Merck, known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) announced a number of new initiatives to help struggling state AIDS Drug Assistance Programmes (ADAPs) continue to provide access to medicines to people living with HIV. This is the third major response from Merck and ACTF in the last four years, as the financial crisis for these critical state programmes continues.
Merck has agreed to lower the price of Isentress (raltegravir) to eligible ADAPs, effective January 1, 2012. The new price will be "frozen" and will be available as part of the existing Merck special pricing program through December 31, 2013. Merck was the first company to freeze the price of an antiretroviral (ARV) therapy to ADAPs in 2003.
In addition, Merck and ACTF have agreed to the following initiatives: increasing support for the Welvista ADAP Programme. After its initial year in 2010 and evaluation of current needs, Merck is increasing it operations funding and medication donations for the Welvista ADAP Programme. The program helps address the medication needs of ADAP clients who are currently on state ADAP waiting lists by expediting access to HIV medicines through a simplified application process. Working to optimize the use of comprehensive health insurance options available to persons with HIV. Between 2009 and 2010, the use of private insurance by ADAPs tripled to more than 110,000 persons. The National Alliance of State and Territorial AIDS Directors (NASTAD) reported about 40 ADAPs used ADAP funds to purchase health insurance or pay insurance premiums, co-payments and/or deductibles for individuals eligible for ADAP (provided the insurance has comparable formulary benefits to that of the ADAP). Merck and NASTAD will seek solutions that overcome barriers to more widespread use of such approaches, such as expanding enrollments in Medicare Part D, private insurance and pre-existing condition insurance plans (PCIPs).
ISENTRESS is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients. The label for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled phase III clinical studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class ARV [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adults and one was conducted in treatment-naïve adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The safety and efficacy of ISENTRESS have not been established in paediatric patients.
Merck and the ACTF maintain a mutual commitment to partner together to assess the situation and to find solutions that will provide relief to sustain ADAPs. The first ADAP response from Merck and the ACTF was announced in August 2008, and the second response was announced in May 2010. At the time of the latest response, it was both parties' expectation that those actions – including a special pricing programme for ADAPs and price freeze for ARV medicines – would be sufficient until 2014. It is believed that, in 2014, the US government's newly-expanded Medicaid programme and subsidized private health insurance programme, mandated by the Patient Protection and Affordable Care Act (PPACA), will provide sufficient, sustainable care to the majority of people served by ADAPs.
It has become clear within the last year that previous agreements coupled with current federal and state funding were not enough to sustain ADAPs until 2014. Merck’s latest response was a result of discussions between Merck and the ACTF over the last few months, and reflects the continuing fiscal circumstances in the states and the unmet needs of people with HIV.
“On behalf of the nearly two hundred thousand clients that ADAPs serve, we applaud Merck for its continued commitment to HIV,” said Dwayne Haught, spokesperson for the ACTF and manager of the Texas ADAP. “Merck's history of HIV research and development, responsible pricing and related efforts are consistent with its track record of working to help ensure access to treatments for the people most in need. We commend Merck for responding once again to the unprecedented fiscal need faced by state ADAPs by providing additional support to help provide people living with HIV access to HIV medicines.”
“With our company's legacy in HIV over the last 25 years, we consider it our obligation to continue to work with the ADAPs on solutions that provide crucial support for uninsured and underserved people living with HIV,” said Chirfi Guindo, vice president and general manager, Merck HIV Franchise. “It is imperative to act now, given the ongoing ADAP funding crisis. We applaud President Obama's recent announcements of enhanced federal support for ADAPs and state HIV programmes, and look forward to working together on sustainable solutions through improvements in the health care delivery system.”
“These actions come at a time when federal funding for ADAPs remains relatively flat compared to enrollment growth, and state funding continues to fluctuate, making it difficult for the ADAP programmes to provide access and care to all the clients they need to serve,” said Lynda Dee, spokesperson for the Fair Pricing Coalition. “The Fair Pricing Coalition commends Merck for its long-standing commitment to providing access to treatment and welcomes Merck's new initiatives to help with the current ADAP funding crises.”
Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS and other suspect agents if severe hypersensitivity, severe rash, or rash with systematic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely.
Grade 2-4 creatine kinase laboratory abnormalities were observed in patients treated with ISENTRESS. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.
ISENTRESS is Merck's integrase inhibitor for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients as part of combination therapy. It is currently the only approved integrase inhibitor for the treatment of HIV-1. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. Other HIV-1 drugs in use inhibit two other enzymes critical to the HIV-1 replication process – protease and reverse transcriptase – but ISENTRESS is the only approved medicine that inhibits the integrase enzyme. ISENTRESS is now approved in combination therapy in more than 45 countries for use in treatment-naïve adult patients with HIV-1 and in more than 90 countries for use in treatment-experienced adult patients with HIV-1. Merck is continuing to move forward with filings in additional countries around the world.
Merck's patient assistance programmes in the US. The SUPPORT Programme is a two-part programme that consists of: free reimbursement support services; and a patient assistance programme for eligible individuals who have been prescribed one or more Merck HIV medicines. One part of this free program provides personalized support and patient advocacy regarding individual reimbursement issues. In addition, the SUPPORT Programme also offers a patient assistance programme, which may provide Merck HIV medicines free of charge to eligible patients which may be delivered directly to the patient's home.
The ACTF works in partnership with pharmaceutical manufacturers of antiretroviral and other HIV-related medications to reduce drug costs and improve access to medications for clients in the nation’s ADAPs. It is estimated that ACTF agreements with companies have saved ADAPs approximately $1.2 billion since 2003. NASTAD provides logistical support for the ACTF.