MARYLAND HEPATITIS C STRATEGIC PLAN

MARYLAND HEPATITIS C

STRATEGIC PLAN

Maryland Department of Health

January 2019

Maryland Hepatitis C Strategic Plan

January 2019

EXECUTIVE SUMMARY

Hepatitis C is a major cause of chronic liver disease and its related complications, including liver

cirrhosis and hepatocellular carcinoma. To continue the work addressing this major health issue,

Maryland intends to work towards the elimination of hepatitis C virus (HCV) as a public health

threat by prioritizing the prevention, testing and treatment of infection with hepatitis C virus to

reduce the number of new infections, ensure access to high-quality health care services and prevent

the negative health impacts of this disease, particularly among groups at highest risk of disease. A

comprehensive, broad-based strategy includes a 4-pronged approach that encompasses prevention

and education, testing, treatment and strengthening the disease surveillance system.

The goals and strategies for Maryland’s hepatitis C approach are outlined below:

Goal 1: Prevent new hepatitis C infections.

Strategy 1.1: Increase community awareness of viral hepatitis and decrease stigma and

discrimination.

Strategy 1.2: Ensure that all people have access to HCV prevention services that are culturally

and linguistically appropriate.

Goal 2: Expand hepatitis C testing, particularly among people who are high risk.

Strategy 2.1: Identify persons infected with HCV early in the course of disease through

promotion of routine testing at key points of contact with service providers.

Strategy 2.2: Promote complete hepatitis C testing (RNA confirmatory, genotype, and liver

fibrosis assessment) after a positive screening test.

Goal 3: Improve access to treatment and adherence services.

Strategy 3.1: Improve linkage to timely and accessible hepatitis C care and adherence services.

Strategy 3.2: Increase health care provider capacity to screen and treat hepatitis C in both rural

and urban settings.

Strategy 3.3: Address the high cost of treatment drugs.

Goal 4: Enhance hepatitis C surveillance, monitoring and evaluation.

Strategy 4.1: Improve timely submission of complete HCV reports to state and local surveillance

by laboratories and clinical providers.

Strategy 4.2: Expand reporting to include HCV RNA negative test results.

Strategy 4.3: Monitor HCV-related health services and outcomes through clinical data such as

electronic health records, claims data, and information shared over the state’s health information

exchange (CRISP).

Maryland Hepatitis C Strategic Plan

MARYLAND HEPATITIS C STRATEGIC PLAN

Maryland Department of Health

January 2019

TABLE OF CONTENTS

Executive Summary

Introduction

I. Background

II. Strengths and Challenges of the Hepatitis C

System in Maryland

III. National and Global Perspectives on Hepatitis C

Maryland Hepatitis C Goals and Strategies

I. Mission

II. Goals and Strategies

Goal 1: Prevent new hepatitis C infections

Goal 2: Expand hepatitis C testing

Goal 3: Improve access to treatment and

adherence services

Goal 4: Enhance hepatitis C surveillance

References

Maryland Hepatitis C Strategic Plan

INTRODUCTION

Background

Hepatitis C in Maryland

Hepatitis C virus (HCV) is a major cause of chronic liver disease, which places individuals at risk for

liver cirrhosis, liver failure, hepatocellular cancer and other complications. Infection can be spread

through exposure to infected blood, such as through injection drug use, needle stick injuries, birth to

an HCV-infected mother or sexual activity. The U.S. Centers for Disease Control and Prevention

(CDC) estimates 3.5 million individuals are living with HCV infection in the United States.

Maryland, there has continued to be increases in chronic HCV reports with 7,922 cases in 2017

(Figure 1).

Between 2015 and 2016, 19 of the 24 Maryland jurisdictions experienced an increase in

reported HCV cases. Seventeen counties had the highest number of HCV cases reported since before

2010.

According to HepVu, a website launched by Emory University Rollins School of Public Health in

April 2017, the estimated number of Marylanders living with HCV antibodies in 2010 was 80,500

which is an estimated prevalence of 1,890 per 100,000 population.

This number is only indicative

of people who have been exposed to HCV. In 2017, 7,922 cases of probable and confirmed chronic

HCV were reported.

The statewide average rate for newly reported cases in 2017 was 130.9 cases

per 100,000 people (Figure 2).

From 2010 (103.4 cases per 100,000) to 2017 (130.9 cases per

100,000), the rate of chronic HCV reports increased by over 25 percent. Since there are hard-to-reach

populations impacted by HCV that are not connected to care, the burden of the disease in Maryland

is estimated to be higher than what is reported.

Baltimore City has the highest rate in the State of Maryland at 384.9 cases per 100,000 people;

however, Somerset County follows with 335.7 cases per 100,000 people.

Cecil, Kent, Washington,

Allegany and Dorchester counties are among the counties with the highest rates at 274.5, 216.7,

216.5, 192.7 and 189.7 reported cases per 100,000 people, respectively.

