How does Medicaid pay for HCV treatment?
Just one pill of Sovaldi costs approximately $1,000. 26 This brings the total cost of the twelve-week treatment to $84,000. 27 Olysio has an estimated cost of $23,600 per month of treatment. 28 However, the treatment duration of Olysio is even longer than Sovaldi at twenty-four to forty-eight weeks. 29 While this is very expensive, the primary problem with the pricing is not the …
Is HCV treatment cost-effective?
Dec 13, 2019 · For HCV medications, pharmaceutical manufacturer coupons are available to lower a member’s cost to $5 per prescription fill, up to a maximum of 25% of the catalog price of a 12-week regimen. 59 ...
What is the Medicaid drug rebate for HCV?
Jan 22, 2019 · It is not unusual for HCV antiviral therapies that have previously ranged from $60,000 to $80,000 for a 12-week course of treatment to require a 20% to 30% cost-sharing responsibility by the patient. 13 AbbVie recently released glecaprevir/pibrentasvir (Mavyret; AbbVie, North Chicago, IL), which has a significantly lower cost than other DAAs on the market …
Can drug prices be negotiated for hepatitis C?
Sofosbuvir, the first polymerase inhibitor approved by the Food and Drug Administration, can achieve extremely high hepatitis C (HCV) cure rates of more than 90% with far less toxicity and shorter treatment duration than can traditional agents.1–4 As a well-tolerated, easily administered tablet used in combination with other medications, sofosbuvir is the first of a …
Does HCV double after availability?
Rates of hepatitis C virus (HCV) treatment in a commercially insured population doubled after availability of new direct-acting antivirals. Member out-of-pocket spending was kept low while the health plan bore 99% of spending on HCV medications.
Can OOP cure HCV?
These medications can cure a prevalent, potentially fatal, chronic infectious disease, but they have a high price. Based on the experience of a regional commercial health plan, on average, patient OOP spending was kept low while the health plan covered 99% of spending on new HCV medications.
Is HCV counseling required for 2020?
However, the study health plan still requires providers to attest that the patient is not participating in illicit substance abuse or alcohol abuse, or is receiving substance or alcohol abuse counseling services as an adjunct to HCV treatment (this requirement is to be lifted in 2020).
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.
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.
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 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 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.
How many people die from hepatocellular carcinoma?
Mortality rates for hepatocellular carcinoma (HCC) are increasing faster than those of any other cancer, nearly doubling since the 1980s. 1 Only one in five individuals diagnosed with HCC will survive 5 years after diagnosis despite the improvements in treatment. 1 One of the top three contributing factors to HCC deaths is the high prevalence of hepatitis C virus (HCV) infection. 1, 2 The number of US residents currently infected with HCV is estimated at approximately 3.5 million. 3 Baby boomers account for 81% of all new HCV diagnoses, and this cohort has the highest rates of HCV-related liver transplantation secondary to the development of HCC. 4 Connecting patients infected with HCV to care has been problematic because approximately half of individuals with HCV are asymptomatic and are not seeking treatment. 5, 6
How many people in Texas rely on Medicaid?
Texas Health and Human Services reports that more than 4 million individuals in the state rely on Texas Medicaid for their health insurance. 16, 17 There are particular concerns, however, that Texas Medicaid poses significant challenges for access to HCV care.
Which region in Texas has the highest liver cancer rate?
However, treating this population has significant challenges. For example, Texas has one of the highest liver cancer death rates in the nation. 1 South Texas, specifically Region 11, encompasses a 19-county area in the Rio Grande Valley and has the highest prevalence of liver cancer in the state.
Is it easier to get DAAs?
Sadly, it is easier for uninsured individuals to obtain DAAs due to medication assistance programs that provide the drugs for free. 15 Health policy change is needed to decrease the out-of-pocket expenditures for insured patients for DAAs.
Does Texas Medicaid require a DAA?
To the second restriction, Texas Medicaid requires that a board-certified specialist must prescribe the DAA. 18 Patients often face transportation challenges for specialist care as a result of the limited number of specialists in rural areas of Texas.
Do oncologists advocate for substance abuse?
In addition, further funding to support substance abuse treatment is needed across the state. Medical oncologists have an ethical obligation to advocate for health interventions that aid in the prevention of cancer , especially in settings where there are limited effective cancer treatment options.
