Step Therapy for Part B Drugs

By Yvonne Tso

In May 2018, the Trump administration announced four key strategies to tackle the rising costs of drugs for payors and consumers who have copays or other cost shares for prescription drugs. In an effort to operationalize the strategies, on August 7, 2018 the Administrator of the Centers for Medicare & Medicaid Services (CMS) published guidance for Medicare Advantage (MA) plans to add step therapy (ST) to the utilization of drugs administered in physicians’ offices, which are Medicare Part B covered benefits. The Administrator cited section 1852 of the Social Security Act that permits the application by MA plans of utilization management (UM) tools such as prior authorization (PA) to “control utilization of services and expenditures.” CMS is acknowledging that step therapy is a recognized UM tool that can potentially lower drug prices by beginning medication therapy with the most preferred drug for a medical condition before progressing to other therapies, if necessary, “promoting better clinical decisions.” Requiring PA for Part B covered drugs is not new; many national MA plans have had standing PA requirements since the inception of the MA program. Drugs that commonly require PA include: hyaluronic acid derivatives for treatment of osteoarthritis, corticotropin injection, erythropoietin stimulating agents (short and long acting), intravenous immune globulin (IVIG) and granulocyte colony-stimulating factor (G-CSF). That these are generally considered “specialty pharmaceuticals” representing the fastest growing expenditure in healthcare is no surprise.

This call to action comes at a time when availability of biosimilar products is rising since passage of the Biologics Price Competition and Innovation Act (BPCIA) of 2009. Zarxio® (filgrastim-sndz) was the first biosimilar drug approved in 2015 and in July 2018, another biosimilar Nivestym® (filgrastim-aafi) was approved. Renflexis® (infliximab-abda), infliximab biosimilar, was approved in April 2017 following approval of Inflectra® (infliximab-dyyb) in April 2016. The list will grow in the next year or so. Using a biosimilar presents an opportunity for implementation of ST to Part B drugs. Integrating Part D drugs into the ST process is another – for instance, for rheumatoid arthritis (RA) treatment, various oral disease-modifying antirheumatic drugs (DMARDs) should be tried prior to reaching out to the tumor necrosis factor-alpha (TNF-alpha) inhibitors (most of the biologicals belong to this therapeutic class). The assumption is that allowing ST along with the growing availability of alternatives as described above will add downward pressure on pricing for some Part B drugs. Before implementing ST protocols, the Administrator also reminds MA plans that:

  1. Implementation of ST should only be applied to new starts so as not to cause disruption of therapy or undue access barriers for beneficiaries;
  2. MA plans are obligated to furnish and provide access to benefits under Parts A and B and beneficiaries can request exceptions to the PA/ST requirement;
  3. MA plans should follow guidelines in National/Local Coverage Determinations when available. If not availablef, MA plans should use their qualified pharmacy & therapeutics committees to help establish policies and procedures for appropriate use of ST for Part B drugs; and
  4. Any plan to adopt and apply ST to Part B drugs in CY 2019 must disclose this in the Annual Notice of Change and Evidence of Coverage for members.

If a MA Prescription Drug (MAPD) plan would like to require a Part D drug to be used prior to a Part B drug, the PA criteria can be submitted during a special 8/17 to 8/21 window. If the MAPD cannot develop the criteria in time, placeholder PA criteria can be submitted with “criteria pending” in the PA submission field. When the PA criteria are submitted during CY 2019, they would be considered negative formulary changes subject to the standard negative formulary change request timeframes.

If you wish to discuss Step Therapy strategies for CY 2019, please contact MCS at 562-498-2218.