Amgen Comments for ICER’s 2020 Value Assessment Framework

Overview

Amgen appreciates the opportunity to provide input for ICER’s 2020 Value Assessment Framework. Our comments are informed by our experience engaging in ICER assessments since late 2015 and are intended to support the evolution of ICER’s framework to better align with scientific best practices.

We acknowledge ICER’s mission is “to help provide an independent source of analysis of evidence on effectiveness and value to improve the quality of care that patients receive while supporting a broader dialogue on value in which all stakeholders can participate fully.”¹

The credibility and impact of ICER as an independent value assessment body seeking to provide evidence aimed at improving patient quality of care and dialogues on value, hinges on a firm grounding in robust and transparent science, methods, and processes.  The US can benefit from rigorous systematic assessments of new technologies to help stakeholders better understand the value of new interventions.  We appreciate the steps ICER has taken to refine its value assessment framework over time, and ICER’s openness to further changes. Our comments are focused on changes that we believe are necessary to move ICER’s current framework towards a more reliable and valid approach that better aligns with its stated mission to enable more objective and robust dialogues on value. Our comments cover three areas:

• Process
• Methods
• Special considerations.

The Amgen team is available to further share detailed observations and insights in support of the below recommendations as needed. ICER’s 2020 Value Assessment Framework has the opportunity to become an evaluation process that is more systematic, transparent, objective, and scientifically robust with continued changes to the existing framework, and we are hopeful that ICER will make the necessary changes to move towards this standard. 

PROCESS  

(i)  Objectivity, Reliability, and Transparency

As an advisor to US healthcare stakeholders, the value of ICER’s contributions relies on its objectivity, reliability, and transparency.  This is especially true in a fragmented payer system where it is impossible for value assessment bodies such as ICER to have accountability to multiple budget holders, or liability for the patients potentially impacted by its recommendations.  The complexity of the US healthcare system is reflected by the diversity in payers with differing appraisal processes, as evidenced in an observed variation in formularies.² Results of independent value assessments will be more credible if the approach used is objective and consistent, and the findings are broad such that they may be adapted based on the needs of individual payers.  Whether it is an assessment group for a single payer, the FDA or an individual US insurer’s assessment group, these bodies universally recognize that organizations making decisions that affect the quality of health or survival of a given group of patients are also subject to legitimacy, regulation, and accountability. It is not without reason that governments set this accountability, as it is necessary and frequently exercised in practice. ^{3, 4, 5, 6, 7}  For example, when the FDA makes a decision to approve a new drug, it is directly accountable to the US government with extensive regulations, audits, and procedures that help to ensure its evaluations are credible, consistent, and as robust as the available evidence base allows.  Value is a highly subjective concept, and independent organizations conducting value assessments in the US, such as ICER, should demonstrate an approach that is objective, reliable, and reproducible (i.e., fully transparent), with measures to ensure these qualities are reflected in practice, such as external audits and internal reviews. 

Recommendation: As an independent organization that makes its reports public to inform discussions on value, ICER’s approach needs to be objective, reliable, and transparent, with measures in place to monitor this and take corrective action when appropriate. 

