Gilead Science has introduced two new agents, Solvadi and the combination treatment agent Harvoni that packages Sovaldi and Jannsen’s Olysio together, while Abbott has introduced one new agent, Viekira. These new drugs used singly or in combination with peginterferon and/or ribavirin are eradicating the Hep C virus with an 8 to 24 week course of treatment.1
There are several drugs being researched both singly and in combination with other Hep C drugs with three companies entering the market in 2 to 5 years with Hep C agents that are at the Phase 3 trial level.2 They are:
- Bristol-Myers Squibb (BMS) with Daklinza in combination with Gilead’s Solvaldi and two other new in-house agents Sunpreva and yet to be named BMS-791325.
- Merck with Grazoprevir being studied along with Elbasvir.
- Gilead with Sovaldi in combination with ribavirin and pegylated interferon, and in combination with their yet to be named GS-5816.
There are drugs also in Phase 2 trials, 5 to 7 years to market, hopefully not far behind drugs in Phase 3 trials. Achillion has three products under investigation alone and in combination. BMS has Daklinza in trials in combination with agents from Jannsen and Vertex. And Jannsen’s Olysio is being studied with Daklinza , Merck’s Samatasvir, and their own TMC647055 with Ritnovir.
That’s the good news. Cost is another issue. Course of treatment hit the market at $1000 per pill translating into treatment costs that range from $86,000 to $160,000. While new entities entering the market could have a major impact by cutting costs, there is no guarantee that costs will be significantly less.
Already market share games are being played at the PBM and health plan level with exclusive agreements that Gilead has with PBMs CVS CareMark, Envision Rx, and health plans Aetna, Humana, and Anthem while AbbVie has a discount agreement (undisclosed rebate) with exclusive formulary position with ESI and United Health Care. Prime Therapeutics has firmly established themselves on the fence by putting both Gilead and AbbVie on their formulary.
How these undisclosed rebates will impact total patient costs remains to be seen. Self-funded employer groups need to be aware of the games being played and the potential impact patient population has on the pharmacy benefit budget. There is money on the table; but without specific contract language, the amount of money shared could all remain with the PBM.
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1. A cure is considered if a sustained virologic response (SVR) is achieved after 12 to 24 weeks following therapy.
2. Clinical trials examine the safety and efficacy of an investigational medicine in a larger number of patients who have the disease or condition under study.
