Special Issue of AJMC Examines Policy Questions Surrounding Hepatitis C Treatment
The arrival of direct-acting antivirals to treat hepatitis C virus raised unprecedented policy questions in healthcare. This drug class was initially met with alarm over cost and barriers to the cure, despite the potential for long-term savings, and represents one of a number of topics explored in a special issue of The American Journal of Managed Care.
May Special Issue: HCV
The American Journal of Managed Care - 2016
The American Journal of Managed Care is the leading peer-reviewed journal dedicated to issues in managed care. AJMC.com distributes healthcare news to leading stakeholders across a variety of platforms. Other titles in the franchise include The American Journal of Accountable Care, which publishes research and commentary on innovative healthcare delivery models facilitated by the 2010 Affordable Care Act. AJMC's Evidence-Based series brings together stakeholder views from payers, providers, policymakers and pharmaceutical leaders in oncology and diabetes management.
FROM THE EDITORS
A Way Out of the Dismal Arithmetic of Hepatitis C Treatment
Jay Bhattacharya, MD, PhD, Center for Primary Care and Outcomes Research, Stanford University School of Medicine; Guest Editor-in-Chief for the HCV special issue of The American Journal of Managed Care
This special issue presents important new peer-reviewed research, covering ground ranging from issues related to access and the out-of-pocket costs of a treatment course, to the real-world consequences—both economic and clinical—of failing to treat.
COMMENTARY
It’s Time to End Insurance Restrictions on Life-Saving Hepatitis C Treatments
Ryan Clary
As consensus on the shortsightedness of insurance restrictions on life-saving hepatitis C treatments continues to build, it’s time for private insurers and Medicaid programs to give all Americans suffering from this devastating disease a chance at a cure.
Real-World Outcomes of Ledipasvir/Sofosbuvir in Treatment-Naïve Patients With Hepatitis C
Zobair M. Younossi, MD, MPH, FACG, AGAF, FAASLD; Haesuk Park, PhD; Stuart C. Gordon, MD; John R. Ferguson; Aijaz Ahmed, MD; Douglas Dieterich, MD; and Sammy Saab, MD, MPH
In the treatment of hepatitis C virus, the gap between efficacy and real-world effectiveness narrows with improved tolerability and ease of use.
Sofosbuvir Initial Therapy Abandonment and Manufacturer Coupons in a Commercially Insured Population
Taruja D. Karmarkar, MHS; Catherine I. Starner, PharmD; Yang Qiu, MS; Kirsten Tiberg, RPh; and Patrick P. Gleason, PharmD
Member cost negatively affects initial medication adherence and manufacturer coupons can decrease member share by up to 98%.
Improving HCV Cure Rates in HIV-Coinfected Patients—A Real-World Perspective
Seetha Lakshmi, MD; Maria Alcaide, MD; Ana M Palacio, MD, MPH; Mohammed Shaikhomer, MD; Abigail L Alexander, MS; Genevieve Gill-Wiehl, BA; Aman Pandey, BS; Kunal Patel, BS; Dushyantha Jayaweera, MD; and Maria Del Pilar Hernandez, MD
The authors examine real-world hepatitis C virus cure rates with direct-acting antivirals among patients coinfected with HIV.
Does Patient Cost Sharing for HCV Drugs Make Sense?
Darius N. Lakdawalla, PhD; Mark T. Linthicum, MPP; and Jacqueline Vanderpuye-Orgle, PhD
Despite the high cost of novel hepatitis C treatments and patients' apparent willingness to bear part of it, high patient cost sharing is both inefficient and inequitable.
POLICY
Value of Expanding HCV Screening and Treatment Policies in the United States
Mark T. Linthicum, MPP; Yuri Sanchez Gonzalez, PhD; Karen Mulligan, PhD; Gigi A. Moreno, PhD; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Darius N. Lakdawalla, PhD; Brian R. Edlin, MD; and Ron Brookmeyer, PhD
Expanding screening for hepatitis C virus infection may generate substantial benefits for patients and society, but only when paired with expanded treatment policies.