• Taking an objective, unbiased stance enhances credibility.  This means equally considering different stakeholder input, providing full transparency and rationale behind decisions and methods deviations, reporting results in a fair and balanced manner based on the available evidence, and avoiding citing personal views or opinions as facts.  Objectivity is also demonstrated by presenting multiple perspectives (health system and patient) and a range of analyses based on different assumptions, rather than anchoring the evaluations to a base case from the perspective of a single type of payer.  Another key area where ICER can be more objective is when moderating appraisal committee meetings, as subjective statements or opinions (as innocuous as they may seem) have had and will continue to have a strong impact on influencing panel outcomes.
• Adhering to a consistent, reliable approach will further lend itself to being trusted.  ICER has several good mechanisms in place that follow a sound approach, such as posting a topic, followed by scope, and then the report.  A key area of focus is providing consistency in approach with ICER published methods and protocol, and when deviations are needed, publicly disclosing amendments in a timely manner with a clear rationale.  Health technology assessment (HTA) is a dynamic process and changes are inevitable; however, these changes need to be managed systematically and transparently to yield a reliable process that may be replicated.
• Offering full transparency fosters greater trust and credibility.  Across all initiatives, ICER should make its process, research methods, assumptions, data inputs, and equations available in a completely transparent manner, such that results are fully reproducible by third parties and reviewed by known experts as part of the assessment.  We also suggest that ICER implement a process allowing for external, independent validation of economic model structure, inputs/assumptions, and results.  ICER has made some advances towards transparency and fostered candid discussions with stakeholder parties on this topic. We encourage ICER to seek out collaborative model agreements that are free from privacy/intellectual property constraints to enable third parties to validate key aspects of its economic analyses, especially given that the outcome is intended as a public good. 

(ii)  Appraisal Committee Composition

As the key body of stakeholders deliberating at ICER’s Public Meetings, the voting panel should include those with relevant expertise and represent those directly impacted by its recommendations for a given disease area.  Patients are the end consumer and arguably the most important stakeholder for any assessment of health and treatment value.  Payers, physicians, and manufacturers are other stakeholders that may be directly impacted by the panel results.  A May 2019 analysis of ICER’s 3 voting panels (CTAF, New England CEPAC, and Midwest CEPAC) found that most members are in the academic field, while there are very few patient advocates.  Of the 59 voting members across the 3 panels, 70% were academics, 9% were payers, and only 7% were patient advocates.⁸  It is a concern that patients in this process are often passengers with highly limited involvement in decisions that most personally impact them.  In addition, the patient advocates currently included on ICER’s panels do not represent the views and perspectives of a typical patient that would be impacted by that assessment (for example a male oncology patient representative on a migraine panel is unlikely to be able to empathize with the burden of a female migraine patient).  It is very hard for those who have not directly experienced the condition as a patient or treated it as a physician to provide an informed judgement on treatment value.  Furthermore, there are no manufacturers or disease experts on the voting panel.  More relevant discussions and appropriate decisions could be made by the panel by adding voices of informed individuals and groups.  In addition, it is important that panelists are held to ethical standards with clear expectations and a code of conduct for preparations, involvement, and interactions leading up to and throughout the appraisal meeting.  The panel moderator should assume an impartial and objective stance and hold the panelists accountable to the appropriate code of conduct.

Recommendation: ICER’s voting panels should include relevant patient advocates, disease experts, physicians, and manufacturers.  A code of conduct regarding panelist expectations and panel moderation should be publicly available. ICER has made progress on its overall stakeholder engagement approach and should continue to engage all relevant stakeholders early on and throughout its process, including panel voting.

(iii)  Impact Monitoring

Based on ICER’s mission, the corresponding value assessments aim to improve overall patient quality of care, which suggests they should have a positive impact on improving patient access when treatments are “good value”.  To remain true to this mission, it is important that ICER’s impact be equally favorable to reducing access hurdles for patients as they may serve as negotiation tools for payers.  ICER’s press releases communicate that products are “low value” without tethering the ‘who’ they are low value to – the insurer.  In the present U.S. healthcare environment, this translates to cost-savings for the insurer, which the patients and the broader society does not benefit from. ICER assessments may be leveraged by payers in negotiations with manufacturers resulting in 1) greater use of prior authorization for patients and step-edits which can put significant delays in patients being able to access the treatments that their physicians believe are in their best interest and 2) placing drugs into higher tiers which could lead to greater cost falling to patients from co-payments and co-insurance rates.⁹ We appreciate instances where ICER has reported treatments to be “good value for money” and encouraged payers to provide access; although soft trends suggest there was no improvement in access.¹⁰  We hope ICER will seize the opportunity to be an advocate for patient access through greater efforts working with payers to reduce access barriers when treatments are good value. 

