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The rapid pace of new pharmaceutical approvals raises questions of whether ICER can keep up and maintain the quality and rigor demanded by healthcare audiences, writes Jeremy Schafer.
The United States is unique among many industrialized nations in that it does not have a government organization that conducts cost-effectiveness assessments on new pharmaceuticals. As the US healthcare system moves from volume to value, the lack of such an organization has become more acute. Enter the Institute for Clinical and Economic Review (ICER). Founded in 2006, ICER conducts cost-effectiveness assessments on healthcare technologies, including devices and drugs.1 ICER grew rapidly in prominence with its assessment of the PCSK9 drugs in 2015.2 The key finding-that the products needed significant price reductions-was publicized broadly, and healthcare stakeholders, especially payers, began to take notice.2 Since then, ICER has prioritized drug reviews by completing assessments at, or even before, major drug launches. The rapid pace of new pharmaceutical approvals has raised the question of whether ICER can keep up. The more important question is, Can ICER not only keep up, but also maintain the quality and rigor demanded by healthcare audiences? Some recent missteps may indicate the answer is no.
Regular readers of ICER reports know that there can be broad differences in the findings between a draft report and the final report. In the draft report for hereditary angioedema, ICER found that lanadelumab needed a 19%-20% discount to reach a $150,000/QALY threshold whereas Haegarda could actually increase its price to reach the same QALY level.3 In the final report published three months later, lanadelumab was found to be 10%-12% under-priced, and Haegarda’s new value price was almost identical to the price needed to achieve a $150,000/QALY.4 Part of these changes can be attributed to the open comment periods that occur at regular intervals in the ICER process.5 Comment periods are opportunities for advocacy groups, manufacturers, and other stakeholders to offer additional evidence and insights. ICER’s process has evolved over the years, and the inclusion of more stakeholder input has been a welcome addition. Recently, however, ICER has retreated on its initial findings and published significant changes in follow-up reports.
In what was described as an “unusual move,” ICER recently reanalyzed two migraine medications.6 The launch of new brands in a heavily generic category was an area of keen interest for payers and they eagerly awaited the ICER findings. In its first analysis, ICER found the drugs’ value price was between $2200 and $3200 per year, which differed significantly from the products’ list prices.6 In a reanalysis, ICER found that both drugs had value prices more in-line with the products’ list prices of $4150 to $4640 per year.6 The reevaluation of the migraine products came shortly after ICER pulled a report on rheumatoid arthritis in October 2019 citing a need to reevaluate its approach.7 Both instances were covered on healthcare websites utilized by a broad section of the healthcare community.6,7 In an effort to bring out findings quickly to an eager audience, ICER’s backtracking may impact its credibility.
The challenge to payers of inconsistent ICER reports is that the results are being used in coverage decisions. A survey by the Academy of Managed Care Pharmacy found that 33% of payer respondents used ICER analyses in policy development.8 The 2019 Magellan Medical Pharmacy Trend report found 56% of surveyed payers utilized ICER analyses in developing medical pharmacy strategies.9 CVS Caremark took ICER results a step further, developing a program that would allow clients to exclude drugs with prices that ICER found to exceed $100,000/QALY.10 These examples illustrate the real consequences of ICER findings on patient access. Access can also take time to change, indicating that even when ICER’s findings are revised, there may be a lag before a payer performs a reassessment and changes access to a product. To be fair, ICER does not actively promote that payers use its findings in coverage decisions; nevertheless, the findings are being used that way. For payers, reliability and consistency is key.
A payer’s coverage decision can be both financial and clinical with both needing to be backed by solid evidence. Payers will argue with knowledgeable healthcare stakeholders, including providers, patients, advocacy, and even the government, on why a pharmaceutical is covered a certain way. If the reliability of the evidence is tenuous, a payer will rely on different sources of evidence instead. This is where the risk lies for ICER’s missteps. Too many, too close together, and too highly publicized reevaluations could make payers question the validity of the process and utility of the reports. Pharmaco-economists may argue that cost-effectiveness assessment is as much an art as a science and that fluctuations will always be present. So what can ICER do to improve consistency and reliability?
ICER has options as it continues to evolve its process. The number of analyses conducted each year could be trimmed to focus only on the most sought-after topics. Doing so could grant ICER more time and resources to go in-depth on the topic. Currently, ICER publicly releases each stage of the evidence report for a review. ICER could consider not releasing the draft report publicly and instead put it through a closed review by stakeholders, including payers, manufacturers, and health economists. Not releasing the draft report would be a setback for full disclosure but could avoid situations where publicity and possibly coverage decisions would not occur based on a report that may change significantly. ICER could also extend the comment and revision periods, giving stakeholders more time to opine and submit evidence, while giving ICER more time to consider feedback and incorporate revisions. The 2020 updates to ICER’s framework prove that the organization is always willing to update methods and listen to feedback,11 so the potential for more changes to improve consistency is possible.
