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Pharmaceutical Manufacturer Assistance Programs
Marie A. Chisholm, PharmD;
Joseph T. DiPiro, PharmD
Arch Intern Med. 2002;162:780-784.
ABSTRACT
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Background and Objective While there have been many public discussions concerning Medicare covering
outpatient prescription medications, currently, Medicare does not pay for
most outpatient prescriptions. Meanwhile, costs associated with prescription
medications as well as the number of underinsured patients are rapidly increasing.
Many pharmaceutical companies offer assistance programs for patients who require
medications but have inadequate financial resources to obtain them. Because
patient access to required prescriptions is critical and clinician involvement
is necessary for patient enrollment, the purpose of this article is to facilitate
awareness of pharmaceutical companies' assistance programs, the availability
of such programs, and their enrollment process.
Methods English-language articles from MEDLINE (1963-2000) and Internet Web
pages describing medication assistance programs were reviewed. Data obtained
from pharmaceutical companies' medication assistance programs were also included.
In addition to general information concerning medication assistance programs,
all studies found in the literature search describing the clinical and financial
impact of using these programs and data obtained from contacting several medication
assistance programs were selected. To determine if an assistance program was
available for a medication listed as one of the top 200 medications prescribed
in the United States, we contacted the pharmaceutical company that manufactures
each medication.
Results Approximately 53% of the top 200 prescribed medications in 1999 were
offered through assistance programs to indigent patients. Physician office
personnel can obtain medications for eligible patients by completing the enrollment
process.
Conclusion Pharmaceutical companies' medication assistance programs can be used
to reduce individual patient drug expenditures and improve patient outcomes
by increasing medication access to those in need.
INTRODUCTION
INADEQUATE PAYMENT mechanisms for prescription drugs present a glaring
defect in the American health care system.1
Drug expenditures in the United States increased by nearly 13% annually between
1994 and 1997. This represents a more rapid growth rate than any other category
of health services.2 While some of this expense
is covered by various health insurance plans, the cost for prescription medications
often falls directly on individuals or health care systems that provide care
for indigent patients. Future increases in the cost of prescription medications
may result in health care systems limiting prescription benefits for patients,
forcing consumers to pay more for medications and resulting in reduced adherence
to medication regimens as prescriptions go unfilled.
Selected groups of patients with limited incomes, such as the elderly,
may have greater difficulty purchasing prescription medications compared with
the population at large.3 Patients who require
medications for chronic diseases usually have a great economic burden, particularly
with diseases that require multiple or high-cost medications. For example,
after solid organ transplantation, the use of many medications are generally
required throughout the patient's life, with outpatient medication cost typically
exceeding $10 000 per year.4 Also, patients
who require short-term use of high-cost drugs, such as cytotoxic agents or
hematopoietic growth factors for malignancies, may exceed the limits of individual
or health care system financial resources. Frequently, these patients go without
needed medications, thereby increasing the risks of untreated diseases and
adverse consequences.
Pharmaceutical manufacturers offer programs that provide medications
to eligible patients at no or reduced cost. These assistance programs are
promoted by pharmaceutical manufacturers as one of their philanthropic efforts.5 Pharmaceutical manufacturers' programs not only aid
indigent patients, but reduce bad debt resulting from uncompensated medication
assistance at institutions serving large indigent populations. While patient
assistance programs have been in existence for many years, they have gained
increased attention in the environment of escalating drug costs and reduced
insurance coverage.
Access to assistance programs by patients in need could be limited if
health care providers and patients are unaware of the existence of such programs
or are not informed of the enrollment process. Therefore, it is important
for physicians and other health care practitioners to become aware of the
opportunities offered through these programs to expand access to prescription
medications for patients in need. By describing pharmaceutical manufacturers'
medication assistance programs and the availability of these programs, we
hope to increase awareness among practitioners and expand access to prescription
drugs for patients who do not have sufficient financial resources to pay for
their medications.
METHODS
The MEDLINE database was searched (1963-2000) for English-language reports
of descriptive, clinical, and economic evaluations of drug company medication
assistance programs, using the terms pharmaceutical company
medication assistance programs, medication assistance
programs, and pharmaceutical companies' assistance
programs. Internet Web sites using the same key terms were identified.
Bibliographies of selected articles were used to extend the search, and published
literature that specifically referred to pharmaceutical companies' medication
assistance programs were included. The RxList (the Internet drug index) Web
page (http://www.rxlist.com/top200.htm) was used to identify the
most commonly prescribed 200 medications in the United States during 1999.
To determine if an assistance program was available for a medication listed
as one of the top 200 medications prescribed, the pharmaceutical company that
manufacturers that medication was contacted.
RESULTS
MEDICATION ASSISTANCE PROGRAMS
Approximately 53% of the top 200 prescribed medications in 1999 were
offered through assistance programs to indigent patients (Table 1). Some of these programs may require patients to pay a fee
or shipment charge, typically ranging from $3 to $50, while many others do
not require patients to pay any fee. For patients who qualify for medication
assistance programs, the medication may be delivered directly to the patient
or to the patient's physician. Alternatively, the patient may be issued a
benefit card or voucher that is to be presented at the patient's pharmacy
to receive the supply of medication. The amount of medication provided to
patients through these programs varies and typically ranges from a 30-day
supply to a 180-day supply. Most medication assistance programs require reenrollment,
usually every few months.
