Medicare and Part D

HMMWG LETTER TO CMS:
Medicare Inclusion of Raltegravir and Maraviroc

March 26, 2007

Leslie Norwalk
Acting Administrator
Centers for Medicare and Medicaid Services
Sent via fax: 202-690-6262

Dear Ms. Norwalk:

We are writing on behalf of the HIV Medicare and Medicaid Work Group (HMMWG) to strongly urge you to ensure that Medicare beneficiaries with HIV/AIDS have timely access to two antiretroviral medications that are expected to be available this year. HMMWG represents more than 80 national and community-based organizations from across the country and includes people living with HIV/AIDS, medical providers, advocates and program administrators that deliver HIV-related healthcare and support services.

The new drug discoveries—raltegravir and maraviroc—offer great hope for people with HIV/AIDS who are no longer responding to the currently available treatment options. In fact, study data released last month indicated that they are highly effective at managing HIV in people that have developed resistance to at least one and in the case of maraviroc—three classes of antiretrovirals.

An estimated 100,000 Medicare beneficiaries living with HIV/AIDS now rely on Medicare for their prescription drug coverage and an estimated 80,000 of them also are dually eligible for Medicaid coverage. Most people with HIV/AIDS qualify for Medicare through the disability requirement, meaning that they are at an advanced disease stage. Their lives depend on reliable, affordable access to a combination of antiretroviral medications that effectively suppresses HIV.

We are very concerned that Medicare beneficiaries, who by virtue of qualifying for the program have been disabled by AIDS for at least two years, will not have timely access to these new antiretrovirals through Medicare Part D. Medicare beneficiaries are much more likely than the general population of people with HIV to be in immediate need of these new medications due to the greater likelihood of drug resistance at the advanced stages of HIV disease. The situation is particularly dire for Medicare beneficiaries that are already taking these medications through expanded access programs. Expanded access programs make promising new therapeutics available to people with limited treatment options before they are approved by the Food and Drug Administration (FDA). Upon FDA-approval, the programs are discontinued. For Medicare beneficiaries with HIV/AIDS that gained early access to raltegravir and maraviroc through these programs, any disruption in therapy poses a serious risk to their health and possibly their life.

We urge you to notify drug plans upon the approval of new antiretrovirals and urge them to add the drugs to their formularies expeditiously. Beneficiaries cannot rely on the burdensome and unpredictable exceptions process that varies from plan to plan to access these critical medications. At a minimum, plans should be encouraged to provide immediate coverage to beneficiaries that have been receiving the drugs through expanded access programs. Please contact Laura Hanen, Director of Government Relations of the National Alliance of State and Territorial AIDS Directors at (202) 434-8090 or Robert Greenwald, Director of the Treatment Access Expansion Project at (617) 877-3223 with any questions or comments.

Sincerely,

HMMWG Steering Committee

AIDS Action
AIDS Alliance for Children, Youth & Families
AIDS Foundation of Chicago
The AIDS Institute
American Academy of HIV Medicine
Community HIV/AIDS Mobilization Project
Gay Men's Health Crisis
Health and Disability Advocates
HIV Medicine Association
Housing Works
Human Rights Campaign
Indiana Minority Health Coalition, Inc.
Lifelong AIDS Alliance
National Alliance of State and Territorial AIDS Directors
National Association of People With AIDS
National Health Law Program
National Minority AIDS Council
New York AIDS Coalition
Project Inform
San Francisco AIDS Foundation
Title II Community AIDS National Network
Treatment Access Expansion Project