Just how big is the hepatitis C market in the United States?

This is a guest post from Rick Shalvoy, CEO, Consumer Health Education Programs

The recent FDA approval of AbbVie’s Mavyret™  DAA (direct-acting antiviral) treatment for HCV (hepatitis C virus) has sparked any number of news stories about the beginning of a new “price war” between AbbVie and Gilead Sciences. Pharma business writers are all abuzz about the HCV market share tug of war, but the methods that are being used by most analysts to evaluate the size of the HCV market seem to be missing one very large piece of the puzzle.

First, consider the strategic nature of the Pharma business model. Each market participant strives for labeling superiority with indication, dosing, tolerance, efficacy, treatment duration and regulatory approval timing advantages. They then negotiate the best deals they can possibly wring out of insurers and PBMs (pharmacy benefit managers), and hope for the best. In this case, Gilead emerged as the big winner beginning with the approval of Sovaldi® in December, 2013, and Gilead has maintained top dog status in the HCV therapeutic market ever since.

After the flood of Sovaldi® and Harvoni® scripts that were falling into Gilead’s lap started to taper off, it was widely assumed that Gilead had successfully squeezed most of the juice out of the HCV market, that HCV drug prices would decline, and that the size of the market would be gradually shrinking from that point forward. Prices did decline as expected, but the number of diagnosed and treatment eligible patients, and the average $ revenue generated per treatment, are not the only factors to consider when evaluating the size of a market.

The projected number of future patients yet to be diagnosed must also be considered. Do you remember what Pfizer did when all of the pundits were saying that the size of the cholesterol-lowering drug market was limited by the existing number of patients with hypercholesterolemia? Well aware of the fact that there were still millions of patients with hypercholesterolemia who had not yet been diagnosed, Pfizer launched a Know Your Numbers DTC education campaign and shipped truckloads of cholesterol test kits to their salespeople with orders to give those test kits away with free samples of Lipitor® during every sales call. The rest is history. Liptior® shot up to, and still holds, the number one spot on the list of the best-selling drugs of all time.

I am certainly not suggesting that Gilead or AbbVie should start giving away free HCV test kits to providers who don’t seem to understand how important it is to screen all baby boomers for hepatitis C (~75% of HCV incidence in the U.S. is in the boomer population), but while so many industry analysts see the HCV market in the U.S. as a diminishing segment of the pharmaceutical industry, there are still millions of HCV-infected people in the United States who have no idea that they’re infected. So if there’s so much potential left in this market, and if we now have the ability to eradicate this disease that kills more people than any other infectious disease in the United States,(1) why is there such a huge gap between market potential and market performance?

Most of the efforts to educate health care providers about the CDC recommendations for screening all baby boomers, and to tell providers exactly why it’s so important to order HCV testing for all of their boomer patients, have failed to make a significant impact. By the end of 2015, over three years after the CDC recommendations were announced, a dismally low percentage (only 13.8%) of the ~76 million boomers in the United States had been tested.(2)

The CDC’s Know More Hepatitis campaign, launched in 2012 with a budget too small for prime time, has given public health officials something to talk (to each other) about at conferences, but the actual impact of the campaign has been disappointing to say the least.

It has now been five years since the CDC screening recommendations were announced. Gilead’s Get Tested campaign, launched in October, 2016, triggered a nice bump in the bimonthly rate at which boomers were being screened, but the baseline rate was so low at the start of the campaign that we’re still only up to about 23% of all boomers who have been tested for HCV, and that includes the several hundred thousand who have already been diagnosed and treated with DAAs.

It is also worth noting that the recently reported increase in the number of insurance approvals for HCV treatment does not mean that there has been an equal increase in the number of newly diagnosed patients. Many of those patients were previously diagnosed and had been waiting for insurance approval for a long time. (There will always be an inverse correlation between price and approvals. As the cost of a therapy goes down, the number of insurance approvals goes up.) And by the way, many thousands of HCV patients are still waiting for approval. They are, in fact, being used by insurers as pawns in a price erosion / liver erosion waiting game.

In a declining price environment, an increase in the number of new treatment starts does not necessarily mean that there has been a significant increase in the number of people who have been tested. Without a mass media public health education campaign to shake things up on the front (diagnostics) end, the full potential of this enormous market may never be realized. The kind of campaign I’m referring to would ideally be designed to evolve into something much greater than an education campaign. I’m thinking of a campaign where the media messaging and the 1-800-GET-TESTED® hotline follow up calls would give rise to a movement with so much energy behind it that insurers and PBMs would be subjected to tremendous political pressure to approve treatment for all HCV patients regardless of symptoms or liver biopsy results.