We encourage ICER to monitor the impact of its assessments on patients’ ability to access treatment, and continue to refine its approach to better help patients achieve optional quality of care. More research is needed to tie HTA presence and type of value framework or methodology to improvements in health delivery and overall healthcare outcomes.^11,12 Without ongoing monitoring and refinements, value assessment outputs may have unintended consequences, causing harm to patients.  There is a distinct lack of research on how HTA affects healthcare efficiency, budgets, and societal health outcomes.¹³  While other factors may be at work, much more research is needed on the impact of HTA and patient access.^14,15  Furthermore, HTA in which cost-effectiveness is the key determinant of value has been observed to result in more restricted patient access compared to HTA where clinical evidence is the key determinant.¹⁶  Additionally, the impact of HTA is inconsistent across therapeutic areas.¹⁷  ICER and others looking to apply HTA in the US should first evaluate the impact of different types of HTA on patient outcomes, patient access, and affordability to avoid  inadvertent effects on patient health status or financial burden on specific patient subgroups (e.g., subgroups that could take a greater role in ICER assessments, such a rare disease patients, pediatrics patients and caregivers). 

Recommendation: We encourage ICER to become an advocate for patient access when treatments are good value, making greater efforts to work with payers to reduce barriers to access and monitor the impact of their findings to understand and learn from how their assessments are being used.

METHODS

i)  QALY and evLYG

ICER should actively supplement the QALY as a starting point, with additional relevant data that is appropriately weighted, informed by patient and stakeholder inputs.  Over-reliance on the Quality-Adjusted Life Year (QALY) as the sole outcome measure for assessing value will diminish the accuracy and applicability of the value assessments given the size and complexity of the US healthcare ecosystem. A dependence on cost-effectiveness introduces severe limitations in HTA decision making, omitting fundamental variables such as unmet need, patient vulnerability, and the potential of breakthrough treatment innovations. Health economic groups, including the ISPOR Special Task Force on US Value Assessment Frameworks, are attempting to identify alternative approaches to the QALY to better characterize value.¹⁸ The empirical application of the QALY is complicated by a multitude of challenges ranging from the inherent unreliability of these outcomes to discrimination in their application that could lead to decisions placing patients’ health at risk.  Key challenges are noted below:

• QALYs have insufficient sensitivity to measure small but clinically meaningful changes in health status.  For example, QALYs disproportionately penalize patients with short life expectancies or reduced endurance limits and additionally, they do not accurately reflect patient preferences.¹⁹
• QALYs cannot be derived for very young or very old populations.  An outcome should not be a function of the ability to elicit a utility (as in children and babies or use of caregiver proxies), and they should not be a function of lifespan.²⁰
• QALYs are not consistent for all patients.  Patients with lower QALYs due to co-morbidities or with a chronic disease whose lives are extended will have overall higher/unfavorable incremental cost per QALYs than patients with mild disease.  Additionally, QALY increments for patients at the lower end of QALYs will be more meaningful than those at the upper end.
• QALYs are inappropriate for rare, life-threatening disease.  See the below section on rare disease.

ICER has introduced the equal value of Life Years Gained (evLYG) to help address a key issue flagged as a limitation of the QALY – undervaluing treatments that extend life but do not improve quality of life. Although the QALY is in much need of supplementation, and the evLYG ensures that years of life irrespective of health state are considered, it also introduces other limitations in that any changes in quality of life are ignored and it does not address many of the very significant methodological and practical inaccuracies of the QALY.

Recommendation: ICER should actively seek to supplement the QALY and evLYG with additional relevant data with appropriate weighting informed by patient and caregiver preferences, and expert input. Also, please refer to the contextual considerations section below.

