John M. O’Brien’s arrival as president and CEO of the National Pharmaceutical Council reinforces a vital role the biopharmaceutical industry can play in the ongoing debate about health care costs and patient outcomes: developing the rigorous evidence base for policies that impact what patients are experiencing right now at the pharmacy counter.
When NPC’s board of directors selected John, it found his wide-ranging, policy-focused experience a perfect fit, but I especially zeroed in on the combination of his academic background as a professor and his real-world experience as a pharmacist.
John’s blend of experience is well-suited to not just NPC, but also to the moment we are in now, amidst a public debate about drug prices and patents and the issues patients face as they try to access medicines.
Some of the proposals now being discussed at the state, federal and even global level – importing foreign price controls, taking away patent rights - could slow innovation and the ongoing long-term improvement in patient health. We often see little productive dialogue about these proposals and their trade-offs, in large part due to oversimplified and well-worn talking points.
Thankfully, that’s not our style at NPC. We bring an evidence-driven perspective to guide a constructive discussion about health care costs and spending, and we ground what we say in research. Under John’s leadership, we’ll continue to focus our key contributions on the interests of the patients.
Successful policy solutions can be found if we take the kind of approach shown with step therapy: using evidence- and science-based research that incorporates input from all partners and all sectors.
A good example of where NPC is doing this already is in its work on step therapy, the utilization management technique employed by health insurers that requires patients to try and fail one or more alternate drugs before they can get the drug their provider believes is most appropriate for them.
NPC’s most recent research on step therapy smartly highlighted the need for common standards around step therapy protocols that promote clinically recommended and safe care while ensuring affordable access.
The step therapy criteria research brought together experts representing patients, providers, insurance plans and others, and it could be used to develop more appropriate protocols and help plan or benefit managers conduct proper monitoring of step therapy practices and policies.
This NPC work also complements an ongoing, important effort at BMS, where we have sponsored research on step therapy that examines its impact on patient costs and overall health outcomes.
Last fall, a BMS-commissioned analysis done by health care consulting firm Avalere looked at the potential negative cost consequences of step therapy by examining out-of-pocket and payer costs for a Crohn’s disease patient under an employer-sponsored plan. What Avalere showed was eye-opening: if a patient with Crohn’s disease was required to “step through” an insurance plan’s preferred product and then had a negative clinical outcome, they not only had to deal with their health challenges, but they also faced higher upfront out-of-pocket costs. A patient without step therapy had more manageable and predictable expenses month over month with an average out-of-pocket cost of $339. Conversely, a patient with step therapy and a negative outcome had a high upfront out-of-pocket liability of $4000 total in the first five months. These higher upfront costs create affordability challenges for patients that can result in them deciding to stop treatment, making their disease worse.
The results were not better for payers, who, theoretically, want to use step therapy to lower costs. In the Avalere analysis, payer costs were 37% higher for patients with step therapy and had a negative outcome compared to patients with no step therapy.
Research like the NPC and BMS-commissioned work forms the basis for a dialogue in Washington, D.C. and state capitals about step therapy reform, an important topic for patients dealing with long-term medication needs. The reform offers common-sense guardrails to ensure transparent, efficient and fair processes for patients and their providers. Bills have passed in over half of U.S. states, including Arkansas, Nebraska and Oregon this year, providing prescribers the ability to override step therapy protocols if a patient’s circumstance meets a set of defined criteria, further helping ensure patients get the right medicine at the right time.
Health care faces numerous challenges today, but successful policy solutions can be found if we take the kind of approach shown with step therapy: using evidence- and science-based research that incorporates input from all partners and all sectors.
Much of the political debate is about winners and losers. That solves no problems, and at best, it’s a very ineffective way to help patients who are dealing on a day-to-day basis with cost and access challenges. Everyone’s future is dependent on access and innovation, and I’m confident we can get to that better future by taking the evidence-based path NPC is traveling.
Michael L. Ryan is Senior Vice President, Worldwide Value, Access, Pricing & Health Economics and Outcomes Research at Bristol Myers Squibb. He also is NPC's Chair of the Board of Directors for 2021.