Pharmaceutical manufacturers should continue to monitor ICER’s website for announcements of future analyses. If a manufacturer’s product or therapeutic class is chosen, the manufacturer should proactively prepare positioning and evidence to submit to ICER during each open comment period with particular attention earlier in the analysis to help steer how the cost effectiveness assessment is conducted. Manufacturers can submit new evidence that may emerge in subsequent comment periods to ensure the latest is covered. At the same time, manufacturers can prepare response guides and counter analyses that can be shared with healthcare stakeholders in the event the ICER analysis does not go in the direction that the manufacturer had planned. Being able to identify shortcomings in an ICER analysis and presenting relevant evidence the ICER analysis may have overlooked will not only aid the manufacturer in discussions with payers but also place pressure on ICER to continue to revamp their process to allow for more time for input and diversity of evidence considered in the assessment. These steps may require manufacturers to devote more time and resources to ICER counter strategy and cost effectiveness assessment but will have the added benefit of better preparing the manufacturer to discuss value in the changing healthcare environment.
The transition to value-based care is not going away and neither is the need for cost-effectiveness assessments. ICER has played an important role in bringing the discussion forward and likely will continue to do so for years to come. ICER will need to continue to evolve in-step with the healthcare marketplace to ensure that the results of its assessments are as reliable and comprehensive as possible. Readers of ICER reports should understand the growing pains and challenges in cost-effectiveness assessment and consider the reports as just one component in an evaluation of a pharmaceutical. Doing so will help payers further understand cost-effectiveness and continue to provide balanced access for patients. For manufacturers, more engagement in the ICER process will potentially improve assessment outcomes but also prepare the manufacturer to discuss cost effectiveness in an increasingly restricted market.
Jeremy Schafer, Pharm.D, MBA, is Senior Vice President at Precision for Value.
1. ICER. About ICER. https://icer-review.org/about/. Accessed March 4, 2020.
2. ICER. PCSK9 inhibitors for treatment of high cholesterol: effectiveness, value, and value- based price benchmarks. Final report. https://icer-review.org/wp-content/uploads/2016/01/Final-Report-for-Posting-11-24-15-1.pdf. Published November 24, 2015. Accessed March 4, 2020.
3. ICER. Prophylaxis for hereditary angioedema with lanadelumab and C1 inhibitors: effectiveness and value. Draft evidence report. https://icer-review.org/wp-content/uploads/2018/03/ICER_HAE_Draft_Evidence_Report_082318.pdf. Published August 23, 2018. Accessed March 4, 2020.
4. ICER. Prophylaxis for hereditary angioedema with lanadelumab and C1 inhibitors: effectiveness and value. Final evidence report. https://icer-review.org/wp-content/uploads/2018/03/ICER_HAE_Final_Evidence_Report_111518-1.pdf. Published November 15, 2018. Accessed March 4, 2020.
5. ICER. Patient, manufacturer, and other stakeholder engagement. https://icer-review.org/methodology/stakeholder-engagement/. Accessed March 4, 2020.
6. Silverman E. ICER, the controversial cost-effectiveness watchdog, reverses course on two migraine drugs. STAT. https://www.statnews.com/pharmalot/2020/02/25/icer-cost-effectiveness-migraines-allergan/. Published February 25, 2020. Accessed March 4, 2020.
7. Weintraub A. ICER pulls report blasting 'marginal' RA drugs, citing need to rethink its approach FiercePharma. https://www.fiercepharma.com/pharma/icer-pulls-report-blasting-marginal-ra-drugs-citing-need-to-re-think-its-approach. Published October 2, 2019. Accessed March 4, 2020.
8. Schafer JA, Galante D, Shafrin J. Value tools in managed care decision making: current hurdles and future opportunities. J Manag Care Spec Pharm. 2017;23(6-a):S21-S27. https://www.jmcp.org/doi/pdf/10.18553/jmcp.2017.23.6-a.s21.
9. Magellan. Medical Pharmacy Trend Report 2019. https://issuu.com/magellanrx/docs/mptr2019?fr=sMmE2MTk0MDI3Nw. Accessed March 4, 2020.
10. Gopalan A. CVS announcement of cost-effective benchmarks puts ICER in the spotlight. STAT.https://www.statnews.com/2018/08/22/cvs-cost-effectiveness-benchmarks-puts-icer/. Published August 22, 2018. Accessed March 4, 2020.
11. ICER. ICER finalizes 2020 updates to methods and public meeting procedures for value assessment framework. https://icer-review.org/announcements/2020_vaf_update/. Published January 31, 2020. Accessed March 4, 2020.