Sofia Simona Jakab, MD, is an attending hepatologist at Yale Medicine/Yale-New Haven Hospital and serves at the West Haven Veterans’ Affairs Medical Center. She specializes in Gastroenterology, Transplant Hepatology, and Internal Medicine. She is passionate to improve the management of liver diseases and to forge multidisciplinary collaborations to benefit patients’ clinical care.
The high price of direct-acting antiviral (DAA) oral medications has made patient access challenging despite the availability of multiple effective treatment options for hepatitis C virus (HCV). Has there been any recent progress in making these treatments more affordable to patients?
Dr. Jakab: Certainly. We used to have great difficulty getting these medications to our patients, regardless of whether they were covered by private insurance or through the United States Department of Veterans Affairs (VA). The last few years have been amazing, not only in terms of availability of more regimens that are equally effective in curing HCV, but also in terms of patient access. I think this is capitalism at its best. Having competition—more regimens on the market—has helped drive the prices down.
These regimens are expensive, but very few patients actually pay the sticker price because the insurance plans end up negotiating a much better fee for a preferred regimen. The reality is considerably better now than it used to be even a few years ago, with more effective regimens available, and at an affordable price.
There is not much transparency in terms of pricing, so it is usually difficult to figure it out how much one insurance plan pays versus another. From the patient's perspective the progress is visible and translated in many patients being cured from HCV.
Have any of your patients faced other treatment access challenges unrelated to financial cost?
Dr. Jakab: Historically, when the first DAAs became available, there were certain requirements put forward by insurance companies before these medications were approved given their high price at that time. Unfortunately, some of them are still in effect.
Providers still must document their clinical evaluation and laboratory testing before these medications get approved, which is important for clinical care, but some insurance plans will only cover HCV treatment for patients with advanced (stage 3 or 4) fibrosis.
Another requirement that pains me a lot—though again, great progress has been made—has to do with sobriety for patients who use drugs or alcohol. Some plans require 3 to 6 months of sobriety, or for the patient to be connected to a substance use disorder clinic or a relapse program.
There have also been some restrictions regarding which providers could prescribe these medications. Initially this was limited to hepatology, gastroenterology, or infectious disease specialists. Given the fact that the current DAA regimens are so easy to use due to their short duration of treatment and minimal side effects, more providers are comfortable with prescribing these medications. It certainly helps that CDC recommendations support the expansion of the provider pool to include primary care providers and substance use disorder providers. Physician assistants and APRNs have been increasingly involved in prescribing these medications as well. Pharmacists help us get the approval from the insurance companies, but PharmDs also treat many HCV patients.
Certain states are ahead of others in terms of eliminating Medicaid requirements that decrease patient access to HCV medications. I am lucky to be in Connecticut, which is one of the states where Medicaid restrictions have pretty much been lifted in terms of fibrosis staging or sobriety or prescriber requirements. This progress had a lot to do with patient and provider advocacy. Back in 2015 the New Haven Legal Assistance lobbied the state’s policymakers and Medicaid leadership to change these requirements. For patients covered by commercial insurance plans there are some requirements still in place, but overall, it is much better.
I have also witnessed the revolution of HCV treatment at the VA. A few years back we were restricting the use of these medications for patients with advanced fibrosis. Now the VA has all the available medications on the formulary, and there are no restrictions in terms of fibrosis staging, or sobriety requirements.
How has your team at the West Haven VA helped patients access HCV care through collaboration with other providers?
Dr. Jakab: It has been amazing to see how innovative people can be. It is true that if there is a will, there is a way. We finally had those medications so effective in curing HCV but were faced with challenges getting them to our patients. There was a huge effort throughout the VA, which is the national leader in the treatment of HCV, with more than 100,000 veterans cured. VA Connecticut was part of the movement: we expanded our liver clinic team to include a nurse practitioner, a PharmD, RN care coordinators, and a health psychologist. This way we could help our patients overcome many psychosocial or medical barriers and get them successfully treated.
The last step was going where the patients were. We realized that some patients who would benefit from treatment would not necessarily engage with us in liver clinic, even if they kept up with seeing their primary care physician. So instead of trying to get the patients into the liver clinic, we developed a program called HELP C, which stands for “HEpatitis C Leaders in Primary Care. The purpose of the program was to educate primary care providers interested in treating HCV. We continue to provide support for them through teleconferences or being available for any questions. This way we could indirectly treat patients with HCV without having them come to the liver clinic.
We also collaborated with our colleagues from substance use disorder clinics, to make sure they are updated in terms of ease of HCV treatment and need to screen for HCV in these high-risk patients.
Is there any other action that physicians can take to help improve HCV treatment accessibility for their patients?
Dr. Jakab: Education of patients, providers and policy makers is most important, and a lot of that responsibility is on those of us who are already helping patients to get to their HCV cure. It has to do with breaking barriers. Many providers still have misconceptions, for example, when it comes to patients who are actively using drugs. They feel that we should not spend resources on these patients because of their lack of engagement in terms of treatment of their substance use disorder and risk of relapse. However, we do have data proving that even patients who are actively injecting drugs achieve a high level of compliance with medications and a high level of cure in the range of 95% or so. Having the sobriety requirement on some insurance plans is a significant barrier to treatment, and it does not help select the patients who will successfully achieve HCV cure. All patients should be treated. In fact, by focusing on this high-risk category of patients, society benefits overall because by decreasing the HCV burden, we get closer to HCV eradication.
It is also important that the providers who are interested in treating HCV get familiar with the paperwork required to get these medications approved, also partnering with subspecialty pharmacies particularly when dealing with commercial insurances. In addition, there are assistance programs for patients who do not have insurance, or they are underinsured, or they get denied by their insurance plan. At the end of the day, helping a patient to get treated is worth the extra time spent with bureaucracy.
I would also encourage providers to continue looking for innovative approaches, and to try to develop multidisciplinary programs. Care coordination—partnering with pharmacy, psychology, and social work subspecialties—is what worked best for us at the West Haven VA. We were able to treat patients that were written off many times before; patients who suffered homelessness, struggled with medication adherence for their high blood pressure, or diabetes. They were patients about whom everybody said, “You guys are crazy. They will never get the treatment completed, never mind getting cured of HCV.” But they did—so it is all about advocating for your patients and partnering with the right people.