Viral hepatitis is a top cause of death worldwide, with 1.46 million deaths reported for 2013.1 Chronic hepatitis C virus (HCV) affects approximately 71 million people globally,2 and 2.4 million people in the United States, where an estimated 41,200 new cases occurred in 2016.3 As part of the World Health Organization’s (WHO) goal to eliminate viral hepatitis as a global health threat by the year 2030, the incidence of chronic new infections must decrease by 90%.1
Although attainment of this goal is feasible because of the availability of highly effective direct-acting antivirals (DAAs), their high cost significantly limits access to such therapies, and thus threatens to hinder these efforts.4 For countries with mandatory health insurance coverage, financing DAA treatment for all people with HCV poses a high burden, and certain populations (such as people living in prison and undocumented residents) remain uninsured. In many other countries, there are larger populations of individuals who lack health insurance and the financial means to cover the cost of the drugs. In the United States, the low rate of treatment (16%) for those with chronic HCV has been mainly attributed to low rates of diagnosis and limited access to care.4
A New Model to Improve Access
In a manuscript published in August 2018, experts from the University of Geneva in Switzerland (a nation with universal health insurance) described an approach that could close gaps in treatment access among patients with HCV.4 They propose a “personal importation scheme for unapproved generics of DAA medications, and the use of a buyers’ club as a strategy for improving universal access to hepatitis C medicines among vulnerable populations such as uninsured patients, in order to achieve the WHO goals with minimal disruption of the conventional, patent-based business model.”
Numerous countries allow individuals to import medications in small quantities for personal use for a limited time; for example, in the United States, individuals have a limit of a 3-month supply.5 Three different categories of drugs are “marketed at the same time in different countries and at different prices.”4 These include the brand patented drug, the generic version, and the unapproved generic. Generic manufacturers in developing countries often have licensing agreements with pharmaceutical companies that allow them to produce generic versions of new medications.
However, personal importation of unapproved generics carries an increased risk of receiving counterfeit drugs with ineffective or harmful ingredients. These risks may be reduced through the use of buyers’ clubs such as those created in the 1990s (on which the movie Dallas Buyers Club is based) to increase access to the unapproved generic versions of HIV drugs that were being held up in the US Food and Drug Administration’s approval process.4
“A buyers’ club is…a structure that aims to help patients import unapproved generic medicines safely, thereby providing treatment access to more patients,” wrote the Swiss study authors. For HCV drugs, FixHepC is the largest buyers’ club in the world. Compared with the brand version of HCV medications, the Swiss cost of the unapproved generic versions was found to be a fraction of the price (1.70%-4.85%) when purchased through buyers’ clubs.4 In a 2017 study, 99% of patients treated with imported generic DAAs demonstrated HCV RNA undetectability at the end of treatment, and sustained virologic response at 12 weeks posttreatment.6
Still, the use of a buyers’ club requires personal initiative, awareness of one’s diagnosis, and knowledge of such clubs, as well as the ability and resources to pay, upload a prescription, and complete several other necessary steps. Noting that vulnerable people with HCV who may gain the most benefit from personal importation typically receive treatment at public healthcare facilities, the study authors suggest that these institutions could collaborate with buyers’ clubs to facilitate access to lower-cost treatment for patients in need: “Hospital physicians retain their traditional role of diagnosing, treating and following up patients, while the buyers’ club provides administrative assistance to help patients import affordable medicines.”4
They recommend a protocol comprised of the steps below.
- High-risk individuals (such as current or former intravenous drug users and people with HIV) should be screened for HCV antibodies, and those with a positive antibody result should be screened for HCV RNA.
- Those with detectable HCV RNA who cannot afford the cost of medication should be informed of the option to use a buyers’ club to assist in importing the drugs.
- Patients should sign a consent form stating that they have been informed of “therapeutic options, the prices of the brand drugs and the unapproved generics available on the market and, finally, the risks and benefits of personal importation.”4
- Before delivering the unapproved generic drug to patients, the buyers’ club and healthcare facilities should perform quality control measures to ensure the integrity and safety of the drugs. Drugs should ideally be purchased from countries with high quality control or, as a second preference, be among medications that have been vetted and prequalified by the WHO.
- To further limit risk, the “buyers’ club or the healthcare facility should perform [high-performance liquid chromatography with ultraviolet detection] to ensure the highest quality control of unapproved generics and allowing identification of the batch number for each tablet.”4
- Physicians should monitor patients for efficacy and adverse effects as they normally would with patients taking brand formulations.
The recommended model should result in minimal disruption to the patent-based pharmaceutical business model, as it is mostly restricted to uninsured patients from vulnerable populations who would likely forgo treatment otherwise. All efforts to “promote access to treatment for patients who cannot afford the costs of antiviral drugs whilst guaranteeing drug safety should be considered ethical, and be promoted to aid the elimination of HCV and to address a major public health problem,” the authors concluded.4
To learn more about the proposed model, Infectious Disease Advisor interviewed Nathalie Vernaz, MBA, PhD, an author of the aforementioned paper.
Infectious Disease Advisor: What are the benefits of buyers’ clubs for HCV treatment, and what has been learned thus far from existing clubs?
Dr Vernaz: Considering that hepatitis C is an infectious disease associated with increased liver- and nonliver-related mortality, and that it is in the interest of the general population to reduce its prevalence, to decrease not only its health burden but also its transmission, the benefit of a buyers’ club for HCV treatment is to allow quasi-universal access to expensive drugs, even for a country with mandatory health insurance, such as Switzerland. We learned from existing clubs that a personal importation scheme is a legal way to increase access to expensive unapproved generic medicines in most countries at a fraction of the original price.
Infectious Disease Advisor: What steps are needed to expand the availability of such clubs?
Dr Vernaz: The populations with high HCV prevalence, such as drug users with psychosocial difficulty, undocumented residents, prisoners, or economically disadvantaged individuals who forgo healthcare for economic reasons, and who are most of the time uninsured, are not even aware of existing clubs. To facilitate access to a buyers’ club, the first step is to promote a liaison of physicians in charge of vulnerable populations with buyers’ clubs themselves. However, to eliminate the risk of importing counterfeit products, the second step is to select a buyers’ club that performs quality controls.
Infectious Disease Advisor: What are some of the key ethical or other issues pertaining to this model?
Dr Vernaz: As long as a human right to health is recognized, ethical considerations are indeed related to issues of equity and access to healthcare. There is a key ethical issue between the need for respecting the conventional patent model, supporting the fundamentals of medical innovation, and the necessity of promoting equal access to care among vulnerable, uninsured populations. We argue that it is possible to promote equal care with minimal disruption to the principles of a patent model, as our innovative model is destined to serve a very small and specific population that would otherwise most likely not be treated.
- World Health Organization. Combating hepatitis B and C to reach elimination by 2030: advocacy brief. http://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en. Accessed November 23, 2018.
- World Health Organization. Hepatitis C. http://www.who.int/news-room/fact-sheets/detail/hepatitis-c. Accessed November 23, 2018.
- Centers for Disease Control and Prevention. Hepatitis C questions and answers for health professionals. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed November 23, 2018.
- Vernaz N, Calmy A, Hurst S, et al. A buyers’ club to improve access to hepatitis C treatment for vulnerable populations. Swiss Med Wkly. 2018;148:w14649.
- Henry B. Drug pricing & challenges to hepatitis C treatment access. J Health Biomed Law. 2018;14:265-283.
- Hill A, Khwairakpam G, James Wang J, et al. High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C. J Virus Erad. 2017;3(4):200-203.