We recognize economic and healthcare circumstances differ across and within countries, and we know that cost can be a barrier to access. To enhance and sustain broader access to our medicines and devices as well as support their appropriate use, we pursue a wide variety of approaches, appropriate to the specific reimbursement systems and legal guidelines of different countries. We also look for ways to shape the future of clinical trial development to better serve patient populations, especially children.
Using tools such as equity-based tiered pricing and partnerships with public health organizations, we strive to engage stakeholders to help achieve broad and timely access to our medicines in a way that is affordable locally. We believe that equitable tiered pricing—which considers and reflects the economic conditions of the country, the purchasing power of the patients, the disease burden, and the specific product under consideration—can provide a fair and sustainable approach to improving access across different markets, particularly in emerging healthcare systems. As an example, we used this framework to guide our pricing decisions for SIRTURO (bedaquiline).
In situations where even the lowest prices from our equity-based tiered pricing model may pose a barrier to access, we institute “safety net” donation programs. These include New Horizons Advancing Therapeutics HIV Treatment, our collaboration with Elizabeth Glaser Pediatrics AIDS Foundation, and our Bedaquline Donation Program with USAID. We also work with payers to explore innovative approaches that tie reimbursement to health outcomes, reflecting the true value our medicines bring to patients and the healthcare system. For more information on our approach to value-based care, click here.
Our access and pricing strategies are developed throughout the R&D process, and especially from Phase 2 onward. The assessment of the disease burden is conducted, and ongoing feedback on the anticipated value of the compound is gathered from key external stakeholders (patients, physicians and payers). As the compound moves through clinical development and is better understood, the pricing strategy is revised to reflect new information.
In our pharmaceuticals business, our pricing approach is grounded in Janssen’s Value, Access and Pricing framework. This includes all Janssen products within the Global Public Health portfolio. We carefully consider three fundamental components when pricing our medicines:
- Value to patients, the healthcare system and society. We consider how each medicine will improve patient health. We also assess the medicine’s potential to reduce other costs—surgeries, hospital stays, or long-term care, for example—and the improvement the medicine represents over the existing standard of care.
- The importance of maintaining affordable access to medicines for people who need them. We consider not just the list price, but also the discounts and rebates we provide insurers, pharmacy benefit managers, governments, hospitals, physicians, and other providers of care to support broad access to our medicines.
- The importance of preserving our ability to develop future groundbreaking cures and treatments. We have an obligation to ensure that the sale of our medicines provides us with the resources necessary to invest in future R&D to address serious, unmet medical needs.
We are committed to transparency within responsible business practices. As a testament to leadership in pricing transparency, Janssen Pharmaceutical Companies of Johnson & Johnson has since 2016 released an annual Janssen U.S. Transparency Report reflecting our commitment to responsible business practices that put patients first, including how we invest our resources, price our medicines, and help people who need Janssen medicines get access to them. For more information, visit Transparency & Disclosures.
* Represents the year-over-year change in the average list price, or wholesale acquisition cost (WAC).
** Represents the year-over-year change in the average net price, which is WAC less rebates, discounts, and returns.
At Johnson & Johnson, we believe intellectual property encourages and promotes innovation – innovation that creates products that profoundly change and save patients’ lives. The intellectual property system provides a framework that allows us to invest in new technologies, fund R&D, and ultimately bring new transformational medicines to the market.
Johnson & Johnson believes we have a responsibility to contribute to providing sustainable access to healthcare around the world, and that includes improving access to medicines in resource-limited settings. We believe that the best way to address these needs is for companies to work with international funders, local governments and non-government organizations to develop approaches that benefit patients in need, while continuing to uphold the value of intellectual property in all parts of the world. We believe that flexible intellectual property management is a key element in an effective and sustainable access to medicines strategy in resource-limited settings, including in low-income and low-to-middle-income countries. As we have experienced with SIRTURO, our treatment for multidrug-resistant tuberculosis, intellectual property protections are a key element of any comprehensive strategy to stimulate innovation and expand access to new treatments.
Johnson & Johnson has in certain circumstances employed a number of diverse targeted approaches to address the needs of patients in resource-limited settings. These approaches include collaborative partnerships with local organizations to develop, manufacture and distribute our medicines, non-exclusive license arrangements, and—where patents describe an essential medicine—pledging not to enforce certain patents provided that the generic version of the drug is medically acceptable and used only in the defined resource-limited territory. Additional information can be found in our Intellectual Property Statement.
We support initiatives that provide access to patent information for our medicines. In addition to patent status information that is accessible and publicly available through regulatory agency and patent office databases, in 2017 Johnson & Johnson joined the Patent Information Initiative for Medicines (Pat-INFORMED). Pat-INFORMED is a joint initiative including the World Intellectual Property Organization and the International Federation of Pharmaceutical Manufacturers and Associations that aims to “promote the accessibility of patent information for health agencies tasked with procurement of medicines."23 The Pat-INFORMED database will seek to link “public patent information to registered medicines in a new online global gateway, helping health professionals to navigate the medicine-procurement process for the benefit of their citizens.”24
We are committed to comprehensive registration efforts to assure the timely availability of our medicines for patients in need. Johnson & Johnson is also committed to strengthening the regulatory science capabilities of local regulatory authorities in order to expedite product registrations, and shaping the environment to accelerate registrations in countries with limited regulatory resources by working with the World Health Organization (WHO) to prequalify our products. The WHO prequalification program covers medicines for HIV, tuberculosis, neglected tropical diseases, malaria, influenza, reproductive health and diarrhea, as well as vaccines. This prequalification is an important step toward advancing global access. Additionally, we work to expedite access in low-income countries, where appropriate.
The focus of our registration efforts in these countries continues to be prioritized by high-burden disease prevalence, immediate patients in need, healthcare infrastructure, maturity of treatment programs, the existence of global/multilateral programs, and economic vulnerability. Prior to the launch of a compound, the need for a specific access program for resource-limited countries is assessed from an unmet public health perspective.
The overall regulatory strategy is driven by multiple aspects such as medical need, local regulatory requirements, company strategy and other third-party strategies. From a regulatory perspective, the availability of dossiers and local registration processes drive how and when products can be registered. Many countries require a certificate of free sale from either the U.S. Food and Drug Administration or European Medicines Agency before a product can be submitted for registration.
We may seek WHO prequalification for our products once an expression of interest is issued by the WHO and our product is then eligible for WHO prequalification. Our global submission plan process and tool start multidisciplinary discussions for local requirements, and coordinate timing strategies.
Our Janssen Pharmaceuticals Companies strive to provide access to patients as soon as possible. To shape the environment to accelerate registrations in countries with limited regulatory resources, in 2017 Janssen participated in pilots of the WHO collaborative procedure. Both procedures—collaborative procedure for WHO prequalified products and collaborative procedure for a product approved by a Stringent Regulatory Authority (SRA)—were tested to facilitate assessment and accelerate national registrations. Johnson & Johnson continues to be actively involved in the development of the WHO guidance for these SRA collaborative registration pilots.
To further accelerate submissions beyond least-developed settings, we have designed a program that assesses emerging markets’ regulatory and commercialization needs during key R&D milestones, and integrates these needs into our global strategies. We track the speed of getting these products to patients using an integrated dashboard. We have also enhanced our approach to global submissions across our product portfolio to advance acceleration of submissions across the globe.
22 Annual percent change vs. prior year calculated at product level and weighted across the Company’s U.S. Product Portfolio.