It is important to distinguish that reported cases may have either acute or chronic HCV infection. The

clinical case definition for acute HCV is dependent on the presentation of symptoms (e.g., jaundice,

fever, headache, nausea) or elevated liver enzyme levels detected in a blood test.

However, due to

the often-asymptomatic nature of HCV, most who become newly infected are not aware of their

disease status. In addition, about 15-25% of acutely infected individuals spontaneously clear the

virus without treatment.

It is thus difficult to make meaningful inferences about acute cases

reported through surveillance because they are often vastly underestimated and not representative of

true disease burden.

Diagnosis of chronic HCV usually occurs if a person has been infected for greater than six months

and is done using two blood tests: a positive test for HCV antibodies (anti-HCV) as well as a positive

RNA confirmatory test (either a nucleic acid test or HCV antigen test).

The state relies on

mandatory clinical and laboratory reporting to generate estimates for newly reported cases of chronic

HCV. Due to lack of clinical symptoms and regular screening, as well as the two-step process for

screening, approximately half of individuals with HCV are unaware of their chronic infection.

For

this reason, HCV is often referred to as the “silent epidemic.”

Maryland uses the Centers for Disease Control and Prevention’s 2016 case definition of chronic hepatitis C available

at: https://wwwn.cdc.gov/nndss/conditions/hepatitis-c-chronic/case-definition/2016/

Maryland Hepatitis C Strategic Plan

Figure 1. Number of Reported Chronic Hepatitis C Cases in Maryland, 2017

Figure 2. Rate of Reported Chronic Hepatitis C Cases in Maryland, 2017

Special Populations

According to estimates by the CDC, 25 percent of people with HIV are co-infected with HCV.

Reported data from 2016 showed that 4,032 people living with HIV in Maryland were co-infected

with HCV.

Over 55 percent of co-infected people in Maryland live in Baltimore City, followed by

Baltimore County (10 percent), Prince George’s County (9.4 percent), and correctional facilities

located in the State (10 percent).

Maryland Hepatitis C Strategic Plan

As seen nationally, in Maryland, the baby boomer cohort has the highest prevalence of HCV

infection among all age groups. Despite making up only 25.7 percent of Maryland’s population, in

2016, people born from 1945-1965 accounted for 54.6 percent of reported chronic HCV cases.

14,15

While information about race and ethnicity is incomplete among reported cases, data from death

certificates show a disproportionate impact among some racial and ethnic minority group. The 2016

U.S. rates of hepatitis C-related deaths are higher among American Indian/Alaskan Natives (10.8

deaths per 100,000 population), black non-Hispanics (7.4 per 100,000), and Hispanics (5.7 per

100,000) compared to white non-Hispanics (4.0 per 100,000).

Hepatitis C infection can also occur through mother-to-child transmission during pregnancy. Rates of

transmission vary between 2-14%, with a higher risk in women co-infected with HIV or who have

injection drug use.

17,18

One report showed that the rate of HCV detection among women of

childbearing age (15 to 44 years) being tested increased by 22% between 2011 and 2014 from 139 to

169 per 100,000, demonstrating that the risk in this group is growing, which in some areas of the

country may be related to increasing injection drug use.

People who inject drugs (PWID) are also at higher risk for having hepatitis C because needle-sharing

behaviors increase the risk of infection, there is a relatively low utilization of health services and the

stigma of substance use in the community, including among health care providers, which is seen as a

barrier to seeking and obtaining appropriate care. In people 20-59 years with hepatitis C, 51%

reported injection drug use as a potential risk factor or exposure.

A higher HCV prevalence exists

among PWID, with some studies showing an estimated HCV antibody prevalence of 73% in the

U.S.

In Maryland, 51% of PWID in Baltimore were reported to be HCV antibody positive between

2002 – 2004, indicating that these individuals have been exposed to HCV.

Prevalence and incidence of HCV within corrections systems are also known to be very high,

corresponding in part to the higher prevalence of substance use disorders in this population. The

most recent data from Maryland are from 2002 during which investigators screened for anti-HCV

antibody among newly incarcerated individuals in state correctional facilities over a two-month

period. They found a prevalence of almost 30% in that population.

A more recent national estimate

from the CDC reports 17.4% of inmates living with past or present HCV infection.

Hepatitis C Treatment

Treatment for hepatitis C has changed considerably in the last decade. Previously, treatment was

primarily comprised of pegylated interferon and ribavirin, which had significant side effects and

relatively low efficacy when compared with the more recently introduced direct acting antivirals

(DAA’s), first approved by the Federal Drug Administration in 2011. The second generation of

DAA’s which came to the market in 2014 represent a significant improvement over the older

treatment regimens because they are >95% effective, are taken for shorter durations, and have

minimal side effects and drug interactions.

The primary barrier has been the high cost of an 8- to

12-week course of treatment, which ranged from $26,000 to more than $90,000, before rebates or

discounts.