Is there a need for health insurance to increase funding or reimbursement for social services?
There is a significant need for health policy to increase funding or reimbursement for social services in this region and regions like these around the United States. Yet even privately insured individuals can experience significant cost barriers to care if they are found to be chronically infected with HCV.
What is the ACA?
The implementation of the Affordable Care Act (ACA) provides multiple opportunities to prevent new viral hepatitis infections and diagnose and care for people with chronic viral hepatitis. The health care law helps people at risk of or living with viral hepatitis in several important ways:
Why is the ACA important?
Making coverage more affordable. The ACA requires most Americans to have qualifying health insurance. To help people access the quality, affordable coverage they need, the ACA created Health Insurance Marketplaces in every state that help consumers compare different health plans and determine what savings they may qualify for.
Does insurance cover viral hepatitis?
Insurance benefits can vary widely across insurance plans so these consumer assistance programs can help people with chronic viral hepatitis to choose a plan that will provide the best coverage for needed services such as ongoing chronic disease management and treatment.
Can chronic hepatitis be denied?
Under the ACA, people living with diagnosed chronic viral hepatitis who may have previously been unable to obtain health coverage can no longer be denied coverage and can now access needed prevention, care, and treatment services.
Does the ACA cover hepatitis?
Under the ACA, all new health plans must cover certain preventive services —like shots and screening tests—without charging a deductible or co-pay. This includes important viral hepatitis services such as hepatitis A and B vaccination and hepatitis B and C testing.
Can you put a lifetime limit on your insurance?
Eliminating lifetime limits and regulating annual limits on insurance coverage. In the past, insurance companies could place lifetime or annual limits on the amount of insurance coverage a customer could use. Now, new plans can’t place yearly limits on what they spend for a customer’s coverage, or lifetime limits on essential health benefits ...
Does the ACA close the donut hole?
The ACA closes, over time, the Medicare prescription drug coverage (Part D) “ donut hole ,” giving Medicare enrollees the peace of mind that they will be better able to afford their medications and helping keep Medicare Part D affordable, sustainable, and working for seniors.
How old do you have to be to get HCV?
Many persons living with chronic HCV infection in the United States are over 50 years of age. With the availability of new, highly effective, safe, well-tolerated regimens, it is likely that more interest and experience will accumulate in treating persons with advanced age. Notably, some clinical trials with newer direct-acting antivirals have enrolled persons older than 70 years of age, but overall relatively little experience exists with treatment of HCV in elderly populations. In some circumstances, individuals with chronic HCV may have advanced age and minimal HCV-related fibrosis, and thus HCV-related liver disease may not be expected to play a major role in shortening their lifespan. In addition, some individuals may have limited life expectancy due to other comorbid conditions, and as such, HCV treatment would not be expected to alter their quality of life or life expectancy. Thus, in some situations involving persons with advanced age or significant medical comorbidities associated with an expected short lifespan (less than 12 months), it may be sensible to withhold therapy.
When is Ledipasvir approved?
Ledipasvir-sofosbuvir is approved for the treatment of HCV genotypes 1, 4, 5, or 6 starting at 3 years of age , with the pangenotypic regimens sofosbuvir-velpatasvir and glecaprevir-pibrentasvir approved starting at ages 6 and 12 years, respectively. [ 5] Contraindications for Treatment.
What is sustained virologic response?
A sustained virologic response is defined as an undetectable HCV RNA level 12 weeks after stopping antivirals;
What is advanced fibrosis?
Advanced fibrosis is typically defined as F3 (pre-cirrhosis or bridging fibrosis) and F4 (cirrhosis) on liver biopsy. In earlier DAA trials, lower SVR rates were observed among persons with compensated cirrhosis. [ 64, 74] In subsequent trials, newer medication, longer duration of treatment, and modified therapy (with the addition of ribavirin) have all contributed to improved responses in patients with compensated cirrhosis. [ 63, 75, 76, 77] The one exception to this has been treatment of persons with genotype 3 HCV and cirrhosis, a group that has emerged as the hardest to treat in the DAA era. Nevertheless, two regimens— glecaprevir-pibrentasvir and sofosbuvir-velpatasvir have been shown to achieve high SVR rates in persons with genotype 3 HCV and compensated cirrhosis. [ 56, 57] Similarly, when using currently recommended DAA regimens for persons with compensated cirrhosis, studies show SVR12 rates are greater than 90% across all genotypes. [ 78] Individuals with decompensated cirrhosis (Child-Turcotte-Pugh class B or C) treated with 12 weeks of ledipasvir-sofosbuvir have lower SVR rates (86 to 87%) compared with SVR rates of 95% or greater in similarly treated persons without cirrhosis. [ 79] In a similar study, SVR12 rates of 94% were observed in persons with decompensated cirrhosis when treated with a 12-week regimen of sofosbuvir-velpatasvir plus ribavirin. [ 80]
How many genotypes are there in hepatitis C?
