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Learning lessons from HIV to change the treatment access landscape

Published on 23/11/17 at 09:56am
Photo Credit: C. Goldsmith Content Providers: CDC/ C. Goldsmith, P. Feorino, E. L. Palmer, W. R. McManus

Greg Alton, Executive Vice President of Corporate and Medical Affairs at Gilead, reveals how the rapid development and distribution of HIV treatments globally holds important lessons in improving patients’ access to medicine.

The rapid expansion of HIV treatment in developing countries is one of the world’s greatest public health success stories. Today, more than 15 million people in low- and middle-income countries receive antiretroviral therapy. While many more people living with HIV are still in need of treatment, the achievements to date have changed both policymaker and public perceptions of what is possible when it comes to improving health in the world’s poorest countries.

But the economic, political and public health landscape of 2017 is very different from that of the 2000s. While progress in HIV treatment access remains an inspiration, to what degree is such access a useful model for other therapeutic areas today? This is a critical question that I and my colleagues at Gilead Sciences have grappled with as we have sought to translate the lessons learned from our successful HIV treatment access programme to our medicines for chronic hepatitis C virus (HCV) infection.

Contrasting our experiences highlights some of today’s major obstacles to greater access to medicines, and points the way toward potential solutions.

Three keys to success in HIV treatment access

Unprecedented global advocacy for HIV treatment led directly to progress on three key fronts in the 2000s: political leadership, donor support and lower drug prices. Political leadership on HIV/AIDS extended to the highest rungs of the United Nations, but even more importantly to the leaders of many heavily affected countries. The willingness of national leaders to speak out about HIV reduced stigma and encouraged people to get tested – both essential steps to greater treatment access. They also elevated HIV prevention and treatment as national public health priorities.

This political leadership in affected countries was both spurred and supported by greatly increased resources from donor governments, who moved to establish new financing mechanisms to subsidise screening, treatment and prevention costs. Since 2002, the Global Fund to Fight AIDS, Tuberculosis and Malaria has committed over $18 billion to support HIV programmes in low- and middle-income countries. Similarly, since its inception in 2003, the US President’s Emergency Plan for AIDS Relief (PEPFAR) has committed over $50 billion to HIV/AIDS programmes in developing countries. Together, they account for the large majority of people on antiretroviral therapy in developing countries today.

On the other side of the equation, the cost of HIV medicines fell substantially, as pharmaceutical companies increasingly recognised their obligation to provide access to their medicines to all those in need, and generic companies proved they had the capacity to develop high-quality, low-cost versions of HIV therapies. At Gilead, we not only lowered prices for our branded HIV medicines, but also licensed our HIV compounds to multiple generic manufacturers, fostering competition that has lowered the base cost of tenofovir disoproxil fumarate in developing countries by 80% since 2006. Today, largely as a result of generic partnerships, Gilead medicines are taken each day by more than 10 million people living with HIV in low- and middle-income countries.

The new landscape

In late 2013, Gilead’s first hepatitis C medicine received US approval, and less than a year later, the drug was launched in Egypt, the country with the world’s highest HCV prevalence. That rapid introduction was made possible by a close partnership between the Egyptian government and Gilead, working together even before US approval to conduct local trials, set up a financing structure and negotiate pricing. Since then, more than a million patients in Egypt alone have been cured of hepatitis C. Yet HCV therapies remain out of reach for many people living with the disease, and prospects for widespread treatment scale-up seem uncertain at best. To understand why the trajectory of HCV treatment scale-up is different than it was for HIV, it is instructive to consider how the landscape has shifted in each of the three critical areas discussed above: political leadership, donor support and lower drug prices.

Securing strong political leadership for hepatitis C – or any single therapeutic area – is highly challenging in the current policy environment. Even in nations with a strong commitment to public health, their attention is splintered by numerous priorities. Ebola outbreaks have plagued Western Africa in the last several years, Zika has emerged as a threat in Latin America, antibiotic resistance is on the rise and non-communicable diseases account for a growing share of morbidity and mortality. And today’s greatest health challenges compete not only with each other, but with other urgent policy crises – terrorism, refugees, climate change – for attention and resources. Among these varied interests, it is exceedingly difficult for any health condition to rise to the top of the political agenda.

At the same time, we are unlikely to see major new global health funding streams that would allow countries to make large health investments. Most donor governments face significant budget constraints, and global health advocates in these countries have their hands full just defending current commitments. And many of the most heavily affected countries receive very little external health aid as it is, because they are classified as middle-income countries, despite the immense internal income disparities. Governments of these nations must devise plans that spread health coverage across income bands, including very poor populations.

Improving patient access

In order to expand access to new medicines – whether in HCV or any other therapeutic area – health officials cannot rely on external support, and instead must convince their Finance Ministry counterparts to commit more of the national budget to health. To lower drug prices, the same strategies are being used in other therapeutic areas. Gilead has modelled its approach to HCV treatment scale up in developing countries on its successful HIV access programme: greatly reduced pricing on branded medicines, tied to a country’s economic status and disease burden, paired with generic licensing to multiple manufacturers. The cost of curing HCV is significantly less than the long term cost of treating HIV (chronic therapy) – a complete curative HCV regimen in low- and lower-middle-income countries is as low as $750 for branded products and even less for generics, while the mean cost of antiretroviral therapy in PEPFAR-supported programmes is approximately $348 per patient per year for a lifetime. Eliminating HCV worldwide could cost less than simply keeping HIV at bay.

However, national health systems are not prepared or designed to make upfront investments in new medicines, even if they will yield long-term savings in healthcare costs. Most governments plan and budget on annual cycles and are not well-equipped to consider future health expenditures and savings.

The path forward: adaptation and innovation

Despite these substantial hurdles, progress is possible. Rather than try to recreate the unique HIV treatment access landscape of the 2000s, we must explore innovative approaches to delivering medicines to those in greatest need.

For example, in Georgia, where 7% of adults have HCV, the government is undertaking an ambitious programme to eliminate the virus nationwide, employing a combination of disease awareness, screening and treatment initiatives. Georgia’s HCV elimination programme started in April 2015 and currently has 29 service centres across the country. Since the end of 2016, Gilead has donated HCV treatment for Georgia enabling over 19,000 people to complete treatment, where cure rates were over 98%.

Although Gilead has donated the HCV treatment for this national scale-up, Georgia and its partners have contributed large investments in the health systems associated with HCV diagnosis and treatment. This underscores the modelling recently done by the World Health Organization and published recently in [The Lancet Global Health] that over “75% of costs are for health systems with health workforces and infrastructure as the main cost drivers” in 67 low-income and middle income countries.

 Gilead is supporting new approaches across the access continuum, from product registration to household healthcare financing. The common thread in all of these efforts is partnership – no single actor can provide access to treatment, so pharmaceutical companies must collaborate with national governments, non-profits and other private sector players in order to reach patients in need.

Today, treatment access looks less like a massive global movement and more like a mosaic of innovative approaches that are tailored to meet the diverse needs of specific diseases, countries and populations. We are unlikely to duplicate the relatively rapid progress seen in HIV, but that experience can teach us important lessons about how to overcome the complex challenges to delivering lifesaving medicines.

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