Come on guys, we’re boomers, and we still have what it takes to form a movement with the same level of passion we had during the 60s and 70s. The time has come to stop waiting for primary care providers to take the lead. We need to fire up the boomers and their family members with a barrage of media messages and a compelling direct response mechanism that will allow the program administrators to interact with respondents and answer questions in real time.

Investing ~$150 million in a campaign of this nature would make a significant impact. Even if only 15% of the ~58 million not-yet-screened boomers get tested during the first year of the campaign, the projected diagnostic yield would uncover about 300,000 new hepatitis C cases. Now do the math using $23,000 or any other average $ amount per treatment that falls into the probable range. However you slice it, it certainly is a nice return on a $150 million investment.

The goal we should be shooting for is to save as many livers and lives as possible. It would make perfect sense for both Gilead and AbbVie to support such a campaign as long as the ROI is there to justify that support. And looking ahead a few years into the future, when safe and effective therapies and advanced diagnostic technologies for nonalcoholic steatohepatitis (NASH) have matured, the time would be ripe for launching a 1-800-GET-TESTED® consumer health education program focused on NASH.

(1)  https://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html

(2)  http://www.ajpmonline.org/article/S0749-3797(17)30092-2/fulltext


Mavyret is a trademark of AbbVie Inc.

Sovaldi and Harvoni are registered trademarks of Gilead Sciences Ireland UC.

Lipitor is a registered trademark of Pfizer Ireland Pharmaceuticals.

1-800-GET-TESTED is a registered trademark of Consumer Health Education Programs.

About the Author

During the summer of 1997, Rick Shalvoy completed his first Row for a Cure after losing a friend to breast cancer in 1996. An annual fundraising event (1997-2009) that involved rowing 300 miles around the outer shoreline of Long Island, NY in a 19-foot ocean rescue boat, Rick completed the entire course alone each year with the exception of the East River segment. Nobel Laureate Dr. Harold Varmus, former Director of the National Institutes of Health and the National Cancer Institute, was Rick’s rowing partner for ten of those years in New York City from Wards Island to South Street Seaport.

An amazing turn of events occurred five months after Rick completed his first Row for a Cure.
After dedicating so much of his life to the fight against cancer, Rick was diagnosed with nodular melanoma and suddenly found himself fighting against his own cancer in addition to fighting for the benefit of all cancer patients.

Six months after being diagnosed, with his four children waiting for him on the beach at Montauk Point State Park, Rick completed his second annual Row for a Cure. By the end of that year, Rick had achieved complete remission and has remained cancer free since December, 1998.

Rick worked for New York State Parks as a member of the Jones Beach Lifeguard Corps for 40 years (summers only, and weekends only for 35 of those summers). Competitive lifeboat rowing has been Rick’s sport ever since his ocean rescue training year (1969), and his passion for the sport continues today. Bay Shore High School physical education teacher Bill Blackman teamed up with Rick, who enlisted the aid of Dowling College administrators and crew team coaches, to establish the first high school rowing program on the south shore of Long Island.

During the early part of his professional career as a freelance science journalist, Rick worked as an animal health technician before branching out into veterinary equipment sales in 1979. Making the transition from veterinary to human health care in 1988, Rick became the New York District Manager for medical test kit manufacturer SmithKline Diagnostics (SKD), and subsequently advanced to become SKD’s Integrated Healthcare Programs Manager in 1992.

In 1995, while juggling responsibilities as President-elect of the Northeast Chapter of the Medical Marketing Association and directing patient education programs for SmithKline Diagnostics, Rick spearheaded SKD’s sponsorship of a nationwide colorectal cancer awareness campaign and other elements of the Digestive Health Initiative, a comprehensive outreach campaign conducted by a consortium of professional medical associations under the umbrella of the American Digestive Health Foundation.

While working as an independent writer, editor and consultant for clients in the health and medical market sectors over the years, Rick was frequently called upon to assist with strategic planning for consumer health education programs.

Retired from SKD and New York State Parks, Rick continues to devote much of his time to professional consulting, pro bono health care consumer advocate work and encouraging other athletes to utilize their respective sports for special causes.

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