New hepatitis C drugs are game changers for treating the chronic viral infection, which was previously very difficult to manage. With cure rates in excess of 90% and improved tolerability, the latest treatments offer new hope for people chronically infected with the virus — an estimated 185 million people worldwide. But the sheer number of people who require these new expensive medicines is putting financial pressure on public and private healthcare providers and leaving patients with an anxious wait to find out if they qualify for treatment.
Current peginterferon-based therapies are associated with severe side effects, such as memory problems, insomnia and depression. Depending on the genotype of the hepatitis C virus causing the infection, some of the newest regimens are peginterferon-free — making them less toxic and easier for patients to adhere to — and have remarkable cure rates. People infected with the virus will quite understandably want access to the drugs.
In January 2014, the European Medicines Agency (EMA) approved a combination hepatitis C treatment incorporating two antiviral products: Viekirax (containing ombitasvir plus paritaprevir, boosted with ritonavir) and Exviera (dasabuvir). Although the regimen has yet to be been priced in Europe, it costs over US$80,000 for a 12-week course in the United States, where it was approved as Viekira Pak by the Food and Drug Administration (FDA) in December 2014.
Lift the burden
The fact that cure rates for the new hepatitis C drugs are so high means that long-term health complications of infection, including liver cirrhosis and cancer, might be avoided for many patients. The public health benefit of scaling up treatment — with a view to eradicating the virus — along with the financial savings to future healthcare budgets cannot be understated.
Such wide-spread adoption of the latest hepatitis C therapies in developed markets will require substantial reductions in current prices. Pharmaceutical companies should look at ways to make the medicines more affordable, such as negotiating bulk purchases with governments or insurers, to ensure as many patients as possible can access the drug while also enabling a return on investment.
There are around 200,000 people living with hepatitis C in the UK, so spending, say, £30,000 per patient would amount to £6bn — more than 20 times greater than the annual budget for England’s Cancer Drugs Fund
Steps have already been taken to make the newer hepatitis C medicines more accessible in developing countries. In September 2014, Gilead Sciences agreed to license its hepatitis C treatment Harvoni (ledipasvir and sofosbuvir) to seven India-based generic manufacturers — meaning more affordable versions of the therapy could become available in 91 developing countries.
It seems that, when it comes to hepatitis C, access to medicine could be most difficult in high- and middle-income countries, where the price of the treatments are set at a premium.
In the UK, two high-cost hepatitis C medicines, sofosbuvir (marketed as Sovaldi) and simeprevir (marketed as Olysio), have recently been given the green light from the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), which make decisions about which whether a medicine is cost effective and worthy of public funding by the NHS in England and Scotland, respectively.
But a treatment being cost-effective does not mean it is affordable. There are around 200,000 people living with hepatitis C in the UK, so spending, say, £30,000 per patient would amount to £6bn — more than 20 times greater than the annual budget for England’s Cancer Drugs Fund.
This is where health technology appraisal organisations such as NICE struggle to assess the affordability of medicines in the real world. NHS England has asked NICE to delay implementation of its final draft appraisals for sofosbuvir and simeprevir, a move that could be considered a breach of the NHS Constitution and likely to open itself to legal challenges.
Rationing drugs is never popular, but the NHS might deem it necessary to prioritise some patients for treatment to spread the cost over time. This could leave many patients waiting for treatment while their condition could deteriorate. The matter is further complicated by the variability of progression of chronic hepatitis C: some people go on to develop end-stage disease requiring liver transplantation; others seem to stay relatively healthy.
A lifeline could come in the form of competition between manufacturers as more highly effective treatments come to market. AbbVie’s hepatitis C products Viekirax and Exviera (Viekira Pak) follow the launch of Gilead’s Harvoni, and the companies have been battling it out in the United States to have large insurers choose their products exclusively, with major discounts said to be agreed.
There may well be a case for investing the considerable sums now to limit the burden of disease in the population and associated costs down the line, although the inflexibility of annual healthcare budgets means there is little incentive to take this approach.
For now, manufacturers must work with healthcare providers to make the sums work out so as many people can be cured of hepatitis C as possible.