At the June annual meeting of the American Society of Clinical Oncology, National Cancer Institute (NCI) Director Dr. Norman Sharpless and FDA Commissioner Dr. Scott Gottlieb each addressed the membership regarding achievements and priorities at their respective agencies to advance the state of cancer care in the United States.1,2

Dr. Sharpless highlighted the power and promise of cancer research—the great progress over the past 15 years with therapies and precision medicine that has contributed to the steady decline in cancer death rates in men, women, children and all major racial and ethnic groups. Dr. Gottlieb outlined steps the agency is taking to advance treatments, including the development of the FDA’s Oncology Center of Excellence to break down agency silos.

The activity in oncology is staggering. In 2017 alone, the FDA approved 16 new oncology drugs and biologics, among them the first two cell-based CAR-T therapies. Further, 30 new oncology indications were approved as well as the first US biosimilars for bevacizumab and trastuzumab.  The cancer pipeline is exploding, with 1,120 cancer medicines and vaccines in development or awaiting FDA approval, of which an estimated 85% are likely to be first-in-class medicines.3

This has left payers facing about one new oncology approval for every week during this last year and an explosion of new entities, new indications and combination agents in development.  Just how do payers keep up with new oncology agents and expanding indications?

While FDA approval is foremost for policy development, payers increasingly rely on oncology network KOL insights and on-staff Board Certified Oncology Pharmacists (BCOP) to review options and make therapeutic recommendations. A number of payers incorporate evidence-based guidelines (eg, NCCN or ASCO) in a way that supports broad-based policy development for added efficiencies (eg, cover all FDA-approved or NCCN Category of Evidence-rated 1, 2A or 2B indications). These guidelines and other CMS drug compendia listings may be updated either before or after FDA approval, and policy language of this type provides flexibility for the plan.

Some payers are moving a step further by adopting specific clinical pathways, which are generally derived from evidence-based guidelines. These pathways may incorporate additional criteria—as well as decision support components—for prioritizing preferred therapy protocols and automating prior authorizations and claims edits in the health plan’s IT and EHR systems.

Regardless of the actions taken, payers are looking for a degree of predictability in their future budget planning, so understanding the impact of existing and pipeline therapies is critical.

Health plan medical directors are typically not oncologists; they have a broad organizational role across all therapeutic categories. Payer decision makers appreciate information that helps them understand the cancer type, unmet therapeutic need and line of therapy, appropriate patient populations, associated companion diagnostics, and the clinical and economic data supporting the new agent/indication. This supports accurate medical policy development and appropriate utilization management criteria as needed.

Consider proactively communicating newly approved indications/data using digital tools for timely updates, as well as providing pathway development companies with new clinical/economic data to support payer updates.  Communicating the relevant drug codes by site of care and billing guidelines—including diagnosis, and dosing and administration—is also critical to support accurate prior authorization criteria and to update internal systems to accommodate automated claims reviews.

Additionally, partnering on initiatives to support evidence-based care for a plan’s membership, provider network communications, and/or customized care management resources for use in patient education on a new therapy will be important.

To sum up: Help payers understand what’s beyond that next curve so they can proactively plan around those potential 1,120 upcoming approvals. Communicating pipeline/HCEI data in compliance with updated FDA healthcare economic information guidance is one way to meet this need.


  1. Sharpless NE. National Cancer Institute. Maximizing the prospects for progress against cancer. Published June 18, 2018. Accessed June 25, 2018.
  2. Gottlieb S. US Food and Drug Administration. FDA commissioner’s remarks to the ASCO annual meeting. Published June 2, 2018. Accessed June 25, 2018.
  3. Pharmaceutical Research and Manufacturers of America. Medicines in development for cancer. Medicines in Development 2018 Report. Accessed June 25, 2018.