It was perhaps a sign of the changing — but not changed — times that last week’s ASCO meeting, highlighting the next-generation of promising new cancer drugs, overlapped almost perfectly with a gathering designed to help figure out how these new treatments will be paid for.
ISPOR (the International Society for Pharmacoeconomics and Outcomes Research) held its annual jamboree in Washington DC June 2-6, making it very tricky for any single person to understand both the clinical strengths of the latest cancer treatments, and how well those might sit with cost-pressured payers making tough coverage choices.
The Real Endpoints team took a stab at it, though. Find out what we learned by joining our June 14 webinar, “Reimbursement Insights From ASCO: More Drugs Means More Cost Pressure”.
As it happened (by design, we wonder?) the third plenary session at ISPOR on June 6 – a full 24 hours after the crowds had left ASCO – focused on performance-based risk sharing arrangements. These schemes – aiming to link the price of a treatment to the outcome it generates – are arguably most pertinent to expensive cancer drugs that don’t, sadly, work for all patients.
Now sure, we know many pharma remain resistant to risk-sharing deals (why share risk unless you have to?). And yes, such deals are few, and exist mostly in Europe and other markets where state-payers call the shots.
But (as we’ve said before) risk sharing isn’t going away. Instead, it’s getting bigger as all health care systems are forced to move towards value-based pricing. How better to fairly link price to value than by linking pricing to outcomes?
There’s no question US payers are under pressure to get higher value for their spending; as Lewis Sandy, United Health’s SVP of Clinical Advancement told the ISPOR audience “I can’t impress on you how much.” The upshot? US payers are extremely interested in what risk-share models are working best in Europe — and why. (You can read more about some successful models here.) Meanwhile, in the mind of Jens Grueger, VP & Head, Global Health Economics & Pricing at Roche, the world’s biggest cancer drug maker, “there’s no doubt that [risk-sharing deals] will become more prominent.” Not least, he continued, because of personalized health care, whereby treatment benefit varies significantly by patient group, requiring risk-shares along the way.
Although Roche hasn’t to date been among the most prominent proponents of risk-shares (Grueger joined Roche in December 2011, from Pfizer), it is quietly experimenting: Grueger explained in the ISPOR sidelines that in Australia, the company is trying to link reimbursement to response in an almost mathematical fashion for one particular unnamed treatment, thanks to the use of biomarkers: 30% response would be reimbursed at level X, 70% at level Y, etc.
Yes, there are significant hurdles to making risk-sharing more mainstream. But these problems — inadequate IT infrastructure, high negotiation costs, minimal evaluation of current schemes, among others — are the same ones preventing the creation of more cost-efficient health care systems. So they’re being addressed.
In Italy, for example, the authorities have set up IT systems and data bases designed for simple and efficient use to coordinate dozens of managed-entry schemes for cancer (and other) drugs and collect outcomes data. Meanwhile UK cancer pharmacists analyzed how well Janssen’s Velcade Response Scheme for its multiple myeloma drug in England was working, and found that up to 50% of the owed rebates weren’t being collected. Despite its imperfections, this doesn’t mean VRS won’t someday be an effective means of sharing risk; for now, however, it’s not a preferred model in England — and it won’t be until appropriate processes are put in place to claw-back money from manufacturers.
Small wonder that many pharma, including Roche’s Grueger, are waiting before they invest heavily in risk-shares. They’re in a phase of “evaluation,” as Grueger put it, waiting to see what the current experiments throw up. Italy hasn’t revealed much data from its risk-sharing initiatives, though it promises some towards the end of the year. “The collection of outcomes data [by AIFA, Italy’s medicines agency] has been lagging,” remarked Grueger at ISPOR, expressing concern that other stakeholders, including academics, patients and industry, have not been involved in any of AIFA’s analyses so far.
According to Lou Garrison, Professor, Pharmaceutical Outcomes Research and Policy Program at the University of Washington School of Pharmacy, outcomes data generated by risk-shares should be widely disseminated as a “global public good”. (Garrison is also co-Chair of ISPOR’s Performance-Based Risk-Sharing Arrangements Good Practices Task Force, which has published a draft report defining good practices for risk-sharing deals.)
So as ASCO presages important new – increasingly personalized – treatments for cancer, ISPOR showed that expectation is building around the most logically compelling means of paying for them. Perhaps next year, if ASCO and ISPOR overlap again, they could at least do so in the same city.