BRISTOL-MYERS SQUIBB CARDIOVASCULAR DRUG EXPANDED ACCESS PROGRAM

BRISTOL-MYERS SQUIBB CARDIOVASCULAR DRUG EXPANDED ACCESS PROGRAM, which goes into effect on March 1, 1992, will make all 17 of the company's cardiovascular products available to patients without health care insurance who meet the program's financial eligibility requirements. The Bristol-Myers Squibb Cardiovascular Access Program, announced by the company on Jan. 23, is an extension of similar assistance and indigent access prescription drug programs for the AIDS drug Videx (ddI), begun in September 1989, and for BMS cancer drugs, begun in 1973. The cardiovascular assistance program is, in essence, an application by BMS of the reimbursement negotiating skills developed in the cancer and AIDS specialty areas to a broader treatment category. The program has significant image value for BMS, but it also should have commercial benefits, expanding third- party reimbursement coverage for BMS cardiovascular products. The program covers the BMS mainframe cardiovascular product, the angiotensin converting enzyme inhibitor Capoten (captopril) for hypertension and heart failure; the ACE inhibitor Monopril (fosinopril), approved in 1991 for mild to moderate hypertension; Pravachol (pravastatin), the HMG-CoA reductase inhibitor cholesterol-lowering drug introduced in mid-November; Corgard (nadolol) for hypertension and angina, the company's sole remaining beta blocker on the U.S. market; and the cholesterol- reducing cholestyramine products Questran and Questran Light. BMS is not publicly estimating the value of the products that will be given away in the expanded access program but called the value "significant." With the probable expansion of the patient population reimbursed by third-party payers, the program presumably does not pose a large financial risk for the company. Searle began a similar indigent giveaway program for Calan-SR in early 1987. While Searle was prepared to give away up to $10 mil. of its product in the first year, the initial indigent care donations did not reach that level. Calan-SR emerged from the promotional effort as a major product in the cardiovascular class. Two parts comprise the BMS program. Physicians who are enrolled in the program will call an 800 toll-free number that connects to a reimbursement counselor. BMS will be educating physicians about the program and providing the 800 number in the interim before the program's March 1 start-up. Based on the patient information provided by the physician, the counselor will identify third-party reimbursement programs for which the patient may be eligible based on individual needs and geographical location. The counselors will follow up with each patient. For patients not eligible for third-party reimbursement, the counselor will send the physician a form for enrolling the patient in the cardiovascular access program, which initially will provide medication for 180 days. Patients eligible for the Bristol-Myers Squibb access program will have a 90-day supply of their cardiovascular medication sent to their physician. A second 90-day supply will be sent upon verification by the physician that the patient's health and financial status remain the same. After 180 days, the patient will have to be requalified to remain in the access program. The system to deliver directly to physicians was also perfected by BMS during its large, open-label trial for Videx. BMS initiated the cardiovascular drug expanded access program in response to an American Heart Association task force report released on Nov. 13 advocating pharmaceutical industry participation in providing cardiovascular drugs to the indigent ("The Pink Sheet" Nov. 25, T&G-2). AHA estimates that $6.1 bil. will be spent in 1992 on cardiovascular drugs for the 69.1 mil. Americans affected by cardiovascular diseases, including heart disease, stroke and hypertension. AHA Past President Harriet Dustan, MD, challenged the drug industry to adopt a widely promoted indigent care program last November. Dustan even urged a federally-funded giveaway program. She appeared at the BMS press conference to praise the program. Similarly, Rep. Stark (D-Calif.), one of the most persistent critics of the drug industry pricing policies, issued a Jan. 23 statement stating that BMS and AHA "deserve commendation" for the program. The BMS program will address the elderly on fixed incomes: workers without health insurance who fail to meet the criteria for Medicaid coverage and those who escape the government safety net. The announcement of the program follows BMS' decision on Jan. 7 to extend its Medicaid drug discount rebate program to fully federally-funded public health service clinics and other agencies that buy pharmaceuticals off the Department of Veterans Affairs- administered federal supply schedule ("The Pink Sheet" Jan. 13, p. 4).