneficiary filled a prescription for the drug in
2009: 7;
$50 copayment: $4,405;
25 percent coinsurance: $4,427;
33 percent coinsurance: $4,437.
Number of months the beneficiary filled a prescription for the drug in
2009: 8;
$50 copayment: $4,460;
25 percent coinsurance: $4,482;
33 percent coinsurance: $4,492.
Number of months the beneficiary filled a prescription for the drug in
2009: 9;
$50 copayment: $4,515;
25 percent coinsurance: $4,537;
33 percent coinsurance: $4,547.
Number of months the beneficiary filled a prescription for the drug in
2009: 10;
$50 copayment: $4,570;
25 percent coinsurance: $4,592;
33 percent coinsurance: $4,602.
Number of months the beneficiary filled a prescription for the drug in
2009: 11;
$50 copayment: $4,625;
25 percent coinsurance: $4,647;
33 percent coinsurance: $4,657.
Number of months the beneficiary filled a prescription for the drug in
2009: 12;
$50 copayment: $4,680;
25 percent coinsurance: $4,702;
33 percent coinsurance: $4,712.
Source: GAO.
Note: All scenarios include a $295 annual deductible paid by the
beneficiary, $2,700 initial coverage limit, and $4,350 catastrophic
coverage threshold.
[End of figure]
Variations in Negotiated Drug Prices Affect Out-of-Pocket Costs for
Most Beneficiaries:
For most beneficiaries--those who are responsible for paying the full
cost-sharing amounts required by their plans--variations in negotiated
drug prices affect out-of-pocket costs during the initial coverage
phase if their plans require them to pay coinsurance.[Footnote 13] All
35 of our selected plans required beneficiaries to pay coinsurance in
2009 for at least some of the 20 specialty tier-eligible drugs in our
sample. Additionally, negotiated drug prices will affect these
beneficiaries' out-of-pocket costs during the coverage gap and the
catastrophic coverage phase because beneficiaries generally pay the
entire negotiated price of a drug during the coverage gap and pay 5
percent of a drug's negotiated price during the catastrophic coverage
phase. As the following examples illustrate, there are variations in
negotiated prices between drugs, across plans for the same drug, and
from year to year.
* Variations between drugs: In 2009--across our sample of 35 plans--
beneficiaries who took the cancer drug Gleevec for the entire year
could have been expected to pay about $6,300 out of pocket because
Gleevec had an average negotiated price of about $45,500 per year,
while beneficiaries could have been expected to pay about $10,500 out
of pocket over the entire year if they took the Gaucher disease drug
Zavesca, which had an average negotiated price of about $130,000 per
year.[Footnote 14]
* Variations across plans: In 2009, the negotiated price for the human
immunodeficiency virus (HIV) drug Truvada varied from about $10,900 to
about $11,400 per year across different plans with a 33 percent
coinsurance rate, resulting in out-of-pocket costs that could be
expected to range from about $4,600 to $4,850 for beneficiaries taking
the drug over the entire year.
* Variations over time: Since 2006, average negotiated prices for the
specialty tier-eligible drugs in our sample have risen across our
sample of plans; the increases averaged 36 percent over the 3-year
period.[Footnote 15] These increases, in turn, led to higher estimated
beneficiary out-of-pocket costs for these drugs in 2009 compared to
2006. For example, the average negotiated price for a 1-year supply of
Gleevec across our sample of plans increased by 46 percent, from about
$31,200 in 2006 to about $45,500 in 2009. Correspondingly, the average
out-of-pocket cost for a beneficiary taking Gleevec for an entire year
could have been expected to rise from about $4,900 in 2006 to more
than $6,300 in 2009.
Plan Sponsors Report Three Main Reasons Why They Have a Limited
Ability to Negotiate Price Concessions for Specialty Tier-Eligible
Drugs:
The eight Part D plan sponsors we interviewed told us that they have
little leverage in negotiating price concessions for most specialty
tier-eligible drugs. Additionally, all seven of the plan sponsors we
surveyed reported that they were unable to obtain price concessions
from manufacturers on 8 of the 20 specialty tier-eligible drugs in our
sample between 2006 and 2008.[Footnote 16] For most of the remaining
12 drugs in our sample, plan sponsors who were able to negotiate price
concessions reported that they were only able to obtain price
concessions that averaged 10 percent or less, when weighted by
utilization, between 2006 and 2008. (See appendix I for an excerpt of
the price concession data presented in our January 2010 report.)