Drug prices have decreased over time with the introduction of lower cost medications

such as glecaprevir/pibrentasvir (Mayvret), and it is anticipated that generic versions of

ledipasvir/sofosbuvir (Harvoni) and sofosbuvir/velpatasvir (Epclusa) will be introduced in January

2019 at a list price of $24,000.

The Maryland Medicaid program has long covered hepatitis C virus treatment in the state plan,

including the newer direct-acting antiviral therapies first approved in 2013. Maryland generally

Maryland Hepatitis C Strategic Plan

follows genotype treatment recommendations for testing, managing, and treating HCV as directed by

the American Association for the Study of Liver Diseases. As of September 20, 2018, the

Department covers the recently-approved glecaprevir/pibrentasvir (Mavyret) drug, as well as

daclatasvir (Daklinza), elbasvir/grazoprevir (Zepatier), ledipasvir/sofosbuvir (Harvoni), ombitasvir,

sofosbuvir/velpatasvir (Epclusa), sofosbuvir (Sovaldi), and sofosbuvir/velpatasvir/voxilaprevir

(Vosevi).

The Maryland Medicaid Pharmacy Program requires providers to submit prior authorization for new

HCV therapies. As of December 1, 2018, the program treats patients with a Metavir score of F2 or

above, unless the individual has a viral condition known to result in more rapid disease progression

and/or liver decompensation than normally expected from the course of chronic HCV. However,

Governor Hogan’s most recent budget allowance includes funds to enable expansion of treatment to

those in the Medicaid program with Metavir scores of F1 and above beginning in Fiscal Year 2020.

The Metavir score indicates the level of liver damage, with the scale going from no fibrosis (F0) to

cirrhosis (F4). A patient’s entire medical history is also considered, including treatment history,

history of substance use disorder, history of medication non-adherence, and co-occurring conditions

(such as cancer or HIV) though the program does not have requirements based on specialty provider

care or length of time in substance use treatment.

II.

Strengths and Challenges of the Hepatitis C System in Maryland

Maryland’s existing viral hepatitis infrastructure provides a strong foundation for HCV prevention

and control. The state’s public health, healthcare, and other public and private sector partners are

actively engaged in expansion of prevention, diagnosis, care, and treatment services for people living

with HCV. The Maryland Department of Health has established programs that contribute to an

improved HCV care system, including enhanced surveillance, increased screening in key populations

including people with substance use disorders and in corrections facilities, expansion of medication

assisted treatment for substance use disorders and integration of HCV screening and treatment into

primary care.

However, a number of challenges remain. There is a general lack of awareness about the potential

risk factors for having hepatitis C, consequences of infection and the need for testing and treatment.

Because there may be few symptoms early in the disease course, many Marylanders do not know

they are infected with HCV and live in jurisdictions where opportunities for testing are limited. In

addition, the disease surveillance system relies on incomplete reporting from clinicians and

institutions mandated to notify public health and does not have the ability to collect more detailed

clinical information from those who are treated. The current opioid overdose epidemic also presents

a threat for increased spread of the disease, with the increased number of people who are using illicit

opioids and other drugs. Those with confirmed chronic infection may lack social supports and

resources needed to link them to and sustain them during treatment and follow-up care. Both the

disease and people with the disease face stigma, which can also contribute to reluctance to seek

testing or treatment. Finally, while generic pharmaceuticals will be available, the cost has posed a

threat to the health care system’s ability to meet the demands of improving access and the overall

health of the population while containing costs. This includes the state’s responsibility to maximize

public funds to be able to fully support treatment services among the low-income residents of the

state. There is also a need to increase the number of community providers, particularly in

underserved communities.

Maryland Hepatitis C Strategic Plan

III.

National and Global Perspectives on Hepatitis C

Worldwide, there are an estimated 130 to 150 million people living with chronic HCV infection. The

advent of highly effective and well tolerated oral medications that cure HCV has led to a shift in

focus from HCV control to disease elimination. According to the World Health Organization, global

elimination of hepatitis C as a public health threat is an achievable goal.

In the United States,

multi-disciplinary experts, convened by the National Academies of Sciences, Engineering, and

Medicine, also concluded that the nation can eliminate HCV and published comprehensive national

strategies to inform action towards national elimination of hepatitis C as a public health threat.

31,32

The U.S. Department of Health and Human Services released the National Viral Hepatitis Action

Plan, 2017-2020 that provides a more detailed set of strategies that are similar to the National

Academies’ recommendations, including enhancing hepatitis testing, improving viral hepatitis

surveillance, expanding access to syringe services and medication assisted treatment, and building

the capacity of primary care providers to treat.

To progress towards statewide HCV prevention and control, Maryland will build upon an

infrastructure to employ and sustain strategic coordinated multi-sector efforts to increase both the

awareness of the infection as well as opportunities to be tested and treated. This strategic plan

outlines the goals, strategies and current activities to progress towards improved prevention and

management of hepatitis C infection in the state.

