Is HCV treatment cost-effective?
Jun 11, 2021 · Download PDF 0.5MB. Share. 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. Sovaldi’s launch kicked off the second generation of DAAs for HCV, which expanded more widely tolerable treatment options to …
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 …
How has the Pharmacoeconomics of HCV treatment changed?
When using WAC as the primary drug price input, the 2018 HCV treatment option was still preferred to other scenarios . Depending on the decision maker’s willingness-to-pay threshold ($50,000/QALY, $100,000/QALY, and $150,000/QALY), the final determination of cost-effectiveness may have changed.
How are HCV DAA regimens compared to cost-effectiveness?
The wholesale acquisition cost (WAC) for a 12-week treatment course with Viekira Pak is $83,319. The cost for a 24-treatment course with the Viekira Pak is $166,638. The exact added cost of ribavirin, if used, is more difficult to determine because of variable daily doses when using the recommended weight-based dosing and the availability of ribavirin through multiple …
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 are the four drugs used to treat HCV?
Here are the medications available to treat hepatitis C, plus some helpful information about what to expect with their treatment.Ribavirin. ... Direct-acting antivirals (DAAs) ... Combination drugs. ... Ledipasvir-sofosbuvir (Harvoni) ... Elbasvir-grazoprevir (Zepatier) ... Sofosbuvir-velpatasvir (Epclusa)More items...
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.
What is the best drug to cure hep C?
Harvoni. Of the interferon-free treatment options for genotype 1 HCV, the fixed-dose combination drug Harvoni provides the simplest regimen and has demonstrated efficacy in patients with advanced liver disease, including decompensated cirrhosis.Feb 26, 2016
What is the latest treatment for Hep C?
The new hepatitis C treatments are sofosbuvir with ledipasvir (Harvoni); sofosbuvir (Sovaldi); daclatasvir (Daklinza); and ribavirin (Ibavyr). These new treatments are now available on the Pharmaceuticals Benefits Scheme.Mar 1, 2016
Is Hep C 100 curable?
Hepatitis C is a curable liver infection that results from the hepatitis C virus. Without proper treatment, chronic hepatitis C infections can lead to severe complications, such as liver disease, liver scarring, and liver cancer.Sep 13, 2019
Is Hep C curable 2020?
Hepatitis C (hep C) infection used to be a lifelong condition for most people. Up to 50 percent of people may clear the hepatitis C virus (HCV) from their body without treatment. For everyone else, the infection becomes chronic. With advances in hep C treatment, most people can now be cured of HCV.
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.
Is Mavyret or Epclusa better?
If you have liver disease, Epclusa may be a better treatment choice for you. Severe scarring of your liver. Mavyret isn't used for treating hepatitis C if you have severe cirrhosis. However, Epclusa can be used with the drug ribavirin for this purpose.Feb 19, 2021
How long is Epclusa treatment?
Epclusa is a two-drug combination administered as a single daily pill containing the viral NS5A inhibitor Velpatasvir and Sofosbuvir. The treatment duration is 12 weeks for all genotypes.
Is Epclusa better than Harvoni?
A: A: When compared in studies, both Epclusa and Harvoni were shown to be highly effective at curing hepatitis C. However, one study showed that Epclusa may cure a slightly higher percentage of people than Harvoni. This study included people with different hepatitis C virus (HCV) genotypes (strains).Feb 19, 2021
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.
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.
When was ombitasvir approved?
On December 19, 2014, the United States FDA approved ombitasvir-paritaprevir-ritonavir and dasabuvir for the treatment of genotype 1 chronic hepatitis C infection in adults, including patients with compensated cirrhosis. The medications ombitasvir, paritaprevir, and dasabuvir do not have FDA approval for use as individual drugs outside ...
What is a Viekira pak?
The Viekira Pak is an all-oral regimen comprised of four medications: ombitasvir, paritaprevir, ritonavir, and dasabuvir. This regimen can be used with or without ribavirin. In the Viekira Pak, the ombitasvir-paritaprevir-ritonavir are combined as a fixed-dose tablet and the dasabuvir is a separate tablet. Ombitasvir is a NS5A inhibitor ...
How long does ombitasvir last without cirrhosis?
Genotype 1b, without cirrhosis: ombitasvir-paritaprevir-ritonavir and dasabuvir for 12 weeks. Genotype 1b, with cirrhosis: ombitasvir-paritaprevir-ritonavir and dasabuvir plus ribavirin for 12 weeks. For patients with unknown genotype 1 subtype or mixed genotype 1 infection, use the regimen and duration as recommended for genotype 1a.
Is ombitasvir a polymerase inhibitor?
Ombitasvir is a NS5A inhibitor with potent pangenotypic picomolar antiviral activity, paritaprevir is an inhibitor of the NS3/4A serine protease, and dasabuvir is a nonnucleoside NS5B polymerase inhibitor. Ritonavir is a potent inhibitor of CYP3A4 enzymes and is used as a pharmacologic booster for paritaprevir—it significantly increases peak ...
Can Viekira Pak cause liver damage?
On October 22, 2015 the United States FDA issued a Drug Safety Warning that treatment with ombitasvir-paritaprevir-ritonavir and dasabuvir ( Viekira Pak) can cause serious liver injury, mostly in patients with underlying advanced liver disease. In most of the reported cases, the liver injury occurred within 1 to 4 weeks of starting treatment.
Can ribavirin be used in combination with ombitasvir?
In patients who have known hypersensitivity to the medication ritonavir. If ribavirin is used in combination with ombitasvir-paritaprevir-ritonavir, the contraindications to ribavirin apply to the treatment regimen. Note: see the prescribing information for a list of medications contraindicated for use with ombitasvir-paritaprevir-ritonavir ...
Does Ritonavir work against HIV?
The medication ritonavir, which is used as a pharmacologic booster, has activity against HIV protease; accordingly any patient with HIV coinfection should have full suppression of HIV RNA levels prior to and during receipt of ombitasvir-paritaprevir-ritonavir and dasabuvir.
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 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.
