The undersigned organizations, medical providers, and community members are alarmed by the escalating crisis in access to new lifesaving hepatitis C treatments. These drugs have the potential to help us end the hepatitis C epidemic and save thousands of lives. Although the Affordable Care Act recently helped millions of Americans gain access to health coverage, many for the first time, the ACA mandate that no individual be denied insurance based on a pre-existing condition is meaningless if that coverage restricts access to the treatment needed to cure that condition. Policies that deny access to new, highly effective hepatitis C treatment altogether or limit treatment only to the sickest patients violate laws that now ban discrimination against specific patient populations. They also undermine our ability to address health inequities and disparities, particularly among communities of color, which are more likely to face barriers to health care access and have disproportionally higher hepatitis C prevalence.
The FDA approval of highly promising hepatitis C treatments last year brought tremendous hope, as it marked the beginning of a new era in treating and curing the disease. With high cure rates, significantly reduced side effects compared to previous regimens, and shorter treatment durations compared to previous regimens, these new therapies, along with others in the pipeline, provide an opportunity to end needless suffering and death from extrahepatic conditions, end-stage liver disease, and liver cancer, while reducing and potentially eliminating new infections. Twenty-five years after the discovery of the hepatitis C virus, the tools are now available to eliminate a chronic, infectious, life-threatening disease that, according to data from the Centers for Disease Control and Prevention needlessly attributes to the death of 15,000 to as many as 50,000 Americans per year.
We are therefore united in our call to all stakeholders, including public and private payers, the
pharmaceutical industry, and government to work together to eliminate the barriers that have caused rationing of hepatitis C treatment:
- Hepatitis C pharmaceutical companies must commit to affordable pricing, broad accessibility, and transparent, good-faith negotiations with payers;
- Stakeholders must engage members of the patient, provider, and advocacy community in a process to address access barriers and to minimize consumer cost-sharing obligations;
- Payers must ensure that individuals who inject drugs, the group most at risk for new infections, are not systemically excluded from treatment; and
- We must send a strong message to all people with hepatitis C: they deserve to be cured and that everything is being done to end the current rationing of treatment.
In addition, any utilization management or prior authorization requirements that might be put in place by public or private payers must not be tolerated except when it can be demonstrated that such restrictions are developed through a transparent process that:
- (a) Is in accordance with clinical factors and not just cost effectiveness;
- (b) Involves consultation with recognized hepatitis C medical experts;
- (c) Includes meaningful input from the hepatitis C patient and advocate community; and
- (d) Requires each payer to maintain an exceptions process for any individual to appeal a denial of access based on their specific individual circumstances.
The only way we will stop the treatment access crisis is for all stakeholders to come to the table and develop solutions. The federal government, through its role in implementing the Affordable Care Act and ensuring access to affordable, quality care for all Americans has a responsibility to ensure that these discussions happen quickly, transparently, and with meaningful input from leading hepatitis C medical experts, community leaders, and, most importantly, people with hepatitis C.
Eliminating hepatitis C in the United States would be one of the greatest public health achievements of the 21st century. The question is not can we eliminate the virus, but do all stakeholders have the will to come together and develop real solutions. As a community, we will not rest until hepatitis C is eliminated, and we are committed to working with all stakeholders to achieve this goal. All people living with or at risk for hepatitis C, along with their families, their friends and their loved ones deserve no less.