Patient Access to New Cancer Drugs in the United States and Australia—Reply to Letter to the Editor by Dr. Wonder

Abstract

Dr. Wonder is correct to point out inconsistencies in our article, among which is our inclusion of zoledronic acid in the data sample as a cancer drug when it is in fact not an antineoplastic. Also, we should have included lenalidomide in our sample because it was approved by the Food and Drug Administration in 2005 for a cancer indication. Furthermore, we failed to mention the fact that earlier approvals of cancer drugs in the United States are in part attributable to the fast-track, accelerated-approval, and priority-review processes. We take issue, however, with several points of critique, starting with the suggestion that our focus on cancer drugs is too narrow. We are aware that the “CER [comparative effectiveness research] movement in the United States (and Australia) is not confined to interventions for cancer.” Clearly, there are other therapeutic categories with drugs with relatively high per-unit prices and questionable value for money. Nevertheless, our decision to focus on cancer drugs was not random or arbitrary. It is a good point of departure, given the current debate on the purported marginal benefits of many recently approved cancer medications [1Fojo T. Grady C. How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question.J Natl Cancer Inst. 2010; 101: 1044-1048Crossref Scopus (309) Google Scholar, 2Chambers J. Neumann P. Listening to Provenge—what a costly cancer treatment says about future Medicare policy.N Engl J Med. 2011; 364: 1687-1689Crossref PubMed Scopus (52) Google Scholar]. Moreover, on average, cancer drugs are priced significantly higher than other drugs, normalized for value, that is, measured in terms of their cost per quality-adjusted life-years [[3]Danzon P. Taylor E. Drug pricing and value in oncology.Oncologist. 2010; 15: 24-31Crossref PubMed Scopus (47) Google Scholar]. Also, we made a conscious decision to examine US Medicare beneficiary access. First, we aimed at a like-with-like comparison of one publicly funded system with another. Second, there was the practical consideration of having at our disposal more transparent public sector pricing and formulary data. Despite our mainly methodological differences, we arrive at similar conclusions. We concur with Wonder that “[w]hile the United States might be ahead in terms of breadth (i.e., more drugs) and timeliness, Australia seems to fare better on equity and sustainability.” In the United States, variability in coverage and high patient cost sharing lessen the effective access patients have to pharmaceuticals. Indeed, elsewhere, in a variety of contexts we have argued that patient access is multidimensional [4Cohen J. Cairns C. Paquette C. Faden L. Comparing patient access to pharmaceuticals in the UK and US.Appl Health Econ Health Pol. 2006; 5: 177-187Crossref PubMed Scopus (35) Google Scholar, 5Cohen J. Faden L. Predaris S. Young B. Patient access to pharmaceuticals: an international comparison.Eur J Health Econ. 2007; 8: 253-266Crossref PubMed Scopus (40) Google Scholar, 6Cohen J. Stolk E. Niezen M. Role of budget impact in drug reimbursement decisions: the increasingly complex fourth hurdle.J Health Polit Policy Law. 2008; 33: 225-242Crossref PubMed Scopus (23) Google Scholar]. We suggest that there may be a trade-off among subdimensions of access. Therefore, although more cancer drugs have been approved in the United States and a higher percentage of available drugs are covered, the evidence-based approach adopted by Australia (and other countries) has contributed to reduced prices, thereby improving affordability for payers and patients for those medications deemed cost-effective by the reimbursement authorities.