The Wider Public Health Value of HCV Treatment Accrued by Liver Transplant Recipients
Anupam B. Jena, MD, PhD; Warren Stevens, PhD; Yuri Sanchez Gonzalez, PhD; Steven E. Marx, PharmD; Timothy Juday, PhD; Darius N. Lakdawalla, PhD; and Tomas J. Philipson, PhD
Advances in treatment for hepatitis C virus (HCV) have the potential to generate considerable spillover benefits to patients awaiting transplants, especially among those with non–HCV-mediated liver failure.
Costs and Spillover Effects of Private Insurers’ Coverage of Hepatitis C Treatment
Gigi A. Moreno, PhD; Karen Mulligan, PhD; Caroline Huber, MPH; Mark T. Linthicum, MPP; David Dreyfus, DBA; Timothy Juday, PhD; Steven E. Marx, PharmD; Yuri Sanchez Gonzalez, PhD; Ron Brookmeyer, PhD; and Darius N. Lakdawalla, PhD
Expanding private-payer coverage of hepatitis C treatment may yield significant long-term cost savings for private payers, reduced costs to Medicare, and increased social value.
Coverage for Hepatitis C Drugs in Medicare Part D
Jeah Kyoungrae Jung, PhD; Roger Feldman, PhD; Chelim Cheong, PhD; Ping Du, MD, PhD; and Douglas Leslie, PhD
It’s Time to End Insurance Restrictions on Life-Saving Hepatitis C Treatments
As consensus on the shortsightedness of insurance restrictions on life-saving hepatitis C treatments continues to build, it’s time for private insurers and Medicaid programs to give all Americans suffering from this devastating disease a chance at a cure.
Published Online: May 03, 2016
Ryan Clary
Take-Away Points
Many private insurers and Medicaid programs across the country have placed onerous restrictions on life-saving treatments for hepatitis C virus (HCV), even though public health officials, researchers, and medical authorities agree that these restrictions needlessly put patient lives at risk, contribute to the spread of disease, and drive up healthcare costs in the long term. As consensus on the futility and shortsighted nature of these insurance restrictions continues to build, it is time for private insurers and Medicaid programs to give all Americans suffering from HCV a chance at a cure. In doing so, commercial and public payers will not only be at the helm of eliminating a life-threatening virus from our borders, but they will help raise the standard of healthcare for generations to come.
Healthcare media coverage over the past year has focused on the costs of breakthrough hepatitis C virus (HCV) treatments, rather than the lives they would save or the insurance roadblocks that are keeping them out of reach for millions of Americans. With little fanfare, many private insurers and Medicaid programs across the country have placed onerous restrictions on these life-saving treatments, ostensibly oblivious to what public health officials, researchers, and medical authorities have categorically accepted: preventing patients with HCV from accessing the safest and most effective treatments needlessly puts patient lives at risk, contributes to the spread of disease, and drives up healthcare costs in the long term.
More deadly, and 10 times more infectious than HIV/AIDS,1 HCV affects more than 3.5 million Americans,2 and it is also a leading cause of liver failure and liver cancer3—the fastest-rising cause of all cancer-related deaths.4 For the past several decades, HCV treatment regimens revolved around painful interferon injections, which carried a high cost per-cure—often higher than innovative treatments—and were vastly ineffective at managing the disease. In fact, in large part due to the debilitating side effects endured during the course of treatment, as many as 85% of patients discontinued traditional HCV therapies.5 In contrast, breakthrough treatments offer cure rates of near 100% with minimal side effects,5 providing patients with HCV with an unprecedented chance to live virus-free, and avoid liver failure, cancer-causing cirrhosis, liver transplants, and other health complications.
