The much-awaited ICER (Institute for Clinical and Economic Review) Final Report for myeloma relapse therapies, issued on June 9th, is very tentative and less of a report than an admission that they do not have the expertise to adequately assess the complexities of new myeloma therapies. Functioning under a microscope for the last few months, ICER concedes in a statement at the end of the report that a “Fail First” policy is a mistake for myeloma patients. They have also indicated that they have come to understand that each patient is unique and different and that all therapies will be required during the course of multiple relapses. Also, a system which favors use of panobinostat (an HDAC inhibitor with limited efficacy) over daratumumab (an anti-CD38 antibody with 30% activity as a single agent in relapse refractory disease) is clearly flawed.

ICER, in essence, defers to the expertise of doctors who work with myeloma therapies every day and the experience of patients who have expressed both their needs and their views as impassioned advocates for all patients. It can now be hoped that payers such as CMS/Medicare will not seek ICER guidance.

While ICER was releasing its report last week, the International Myeloma Working Group (IMWG) Annual Meeting was occurring in Copenhagen. At a key session, an emotional, vigorous debate emphasized the need for clear treatment guidelines which consider myeloma treatment cost and access. For the first time, there was strong public unity among IMWG members on this topic—an acceptance of responsibility to protect patients from all processes which may limit or distort access. Two decisions were made:

1. To proceed immediately to prepare access or cost-stratified guidelines for use of therapies throughout the course of the disease from Frontline to Refractory Relapse. This will be a global document for which consensus review will occur. Key experts leading this effort will be Dr. Philippe Moreau, Dr. Vincent Rajkumar, and myself.

2. Initiate meetings bringing all stakeholders to the table, including, of course, patients, pharmaceutical companies, insurers, central pharmacies, hospitals and clinics, and regulators, who will ultimately need to change the cost and reimbursement landscape. Prof. Jean-Luc Harousseau from France led an elegant discussion and prepared the work group report for this IMWG session. There was tremendous energy and motivation to produce rapid results.

The IMWG is ready to function under the microscope! Consensus statements and guidelines routinely seek the maximum input and feedback to incorporate all opinions and suggestions. We anticipate that useful guidelines will also spur desperately needed changes and will transform the cost/payer landscape. We must develop a system in which treatment costs do not overwhelm the budgets of individuals and healthcare systems alike.

Everyone's input will be welcome! ICER may have blinked, but the ON buttons of tweeting advocates are blinking to point the way to a better cost and access system.

Image of Dr. Brian G.M. DurieDr. Brian G.M. Durie serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.

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