Navigating HCV Prior Authorization

According to the Centers for Disease Control and Prevention an estimated 3 million people are living with chronic Hepatitis C (HCV). However, 30% of people living with HCV will die of HCV-related complications that could have been avoided with care and treatment. Within the last few years, advancements in treatment options, including direct acting antivirals (DAAs), provide lifesaving opportunities. The treatments available are significantly more tolerable, effective, and have a shorter treatment duration. Unfortunately, access to care and treatment can be difficult to obtain.

The cost of these medications has been identified as a significant barrier, causing insurance companies to develop strict guidelines that often deny access to opportunities for treatment. However, even though the costs of the treatment regimens are steep; early diagnosis and treatment is imperative in order to prevent and manage more serious effects of chronic HCV infection. Left untreated HCV can lead to liver damage including cancer and liver failure. However, in many cases the patients with the most advanced liver disease are those whose medication is approved (often, not without a battle).

The process of medication approval, or prior authorization, can be daunting. Here is an overview and a few tips for the navigating the process.

Review Your Benefit Information

First, it may be beneficial to review your insurance benefits to learn the requirements for authorization of HCV treatment. Each insurance company has its own guidelines.

Insurance companies may restrict approval of HCV treatment to a treating provider who has HCV clinical experience. Approval will also be considered if your doctor is managing and treating HCV infection in partnership with an HCV experienced provider. Therefore, linkage to a specialist, most often times a gastroenterologist or hepatologist, may be beneficial. Talk to your primary care provider, if you have not already been referred.

Understand medical requirements or restrictions

States may also have restrictions that require patients to have certain symptoms, including fatty liver or advanced staged scarring. Some states may only authorize treatment for patients if they are diagnosed with severe scarring, also known as cirrhosis. Various methods can be utilized to determine the amount of scarring on your liver.

Historically, providers have ordered a liver biopsy which removes a small piece of liver tissue which is then examined under a microscope for signs of damage. However, newer noninvasive, methods are available that can also determine the amount of scarring on your liver. A few examples can include: a Fibrosure score. An HCV Fibrosure is a blood test that combines the results of six blood serum markers (serum is plasma from which the clotting proteins have been removed), along with a patient’s age and gender. A numerical estimate is calculated to assess the amount of liver scarring; scores range from F0=no fibrosis to F4=cirrhosis.

A Fibroscan is another tool that uses vibrations to provide an accurate assessment of liver fibrosis. Fibroscan technology measures the velocity of a sound wave passing through the liver and then converts that measurement into a liver stiffness measurement. Another important assessment tool is a liver ultrasound; an ultrasound uses sound waves to make a picture of the liver. An ultrasound may be done in order to check for abnormalities, such as masses or discolorations that may indicate a liver condition, including cirrhosis or cancer.

Know your genotype & viral load

Besides knowing the stage of your liver disease, it is also imperative to know your HCV genotype and have a recent HCV viral load drawn. Your HCV genotype guides which treatment regimen is best for you. A viral load is important to have drawn, however, does not indicate the stage of your liver disease.

It is important for your doctor to document any medical co-morbidities both in your medical records and on prior authorization forms. Any symptoms associated with HCV should also be included; conducting and documenting results of a standardized fatigue scale, such as the Fatigue Severity Scale (FSS) may also be beneficial to demonstrate various effects of HCV.

Other common insurance restrictions include verification of abstinence from alcohol or drug use; often times toxicology screens are required. Avoiding or abstaining from alcohol and illicit drug use is always recommended; alcohol speeds up the progression of liver disease.  It is important to always be honest with your doctor, especially if you have engaged in alcohol or substance use. If you need support or counseling, talk to your doctor and social worker for support, resources and linkage to a specific counseling center.

Ask questions

Make sure to ask questions, speaking with members of an interdisciplinary team including a pharmacist, nurse, dietician and social worker may help you have a better understanding of the spectrum of impacts that HCV may have on your body. Understanding which medication you will be prescribed and knowing both how and when to take it is important. Some insurance companies also require documentation that a patient is both able and ready to adhere to their plan of care for treatment; signing a treatment adherence agreement may be beneficial.

Make sure your insurance benefits are stable. Maintaining the same insurance plan throughout the course of HCV treatment is very important! Each insurance company has different requirements for medication approval. You do not want to risk the chance of missing a dose of medication once you initiate treatment. If you need assistance with your insurance contact a social worker/case manager for benefit assistance.

Specialty pharmacies may be very beneficial in assisting with medication application/approval processes. A significant amount of time must be devoted to the prior authorization process; specialty pharmacies have experience in this process. They also assist with insurance verification, reimbursement support and financial resource assistance. Specialty pharmacies will ship medications directly to a person’s home; they will also monitor when you are due for refills. Specialty pharmacies will coordinate your care with you and your prescriber; they can provide education and discuss patient concerns.

Learn about potential programs that can help

Your doctor may also have a relationship with pharmaceutical representatives; each pharmaceutical company offers a program to assist with the financial burden of treatment. Please see the HepatitisC.net resource page for links to patient assistance programs. Help4Hep can link you with available resources.

Remember, this can be a long process. In some cases, it can take weeks or months to receive approval. Many patients will receive a denial at first. Make sure that an appeal is submitted on your behalf. HepFree Hawaii offers examples of letters of an appeal (see website).

In the meantime, make sure that you engage in activities that support your well-being. Follow up with your doctor’s office if you have questions or concerns. Eat a well-balanced diet that limits both fat and salt intake is important. Consider joining a support group and talking to others who are living with a similar situation. Advocate for yourself and others, everyone living with HCV deserves an opportunity to access treatment!