AIDS Drug Assistance Programs Quickly Added Merck’s Isentress, Pfizer’s Selzentry, Despite Coverage Grace Period

Funding infusion, Medicare Part D helped ADAPs add new drugs and clear up patient waiting lists, according to report from Kaiser Foundation and state AIDS directors.

Most AIDS Drug Assistance Programs have quickly added both Merck's Isentress and Pfizer's Selzentry to their formularies, even though program rules permit a delay, according to an overview of ADAPs released April 8.

Effective July 1, 2007, ADAPs must cover at least one drug in every antiretroviral class, but are given a grace period for new drugs. The programs have until 90 days after a drug is added to HHS' "Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents" to update their formularies.

Both Isentress and Selzentry are still within the grace period, but 43 ADAPs have already added Isentress, the first approved HIV integrase strand transfer inhibitor, and 44 have added Selzentry, the first CCR5 co-receptor antagonist, according to the report.

"All states [included in the report] added them before that period had come, so that's another telling finding that states are ready and want to provide that access," said Julie Schofield, executive director of National Alliance of State and Territorial AIDS Directors.

Selzentry (maraviroc) was approved in August (¹ (Also see "Pfizer’s Selzentry Wins FDA Approval For HIV" - Pink Sheet, 6 Aug, 2007.)). Isentress (raltegravir) was approved two months later (² (Also see "Isentress Approval Carries Limited Indication" - Pink Sheet, 12 Oct, 2007.)).

The report, prepared by the Kaiser Family Foundation and NASTAD, is based on data for fiscal 2007 or as of June 2007.

It notes that 29 ADAPs covered all drugs in all antiretroviral classes, including Selzentry, Isentress, the 12 products that are either nucleoside reverse transcriptase inhibitors and four that are non-NRTIs, as well as Gilead/Bristol-Myers Squibb's multi-class combination product Atripla .

The minimum formulary requirements do not include combination products, nor drugs to treat or prevent opportunistic infection, treat hepatitis C or treat other conditions common in the AIDS/HIV population, such as diabetes or depression, although programs can cover such products.

ADAPs, which operate in all states and U.S. territories, are federally-funded payers of last resort. They can either pay for drugs directly or help participants with premiums and copayments for other reimbursement programs. They are a subset of the Ryan White AIDS program, administered by the HHS Health Resources and Services Administration.

The report notes that a number of initiatives helped states to both add additional drugs to their formularies and clear up waiting lists of patients seeking assistance.

These include the President's ADAP Initiative, a one-time $20 million effort announced in June 2004 to help states with patient backlogs.

Another factor was the start of Medicare Part D. ADAPs could help eligible individuals enroll in the Part D drug benefit, assist them with copayments, and use resulting savings for other patients. Drug treatment grants were also increased as part of the 2006 reauthorization of the Ryan White program and some states have boosted contributions to their ADAPs.

But Noreen O'Donnell, Ryan White program manager for South Carolina, a state that had 600 people on its waiting list just last year, said the most important action that helped the state eliminate the list by September 2007 was the help of community-based HIV/AIDS organizations that joined together to advocate with the legislature for ADAP, eventually gaining an additional $3 million in recurring funds.

Overall, ADAPs assisted almost 146,000 individuals in 2007, many of whom otherwise "would likely have limited or no access to medications and fall through the cracks in our larger health care system," the report says.

The total ADAP budget, including state and federal allotments and manufacturer rebates, was $1.43 billion for fiscal 2007, the large majority going specifically for drug expenditures.

-Lauren Smith ([email protected])