Insurers Seek to Ration a Cure
Still, despite this unparalleled progress in treating the nation’s deadliest blood-borne disease, many state Medicaid programs and private insurance plans across the country are rationing care, such as barring those with current or recent substance use issues, forcing patients to “fail first” on debilitating and far less effective treatments, and requiring patients to develop deadly liver complications before being covered for HCV treatment. According to new research by the University of Pennsylvania, these policies have become so pervasive among state Medicaid programs that nearly half of Medicaid recipients with HCV are being denied access to a cure.6 And these restrictions may even be illegal; the Center for Health Law and Policy at Harvard Law School recently found that 42 state Medicaid programs with stringent limitations on who can access a cure could be violating federal Medicaid law, which requires states to cover drugs consistent with their FDA labels.7
The Growing Case for Curing HCV
Thankfully, the tide may finally be turning—if insurers will just pay attention to the facts. Several studies are now coming out that prove the case for curing HCV from both a public health and cost-savings perspective. For example, one recent study, published in the Annals of Internal Medicine and funded by the National Institutes of Health, suggests that innovative treatments are cost-effective in 83% of new patients and in 81% of previously treated patients.8 Another study, published in Clinical Infectious Diseases, suggests that immediately treating patients with HCV with new treatments is cost-effective, even for those with only moderate disease progression.9 Any remaining doubt about the cost effectiveness of treating the virus early should be put to rest by a new Avalere Health study, which found that the true calculated value of HCV treatments to payers is likely even greater than previously thought, due to the growing number of HCV treatments entering into the marketplace and other pricing offsets, such as discounts and rebates.10
However, although studies such as these are essential to underscoring the futility of onerous HCV treatment restrictions for patients seeking to access a cure, a true shift in public discourse on this issue will likely require firm objection by medical community leaders. Fortunately, key organizations are now starting to publicly speak out against unchecked insurance policies. Recognizing the severity of the problem within state Medicaid programs across the country, CMS recently issued a letter advising states against unreasonable restrictions on HCV treatments. CMS warned that HCV treatment restrictions should not result in the denial of access to “effective, clinically appropriate, and medically necessary treatments” for Medicaid recipients, and urged states to carefully monitor HCV drug-coverage policies of their Medicaid Managed Care Programs (MCOs) to ensure that all enrollees have appropriate access to treatment.
The medical community has also spoken out about the need to effectively treat the virus early. Two of the nation’s leading medical authorities on HCV, the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, recently issued joint guidance underscoring the need to treat all patients with HCV as promptly as possible to prevent disease progression and transmission.11 There is no doubt that consensus on this issue is building. Not only are researchers, CMS leadership and medical authorities all aligned on the need to promptly cure HCV, but patients are increasingly seeking legal recourse against these shortsighted insurance barriers. After being denied coverage for a cure on the grounds that it was not “medically necessary,” several patients with HCV recently filed lawsuits against their insurers, including United HealthCare, Anthem Blue Cross, Florida Blue Cross and Blue Shield, and others. The patients alleged that the plans breached their contractual duty to provide coverage for medically necessary treatment, engaged in a breach of good faith, and negligently inflicted emotional distress.12 While these cases are ongoing, Anthem Blue Cross and United HealthCare both recently eased their fibrosis requirements for HCV cures, perhaps in response to the mounting pressure across these various fronts.
Conclusions
Such progress is encouraging, but without concrete action by states and all private payers to scale back these restrictions across the board, Medicaid recipients and commercial policyholders won’t see a change in treatment access. As the momentum continues to build, the time is ripe for wholesale rejection of these draconian restrictions on the safest and most effective HCV treatments. Insurers should be helping to lead the fight against HCV, not turning their backs on patients seeking to be cured.
With advancements in science and biomedical breakthroughs occurring every day, it is only a matter of time before we discover revolutionary cures for other complex and devastating diseases. That is why this is a pivotal moment: our response today to patients seeking quality HCV care will determine how we respond to patients suffering from what promise to be even more challenging diseases tomorrow.
