Treatment FAQ

what is the total wac of hcv treatment

by Neil Moore Published 2 years ago Updated 2 years ago
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Analysis of prescription drugs for the treatment of hepatitis C in the United States. Sovaldi, a direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV), had an average wholesale acquisition cost (WAC) of $1,000 per day in 2013, or $84,000 for a 12-week course of treatment.Jun 11, 2021

Is HCV treatment cost-effective?

Oct 09, 2019 · Treatment for hepatitis C is now done with all-oral medications. These pills, called antiviral medications, are usually taken once per day. The provider treating your hepatitis C may recommend one or a combination of two to three medications to be taken for about 12 weeks.

How is hepatitis C virus (HCV) infection treated?

Mar 14, 2022 · Current treatment for chronic hepatitis C (CHC) is highly efficacious, well-tolerated, and of short duration for the majority of patients. Despite the dramatic advances in therapy, there remain several barriers to disease eradication. These include deficiencies ...

How long does it take to cure HCV?

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Hepatitis C is spread through contact with blood from an infected person. Today, most people become infected with the hepatitis C virus by sharing needles or other equipment used to prepare and inject drugs. For some people, hepatitis C is a short-term illness, but for more ...

How does Medicaid pay for HCV treatment?

However, while Sovaldi’s wholesale acquisition cost (WAC) is listed for $84,000 and Harvoni’s at $94,500 for a 12-week treatment, the average revenue per treatment reported by Gilead in 2015, including both 12- and 24-week-long treatments, was estimated to be around $54,000 and during the first 6 months of 2016 the price per treatment dropped another 22% — a possible response …

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What is the cost of HCV treatment?

A 2018 study found that a single pill of one hepatitis C drug cost $1,000. The total was $84,000 for its 12-week course of treatment. Another drug cost $23,600 per month. That's for treatment that could take 6 months to a year.Jun 26, 2020

What is the best treatment of HCV?

Hepatitis C is treated using direct-acting antiviral (DAA) tablets. DAA tablets are the safest and most effective medicines for treating hepatitis C. They're highly effective at clearing the infection in more than 90% of people.

How much do direct-acting antivirals cost?

Conclusions: Within the next 15 years, large-scale manufacture of 2 or 3 drug combinations of HCV DAAs is feasible, with minimum target prices of $100-$250 per 12-week treatment course. These low prices could make widespread access to HCV treatment in low- and middle-income countries a realistic goal.

WHO guidelines HCV treatment?

WHO recommends therapy with pan-genotypic direct-acting antivirals (DAAs) for persons over the age of 12 years. DAAs can cure most persons with HCV infection, and treatment duration is short (usually 12 to 24 weeks), depending on the absence or presence of cirrhosis.Jul 27, 2021

Can hep C be cured completely?

Today, chronic HCV is usually curable with oral medications taken every day for two to six months. Still, about half of people with HCV don't know they're infected, mainly because they have no symptoms, which can take decades to appear.Aug 31, 2021

Can you get hep C twice?

Yes. Having had hep C once does not make you immune from getting it again. You can be reinfected with hep C whether you clear the virus by successful treatment (called a sustained virologic response, or SVR) or by spontaneously clearing it on your own.Apr 15, 2016

How much is hep C treatment in India?

The generic version of these drugs are available in cities such as Bengaluru Hyderabad and Chennai at the cost of Rs70000 or around $1000 USD for the entire treatment regimen.

How much does hep C treatment cost UK?

A 12-week course of treatment with elbasvir-grazoprevir usually costs £36,500 per patient, but the NHS will pay less than this as the company has offered a confidential discount. Taken once daily, the tablet could treat around 4,000 patients in the first year, alongside other options already available for hepatitis C.

What is the antiviral drug ribavirin?

Ribavirin, also known as tribavirin, is an antiviral medication used to treat RSV infection, hepatitis C and some viral hemorrhagic fevers. For hepatitis C, it is used in combination with other medications such as simeprevir, sofosbuvir, peginterferon alfa-2b or peginterferon alfa-2a.