(ii)  Cost-Effectiveness (Incremental Cost-Per-QALY) Thresholds

Cost-effectiveness thresholds vary significantly based on context, and therefore must be flexible, updated periodically to reflect societal preference and the willingness to pay for care, and only established by budget holders to inform their decisions. We appreciate that ICER seems to accept that a single static threshold may not be the most appropriate approach, and hence, is seeking feedback on this topic.  Given the complexities of the US healthcare system and extensive limitations of the QALY, ICER should abandon static cost-effectiveness (C/E) thresholds based on the incremental cost per QALY.  Use of static C/E thresholds has consequences on patient outcomes and costs; while greater research is needed, there is evidence suggesting countries that apply static thresholds to decision making also have correlated poorer health outcomes. One study compared the impact of C/E thresholds in decision making for cancer drugs between five countries that use C/E thresholds and five countries that do not.  The results showed that patients in countries that use C/E thresholds have both more restricted and delayed access to cancer drugs, with lower associated survival rates.²¹  ICER should carefully evaluate the possible impact of using static C/E thresholds in the US through the lens of how it could limit access to innovative, lifesaving treatments.  ICER has a unique opportunity to deliver good service to decision makers in providing robust cost-per-QALY estimates, without framing these with highly subjective and static C/E thresholds.

Cost-effectiveness thresholds should represent broad ranges that are flexible enough to enable assessments to be appropriately tailored according to important contextual nuances.  There is no scientific foundation to leverage a static $50,000 to $150,000 threshold to inform value-based prices, which is pulled from a contextually irrelevant and widely criticized WHO “benchmark” of one to three times per capita GDP, or to adapt thresholds from other countries given the fragmented US healthcare system where there are no data to inform that the true opportunity cost of a new technology is at the margin of health spending.^{22,23,24,25,26,27,28}   Appropriate C/E thresholds could range from as low as $50,000 to greater than $500,000 depending on a number of key contextual variables such as (a). availability of treatments, (b). rule of rescue, (c). severity of condition, (d). prognosis, (e). societal fear, (f). impact to specific populations, and (g). information available to budget holder to optimize healthcare efficiency.  Examples of how C/E thresholds could vary from less than $150,000 to greater than $500,000 based on such variables include the following; however, one should keep in mind that C/E thresholds are inherently biased against the oldest and sickest patients, as well as those with rare diseases.   

• Less than $150K/QALY: This is less relevant for innovative treatments addressing areas of high unmet need.  Generally lower thresholds are designed for less resourced countries or highly restrictive markets where tough trade-off decisions regarding resource allocation needs to be made.  Lower thresholds may also be relevant to circumstances where the disease is common, prognosis is good, and patients are well-served through available treatment options, including generic standard of care.  For example, screening and treatment for some types of clinical and subclinical disease as suggested by one researcher.²⁹
• Greater than $150K/QALY: May be more relevant for innovative treatments where there is an unmet need. For example, this may be acceptable for some cardiovascular diseases depending on the incidence, patient disability, access issues and available alternatives.^30,31
• Greater than $250K/QALY: May be more relevant for illnesses with high burden, poor prognosis or that are devastating in nature.  For example, certain oncology treatments may have acceptable C/E threshold above $250,000³².
• Greater than $500K/QALY: Rare diseases likely command a C/E threshold of greater than $500,000 based on a recent systematic review.³³ These diseases are characterized by extremely low incidence, few/no treatment options, poor prognosis without treatment, and high disease burden (e.g., paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, hemophilia, and Gaucher’s disease).

We encourage ICER to empower the appraisal committee’s contributions by enabling deliberation based on the available evidence, without the confines of a threshold that suggests what the voting results should be.  The current assessment framework allows ICER’s QALY threshold to overrule the panel’s deliberation and disempowers the committee by automatically designating a ‘low value’ for treatments with an incremental cost per QALY above $175K.  This eliminates ICER’s spirit and intent of a process initially designed to allow the committee to appropriately gauge the intangible costs of a disease and the nuanced benefits of each new treatment.  It also removes the opportunity for the committee to rate promising new treatments any higher, limiting the committee’s contribution.  ICER has the opportunity to abandon this approach and recapture the full richness and patient relevance of contextual criteria reflected in its assessments, aided by a truly empowered independent public appraisal committee.

