News Release
FOR IMMEDIATE RELEASE Thursday, June 24, 2004 |
Contact: CMS Public Affairs (202) 690-6145 |
Medicare to Extend Access to Certain Drugs for Beneficiaries with Serious and Chronic Illnesses
HHS Secretary Tommy G. Thompson today announced a new Medicare
demonstration program that will save seniors and persons with
disabilities substantial money -- up to 90 percent in some cases --
on the life-enhancing medicines they take for serious diseases,
including cancer, multiple sclerosis and rheumatoid arthritis.
The demonstration program, created as part of the Medicare
Modernization Act, will extend Medicare coverage to prescription
medicines that can be self-administered rather than administered by
a health care provider. The demonstration will help up to 50,000
beneficiaries with serious illnesses who do not have comprehensive
prescription drug coverage today.
“This demonstration will provide access and affordability to
life-saving medicines for people fighting serious diseases,”
Secretary Thompson said. “Through this coverage, seniors
will save thousands of dollars on essential medicines that they can
take at home. It will relieve some of the burden of battling a
debilitating disease.”
The initiative, known as the Medicare Replacement Drug
Demonstration, was mandated under Section 641 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003
(MMA). As set by Congress, enrollment in the demonstration will be
open to 50,000 people and total spending on the covered drugs will
be up to $500 million.
Under this initiative, Medicare will pay for certain drugs and
biologicals that can be taken by the patient at home and that
replace drugs which are currently covered under Medicare Part B
when given in a doctor’s office. In addition, newer, more
effective medications that replace some currently covered oral
anti-cancer drugs will also be covered.
“Covering drugs that you can administer yourself improves
access to high-quality care,” said Mark B. McClellan, M.D.,
Ph.D., administrator of the Centers for Medicare & Medicaid
Services (CMS). “In some cases, by avoiding the need for
doctor visits and intravenous injections, costs and medical
complications may be reduced and access and ease of treatment will
increase. And many beneficiaries will get literally tens of
thousands of dollars worth of help in purchasing these critical
medicines right away, ahead of the Medicare drug benefit in
2006.”
Drugs for treatment of such diseases as rheumatoid arthritis,
multiple sclerosis, pulmonary hypertension and a variety of cancers
will be included in the demonstration. The drugs were selected
based on criteria developed after extensive input from physicians
and other experts. The drugs and the diseases that are covered are
listed below.
Beneficiary cost sharing for these drugs will mirror the
“standard” Medicare Part D prescription drug benefit
when it is implemented in 2006 (participants will not pay the
monthly premium in the demonstration, however). Beneficiaries with
limited resources and incomes of less than 150 percent of the
federal poverty level (FPL) will have even lower cost sharing
requirements.
The demonstration will give Medicare beneficiaries a glimpse of the
significant savings coming their way when the Part D prescription
drug benefit is fully implemented in 2006.
Examples of estimated savings over a year include:
Patients with Chronic Myelogenous Lymphoma (a cancer) using Gleevec
could save nearly 90 percent or $40,654 annually. Gleevec has an
estimated annual cost of $45,952, but patients in the demo would
o nly pay $5,298.
-
Patients with Multiple sclerosis could save 75 percent or $12,260
annually off medicines that cost an estimated $16,298 annually.
They would pay only $4,038.
Patients with rheumatoid arthritis could save 75 percent or $11,975
annually off medicines that cost an estimated $16,000. They would
pay only $4,025.
And patients with pulmonary hypertension using Tracleer could save
86 percent or $31,255 off of a cost that otherwise could reach
$36,136. They would pay only $4,881.
Low–income beneficiaries in the demonstration would save
significantly more. Using the above examples, for those between
135 and 150 percent of the FPL estimated savings would be: for
Gleevec they would pay $638, for MS and rheumatoid arthritis
patients they would pay $628, and for someone taking Tracleer their
annual cost would be $638. For those between 100 and 135 percent
of the FPL, they would pay at most $60 per year for any of the
drugs covered in the demonstration program, and seniors below 100
percent of FPL could pay less.
“Seniors are going to save substantial money on their
prescription medicines thanks to the new drug benefit under
Medicare, and this demonstration will give them a sense of the
savings that are on the way,” Secretary Thompson said.
