For more than 30 years, our company has been committed to addressing the global challenge of the HIV epidemic.
With over 35 million people infected and 2 million new infections each year globally, the challenges of HIV are vast, impacting both developed and developing countries. These challenges include scientific, behavioral and programmatic aspects that continue to change as the epidemic evolves.
Since 1985, we’ve been engaged in research and development (R&D) efforts in both prevention and treatment of HIV. These efforts continue today with a focus on prevention, treatment, and cure for HIV.
Research is just one part of our comprehensive strategy to address unmet needs in combatting HIV. Our company has also sought to make a difference in the fight against HIV through efforts to enhance access to our HIV medicines, in both the developed and the developing world, and through partnerships that seek to strengthen health systems to better deliver prevention and treatment services. Clearly, the need is too great for any one stakeholder to address, requiring coordinated efforts among many organizations.
Our company has had an intensive, broad-based HIV clinical research program in place since 1985 which has sought to address both treatment and prevention.
In addition to our own research efforts, we have entered into collaborations with other researchers and scientific organizations to help accelerate the search for new treatments and possible cures. Our work has been pioneering, and was pivotal in the development of new antiretroviral (ARV) treatments, including protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and integrase inhibitors. We have also played an important role in collaboration with others to define the principles for combination ARV treatment that are the standard for today’s treatment paradigm.
Since our company’s HIV products became available more than two decades ago, our company has worked to expand access to our medicines, build health care infrastructure, and address health and development challenges around the world. Learn more.
We continue to focus on comprehensive R&D that targets HIV, recognizing the need for new methods to address the epidemic. Our current R&D work in HIV includes programs to develop novel HIV-prevention technologies, new HIV antiretroviral medicines, and approaches to addressing HIV latency and eradication.
We have an active HIV R&D program to develop new HIV antiretroviral medicines that address unmet needs in HIV treatment. Our company has an ongoing commitment to HIV therapeutic R&D. Our clinical development programs include an NNRTI in Phase III and several earlier-stage clinical development programs.
FOCUSING ON UNMET NEED IN PEDIATRIC TREATMENT
As part of the company’s commitment to fighting HIV/AIDS, we have conducted extensive R&D efforts to develop pediatric formulations for our HIV ARVs.
The burden of pediatric HIV falls primarily in sub-Saharan Africa and in lower-income countries. The lack of demand for pediatric HIV medicines in high-income countries provides little commercial incentive for the development of optimized pediatric combinations, such as those seen in adults. Consequently, public-private partnerships are key mechanisms to facilitate availability of new pediatric formulations and to develop optimized formulations and combinations of pediatric ARVs.
Most recently, we have worked to increase access to the pediatric formulations of raltegravir, our integrase inhibitor, in the areas of greatest need. We have developed several pediatric formulations of raltegravir, which, following clinical studies conducted in collaboration with the IMPAACT Network, have been approved by the U.S. Food and Drug Administration (FDA). In November 2017, raltegravir received approval from the FDA for the treatment of neonates from birth. In its various dosage formulations, raltegravir is now approved by the FDA from birth through adulthood.
In February 2015, we entered into an agreement with the Medicines Patent Pool (MPP). The agreement is designed to improve access to raltegravir for pediatric populations in 92 low- and middle-income countries, where 98 percent of the children infected by HIV live. Through this agreement, our company has licensed our pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children from 4 weeks to under 12 years of age in developing countries. This is MPP’s first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy for infants and children in this age range.
The agreement also allows for the development of novel pediatric formulations of raltegravir and novel combinations, in support of the “Global Pediatric Antiretroviral Commitment-to-Action” announced by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Pediatric HIV Treatment Initiative (PHTI), and the Global Fund to Fight AIDS, Tuberculosis and Malaria to accelerate the development of new, high-priority pediatric ARV co-formulations.
In November 2017, our company joined other key stakeholders at the Vatican in Rome as part of the meeting that endorsed the Rome Action Plan for Scaling Up Early Diagnosis and Treatment of Children and Adolescents.1 As part of the Rome Action Plan, our company has committed to making pediatric raltegravir available at no profit in low-income countries, Least Developed Countries (LDCs), and across sub-Saharan African countries, until generics are available.
Efforts to register the formulations of raltegravir broadly in the countries with the greatest pediatric HIV burden are ongoing. And, as of December 2017, ISENTRESS® (raltegravir) chewable tablets (25mg and/or 100mg) have been approved in 72 countries, and ISENTRESS granules for suspension (100mg) have been approved in 34 countries for use in pediatric patients.
REGULATORY APPROVAL OF NEW RALTEGRAVIR ONCE DAILY DOSE
In May 2017, the FDA approved ISENTRESS® HD in the U.S., a 1,200 mg (2 x 600 mg) once-daily dose of ISENTRESS, to be given in combination with other antiretroviral agents, to adults as well as to pediatric patients weighing at least 40 kg, who are treatment-naïve or who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Multi-stakeholder efforts, including those of governments, civil society, donors and the private sector, are needed to address the challenges of delivering comprehensive HIV prevention, care and treatment.
