Prescription Drug Payment: Pharmaceutical Manufacturers' Patient Assistance Programs

The high prices of many prescription drugs create serious
obstacles to receiving necessary care, for persons with no
health insurance or inadequate insurance. To help respond to
this problem, almost every pharmaceutical company of
significant size doing business in the U.S. has set up some
sort of assistance program for "medically indigent" patients
-- generally defined as those with low income, without
insurance, and ineligible for public programs that pay for
prescription drugs. These patient assistance programs supply
free medicines to those who are eligible. Some provide an
annual "cap" or limit to the cost of extremely expensive
drugs, regardless of the patient's income or insurance.

The details vary from company to company, but most work in
basically the same way: A toll-free phone line takes calls
from doctors or other health-care providers. (While most of
these services will give basic information to patients who
call, generally it is the physician who must actually enroll
the patient in the program). Most programs require
application forms, which are either supplied in advance to
the doctor or sent out on request, but some will allow at
least an initial sign-up by phone if the patient seems to
meet eligibility requirements.

Not surprisingly, the companies would much prefer to be paid
for their products than to give them away for free. Most will
gladly provide assistance in locating and dealing with state-
run AIDS drug programs or other possible sources of
reimbursement. Most companies will provide free medication
only to those who are ineligible for other forms of
assistance, although some offer temporary supplies to those
who need the product while an application for such assistance
is pending.

Income requirements vary considerably. Several companies
define "indigent" as an uninsured person with an annual
income below $25,000 (higher if there are dependents). Some
are lower; the lowest published income requirement we could
find was SmithKline Beecham's at $7,000 per year for a single
person. A number of companies, including Burroughs Wellcome,
declined to specify their income thresholds, apparently
fearing that publishing a specific income requirement might
facilitate cheating. Most say they will consider mitigating
factors, such as other out-of-pocket medical expenses, as
well.

Rules regarding off-label use of drugs vary. Some programs
specify that free products may be used for labeled
indications only. Others, such as Amgen, are less precise,
requiring that the products be used for "medically
appropriate" purposes, or setting up specific requirements
for off-label indications.

Real-world practice, however, seems to be somewhat looser
than what the companies put on paper. Although application
forms ask the physician to indicate the purpose of the
prescription, in most cases the companies take the doctor's
word for it. "Officially all I can tell you is what the
brochure says," one company spokesman who requested anonymity
commented. "But if you've got a friend, tell them to have
their doctor tell us whatever works."

How well do the programs work in real life? As this writer
found when researching a similar article two years ago
(published in PAACNOTES, January/February 1992), most of the
providers with whom we spoke -- doctors, pharmacists, AIDS
service and advocacy organizations, etc. -- had only limited
experience with the programs. While some took that as a sign
that the programs are underpublicized and underused, our
limited sampling did not give us enough information to draw
firm conclusions. But physicians and patients should be aware
that it may take weeks to get a supply of the drug.

The programs get mixed reviews from those who have used them.
The office manager for one San Francisco doctor with a
substantial HIV/AIDS practice (who asked not to be named)
complained of "a maze of bureaucracy" in the programs she'd
dealt with. "It is a very involved process for everyone," she
said.

One common hang-up occurs when there is some question about
an individual's insurance status, or about whether or not a
given prescription is covered by the person's policy. The
office manager above cited a particularly horrific case
involving Neupogen (filgrastim, G-CSF), marketed by Amgen, in
which the drug company and the patient's insurer went around
in circles for months while the patient at times went without
medication.

But for every such horror story, there seems to be someone
who's had a much easier time. Ed Miller, patient advocate at
Castro Village Pharmacy in San Francisco, says his
experiences with Amgen's patient assistance program have been
"really good" with "quick service." He says his encounters
with other programs have ranged from "good" to "nightmarish,"
adding, "sometimes they make them so cumbersome you don't
want to use them."

Still, he and others we contacted hasten to add that these
programs can be genuinely helpful, and that perseverance pays
off. "You can get on the programs," Miller says, "but you
have to be persistent."

Note: This article only lists drug assistance programs of
pharmaceutical manufacturers. For an overview of other
programs and methods of reducing the cost of prescription
drugs -- many of which are poorly known and underused -- see
"Prescription Drug Assistance for the Moderate- and Low-
Income Disabled," by Thomas P. McCormack, PAACNOTES June
1993. That article includes Medicaid, state drug assistance
programs, a number of Federal programs for veterans, HMOs for
Medicare beneficiaries, Medicare coverage of pain and certain
other medications under certain conditions, state health
insurance risk pools, "Medigap" insurance, mail-order
pharmacies that waive deductibles and copayments, low-income
clinics, certain programs for children, Blue Shield programs
in some states, an AARP program for persons over 50, and
buying drugs abroad (often for a third of U.S. cost, and
often paid for by private U.S. health plans).

Also note that the list below includes only approved
prescription drugs, not expanded-access programs for
experimental drugs which have not been approved for
marketing.

Partial List of Companies, Drugs

The 1994 Directory of Prescription Drug Indigent Programs,
published by the Pharmaceutical Manufacturers Association,
lists 63 company programs that cover hundreds of different
prescription drugs. Our list below has included drugs most
likely to be used in treatment of HIV/AIDS and associated
conditions, whether or not this is their most common or well-
known application, but space does not permit us to list every
drug which might come up. The fact that a product or company
is not listed should not be taken to mean that no assistance
program exists. Virtually all major drug companies doing
business in the U.S. have some sort program to assist
indigent patients, covering most or all of their products
(the most common exception being narcotics). When in doubt,
call.

