Case Study: Expanding Availability of Healthcare Services
Janssen Global Access and Partnership Program (GAPP), Janssen, the Pharmaceutical Companies of Johnson & Johnson
A) At Janssen, our vision is to improve & save more lives in RLS by ensuring access to our products & services, sharing our knowledge, & performing research to address public health. We are committed to helping people living with HIV in resource-limited settings by ensuring effective and sustainable access to our HIV medicines, or antiretrovirals (ARVs). We believe that effective HIV drug access has two important components: ensuring quality and affordable medicines are available sustainably, and that these medicines are used safely and in the most appropriate way for people living with HIV/AIDs (PLWHA).
B) The results of our innovations are sustainable, not-for-profit drug access in resource-limited countries with high HIV burden and economic vulnerability. We achieve this through 4 key strategic pillars:
- Affordability – Licensing (for both branded and generic versions or our medicines) & Access Pricing
- Availability – Priority Branded Registration where there is a public health need
- Appropriate Use – Clinical Trial Programs & Medical Education to ensure optimal, appropriate and safe use of our HIV medicines
- Adoption – Guideline Inclusion & WHO Prequalification In order to achieve our goals, we work together with many stakeholders—including: NGOs, multilateral organizations, generic manufacturers, governments, healthcare providers, regulators and other organizations.
A key learning of the GAPP is that the access to medicines environment is constantly evolving – new and creative approaches are always needed to reach more people in need of innovative and life-saving medicines. For example, when Janssen launched GAPP 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 price in sub-Saharan Africa (SSA) and least developed countries (LDCs); Janssen proactively and transparently share the special effort price of its product as part of the agreement. When GAPP developed its access approach for Janssen’s newest HIV medicine, rilpivirine, it became the first company to proactively out-license to multiple generic manufacturers before any regulatory approval by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to allow generic manufacturers time to develop formulations & submit faster regulatory dossiers to make drugs available for patients. In addition, Janssen recognizes the importance of collaboration and information-sharing in order to address unmet access needs. GAPP 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 and sustainable access to medicines in resource-limited countries.
Results to Date
- At the end of 2012, GAPP has reached approximately 70% of the estimated total 3rd-line HIV treatment market in resource-limited countries.
- GAPP offers its branded medicines at Reduced Special Effort prices in sub-Saharan Africa (SSA) and Least Developed Countries (LDCs) at an average price reduction of 95% as compared the US price.
- GAPP jointly supports medical education on appropriate and safe use of its HIV medicines and its training sessions have reached over 680 HCPs from 22 countries in SSA and Asia.
- GAPP’s generic licensing agreements with five manufacturers for rilpivirine cover 112 countries which represent 89% of people living with HIV (PLWH) and 90% of people on treatment in low- and middle-income countries.
- Janssen HIV drug formulations have been filed in 39 high-burden, low- and middle-income countries via the GAPP.
- Four of Janssen’s HIV drug formulations have been included in the WHO’s List of Prequalified Medicines—PREZISTA® 600 mg, PREZISTA® 75 mg, PREZISTA® 150 mg and INTELENCE® 100 mg.
- GAPP supplied its HIV drugs for the first time to Cuba and Haiti in 2012; this is the first time any Janssen product has been provided to Cuba and the first time a non-vaccine have been supplied to Haiti.
- Janssen has adopted a policy not to enforce its patents for darunavir in SSA & LDCs, so long as the generic version is medically acceptable. We provided an explicit waiver to enable generic manufacturers to meet the need for a sustainable supply of quality, medically acceptable generic darunavir in these countries without the concern that Janssen will accuse these generic manufacturers of infringing its darunavir patents.
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