Who pays for HCV treatment?
Dec 13, 2019 · Rates of hepatitis C virus (HCV) treatment in a commercially insured population doubled after availability of new direct-acting antivirals. Member out-of …
How do pharmaceutical companies price HCV drugs?
Nov 10, 2014 · The average spending on HCV treatment would be $27 billion per year, which they estimated was 10% of the prescription drug spending for the year 2012. Compared to the oSOC drugs, the newer...
Is HCV treatment cost-effective?
May 20, 2021 · Recent price reductions for HCV treatments improve the outlook on affordability at the system level, as the $26,400-plus price tag still makes it …
When was HCV treatment approved by the FDA?
Jun 01, 2018 · The table below highlights the average cost of treatment for the combination DAAs currently available. Most of these drugs take at least 12 weeks to cure HCV, while the most recently approved drug ...
How much money will Medicare save on HCV?
This coverage policy could save $1.4 billion over 25 years.
Why is Medicare not treating HCV?
Objectives: Most Medicaid beneficiaries with hepatitis C virus (HCV) are not treated with direct-acting agents because of budget constraints, but they experience costly complications after becoming Medicare eligible. Maryland’s “total coverage” proposal could receive a credit from Medicare to offset Medicaid investments in treatments ...
What is the semi infectious disease model?
The semi-infectious disease model assessed the cost-effectiveness of HCV outcomes based on increased treatment probabilities under the total coverage scenario, compared with 2 scenarios reflecting the current payer model with standard coverage for all beneficiaries or prioritized coverage for all high-risk beneficiaries ( Figure 1 ). In the latter alternative, the 60% of patients with chronic HCV who had a liver fibrosis score of 2 or higher, as opposed to a fibrosis score of 0 or 1, received DAAs first, before lower-risk patients, in order to better manage budget impact. 15
What is the cure rate for hepatitis C?
Direct-acting antivirals (DAAs) are associated with cure rates above 95% for hepatitis C virus (HCV). 1 However, the exorbitant costs of DAAs historically have made access prohibitive for many patients.
Is Maryland a total coverage state?
Maryland may be one of the first states to pilot the concept of a total coverage solution for HCV treatment through joint Medicare-Medicaid payments. However, most of the 50 states are grappling with similar solutions.
Is DAA coverage for HCV?
Providing total coverage for DAA medications for all patients with HCV is systematically complex and may not be economically viable for state Medicaid programs that face some of the highest rates of HCV among payers. Joint Medicaid-Medicare coverage provides an efficient solution to treat all patients now to reduce harm caused by chronic infection in the United States. Recent price reductions for HCV treatments improve the outlook on affordability at the system level, as the $26,400-plus price tag still makes it inaccessible to individual Medicaid enrollees. Furthermore, the long-term costs of untreated HCV typically borne by Medicare are offset under this concept. The Maryland TCOC model gives Medicare the option of crediting Medicaid for spending money today that it will save on health care costs in the future. This is an approach to resolve the mismatch between investing today and getting future returns.
What is the treatment for HCV?
The AASLD-IDSA HCV Guidance recommends treatment for all persons with chronic HCV, except those with a short life expectancy that cannot be remediated by HCV treatment, liver transplantation, or another directed therapy. [ 2, 3] The general approach to considering initiation of treatment of HCV for individuals with a prior history of substance use, including injecting drugs, should be the same as in persons with no history of drug use. Persons with substance use disorder, including those with injection-drug use or alcohol use should have the same HCV pretreatment screening requirements as those without a substance use disorder. [ 2]
What drugs can cause HCV?
Injection of cocaine or methamphetamine is another major driver of HCV transmission. [ 38, 39, 40] Other routes of administration of stimulants, such as intranasal, may also be associated with HCV transmission. [ 41] In addition, prolonged stimulant use may result in cardiac and cerebrovascular toxicity.
How long do you have to abstain from alcohol before a drug test?
Although some payers require 6 months or more of abstinence prior to HCV treatment, studies of both injection-drug use and alcohol use have found no impact of duration of abstinence on likelihood of achieving a sustained virologic response (SVR)12 weeks after completing DAA-based therapy SVR. [ 4] Thus, there is no medical reason to ensure abstinence (for any duration) prior to HCV treatment. Current AASLD-IDSA HCV Guidance recommendations state that current or prior substance use should not be a contraindication to HCV treatment. [ 2]
Is active substance use a contraindication to HCV?
Active substance use, substance use disorders, or injection-drug use, are not contraindications to HCV treatment. Treatment of HCV in persons with active injection drug use likely has major public health benefits in terms of reducing secondary HCV transmission.
Can HCV be treated with opioids?
For persons with a past or current history of opioid use disorder, treatment of HCV infection would ideally be performed in a multidisciplinary setting whereby HCV treatment and opioid use disorder can be addressed, as well as other comorbidities that may exist. [ 2] . Multiple treatment options exist for opioid use.
Does opioid use affect HCV?
Impact of Opioid Use on Natural History of HCV. Opioid use by injection is a major driver of HCV transmission, but opioid use itself, either orally or by inject ion, does not appear to speed progression of liver disease in persons with chronic HCV. [ 10] .
Does alcohol affect HCV?
