How Clinical Evidence Drives Formulary Decision-Making

Laurie Wesolowicz, PharmD, director, pharmacy services clinical, Blue Cross Blue Shield of Michigan (BCBSM), says that clinical evidence and other factors can drive formulary decision-making. Evidence can influence the value and coverage recommendations for drugs covered under the pharmacy (formulary) and medical benefits.

In particular, she addresses BCBSM’s formulary decision-making structure, which includes the BCBSM/Blue Care Network (BCN) Pharmacy and Therapeutics Committee. The Committee is comprised of a Clinical Core Workgroup, Blue Cross Blue Shield, BCN HMO, BCBSM Medicare Part D, a Specialty Drug Workgroup, and BCN Medicare Part D.

Dr Wesolowicz also suggests that comparative effectiveness research can influence the overall assessment of a given drug’s safety and quality for formulary and coverage decisions. She adds that there is a growing focus on evidence-based decision-making, especially in administration of high-cost specialty drugs. Other coverage decision-making challenges include the site of care, employer group pressures for cost-containment, the Affordable Care Act marketplace, and Centers for Medicare & Medicaid Services Medicare Part D rules.

She notes that the old models of pharmacy and therapeutics decision-making processes focus on comparing the effectiveness, safety, and expense of new drugs against older drugs in the same class. Newer models ask questions such as:

• Will this drug be covered under the medical or pharmacy benefit (or both)?
• What is the quality of the clinical efficacy and safety evidence?
• How does the new drug compare to current therapeutic alternatives in terms of efficacy and safety?
• Is there a requirement or recommendation for genetic testing?
• How does the product cost align with outcomes achieved?

Dr Wesolowicz says that value-based healthcare delivery will require a multi-stakeholder vision for innovation. Dr Wesolowicz asks, “What’s really a value?” A common definition of value, according to Dr Wesolowicz, “will be the way to produce better outcomes for patients.” For instance, the Christiana Care Health System in Delaware has developed a “value framework” that evaluates new specialty medications. Like BCBSM, they leverage a committee to guide decision-making. They also use scorecards to assess efficacy, risk, cost, and societal benefit of medications. These specific indicators identify a medication’s “value score.”

She suggests that new tools such as these will assist health plans and systems in evaluating clinical evidence of new and emerging drugs in formulary decision-making. “We are going to have to come up with a common framework to evaluate evidence,” says Dr Wesolowicz.

Rapid FDA approval and coverage decisions on Medicare Part D medications, the need for real-world data in evidence, rapid communication of clinical findings, and more will continue to challenge formulary decision-making.