ising drug prices and national expenditures are receiving increasing attention after 2018 yielded a record 59 novel drug approvals by the US Food and Drug Administration (FDA). In the US, cancer drug spending has grown 12% to 15% annually and is projected to continue on this trajectory in the coming years. 1 Cancer drug spending outpaces spending in other common sectors with growth of 3.3% for all prescription drugs and 4.4% for hospital spending in 2018. 2 For 2020 through 2027, US prescription drug spending is projected to grow 6.1% annually. Many factors contribute to the exceptional growth in cancer drug spending, including changing demographics, improved survival, and rising drug prices. 3 Currently, 35% of the drug development pipeline is dedicated to cancer drugs-a 30% increase over the past decade. 4 The increasing interest in the development of anticancer therapeutics is presumably a product of technologic advances and perceived financial opportunity for manufacturers. Marketing authorization for a new cancer drug can yield a significant financial return irrespective of the clinical benefit demonstrated in pivotal trials with median launch price more than $100 000 per treatment course. [5][6][7] Regardless of whether the high prices are justified by efficacy, the need to recoup development costs, or other factors, there are signs that patient access to new treatments may be in jeopardy. New high-cost therapies may be unaffordable for payers balancing short-term budgets. This principle was demonstrated with the approval of direct-acting antivirals for treatment of hepatitis C. The curative therapy was widely con-IMPORTANCE The growth of cancer drug spending in the US has outpaced spending in nearly all other sectors, and an increasing proportion of the drug development pipeline is devoted to oncology. In 2018, there was a record number of drugs entering the US market.OBJECTIVE To estimate the number of patients with cancer who are eligible for the newly approved drug-indication pairs, and project potential spending and use of the approvals in the US.DESIGN, SETTING, PARTICIPANTS This is a retrospective review of 2018 US Food and Drug Administration (FDA) oncology drug approvals with estimation of the eligible population. The cost of new therapy was estimated, and savings from displaced therapies were subtracted. Two-way sensitivity analysis explored uncertainty in pricing and market diffusion. Data were collected between March 1, 2019, and September 30, 2019.EXPOSURES Data related to the cancer drug approval (ie, indications, approval pathway, basis for approval), cancer incidence, and drug price were extracted from publicly available sources, including the FDA, National Cancer Institute, and American Cancer Society websites, as well as the RED BOOK database.
MAIN OUTCOMES AND MEASURESThe primary outcome was the projected net expenditure in the US associated with the new therapies. The secondary outcome described how variable market diffusion and pricing permit expected levels of spending.RESULTS A t...