The plan sponsors we interviewed cited three main reasons why they
have typically had a limited ability to negotiate price concessions
for specialty tier-eligible drugs. First, they stated that
pharmaceutical manufacturers have little incentive to offer price
concessions when a given drug has few competitors on the market, as is
the case for drugs used to treat cancer. For Gleevec and Tarceva, two
drugs in our sample that are used to treat certain types of cancer,
plan sponsors reported that they were not able to negotiate any price
concessions between 2006 and 2008. In contrast, plan sponsors told us
that they were more often able to negotiate price concessions for
drugs in classes where there are more competing drugs on the market--
such as for drugs used to treat rheumatoid arthritis, multiple
sclerosis, and anemia. The anemia drug Procrit was the only drug in
our sample for which all of the plan sponsors we surveyed reported
that they were able to obtain price concessions each year between 2006
and 2008.
Second, plan sponsors told us that even when there are competing
drugs, CMS may require plans to include all or most drugs in a
therapeutic class on their formularies, and such requirements limit
the leverage a plan sponsor has when negotiating price concessions.
When negotiating price concessions with pharmaceutical manufacturers,
the ability to exclude a drug from a plan's formulary in favor of a
therapeutic alternative is often a significant source of leverage
available to a plan sponsor. However, many specialty tier-eligible
drugs belong to one of the six classes of clinical concern for which
CMS requires Part D plan sponsors to include all or substantially all
drugs on their formularies, eliminating formulary exclusion as a
source of negotiating leverage.[Footnote 17] We found that specialty
tier-eligible drugs were more than twice as likely to be in one of the
six classes of clinical concern compared with lower-cost drugs in
2009.[Footnote 18] Additionally, among the 8 drugs in our sample of 20
specialty tier-eligible drugs for which the plan sponsors we surveyed
reported they were unable to obtain price concessions between 2006 and
2008, 4 drugs were in one of the six classes of clinical concern. Plan
sponsors are also required to include at least two therapeutic
alternatives from each of the other therapeutic classes on their
formularies.
Third, plan sponsors told us that they have limited ability to
negotiate price concessions for certain specialty tier-eligible drugs
because they account for a relatively limited share of total
prescription drug utilization among Part D beneficiaries. For some
drugs in our sample, such as Zavesca, a drug used to treat a rare
enzyme disorder called Gaucher disease, the plan sponsors we surveyed
had very few beneficiary claims between 2006 and 2008. None of the
plan sponsors we surveyed reported price concessions for this drug
during this period. Plan sponsors told us that utilization volume is
usually a source of leverage when negotiating price concessions with
manufacturers for Part D drugs. For some specialty tier-eligible drugs
like Zavesca, however, the total number of individuals using the drug
may be so limited that plans are not able to enroll a significant
enough share of the total users to entice the manufacturer to offer a
price concession.
Agency Comments and Our Evaluation:
The Department of Health and Human Services (HHS) provided us with
CMS's written comments on a draft version of our January 2010 report.
CMS agreed with portions of our findings and suggested additional
information for us to include in our report. We also provided excerpts
of the draft report to the eight plan sponsors who were interviewed
for this study and they provided technical comments. We incorporated
comments from CMS and the plan sponsors as appropriate in our January
2010 report.
Mr. Chairman, this completes my prepared remarks. I would be happy to
respond to any questions you or other Members of the Committee may
have at this time.
GAO Contact and Staff Acknowledgments:
For further information about this statement, please contact John E.
Dicken at (202) 512-7114 or DickenJ@gao.gov.
Contact points for our Offices of Congressional Relations and Public
Affairs may be found on the last page of this statement. Key
contributors to this statement in addition to the contact listed above
were Will Simerl, Assistant Director; Krister Friday; Karen Howard;
Gay Hee Lee; and Alexis MacDonald.
[End of section]
Appendix I: Comparison of Price Concessions Negotiated by Seven Plan
Sponsors for a Sample of 20 Drugs in 2008:
Multiple sclerosis:
Drugs (including strength and dosage form), by indication: Glatiramer
acetate (Copaxone) 20 mg/ml injection;
Number of plan sponsors that obtained price concessions: 7;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,867;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,732.
Drugs (including strength and dosage form), by indication: Interferon
beta-1a (Avonex) 30 mcg intramuscular injection;
Number of plan sponsors that obtained price concessions: 5;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,935;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,884.
