Patients Rising is a Washington, DC-based non-profit organization with a very specific mission: we advocate for access to vital therapies and services for all patients with life-threatening and chronic diseases.  That is why Patients Rising is committed to bringing forward the patient voice as part of a balanced dialogue with providers, payers, policymakers and the advocacy community to address the complement of cost and access challenges Americans with serious diseases face every day.

One of the most pressing issues in health care today is improving access to, and reimbursement for, precision and personalized medicines that enhance and extend people’s lives. That is why we are in a unique position to closely observe and make direct comments to all of the frameworks ICER proposes. In our review of the Draft Scoping Document for Non-Small Cell Lung Cancer, we have many concerns about both the chosen focus and ICER methodology in selecting the criteria for the forthcoming Draft Report.

1. The Limited Time Frame for Comments

ICER’s allotted five-day time frame for commenting is an unwise and practically unworkable and inappropriate standard. It shows an underlying lack of interest in the viewpoint for those wishing to comment, and we implore ICER to reconsider and adopt a more accepted practice of at least two weeks for Draft Scoping Documents and at least one month for Draft Reports. By operating at this restrictive pace, you are surely missing vital input for the stakeholders you profess to want input from.

2. The Limited Scope of Draft

Lung cancer is known in many patient circles as the “poster child for personalized medicine.” It’s among the most profound health care success stories of the decade, detailing how getting the right patient, the right treatment at the right time through genomic profiling of tumors continues to help patients live longer and stronger.

Tumors in approximately 60 percent of patients with lung adenocarcinoma have been found to be linked to specific mutations. While we concede that EGFR+ tumors and tumors with wild type EGFR represent the highest percentage of patients overall, we still question ICER’s exclusion of KRAS, ALK and ROS-1 in P1 population – all of which have FDA approved therapies.

We cannot help but conclude that ICER is specifically excerpting some research to focus on that which provides the outcomes you are seeking to plug into your fiscal formula. The budget impact assessment appears to be the main focus for ICER, leaving us to wonder how useful this document could possibly be for determining what is best for the patient.

It seems rather than calling your report one for Non-Small Cell Lung Cancer, you might consider calling it a Non-Small Cell Lung Cancer Report for EGFR+ Tumors and those with wild type EGFR, or no tumor target.

3. The Inability to Determine EGFR-mutation Negative Tumors

Despite the fact that it is widely known and accepted that genome testing for lung cancer patients should be quickly ordered when determining the patient’s best treatment path, it still is not. How will you determine that all patients with a wild type EGFR have been tested negative, or have simply never been tested?

We believe it would be of far better service to patients to ensure that genomic profiling is provided to all patients. If we are looking to identify and cut waste in the system, this is one test that would be a much more cost-effective way of matching right patient with right treatment – avoiding ineffective procedures and prescriptions and the toxicities that go with them for patients and the health care system as a whole.

4. Working with the Patient Advocacy Community

Every patient advocate in the lung cancer community wants to help move towards more efficient, patient-focused care aimed at eliminating waste and fraud within each sector of the health care ecosystem. We hope that ICER will choose to genuinely and comprehensively reach out to the advocacy community for a robust exchange in search of ways to collaborate.

We recognize that this broader, more inclusive goal does not fit ICER’s stated methodology in creating a series of value-based benchmarks for payers. Our aim is to fight for what is best for patients – not the system – and we believe that focusing on healthcare in its totality and what is best for patients will bring real relief to the system at large.

We hope ICER will acknowledge that the U.S. health care system will not be improved or enhanced by focusing on one expense sector or one methodology. And we call on your organization to address the fundamental flaws in its approach and seek a process to address patient needs and health care challenges in a fair and reasonable way.

Thank you in advance for considering our views.


Terry Wilcox

Co-Founder & Executive Director, Patients Rising

The full letter can be viewed here.