What is normal range of anti HCV?

Normal range for this assay is "Not Detected". The quantitative range of this assay is 10 - 100,000,000 IU/mL (1.0 - 8.0 log IU/mL).

How long does Hep C take to damage liver?

After many years some people will have minimal liver damage with no scarring while others can progress to cirrhosis (extensive scarring of the liver) within less than ten years. On average it takes about twenty years for significant liver scarring to develop.

Which type of hepatitis is more severe?

Hepatitis Delta is considered to be the most severe form of hepatitis because of its potential to quickly lead to more serious liver disease than hepatitis B alone. Of the 292 million people living with chronic hepatitis B, approximately 15-20 million are also living with hepatitis D.Jan 9, 2019

How long does it take to get tested for hepatitis C?

Getting tested for hepatitis C is important, because treatments can cure most people with hepatitis C in 8 to 12 weeks.

How is hepatitis C spread?

Hepatitis C is spread through contact with blood from an infected person. Today, most people become infected with the hepatitis C virus by sharing needles or other equipment used to prepare and inject drugs.

Is hepatitis C a long term illness?

For some people, hepatitis C is a short-term illness, but for more than half of people who become infected with the hepatitis C virus, it becomes a long-term, chronic infection. Chronic hepatitis C can result in serious, even life-threatening health problems like cirrhosis and liver cancer. People with chronic hepatitis C can often have no symptoms ...

Is hepatitis C a risk factor?

CDC continues to recommend people with risk factors, including people who inject drugs, be tested regularly. CDC recommendations for hepatitis C screening among adults – United States, 2020. Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Hepatitis C is spread through contact with blood from an infected person.

How high is the cure rate for hepatitis C?

Driven by several novel regimens recently receiving approval in the US and in Europe, high cure rates exceeding 90% are now achievable for most patients suffering from chronic hepatitis C. As a result of this unprecedented success, the industry is reaching a new phase in the fight against this deadly infectious disease. The pressure is now shifting to the healthcare providers to determine if the future of hepatitis C treatment will include a (near) eradication in the developed world, or if hepatitis C will remain a debilitating and life-threatening factor in our society.

What is the treatment for hepatitis C?

The treatment of chronic infections caused by the hepatitis C virus (HCV) has undergone a dynamic shift in recent years. Historically, treatments were based on interferon, which was subsequently replaced by peginterferon, administered in combination with ribavirin.

How long does Harvoni work?

Harvoni already demonstrated high efficacy after 8 weeks of treatment in patients with GT1 and no cirrhosis, and both Gilead and Janssen are currently developing possible pan-genotypic DAAs that might be able to cure the same patient population after only 6 weeks of treatment.

What was the first NS5B inhibitor?

However, the main breakthrough came in 2013 with the approval of the first NS5B inhibitor, Gilead’s Sovaldi (sofosbuvir). Gilead followed up on the success it achieved with Sovaldi with the launch of Harvoni (a fixed-dose combination of sofosbuvir and ledipasvir, an NS5A inhibitor). The ability to cure over 95% of many patient populations, ...

How many markets does Gilead have?

Together, Sovaldi and Harvoni helped to position Gilead as the unquestionable market leader in the 9 major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and Brazil), providing the pharmaceutical giant with global revenues of $19.1 billion in 2015 alone. However, other companies did not remain on the sidelines.

How long does it take to cure hepatitis C?

The ability to cure over 95% of many patient populations, simultaneously shortening treatment durations to 12 weeks with a once-daily single pill, while also eliminating peginterferon and ribavirin for most patients, truly revolutionized the hepatitis C treatment paradigm.

How many people have been treated with Sovaldi?

However, several factors are driving the market toward more inclusive national treatment approaches. In the past 3 years alone, over 1 million people have been treated with Sovaldi-based regimens. Since most of these people will have been cleared of the virus, the total prevalence in most of the 9MM is now slowly decreasing.