Inflammatory conditions (e.g., rheumatoid arthritis, psoriasis,
Crohn's disease)[A]:
Drugs (including strength and dosage form), by indication: Adalimumab
(Humira) 40 mg/0.8 ml injection;
Number of plan sponsors that obtained price concessions: 7;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,600;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,469.
Drugs (including strength and dosage form), by indication: Anakinra
(Kineret) 100 mg injection;
Number of plan sponsors that obtained price concessions: [B];
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,424;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,423.
Drugs (including strength and dosage form), by indication: Etanercept
(Enbrel) 50 mg/ml injection;
Number of plan sponsors that obtained price concessions: 6;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,527;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,470.
Human immunodeficiency virus (HIV):
Drugs (including strength and dosage form), by indication: Atazanavir
sulfate (Reyataz) 150 mg tablet;
Number of plan sponsors that obtained price concessions: 6;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $853;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $810.
Drugs (including strength and dosage form), by indication:
Emtricitabine and tenofovir disoproxil fumarate (Truvada) 200 mg/300
mg tablet;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $881;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $881.
Drugs (including strength and dosage form), by indication: Lamivudine
and zidovudine (Combivir) 150 mg/300 mg tablet;
Number of plan sponsors that obtained price concessions: 6;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $741;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $714.
Drugs (including strength and dosage form), by indication: Lopinavir
and ritonavir (Kaletra) 200 mg/50 mg tablet;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $745;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $745.
Cancer:
Drugs (including strength and dosage form), by indication: Erlotinib
(Tarceva)[C[ 150 mg tablet];
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $3,393;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $3,393.
Drugs (including strength and dosage form), by indication: Imatinib
mesylate (Gleevec) 400 mg tablet;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $3,389;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $3,389.
Hepatitis C:
Drugs (including strength and dosage form), by indication: Interferon
alfa-2b (Intron-A) 3 million IU injection;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $580;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $580.
Drugs (including strength and dosage form), by indication:
Peginterferon alfa 2a (Pegasys)[C] 180 mg/0.5 ml injection];
Number of plan sponsors that obtained price concessions: 6;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,817;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,561.
Anemia:
Drugs (including strength and dosage form), by indication: Darbepoetin
alfa (Aranesp) 100 mcg/0.5 ml injection;
Number of plan sponsors that obtained price concessions: 4;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,128;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $994.
Drugs (including strength and dosage form), by indication: Epoetin
alfa (Procrit) 40,000 units/ml injection;
Number of plan sponsors that obtained price concessions: 7;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $1,593;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $1,420.
Enzyme disorders (e.g., Gaucher disease):
Drugs (including strength and dosage form), by indication: Miglustat
(Zavesca) 100 mg capsule;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $8,344;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $8,344.
Pulmonary arterial hypertension:
Drugs (including strength and dosage form), by indication: Ambrisentan
(Letairis) 10 mg tablet;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $4,416;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $4,416.
Drugs (including strength and dosage form), by indication: Bosentan
(Tracleer) 125 mg tablet;
Number of plan sponsors that obtained price concessions: 0;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $4,423;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $4,423.
Other (selected based on high utilization):
Drugs (including strength and dosage form), by indication:
Mycophenolate mofetil (CellCept)--immune suppressant 500 mg tablet;
Number of plan sponsors that obtained price concessions: 7;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $681;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $652.
Drugs (including strength and dosage form), by indication:
Teriparatide (Forteo)[C]--osteoporosis 250 mcg/ml injection;
Number of plan sponsors that obtained price concessions: 4;
Average negotiated price per 30-day supply, before price concessions,
weighted by utilization: $748;
Average negotiated price per 30-day supply, after price concessions,
weighted by utilization: $641.
Source: GAO analysis of price concessions data provided by seven plan
sponsors GAO surveyed.
[A] These three distinct diseases (rheumatoid arthritis, psoriasis,
and Crohn's disease) may be treated using some of the same drugs. We
selected three of those drugs for our sample.
[B] The total number of plan sponsors who reported receiving price
concessions for this drug was too small to allow us to report this
value while maintaining confidentiality.
[C] One of the seven plan sponsors we surveyed did not submit any data
for this drug. Therefore, values listed for this drug are based on
data submitted by six plan sponsors, rather than seven plan sponsors.
[End of table]
[End of section]
Footnotes:
[1] GAO, Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-
Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier,
[hyperlink, http://www.gao.gov/products/GAO-10-242] (Washington, D.C.:
Jan. 29, 2010).
