Hepatitis C treatment challenged by rising costs

The total spending trend for hepatitis C-related medications rose 33.7% in 2012 compared with 2011, according to a recent Express Scripts report. The increase is primarily due to new medications on the market, experts said. In a field where the medications did not change for about a decade, major cost increases associated with changes in hepatitis C-related treatments are challenging patients and clinicians but also showing promise for better cure rates.

Incidence rate for hepatitis C

The incidence rate for hepatitis C has remained generally unchanged in recent years, clinicians note.

“The incidence of hepatitis C has not really spiked in the last couple years,” Andrew J. Muir, MD, director of hepatology at Duke University, told Healio.com. “Awareness on the part of clinician providers as well as the patients themselves has led to more people being in our clinics and to more overall awareness of hepatitis C.”

Andrew J. Muir

Muir said most patients he sees were infected years ago and are just now presenting with complications from advanced hepatitis C.

“We are seeing increased rates of cirrhosis and liver transplants and liver cancer all related to hepatitis C. But, new cases of hepatitis C are somewhat reduced compared with 20 years ago,” Muir said.

Bruce R. Bacon

Bruce R. Bacon, MD, James F. King MD Endowed Chair in Gastroenterology, professor of internal medicine, Saint Louis University School of Medicine, is seeing similar patterns in his practice.

“The incidence rate has not changed,” he told Healio.com. “What has changed is that there is a little bit of increased awareness, so a few more people are being diagnosed.”

Jumps in treatment costs

Researchers of the Express Scripts report credited the rise in the total spending trend for hepatitis C-related medications to the release of two protease inhibitor (PI) drugs that help treat genotype 1 hepatitis C. Incivek (telaprevir, Vertex Pharmaceuticals) and Victrelis (boceprevir, Merck) were released in May 2011, and experts agree these drugs have helped to drive treatment cost increases.

“Overwhelmingly, what has made the difference … is the increased cost for new treatments,” Bacon said. “We used the same treatment of pegylated interferon-alfa and ribavirin since 2001 to 2011. So, for 10 years the treatment regimen that we used didn’t change.”

With the availability of Incivek and Victrelis, patient options and costs changed. According to the Express Scripts report, 4 months after market availability for the two new drugs, more than 46% of patients treated for hepatitis C had been prescribed one of the new PIs.

“In 2011, for most patients of hepatitis C, when the two new drugs telaprevir and boceprevir were added to the current regimen of pegylated interferon-alfa and ribavirin, there was a substantial increase in cost,” Muir said.

The total spending trend for hepatitis C-related medications had the largest increase — 194.8%, or more than 10 times the total trend for any other specialty therapy class — in 2011 compared with 2010 among drugs for all observed major illnesses, according to the Express Scripts report. In 2011, the average cost for a hepatitis C prescription was estimated at $3,370, compared with $1,389 in 2010, the report said.

Along with the prescription costs, the current regimen, even with telaprevir or boceprevir, requires frequent lab tests, close monitoring and follow-up clinician visits, which drive up overall costs, Muir said.

More predicted cost jumps

Spending for hepatitis C-related medications will continue to grow, the report researchers predicted. As new treatments and screening guidelines are introduced, spending is estimated to grow by 32.3% in 2013 and 56.3% in 2014. Experts note, however, the cost of new treatments is not yet apparent.

“The hepatitis C treatment field is evolving,” Muir said. “There are a number of medications that are in phase 3 trials that are hopefully going to be approved in a couple of years.”

Some of those medications are initially going to be administered with peginterferon-alfa and ribavirin and some without interferon. The cost of those new drugs is unclear, according to Muir.

Better cure rates with increased costs

Clinicians are seeing better cure rates with telaprevir and boceprevir and hope for fewer side effects with new interferon-free treatments that are currently being studied. Side effects associated with interferon therapy include fatigue, anemia, depression, rash and flu-like symptoms.

Within the next 18 to 24 months, Muir anticipates that most Americans will be eligible for an interferon-free regimen that produces a greater response rate and “much better side effect profile.”

“Between 2001 and 2011, when we didn’t have telaprevir and boceprevir for genotype 1 patients, who are the most common in the United States — about 70% to 75% of all patients — we could only cure about 40% of those patients,” Bacon said. “Now with telaprevir and boceprevir we can cure between 70% and 75% of those patients. With newer agents that are in the pipe for another year or two, we are going to be able to cure 90% to 100% of these patients.

“So with the increase in costs with telaprevir and boceprevir, we are getting results. We are getting better cure rates. And, with the next round of treatments in the next couple of years, we are going to get even better cure rates. It is going to cost a little bit more, but fortunately it is going to be associated with fewer side effects.”

Financial burden

The promise of better cure rates and fewer side effects has prompted some patients to elect to wait for interferon-free medications.

