Healthcare Reform in GeorgiaHealthcare reform in Georgia has contributed greatly to its population’s quality of life. Located east of the Black Sea in Europe, the country of Georgia finally gained independence in 1991 from the Soviet Union. In recent centuries, Turkey, Persia and Russia fought over control of its land, and the region still experiences tensions with Russia. The United States’ political and economic involvement with Georgia was a cause of concern to Russia, especially given Georgia’s interest in joining NATO and the EU. The Georgian- and Russian-speaking country has a population of 4.3 million, with a life expectancy of 71 for males and 77 for females.

Privately Funded Healthcare

After making the transition from a communist regime to a market economy, healthcare in Georgia was primarily privately financed. By the year 2002, healthcare spending per capita was $64. Over the period from 2002 to 2013, that figure saw an increase to $350. The country has been alleviating regulations ever since 2003, easing private companies’ entry into the market.

Recently there have been further reforms, such as the government supporting private insurers to invest and operate in 2010. This led to the private ownership of 84.3% of hospital beds by the end of 2014. Additionally, private insurers generated 43.2% of written premiums that same year.

Rising Standards of Health

Ever since its independence, Georgia has been one of the poorer countries of the region, its population subject to mainly noncommunicable diseases. However, the country’s standards have been slowly catching up to the rest of Europe. For example, the poverty rate went from 33.2% in 2005 to 21.3% in 2016.

One issue with healthcare in Georgia, and with the general health of the population, has been the flawed death reporting system. This system has led to an exaggerated rate of illness-induced deaths. It reached 55% in 2010, even though research suggests that a rate higher than 20% should be considered unreliable. While the rate remains high and unreliable, the country made tremendous progress after improving software systems, resulting in a rate of 27.3% in 2015.

A New Universal Healthcare System

Healthcare in Georgia took a big leap in 2013, when the government introduced a universal healthcare system for which the entire population qualified. Healthcare reform in Georgia downsized the role of private insurers and changed the system’s entire financing and funding structure. Instead of supporting private companies, government funds were allocated directly to the healthcare providers. The vast majority – 96.4% – of patients reported satisfaction with the system.

One of the main diseases affecting the country during this century is Hepatitis C. According to the CDC and the NCDC, “in 2015, estimated national seroprevalence of hepatitis C is 7.7% and the prevalence of active disease is 5.4%.” Healthcare reform in Georgia sought to combat the disease through a national program initiated in 2015. This program electronically improved screening and data collection from national and local agencies. From 2015 until 2017, the cure rate reached 98.2% and 38,506 patients were treated.

Healthcare in Georgia has undergone many reforms since 2003. It began with the support of privatization, but eventually the government transitioned to a single-payer universal healthcare system that serves approximately 90% of citizens. The current system also took measures to address the effects of the Hepatitis C disease. Even though the country still lags behind other European countries in poverty and health standards, recent years have seen significant progress.

Fahad Saad
Photo: Pixabay

A large portion of the countries currently affected by hepatitis B and C are taking proactive approaches to eliminate the disease in their areas.

According to information from the World Health Organization (WHO), 28 countries representing approximately 70% of the global health burden are establishing hepatitis elimination committees. More than half of these countries have already committed funding for hepatitis responses.

Dr. Tedros Adhanom Ghebreyesus, the WHO Director-General, finds the commitment of these countries encouraging. “Identifying interventions that have a high impact is a key step towards eliminating this devastating disease. Many countries have succeeded in scaling-up the hepatitis B vaccination. Now we need to push harder to increase access to diagnosis and treatment,” Dr. Tedros said in a statement from the WHO.

Hepatitis (which means inflammation of the liver) is caused by toxins, certain drugs, diseases, heavy alcohol use and bacterial and viral infections. The disease is spread when blood or other bodily fluids enter the body of an uninfected person. Symptoms include jaundice (yellowing of the skin and eyes), fatigue, abdominal pain, swelling, chest pain, abdominal swelling, fever, and diarrhea.

The WHO report was released to coincide with World Hepatitis Day and is calling on countries to increase their commitment to end the disease. The current theme of World Hepatitis Day is Eliminate Hepatitis, focusing on increased awareness, diagnosis, universal vaccination and treatment.

