December 13, 2019
Steven D. Pearson, MD, MSc, FRCP
Institute for Clinical and Economic Review
One State Street, Suite 1050
Boston, MA 02109 USA
RE: ICER Seeks Public Input to Guide Selection of Non-Drug Assessment Topics for 2020
Submitted electronically via: firstname.lastname@example.org
Dear Dr. Pearson:
The National Pharmaceutical Council (NPC) appreciates ICER’s call for public input to guide the selection of non-drug assessment topics for 2020. Over the past three years, NPC has strongly recommended in six different comment letters to ICER that it should broaden its assessment focus to include non-drug topics. [2,3,4,5,6,7] This recommendation stems from NPC’s Guiding Practices for Patient-Centered Value Assessment (Guiding Practices). We are pleased to see ICER has finally accepted this important recommendation, and we urge ICER to select financially significant non-drug assessment topics with the potential to have a meaningful impact and to conduct more than two such assessments in 2020.
NPC is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. NPC is supported by the major U.S. research-based biopharmaceutical companies. We focus on research, development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients. Our research helps inform critical health care policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.
As stated in our Guiding Practices and in our previously cited comments to ICER on needed changes to ICER’s framework and approach to value assessment, we believe value assessment can be an important tool for the complex decisions organizations and patients face when considering treatment options. Assessments that adhere to the Guiding Practices can support optimal value for patients.
For ICER’s assessments to achieve ICER’s stated goal of translating “evidence into policy decisions that lead to a more effective, efficient, and just health care system,” those assessments must meaningfully and proportionately focus on the entire U.S. health care system, of which drug spending only accounts for 16%.  From 2017 to 2019, ICER has conducted more than 20 assessments, and only 1 of them – conducted in 2017 – focused solely on a non-drug topic. That equates to less than 5% of reviews focused on the 84% of non-drug health spending in the United States. ICER should conduct more than two non-drug reviews per year, and it should select non-drug review topics that significantly impact expenditures in the U.S. health care system.
I. Topic Selection Criteria
When selecting past topics for drug reviews, ICER has prioritized emerging therapies with the potential for significant financial impact. However, past topics for non-drug reviews have been rather innocuous, such as alternative interventions for low back pain (i.e., unlike the 2011 review, the 2017 review did not address surgical approaches). The list of potential topics under consideration by ICER for 2020 similarly misses important opportunities. ICER should prioritize non-drug reviews that could make a real impact on the effectiveness and efficiency of our health care system:
- financially significant – expenditures are large enough to matter, such as big-ticket procedures
- strong evidence base – topics with an informative and suitable supply of evidence
ICER should not shy away from pursuing areas that have been politically sensitive or historically immune from criticism. ICER should select topics that enable it to pursue change in the rest of the health care system with the same tenacity with which it has sought to impact the relatively small biopharmaceutical share of the system.
II. Suggested Topics
NPC recommends the following topics for consideration:
- Excision surgery for the treatment of endometriosis vs. drug therapy
- Robotic approaches to surgical interventions
- Coronary artery bypass surgery or stents vs. drug therapy
Excision surgery for the treatment of endometriosis vs. drug therapy
Excision surgery is a go-to option for many endometriosis specialists, but surgery may only be a temporary solution to endometrial growths, which tend to recur. Some patients undergo surgery multiple times, with each surgery being accompanied by costs to the patients and health system and inherent risk to the patient. This topic could further inform ICER’s previously conducted endometriosis assessment and provide a more holistic view of the endometriosis treatment landscape.
Robotic approaches to surgical interventions
The technology enabling robotic surgery has grown rapidly, including applications such as abdominal surgery, colon and rectal surgery, partial knee replacement, cardiovascular and gynecologic surgery, and spine interventions. The surgery has been touted as providing greater precision with benefits such as fewer complications, reduced blood loss, quicker post-operative recovery and less noticeable scarring. However, these benefits come at a much higher cost. Are the higher costs commensurate with identifiable clinical improvements compared to conventional approaches? An ICER review could shed light on an important growth area that has both budgetary and clinical impact.
Coronary bypass surgery or stents vs. drug therapy
There has been a plethora of recent evidence on the value of coronary artery bypass surgery and stents as a treatment for coronary artery disease, including:
• the ORBITA trial , which showed stents were no better than placebo for stable patients, and
• a new study, released earlier this month at the American Heart Association’s annual conference, confirmed the ORBITA findings, yet also found that stents and coronary artery bypass surgery provided better pain relief . Pain relief could be captured as a quality-of-life (QoL) improvement and translated into a quantifiable benefit.
