Patient Assistance Programs In The Us
If you live in the United States and are struggling to afford your hepatitis B medication, there may be programs available to help you with the cost. Programs generally fall into one of 4 general categories: Manufacturer-Sponsored Patient Assistance Programs Nonprofit Co-Pay Assistance Programs Mail-order Discount Pharmacies and Discount Prescription Cards.
Key Points To Remember
- Some people with chronic hepatitis B don’t develop serious problems and can live active, full lives without treatment. But others may develop severe liver damage. If this happens, you may need a liver transplant.
- Treatment may not be an option for everyone who has hepatitis B, because antiviral medicines cost a lot and may not work for everyone.
- Experts recommend antiviral medicines if you have high levels of both the hepatitis B virus and liver enzymes in your blood for at least 6 months or if you have liver disease.
- Some antiviral medicines that stop or slow the growth of the hepatitis B virus can have serious long-term side effects. And some can make you feel sick while you are taking them.
- You may not need to take antiviral medicines if you have normal or only slightly higher-than-normal levels of liver enzymes in your blood and a biopsy shows no signs of liver damage.
- People who have had an organ transplant or who drink too much alcohol or use illegal drugs may not be able to take some antiviral medicines.
- You will probably need to take medicine for many years. And you’ll need to have regular exams and blood tests to see if the virus is still active in your body and to find out how well your liver is working.
A Convenient Truth: Cost Of Medications Need Not Be A Barrier To Hepatitis B Treatment
Drugs that are inexpensive to manufacture and simple to administer greatly expand the potential to help tens of millions of people who need treatment for chronic hepatitis B virus infection. Key program implementation challenges include identifying who would benefit from antiviral medication and ensuring long-term and consistent treatment to people who feel well. The best opportunities are where health systems are advanced enough to effectively address these challenges and in settings where HIV service platforms can be leveraged. Research, innovation, and collaboration are critical to implement services most efficiently and to realize economies of scale to drive down costs of health care services, drugs, and diagnostics.
Viral hepatitis, principally due to chronic hepatitis B virus and chronic hepatitis C virus , claimed 1.4 million lives worldwide in 2013, a rising toll that is now actually greater than that of mortality from HIV. Of the annual deaths caused by viral hepatitis, almost half are attributable to HBV.
The toll of viral hepatitis is now greater than that of mortality from HIV.
WHO-issued targets aim to reach 80% of people with chronic hepatitis B in need of treatment by 2030.
Considering that CHB treatment is lifelong in many cases, it might at first glance seem unaffordable to seek to expand treatment access to so many. But here is the convenient truth: CHB medications are simple to administer and potentially very inexpensive.
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Direct Nonmedical And Indirect Costs
|Medical leave and time off
|Productivity lossMonthly cost of reduced productivity = Reported loss of productivity × monthly wage rate, where Reported loss of productivity = number of sick days due to HBV/total number working days of a month.
|Transportation, meals, accommodation
|Annual direct nonmedical and indirect costs
|A. Base-case estimates
|Mean direct nonmedical and indirect cost per patient
|Total direct nonmedical and indirect cost per year
|Range of estimated number of patients
|Range of estimated direct nonmedical and indirect cost
|First one-way sensitivity analysis Lower and upper limits of the cost components from the direct medical cost calculation were tested and the number of patients was unchanged.
|Second one-way sensitivity analysis Cost components remained constant and the number of patients per disease stage was varied.
|Range of estimated number of patients
|Range of estimated direct nonmedical and indirect cost
|Two-way sensitivity analysis
|Two-way sensitivity analysis
What Is Hepatitis B
Hepatitis B is caused by a virus that infects the liver. It is one of the most common vaccine-preventable diseases affecting travellers and can cause either acute or chronic infection.
About 90 to 95 percent of adults with acute hepatitis B infection will clear the virus on their own within six months, and develop lifelong protection against it.
Some people are unable to clear the virus, and develop chronic hepatitis B. Untreated chronic hepatitis B can later develop into serious health problems. Children under four years old are at particular risk of chronic hepatitis B, because only up to 10% will clear the virus.
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What Is My Risk
Your risk depends of several factors: destination, length of stay, what you do when you are travelling and whether you have direct contact with blood or other body fluids. In certain destinations, your risk may be higher, as some areas have higher numbers of people with chronic hepatitis B in the general population.
The risk increases with certain activities, such as unprotected sex, sharing needles, tattooing and acupuncture.
Aid and health care workers and anyone who receives medical or dental care with unsterilized or contaminated equipment in a country where hepatitis B occurs are also at greater risk.
What Matters Most To You
Your personal feelings are just as important as the medical facts. Think about what matters most to you in this decision, and show how you feel about the following statements.
Reasons to take antiviral medicine for hepatitis B
Reasons not to take antiviral medicine for hepatitis B
I’m willing to take pills or get shots to help get rid of the virus in my body.