A MULTIFACETED APPROACH TO IMPROVING ACCESS
We are committed to working with governments, donors, innovative and generic manufacturers, multilateral organizations, and civil society to address the full range of factors affecting access. We strive to find new ways to apply our expertise, human and financial resources, and market-based solutions to addressing the complex challenge of patient access. Our strategies are designed to enable us to facilitate access while continuing to develop new medicines. They also help us move beyond the limits of what we can achieve if we work alone. Collaboration has been essential to the progress made against HIV.
We have seen that increasing access requires a broad, comprehensive approach. Consequently, we are committed to improving patient access through expanded availability, enhanced access strategies and multi-sectoral partnerships.
To make these possible, we have employed multiple strategies to address the needs of particular regions and countries, including: seeking broad registration of our antiretroviral medicines (ARVs); implementing differential-pricing strategies; signing voluntary licenses with generic manufacturers; developing pediatric formulations; and establishing strong collaborations with governments, manufacturers and other stakeholders.
ENHANCING ACCESS IN THE DEVELOPING WORLD
To facilitate access to raltegravir in sub-Saharan Africa and in World Bank-defined low-income countries, the areas of greatest need and the least ability to finance health care, we instituted a multi-strategy model that includes implementing a low-cost supply chain with manufacturing partners that has enabled us to reduce our access price in sub-Saharan Africa, low-income countries and LDCs, and to grant nonexclusive voluntary licenses to multiple generic manufacturers to supply generic raltegravir in these regions.
Public-sector purchasers in these 62 countries are eligible for our lowest price. According to the WHO, three-fifths of patients in need of therapy live in these countries. A complete list is available here.
Given the varying levels of economic development and national strategies, in other middle-income countries, we have implemented strategies to make meaningful improvements in patient access. We are focusing on working with governments and with other country stakeholders to develop strategies tailored to each country’s HIV-access needs. As part of this effort, we have implemented a differential pricing policy based on country income level, disease burden, treatment-guideline position, patient access through national AIDS treatment programs, and market conditions. As conditions evolve, we continue to refine these country-specific models.
To truly enhance access to treatment in low- and middle-income countries, the international community must collaborate to strengthen health care infrastructure, to ensure adequate financing for health, and to help to build local health care capacity through training and support. Pharmaceutical companies alone cannot solve these immense public-health problems. Sustainable solutions will come from comprehensive approaches that draw on the expertise of all stakeholders.
ADDRESSING ACCESS ISSUES IN THE DEVELOPED WORLD
In developed countries, we continue to work to address patient access needs. In the United States, for example, many state AIDS Drug Assistance Programs (ADAPs) have struggled to meet growing need. Over the last two decades, our company has lowered or frozen the price of our ARVs five times. We also continue to offer support to eligible patients through our U.S. Patient Assistance Program and Co-Pay Assistance Program. Since 2010, we have worked with Welvista and with HarborPath to offer immediate access to no-cost HIV medicines to patients on ADAP waiting lists.
State AIDS Drug Assistance Program (ADAP)
We have a long history of working closely with leaders from the HIV community to ensure that our approach to pricing our medications is fair and reasonable, balancing our interest in conducting extensive HIV research with efforts to support broad access to our medicines.
We were one of the first companies to provide our HIV medicines to uninsured patients on waiting lists for drugs under the AIDS Drug Assistance Program (ADAP). In addition, we were the first company to provide a price freeze for state ADAPs in the late 1990s, when they began to suffer a funding challenge.
We expanded our price-freeze policy to subsequent products, and also continue to provide expanded financial relief to state ADAPs through increased discounts. Through the agreement, which has been extended through December 31, 2018, we provide continued support for initiatives that give low-income individuals living with HIV access to medicines.
ADAPs reach approximately one-third of the people with HIV estimated to be receiving care nationally.
U.S. Patient Assistance Program
Our commitment to patients’ access to our products is reflected in our U.S. Patient Assistance Program. CRIXIVAN® (indinavir sulfate) and ISENTRESS qualify for this program. This private and confidential program provides product free of charge to eligible individuals, primarily the uninsured, who, without our assistance, could not afford this medicine. Learn more.
Co-Pay Assistance Program in the U.S.
In addition to our Patient Assistance Program, we have a program in the United States for eligible patients on ISENTRESS or ISENTRESS HD. If patients have private insurance and an out-of-pocket cost for ISENTRESS or ISENTRESS HD, they may be eligible to receive a savings coupon. The coupon provides savings toward their out-of-pocket costs. Restrictions, terms and conditions apply. Learn more.
