Payer and regulatory pressures are likely to take some steam off of heady projections of market growth in this sensitive therapeutic area.
Against a backdrop of new figures detailing the mounting cost of fighting cancer, Pharm Exec’s sister CBI conference unit held its annual meeting — co-chaired by Alison Ayers of Pfizer and Ben Steinmetz of GSK — on trends in price, reimbursement and access to oncologics in Philadelphia on January 20-21. Here are a few highlights:
o Latest data from the National Cancer Institute [NCI] published last month project that the US will spend $173 billion to treat cancer in 2020 – a 39 per cent increase over 2010. New technologies will drive the bulk of these costs, with treating breast and prostate cancer rising the highest due to the positive impact of these new tools in prolonging survival among patients. Participants questioned some of the assumptions behind the spending projection, noting that growing resistance among payers to pricing of cancer medicines had not been factored in.
o The era where pricing and access were simply left to the discretion of the manufacturer is over. The major precedent cited is the CMS National Coverage Assessment for the anti-cancer vaccine Provenge. The NCA discourages traditional options in pursuing broad off-label use; guidelines and other access control methods will foster strict observance to the label indication alone. In addition, risk-based contracting is starting to take root here in the US, with the private-sector [US Oncology] taking the lead.
o Regulatory hurdles are mounting and the climate for reimbursement and access long-term is unpredictable. The recent FDA decision involving withdrawal of a marketing license for Avastin as first-line treatment for breast cancer indicates that for many future cancer therapies “fast track” approval will only mean contingent approval. The prospect of a periodic, rolling process in maintaining license rights means that more monies must be invested in “robust data” which in cancer will mean clear evidence of an increase in overall survival rates, compared to existing therapies. The content of related REMS commitments will also assume far more importance – getting the right terms that work for clinicians and patients as well as the patent holder will be critical to success.
o The Avastin case is not an exception – increasingly it will be the rule. According to CBI conference speaker Carol Marchione, some 5 other cancer drugs now on the agenda at the next FDA Oncology Drug Advisory Committee on February 8 are going to face evaluation using similar parameters and thus could confront restricted indications going forward.
o Companion diagnostic and assays that link cancer drugs to personalized therapy is no panacea to the cost challenge. Although Roche has broken some ground in this area, several speakers emphasized their utility remains “largely unvalidated, “ not only by the industry itself but especially by regulators. The FDA has not defined a pathway that is clear on how clinicians – let alone payers – should use such tests and a consensus on this among stakeholders is “at least ten years off.” There is also the prickly issue of the adequacy of tissue samples required to conduct the tests and the consistency of standards that can validate them. In the interim, diagnostics are likely to serve only as an adjunct that in some cases can strengthen the value proposition – but is that enough the justify the expense?
o An issue the industry must focus on is the absence of good comparative, cross-market information on the incidence of cancer in key emerging markets. The Globocon database administered by the Lyons-based International Agency for Research on Cancer [IARC] is acknowledged as sketchy and riddled with gaps and inaccuracies. Until the information base improves, drug companies are forgoing opportunities for real market growth in these countries because the public health implications of improved cancer treatment cannot be quantified. It also complicates pricing decisions in markets where there is a diverse payer base that needs to be segmented to maximize ROI.
o A panel of payers was asked what they thought should be the drivers of good pricing practices three to five years from now. Their wish list?
1. Better evidence from industry on which drugs really work, particularly in moderating the huge hidden costs of side-effects.
2. More consistent and widespread application of clinical practice guidelines that require use on the basis of the official label indication.
3. Improvements in randomized clinical trial design, with end points centered on demonstrating real improvement in overall cancer survival rates.
4. Efficient ways to track and capture pharmacy utilization, at the point of purchase, in turn reducing reliance on high-overhead claims brokering and prior authorization activities.
5. As the pipeline for cancer drugs moves more toward oral agents, effectively managing the supply chain to reduce the perverse incentives around fixed co-pays and “pill filling” not linked to patient needs.
6. Defining a societal consensus on managing end of life issues.