What Compounding Pharmacists Should Know About Hepatitis C Treatment and Cost-Effectiveness
A portrait of hepatitis C would have to include people of every age, from all walks of life, and living in every corner of the United States, but two groups are affected more than others—injection drug users and baby boomers. Acute cases of hepatitis C in injection drug users have doubled since 2010, with most new cases occurring in rural and suburban areas. Baby boomers account for half of all hepatitis C-related deaths because they’re not aware they contracted the virus during medical procedures many years ago. The impressive cure rates of the new generation of medications give them reason to hope, but first they must be able to buy these high-cost therapies. That’s where compounding pharmacists can intervene to help.
Hepatitis C Treatment Achieves 90 Percent Cure Rate
The new generation of direct-acting antiviral (DAA) agents changed the course of hepatitis C by delivering cure rates of 90 percent, sometimes even higher. The fixed-dose combination ledipasvir-sofosbuvir achieves a 94 to 98 percent cure rate.1 Now attention must turn to difficult-to-treat patients because their cure rates are lower compared to treatment-naïve patients.2
FDA approvals of DAA medications began in 2014, so it will be some years before CDC surveillance data reflects their impact. As a result, death rates continue to contrast sharply with cure rates. Hepatitis C-related deaths are at an all-time high—19,659 in 2014—with more than half occurring in people aged 55 to 64.3 In addition to reversing the years-long upward trend in deaths, the need for DAA agents is reflected in these statistics:
- About 3.5 million Americans currently have hepatitis C—only half are aware they’re infected.
- If they go untreated, 75 to 85 percent will develop chronic infection
- 60 to 70 percent will develop chronic liver disease
- 5 to 20 percent will be diagnosed with cirrhosis
- An estimated 1 to 5 will die from liver cancer or cirrhosis
It makes sense for researchers to reprioritize their efforts, but it’s too early for people with HCV and health care professionals to celebrate progress—they’re caught in the middle of the promise of a cure and harsh reality. Great cure rates don’t count for much if people can’t afford the medication.
Cost-Effectiveness, Affordability and Helping Patients Navigate Expenses
The current debate over cure rates versus treatment costs and estimated cost-effectiveness—the American Journal of Managed Care calls it the “dismal arithmetic of hepatitis C treatment”—makes it impossible to know whether insurance companies and Medicaid will change policies to increase coverage.4 The one thing that’s certain is that DAA medications carry price tags far beyond the reach of most people. Depending on the medication, prices range from $66,000 to $94,500 for a 12-week course of therapy and can go as high as $150,000 to $189,000 for extended therapy or if the patient develops resistance and needs to combine multiple medications.5
Pharmacists are key experts when it comes to working with insurance companies. In fact, Hepatitis C Online, a site that offers training modules approved for continuing medical education credits, recommends that physicians work with pharmacists to obtain optimal coverage for patients. Most of the pharmaceutical companies offer assistance programs that subsidize co-pays or cover the costs, depending on the patient’s financial status and insurance coverage. Beyond that, you’ll need to keep up with the latest developments as policies unfold.
Prior authorization and requirements
Each insurance company has different limitations and requirements, which may change as policies evolve. In the meantime, be prepared to run across any of these:
- Advanced fibrosis: Most only approve payment for patients with advanced liver fibrosis and will require proof of fibrosis staging.
- Treatment expertise: Many insurance and state Medicaid policies say that only medical providers with adequate expertise in treating hepatitis C can prescribe DAAs.
- Lab studies: Baseline lab studies are required prior to receiving medication approval.
- Patient-specific info: Additional requirements may include alcohol sobriety for at least six months, no injection drug use for at least six months, drug and alcohol screening tests, pregnancy status and evaluation of psychosocial readiness for treatment.
State Medicaid programs have the discretion to limit coverage, usually using tools like preferred drug lists and prior authorization requirements. But in November 2015, the Centers for Medicare and Medicaid Services (CMS) released a guidance document stating they could not deny payment for hepatitis C medication based on these unreasonable restrictions:
- Limiting access to treatment for patients with a fibrosis score of F3 or F4
- Requiring a period of abstinence from drug and alcohol use
- Limiting the types of providers able to prescript hepatitis C drugs
In spite of the guidance document, “state Medicaid programs can’t afford to treat everyone infected with HCV,” said Matt Salo, Executive Director of the National Association of Medicaid Directors. If they did, they’d spend as much on hepatitis C treatments as all other drugs combined, and that’s not sustainable. Salo suggested that CMS put an unreasonable burden on states, which opens them up for lawsuits. The state of Pennsylvania just decided to expand Medicaid access to DAA drugs, but only time will tell the direction each state takes.
A handful of studies try to justify the high costs of DAA drugs by analyzing cost effectiveness. The argument can be made that treatment costs are less than the costs to treat advanced disease, future hospitalizations and liver transplants, but that didn’t stop CMS from asking manufacturers to curtail costs. Another perspective suggests that 16 to 20 percent of costs could be saved by individualizing the duration of DAA therapy rather than following pre-determined protocols. Cost-effectiveness studies are worth keeping up with because they’ll influence future decisions, but practically speaking, pharmacists must work with the system as it exists and patients only care about whether they can buy the medications they need today.
Proactive Advocacy Boosts Chance of Patient Treatment
No one with hepatitis C can afford to wait for insurance companies and Medicaid providers to figure out payment guidelines. Compounding pharmacists are invaluable for helping patients navigate the maze to find ways to obtain DAA medications. Beyond that, it’s important to alert your patients born between 1945 and 1965 that they’re at a higher risk and one-time screening is highly recommended.6 Proactive outreach may save someone’s life.
Pharmaceutica North America provides high-quality bulk APIs, active injection kits, custom compounding kits and over-the-counter dietary supplements. Contact us today to talk about how we can help meet all your patient’s health care needs.
- “Real-World Outcomes of Ledipasvir/Sofosbuvir in Treatment-Naïve Patients With Hepatitis C, May 2016, http://www.ajmc.com/journals/issue/2016/2016-5-vol22-sp/Real-World-Outcomes-of-Ledipasvir-Sofosbuvir-in-Treatment-Naive-Patients-With-Hepatitis-C ↩
- “Hepatitis C in Limelight Again at Liver Congress,” April 2016, http://www.medscape.com/viewarticle/861529 ↩
- “Hepatitis C Kills More Americans Than Any Other Infectious Disease,” May 2016, http://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html ↩
- “A Way Out of the Dismal Arithmetic of Hepatitis C Treatment,” May 2016, http://www.ajmc.com/journals/issue/2016/2016-5-vol22-sp/A-Way-Out-of-the-Dismal-Arithmetic-of-Hepatitis-C-Treatment ↩
- “Medications to Treat HCV” 2016, http://www.hepatitisc.uw.edu/page/treatment/drugs ↩
- “Recommendations for Hepatitis C Screening,” October 2015, http://www.hepatitisc.uw.edu/go/screening-diagnosis/recommendations-screening/core-concept/all ↩