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Medication Assistance Programs for the Most Commonly Prescribed Drugs
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SOURCES OF INFORMATION ABOUT MEDICATION ASSISTANCE PROGRAMS
Information concerning pharmaceutical company–sponsored medication
assistance programs can be obtained from a variety of sources including the
Pharmaceutical Research and Manufacturers of America Web page (http://www.phrma.org), publications including the Reimbursement Assistance
Programs Sponsored by the Pharmaceutical Industry6
and the Directory of Prescription Drug Patient Assistance
Programs,7 and Internet Web sites. Examples
of Internet Web sites that can be used as an information source to increase
medication access include http://www.needymeds.com and http://www.themedicineprogram.com. However, the best information source concerning a company's assistance
program for a particular agent and for specific details concerning patient
eligibility and program enrollment is the manufacturer of the medication.
Approximately 53% of the top 200 medications prescribed have medication assistance
programs. Table 1 lists the names
and phone numbers of the manufacturers of these medications.
PROGRAM ELIGIBILITY AND ENROLLMENT
Medication assistance programs have varying eligibility criteria and
requirements for enrollment. Eligibility criteria for each medication program
are established by the individual pharmaceutical company. Some eligibility
criteria are common to many programs and may include limited or no prescription
insurance coverage, income and asset limitations, and ineligibility for public
assistance for medications, such as assistance from Medicaid and the Department
of Veterans Affairs. Income limitations typically range from $12 000
to $25 000 for a single person or 300% of the federal poverty thresholds.
Most companies have their own processes for patient enrollment that
typically require the completion of an application and reporting of the patient's
health insurance coverage, assets, salary, and liabilities. A prescription
for the medication is usually required. Many programs allow enrollment over
the phone and may determine patient's eligibility for the program at that
time. However, others require a completed application with original documents
before determining a patient's eligibility status. Development of a "universal"
application process that would be acceptable to most companies would greatly
benefit patients and health care providers while reducing personnel time required
to complete individual applications.
To determine eligibility, many companies require verification of patients'
financial status by certain documents including income tax returns, W-2 forms,
social security benefits and other government benefits, bank statements, mutual
fund and stock statements, and other asset reports. Once the information is
received by the company it is then evaluated and the patient's acceptability
determined.
Program enrollment is typically initiated by the patient's physician,
although enrollment may occur by other health care professionals such as a
pharmacist, nurse, social worker, or a patient's advocate (eg, medical personnel
or someone who maintains a relationship with the patient such as a family
member or friend). A few programs allow the patient to initiate enrollment
(eg, programs offered by Novartis Pharmaceuticals and some by Procter &
Gamble Pharmaceuticals Inc); however, the prescribing physician must be involved
regardless of who initiates the process. Information frequently needed to
process the application includes the patient's and physician's names and contact
information; the physician's state license number and drug enforcement number;
name, strength and amount of medication requested; specific medical data such
as diagnosis; the patient's financial documentation and insurance coverage;
and the physician's and patient's signatures.
COMMENT
IMPACT OF MEDICATION ASSISTANCE PROGRAMS
Successful enrollment of patients in manufacturers' medication assistance
programs reduces pharmacy expenditures at institutions that have a large indigent
population. For example, Hotchkiss and colleagues8
reported an estimated savings of greater than $7000 per month to their institution
from the enrollment of psychiatric patients into pharmaceutical manufacturers'
assistance programs. In 1994, Decane and Chapman9
calculated a cost avoidance of $448 852 for the first year after implementing
of a pharmacist-managed program to assist oncology patients in procuring medications
through pharmaceutical manufacturers.
Since medication assistance programs provide medications to patients
who cannot afford to purchase them and have no other means of attaining them,
it seems logical that these programs improve compliance, decrease adverse
experiences, and decrease cost. Nykamp and Ruggles10
conducted a study to determine if provision of both medical care and prescription
drugs at no cost would be associated with a change in health care charges.
Thirty-six indigent patients hospitalized within 6 months of study initiation
and who met criteria were enrolled in a 6-month assistance program. A historical
control was used in this study. Inpatient admissions decreased by 39.5% and
outpatient visits decreased by 64%, with a cost avoidance to the hospital
of $378 183. Providing outpatient visits, inpatient admissions, and prescription
drugs at no cost lowered overall costs to the hospital and decreased the number
of outpatient visits and hospitalizations.10
Additional studies evaluating the impact of assistance programs on health
outcomes are needed.
CONCLUSIONS
Noncompliance with medication therapy is one of the most significant
problems facing medical practice. The inability of patients to pay for their
medications is a major cause of noncompliance, leading to premature loss of
life, loss of work, an increase in adverse effects leading to hospitalizations
and other consequences, and a decrease in quality of life. In light of this,
as well as the increasing amount of money spent on prescription drugs and
limited prescription coverage for many individuals, medication assistance
programs are a valuable resource that can provide medications to eligible
patients at little or no cost. However, access to these programs may be limited
if health care providers are unaware of their existence or are not informed
of the enrollment process. Health care professionals should assist patients
by directing them to lines of assistance for which they are the most eligible.
This includes insurance coverage, government assistance programs, foundations,
and pharmaceutical companies. Pharmaceutical companies' patient assistance
programs increase medication access to patients in need.
AUTHOR INFORMATION
Accepted for publication July 31, 2001.
This research was partially funded by the Carlos and Marguerite Mason
Trust in support of the Medication Access Program.
Corresponding author and reprints: Marie A. Chisholm, PharmD, University
of Georgia College of Pharmacy at the Medical College of Georgia, Room CJ-1020,
Augusta, GA 30912-2450 (e-mail: mchishol{at}mail.mcg.edu).
From the Department of Clinical and Administrative Sciences, University
of Georgia College of Pharmacy, Athens, and the School of Medicine, Medical
College of Georgia, Augusta.
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