Sales of Gilead Sciences' hepatitis C treatment Sovaldi have blown away pre-launch expectations since the product became available in the US in December. Its level of initial usage was severely underestimated, particularly among genotype 1 patients (either in combination with interferon, without interferon but over a longer duration of therapy and in combination with Johnson & Johnson's Olysio), which have accounted for approximately 70 percent of use to date, according to Gilead.
See Physician Views Poll Results – Gilead Sciences' sofosbuvir could take significant share of warehoused HCV population prior to launch of interferon-free regimens and Spotlight On: History in the making – How does Gilead manage lofty Sovaldi expectations?
Despite this impressive launch – which is projected to drive annual sales to around $9 billion, according to current consensus estimates – the real revolution in hepatitis C is expected to occur in the fourth quarter when Gilead gains approval for its Sovaldi plus ledipasvir combination therapy (the company has been granted a PDUFA date of October 10). This product will allow many hepatitis C patients to be treated over a 12-week period without the requirement of either interferon or ribavirin.
Recent US prescription data for Sovaldi – which shows a flat-lining of new usage – indicates that anticipation levels for this new all-oral regimen (and another being developed by AbbVie which is expected to gain FDA approval by year end) are on the rise. A secondary phase of patient warehousing for these drugs is now occurring, says ISI analyst Mark Schoenebaum. See ViewPoints: Secondary warehousing starts to bite into Sovaldi sales.
This trend has been expected, adds Schoenebaum, although it is fair to say that the aggressive response among US payers (and some politicians) to the initial influx of patients seeking treatment with Sovaldi has shifted the dynamic of the future hepatitis C market somewhat. Sovaldi's initial success may have had some impact not only on the number of patients now being warehoused for usage with all-oral combinations, but could dictate the speed at which these patients are treated as payers look to better manage their cost structures.
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With these factors in mind, FirstWord is polling US based specialists in the hepatitis C physician setting to ascertain both how aggressively they are now warehousing patients and whether they are under increased pressure to do so. Specifically we are asking them...
What percentage of genotype 1 hepatitis C patients they are currently warehousing (i.e. are diagnosed but not being treated)?
What percentage of these patients they expect to treat with the fixed-dose combination of Sovaldi plus ledipasvir within six months of its launch?
How they expect (from a volume perspective) the initial six-month uptake of Gilead's Sovaldi plus ledipasvir fixed-dose combination to compare to the initial six-month uptake of Sovaldi?
How they assess the current level of 'enforced' patient warehousing/delayed therapy for patients due to pressure from Medicaid providers?
How they assess the current level of 'enforced' patient warehousing/delayed therapy for patients due to pressure from pharmacy benefit managers (PBMs)?