08/18/17

Public Health Time Bomb

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May came and went with the vast majority of people in the U.S.—including me—being totally unaware that it was Hepatitis Awareness month. May 19th was National Hepatitis Testing Day. Hepatitis-C (HCV) is the most common form of viral hepatitis in the U.S. The number of new HVC infections almost tripled between 2010 (850) and 2015 (2,436). We need to be more aware of this disease and its treatment because it kills more Americans than any other infectious disease, including HIV. Yes, more people than HIV. CDC data indicated nearly 20,000 Americans died from hepatitis-C-related causes in 2015; and the majority of those deaths were people 55 and older.

“Because hepatitis C has few symptoms, nearly half of people living with the virus don’t know they are infected and the vast majority of new infections go undiagnosed.” The highest rate of new infection occurs among 20- to 29-year-old injection drug users. But ¾ of the 3.5 million Americans living with hepatitis C are baby boomers born between 1945 and 1965. They are six times more likely to be infected with hepatitis C and are at much greater risk of dying from the virus. Around ½ of all the deaths from HCV in 2015 occurred within this age range. You can read the three CDC press releases this information was taken from here, here and here.

These press releases highlighted information in report, “A National Strategy for the Elimination of Hepatitis B and C” that suggested a strategy to eliminate both as public health problems by 2030. Immunization against hepatitis B (HBV) can prevent 95% of infections. There is no vaccine against HCV, but there are anti-viral drugs that can cure hepatitis C, but the costs are prohibitive. The introduction of the report said:

There is no longer any reason to disregard these diseases. There is an effective vaccine to prevent hepatitis B, advances in treatment can prevent most deaths in those chronically infected with HBV, and hepatitis C is now curable with a short course of easily tolerated treatment.

CDC data on HCV suggested that 75% to 85% of newly infected adults and adolescents develop chronic infections. From 2000 to 2002 incident rates for acute HCV decreased for all age groups except for persons aged 0-19. Then the rates remained fairly steady from 2002 through 2010. Between 2010 and 2015 rates increased for persons in all but the oldest (<60 years old) and youngest (0-19 years old) age categories. The largest increase was among persons between 20 and 29 years old. See the following graph of the reported CDC data.

The drug companies charge between $60,000 and $90,000 for a 12-week course of treatment. This is way out of proportion to the cost of treatment in third world countries. Eliminating HCV as a public health problem by 2030 would require mass treatment, but none of the direct-acting agents come off patent before 2029. In the long run, HCV treatment is cost-effective, but that doesn’t address the upfront costs charged by pharmaceutical companies for their drugs. So the cost of antivirals that cure HCV is a major obstacle. 

These drugs have strained the budgets of public and private payers alike. Faced with the unenviable task of allocating scarce treatment, payers gave first priority to the sickest patients, those at most immediate risk of death. Many also imposed sobriety restrictions, fearing the risk of re-infection in active drug users too great to justify the expense of treatment. Such restrictions have met with criticism. Overt drug rationing offends the American public, but it is difficult to know how else to act in the face of such high prices.

One of the recommendations of the report is for the federal government to purchase the rights to one of the direct-acting antiviral treatments for use with neglected populations such as individuals on Medicaid, in prisons and those treated through the Indian Health Services. This would be a voluntary transaction between the government and the pharmaceutical companies providing the antivirals. The company would be guaranteed reasonable compensation and the licensed drug would only be used in the limited markets (noted above) the companies aren’t now reaching.

Calculations show that the licensing rights should cost about $2 billion, after which states would pay about $140 million to treat 700,000 Medicaid beneficiaries and prisoners. By comparison, the status quo would cost about $10 billion over the next 12 years to treat only 240,000 similar patients.

Critics of the strategy suggest it sets a dangerous precedent by having the government negotiating a license for a costly medicine. Actually, it seems that the federal government’s reluctance to interfere with the pharmaceutical industry may have emboldened it to initially set the extremely high prices foe HCV drugs.

The Senate Finance Committee’s 2014 investigation into the pricing of sofosbuvir [Solvadi] concluded that Gilead had deliberately elevated the price in an effort to raise the market floor, ensuring continued high prices for all future hepatitis C treatments. Action now might discourage other companies from pursuing this strategy in the future.

A CNN article on the report by Susan Scutti noted the hardest hit areas of the U.S. in terms of new HCV infections are parts of Appalachia and rural areas of the Midwest and New England. Seven states, Indiana, Kentucky, Maine, Massachusetts, New Mexico, Tennessee and West Virginia, have infection rates that are two times or more than the national average. Ten other states have rates above the national average: Alabama, Montana, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Utah, Washington and Wisconsin.