Maryland Hepatitis C Strategic Plan

MARYLAND HEPATITIS C GOALS AND STRATEGIES

Mission

Maryland will work towards the elimination of hepatitis C disease as a public health threat by

prioritizing the prevention, testing and treatment of infection with hepatitis C virus (HCV) to reduce

the number of new infections, ensure access to high-quality health care services and prevent the

negative health impacts of this disease.

II.

Goals and Strategies

Maryland’s Hepatitis C Strategy builds on the foundation of programs and services that have been

established since the 2002 Maryland Hepatitis C Prevention and Control Plan was released.

The

plan is based on 4 pillars which provide the structure for the broad-based approaches needed in the

state in order to achieve the mission (see Figure 3). The pillars include:

Prevent new hepatitis C infections;

Expand hepatitis C testing, particularly among people who are high-risk;

Improve access to treatment and adherence services; and

Enhance hepatitis C surveillance, monitoring and evaluation.

Figure 3. Maryland’s Hepatitis C Strategy: Four Pillars

population

Treatment

treatment to

data

prevent

with infection,

risk

Maryland Hepatitis C Strategic Plan

Goal 1: Prevent new hepatitis C infections.

Efforts to eliminate HCV must include primary prevention. As noted in the federal Health and

Human Services’ Action Plan, low public awareness about hepatitis and low perceived risk lead to

late diagnoses, more severe disease outcomes, and premature death among those who are chronically

infected.

Evidence-based prevention methods include educating individuals and communities

about risk factors for HCV infection, risk reduction techniques, treatment options, and how to access

testing and care. In addition to targeting the general population, Maryland’s prevention efforts should

focus on developing targeted interventions for populations at highest risk for HCV infection,

especially people who inject drugs (PWID). HCV prevention efforts can build on existing

partnerships with community- and faith-based organizations around the state.

Strategy 1.1: Increase community awareness of viral hepatitis and decrease stigma and

discrimination.

Many people may remain unaware of risk factors for contracting HCV infection, such as age (people

born between 1945 and 1965) or risky behaviors such as IV drug use. The introduction of highly

effective cures for HCV is relatively new, and many are still uninformed about the availability of

these new treatments with fewer side effects and better outcomes. An important aspect of promoting

testing and treatment is that curing HCV prevents onward transmission of the infection, a concept of

treatment as prevention. Social stigma about hepatitis C infection as well as about high-risk groups

(e.g. people with history of substance use disorders or incarceration) can prevent people from

seeking testing or treatment. Educating providers, communities, government, and law enforcement

may reduce stigma of both HCV and drug use to further promote a test and treat approach for these

populations. Increased messaging and education about the importance of routine screening is needed

for people at higher risk for infection as well as health care providers. Education should include

information about the availability and effectiveness of treatment and the personal and public health

benefits of treatment.

Strategy 1.2: Ensure that all people have access to HCV prevention services that are culturally

and linguistically appropriate.

Outreach and education on HCV prevention and treatment are needed for everyone, but especially

important for high-risk populations such as people who inject drugs (PWID) and incarcerated

persons. One key strategy is to target programs within settings such as prisons and jails, homeless

and housing services, substance use treatment facilities, and peer networks of active drug users.

Access to high-quality substance use disorder treatment and recovery support services, including

medication-assisted treatment, can also reduce the risk of hepatitis C infection by decreasing risky

behaviors and facilitate hepatitis C testing and linkage to treatment.

In addition to reducing overdose deaths and drug-use related injury, syringe service programs (SSP)

can reduce new HIV and viral hepatitis infections by decreasing needle and other equipment sharing,

providing infectious disease prevention education, and offering HIV and viral hepatitis testing. SSP’s

provide ongoing contact with, improve the health of, and encourage treatment for, persons who inject

drugs. The 2016 authorization of SSP’s in Maryland counties presented the opportunity for

statewide implementation of harm reduction models that incorporate infectious disease prevention.

The Department has partnered with local health departments and community-based programs to

implement SSP, with 4 jurisdictions having operational programs as of August 2018. Local

communities should work together across health, public safety, and community advocates to expand

access to syringe services programs.

Maryland Hepatitis C Strategic Plan

Goal 2: Expand hepatitis C testing, particularly among people who are high risk.

Identification of people with HCV requires that diverse and flexible opportunities for screening and

confirmatory testing are available. Methods to increase universal testing in Maryland should build

upon existing healthcare provider trainings on screening and diagnosis of HCV and increase

resources to support testing, diagnosis, and linkage to care in non-clinical settings, including in the

community. Increasing knowledge of hepatitis C status can also impact behaviors that can transmit

infection; some studies have shown that people who are aware of being infected with hepatitis C

have a decrease in risky behaviors such as needle sharing and injection drug use.