“We [Bacon and fellow hepatologists] have large backlogs of patients who are waiting for new medicines,” Bacon said. “Mostly, these are patients who have been treated before with interferon and don’t want to deal with the side effects again.”

With patients awaiting interferon-free regimens and the cost estimated to rise considerably, the cost burden on the health care system is going to go up considerably within the next 1 to 2 years, explained Bacon. These costs also may cause patients to forgo treatment altogether.

Neel T. Shah

“We are seeing across the country that increasingly Americans are on high deductible health plans. Health care is becoming increasingly unaffordable,” Neel T. Shah, MD, executive director and founder of the nonprofit, Costs of Care, told Healio.com. “Traditionally, we are not trained to think about how patients will pay for care, but it is becoming increasingly important that we do that.

“There is very good evidence from other aspects of health care that when you increase the proportion that patients have to pay, they forgo treatments, even treatments that are necessary.”

“It is difficult to answer the question about costs and what it is going to be like because it is challenging for the patients to keep up,” Muir said, “and it’s actually challenging for the payers to plan on what a likely budget will be for a patient and the population with hepatitis. Because we have many patients who are uninsured or underinsured, we hope they will benefit from new health care legislation.

“This is a rapidly evolving field and people do essentially need to stay tuned. The big picture message is that hepatitis C treatment is getting better as far as better response rates and better side effect profiles in the next couple of years,” Muir said, adding that increased awareness and screening are important parts of this picture.

“If we can treat the patients before they develop advanced complications and cure them of their hepatitis C, then we can prevent them from going on to develop the complications of cirrhosis and liver cancer. The goal is to cure the disease,” Muir said.

Disclosure: Muir has received grant support from Abbott Laboratories, Achillion Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, Pfizer, and Vertex Pharmaceuticals.

Bacon has received research support from Roche/Genentech Laboratories, Bristol-Myers Squibb and Abbott Laboratories. He is a consultant, on the speakers’ bureau and has received research support from Merck. He has received research support, is a speaker on the hepatitis advisory board and on the Data and Safety Monitoring Board for Gilead Sciences. He has received research support, is a speaker and is on the hepatitis advisory board for Kadmon Pharmaceuticals; he has received research support, is an advisory board and Data and Safety Monitoring Board member, and is a speaker for Vertex Pharmaceuticals; and is a Data and Safety Monitoring Board member for ISIS Pharmaceuticals.

Shah is on the advisory board for Haymarket Media’s electronic Monthly Prescribing Reference (eMPR) and also receives funding from the ABIM Foundation.

- Suzanne Bryla Reist

The total spending trend for hepatitis C-related medications rose 33.7% in 2012 compared with 2011, according to a recent Express Scripts report. The increase is primarily due to new medications on the market, experts said. In a field where the medications did not change for about a decade, major cost increases associated with changes in hepatitis C-related treatments are challenging patients and clinicians but also showing promise for better cure rates.

Incidence rate for hepatitis C

The incidence rate for hepatitis C has remained generally unchanged in recent years, clinicians note.

“The incidence of hepatitis C has not really spiked in the last couple years,” Andrew J. Muir, MD, director of hepatology at Duke University, told Healio.com. “Awareness on the part of clinician providers as well as the patients themselves has led to more people being in our clinics and to more overall awareness of hepatitis C.”

Andrew J. Muir

Muir said most patients he sees were infected years ago and are just now presenting with complications from advanced hepatitis C.

“We are seeing increased rates of cirrhosis and liver transplants and liver cancer all related to hepatitis C. But, new cases of hepatitis C are somewhat reduced compared with 20 years ago,” Muir said.

Bruce R. Bacon

Bruce R. Bacon, MD, James F. King MD Endowed Chair in Gastroenterology, professor of internal medicine, Saint Louis University School of Medicine, is seeing similar patterns in his practice.

“The incidence rate has not changed,” he told Healio.com. “What has changed is that there is a little bit of increased awareness, so a few more people are being diagnosed.”

Jumps in treatment costs

Researchers of the Express Scripts report credited the rise in the total spending trend for hepatitis C-related medications to the release of two protease inhibitor (PI) drugs that help treat genotype 1 hepatitis C. Incivek (telaprevir, Vertex Pharmaceuticals) and Victrelis (boceprevir, Merck) were released in May 2011, and experts agree these drugs have helped to drive treatment cost increases.

“Overwhelmingly, what has made the difference … is the increased cost for new treatments,” Bacon said. “We used the same treatment of pegylated interferon-alfa and ribavirin since 2001 to 2011. So, for 10 years the treatment regimen that we used didn’t change.”

With the availability of Incivek and Victrelis, patient options and costs changed. According to the Express Scripts report, 4 months after market availability for the two new drugs, more than 46% of patients treated for hepatitis C had been prescribed one of the new PIs.

“In 2011, for most patients of hepatitis C, when the two new drugs telaprevir and boceprevir were added to the current regimen of pegylated interferon-alfa and ribavirin, there was a substantial increase in cost,” Muir said.

