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A drug pricing watchdog group had its final say Friday on targeted arthritis treatments – and it may not be good news for patients.

The Institute for Clinical and Economic Review assembled its New England council to review the group’s analysis of cost effectiveness for rheumatoid arthritis therapies.  ICER’s March report considered major targeted immune modulators, which include both biologic and non-biologic medications, and arrived at a single conclusion: all are more effective than traditional treatment, and all are too expensive.

In fact, ICER suggests that the therapies analyzed would need to be discounted 29% to 69% to meet the group’s cost-effectiveness threshold.

Stakeholders and advocates question ICER’s findings.  Several participants in the afternoon policy roundtable noted that the data did not sufficiently incorporate the patient experience.  The data ICER used “was all clinical trials data…designed to prove drug effectiveness,” Janet Stearns Wyatt, PhD, RN, noted.  The analysis did not incorporate patient-reported outcomes or other more patient-centric measures.

The Arthritis Foundation had noted that ICER’s modeling focused on older patients, explaining that, “If patients with early diagnosed mild RA were included in the economic model, we would expect the population…to accrue greater additional quality adjusted life years.”

The Institute for Patient Access argued in a February 16 letter that ICER’s modeling simply doesn’t work for rheumatoid arthritis treatments.  Among other points, IfPA argued that ICER’s homogenous patient model doesn’t match the real-world diversity of arthritis patients.  IfPA also noted that the lifetime treatment horizon used to calculate cost effectiveness far overestimates a patient’s likely treatment with a given drug.

[Read: Why ICER’s Model Doesn’t Work for Rheumatoid Arthritis Patients]

So where does this debate leave patients?

Several patient advocacy groups expect health plans to seize ICER’s cost data to justify limiting patients’ access to arthritis treatments.   Alliance for Patient Access Executive Director Brian Kennedy cautioned that, “Population-level analytics cannot predict which treatment will work for any individual patient,” adding that “these data points should not be used by health plans to override the physician-patient relationship and impede a physician’s ability to determine the best course of treatment for a given patient.”

An afternoon panel on the report’s policy impact underlined these concerns with a discussion on prior authorization and step therapy, or “fail first.”  Panelists represented the patient, manufacturer, health plan and physician viewpoints.

In particular, panelists considered requirements that patients “max out” traditional methotrexate treatment before getting health plan approval for a biologic.  Matthew H. Liang, MD, MPH of Brigham and Women’s hospital emphasized that, “If step therapy is going to be there, there should be a medical exception process in place.” He explained that women of childbearing age and some others shouldn’t be subject to the requirement.

Himanshu R. Patel, D.O., of Eli Lilly and Company raised related questions. “The conundrum is how well do patients adhere to [methotrexate]?  How well can they tolerate it?” he asked.

He advised policymakers to “be careful about creating a strict protocol.”

ICER will post its final report and a summary of the meeting’s proceedings on April 7.

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