The Centers for Disease Control and Prevention (CDC) recommends HCV testing for people based

on their individual risks:

●

Adults born from 1945 through 1965 should be tested once (without prior ascertainment of

HCV risk factors).

●

HCV testing is recommended for those who:

○ Currently injecting drugs.

○ Ever injected drugs, including those who injected once or a few times many years ago.

○ Have certain medical conditions, including persons:

■

who received clotting factor concentrates produced before 1987.

■

who were ever on long-term hemodialysis.

■

with persistently abnormal alanine aminotransferase levels (ALT)

■

who have HIV infection.

○

Were prior recipients of transfusions or organ transplants, including persons who:

■

were notified that they received blood from a donor who later tested positive for

HCV infection.

■

received a transfusion of blood, blood components, or an organ transplant before July

1992.

●

HCV- testing based on a recognized exposure is recommended for:

○ Healthcare, emergency medical, and public safety workers after needle sticks, sharps, or

mucosal exposures to HCV-positive blood.

○ Children born to HCV-positive women.

However, while not explicitly included in the CDC recommended screening categories, there may be

other groups who may benefit for hepatitis C screening, including pregnant women and people who

have a history of incarceration, use non-injection illicit drugs or frequent non-licensed tattoo

parlors.

It is also important to conduct risk-based screening for women of child-bearing age to

prevent mother-to-child transmission.

Strategy 2.1: Identify persons infected with HCV early in the course of disease through

promotion of routine testing at key points of contact with service providers.

Promoting routine testing is a key component of a comprehensive plan, particularly among high-risk

individuals, including people who inject drugs (PWID), persons born between 1945 and 1965,

persons who were formerly or are currently incarcerated. Approaches to improve the availability of

testing in the community must engage all providers of care and services, including primary care

providers, pharmacies, local health departments, syringe service programs, substance use disorder

treatment centers, urgent care centers, hospital emergency departments, and community-based

organizations.

Maryland Hepatitis C Strategic Plan

In 2017, the Department launched a rapid HCV testing program to identify individuals with HCV

who are unaware of their status. The program provides free HCV rapid test kits and controls to a

growing number of local health departments and agencies that serve populations at risk for HCV.

Modeled after the Department’s HIV testing and linkage-to-care program, initial efforts focused on

integration of HCV rapid testing at existing HIV testing partner sites. While still limited in scope,

increasing access to rapid testing in more locations has the potential to reach even more people.

Strategy 2.2: Promote complete hepatitis C testing (RNA confirmatory, genotype, and liver

fibrosis assessment) after a positive screening test.

After an initial screening test is found positive, a viral RNA test is necessary to confirm HCV

infection and is also used to track treatment response. Despite long standing clinical guidelines

emphasizing the need for confirmatory HCV RNA testing following an initial reactive HCV

antibody test, recent surveys have indicated that 50% of those with a positive HCV antibody have

not completed HCV RNA testing.

39,40

New York City recently made RNA reflex testing a

requirement for laboratories when they identify a reactive antibody test, and this may also be a

strategy in Maryland. Additional testing, including viral genotyping and liver fibrosis assessment

should be completed when an individual with confirmed hepatitis C infection is connected to a

treatment provider to guide clinical decision making. At this time, Maryland law does not require

reporting of this additional information to the MDH disease surveillance program.

Maryland Hepatitis C Strategic Plan

Goal 3: Improve access to treatment and adherence services.

Early treatment in the course of HCV is associated with an overall reduction in morbidity and

mortality as well as health care costs for treatment of complications of advanced disease including

cirrhosis, liver transplant and liver cancer. A significant challenge to treatment of HCV has been the

relatively high cost of new medications. Efforts to expand treatment access must continue to include

strategies to reduce the cost of HCV medications. Some states have explored opportunities to work

directly with pharmaceutical companies to negotiate lower drug costs charged to Medicaid to

improve the feasibility of expanding HCV treatment criteria. Working towards removing barriers to

treatment in Medicaid and commercial insurers and addressing care for those without insurance are

key strategies.

Maryland must have a healthcare workforce sufficiently resourced, sizeable, and competent enough

to address the burden of HCV in the state. The National Academies of Science recommend building

the capacity of primary care providers to address HCV as a strategy for elimination. To expand the

capacity of primary care in Maryland, clinicians need training to provide them with the tools and

skills required to screen, diagnose, and treat HCV. Clinicians must also be able to effectively

communicate to patients the benefits of screening, the benefits and risks of HCV treatment, and

describe potential barriers HCV patients may encounter when seeking treatment coverage.

Strategy 3.1: Improve linkage to timely and accessible hepatitis C care and adherence services.