I don’t like taking pills or getting shots.
I’m worried that I might spread the virus to others if I don’t treat the infection.
I’m not worried about spreading the virus to others.
I’ll do whatever I can to avoid getting liver disease or liver cancer.
I’m not worried about getting liver disease or liver cancer.
I’m willing to deal with the side effects of treatment.
I’m worried that I might not be able to deal with the side effects of treatment.
I’m not worried about missing work to go to the doctor for the exams and tests that I need.
I can’t afford to take time off from work to go to the doctor.
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Increased Use Of Higher
High-cost drugs accounted for over one third of total drug costs in 2019-20 but were only used by 2% of beneficiaries. November 9, 2021 Ottawa, ON Patented Medicine Prices Review Board A new Patented Medicine Prices Review Board report finds that prescription drug expenditures by Canadian public drug plans increased by 3.
Natural History Of Hepatitis B
To establish a baseline of cost and clinical outcomes of hepatitis B without treatment or vaccination, we modeled a no intervention group. The model portrays progression through immune-tolerant, inactive, immune-active, cirrhosis, and mortality . Immune-tolerant is characterized by high HBV DNA, e-antigen-positive , and no discernible liver damage . Immune active has high DNA levels, HBeAg-positive or -negative, with elevated ALT . Immune-inactive has low or undetectable DNA levels and is HBeAg-, with normal ALT . These distinct phases are a reasonable representation of a natural history that includes some indeterminate, heterogeneous states. Annual probabilities for initial infection and progression to acute and chronic phases were collected from the literature, including quantitative synthesis, as needed . We assumed that CHB progression probabilities from immune-active HBeAg+ and HBeAg- are equivalent as the literature does not clearly distinguish their transition probabilities. We used +/- 25% of base case to portray uncertainty for inputs lacking formal confidence intervals.
As Sub-Saharan Africa-born black individuals have higher incidence of HCC at a younger age than the general CHB population, we increased annual incidence of HCC by 1.5 . PWID may have higher risk of CHB after initial exposure than general population thus, we simulated this risk for PWID at 10% , compared with 5% for other populations .
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Hepatitis B And C Can Be Wiped Out In The Us By 2030 Heres How
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Health experts have devised an aggressive plan to stamp out a viral disease that is fueling a sharp rise in liver cancer in the United States and killing 20,000 Americans per year.
Their national strategy for eliminating two types of hepatitis by 2030 hinges on persuading the federal government to purchase the rights to one or more of the costly new medications that can essentially cure hepatitis C.
That unprecedented step is one of a raft of recommendations issued Tuesday by the National Academies of Sciences, Engineering, and Medicine. The academies expert panel also recommended a campaign to vaccinate all adults against hepatitis B, expanding needle exchanges for intravenous drug users and a nationwide effort to identify and treat the legions of Americans who are unknowingly infected with either strain of the virus.
All these efforts should be coordinated by a single federal office, the panel proposed.
With about 2.7 million Americans infected with hepatitis C and 1.3 million people infected with hepatitis B, the stakes are high. A 2009 report estimated that the annual cost to Medicare of caring for hepatitis C patients alone would increase from $5 billion in that year to $30 billion in 2030. And that forecast didnt include a new generation of expensive drugs.
There are times when the government must act to correct a market failure, the panel wrote.
Cost Of Illness Of Chronic Hepatitis B Infection In Vietnam
- Unit of PharmacoEpidemiology and PharmacoEconomics , Department of Pharmacy, University of Groningen, Groningen, The NetherlandsDepartment of Pharmaceutical Management and Policy, Hanoi University of Pharmacy, Hanoi, Vietnam
- Shu Chuen LiCorrespondenceAddress correspondence to: Shu Chuen Li, Discipline of Pharmacy and Experimental Pharmacology, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, NSW, AustraliaAffiliationsDiscipline of Pharmacy and Experimental Pharmacology, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, NSW, Australia
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What Medicines Are Used To Treat Chronic Hepatitis B
There are several antiviral medicines that can be used to treat chronic hepatitis B. They are sorted into two groups:
- Interferons, such as interferon alfa-2b and peginterferon alfa-2a. Interferons are given as a shot 1 to 3 times a week for 4 to 12 months.
- Nucleoside reverse transcriptase inhibitors such as adefovir, entecavir, lamivudine, telbivudine, and tenofovir. NRTIs are taken as a pill once a day for at least a year, and usually for many years.
Experts recommend antiviral medicines if you have high levels of both the hepatitis B virus and liver enzymes in your blood for at least 6 months or if you have liver disease.
But antiviral medicines may not be right for everyone. The medicines can be helpful if you have or are likely to get liver damage, such as cirrhosis. But they may not help if you already have severe liver damage. People who have had an organ transplant or who drink too much alcohol or use illegal drugs may not be able to take some of these medicines.