There is a website, HepVu, presented by the Rollins School of Public Health at Emory University, which partnered with Gilead Sciences, the original price gauging pharmaceutical company with its antivirals, Solvadi and Harvoni. The original drug development research into Solvadi was done at Emory. Despite the Gilead partnership, HepVu has some helpful information, including an interactive map by state in the U.S. The home page stated there are an estimated 3.9 million people in the U.S. living with past or current hepatitis C infection. You can look up each state’s individual profile.

For example, within my home state of Pennsylvania, there are an estimated 142,100 people living with Hepatitis C. The HCV mortality rate is 4.952 per 100,000 persons, with 629 hepatitis C deaths in 2014. In West Virginia, there are an estimated 24,400 people living with Hepatitis C. The HCV mortality rate is 5.9 per 100,000 persons, with 110 hepatitis C deaths in 2014. In Ohio, there are an estimated 119,100 people living with Hepatitis C. The HCV mortality rate is 4.9 per 100,000 persons, with 567 hepatitis C deaths in 2014. Go to the site and check out your own state’s data.

The outrageous price of medications to treat hepatitis C illustrates how pharmaceutical companies are feeding off of the problems they had a hand in creating. The rise in hepatitis C infections comes as a result of increased IV drug use, which resulted from the prescription opioid epidemic leading individuals to switch from prescription opioids to heroin. And the public health problems with hepatitis C will only get worse since it often goes undiagnosed for years. It’s a public health time bomb.

The above recommendation to have the federal government negotiate a license for one of the existing Hepatitis C treatments is a good one. It just might deter other companies from trying the same pricing trick in the future with other medications. But the cozy lobbying relationship between Pharma and Congress could prevent it.

For more on this issue, see: “Is There No Balm in Gilead?,” “I Guess I’m a Little Bit Socialist,” “Riding the Hep C Gray Train,” “Impeccable Timing” and “Hepatitis Hostages.” Also see “Pharma Companies Hunt in Packs” for more information on the issues of the high cost of prescription drugs.

06/17/16

Impeccable Timing

31118385_sTiming is everything—even with medications coming to market. In the last few years new, effective treatments for the Hepatitis C Virus (HCV) have come to market as the death rates steadily climbed. Solvadi (12/2013) and Harvoni (10/2014) by Gilead Sciences; Viekira Pak (12/2014) by AbbVie and Zepatier  (01/2016) by Merck are the main ones. They have cure rates over 90% in many cases. Although their prices have been sky high, according to the WHO, the production costs of these drugs are quite low. Harvoni prices were expected to drop, but I haven’t anything much cheaper than $94,500 for 12 weeks of medication. Viekira Pak lists at $83,300 for 12 weeks; Zepatier is the bargain at $54,600.

New CDC data in May of 2016 indicated that HCV deaths for 2014 reached an all-time high of 19,659. The rates have been steadily rising since 2010 when the total was 16,627. The CDC also stated their numbers were most likely a fraction of the deaths attributable in whole or in part to chronic hepatitis C. There are an estimated 2.7 to 3.9 million chronic cases of HCV in the U.S. New acute cases of HCV have also been steadily increasing. In 2014 there were 2,194 new cases of HCV reported, a 300% increase since 2005. The CDC suggested that actual cases are estimated to be 13.9 times higher than the number of reported cases in any year. The following chart was compiled from the CDC data.

2010

2011

2012

2013

2014

Actual 

New HCV

853

1,230

1,778

2,138

2,194

Estimated

New HCV

11,800

16,500

24,700

29,700

30,500

Cause of Death

as HCV

16,627

17,721

18,650

19,368

19,659

A study done on the CDC HCV data found that from 2003-2013 the number of deaths from HCV surpassed the combined total of 60 other infectious conditions. This was despite the improving therapies now available. The HCV death statistics could begin decreasing in the next few years, as the impact of the new drugs is felt in treatment. But the high cost of medications has resulted in health insurance companies prioritizing treatment for the worst HCV cases. So as the heroin and prescription pain medication epidemic rages on, new HCV patients have to wait their turn until their HCV gets serious enough for their health insurance to approve treatment.

Despite enthusiasm for the new curative, brief (12-week), all-oral antiviral treatments for hepatitis C virus (HCV) infection, the continued health burden and increased mortality for HCV-infected patients in the United States remain underappreciated.