Recommendation: ICER should disaggregate estimates of cost effectiveness (incremental cost per QALY) from C/E thresholds and leave willingness to pay up to each respective decision maker instead of attempting to define it on behalf of the US public. We also encourage ICER to eliminate the C/E threshold constraints imposed upon the committee and directly include valuation methods in the framework and cost-effectiveness analysis that allow value and contextual considerations to have a greater impact.

(iii)  Contextual Considerations

ICER’s framework should be modified to place less weight on the QALY and enable more emphasis on capturing value based on important determinants from all stakeholder perspectives.  It is well recognized by many experts that HTAs are limited by an overreliance on QALYs, which place too much emphasis on cost-effectiveness and willingness-to-pay thresholds to guide decision making, and alternative tools that provide a more holistic assessment of value are needed.  ICER has a good starting point with its list of contextual considerations reviewed by the appraisal committee.  However, based on the current approach, important determinants of value buried within contextual considerations largely sit ‘outside’ of the framework, where they have much less visibility and do not influence the quantitative analysis nor do these influence the panel vote.  The treatment of these data obscure value determinants resulting in minimal or no impact on the ultimate assessment of value. 

We encourage ICER to explore new methodologies with empirical application that is scientifically sound, robust, and validated.  Several techniques are in development to more comprehensively capture aspects of value that include both health and non-health benefits such as wider public health effects, positive net tax flow, distribution of health, stimulation of medical innovation, peace of mind, and increased macroeconomic growth.  Examples of methodologies in development and being tested are listed in the Appendix, and include multi-criteria decision-analysis (MCDA), augmented or extended cost-effectiveness analysis (ACEA/ECEA), and the Burden Augmented by Deadliness and Impact.^34,35

Recommendation: Make central in the framework varied and flexible valuation methods that synthesize the value from all the areas ICER currently recognizes, rather than as additional contextual criteria that have minimal impact on the ultimate assessment of value.  ICER had previously attempted a modified MCDA and should secure learnings from that experience and expert input to inform alternative approaches to incorporate additional data in a robust manner, with relevant weights.  This is an evolving field and an iterative approach may be needed which can be refined over time.  Until best practices are identified, emphasis should be placed on flexibility, enabling early patient preference and expert input to inform weighting, and ensuring full transparency around the process. 

(iv)  Uncertainty

Uncertainty is unavoidable and should be managed by incorporating all relevant data as part of the assessment and enabling more data collection over time without penalizing innovation from the start.  This includes explicit methods that allow for the incorporation of real-world evidence (RWE) and other data beyond randomized, controlled trials (RCTs). Until more data are available, ICER should take extra caution when reporting results of scenario analyses and sensitivity analyses that are not comprehensive enough to address uncertainty but are communicated with results as absolutes and averages, without context or robust quantification of unknowns.  There are examples where ICER used optimistic assumptions when little to no data was available (e.g., gene therapies, CAR-T) and we encourage ICER to continue to incentivize innovation in areas of high patient burden, when data is initially limited and over time becomes available. 

Recommendation: ICER’s value framework should incorporate all relevant data beyond RCT data, including real-world evidence (RWE) such as that derived from claims databases and electronic records.  In addition, patient-generated data should have equal weight to other types of data and every effort should be made to include local community patient data to ensure that the assessment is relevant to the patient community it is designed to serve.  Adequate measures should be recommended to address the uncertainty in evidence in a manner that protects patient access, such as risk share agreements and innovative contracts.  Results should be presented as ranges rather than absolutes to acknowledge the significant uncertainty associated with these assessments. Reports should state how the results may differ under scenarios where patients respond differentially to alternative treatment options and value the various outcomes accordingly.

