Blame for the hefty price tags on cancer therapies is often pinned on research and development (R&D), but on average pharmaceutical companies made over 10 times what these agents cost to develop, a new analysis found.
For the 99 FDA-approved oncology drugs with available sales data, these agents generated a median cumulative revenue of $14.50 for every $1 spent on R&D through the end of 2017, reported Kiu Tay-Teo, PhD, and colleagues from the World Health Organization (WHO) in Geneva.
“This study has shown that cancer drugs, through their high prices, have generated substantial financial returns for the originator companies,” the authors wrote in JAMA Network Open. “Excessive returns on investment may distort R&D investment and stifle future clinically meaningful innovation, with evidence of such a trend having already emerged in the R&D of cancer drugs.”
One example of this trend possibly over-incentivizing investment in cancer therapies is the 4,006 oncology trials in 2017, which made up roughly half of all pharma trials and outnumbered cardiovascular disease trials by about a factor of 10 (n=446). Costs for these trials are estimated at $4.6 million for each phase I trial, $11.5 million for phase II, and $22.8 million for each phase III trial.
Tay-Teo and co-authors argued that along with restricting patients’ access to these drugs, high prices have compromised the sustainability of health systems across the world and said actions must be taken to correct this “unsustainable trend.”
Risk-adjusted R&D estimates for cancer drugs range from $219 million to $2.82 billion (median $794 million), the researchers noted, which includes not only the costs of approved agents themselves but also that of drugs that failed in early trials and never came to market.
Even when assuming the $2.82 billion upper threshold for an approved agent’s R&D, the revenue-to-cost ratio was even greater for some blockbuster agents:
- Imatinib (Gleevec): $22.60
- Pegfilgrastim (Neulasta): $22.60
- Bevacizumab (Avastin): $29.50
- Trastuzumab (Herceptin): $31.20
- Rituximab (Rituxan): $33.20
Half the drugs examined in the study had generated sales of over $5 billion through the end of 2017, with the agents above leading the way: imatinib ($63.8 billion), pegfilgrastim ($64.0 billion), bevacizumab ($83.4 billion), trastuzumab ($88.2 billion), and rituximab ($93.7 billion).
And a number of biologics continued to be profitable and yield billion-dollar returns even after their protected period of market exclusivity expired. However, with a recent push by the FDA, biosimilars have now started to hit the market in the U.S., with biosimilars trastuzumab, rituximab, and bevacizumab all getting approval for a number of different cancer types.
“We hope the entry of biosimilars would bring greater competition and hence reduction of prices to a level that is affordable to healthcare systems and patients,” Tay-Teo told MedPage Today.
He pointed to a recent WHO report on cancer drug pricing that found pharmaceutical companies’ pricing strategies were largely “based on commercial goals” rather than the clinical value of a given agent.
The study did not examine the effects of multiple indications for a given agent on drug pricing, but Tay-Teo said that “multi-indication pricing” — wherein manufacturers and government regulatory agencies agree on pricing for different indications of use — has been used in some countries such as Sweden and Italy.
“This pricing approach aims to set distinct prices for the same medicine to reflect the differences in efficacy of that medicine when used for different conditions or in specific patient populations,” according to the WHO report. “Depending on the pricing arrangements, multi-indication pricing may either link the prices or discounts individually for each indication, or present a single price weighted for the anticipated utilization for each indication.”
For their study, the researchers looked at all 156 oncology drugs approved by the FDA since 1989, identifying the 99 drugs where sales data were available for at least half the years since coming to market. They estimated that it took a median of 5 years (range 2-10) for companies to recover the maximum R&D costs of $2.82 billion.
A number of limitations to the study were cited by the authors, including that some drugs had public sector money as part of their R&D and sales data were based on companies’ annual reports, which might have aggregated revenues for “drugs with lower returns.” Lastly, sales data were total revenues rather than actual company profits (sales minus expenses), but they added that oncology drug profits are likely to be “supernormal.”
The authors are all on staff at the World Health Organization. Tay-Teo disclosed that he was formerly an employee of Deloitte Access Economics in Australia.