From the Guidelines
To ensure patients have access to Mavyret (glecaprevir/pibrentasvir) for the treatment of Hepatitis C, healthcare providers should first verify insurance coverage and explore patient assistance programs, such as AbbVie's myAbbVie Assist program, which can provide the medication at no cost to eligible patients. According to the EASL recommendations on treatment of hepatitis C 1, Mavyret is a highly effective treatment option for various hepatitis C genotypes, with cure rates exceeding 95% for most genotypes with an 8-12 week treatment course.
Key Considerations for Access
- Verify insurance coverage: Most commercial insurance plans and government programs like Medicare and Medicaid cover Mavyret, but prior authorization is typically required 1.
- Explore patient assistance programs: AbbVie's myAbbVie Assist program can provide Mavyret at no cost to eligible patients, while their co-pay assistance program can reduce out-of-pocket costs to as little as $5 per month for commercially insured patients.
- Complete a benefits investigation: Healthcare providers should complete a benefits investigation before prescribing Mavyret to determine the patient's coverage and any potential out-of-pocket costs.
- Utilize specialty pharmacies: Specialty pharmacies that dispense Mavyret can help navigate insurance requirements and facilitate access to the medication.
Additional Support
- Patient advocacy organizations: Organizations like the Patient Advocate Foundation or hepatitis-specific organizations can provide additional support and resources to help patients access Mavyret.
- Dedicated staff: Healthcare providers should have staff dedicated to handling prior authorizations and navigating insurance requirements to ensure timely access to Mavyret. As noted in the EASL recommendations 1, treatment-naïve and treatment-experienced patients infected with HCV genotypes 1a, 1b, 2,4,5 or 6 without cirrhosis should be treated with Mavyret for 8 weeks, making it essential to secure access to this curative therapy.
From the FDA Drug Label
PRINCIPAL DISPLAY PANEL NDC 0074-2625-28 Rx only Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg This carton contains 21 tablets packaged as follows: 7 wallets for 1 week of treatment. Each wallet contains 3 tablets. Do not use if seal on top of carton is broken or missing Keep out of reach of children Store at or below 30°C (86°F) See Package Insert for full Prescribing Information AbbVie Inc. North Chicago, IL 60064 ©2020 AbbVie Inc. abbvie
The FDA drug label does not answer the question.
From the Research
Access to Mavyret for Hepatitis C Treatment
To improve patient access to Mavyret (glecaprevir/pibrentasvir) for the treatment of Hepatitis C, several strategies can be employed:
- Integrating HCV treatment into community health centers, as seen in the study 2, can help bridge the gap in treatment for substance-users and other vulnerable populations.
- Utilizing primary care clinics to provide HCV treatment, as demonstrated in 2, can increase access to care and cure rates for patients.
- Implementing partially randomized phase 3 clinical trials, such as SURVEYOR-II, Part 3 3, can assess the efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 3 infection and prior treatment experience and/or compensated cirrhosis.
- Offering 12 or 16 weeks of treatment with glecaprevir/pibrentasvir, as shown in 3 and 4, can achieve high sustained virologic response rates in patients with HCV genotype 1,2,3,4,5, or 6 infection.
- Retreating patients who fail glecaprevir/pibrentasvir with sofosbuvir/velpatasvir/voxilaprevir, as demonstrated in 5, can be an effective option for achieving sustained virologic response.
Key Considerations
When providing access to Mavyret, consider the following:
- Patient population: Substance-users, patients with compensated cirrhosis, and those with prior treatment experience may require specialized care and treatment regimens.
- Treatment duration: 12 or 16 weeks of treatment with glecaprevir/pibrentasvir may be necessary to achieve high sustained virologic response rates.
- Resistance-associated substitutions: Baseline and treatment-emergent resistance-associated substitutions in NS3 and NS5A should be monitored, as seen in 4.
- Safety profile: Glecaprevir/pibrentasvir has a favorable safety profile, with few adverse events and no serious adverse events related to the study drug, as demonstrated in 6.