(v)  Broad Societal or Multiple Perspectives

ICER should incorporate patient, caregiver, and employer costs in its 2020 Framework, and reflect costs incurred by wider society in its value assessments.  ICER’s current framework employs the perspective of the payer/healthcare system not the wider population. Limiting costs to those incurred by payers and the healthcare system will lead to decisions that shift costs to patients, their caregivers, employers, and wider society.  By modifying this to reflect wider society, or at least including multiple perspectives as opposed to the payer/healthcare system perspective as the base-case, the results will have greater accountability to the impact of costs on wider society including patient out-of-pocket costs, employer costs and productivity losses.

In ICER’s current approach, costs are not ‘saved’ but simply shifted away from the payer; ICER has the opportunity to present broader savings for society.  Specific patient groups, their caregivers and employers are likely to be penalized because of this choice of perspective.  For example, depression is a disease that the World Health Organization reports as the largest single cause of global burden of illness and more than half of costs are from lost productivity; this cost burden is similar for pain.^36,37  In autism spectrum disorders, 90% of lifetime costs are borne by patients, their caregivers, and society, with patient out-of-pocket costs three times greater than direct healthcare costs.³⁸  High costs outside of the medical system are not limited to a few indications.  In a recent systematic review of high-cost drugs, non-medical costs on average comprised 45% of total costs and their inclusion materially changed decision-making in 31% of cases.³⁹  These are conditions affecting patients and caregivers who cannot easily advocate for themselves and are affected by cost burdens that would be silent in ICER’s approach to measuring cost.  Exclusion of these costs in assessing the value of new health interventions puts a significant burden not only on patients and their caregivers, but also on employers.  Self-insured employers represent 91% of people working in companies above 5,000 employees.⁴⁰ 

By adopting a broad societal perspective, ICER’s choice of perspective will better align with over 20 years of expert input.  The First Panel on Cost-effectiveness in Health and Medicine convened by the US Public Health Service (PHS) recommended using a societal perspective as the reference case.⁴¹  The panel, made up of leading experts in medicine, health economics and health technology assessment, recommended capturing all costs from the perspective of society over 20 years ago as best practice.⁴²  This was confirmed in the Second Panel on Cost-effectiveness in Health and Medicine in 2016.⁴³ 

Recommendation: Payer-borne direct monetary costs are only one aspect of healthcare burden.  ICER should include costs and cost savings resulting from treatment that are relevant to all stakeholders, including non-medical costs, such as patient and caregiver out-of-pocket costs and lost productivity costs in its 2020 Framework reference case as is recommended by the Panel on Cost-effectiveness in Health and Medicine.

 ADAPTATIONS/SPECIAL CONSIDERATIONS

(i)  Rare Disease & Special Considerations

ICER’s Framework should make special provisions for patients with rare disease and other special populations, as it has done for patients with ultra-rare conditions.  Although ICER has made advances to allow special considerations for ultra-rare conditions, the current framework runs counter to the US Orphan Drug Act (ODA) of 1983, the legislation designed to incentivize innovation and protect all patients with rare diseases (not just those with ultra-rare conditions).⁴⁴  By limiting special considerations to those conditions with a prevalence of 10,000 or less (i.e., ultra-rare), ICER’s current framework arbitrarily puts all other rare diseases with a prevalence of 10,001 or more into the same category as common illnesses, with the same evidence requirements and value assessment criteria.  This ignores the magnitude of difficulty in performing clinical trials and collecting real-world evidence for rare diseases that do not meet the criteria for ultra-rare disease.  The current framework also excludes the costs incurred by patients, caregivers, employers and society, undervaluing the ability of new treatments to offset the significant burden of both rare and ultra-rare disease.  The framework’s application of the QALY presents several very specific challenges, excluding these patients from an equal chance at health, or a healthy life and devaluing rare disease patients who have a limited life expectancy.  In addition, the choice to use static cost-effectiveness thresholds is not informed by preferences of US citizens or the government.  This unfortunate categorization will essentially lead to most (if not all) interventions for these rare disease patients (with disease prevalence >10,000) receiving a ‘low’ value rating, without proper appraisal.  This will likely have consequences in slowing the pace of scientific innovation necessary to prolong survival, improve quality of life, and potentially find cures for patients with all rare diseases.

