Considerations on bringing warehoused HCV patients into active care following interferon-free, direct-acting antiviral drug approval

ABSTRACT

Objectives: Until recently, lack of efficacious and tolerable hepatitis C virus (HCV) treatments prompted patient warehousing until better treatment options became available. We investigated whether the introduction of ledipasvir/sofosbuvir precipitated patient return to clinics, thereby changing HCV clinic dynamics.

Methods: Online questionnaire responses indicated the volume of HCV patients followed, the proportion of warehoused patients and those who were proactively offered new options, methods for identifying and contacting patients, and insurance authorization/reimbursement-related information.

Results: Of 168 practices surveyed, 19% indicated no patient warehousing in the previous 3 years; 81% had warehoused 40% of patients; 92% were able to handle their patient load; and 82% had not changed practices to accommodate more HCV patients in the previous 12 months. Of the 35% of patients who were ledipasvir/sofosbuvir-eligible, 50% already completed/are completing therapy, 21% were not treated due to insurance denial, and 19% were awaiting responses from insurance companies.

Conclusions: Launch of a new treatment did not overburden HCV practices. Patients eligible to receive new treatments were being treated, but pre-authorization processes and reimbursement denials reduced the numbers of treated patients.

KEYWORDS:

• Interferon-free therapy
• Harvoni
• HCV
• ledipasvir/sofosbuvir
• warehousing

Acknowledgments

The authors thank Aric Fader, PhD, and Michelle Jones, PhD, of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: The GPP3 Guidelines.’

Declaration of interest

Funding to support the preparation of this manuscript was provided by Deerfield Institute to MedVal Scientific Information Services, LLC, Skillman, NJ, who provided medical writing and editorial assistance. A Palak, C Livoti, and C Audibert are employees of Deerfield Institute. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This study was funded by Deerfield Institute.