Common Patient Assistance Program Application
We also participate in the national Common Patient Assistance Program Application (CPAPA) for HIV medications. The form was developed by the Department of Health and Human Services (DHHS), participating pharmaceutical companies, the National Alliance of State and Territorial AIDS Directors (NASTAD), and community stakeholders. The form can be used both by people living with HIV and by their providers, and reduces the need to complete several different and individual PAP application forms for HIV medications.
We have sought to reduce the cost of our ARVs for people living in the world’s poorest countries and those hit hardest by the epidemic.
We have worked with external manufacturers and suppliers to achieve incremental efficiencies for our branded raltegravir, ISENTRESS. We established a low-cost supply chain with external partners for commercialization in all low-income countries and all countries in sub-Saharan Africa.
With the implementation of this supply chain, we were able to reduce our price of ISENTRESS to $1.85 per day for these countries. We have also granted multiple nonexclusive licenses to several Indian generic manufacturers for the manufacture and commercialization of the 400mg tablet formulation of raltegravir in 60 low-income and sub-Saharan African countries. In addition, in February 2014, together with Cipla, we announced a strategic partnership to co-market raltegravir (400mg tablet) in India.
In February 2015, together with the Medicines Patent Pool (MPP), we announced a licensing agreement for pediatric formulations of raltegravir for children less than 12 years of age covering 92 low- and low-middle-income countries.
HIV PRICING POLICIES
Our differential-pricing policy is part of our commitment to addressing HIV through a multi-pronged strategy, with the goal of ensuring that our HIV antiretroviral (ARV) medicines reach as many of those in need as possible.
ISENTRESS® (raltegravir), STOCRIN® (efavirenz), CRIXIVAN® (indinavir sulfate)
The lowest Access price for our HIV medicines is offered to countries with a combination of highest disease burden and lower country income (gross national income [GNI] per capita), as defined by the World Bank. A list of eligible Access countries is provided here.
As of July 1, 2017, the Access prices for our HIV medicines for eligible customers1 are:
|Product Name||Daily Dose||Cost Per Year of Treatment (cost $ per unit)|
|50mg tablet||based on weight||(0.12)|
|200mg tablet||based on weight||(0.36)|
|600mg tablet||1||237 (0.65)|
|30mg/ml suspension (bottle)||based on weight||(0.094 per ml)|
|400mg cap||4||394 (0.27)|
|400mg tablet||2||675 (0.925)|
|100mg chewable tablet||based on weight||(0.6)|
|25mg chewable tablet||based on weight||(0.3)|
Countries classified as lower-middle-income and upper-middle-income2 by the World Bank are eligible for prices that are discounted from those in high-income countries. These prices are based on, among other things, a combination of country income, disease burden, treatment guideline positioning, patient access through national AIDS treatment programs, and market conditions, and will be negotiated with each government. For high-income countries, we make ISENTRESS available at competitive prices that take into account the innovation and value that ISENTRESS represents.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
We sell ATRIPLA at $1.68 per day, or $613 per year, in 98 Access countries, as defined by our agreement with Gilead.
We are committed to pursuing registration of our antiretrovirals (ARVs), including registration in those countries most affected by HIV/AIDS. Currently, our ARVs are registered or available through import waiver in many countries. Since the first approval in 2007, ISENTRESS has received regulatory approval in more than 110 countries.
Details of registration and availability of our four ARVs are available through the links below:
- ATRIPLA® (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
- CRIXIVAN® (indinavir sulfate)
- ISENTRESS® (raltegravir)
- STOCRIN® (efavirenz)
All of our company’s formulations of ISENTRESS, including the 600mg tablet, the 400mg tablet, the 100mg and 25mg chewable tablets, and the granules for suspension, have been approved by the U.S. Food and Drug Administration (FDA) and the European Medical Agency, making these formulations eligible for purchase by both the U.S. PEPFAR program and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
|1. Customers eligible for public-sector Access pricing in eligible Access countries will include: governments and programs fully funded by governments and/or by multi- and bilateral donors (e.g., the Global Fund, PEPFAR, UNITAID); UN System organizations; NGOs and other noncommercial providers of HIV treatment in sub-Saharan Africa; World Bank–defined low-income countries, UN-defined least-developed countries, and India. We offer these products on a Delivered Duty Unpaid (DDU), Carriage and Insurance Paid (CIP), or Carriage Paid To (CPT) airport-of-destination (Incoterm, 2000) basis. Additional costs may include freight, insurance, customs handling, taxes and duties.|
2. Customers eligible for public-sector pricing in lower-middle- and upper-middle-income countries will include: governments and programs fully funded by governments and/or by multi- and bilateral donors (e.g., the Global Fund, PEPFAR, UNITAID); UN System organizations; and NGOs. Low- and middle-income countries that are members of the European Union are not eligible for pricing under this Access program.