Recommendation: ICER should include special framework adaptations for all rare (orphan) diseases, not just ultra-rare diseases.  We encourage ICER not to apply the same value framework to orphan drugs as for common drugs as the methodological concerns around common diseases would be further amplified in orphan diseases, and not to attempt to set a national threshold for orphan drugs.  ICER’s 2020 Framework should align with the definitions and provisions in place to protect patients with rare diseases, including provisions that account for the difficulty in designing, recruiting, and performing clinical studies. ICER should ensure the patient voice is heard and put at the center of assessments and should include costs relevant to both them and wider society.

(ii)  Biosimilars

The introduction of a biosimilar marks a significant milestone in the treatment landscape, providing more options for patients, and all available biosimilars should be included in value assessments, including those conducted by ICER.Biosimilars present the opportunity for greater value for biologic medicines and greater savings potential that will contribute to the sustainability of the healthcare system.

A biosimilar is not a new category of medicine but an FDA-approved molecule deemed highly similar to a prior approved biologic medicine and should not be treated as a separate class in value assessments.  Highly similar is defined by the FDA as having no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) when compared to an existing FDA-approved reference product.⁴⁵  The totality of evidence, including analytical, non-clinical, and clinical data is the basis of the FDA assessment of the biosimilarity of a drug and of the marketing authorization in all approved indications of the reference product, including those in which the biosimilar has not been studied in a phase 3 clinical study.  To be consistent with this, it is important not to create the perception that these are a separate category.

In the US marketplace, biosimilar medicines compete directly with the biosimilar’s reference product, and other products approved as biosimilar to that reference product. A biosimilar product may be approved only to treat conditions for which its reference product is already licensed and intended to be used.  For these reasons, instead of creating a separate biosimilars category (such as “Exemplar Biosimilars”), ICER’s analysis should treat biosimilars in the same manner as the reference products, just as they compete directly against the reference products on a level-playing-field basis in the marketplace.  In keeping with this, ICER’s ongoing Rheumatoid Arthritis Condition Update for example, should include all available biosimilars, including Renflexis^® in addition to Inflectra^®.⁴⁶  With this approach, ICER has the opportunity to help accelerate patient treatment with all biologics, not just a limited few.  Equally, this is aligned with precedents in how ICER has considered biosimilars in prior assessments and updates.

Recommendation: ICER should employ a consistent approach to biosimilars as with prior assessments and include all available FDA-approved biosimilars in the assessment and avoid introducing it as a new category.

Conclusions

Amgen appreciates ICER’s engagement of stakeholders in an effort to continuously update its Framework.  We urge ICER to modify the current framework based on these recommendations, which are founded in guiding principles representing best practice and rigorous scientific methods.  ICER has an opportunity to take a longer-term view of its role and command greater credibility by defining its role as one that offers guidance and informs decisions with a systematic approach to the evaluation of evidence with flexibility, inclusiveness, scientific integrity, transparency, and patient centricity, in the absence of absolutes based on subjective thresholds.  Taking this direction will allow ICER to become a more trusted independent organization. Budget holders and decision makers can benefit if ICER focuses on key pillars of evidence, robust analytics, and the identification of areas of uncertainty.  This ultimately allows the budget holders and decision makers to leverage ICER’s insights in making their decisions on value.  Thoughtful attention should be given to the fact that at any given time we are all patients who will likely feel the impact of ICER’s assessments.  These assessments could have far reaching and unintended human costs and implications for all of us.

REFERENCES