Private insurers and Medicaid programs have a critical role to play in connecting our nation’s most vulnerable patients with the medicines they need and deserve. By giving all Americans suffering from HCV a chance at a cure, commercial and public payers will not only be at the helm of eliminating a life-threatening virus from our borders, but they will help raise the standard of healthcare for generations to come.
http://www.ajmc.com/journals/issue/2016/2016-5-vol22-sp
Author Affiliation: National Viral Hepatitis Roundtable, Washington, DC.
Source of Funding: None.
Author Disclosures: Mr Clary is on the paid advisory board for Gilead and Merck (funds go to his organization); his employer also receives funding from several drug companies, including Gilead, AbbVie, Merck.
Authorship Information: Concept and design; analysis and interpretation of data; drafting of the manuscript.
Address correspondence to: Ryan Clary, Executive Director, National Viral Hepatitis Roundtable, 1424 K St, Washington, DC 20005. E-mail: rclary@nvhr.org.
REFERENCES
1. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: hepatitis C virus infection. AIDSInfo website. https://aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-oi-prevention-and-treatment-guidelines/345/hcv. Updated October 28, 2014. Accessed January 22, 2016.
2. Hepatitis C FAQs for the public. CDC website. http://www.cdc.gov/hepatitis/c/cfaq.htm. Updated January 8, 2016. Accessed March 24, 2016.
3. Hepatitis C: information on testing & diagnoses. CDC website. http://www.cdc.gov/hepatitis/hcv/pdfs/hepctesting-diagnosis.pdf. Published October 2013. Accessed January 22, 2016.
4. Lushniak BD. Testing baby boomers for hepatitis C virus infection. Public Health Rep. 2014;129(3):220-221.
5. Fitch K, Iwasaki K, Pyenson B, Engel T. Health care reform and hepatitis C: a convergence of risk and opportunity. Milliman website. http://us.milliman.com/uploadedFiles/insight/2013/convergence-of-risk-and-opportunity.pdf. 2013. Published December 10, 2013. Accessed January 22, 2016.
6. Perelman School of Medicine at the University of Pennsylvania. Nearly half of hepatitis C patients on Medicaid denied coverage for life-saving drugs. San Francisco, CA: Newswise; November 16, 2015. http://www.newswise.com/articles/nearly-half-of-hepatitis-c-patients-on-medicaid-denied-coverage-for-life-saving-drugs. Accessed January 22, 2016.
7. Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid reimbursement of sofosbuvir for the treatment of hepatitis C virus infection in the United States. Ann Intern Med. 2015;163(3):215-223. doi: 10.7326/M15-0406.
8. Najafzadeh M, Andersson K, Shrank WH, et al. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med. 2015;162(6):407-419. doi: 10.7326/M14-1152.
9. Rein DB, Wittenborn JS, Smith BD, Liffmann DK, Ward JW. The cost-effectiveness, health benefits, and financial costs of new antiviral treatments for hepatitis C virus. Clin Infect Dis. 2015;61(2):157-168. doi: 10.1093/cid/civ220.
10. Pearson CF. A case for market-based costs in determining cost-effectiveness: the hepatitis C example. Avalere Health website. http://avalere.com/expertise/life-sciences/insights/new-analysis-finds-cost-effectiveness-models-for-hepatitis-c-drugs-often-ov. Published November 12, 2015. Accessed January 22, 2016.
11. American Association for the Study of Liver Diseases; Infectious Diseases Society of America. Hepatitis C guidance underscores the importance of treating HCV infection: panel recommends direct-acting drugs for nearly all patients with chronic hepatitis C. HCV Guidelines website. http://hcvguidelines.org/sites/default/files/when-and-in-whom-to-treat-press-release-october-2015.pdf. Published October 2015. Accessed January 22, 2016.
12. Harvoni denied insurance claim lawsuit. Lawyers and Settlements website. https://www.lawyersandsettlements.com/lawsuit/harvoni-denied-insurance-claim.html. Published June 8, 2015. Accessed January 22, 2016.
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