Case Study: Expanding Availability of Healthcare Services
Janssen Global Public Health HIV Medicines Access & Partnerships Program, Janssen, the Pharmaceutical Companies of Johnson & Johnson
At Janssen, our vision is to improve and save more lives in resource-limited countries (RLCs) by ensuring access to our products and services, sharing our knowledge, and performing research to address public health. We are committed to helping people living with HIV/AIDS (PLWHA) in RLCs by ensuring that they have effective, sustainable access to our HIV medicines. We believe this objective requires two important components: ensuring high-quality, affordable medicines are available sustainably and are used in the most appropriate way.
The result of our initiative is sustainable, not-for-profit HIV medicine access in RLCs that have a particularly high HIV burden and are economically vulnerable. We achieve this goal through four strategic pillars:
- Branded and generic availability, including branded licensing agreements, the coordination of orders from institutional buyers, generic licensing agreements for our HIV medicine rilpivirine, and an Intellectual Property (IP) waiver for our HIV medicine darunavir.
- Priority registration, including local regulatory dossier submissions in 20-plus countries, engagement with the World Health Organization (WHO) prequalification mechanism, and participation in regional harmonization and policy initiatives.
- Reduced pricing, including special effort access prices in Sub-Saharan Africa (SSA) and least developed countries (LDCs) and reduced tiered pricing in other low- and middle-income countries.
- Medical education and clinical research, including holding joint medical education sessions on HIV drug resistance and the use of third-line treatments, conducting clinical research, and supporting investigator-initiated studies.
In order to achieve our goals, we work with many stakeholders, including NGOs, multilateral organizations, generic manufacturers, governments, healthcare providers, regulators, and other organizations.
A key lesson we learned is that access to medicines is constantly evolving—new and creative approaches are always needed to reach more people in need of innovative, life-saving medicines. For example, when Janssen launched its HIV Medicines Access Program, its first major activity was to sign a royalty-free agreement to provide our first branded HIV medicine, PREZISTA (darunavir), at a low, special effort access price in SSA and LDCs. Janssen proactively and transparently shared this price as part of the agreement.
When the program developed its access approach for Janssen’s newest HIV medicine, rilpivirine, it became the first company to proactively license out to multiple generic manufacturers before any regulatory approval by stringent regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). Such an approach allowed generic manufacturers time to develop formulations and submit regulatory dossiers to make drugs available for patients. Then, in 2012, after regulatory agencies approved darunavir for more than 20 countries in SSA, and in anticipation of a growing need for generic versions, Janssen announced that it would not enforce the patents it owns and controls, provided that the darunavir product is medically acceptable and used only in SSA and LDCs.
In addition, Janssen recognizes the importance of collaboration and sharing information in order to address unmet access needs. The program regularly engages with key stakeholders to understand their thinking on critical scientific, regulatory, policy, and access needs and ways that Janssen can contribute to enabling meaningful, sustainable access to medicines in RLCs.
Collaboration with stakeholders includes those within Janssen. In 2014, the program was integrated into the new Janssen Global Public Health (Janssen GPH) group, which focuses on addressing unmet public health needs through R&D, innovative access models, policy and systems strengthening, and collaborations. The program now has access to a broader set of expertise and resources—critical tools that will help expand its reach, produce measurable results, and further realize its goals and commitments.
Results to date?
- The program operates in countries whose populations meet the following criteria: at least 92 percent of people are living with HIV/AIDS and at least 91 percent of people are being treated for HIV.
- More than an estimated 3,000 patients in RLCs were receiving a Janssen HIV medicine at the end of 2013.
- The program offers its branded medicines at reduced special effort prices in SSA and LDCs, an average reduction of 95 percent compared to the U.S. price.
- The program jointly supports medical education on appropriate and safe use of its HIV medicines, and its training sessions have reached more than 1,000 healthcare providers (HCPs) from SSA and India.
- Janssen HIV drug formulations have been filed in 39 high-burden, low- and middle-income countries via the program.
- Five of Janssen’s HIV medicine formulations have been included in the WHO’s List of Prequalified Medicines—Prezista (600, 150, and 75 milligrams) and Intelence (100 and 25 milligrams).
- The program supplied its HIV medicines for the first time to Cuba and Haiti in 2013; this is the first time any Janssen product has been provided to Cuba and the first time a nonvaccine has been supplied to Haiti.
- Janssen has adopted a policy of not enforcing its patents for darunavir in SSA and LDCs, so long as the generic version is medically acceptable and used within the territory. This policy assures generic manufacturers that they may manufacture high-quality darunavir that is used in SSA and LDCs without worrying that the company will accuse them of infringing on darunavir patents.
- In December 2013, Janssen announced a first-of-its-kind pediatric HIV medicine donation program to improve access to HIV medicines for children and adolescents who are failing HIV treatment in SSA. The company is working with a number of organizations to fully maximize the impact and reach of this initiative.
- Also in December 2013, Janssen launched its eMedical Advisor platform, a new training tool specifically designed to help address the limited knowledge of Janssen’s HIV medicines among HCPs in SSA.
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