“For seniors currently without drug coverage, this new
benefit will help strengthen their health and their pocketbook. It
provides substantial savings on the out-of-pocket costs they
currently pay for medicines.”
As directed by Congress in creation of the demonstration,
approximately 40 percent of the funding will be allocated for oral
anti-cancer medications. If more beneficiaries apply than Medicare
is able to serve, CMS will select participants among the cancer and
non-cancer groups randomly from the applications received, on an
alternating basis between the two groups.
To be eligible for the demonstration, a beneficiary must be
enrolled in Medicare Part A and Part B, Medicare must be their
primary payer, and the beneficiary may not have comprehensive drug
coverage through other sources (such as TriCare, Medicaid, or an
employer or union sponsored plan). A beneficiary must also have a
signed certification from a doctor that he or she requires one of
the drugs covered under the demonstration for the indicated
disease.
“We intend to work with our state and local partners, and
with patient organizations and others, to help beneficiaries with
these serious diseases find out about how to take advantage of this
program -- and about the additional help now available to assist
with drug costs,” Dr. McClellan said.
CMS is conducting an Open Door Forum on June 29 with patient
advocacy groups, physician specialty groups, physicians and drug
manufacturers so they can help beneficiaries in applying for the
program.
To enroll in the demonstration program, beneficiaries should
complete an application, get their physician to complete the
required form certifying their need for the covered drug, and
submit both forms to CMS’ demonstration contractor,
TrailBlazer Health Enterprises.
Participants in the demonstration will be able to get their drugs
at a local retail pharmacy or by home delivery through Caremark,
Trailblazer’s subcontractor for administering the drug
benefit.
The demonstration will run through Dec. 31, 2005, at which time all
beneficiaries will be able to enroll in the new Medicare Part D
drug benefit.
Starting immediately, applications may be downloaded from the CMS
Web site at http://www.cms.hhs.gov/researchers/demos/drugcoveragedemo.asp.
Starting July 6, customer service representatives will be available
at 1-866-563-5386, TTY Number: 1-866-536-5387 to answer questions
about the demonstration and assist beneficiaries in obtaining and
completing the application forms. Between now and July 6,
beneficiaries who have questions can call 1-800 MEDICARE.
Applications will be accepted for consideration beginning July 6
through Sept. 30.
Those beneficiaries who are able to get their applications in by
Aug. 16 will be in an “early selection” process that
will give them coverage by Sept. 1.
Applications will be accepted through Sept.30, at which time
another selection process will be held. As long as the application
is received by Sept.30, all applicants will have an equal chance to
get into the demonstration. If enrollment slots are still
available, applications will continue to be accepted after that
date.
MEDICARE REPLACEMENT DRUG DEMONSTRATION – ANNUAL BENEFICIARY
COSTS
Disease |
Compound Name
(Brand Name) |
Estimated Annual Retail Cost
(1) |
Estimated Cost under Standard
Cost Sharing (2) |
Savings
(Percent) |
Estimated Cost under Low Income
Subsidy
(135-150% of FPL)
(3) |
Savings
(Percent) |
Estimated Cost under
Low Income Subsidy
