Evaluating the Value of New Medications Through Evidence-Based Assessments

Medication assessments directly impact the way a drug is covered, and drugs with better quality data with a higher level of certainty are more favorably covered. Accurately assessing the evidence for new medications will help payers summarize a drug's benefit-to-risk ratio.

Medication assessments directly impact the way a drug is covered, and drugs with better quality data with a higher level of certainty are more favorably covered. Accurately assessing the evidence for new medications will help payers summarize a drug’s benefit-to-risk ratio.

The evaluation of new medications and accompanying technologies requires sophisticated evidence and assessments, according to Sean Karbowicz, PharmD, of the Medication-Technology Assessment and Guidance Group at Regence Rx. Regence Rx is a pharmacy benefit management company that conducts medication and technology assessments in order to provide formulary guidance to companies such as BlueCross BlueShield. Medication assessments directly impact the way a drug is covered, and drugs with better quality data with a higher level of certainty are more favorably covered.

Potential gaps in clinical evidence could impact medication coverage, says Dr Karbowicz. From a payer’s perspective, significant gaps exist in evidence that describes clinical value. Common concerns include study design, end points, and attrition. In his presentation, entitled “Evidence-Based Value Assessment of New Medications: 2012 Update,” Dr Karbowicz used the ICER matrix to describe the synthesis of clinical evidence that exists for Inlyta (axitinib), Jakafi (ruxolitinib), Adcetris (brentuximab), Zelboraf (vemurafenib), Perjeta (pertuzumab), Xalkori (crizotinib), and Kalydeco (ivacaftor).

Managed care toolboxes, including models for determining clinical benefit, are designed to deal with small molecules, and specialty medications challenge these clinical benefit models. Accurately assessing the evidence for these new medications using efficacy and safety profile data, cost measurements, end points, progression-free survival data, overall survival data, genetic testing, adverse side effect reports, study and sample design, equivalent comparators, and quality-of-life measurements will help payers summarize a drug’s benefit-to-risk ratio. Many of the new specialty drugs currently being released are considered to be of “uncertain value” because much is still unknown regarding their safety profiles.