There are currently 2.7 million to 3.9 million Americans with hepatitis C. Many do not show symptoms until the disease is in its advanced stages, and more than half of those with the disease have not yet been diagnosed. This year alone, 19,000 Americans will die of complications from the disease.
According to Dr. Frederick Altice, chairman of the Hepatitis Therapy Access Physicians Working Group for AfPA (Alliance for Patient Access), that makes screening a first and critical step towards widespread treatment. Unfortunately, many of the patients with hepatitis C are unable to access curative treatment. For those in prison, the challenge is even greater. Needed medicine is not available in prison formularies, and insufficient screening methods and guidelines limit treatment. But, according to Altice, the prison system presents an opportunity to treat and cure potential transmitters of the disease.
The problem with this solution, as is often the case, revolves around the cost. Treatment costs can strain government budgets. And although the treatments will benefit the patient as well as society as a whole, the idea is unpopular to the general public which believe those funds could be better spent elsewhere. This leaves policy makers with a challenge they must solve. But it also creates what could be a great opportunity for pharma companies to recruit patients for studies and gather real-world evidence on a diverse population of individuals.
How Bad Is The Hep C Problem?
Approximately 12 million Americans, or 3.4 percent of the U.S. population, spend time in jails and prisons every year. Policies force prisons to concentrate individuals with like diseases together, including those with substance use disorders and mental illness. These individuals are at the highest risk for hepatitis C. But Altice notes this also presents an opportunity for screening and treatment.
Nearly one in five Americans with hepatitis C will spend time behind bars each year, according to the Centers for Disease Control and Prevention. That means more than 750,000 people with hepatitis C will interface with a jail or prison every year. Only about half of them will even know they are infected.
Unlike cancer, which can’t be spread from one person to another, hepatitis C can be spread between individuals. That makes an effective treatment program even more vital. If a prisoner is treated for hepatitis C, they can be cured of the disease and have a reduced risk of liver failure and liver cancer. They will also be relieved of side-effects such as fatigue and depression. The prison system benefits from the reduced risk of hepatitis C transmission within the prison and will see improved health within the inmate population. Society at large will also benefit from the reduced risk of hepatitis C transmission after prisoners are released as well as the long-term cost savings of the government, insurance companies, and the healthcare system having to treat patients. According to Altice, treating these prisoners is an effective public health strategy.
Is There A Role For Pharma?
There is certainly a role that pharma can play in this process. Patients with hepatitis C can be cured in just 8 to 12 weeks of treatment. That means even a brief period of incarceration could provide the time needed to cure patients. Additionally, research has shown that the period of incarceration is a crucial time to instill health-promoting behaviors in individuals, which can continue after their release. At the very least, this process could identify patients who might benefit from treatment after their release.
Pharma needs patients to perform trials, and every new hepatitis C medicine will need require clinical trials for approval. Considering the difficulty companies can experience recruiting patients, prisons seem like a perfect place to find needed patients. A recent search for hepatitis C trials on ClinicalTrials.gov produced 1,936 results, including some testing for hepatitis C infection at urban hospitals and outpatient clinics. If patients can be tested in those facilities, why not prisons?
One of the major focuses on real-world evidence seems to be for the purpose of testing drugs on a more diverse patient population. The diversity of individuals in jails and prisons seems like a good way for pharma to get additional data on patients of both genders as well as minority populations.
Patients Require Treatment
A Supreme Court decision (Estelle v. Gamble) ruled that prisons are responsible for treating inmates’ health conditions and providing the current standard of care. Still, state governments have to juggle budget concerns as well as public scrutiny. Additionally, states believe they might struggle to complete testing and treatment due to prison medical personnel lacking the expertise to treat prisoners with hepatitis C.
Prison systems are also not inclined to test patients for the disease. If both patients and physicians remain in the dark about a patient’s hepatitis C status, the prison is not obligated to treat it. This approach has forced patients to resort to the court system to get the needed treatment.
This seems to be another area where pharma could assist. Pharma has the ability to properly train prison physicians on how to test and treat patients. They could also be trained on how to record data and report adverse events.
The patients are out there. The solution seems to be shifting spending priorities or working with pharma to devise a manageable solution. It seems logical for policymakers to work with pharma to find a solution that will help patients while also protecting the long-term public health.