Hepatitis C is classified into 6 major genotypes, numbered 1 through 6. In the prior interferon era of treatment, genotype was the strongest predictor of obtaining an SVR. [ 50, 51, 52] In the current direct-acting antiviral (DAA) era, particularly with the approval os pangenotypic regimens, the role of HCV genotype in predicting treatment response has decreased significantly given the high efficacy of different DAA combinations across all genotypes and the introduction of pangenotypic agents. Overall, with a preferred regimen, the SVR12 rate is greater than 95%, regardless of HCV genotype. [ 53, 54, 55, 56, 57]
What are the goals of treating hepatitis C?
The goals for treating persons with chronic hepatitis C virus (HCV) are threefold: (1) eradicate HCV, (2) improve HCV-related health outcomes and survival in all populations, and (3) reduce transmission of HCV to others. For clinicians, the primary and immediate goal is to treat the individual with a regimen that has a very high likelihood ...
Is ribavirin contraindicated for HCV?
[ 5] Available data from animal studies indicate that ribavirin has significant teratogenic and embryocidal adverse effects. [ 7] Accordingly, the use of ribavirin is contraindicated in women who are pregnant, women who may become pregnant, or men whose female partners are pregnant or trying to conceive. [ 8, 9] Persons with chronic HCV who are of reproductive age and are to receive a regimen that includes ribavirin should be advised to use two forms of contraception during treatment and for at least 6 months following the end of treatment. [ 10] With DAA therapy, decompensated cirrhosis, renal failure, and recent or active substance use (e.g. drugs and alcohol) are not contraindications to treatment. [ 11, 12, 13] Indeed, multiple studies involving persons with past or current injection-drug use have shown very good adherence and excellent SVR rates with HCV DAA therapy. [ 14, 15, 16, 17]
Drug Cost and Reimbursement
- Many organizations are involved with hepatitis C drug distribution and each can impact costs as well as decisions about which regimens are reimbursed (US GAO, 2015); (US CBO, 2015). The roles these organizations have in determining the actual price paid for drugs and who has access to treatment include the following: 1. Pharmaceutical companies determine the wholesale acqui…
Cost-Effectiveness
- 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 …
Affordability
- An intervention that is cost-effective is not necessarily affordable. Affordability refers to whether a payer has sufficient resources in its annual budget to pay for a new therapy for all who might need or want it within that year. Several characteristics of CEA limit its ability to speak to the budgetary impact of interventions being implemented in the real world. 1. Perspective on cost CEA seeks t…
Cost vs Affordability For HCV Treatment
- Despite a growing body of evidence that HCV treatment is cost-effective and may even be cost saving over the long term in some cases, many US payers—especially those offering Medicaid insurance products—continue to limit access to HCV treatment. Access has improved as cost has decreased but limitations remain. Proposed reductions in healthcare spending for Medicaid wou…
Cost-Effectiveness of Screening For HCV
- Several cost-effectiveness studies demonstrate that routine, one-time testing for HCV among all adults in the US would likely identify a substantial number of cases of HCV that are currently being missed, and that doing so would be cost-effective. One study employed simulation modeling to compare several versions of routine guidance, including routine testing for adults over the ages …
Conclusions
- Many studies have demonstrated the economic value of HCV screening (Chaillon, 2019); (Eckman, 2019); (Tasillo, 2019); (Assoumou, 2018); (Barocas, 2018); (Schackman, 2018); (Schechter-Perkins, 2018); (Lyons, 2016); (Hsieh, 2016); (Schackman, 2015) and treatment (Goel, 2018); (Chhatwal, 2017); (He, 2017); (Chahal, 2016); (Chhatwal, 2015); (Chidi, 2016); (Martin, 201…