AIDS Treatment News #186 - November 5, 1993
Bruce Mirken

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.

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