Background

Hepatitis C is a disease caused by the hepatitis C virus (HCV) that can be a short-term illness, but for more than one-half of people who become infected, it can become a long-term, chronic infection ( 78 ). HCV is one of the most common bloodborne pathogens in the United States ( 58, 79, 80 ).

Cases and Clusters of Potential Public Health Importance

Jurisdictions should review and analyze hepatitis C data regularly to identify cases and clusters of hepatitis C that merit further investigation. When resources are limited, these should be prioritized for investigation according to degree of public health importance. The following are examples of high priority cases and clusters:

Interpretation of Laboratory Test Results

The two tests used primarily for hepatitis C screening and diagnosis are an antibody test (often an immunoassay) and an RNA test (NAT), respectively ( 94 ). A description of hepatitis C laboratory markers can be found in Appendix B. Figure 4-1 describes the typical serologic course of HCV infection ( 95 ).

Recommended Reportable Laboratory Markers

The following laboratory markers are recommended for reporting to public health to aid in case ascertainment, case classification, and monitoring cure continua for hepatitis C:

Case Reporting and National Notification

Cases of acute, chronic, and perinatal hepatitis C and hepatitis C during pregnancy should be reported to HDs as specified by state, territorial, or local regulations. Acute, chronic, and perinatal hepatitis C are nationally notifiable conditions ( 5 ).

Surveillance of Acute and Chronic Hepatitis C

New cases of acute hepatitis C have increased rapidly in the United States since 2010, most being associated with IDU. The highest incidence of acute hepatitis C is typically found among people in younger age groups. For hepatitis C surveillance statistics for the United States, visit the CDC Viral Hepatitis Surveillance website ( 17 ).

Surveillance of Hepatitis C During Pregnancy and Perinatal Hepatitis C

From 2009–2014, the prevalence of hepatitis C among pregnant people in the United States significantly increased by 89%, from 1.8 to 3.4 per 1,000 live births based on maternal HCV infection status reported on birth certificates from NVSS ( 112 ).

How much did HCV drugs cost in 2013?

The financial impact of the new HCV drugs has been particularly salient in Medicare Part D, where spending on these drugs jumped from $283 million in 2013 to $4.5 billion in 2014.

How many people in the US have HCV?

More than 3 million Americans are infected with HCV, with its prevalence concentrated among baby boomers, who were born between 1945 and 1965. 7 HCV causes more deaths in the United States than HIV/AIDS. 8 Chronic HCV is a cause of serious and costly liver diseases, such as cirrhosis and liver cancer, and related hospitalizations and costs have increased during the past decade. 9 Although the burden of HCV can be reduced through screening and treatments, the implementation of recommended screening is limited, and half of the infected population goes undiagnosed. 9

How long is Sovaldi used?

However, Sovaldi is used with either Olysio (AASLD recommendation) or PR therapy for 12 weeks; it can also be used in combination with ribavirin for 24 weeks. Total spending for a combination of Sovaldi + Olysio was $150,360, and total spending for Sovaldi + PR therapy was $94,950.

What drugs did Part D cover?

All Part D plans covered 2 new HCV drugs, Olysio and Sovaldi, and 98% of plans covered Harvoni ( ). Only 33% of MAPDs and 30% of PDPs covered Viekira Pak. Nearly every plan that covered these new drugs used prior authorization and nearly half of the plans used quantity limits. Almost all plans placed new HCV agents in a specialty tier and required coinsurance rather than co-payment. The average coinsurance rate was slightly higher among MAPDs than PDPs (31.4% vs 28.7%), but it varied more among MAPDs (20%-50%) than PDPs (25%-33%).

What is the primary data source for Medicare Advantage?

The primary data source was the July 2015 Prescription Drug Plan Formulary and Pharmacy Network Files from CMS, which contains information on plan characteristics and benefits for drugs covered by each Part D plan. We excluded special needs plans (n = 540) because they serve certain specific beneficiaries (eg, institutionalized people) and may have special benefit schemes. After this exclusion, we identified 1635 Medicare Advantage prescription drug plans (MAPDs) and 1013 PDPs.