Screening is essential to identify persons living with HCV, and by increasing testing opportunities

across the state, a greater number of previously undiagnosed individuals will be identified who will

need to be referred for follow-up testing and treatment. A number of barriers can prevent or delay

linkage to treatment and adherence to treatment regimens, including unknown insurance status, lack

of provider referral, and patient drug or alcohol misuse. The next crucial step is linking diagnosed

individuals to appropriate care and support, so they can receive and be able to adhere to the

prescribed treatment and follow-up care. This is a strategy that has been successful among people

with HIV such as through Ryan White case management services and has also shown similar

positive outcomes among people with HCV infection.

41,42,43

Maryland Medicaid currently provides hepatitis C treatment services to its enrollees who meet

certain clinical criteria, including having a Metavir score of F2 or above. Table 1 presents HCV-

related intervention data for CY 2016. Of the approximate 1.5 million individuals with any period of

Medicaid enrollment in CY 2016, 61,849 received an HCV antibody test and 12,436 received an

HCV RNA test for diagnosis of HCV. A total of 22,352 unique participants had an HCV diagnosis

code, corresponding to an HCV prevalence of 1.47 percent among all Maryland Medicaid

participants. Of the 22,352 participants with HCV diagnoses, 1,041 received non-interferon-based

treatment. Assuming only people with an F2 score or above (an estimated 54 percent of people with

chronic HCV are F2 or above, or 12,070 people) accessed treatment, the overall treatment rate was

8.62 percent.

Overall for CY 2015 and CY 2016, the percentage of eligible people receiving

treatment is 11.64 percent across all Metavir score groups (average of proportion of people with F2

Metavir score or above that received DAA treatment in CY 2015 and CY 2016). Working towards

the expansion of treatment criteria for low-income residents will allow additional people to be

treated and cured.

Maryland Hepatitis C Strategic Plan

Table 1. Frequency of Hepatitis C Interventions Among Medicaid Participants Meeting

Clinical Criteria and with Any Period of Enrollment, CY 2016.

Total

Number of

Unique

Participants

Unique

Participants

with HCV

Antibody

Test

Unique

Participants

with HCV

RNA Test

Unique

Participants

with HCV

Diagnosis

Code

Unique

Participants

with

Prescription for

Interferon-

Based HCV

Treatment

Unique

Participants

with

Prescription for

Non-Interferon-

Based HCV

Treatment

1,535,414

61,849

12,436

22,352

1,041

*Not reported due to small cell size.

In addition to these efforts, targeted work must be done to address the special needs of key

populations often at highest risk for infection.

People Who Inject Drugs

People who inject drugs (PWID) are one of the populations at highest risk for chronic HCV infection

in Maryland. Therefore, primary care-based HCV interventions present one means to engage PWID.

Partnerships with substance use providers and recovery support services are another key strategy in

reaching this population. Syringe service programs (SSP) are also an important avenue to offer a

comprehensive approach to harm reduction and support services for PWID. These programs include

the integration of HCV testing and linkage to care. In 2019, the Department will launch a hepatitis C

peer navigation program to help newly diagnosed SSP clients navigate linkage to HCV care in their

respective communities.

Women of Child-Bearing Age

The number and rate of HCV infections among women of child-bearing age in the U.S. has

increased—driven at in least in part by the opioid epidemic in some geographic locations.

Therefore, in addition to increased HCV screening among high-risk women of child-bearing age,

additional efforts are needed to ensure that women who are diagnosed with HCV receive follow up

care and treatment prior to becoming pregnant. Women diagnosed during pregnancy should receive

HCV management in accordance with accepted standards of care to protect the health of the woman

and her infant. This requires that providers have access to comprehensive guidance on how to care

for pregnant women with HCV and monitoring of infants at risk for vertical transmission.

Currently or Previously Incarcerated Individuals

Hepatitis C disproportionately affects individuals who are currently incarcerated and

individuals with a history of incarceration. The Maryland Department of Public Safety and

Correctional Services (DPSCS) enrolls incarcerated individuals with HCV in a chronic care clinic.

Each individual is then referred to and assessed by an infectious disease specialist. Finally, DPSCS’

HCV panel completes a comprehensive clinical review and determines whether the inmate will begin

treatment while incarcerated. Although a person may be released prior to treatment initiation,

DPSCS makes every effort to begin treatment as soon as possible after a positive screening. In

October 2017, the Maryland Department of Public Safety and Correctional Services (DPSCS)

launched a Testing and Linkage to Care program in collaboration with Maryland Department of

Maryland Hepatitis C Strategic Plan

Health. This program aims to increase the number of inmates who are aware of their HCV status

prior to being released into the general population. Inmates due for release from corrections are

tested using rapid HCV test kits. All inmates with a positive rapid HCV result and those known to be

HCV positive are linked to clinical providers in their respective communities.

Strategy 3.2: Increase health care provider capacity to screen and treat hepatitis C in both

rural and urban settings.

The burden of HCV disease far outstrips the capacity to treat expeditiously. More providers must be

engaged to treat HCV in their practices. This means moving beyond specialist-only treatment.

