The launch of new and incredibly effective hepatitis C treatments has provided a breakthrough in recent years. Patients who had failed on previous generations of therapies now have access to drugs with a SVR rate north of 90%, offering a cure where before there was only the long wait to a liver transplant. But while these therapies offer the promise of a new life in countries with affluent healthcare systems, a slightly different story has been at play in those middle-income nations that struggle to afford high-cost options.
Globally, 130 million to 150 million people are afflicted with chronic hepatitis C virus (HCV), 73% of whom belong to middle-income countries. Moreover, an estimated 500,000 patients die each year from hepatitis C-related diseases. To date, there is no known vaccination available that could prevent the occurrence or transmission of this infection.
However, the global outlook for HCV is incredibly promising. Treatment advances have moved forward at a momentous pace that would seem fanciful just a few decades ago. The launch of a new generation of therapies has created fresh opportunities to defeat HCV. Of particular note, Gilead’s sofosbuvir (marketed as Sovaldi) created a seismic shift in HCV treatment with efficacy gains, but this advancement came at a high cost (sofosbuvir sells at $1,000 per pill in the US). Gilead’s follow-up option Harvoni, a fixed dose combination of sofosbuvir and ledipasvir, offers the potential to ditch interferon-based treatment but comes at an even higher price.
Gilead argues the high prices are needed to recoup investments made during the drug lifecycle. Yet, despite the advances of these new therapies, some payers have blanched at the price, opting to implement policies to constrain spending. In December 2014, US PBM Express Scripts dropped Gilead’s HCV drugs from its national preferred formulary with the exception of patients already using it and those with advanced liver disease; in their place, Express Scripts favored AbbVie’s less expensive HCV drug, Viekira Pak. In France, the government decided to levy a selective tax on drug makers if the spending on HCV exceeded a certain expenditure ceiling each year and ended up negotiating a huge discount for Sovaldi. As a result, France has the lowest price for Sovaldi in all of Europe.
Although cost-containment efforts are underway in the more advanced markets, those nations with less financial resources face their own challenges. Because the majority of HCV patients reside in low and middle income countries, high drug prices represent barriers to access. This becomes a crucial issue for patients as well as drug makers. A recent strategy report from the Drug for Neglected Diseases initiative (DNDi) asserts that negotiation, patent opposition, tiered pricing, and compulsory or voluntary licensing might pave the way for affordable HCV treatments.
The nightmare scenario for industry remains compulsory licensing. Possibly to head off this option, industry has sought more peaceful negotiations. For instance, Egypt and India are among 101 countries benefiting from a voluntary licensing strategy with Gilead, which offers Sovaldi at $900 for a full course of treatment. Under voluntary licensing patent holders grant the right to local pharmaceutical companies to manufacture, import and/or distribute drugs. However, about 50 middle-income countries are excluded from these benefits, thus restricting drug access to close to 49 million afflicted patients. According to a Médecins sans Frontières (Doctors without Borders) report, sofosbuvir is not yet patent-protected in some of these countries. This raises potential for access to low-cost generic versions. Compulsory licensing can be exercised by governments to provide authorization to a third party without the consent of patent holders. Experts believe that it can also enable the excluded countries to import or manufacture low-cost generics for HCV treatment. It’s a blunt instrument that could prove challenging for industry.
Other strategies involve attacking the patents themselves. Gilead’s patent applications were rejected in a few developing nations such as India and Egypt primarily due to what the countries saw as technical weakness. Adopting stringent patent regulations protects countries from spending millions of dollars for products that do not meet the required criteria. Moreover, it gives nations a negotiating lever to use against industry. Among additional strategies, the availability of cheap biosimilars, affordable point-of-care diagnostics, compassionate use and funding programs could also help lower the disease burden in developing markets. Inclusion on national or WHO Essential Medical List could also ensure access to affordable versions.
While patients, payers and providers brainstorm over ways to negotiate prices for prized brands down, a few organizations are thinking outside of the box. DNDi and Pharco Pharmaceuticals, for instance, are working to bring a fixed-dose combination of ravidasvir and sofosbuvir to market with a price tag of less than $300 through licensing deals and other strategies. This combination has demonstrated promising pan-genotypic benefits in Egyptian patients afflicted with HCV and is due to be tested in Thailand and Malaysia in the near future.
Under the details released in a report, Pharco would provide DNDi with the fixed-dose combination of ravidasvir and sofosbuvir for its clinical trials in Malaysia and Thailand, where HCV is highly prevalent and patients are unable to afford the currently available treatments. To meet its goal, DNDi will be working with governments and various stakeholders to overcome pricing, trade, regulatory and intellectual property barriers. If successful, other countries may follow suit.
A recent study from MD Anderson predicted that hepatitis C could become a rare disease in the next two decades. With the current trends and challenges in access to life-altering drugs, this seems far-fetched in the middle-income markets where the price of a cure is seen as too high. However, with various strategies such as initiatives like that of DNDi and Pharco, worldwide treatment could be a possibility. How this goal is realized – whether through voluntary licensing, pricing strategies, or the more aggressive compulsory licensing – will go a long way to shaping the opportunities and pitfalls for industry in developing and middle-income countries.