What is Medicare Part D?

Medicare Part D provides outpatient prescription drug coverage to the elderly and disabled. It is delivered through private plans, including standalone prescription drug plans (PDPs) or Medicare Advantage plans with prescription drug coverage (MA-PDs). Medicare specifies a standard Part D benefit package, but plans can modify the benefits as long as their schemes are equal in value to the standard package.

Is HCV covered by Part D?

It is discouraging that the effectiveness or the therapeutic values of drugs are not considered in benefit decisions. New HCV drugs are highly efficacious, but Part D plans’ coverage for them differs little from coverage for less-effective HCV drugs, such as the first DAAs.

What is the primary analysis for this methodology study focused on?

The primary analysis for this methodology study focused on the changing costs and effectiveness estimates at each time point to estimate incremental cost-effectiveness ratios. A scenario analysis was conducted using only the WAC for each drug referenced in RED BOOK to describe the effect of using list versus net price in the CEA. 21

Is hepatitis C treatment pharmacoeconomic?

With lower drug prices and increased effectiveness, the pharmacoeconomics of hepatitis C virus (HCV) treatment have rapidly changed in a very short time span, with several new products and multiple products withdrawn. Cost-effectiveness analyses (CEAs) for any treatment, including HCV, are typically fixed to answer a single question ...

Is HCV treatment effective?

Treatment effectiveness for HCV has increased steadily, while treatment costs increased substantially from 2010-2014 before decreasing to its lowest point in 2018. The dynamic nature of CEAs in a disease state with rapid pharmaceutical innovation may cause some concern for decision makers who rely on a single analysis over time. Model transparency along with resources to update or revise model assumptions would enable organizations to provide more up-to-date results to inform formulary decisions.

What does CEA mean when making coverage decisions for therapy?

When making coverage decisions for therapy, however, an insurer considers only its own revenues and expenses. Time horizon. From a societal perspective, CEA uses a lifetime time horizon, meaning it considers lifetime costs and benefits, including those that occur in the distant future.

What is cost effectiveness analysis?

Cost-effectiveness analysis (CEA) compares the relative costs and outcomes of 2 or more interventions. CEA explicitly recognizes budget limitations for healthcare spending and seeks to maximize public health benefits within those budgetary constraints. The core question that CEA addresses is whether to invest limited healthcare dollars in a new treatment/therapy or use that money to invest in another healthcare intervention that would provide better outcomes for the same monetary investment. The focus of CEA is, therefore, not simply cost or saving money but health benefits. It assumes that all available resources will be spent and provides a framework for prioritizing among available treatment options by formally assessing the comparative costs and health benefits accrued from a new treatment relative to current treatment.

What does private insurance do?

Private insurance companies often have separate pharmacy and medical budgets, and use PBMs or directly negotiate drug pricing with pharmaceutical companies. Insurance companies determine formulary placement, which impacts the choice of regimens and out-of-pocket expenses for patients.

Why is prevention of long term complications important?

Prevention of long-term complications is especially important when considering the cost-effectiveness of HCV treatments because the costs of the therapy are immediate, while those avoided by preventing advanced liver disease and other complications of chronic infection often accrue years in the future.

What is patient assistance?

Patient assistance programs offered by pharmaceutical companies or foundations can cover many of these out-of-pocket expenses or provide drugs at no cost to qualified patients who are unable to pay.

Does Medicare cover HCV?

Medicare covers HCV drugs through part D benefits and is prohibited by law from directly negotiating drug prices.

Is DAA more efficient than HCV?

In general, when given a choice between recommended HCV DAA regimens, the less costly regimen is preferred as a more efficient use of resources (even if it requires multiple tablet dosing). Because of the similar efficacy of most DAA regimens, cost becomes the critical factor driving relative cost-effectiveness.

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