PI Action alerts & updates ... 1997

Urge California State Office of AIDS
to Approve the Inclusion of nevirapine to
AIDS Drug Assistance Program Formulary

Project Inform is encouraging the California State Office of AIDS to add Nevirapine (Viramune) to the AIDS Drug Assistance Program (ADAP) formulary. Nevirapine, manufactured by Boehringer Ingelheim, is the first of a new class of drugs called non-nucleoside reverse transcriptase inhibitors to be approved by the Food and Drug Administration (FDA). Cost projections on adding this therapy to the list of available drugs suggest no increase—and possibly a decrease—in spending for the state; therefore, it should be included immediately. The drug may benefit those who are resistant to their current drug combination. Please urge the California Department of Health Services to move quickly to make this promising treatment available!

Action Needed:
Write or fax Kim Belshé, Director of the California Department of Health Services. Urge her to add Nevirapine to the California ADAP formulary immediately. Stress that including this therapy is expected to be cost neutral or a cost savings for the state. You can use the following information from Project Inform’s statement on Nevirapine to help craft your message.

Contact Information:
Kim Belshé
Director, California Department of Health Services
714 P Street, #1253
Sacramento, CA 95814
FAX: 916-657-5183

Sample Letter:

Dear Ms. Belshé,

I am writing to urge you to add Nevirapine immediately to the California AIDS Drug Assistance Program formulary. This is a promising new treatment that may be beneficial to those who have developed resistance to their current drug regimen.

Insert a short personal note here. Explain if you or someone you care about may need access to this treatment. Otherwise, discuss the importance of providing access to all promising HIV/AIDS therapies to those who can not otherwise afford them.

Cost projections for including this therapy indicate no increase in spending for the state, and possibly a cost savings. Please act now to provide this drug to those who want access to it.

Sincerely,
Your name

Project Inform’s statement
on Nevirapine & the California ADAP formulary:
Project Inform encourages the California State Office of AIDS to approve the inclusion of Nevirapine (Viramune, Boehringer Ingelheim) in the California AIDS Drug Assistance Program (ADAP) as quickly as possible. We feel that Nevirapine should be immediately covered under ADAP for the following reasons:

• Nevirapine gained U.S. Food and Drug Administration (FDA) approval for use in combination therapy in June of 1996.
  The Medical Advisory Board for ADAP has recommended as one of its highest priorities the addition of this therapy to the ADAP formulary.
  Cost projections regarding the use of this therapy would suggest that its addition to the formulary would be either cost neutral or, more probably, a cost savings.
• Nevirapine is the first of a new class of drugs, called non-nucleoside reverse transcriptase inhibitors, to be approved by the FDA.
• Recent data strongly suggests that individuals who have been using anti-HIV drugs for a period of time and have developed resistance to their current protocol should switch to two drugs they have not used simultaneously in order to combat HIV most effectively. The inclusion of Nevirapine, as both a new class of drugs and a new option, on the ADAP formulary is especially urgent for those who may no longer be benefiting from their treatment regimen and need to switch therapies.
  Nevirapine is known to cross the blood-brain barrier, and may therefore be helpful in preventing and/or treating neurological manifestations of HIV-disease, including AIDS Dementia Complex. Currently available protease inhibitors do not cross the blood-brain barrier.
• Nevirapine is less expensive than protease inhibitors and may be an attractive option for people initiating therapy for the first time (e.g. have never previously been on antivirals). The best data supporting the use of the drug is in this setting. Currently people who access ADAP for therapy do not have the option of this less expensive alternative, which in some cases may be more desirable than the more expensive options available through ADAP.
• Nevirapine has been tested in a few pregnant women and larger studies are underway.
• Nevirapine may be useful in preventing mother-to-child transmission of HIV.