You may not need to take antiviral medicines if you have normal or only slightly higher-than-normal levels of liver enzymes in your blood and if your liver isn’t damaged. Your doctor may remove a tiny piece of your liver to see if it has been affected by the virus.
Patent Expirations Will Help
While it is potentially very inexpensive to manufacture generic ETV, current prices of the drug are unfortunately very high, with a lowest global price of US$427 for a generic version not approved by a stringent regulatory authority such as the U.S. Food and Drug Administration, and US$6,127 for a generic version sold in the United States. This is because use of entecavir is currently very low, due in part to the very high prices of branded ETV and TDF, which have to some degree limited the uptake of these drugs in middle- and high-income countries . However, patents on ETV have recently expired in much of the world, including in the United States, and TDFs main patents will have expired by 2018 in most countries. This will create a dramatically different situation, as it should enable patients throughout the world to receive the most effective treatments while also making it economically feasible to explore the provision of treatment earlier in infection using a simplified public health approach.
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Why The High Costs
At this time, theres a short list of blockbuster HCV drugs. Because the FDA only recently approved these drugs, the companies that manufacture them have market exclusivity. That means only these companies can promote and sell the drugs. 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. And those who developed the new HCV drugs have set the pricing bar high.
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, Mavyret, can take only eight weeks.
These costs are averages derived from information provided by www.goodrx.com. They were current at the time this article was published.
How Is It Transmitted
Hepatitis B is highly infectious, and is spread from one person to another through exposure to infected blood and body fluids . It can be spread through:
- blood transfusions or organ transplantation in countries where blood or blood products have not been properly screened for hepatitis B and other viruses transmitted through blood
- unprotected sex with an infected person
- sharing needles or equipment for injecting drugs
- unsterilized medical/dental equipment and shared/contaminated materials or equipment used for tattooing, body piercing or acupuncture
- sharing toothbrushes or razors
- household contact between family members
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What Is Chronic Hepatitis B
You have chronic hepatitis B when the virus is active in your body for more than 6 months. The virus can damage liver cells and cause your liver to become swollen and tender.
Most people who have chronic hepatitis B don’t have symptoms. But they can still pass the infection to other people, especially the people they live with or have sex with, unless they receive treatment that gets rid of the virus.
Most people with chronic hepatitis B don’t develop serious problems. But about 15 to 25 people out of 100 who have the infection will die of cirrhosis or liver cancer.footnote 1 When there is a lot of the virus in your body, your chance of having these problems is greater. Sometimes, chronic hepatitis B can lead to severe liver damage. If this happens, you may need a liver transplant.
Costs And Prices Of Entecavir To Treat Hepatitis B
Generics/Research |Posted 25/03/20160
In an analysis of the costs and target prices of Hepatitis B treatment entecavir, author Andrew Hill from Liverpool University, UK and colleagues from Imperial College London, UK and Howard University, Washington DC, USA investigated how use of generics is affecting the cost of Hepatitis B treatment around the world .
In 2013, an estimated 686,000 people died from Hepatitis B infection worldwide. Mass treatment programmes for Hepatitis B will require drugs available at very low costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir. While the basic patent on tenofovir expires in 2017/8, entecavir is already available as a generic drug in several countries, including the US. The chemical structure of entecavir is closely related to abacavir, which costs < US$200 per person-year in low-income countries at the dose of 600 mg OD , versus 0.5 mg OD for entecavir.
The authors investigated the clinical efficacy, chemical structures, daily doses, routes of chemical synthesis, costs of raw materials and patent expiry dates for entecavir and tenofovir. Costs of sustainable generics production were calculated for entecavir and compared with published originator and generics prices worldwide. Target prices assumed at least five million people with chronic Hepatitis B treated worldwide .
Table 1: Price of entecavir per person-year
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Hepatitis C Drugs Are Pricey
Antiviral drugs for hepatitis C are very effective, but they come at a steep cost. Just one Sovaldi pill costs $1,000. A full 12-week course of treatment with this drug costs $84,000.
The price of other hepatitis C drugs is also high:
- Harvoni costs $94,500 for a 12-week treatment
- Mavyret costs $39,600 for a 12-week treatment
- Zepatier costs $54,600 for a 12-week treatment
- Technivie costs $76,653 for a 12-week treatment
Hepatitis C drugs are expensive due to the large demand for them, and the high cost of bringing them to market. Developing a new drug, testing it in clinical trials, and marketing it can run pharmaceutical companies nearly $900 million.
Another factor adding to the high cost is the lack of a national health care system to negotiate medication costs on behalf of consumers. Theres also little competition from other drug companies. As a result, hepatitis C drug manufacturers can essentially charge whatever they want.
Prices could drop in the future as more pharmaceutical companies get into the hepatitis C drug market. The introduction of generic versions of these drugs should help drive costs down.