Studies have found no significant difference in sustained virologic response (SVR) among patients

treated with direct acting antiviral (DAA) therapy prescribed by non-specialists versus specialists.

By engaging both specialists and non-specialists in HCV treatment, the state’s overall capacity to

cure HCV infection can be increased.

To increase the availability of HCV care in Maryland, health care providers throughout the state have

taken the initiative to integrate HCV services into their practices or expand their HCV patient panel

size to facilitate increased treatment access. To meet this need, the Department established the

Maryland Community-based Programs to Test and Cure Hepatitis C (“Test and Cure Program”)

through a CDC grant totaling $1.2 million. This four-year cooperative agreement with CDC supports

a multi-pronged approach to clinical integration of HCV testing, care, and treatment at health care

settings in Baltimore City, Baltimore County, Montgomery County, and Prince George’s County,

which are the Maryland counties with the highest prevalence of HCV. This work has revealed the

substantial infrastructure and coordination necessary to implement and maintain high quality HCV

service delivery. Additionally, it has demonstrated the need to develop clinical expertise related to

HCV screening, care and treatment in community-based health care centers. Most importantly, it has

increased the availability of HCV care in settings where individuals in the state’s highest burden

jurisdictions already access health care and other services. The Maryland Primary Care Program, an

essential element of the State’s Total Cost of Care Model,

launched in 2018 and will include

primary care providers from across the state who could be part of these efforts to increase integration

of comprehensive HCV care into their practices. Governor Hogan’s Fiscal Year 2020 budget

allowance includes state funds to continue the HCV surveillance after the CDC funding ends.

In 2015, the Johns Hopkins University, in collaboration with the Maryland Department of Health,

launched a comprehensive clinical hepatitis C training and certification program for primary care

providers in Baltimore City and Baltimore County. Titled Sharing the Cure, the HCV training and

certification program for clinicians (physicians, physicians assistants, and nurse practitioners) was

modeled after the University of New Mexico’s Project ECHO (Extension for Community Healthcare

Outcomes), clinicians from the participating clinical sites receive HCV certification upon completion

of a one-day intensive training, a half-day preceptorship at an HCV specialty clinic, and ongoing

videoconference training by leading specialists. Additionally, the training addresses the need for

improved cultural competency of providers to care for the key populations noted in Strategy 3.1.

Provider training in conjunction with developing internal clinical infrastructure to support HCV

services is leading to the overall aims of increased screening and treatment at participating clinics.

The program’s success is evidenced not only by staff outreach to over 1,600 people for HCV linkage

to care and over 5,000 patients seen by trained providers, but also by interest in the training that

surpasses the program’s current capacity and requests from specialists and other medical

professionals (e.g., pharmacists) seeking to participate in the training program. In 2019, the training

program will expand to include clinicians who provide Ryan White HIV/AIDS services throughout

Maryland Hepatitis C Strategic Plan

the state, including western Maryland and the lower Eastern Shore. Initiating an HCV training cohort

for HIV care providers will increase HCV treatment among individuals co-infected with HIV and

HCV. Additionally, the training program will run two simultaneous training cohorts for primary care

providers, thereby doubling the number of trainees that will be certified in the coming year.

Strategy 3.3: Address the high cost of treatment drugs.

Hepatitis C drug pricing is a significant barrier to HCV treatment. The cost of some of the newer

HCV direct-acting antivirals have been upwards of $90,000 for 8-12 weeks of treatment per patient.



While the recent introduction of lower cost and effective DAA’s have created downward market

pressures on prices, many states continue actively exploring options to drive down the cost of HCV

DAAs through a variety of strategies such as use of multi-state agreements with pharmacy benefit

management companies, direct negotiation with pharmaceutical companies or purchasing patents for

HCV DAAs. Generic versions of ledipasvir/sofosbuvir (Harvoni) and sofosbuvir/velpatasvir

(Epclusa) will be introduced in the U.S. in January 2019, which will also continue to drive down

costs and improve treatment accessibility. However, people who have high-deductible insurance or

are uninsured may not be able to afford the total cost of treatment, including not only the medications

but also health care provider visits and testing.

In the state’s Medicaid program, due to the high cost of treatment, new HCV drugs are carved out of

MCO capitation rates. The Department makes supplemental payments to the MCOs for the

prescriptions prescribed to Medicaid participants. The Department pays the cost for Fee for Service

(FFS) enrollees directly. Both the FFS program and MCOs are eligible for rebates, which make

estimating the total cost of treatment difficult.

Using Medicaid data from CY 2016 about people treated with new HCV drugs, the total cost of

treating 1,042 participants in Medicaid MCOs or FFS was $138,912,867, or about $133,000 per

person before rebates. The cost was $71,000 after rebates, which accounts for 47 percent of the total

per-person cost.