Viral hepatitis affected 325 million people worldwide in 2015 and is responsible for 1.34 million deaths. The two main killer strains of hepatitis B and C affected 257 million and 71 million people respectively. WHO data shows that more than 86% of countries that were reviewed have already set national hepatitis elimination targets. More than 70% have begun to develop national hepatitis elimination programs by enabling access to effective prevention, diagnosis, treatment and care services.

Dr. Gottfried Himschall, WHO’s Director of the HIV Department and Global Hepatitis Program acknowledges that awareness of hepatitis is gaining momentum but also states that there are too many people living with hepatitis that don’t know they have the disease or cannot access treatment.

“For hepatitis elimination to become a reality, countries need to accelerate their efforts and increase investments in life-saving care. There is simply no reason why many millions of people still have not been tested for hepatitis and cannot access the treatment for which they are in dire need,” Dr. Himschall said in a statement from the WHO.

The World Hepatitis Summit in Sao Paulo, Brazil, organized jointly by the WHO, the World Hepatitis Alliance (WHA) and the government of Brazil, will bring together key players in hepatitis elimination. The summit will be held Nov. 1-3 and promises to be the largest global event to advance the viral hepatitis agenda.

Drew Hazzard

Photo: Flickr

Hepatitis CHepatitis C is an infection transmitted by contact with infected blood or other body fluids that can result in fatal liver disease. The World Health Organization (WHO) reports that Hepatitis C infects more than 185 million people around the world, and 350,000 people die from the infection every year. In the Ukraine, more than two million of its 45.2 million population are infected with Hepatitis C.

Seventy to 80 percent of those with an acute Hepatitis C infection do not show symptoms, which can prove dangerous when trying to prevent the spread of Hepatitis C. The annual mortality rate from Hepatitis C in Ukraine has increased by 141.7 percent since 1990 (an average 6.2 percent per year).

Hepatitis C treatment can be prohibitively expensive for the world’s poor. In 2015, the lowest cost for the 12-week treatment course of Sofosbuvir, an antiviral used to treat Hepatitis C, was $900, a price not suitable for low-income Ukrainians suffering from the infection.

In 2013, the Ukrainian government approved the first National Targeted Program of HCV Prevention, Diagnosis and Treatment. The state budget only funds the treatment component of the program, and this funding accounts for a mere 20 percent of the existing need.

U.S. organizations are doing their part as well. The United States Agency for International Development (USAID) launched the EQUIP project to fight HIV and AIDS, but EQUIP and USAID recently partnered with the Ukrainian government to fight Hepatitis C in Ukraine. EQUIP provides a simplified system with two stages of testing and treatment for 4,000 patients with Hepatitis C. In the first stage, 800 people with serious cases of double and triple pathology – a combination of HIV, Hepatitis C and Tuberculosis — will be treated; in the second, 3,200 individuals will receive treatment. Patients will be given a fixed dose of Ledipasvir and Sofosbuvir.

EQUIP is aimed at developing new treatment protocols and calculating its cost for Ukrainian patients. As well as giving doctors the experience they need with the medication to effectively treat patients and consult with the Ukrainian Government to create programs to increase access to those who need treatment. EQUIP is determined to eliminate viral Hepatitis by 2030.

With a combination of national and international efforts, we can end the spread of Hepatitis C in Ukraine.

Tiffany Santos

Photo: Google

July 28, 2015 marked the sixth World Hepatitis Day, designated by the World Health Organization (WHO) in 2010. According to the WHO, there are 400 million people with Hepatitis B or C, 240 million and 150 million, respectively. This amounts to 1.5 million deaths per year from viral hepatitis, which translates to 4,000 deaths per day that could be prevented with awareness and understanding regarding prevention.

Despite the disease being the seventh leading cause of death, everything is available to prevent infection and death, according to WHO Global Hepatitis Program team leader Stefan Wiktor. The most common method for treatment are injections. An estimated 16 billion injections are done yearly. Unfortunately, 40 percent of them are unsafe. WHO is promoting the exclusive use of sterile syringes that are specific for hepatitis treatment, to prevent unsafe injections.

