Document will inform development of report for public deliberation by the Midwest CEPAC
June 21, 2016- The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will inform a report on drug therapies for treatment of non-small cell lung cancer (NSCLC). The document will be open to public comment for one week.
The draft scoping document was developed with input from a number of patient organizations, clinical experts, relevant drug makers, and other stakeholders. The resultant report will serve as the basis for deliberation and discussion at the next public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) on October 20, 2016.
The Midwest CEPAC is a core program of ICER. Midwest CEPAC is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.
The report will evaluate the comparative clinical effectiveness and value of several drug therapies for treatment of NSCLC, including:
Tyrosine kinase inhibitors:
- Afatinib (Gilotrif®, Boehringer Ingelheim Pharmaceuticals, Inc.)
- Erlotinib (Tarceva®, Genentech, Inc. and Astellas Pharma US, Inc.)
- Gefitinib (Iressa®, AstraZeneca)
Immunotherapy targeting the programmed death 1 (PD-1) receptor or its ligand (PD-L1):
- Atezolizumab (Tecentriq®, Genentech, Inc., Roche Group)
- Nivolumab (Opdivo®, Bristol-Meyers Squibb Co.)
- Pembrolizumab (Keytruda®, Merck & Co.)
Each ICER report includes a full analysis of how the drugs work (comparative effectiveness), and the value the treatments represent to patients and the health care system (cost-effectiveness and the potential budget impact). The reports support the goal of getting excellent drugs to market quickly and at a price that is affordable to patients and the health system, without hindering the development of new and effective drugs.
The scoping document will be open to public comment for a period of one week, during which time we invite all interested stakeholders, including patients, providers, payers, and manufacturers, to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by Tuesday, June 28, 2016 at 5:00PM CST. More information about submitting a public comment, including formatting specifications, is available in our Public Comment Guide.
Following the public comment period, a revised scoping document will be posted on or about July 5, 2016. The revised scope will guide development of a Draft Evidence Report, scheduled to be posted on or about August 19, 2016. Once posted, the Draft Evidence Report will be open to a two-week public comment period, during which time we again invite all interested stakeholders to provide comments, suggestions, and refinements to the report.
During the October 20, 2016 Midwest CEPAC public meeting, the independent Council will vote on key questions raised in the report, and a policy roundtable of experts in the field of lung cancer will discuss recommendations for how best to apply the evidence to policy and practice.
Additional key dates for the draft report, as well as further information about the October meeting, are included below and available on ICER’s website:
June 21st: Draft scoping document posted
June 21st-June 28th: Public Comment Period on Draft Scoping Document
July 5th: Final scoping document posted
August 19th: Initial Draft Evidence Report and Draft Voting Questions Posted
August 19th-September 2nd: Public Comment Period on Draft Evidence Report and Draft Voting Questions
September 28th: Evidence Report Posted
October 20th: Public Meeting of the Midwest CEPAC
On or about October 27th: Final Report Posted
Date: October 20, 2016
Location: St. Louis, MO
Additional details will be posted to the ICER website as they become available.