Summaries of the written research OMS clients receive
Recent assessments of melanoma drug Zelboraf by Germany’s IQWiG and the UK’s NICE show that side-effects can blunt the benefit score in Germany, while clean OS data remains top-of-list for NICE. Pharma must understand and exploit such differences in their quest for healthy reimbursement.
Data released at the 2012 ASCO meeting provide a scientific rationale for prioritizing the much cheaper generic paclitaxel over Celgene’s Abraxane. A new survey shows payers are aware of the study and will take steps to limit Abraxane use. Increasingly US payers see a need to manage oncology products and will take steps to do so when data permit, particularly when the expensive products are tweaks of generics.
FDA concerns over tivozanib’s negative-trending overall survival (OS) reinforce the notion that progression-free survival isn’t sufficient to support approval in crowded oncology markets, and underscore the challenge of active comparator trials. By pitting its drug against less-effective Nexavar rather than standard-of-care Sutent, AVEO must now prove that trial design explains the anomaly – and be prepared to face tough questions from regulators and payers.
The Oncotype Dx breast cancer assay has become a market leader. But questions about its outcomes evidence, plus the appearance of much lower cost technology, mean new tests (and possibly Oncotype itself) will need to provide water-tight, prospective outcomes data or additional clinical information that can’t be replicated via cheaper technologies.
In crowded markets, the success of new cancer drugs is increasingly tied to head-to-head efficacy data. When the standard-of-care is fast-changing, though, choosing the right comparator is tricky – and risky. Thus AVEO’s betting that it can distinguish RCC hopeful tivozanib through highlighting patient preference and better tolerability – and that these factors, likely with some creative contracting on top, can together compensate for the lack of direct comparative data versus the dominant incumbent, Sutent. The success of AVEO’s gamble will be determined largely by how convincingly the company translates patient preference into lower costs. Either way, its outcome should determine pharma and payer strategies across other cancers too.
Bundled payments that divorce physician income from drug selection are one means of changing oncology reimbursement to include a value metric. Priority Health’s fixed case management fee isn’t as sophisticated, but its simple design means it can be replicated by any payer or provider interested in new payment reforms.
Payers and pharma should engage now in selected value-based pricing experiments, drawing on lessons from the UK, where single-payment access schemes are working, and from Italy on the more ambitious requirements for outcomes-based reimbursement. Doing so would allow both sides to test the economics of risk sharing, and to carve out tailored, product-specific deals before payers are forced into blunter, more radical cost-cutting measures.
The National Institute for Health and Clinical Excellence in England & Wales rarely approves oncology drugs for reimbursement without heavy discounting. Yet there are sufficient precedents for pharma to work out how to maximize the chance of success without relying only on price cuts. Doing so will become more important in the UK in 2014 when additional funding for cancer drugs dries up, and internationally, as efficiency drives spotlight US drug prices too.
Managing the costs associated with end-of-life care in advanced cancer patients is a top priority for payers. Their best path forward is to contract with third-party vendors who can provide palliative services. Biopharmas with drugs with palliative properties should seize the emerging opportunity to work with these vendors, while also wooing payers by collecting cost data themselves.
Despite their compelling logic, risk-sharing deals between payers and pharma have proven challenging to implement. But the fixed-price access deal between the UK’s National Health Service and AstraZeneca offers a successful template for contracts on new molecules with specific, though not uncommon, characteristics. Such case-studies are important as a growing share of US payers start to consider new payment models.