Most phone lines operate during normal business hours,
although some are staffed into the evening. Almost all are
based on the east coast and set their hours according to
Eastern Time. The companies tinker with these programs
relatively frequently, and so procedures, eligibility
requirements, products covered, etc., may be subject to
change. When in doubt, call.

Patient Assistance Programs

Abbott Laboratories: Biaxin (clarithromycin). 800/688-9118.
Pending FDA approval of Biaxin for MAC treatment, program is
part of an ongoing clinical trial; some additional
documentation is required from physicians.

Adria Laboratories: Mycobutin (rifabutin). 800/795-9759.

Amgen Inc: Neupogen (filgrastim, G-CSF); Epogen (epoetin
alfa, erythropoietin). 800/272-9376. Epogen program is for
dialysis patients only. For other indications see listing for
Ortho Biotech (Procrit).

Astra Pharmaceutical Products, Inc: Foscavir (foscarnet
sodium). 800/488-3247.

Bristol-Myers Squibb Company: Videx (ddI); Megace (megestrol
acetate). 800/788-0123.

Burroughs Wellcome Co: Retrovir (AZT); Zovirax (acyclovir);
Septra (TMP-SMX); Mepron (atovaquone); Daraprim
(pyrimethamine); Wellcovorin (leucovorin). 800/722-9294.
[Note: On September 17, 1993, Burroughs-Wellcome announced
that it had improved its program to make it easier to use.
Under the new program, eligible patients will receive a
prescription benefit card that can be used in any pharmacy.
To be eligible, patients must be a resident of the U.S. or
its territories, be financially disadvantaged, and have
applied and be awaiting reply from other prescription funding
sources, or not qualify for private or government
assistance.]

For leucovorin, also see listing under Immunex, below.

Ciba Pharmaceuticals: Rimactane (rifampin); Lamprene
(clofazimine). 800/257-3273. For rifampin, also see listing
under Marion Merrell Dow Inc., below.

Fujisawa USA, Inc: Nebupent (pentamidine). 800/366-6323.
Hotline provides reimbursement assistance. Free drug is
distributed mainly via nonprofit groups and clinics, but
requests from doctors for individual patients will be
considered when "special circumstances" apply.

Hoechst-Roussel Pharmaceuticals Inc: Trental
(pentoxifylline). 800/422-4779. HIV infection is not an
approved indication for Trental; a company spokesperson was
unsure of Hoechst Roussel's policy on off-label uses.

Hoffmann-La Roche: See Roche Laboratories, below.

Immunex Corporation: Leukine (sargramostim, GM-CSF);
Leucovorin (leucovorin calcium). 800/466-8639. Note:
Burroughs Wellcome also markets leucovorin; see above.

Janssen Pharmaceutica: Nizoral (ketoconazole); Sporanox
(itraconazole). 800/544-2987.

Lederle Laboratories: Myambutol (ethambutol). 800/533-2273.

Marion Merrell Dow Inc: Rifadin (rifampin). 800/362-7466.

Miles Inc. Pharmaceutical Division: Cipro (ciprofloxacin).
800/998-9180.

Ortho Biotech Inc: Procrit (epoetin alfa, erythropoietin).
800/553-3851 reimbursement assistance; 800/447-3437 financial
assistance (indigent patients); 800/441-1366 "cost sharing"
(caps annual of treatment at $8500).

Ortho Pharmaceutical Corporation: Monistat (miconazole).
800/682-6532.

Pfizer Inc: Zithromax (azithromycin). 800/646-4455. Note:
Fluconazole handled through separate number, below.

Pfizer Inc Roerig Division: Diflucan (fluconazole). 800/869-
9979.

Roche Laboratories: HIVID (ddC). 800/285-4484. Program is
similar but administered separately from those listed below.

Roche Laboratories: Roferon-A (interferon alfa-2a). 800/443-
6676. Separate from the free-drug program, a "cap" program
limits annual cost to $9800 whether or not patient is
insured.

Roche Laboratories: Bactrim (TMP-SMX). 800/526-6367.

Roxane Laboratories. Marinol (dronabinol). 800/688-9118.

Sandoz Pharmaceuticals Corporation: Sandostatin (octreotide).
800/447-6673. Drugs usually dispensed through a mail order
pharmacy; patient is responsible for dispensing and shipping
fees.

Schering Laboratories: Intron A (interferon alfa-2b).
800/521-7157. Free drug for uninsured/low income, and $9800
annual cap for all patients.

SmithKline Beecham Pharmaceuticals: Tagamet (cimetidine);
Compazine (prochlorperazine). 800/546-0420. On paper this is
the toughest program we found -- labeled indications only and
"indigent" defined as an annual income of $7000 or less for
single persons. No provider we contacted had direct
experience with it.

Syntex Laboratories, Inc: Cytovene (ganciclovir sodium).
800/444-4200.

The Upjohn Company: Cleocin (clindamycin). 800/253-8600 ext.
36004. Covers oral drug only, not the IV drug. Presently the
program is handled informally, through the company's sales
representatives. If unsure how to reach his sales rep, the
doctor can call the number listed. Program may be revised
shortly.