Although abstinence from alcohol prior to HCV DAA treatment is no longer required, efforts should be made to ensure that ongoing alcohol use does not interfere with adherence or medical follow-up. Alcohol consumption is discouraged in patients with chronic HCV infection due to the hepatotoxic effects of alcohol and its acceleration in liver fibrosis. Multiple pharmacologic agents are available for alcohol use disorder, including naltrexone, acamprosate, and topiramate. [ 58] Among these, the most promising results have been seen with naltrexone, particularly when given as a monthly injection. Brief counseling on alcohol has also shown reductions in use among persons with HCV infection. A multidisciplinary approach, involving personalized addiction care and case management, may provide further benefit in managing alcohol dependence. [ 9] Following DAA-based therapy, one study that included 123 participants found provider-delivered, alcohol-related counseling during HCV treatment was successful in reducing alcohol consumption patterns both during and after treatment in individuals with harmful alcohol use. [ 59]
What is the new drug called for HCV?
Trusted Source. of people who take them, depending on the type of HCV infection and treatment exposure. These new drugs are called direct-acting antivirals (DAAs).
When was HCV approved?
The U.S. Food and Drug Administration (FDA) approved the first of these medications for HCV treatment in 2011. Several more medications have been approved since that time. Most of these individual drugs are effective for specific strains, or genotypes, of HCV.
What is the liver infection?
Hepatitis C is a viral infection that attacks the liver. Infection with hepatitis C can lead to serious liver disease, including cirrhosis and cancer. Hepatitis C virus (HCV) is transmitted by exposure to blood or other bodily fluids that contain HCV.
How many people die from hepatitis C each year?
Americans have chronic hepatitis C. About 19,000 of these people die each year from cirrhosis or liver cancer. Fortunately, recent advancements in the fight against this virus have changed the outlook for people with HCV. New drugs have transformed the disease from one that can, at best, be controlled to one that can be cured for most people who ...
What are the criteria for liver disease?
These criteria may be based on: the severity of liver disease. whether the person avoids alcohol and drug use. whether the drug’s prescribed by a doctor who specializes in liver diseases. the life expectancy of the person seeking treatment. whether less expensive treatments could be used first.
Is generic medicine cheaper than brand name?
It also means there are no generic versions of these drugs yet. Generics are typically much cheaper than brand- name versions. The FDA determines how long this period of exclusivity will last. During this time, the pharmaceutical companies have a lot of freedom in establishing prices.
Does insurance cover cirrhosis of the liver?
Payment restrictions. Based on your insurance provider, some companies will only pay for treatment if you have cirrhosis of the liver or bridging fibrosis , which is a thickening and scarring of the liver.
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 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 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.
Impact of Opioid Use on Natural History of HCV
- Opioid use by injection is a major driver of HCV transmission, but opioid use itself, either orally or by injection, does not appear to speed progression of liver disease in persons with chronic HCV.[10] Opioid analgesic use disorder is also a risk factor for HCV acquisition and transmission, particularly as some users transition from oral ingestion of prescribed opioids to illicit opioids, a…
Impact of Treating People with Active Injection-Drug Use on HCV Transmission
- Mathematical modeling, even assuming a reinfection rate equal to initial infection rates, has demonstrated that HCV treatment among persons with active injection-drug use would result in a significant reduction in HCV transmission.[13,14,15,16] Several recent studies utilizing mathematical modeling based on DAA regimens concluded that scaling up HCV treatment in pe…
Impact of Opioid Use and HCV Treatment Adherence
- Figure 2. Adherence with HCV Therapy in C-EDGE CO-STAR Trial In this trial, investigators evaluated HCV treatment with elbasvir-grazoprevir in 301 persons with a history of injection-drug use who were receiving opioid agonist therapy (e.g. methadone, buprenorphine, or buprenorphine-naloxone maintenance) for at least 3 months prior to enrollment. This graph shows excellent rat…
HCV Treatment Outcomes with Daa Therapy in PWID
- Despite the extensive overall data that have been generated with DAA-based therapies, only a moderate amount of data exists specific to the use of DAAs in persons with active injection drug use. The following summarizes several key studies that have analyzed HCV treatment responses with DAA-based therapy in persons who inject drugs or who have previously injected drugs and …
Pretreatment Requirements
- The AASLD-IDSA HCV Guidance does not have a requirement for abstinence from opioids prior to HCV treatment.[2] Indeed, active injection drug use in an individual with chronic HCV is considered by many to be a direct indication for HCV treatment, due to the potential benefit of reducing secondary HCV transmission.[27,28] In contrast to these expert recommendations, some payer…
Management Strategies
- For persons with a past or current history of opioid use disorder, treatment of HCV infection would ideally be performed in a multidisciplinary setting whereby HCV treatment and opioid use disorder can be addressed, as well as other comorbidities that may exist.[2] Multiple treatment options exist for opioid use. Agonist maintenance therapy is the most effective known treatment and ha…
Potential Reinfection with HCV Among Persons Who Inject Drugs
- Multiple studies have shown significant risk of HCV reinfection in persons cured with HCV therapy. Thus, it is essential that persons with past or active injection-drug use be counseled that they can become reinfected with HCV after achieving an SVR. This risk is significant in persons who inject drugs, but reinfection can also occur through sexual contact, particularly among men …