(100-135% of FPL)
(4) |
Savings
(Percent) |
Cutaneous T Cell Lymphoma |
Bexarotene (Targretin) |
$61,320 |
$5,951 |
$55,369
(90%) |
$643 |
$60,677
(99%) |
$60 |
$61,260
(100%) |
Gastrointestinal Stromal Tumor |
Imatinib Mesylate (Gleevec) |
$45,952 |
$5,298 |
$40,654
(88%) |
$638 |
$45,314
(99%) |
$60 |
$45,892
(100%) |
Chronic Myelogenous Lymphoma |
Imatinib Mesylate (Gleevec) |
$45,952 |
$5,298 |
$40,654
(88%) |
$638 |
$45,314
(99%) |
$60 |
$45,892
(100%) |
Anaplastic astrocytoma |
Temozolomide (Temodar) |
$27,878 |
$4,530 |
$23,348 (84%) |
$638 |
$27,240
(98%) |
$60 |
$27,818
(100%) |
Epithelial Ovarian Cancer |
Altretamine (Hexalen) |
$25,631 |
$4,434 |
$21,197
(83%) |
$638 |
$24,993
(98%) |
$60 |
$25,571
(100%) |
Multiple Myeloma |
Thalidomide (Thalomid) |
$24,098 |
$4,369 |
$19,729
(82%) |
$633 |
$23,465
(97%) |
$60 |
$24,038
(100%) |
Lung Cancer
(non-small cell) |
Gefitinib (Iressa) (5) |
$3,500 |
$1,475 |
$2,025
(58%) |
$489 |
$3,011
(86%) |
$60 |
$3,440
(98%) |
Breast Cancer
Stages 2-4 |
Letrozole (Femara) |
$2,843 |
$917 |
$1,926
(68%) |
$405 |
$2,438
(86%) |
$60 |
$2,783
(98%) |
|
Exemestane (Aromasin) |
$2,827 |
$903 |
$1,924
(68%) |
$403 |
$2,424
(86%) |
$60 |
$2,767
(98%) |
|
Anastrozole (Arimidex) |
$2,700 |
$795 |
$1,905
(71%) |
$387 |
$2,313
(86%) |
$60 |
$2,640
(98%) |
|
Tamoxifen (Nolvadex) |
$1,642 |
$536 |
$1,106
(67%) |
$252 |
$1,390
(85%) |
$60 |
$1,582
(96%) |
|
Toremifene (Fareston) |
$1,411 |
$487 |
$924
(65%) |
$222 |
$1,189
(84%) |
$60 |
$1,351
(96%) |
NON-CANCER DISEASES |
Pulmonary Hypertension |
Bosentan (Tracleer) |
$36,136 |
$4,881 |
$31,255
(86%) |
$638 |
$35,498
(98%) |
$60 |
$36,076
(100%) |
CMV Retinitis |
Valcyte (Valganciclovir) |
$22,911 |
$4,319 |
$18,592
(81%) |
$633 |
$22,278
(97%) |
$60 |
$22,851
(100%) |
Hepatitis C |
Pegylated interferon alfa-2a (Pegasys, PEG-Intron)
|
$17,600 |
$4,093 |
$13,507
(77%) |
$633 |
$16,967
(96%) |
$60 |
$17,540
(100%) |
Multiple Sclerosis |
Interferon beta-1a (Avonex, Rebif), Interferon
beta-1b (Betaseron)
Glatiramer acetate (Copaxone) |
$16,298 |
$4,038 |
$12,260
(75%) |
$628 |
$15,670
(96%) |
$60 |
$16,238
(100%) |
Rheumatoid Arthritis |
Anakinra (Kineret), Adalimumab (Humira),
Etanercept (Enbrel) |
$16,000 |
$4,025 |
$11,975
(75%) |
$628 |
$15,372
(96%) |
$60 |
$15,940
(100%) |
Paget’s Disease |
Risedronate (Actonel) |
$2,700 |
$795 |
$1,905
(71%) |
$387 |
$2,313
(86%) |
$60 |
$2,640
(98%) |
Secondary Hyperparthyroidism |
Doxercalciferol (Hectoral) |
$2,204 |
$656 |
$1,548
(70%) |
$324 |
$1,880
(85%) |
$60 |
$2,144
(97%) |
Paget’s Disease |
Alendronate (Fosamax) |
$940 |
$387 |
$553
(59%) |
$162 |
$778
(83%) |
$60 |
$880
(94%) |
Osteoporosis (patient must be homebound) |
Calcitonen-nasal (Miacalcin-nasal) |
$778 |
$353 |
$425
(55%) |
$142 |
$636
(82%) |
$60 |
$718
(92%) |
(1) Estimate based on 100% of Average
Wholesale Price (AWP) from March 2004 Redbook for a typical dosage;
Actual retail price for a beneficiary may be more or less. |
(2) Program cost estimated at 85%
of AWP. Retail dispensing fee of $1.50 not included. |
(3) Reduced deductible and coinsurance
if income between 135 and 150 percent of poverty level. |
(4) Flat per-prescription payment
if income between 100 and 135 percent of poverty level. |
(5) Cost estimated for 3-month course
of treatment. |
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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last Revised: June 24, 2004
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