CVS Health has some hard data on Sovaldi's excursion from the Gilead Sciences ($GILD) clinic and into the world. It's not encouraging: More than four times as many real-world patients are dropping off the pricey hepatitis C treatment than in clinical trials.
The stats add weight to concerns about the price of Sovaldi treatment: If patients start using the $1,000-per-pill therapy only to stop taking it, that's a lot of money down the drain. Or as the pharmacy company's white paper puts it, "a substantial cost to the healthcare system without the corresponding clinical benefit and value."
The stats also give payers more back-up for restricting Sovaldi treatment to specific groups of patients. In the CVS study, patients who'd been treated before--and failed--were more likely to stick to their Sovaldi-based regimens. Only 5.3% of patients with previous treatment dropped off, compared with 8.7% among the treatment-naive.
According to the pharmacy company's white paper, the dropout rate was highest--10.2%--with patients on a triple-drug cocktail of Sovaldi, interferon and ribavirin. That's not surprising; interferon treatment can be ugly, and that's why these new, all-oral regimens have been developed in the first place.
Meanwhile, of those on a two-drug cocktail of Sovaldi plus ribavirin, 9% didn't stick to their treatment. The lowest dropout rate was seen in patients using two brand-new drugs, Sovaldi plus Johnson & Johnson's ($JNJ) Olysio, even those who hadn't been previously treated. Only 2.6% of experienced patients on that combo discontinued treatment, and 4.6% of the never-before-treated.
"These findings underscore the well-recognized fact that real world adherence to medication is often poorer than that observed in clinical trials," the CVS white paper states.
It's possible that this adherence surprise is circumstantial: The Sovaldi cocktails with the most unpleasant side effects are the ones patients are abandoning. Patients who hadn't been treated before--a group less likely to be seriously ill than those who failed on prior treatment--may have slogged off the cocktails because they know more treatment options are coming. AbbVie's ($ABBV) hep C regimen is expected to win approval later this year, and Gilead's Sovaldi combo pill could be coming even sooner. Bristol-Myers Squibb ($BMY) has its own combinations on their way, too.
There's another set of conclusions that could give Gilead and its coming rivals a clue about justifying their pricing to payers. CVS found that patients using its pharmacies--compared with those outside its own chain--were more likely to stick to their meds. The company offers counseling and various support services designed to boost adherence.
So, Gilead might want to do some of that adherence work itself--adding value to their pill's impressive cure rates. At the least, it could be a goodwill gesture toward the people footing the bill.
Or one of Gilead's competitors might take on the task, as an added incentive for payers to back their hep C therapies. With Gilead's head start in the market, AbbVie and Bristol-Myers have reason to go beyond the pill for market share.
- see the CVS Health report (PDF)
- and here's the release