[2] A copayment is usually a fixed dollar amount paid by the
beneficiary, while coinsurance is a percentage of the cost.
[3] Sponsors must pass price concessions on to the program. See the
Social Security Act §§ 1860 D-2(d)(1)(A), -15(b)(2), and -15(e)(1)(B)
(as added by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 [MMA]) (codified at 42 U.S.C. §§ 1395w-
102(d)(1)(A), -115(b)(2), and -115(e)(1)(B)).
[4] Negotiated drug prices are prices negotiated between pharmacies
and plan sponsors for drugs dispensed by a pharmacy to plan
beneficiaries and are reported by plan sponsors to CMS. CMS negotiated
price data, which reflect average prices reported by plans across
pharmacies available to beneficiaries, can be used only to estimate
average beneficiary out-of-pocket costs, and may not reflect actual
out-of-pocket costs paid by beneficiaries. The latter are influenced
by factors--such as the extent of price concessions negotiated between
plans and pharmacies--that vary by pharmacy and region.
[5] CMS was unable to provide negotiated drug price data and estimated
out-of-pocket costs for all 4 years--2006 through 2009--for one plan
in our sample. Therefore, we excluded this plan from our analyses.
[6] In designing an actuarially equivalent alternative plan, plan
sponsors must maintain the catastrophic coverage threshold set by CMS
pursuant to law ($4,350 in 2009). See the Social Security Act §1860D-
2(b)(4)(B) (as added by the MMA) (codified at 42 U.S.C. §1395w-
102(b)(4)(B)).
[7] For 2010, the standard benefit amounts set by CMS are as follows:
a $310 deductible, a $2,830 initial coverage limit, and a catastrophic
coverage threshold of $4,550.
[8] "A Status Report on Part D for 2009," Report to the Congress:
Medicare Payment Policy (Washington, D.C.: Medicare Payment Advisory
Commission [MedPAC], March 2009), [hyperlink,
http://www.medpac.gov/document_search.cfm] (accessed Aug. 13, 2009).
[9] These amounts include spending by Medicare, the plans, and
beneficiaries.
[10] LIS beneficiaries' out-of-pocket costs for all drugs, including
specialty tier-eligible drugs, are not significantly affected by
different plans' cost-sharing structures because Medicare has
established fixed cost-sharing levels for all LIS beneficiaries,
regardless of the plans in which they are enrolled.
[11] $1,100 per month was the utilization-weighted average of the
median negotiated price of all specialty tier-eligible drugs in 2007
based on PDE claims data.
[12] While not common, some plan sponsors offer MA-PD plans with lower
cost sharing than the usual 100 percent during the coverage gap or the
usual 5 percent during the catastrophic coverage period. In these rare
cases, beneficiaries would have lower out-of-pocket costs for
specialty tier-eligible drugs over the course of the calendar year.
[13] Out-of-pocket costs for LIS beneficiaries are generally not
affected by variations in negotiated drug prices because most LIS
beneficiaries pay a flat monthly copayment for all drugs regardless of
the drug's price.
[14] Values reported are averages in 2009 across the 35 selected plans
used in our analysis.
[15] We calculated average negotiated drug prices separately for 2006
and 2009 across all plans that covered a given drug for each year and
then compared the two average prices to determine the percent
increase. CMS did not provide negotiated prices or estimated out-of-
pocket costs for four drugs in our sample--Aranesp, Intron-A, Kaletra,
and Letairis--for 2006. Therefore, these drugs are excluded from this
calculation.
[16] One of the plan sponsors we interviewed declined to provide price
concession data through our survey.
[17] A therapeutic class or category of drugs is generally based on an
indication approved by the Food and Drug Administration. Part D
sponsor formularies must include all or substantially all drugs in the
following six classes of clinical concern as identified by CMS:
immunosuppressant (for prophylaxis of organ transplant rejection),
antidepressant, antipsychotic, anticonvulsant, antiretroviral, and
antineoplastic. Examples of other therapeutic classes include
analgesics, blood glucose regulators, cardiovascular agents,
dermatological agents, respiratory tract agents, and sedatives.
[18] This analysis was conducted by comparing specialty tier-eligible
and nonspecialty tier-eligible drugs at the drug (ingredient) level
with a list of drugs in the six classes of clinical concern provided
by CMS.
[End of section]
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