The total spending trend for hepatitis C-related medications had the largest increase — 194.8%, or more than 10 times the total trend for any other specialty therapy class — in 2011 compared with 2010 among drugs for all observed major illnesses, according to the Express Scripts report. In 2011, the average cost for a hepatitis C prescription was estimated at $3,370, compared with $1,389 in 2010, the report said.

Along with the prescription costs, the current regimen, even with telaprevir or boceprevir, requires frequent lab tests, close monitoring and follow-up clinician visits, which drive up overall costs, Muir said.

More predicted cost jumps

Spending for hepatitis C-related medications will continue to grow, the report researchers predicted. As new treatments and screening guidelines are introduced, spending is estimated to grow by 32.3% in 2013 and 56.3% in 2014. Experts note, however, the cost of new treatments is not yet apparent.

“The hepatitis C treatment field is evolving,” Muir said. “There are a number of medications that are in phase 3 trials that are hopefully going to be approved in a couple of years.”

Some of those medications are initially going to be administered with peginterferon-alfa and ribavirin and some without interferon. The cost of those new drugs is unclear, according to Muir.

Better cure rates with increased costs

Clinicians are seeing better cure rates with telaprevir and boceprevir and hope for fewer side effects with new interferon-free treatments that are currently being studied. Side effects associated with interferon therapy include fatigue, anemia, depression, rash and flu-like symptoms.

Within the next 18 to 24 months, Muir anticipates that most Americans will be eligible for an interferon-free regimen that produces a greater response rate and “much better side effect profile.”

“Between 2001 and 2011, when we didn’t have telaprevir and boceprevir for genotype 1 patients, who are the most common in the United States — about 70% to 75% of all patients — we could only cure about 40% of those patients,” Bacon said. “Now with telaprevir and boceprevir we can cure between 70% and 75% of those patients. With newer agents that are in the pipe for another year or two, we are going to be able to cure 90% to 100% of these patients.

“So with the increase in costs with telaprevir and boceprevir, we are getting results. We are getting better cure rates. And, with the next round of treatments in the next couple of years, we are going to get even better cure rates. It is going to cost a little bit more, but fortunately it is going to be associated with fewer side effects.”

Financial burden

The promise of better cure rates and fewer side effects has prompted some patients to elect to wait for interferon-free medications.

“We [Bacon and fellow hepatologists] have large backlogs of patients who are waiting for new medicines,” Bacon said. “Mostly, these are patients who have been treated before with interferon and don’t want to deal with the side effects again.”

With patients awaiting interferon-free regimens and the cost estimated to rise considerably, the cost burden on the health care system is going to go up considerably within the next 1 to 2 years, explained Bacon. These costs also may cause patients to forgo treatment altogether.

Neel T. Shah

“We are seeing across the country that increasingly Americans are on high deductible health plans. Health care is becoming increasingly unaffordable,” Neel T. Shah, MD, executive director and founder of the nonprofit, Costs of Care, told Healio.com. “Traditionally, we are not trained to think about how patients will pay for care, but it is becoming increasingly important that we do that.

“There is very good evidence from other aspects of health care that when you increase the proportion that patients have to pay, they forgo treatments, even treatments that are necessary.”

“It is difficult to answer the question about costs and what it is going to be like because it is challenging for the patients to keep up,” Muir said, “and it’s actually challenging for the payers to plan on what a likely budget will be for a patient and the population with hepatitis. Because we have many patients who are uninsured or underinsured, we hope they will benefit from new health care legislation.

“This is a rapidly evolving field and people do essentially need to stay tuned. The big picture message is that hepatitis C treatment is getting better as far as better response rates and better side effect profiles in the next couple of years,” Muir said, adding that increased awareness and screening are important parts of this picture.

“If we can treat the patients before they develop advanced complications and cure them of their hepatitis C, then we can prevent them from going on to develop the complications of cirrhosis and liver cancer. The goal is to cure the disease,” Muir said.

Disclosure: Muir has received grant support from Abbott Laboratories, Achillion Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, Pfizer, and Vertex Pharmaceuticals.

Bacon has received research support from Roche/Genentech Laboratories, Bristol-Myers Squibb and Abbott Laboratories. He is a consultant, on the speakers’ bureau and has received research support from Merck. He has received research support, is a speaker on the hepatitis advisory board and on the Data and Safety Monitoring Board for Gilead Sciences. He has received research support, is a speaker and is on the hepatitis advisory board for Kadmon Pharmaceuticals; he has received research support, is an advisory board and Data and Safety Monitoring Board member, and is a speaker for Vertex Pharmaceuticals; and is a Data and Safety Monitoring Board member for ISIS Pharmaceuticals.

Shah is on the advisory board for Haymarket Media’s electronic Monthly Prescribing Reference (eMPR) and also receives funding from the ABIM Foundation.

- Suzanne Bryla Reist

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