Clinical Corner: Harvoni’s FDA Approval

Last week, Gilead’s combination Genotype I Hepatitis C product, now officially named Harvoni, was approved by the FDA[1]. The drug is a combination of Gilead’s Sovaldi with a second antiviral agent, ledipasvir, in a single tablet. It will cost ~$94,500 per 12-week treatment course, in contrast to Sovaldi’s $84,000 cost per 12-week treatment course. Unlike Sovaldi, however, an 8-week treatment course costing $63,000 will also be possible for certain patients receiving Harvoni.

Why is this drug’s launch so important?

94% of treatment-naïve patients who received Harvoni for 8 weeks, and 96% of treatment-naïve patients for 12 weeks achieved sustained viral response (SVR). This means the virus could not be detected in the patient following the course of treatment [2]. Although some physicians may have been withholding pharmaceutical treatment in anticipation of the approval of Harvoni, it is unlikely that the spike in utilization that will follow Harvoni’s approval will be as material as the spike in utilization that followed Sovaldi’s approval. There is potential for Harvoni to replace Sovaldi as the treatment of choice for these patients [3]. Harvoni launched as the first oral, combination product to be approved for the treatment of Hepatitis C and this category is changing rapidly.

What are some immediate actions to take?

While we still anticipate the hepatology community experts to issue revised treatment guidelines that reflect Harvoni’s availability, in the meantime our recommendations include the following:

  1. Patients currently receiving and responding positively to Sovaldi should continue their Sovaldi treatment to its natural conclusion.
  2. No changes to current therapy should be made without consultation with the prescriber of the current Hepatitis C therapy, whether it is Sovaldi or any other Hepatitis C treatment.
  3. New patients, not previously treated for Hepatitis C, may be candidates for the 8-week Harvoni treatment course. Whether or not a given patient will be a candidate for an 8-week course of Harvoni will be a prescribing physician decision, but the availability of an 8-week option with Harvoni for certain patients certainly argues for favorable formulary positioning for Harvoni.

What should my future planning look like for Hepatitis C drugs?

Long term, plans and employers should consider their strategy for coverage of these and other Hepatitis C drugs. Some considerations, depending on your PBM”s ability to administer:

  1. Prior Authorization and Step Therapy: Clarify the plan/employer’s formulary and utilization management strategies in the Hepatitis C class. Ensure a prior authorization strategy is deployed on the Hepatitis C drugs. Further, as more therapies enter the market, applying step therapy requirements to leverage lower cost drugs is a prudent approach.
  2. Exclusive Specialty Arrangement: Consider exclusive arrangements with one specialty pharmacy for Hepatitis C medications. This offers the potential of price optimization and better care management.
  3. Split Fills: For therapies that are closely modulated and monitored, consider partial fills (typically 15 days or less), until the appropriate dose is identified.
  4. Costing out Underwriting/Actuarial Impact: While the cost of a 12-week cost of Harvoni will be $10,500 MORE than a 12-week course of Sovaldi ($94,500 vs. $84,000), there is an option for an 8-week course of Harvoni that will cost $63,000, or $21,000 LESS than a 12-week course of Sovaldi alone. Implementing cost analysis and policies that ensure every patient is evaluated for a less expensive 8-week course of Harvoni makes financial sense.

How we can help:

As you examine the appropriate short and long-term strategies, ask yourself questions such as:

  • Should a Plan/Employer cover Sovaldi and Harvoni?
  • Should patients on Sovaldi switch to Harvoni?
  • When should Hepatitis C treatment be discontinued to avoid opportunity costs of >$1,000 per day?

Did you know there is another product that will be approved before the end of the year? That means all of the immediate and future planning will have to occur again very soon! Our experts can help you to manage the material and dynamic changes that are occurring in this category — changes that if left unattended have the potential to severely impair pharmacy and pharmacy benefit budgets for health plans and employers, respectively. We excel in developing clinically appropriate treatment guidelines, benefit edits, and formulary placement for Hepatitis C Drugs, estimating their actuarial/underwriting impact, and evaluating specialty pharmacy contractual arrangements.


[1] Complete link from FDA is here:

[2] Treatment-naïve = patients who had never received any prior treatment for Hepatitis C


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