BETA News Briefs: Wider Access to Human Growth Hormone


BETA News Briefs: Wider Access to Human Growth Hormone

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

As a direct result of lobbying by California AIDS treatment advocates and activists, MediCal will now reimburse for the recombinant human growth hormone (Serostim) from Serono Laboratories through an FDA-sanctioned TIND (Treatment Investigational New Drug) program. TIND status allows physicians to obtain experimental drugs for their patients from the drug's manufacturer, usually for free. Serono has a "cost recovery" TIND for Serostim, which allows them to charge about $150 a day for the drug.

The drug has shown promising results in the treatment of AIDS-related wasting. MediCal's decision to reimburse for Serostim was supported by a collaborative advocacy effort by the AIDS Project Los Angeles, San Francisco AIDS Foundation, ACT/UP Golden Gate and Project Inform. MediCal will reimburse for at least 12 weeks of treatment with Serostim. AIDS community advocates are working to change the TIND protocol to allow for longer treatment with the drug.

The California legislature has appropriated approximately $10 million for Serostim for MediCal clients. The action by MediCal will likely set a precedent that may favorably impact Serostim reimbursement decisions by other states. For information on how to obtain Serostim, patients and physicians may call the Serostim Access Line at 1-800-714-2437. For the names and telephone numbers of doctors in the greater San Francisco Bay Area who accept MediCal and who are TIND sites for Serostim, call the San Francisco AIDS Foundation Hotline at 415-863-2437.

The FDA recently made a favorable change in the protocol that defines eligibility requirements for obtaining Serostim prior to its marketing approval. Previously, patients had to fail 2 FDA-approved treatments for AIDS-related wasting -- Megace and Marinol -- in order to qualify for Serostim under a Treatment Investigational New Drug (TIND) protocol.

Under the terms of the new Serostim protocol, patients qualify to receive the drug if they have failed either Megace or Marinol. The protocol change also permits a waiver of the requirement for prior use of Megace or Marinol altogether if the physician decides that these appetite stimulants are contraindicated for the patient. These changes to the protocol for receiving human growth hormone will create significantly broader access to Serostim.

Patient reimbursement advocacy activities and the distribution of Serostim are now handled by Stadtlanders Pharmacy, a mail-order business that has high visibility among people living with HIV infection and AIDS. The Stadtlander/Serostim connection may help to generate increased awareness of the availability of recombinant human growth hormone through a TIND program.


9509
BETA2621

Always watch for outdated information. This article first appeard in 1995. This material is designed to support, not replace, the relationship that exists between you and your doctor.

Copyright © 1995 - Bulletin of Experimental Treatments for AIDS (BETA). Reproduced with permission. BETA is published four times a year by the San Francisco AIDS Foundation. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. Call 415.487.8060; FAX: 415.487.8069. Mailing Address: P.O. Box 426182, San Francisco, CA 94142-6182.  beta@sfaf.org  http://www.sfaf.org/beta.html

This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.