Drug developers plan to improve R&D management and operations in 2015 in order to cut development costs and avoid the glare of payers increasingly intent on containing drug prices, the Tufts Center for the Study of Drug Development (CSDD) said in this year’s edition of its annual Outlook report.
Biopharmas told Tufts they will work to improve clinical study design feasibility, data transparency, and disclosure, as well as collaborative effectiveness with CROs and investigative sites, to boost patient engagement and satisfaction—and, they hope, deliver better results. Those moves are part of what the report said was drug developers’ increased focus on developing cost-effective therapies that can help lower healthcare spending.
“The key challenge for drug sponsors, policy makers, and payers is to balance the need for new, innovative medicines with the equally pressing need to bring healthcare spending under control,” Tufts CSDD Director Kenneth I Kaitin said in a statement.
That will be easier said than done. Kaitin noted the finding of a Tufts CSDD report from November that the cost of developing and winning marketing approvals for a new drug had more than doubled in the past decade, ballooning to $2.558 billion in 2013.
Kaitin also said biopharmas intent on boosting their return on investment have done so by transitioning from a high-volume, low-margin business model to a low-volume, high-margin model. Drug developers are increasingly directing a growing share of their resources toward development of precision medicines, specialty pharmaceuticals, and orphan drugs, he said.
Yet such medicines may meet resistance from payers given their high costs. Last year, Express Scripts, the World Health Organization, and three Democrats in the Republican-majority U.S. House of Representatives criticized Gilead Sciences for the $84,000 price tag of a 12-week treatment course for the hepatitis C drug Sovaldi (sofosbuvir). Gilead has defended its $1,000-a-pill pricing by noting that the cost of Sovaldi is lower than the cost of complications associated with hepatitis C treatment, such as liver damage or liver failure.
The Tufts CSDD Outlook report outlines other trends it said would shape drug development in the coming year:
- Oncology drug development will expand, driven by advances in science, medical need, and regulatory and market incentives. Across all therapeutic areas, developers will try to lower costs increasingly through risk-sharing and collaborative relationships, from discovery through development.
- Regulatory authorities will increase engagement with stakeholders and encourage sponsors to explore novel development pathways, in response to what the report said will be growing public demand for new and innovative medicines for a wide range of diseases, both for broad and narrow populations.
- Biotechnology development and product approvals will continue to step up as the sector gains a growing share of total pharmaceutical sales—including 25 biologics in the first 10 months of 2014. Biologics represented a majority of the 41 new medicines approved in 2014 by the FDA.
- Prescription Drug Prices will continue to rise, especially for specialty treatments, but those increases will be tempered by competition in several key therapeutic classes, and the expected introduction of biosimilars, Tufts CSDD said.