A CDC press release indicated the greatest HCV burden falls on baby boomers, born between 1945 and 1965. A study published in The Lancet Infectious Diseases in 2016 suggested injection and blood transfusion technologies were not as safe as they are today, so many boomers may have been unknowingly living with HCV for many years. Jonathan Mermin of the CDC said: “Why are so many Americans dying of this preventable disease? Once hepatitis C testing and treatment are as routine as they are for high cholesterol and colon cancer, we will see people living the long, healthy lives they deserve.” The outrageous price for HCV medications may be part of your answer, Dr. Mermin.

A Live Science article on the CDC study noted that HCV is primarily spread today through people sharing needles, syringes or other equipment used when injecting drugs. “But before 1992, when the U.S. began screening the blood supply for the virus hepatitis C was also commonly spread through blood transfusions and organ transplants.” The following chart from Wikimedia Commons, composed by Opigan13, was compiled from CDC figures. It shows data on hepatitis C infection by source.

 576px-Hepatitis_C_infection_by_source_(CDC)_-_en

HCV can be a “silent illness,” with people having no symptoms for decades. This allows the disease to progress unnoticed. Hepatitis C is “a different beast” from other liver infections that have more symptoms or are shorter in duration, according to Dr. Raymond Chung, director of hepatology and the Liver Center at Massachusetts General Hospital. Dr. Chung thought the increase in HCV deaths could continue for five more years or longer.

Amy Nunn, an associate professor of behavioral and social sciences at the Brown University School of Public Health said the rise in HCV deaths was alarming. About 85 percent of individuals who are infected with HCV don’t know they have it. Most people are not routinely screened for the virus. Nunn also pointed to the high cost of the new hepatitis C drugs as one reason that some people are having trouble getting access to them in the early stages of the disease.

A report by IMS Health for 2015 indicated that nearly 250,000 new patients received treatment for HCV in 2015. Added to the 170,000 new patients in 2014, the past two years have seen 5 times the number of patients than the previous three years combined. The majority of patients were treated by Medicare (50%); followed by commercial insurance (28%) and Medicaid (19%); 3% paid cash. Non-discounted spending over the past two years for the newer HCV drugs was $31.0 billion. “The discussion continues over the price of these medicines and the criteria for determining patient access and insurance coverage.” See chart 10 in the report for this data.

Spending on HCV went from so small an amount in 2013 that a figure couldn’t be shown in chart 8, to 12.2 billion in 2014 and 18.8 billion in 2015. Looking at the top medicines by spending in 2015, Harvoni was #1 with $14.3 billion. Solvadi dropped to 19th with $3.0 billion spent. In 2014 Solvadi had been tied for 1st with Humira at $7.8 billion in spending.

The World Health Organization (WHO) estimates that 130 to 150 million people globally have chronic hepatitis C infection. Around 500,000 people die yearly from HCV-related liver diseases. The most affected regions are Africa, Central Asia and East Asia. Populations at risk of HCV include: people who injects drugs, people who have used intranasal drugs, people who have tattoos or piercings, people with HIV, prisoners or previously incarcerated individuals, and children born to mothers with HCV.

The incubation period for hepatitis C ranges from 2 weeks to 6 months. After the initial infection, 80% of people do not show any symptoms. Individuals who are acutely symptomatic could exhibit “fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, grey-coloured faeces, joint pain and jaundice (yellowing of skin and the whites of the eyes).” The WHO said:

Recently, new antiviral drugs have been developed. These medicines, called direct antiviral agents (DAA) are much more effective, safer and better-tolerated than the older therapies. Therapy with DAAs result can cure most persons with HCV infection and treatment is shorter (usually 12 weeks) and safer. Although the production cost of DAAs is low, the initial prices are very high and likely to make access to these drugs difficult even in high-income countries.

So pharmaceutical companies like Gilead Sciences, AbbVie and Merck are making enormous profits from their HCV treatments and will continue to do so for many years (see “Riding the Hep C Gravy Train”). The low production cost for HCV drugs is also an explanation for why Gilead Sciences was so willing to offer steep discounts to countries like Egypt (See “Is There No Balm in Gilead?” and “Hepatitis Hostages”)—it’s good PR and they either still make a profit or buy a lot of goodwill for a nominal cost. As Amy Nunn said, “This is an epidemic of enormous magnitude.” And it looks like it will be around for awhile longer. Gilead, Merck and AbbVie, your timing for drug development was impeccable.