Chisholm MA, DiPiro JT. Pharmaceutical Manufacturer Assistance Programs. Arch Intern Med. 2002;162(7):780-784. doi:10.1001/archinte.162.7.780
Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: email@example.com).