New California Law Requires Off-Label Coverage

In what could become model legislation for other states, a
recent California law (effective since January 1993)
requires insurance companies and health-care plans, if they
cover prescription drugs, to include coverage for off-label
use of approved drugs for life-threatening conditions,
provided that, RTwo articles from major peer reviewed medical
journals ... present data supporting the proposed off-label
use or uses as generally safe and effective unless there is
clear and convincing contradictory evidence presented in a
major peer reviewed medical journal.S The drugs also have to
be paid for if they are approved by the American Medical
Association Drug Evaluations, the American Hospital Formulary
Service Drug Information, or the United States Pharmacopoeia
Dispensing Information, Volume 1, Drug Information for the
Health Care Professional. (Off-label use means that a drug
has been approved by the FDA, but is being used for a purpose
not specifically approved by the FDA -- for example, a cancer
drug approved for certain tumors but then used in treating
other tumors.)

Off-label use of approved drugs has become a continuing
issue for people with AIDS. AIDS requires that many powerful
antimicrobial therapies be administered under new, emergency
conditions, although the manufacturers have been slow to do
the research and paperwork needed for approval for AIDS
indications. Many of these therapies are expensive, and
health insurance companies are often reluctant to pay unless
presented with irrefutable justification for the therapy.

For example, the drug clarithromycin was only approved in
December for mycobacterium avium complex (MAC) in people with
AIDS, although it was approved over a year ago for certain
respiratory infections in non-immune compromised individuals.
Clarithromycin was the treatment of choice for MAC well
before it was approved, due to promising results from early
trials and experience with the drug. Even though
clarithromycin was regarded as an essential life-saving
weapon against MAC, many people with AIDS found that their
insurance companies balked at the cost, which is several
hundred dollars a month.

Under the new California law, which added section 1367.21 to
the Health and Safety Code and sections 10123.195 and
11512.182 to the Insurance Code, insurers can no longer
refuse to pay. The law includes out-of-state companies which
issue policies in California. There are some exemptions,
especially contracts for delivery of Medicaid coverage.

The San Francisco-based organization Project Inform has
prepared an information packet to help people obtain
insurance payment for intravenous immune globulin (IVIG)
treatment. This therapy costs upwards of $1500 a month. It
consists of administering antibodies collected from the blood
of healthy individuals to those with low T-helper cell
counts. IVIG, which has just been approved for use in
children with AIDS but not adults, is a relatively nontoxic
way to prevent recurring viral and bacterial infections.
Those wishing to obtain the Project Inform packet on IVIG
reimbursement may call the Project Inform hotline at 800/822-
7422, or 415/558-9051.

If you know of other off-label treatments for an AIDS-related
condition which should be covered, and know of two journal
articles which support such a treatment, please contact Bill
Thorne, ACT UP/Golden Gate, 519 Castro Street, Box #M-93, San
Francisco, CA 94114, fax 415/252-9277. The HIV/AIDS Treatment
and Resource Library of Healing Alternatives Foundation
buyersU club in San Francisco will house the collection. The
buyersU club/library is located at 1748 Market St., Suite
204, San Francisco, CA 94102, 415/626-4053, fax 415/626-0451.