While both Hepatitis B and C attack the liver and cause acute or chronic illness, there are different methods to treat each of them. For Hepatitis B, there is a vaccine, lab tests to screen out infection and safe treatment injections. Treatment can control the virus, but doesn’t cure it. All the more reason to know that Hepatitis B is transmitted through bodily fluids, and usually happens from mother to child. It is most prevalent in sub-Saharan Africa and East Africa. Unsafe injections of Hepatitis B account for 32 percent of infections.

Hepatitis C provides a little bit more hope. Its medications can cure almost everybody, but they cost $84,000 in wealthy nations, for a 12-week treatment. Egypt has been able to negotiate $900 for the medications. WHO believes prices will go down in the future.

To prevent Hepatitis C, it is worth knowing that it is a blood borne virus which is most commonly transmitted with drug use. Unsafe injections account for 40 percent of infections. WHO Service Delivery and Safety Department Director Edward Kelley comments, “preventing unsafe injections is key to curbing this epidemic”.

Despite the expensive medications for Hepatitis C, there has been a breakthrough this year. An inexpensive allergy medication has been discovered to block the virus so it doesn’t infect the liver cells, according to the U.S. National Institutes of Health. The antihistamine, chlorcyclizine, and similar “re-purposed” drugs were tested for their effectiveness against viral and bacterial infections in a high throughput screening method used in the analysis of government-approved compounds.

The only thing left is to determine a therapeutic dose for its use in the treatment of Hepatitis C, potentially giving millions of people who can’t afford the current $84,000 treatment.

– Paula Acevedo

Sources: Science Translation Magazine, Voice of America 1, Voice of America 2, World Hepatitis Day Campaign
Photo: World Hepatitis Day

Controversial Hepatitis C Drug Patent Rejected by China-TBPIn June 2015, China rejected Gilead Sciences, Inc.’s patent application for a drug related to its controversial but highly curative hepatitis medication, Solvadi. China rejected the application for the sofosbuvir prodrug, although it had previously granted a patent to Gilead for the base compound in the drug, also identified by its generic name, sofosbuvir.

A prodrug is a precursor of a drug. It is inactive or partially inactive until it is metabolically converted within the body. The Initiative for Medicines, Access & Knowledge, a group of lawyers and scientists based in New York, opposed the patent application on the grounds that the drug is not a new invention; it is “old science” derived from a line of antiretroviral drugs. I-MAK and Natco Pharma Ltd. did the same in India when Gilead’s hepatitis C drug patent request was turned down in January. I-MAK also legally challenged Gilead’s patents or patent applications in Argentina, Brazil, Russia and Ukraine. Such challenges are hoped to enable the production of a much less expensive generic version of Solvadi.

Gilead, a California-based firm, has been criticized for its pricing of Solvadi at $1,000 a pill in the United States. The 12-week course of treatment costs $84,000, a prohibitive cost for rich and poor alike. Adding to the cost, Solvadi must also be used in combination with at least one other antiviral drug. Since December 2013, when sofosbuvir was first approved in the United States, Gilead was sufficiently pressured to lower the price, agreeing to do so in 2014 for 91 developing countries.

Hepatitis C is found around the world but is most prevalent in developing countries, especially Central and East Asia and North Africa. The World Health Organization (WHO) estimates that as many as 150 million people are infected with chronic hepatitis C. The influential organization recently added Sovaldi to its list of essential medicines and pressed for lower prices.

Solvaldi/sofosbuvir offers a far better treatment plan than drugs currently in use: a 12- to 24-week course of once-daily pills with few minor side effects and a superior rate of cure. The currently used drug, interferon, is administered by injection several times a week for at least six months with a number of major side effects, and most patients suffer a relapse requiring more treatment.

According to Doctor’s Without Borders’ Director of Policy and Analysis, Rohit Malpani, Gilead’s price should reflect the cost of research and development, but, instead, it reflects what it believes the market will bear. This is because, he adds, Gilead paid $11 billion to acquire Pharmasset, the original producer of the drug. Other countries have made agreements with Gilead for lower prices. Egypt, which has the highest prevalence of the disease, has a deal with Gilead to lower its price by 99% after rejecting Gilead’s bid for a patent. India has also been in talks with Gilead to reduce the price since 2014.