From the standpoint of hard clinical endpoints such as myocardial infarction and mortality, the invasive and non-invasive approaches have similar outcomes. However, the invasive approaches have a QoL benefit and a substantially higher cost. Thus, an ICER assessment could be quite interesting.
III. Identify Low-Value Care
NPC encourages ICER to become more engaged in identifying low-value care and opportunities to reduce or eliminate it. Low-value care is a pervasive and ongoing challenge in our health care system, estimated to cost from $158 billion to $266 billion annually.
An example of low-value care that ICER could explore as part of the evidence review process and as a variable in its models is site of care for infused and injectable medications. The cost and benefit of care will vary by drug administration site (e.g., hospital-based, in-office, infusion center) for various conditions and patient populations. In many cases, in-office administration is not only less expensive, but it can provide greater benefits such as better access to care (especially for patients in rural areas), reduced patient and caregiver burden, higher productivity, improved quality of life and better adherence.
The Center for Value-Based Insurance Design at the University of Michigan, the U.S. Preventive Services Task Forces, the Stanford Clinical Excellence Research Center, and the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely initiative have all identified a number of low-value care services, with a particular focus on diagnostics, screening and procedures. Their collective work provides a number of opportunities where ICER could play an important role in spotlighting low-value care.
We appreciate this opportunity to provide input to ICER on non-drug assessment topics for 2020 and reiterate how pleased we are to see ICER’s recognition of the importance of conducting non-drug reviews. We urge ICER to use this opportunity to select truly impactful topics and to focus a larger share of its reviews on non-drug topics.
Robert W. Dubois, MD, PhD
Chief Science Officer
Kimberly Westrich, MA
Vice President, Health Services Research
 ICER Seeks Public Input to Guide Selection of Non-Drug Assessment Topics for 2020. https://icer-review.org/announcements/potential_2020_non-drug_topics/. November 13, 2019. Accessed November 27, 2019.
 NPC Submits Comments to Institute for Clinical and Economic Review on Its Value Framework. https://www.npcnow.org/newsroom/commentary/160912icer-comments. September 12, 2016. Accessed November 27, 2019.
 NPC Comments on Proposed Updates to ICER’s Value Assessment Framework. https://www.npcnow.org/newsroom/commentary/npc-comments-proposed-updates-icers-value-assessment-framework. March 30, 2017. Accessed November 27, 2019.
 NPC Submits Comments on ICER Draft Unsupported Price Increase Assessment Protocol. https://www.npcnow.org/newsroom/commentary/npc-submits-comments-icer-draft-unsupported-price-increase-assessment-protocol. February 13, 2019. Accessed November 27, 2019.
 NPC Public Comments on ICER 2020 Value Assessment Framework. https://www.npcnow.org/newsroom/commentary/npc-public-comments-icer-2020-value-assessment-framework. June 10, 2019. Accessed November 27, 2019.
 NPC Comments on ICER's Value Assessment Methods for Single or Short-Term Transformative Therapies. https://www.npcnow.org/newsroom/commentary/npc-comments-icers-value-assessment-methods-single-or-short-term-transformative. September 6, 2019. Accessed November 27, 2019.
 NPC Comments on Proposed Changes for ICER 2020 Value Assessment Framework. https://www.npcnow.org/newsroom/commentary/npc-comments-proposed-changes-icer-2020-value-assessment-framework. October 18, 2019. Accessed November 27, 2019.
 Guiding Practices for Patient-Centered Value Assessment. National Pharmaceutical Council. http://www.npcnow.org/sites/default/files/npc-guiding-practices-for-patient-centered-value-assessment.pdf. Accessed September 22, 2019.
 About ICER. https://icer-review.org/about/. Institute for Clinical and Economic Review. Accessed November 27, 2019.
 Kleinrock M, et al. Reconciling the Seemingly Irreconcilable: How Much Are We Spending on Drugs? Value in Health. https://www.valueinhealthjournal.com/article/S1098-3015(18)36310-1/fulltext. Accessed November 27, 2019.
 Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, et al. ORBITA Investigators Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31–40.
 McKay B. Study Finds Limited Benefits of Stent Use for Millions With Heart Disease. Wall Street Journal. https://www.wsj.com/articles/study-finds-limited-benefits-of-stent-use-for-millions-with-heart-disease-11573931727. November 16, 2019. Accessed November 27, 2019.
 Reducing Use of Low-Value Medical Care: Task Force on Low-Value Care. http://www.vbidhealth.com/low-value-care-task-force.php. Accessed November 27, 2019.