The actual amount per person may be lower if certain individuals required

retreatment (if their HCV was not cured by the initial treatment course) or became re-infected. The

cost per person has decreased further since that time as lower cost drugs have been introduced.

Similar to approaches employed by other states, the state may consider options to lower HCV drug

costs paid by including an intra-agency approach to negotiation with pharmaceutical companies.

Options to negotiate may include bulk purchasing at a fixed price. In considering these options, the

state can utilize the assistance of and lessons learned from the National Governors Association’s

initiative to lower HCV treatment costs through collaboration between states and pharmaceutical

companies. Additionally, the state could coordinate with all payers to identify strategies that can

address costs to expand treatment availability and establish a standardized approach for covering

HCV care and treatment.

◆

For Medicaid, this would represent the pre-rebate cost.

Maryland Hepatitis C Strategic Plan

Goal 4: Enhance hepatitis C surveillance, monitoring and evaluation.

Both knowing the burden of HCV in Maryland and having the capacity to evaluate whether efforts to

prevent and cure HCV infection are successful are essential to the development of effective

elimination strategies. The Maryland Department of Health’s Infectious Disease Epidemiology and

Outbreak Response Bureau manages statewide surveillance processes and data for reportable

infectious diseases, including hepatitis C. Currently, Maryland has a passive surveillance system

with a limited capacity to investigate and monitor HCV infections at the local and state level.

Reported cases often have incomplete information, such as about race demographics, which limits

the ability to fully characterize the disease in Maryland. Working towards an improved HCV data

collection system will allow the state to better understand the burden of HCV in Maryland and to

evaluate whether efforts to prevent and cure HCV infection are successful, both of which are

essential to the development of effective prevention and control strategies.

Strategy 4.1: Improve timely submission of complete HCV reports to state and local

surveillance by laboratories and clinical providers.

Maryland has continued to expand electronic laboratory reporting (ELR), which will vastly

strengthen HCV surveillance data. Laboratories are the source of the majority of reports of HCV in

the state and ELR reduces the need for hand entry by surveillance staff at local health departments

and makes timely data available through the electronic National Notifiable Diseases Surveillance

System (NNDSS). In addition to laboratories, health providers are also accountable for reporting

cases of HCV per COMAR 10.06.01.03. Educating providers about reporting responsibilities and

encouraging adherence to regulation ensures more complete demographic and health data are

included in surveillance cases reports. More complete and accurate surveillance data will require

additional follow-up with providers by local and state health department staff. Such detail allows the

state and local surveillance teams to better quantify and characterize disease burden, outcomes, and

HCV-related health disparities. Governor Hogan’s fiscal year 2020 budget allowance also includes

state funds to further enhance the HCV surveillance system.

Strategy 4.2: Expand reporting to include HCV RNA negative test results.

Currently, only positive/reactive RNA tests for HCV are reportable. In order to accurately

characterize the burden of HCV and the success of cure efforts, the Department must also have

negative RNA test results. A negative HCV RNA test result after an initial positive test reflects cure

(if tested twelve weeks after completion of a full treatment course) or spontaneous clearance of the

virus, which occurs in about 15 – 25% of those infected. Without negative results, the prevalence of

chronic HCV disease cannot be accurately reported, nor can the population-level impacts of the

state’s efforts to cure and prevent HCV. The Department will consider regulatory changes to

establish a requirement for laboratories and providers to also report negative RNA test results.

Strategy 4.3: Monitor HCV-related health services and outcomes through clinical data such as

electronic health records, claims data, and information shared over the state’s health

information exchange (CRISP).

Even with expanded surveillance activity, HCV population-level data will remain limited for some

time and will likely not include important data points such as fibrosis staging and complete SVR

data. These data could be monitored within other systems, such as large medical systems and

insurers, to be able to follow more detailed information about testing, staging, and cure. Promising

avenues for data to supplement surveillance include Medicaid and other insurers, large specialty

Maryland Hepatitis C Strategic Plan

providers such as Johns Hopkins Viral Hepatitis Center, University of Maryland Medical System,

and providers participating in the MDH-JHU Community Based HCV Test and Cure project.

In 2017, Maryland Medicaid and the Infectious Disease Bureau at the Prevention and Health

Promotion Administration (PHPA) partnered to participate in a national Affinity Group for states

working on hepatitis C-related projects. The Maryland team is working to improve collaboration and

data sharing to gain a better understanding of the continuum from initial diagnosis to treatment for

Medicaid enrollees. The team is developing a Cure Cascade, which is a visual representation of

people in all stages of HCV care, from tested and diagnosed to treated and cured. Maryland

anticipates developing Cure Cascades for each Medicaid MCO to identify strengths and

opportunities for improvement in testing, diagnosis, and treatment. Additionally, Medicaid and

PHPA are in the process of finalizing a data use agreement that will facilitate data matching to better

identify high-risk enrollees with HIV/AIDS and HCV.

Maryland Hepatitis C Strategic Plan

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