No vaccine exists to prevent hepatitis C. According to the WHO, 350,000 to 500,000 people die every year due to liver diseases resulting from hepatitis C. Without a much less expensive generic version of Solvadi, it is unlikely that this figure will change any time soon.

– Janet Quinn

Sources: BioPharmaDIVE, IRIN, Reuters 1, Reuters 2, World Health Organization,
Photo: Everyday Health

Gilead Sciences Inc., a drug company based in California, has licensed Sovaldi, its highly effective but expensive Hepatitis C drug, to seven Indian drug companies to distribute the drug to 91 developing countries at a much lower cost.

With approximately 180 million people suffering from Hepatitis C and nearly 350,000 dying each year in countries of low- and middle-income, the licensing will allow many of these people to receive treatment they most likely would not have been able to receive at the original cost.

The licensing agreement provides the Indian companies with direct access to Gilead’s manufacturing process so that production can be scaled up immediately and as quickly as possible.

Hepatitis C is typically transmitted through medical procedures, intravenous drug use or sexual intercourse, and it can remain undetected and unnoticed for a number years, eventually causing liver scarring and failure.

Chemically known as sofosbuvir, Sovaldi is radically more effective than previous injection regimens. Clinical trials showed a 90 percent cure rate after 12 weeks of treatment, a substantial increase over the 60 percent cure rate of previous treatments. Moreover, previous treatments had typically required taking numerous pills a day and antiviral injections, making the routine of Sovaldi, one pill a day, particularly appealing as well.

However, Gilead has received criticism regarding how extraordinarily expensive the drug is, costing $1,000 for one pill or $84,000 for a 12-week course in the United States. Its next-generation is expected to cost even more.

Gilead is planning to release its own brand of the drug in India for about $10 a pill or 1 percent of the cost in the United States. With India accounting for more than half of the world’s affected population, the cheap price is especially promising. In addition, Egypt, having the highest prevalence of Hepatitis C in the world, is also going to be provided with Sovaldi at $10 a pill by Gilead.

The seven Indian generic producers are allowed to set their own prices, and Gilead’s planned prices are expected to force the seven Indian companies to charge even lower prices to compete. They are also to pay royalties based on their sales to Gilead under the licensing agreement.

The licensing agreement also includes the next generation of Sovaldi, which is a combination of sofosbuvir and the experimental therapy ledipasvir, currently being tested by U.S. regulators.

In the U.S., officials have said Gilead’s drug could drain Medicaid budgets and increase private insurance premiums. In addition to the intense criticism the company has attracted domestically, Gilead’s licensing choices have attracted criticism due to their omission of middle-income countries that struggle to afford Sovaldi as well.

In more developed countries that were not included in the licensing agreements, such as China and Brazil, Gregg Alton, Gilead’s executive vice president, has stated Gilead will sell the drug at more than $10 a pill.

Regardless of the controversial nature of the Gilead’s licensing choices, the provision of a cheaper Hepatitis C drug to much of the world’s affect population is going to make a powerful impact and serve to help alleviate poverty around the world.

– William Ying

Sources: Gilead, Reuters, New York Times, Time, Wall Street Journal
Photo: Flickr

The Hepatitis C virus affects an estimated 180 million men, women and children worldwide. Patients in low to moderate income nations benefit from treatment at the same rate as those in developed regions. Yet, the high cost of this treatment prevents many from recovering.

One of the largest biopharmaceutical companies, Gilead Sciences, developed an $84,000 cure in 2013 with one pill priced at a thousand dollars. The total cost for a three-month regimen far exceeds most patients’ price range.

Solvadi, the pill, offers a solution to the pressing danger of this disease in developing countries. Egypt (22%), Pakistan (4.2%) and China (3.2%) rank the highest in disease prevalence, bearing most of the burden today.

How, though, can patients in these nations afford an $84,000 bill?

Gilead answered this question with a promising discount in sixty developing countries. Negotiating with generic drugmakers in India, the company plans to offer the treatment at 2 percent of the cost in the United States.

Rohit Malpani, a policy director at Doctors Without Borders, hopes for a more reasonable price. The company could produce Solvadi at a far lower cost, he contends. Malpani and other advocates estimate Gilead could cut the cost to $68 to $136 for a twelve-week treatment regime.

The company must revaluate how much the drug costs compared to patients’ ability to pay, Malpani asserts.

“If we want to see Hepatitis C treatment scaled up globally, we are going to need much lower prices in all countries with a high burden of the disease,” he remarks in a recent Doctors Without Borders statement.

Gregg Alton of Gilead reports future partnerships with three to five different companies. Gilead, he notes, plans to allow flexibility of price from the Indian companies. Alton also contends the starting point of $2,000 is “substantially less” that current costs in India – for inferior drugs. He promoted Solvadi in The Hindu Business Line, highlighting the drug as “more effective, less toxic…and without side-effects.”

Ideally, Alton remarks, the company signs voluntary licensing deals “in the next couple months” and market availability in two years. Last November, the Initiative for Medicines, Access and Knowledge(I-MAK) filed a legal challenge against its patent application.

I-MAK claims Solvadi relies on “on science” with a “known compound.” Voluntary licensure protects Gilead from patent problems, adds Malpani. These licensing agreements prevent generic companies from overturning patents. Without these agreements, the Indian manufacturers could sell Solvadi at any cost and without paying royalties to the company.

The company also plans to limit the scale of these licensing agreements, allowing generic drugmakers to sell in 60 countries. In contrast, Gilead sells HIV drugs in more than 100.

The pricing and limited access to this drug threatens the health of more than 180 million patients. Brook Baker, an advisor to the Health Global Access Project, sees delinkage as the solution. With this system, governments fund pharmaceutical research and development as a public service.

Today, pharmaceutical companies absorb about 60 percent of the total cost. Treating these drugs as a public good offers the most in need. And though these companies need to profit, Hepatitis C patients around the world also need treatment.

Ellery Spahr 

Sources: NPR, WHO
Photo: Don’t Trade Our Lives Away

Approximately 150 million people around the world are afflicted with Hepatitis C, a deadly liver infection that causes severe complications among its patients. It looks as if this viral infection might have finally met its match with the introduction of Sovaldi (sofosbuvir), a supposedly highly effective new drug made by California-based pharmaceutical company Gilead Sciences Inc.

Gilead’s executive vice president, Gregg H. Alton, claims that the drug is among “the biggest breakthroughs in medicine in the last 10 years.”

Countries around the globe will be the judge of that, as the current high price of the drug is unaffordable to all but the wealthiest in most low and middle-income countries. In the United States, Sovaldi sells for $1,000 per pill, meaning that a twelve-week regimen would cost an estimated $84,000.

As most people afflicted with the virus are poor or incarcerated, this is fueling anger even in one of the world’s wealthiest nations. Gilead Sciences is attempting to solve this issue by licensing the drug to a number of generic pharmaceutical manufacturers in India. Discussions are still underway but the price for a 24-week regimen of Sovaldi would run at about $2,500 for patients in public hospitals, community clinics, and NGOs.

This amounts to 2% of the U.S. price and the deal is slated to affect up to 60 low-income countries.

That said, activists continue to raise concerns about the cost of the drug.

Rohit Malpani, a policy director of Doctors Without Borders, agrees with other critics that Sovaldi could be sold for as little as $136 for a twelve-week regimen, substantially less than the licensing deal currently underway with Gilead. However, it is important to note that the pharmaceutical companies in India are the only players who will be able to bring the price of the drug down, depending upon the amount of competition.

Gilead has created programs for lower-cost versions of its HIV/AIDS drugs, so why not allow similar access to the Hepatitis C drug? Either way, Gilead Sciences will be making its fair share of money.

Analysts estimate that the drug will generate billions of dollars in annual sales, as about 3% of the world’s population has been infected with the virus. The last three weeks of 2013 alone generated more than $139 million for the medication.

With the price of Sovaldi in India currently up for debate, clinical trials are already being conducted to test the drug on the local population. If the licensing deal goes through with Gilead Sciences, it will take about two years before the product is actually available in India, and hopefully a number of other countries.

The hopes are that Sovaldi will eventually be accessible in resource-limited settings where it is most needed.

– Mollie O’Brien

Sources: NPR, The Hindu Business Line
Photo: NPR