Access
Addressing government policy changes that negatively impact access to care for those living with CLL / SLL is a very important part of our Policy Institute work. We are dedicated to addressing health equity initiatives, as not all patients have equal access to the care they need. Certain communities such as those with low-income levels, persons of color, and those who live in rural settings often face systemic social, economic, and environmental disadvantages that directly impact their ability to receive quality care. CLL Society’s Policy Institute aims to gain a more granular understanding of health inequities that exist for those with CLL / SLL, look at ways to break down barriers to care that patients often encounter, increase accessibility to clinical trials, reach out to equity stakeholders, and ensure that CLL Society can articulate how its policy objectives facilitate equitable care.
The following are some examples of the efforts that fall under the Policy Institute's ‘Access’ pillar:
Inflation Reduction Act of 2022 (IRA) Implementation.
The recently enacted landmark healthcare law empowers the Centers for Medicare & Medicaid Services (CMS) to negotiate lower prescription drug prices and purports to make drugs more affordable, resulting in a savings of up to one billion dollars over ten years.
CLL Society’s Policy Institute aims to carefully identify provisions within this law that will potentially impact both patients and healthcare providers. Our efforts will begin with an overarching assessment of key provisions within this law and identifying their potential impact upon the CLL / SLL community.
The mechanisms for identifying the medications that will be subject to drug price negotiation and the factors implicated in those negotiations will be critical too. We anticipate the need to articulate the value of innovative treatments for patients through a dialogue with Congress, CMS, Payers, and the Institute for Clinical and Economic Review (ICER) if needed.
Provider Economics.
As we discover more about provider economics and how the Inflation Reduction Act (IRA) and other policies change the incentive framework for healthcare providers, CLL Society is concerned about the impact on treatment patterns. Progress in improving survival outcomes for CLL / SLL patients requires patient-specific treatment decisions and a sequential approach to therapeutic options that occurs through shared decision making between the patient and their healthcare provider.
Any downstream impact that slows innovation or artificially influences treatment pathways between a patient and their healthcare provider could substantially slow drug development advances that have extended patient lives and could even reverse previous progress made to date.
In addition, the newly revamped Enhancing Oncology Model (EOM) will launch in July of 2023, and continue for 5 years. Given that one of the focus areas for EOM is chronic leukemias, CLL Society plans to utilize the Policy Institute’s strategic framework to work alongside healthcare providers to gain a better understanding of how the bundled payment levels were set. We also aim to determine whether the model is meeting its goal of improving the care experience for CLL / SLL patients, and the impact it is having on patient care.
Pharmacy Benefit Manager (PBM) Practices.
PBMs have been a focus for policymakers and other stakeholders, particularly around the cost of medications. Congress, regulators, and market disrupters are interested in pursuing solutions to address PBM practices that have led to consolidation, lack of transparency, and spread pricing.
Some proposed legislative efforts include a Medicaid bill to prohibit PBMs from adding premiums to the cost of drugs, rebates have also been a significant driver of overall drug prices, and the Federal Trade Commission may launch a formal inquiry into PBM practices. In late 2022, The Centers for Medicare and Medicaid Services (CMS) proposed to require that the ACA Plans include generic formularies on the generic tier, circumventing PBM practices to extract larger rebates for preferential tiering of branded products.
Payer Models.
Some drug manufacturers provide copay assistance programs, copay coupons, and copay cards to patients in order to help reduce their out-of-pocket costs. Copay accumulators would allow insurers and PBMs to exclude financial support from a drug manufacturer in calculating a patient’s deductible or annual out-of-pocket maximum. These programs are sometimes called “copay accumulator” or “copay maximizer” programs. The maximum value of the manufacturer’s coupon/card is then applied evenly throughout the benefit year, and the patient may remain responsible for a drug copayment throughout the year.
Alternative payment models are meant to incentivize low-cost, high-quality care. For CLL / SLL patients, it will remain important to review the contours of each proposed model and its incentive framework to identify potential pitfalls that might compromise patient care, monitor the implementation of models, evaluate results, and understand potential implications for patients. CLL Society’s understanding is that many efforts have already been underway with other leading patient advocacy organizations. However, there has been growing frustration given limited successes. We look forward to engaging those who are leading such efforts and consider ways in which we can substantively provide support.
Utilization Management.
Utilization management efforts, including prior authorization and step-therapy, continue to take more aggressive forms that can undermine patient care. Treatment decisions for CLL / SLL patients are never one-size-fits-all, as each patient can have a type of disease that is unique to them. Implementing burdensome documentation requirements to, for example, diverge from a payer’s step-therapy protocol takes valuable time away from healthcare providers and makes it more difficult for them to appropriately treat their patients using a shared-decision model of care.
Health Equity.
Black patients with CLL / SLL have significantly lower overall survival compared to other racial groups according to findings presented at the 2022 American Society of Clinical Oncology’s Annual Meeting. Moreover, the survival disparities for Black patients have remained consistent despite recent advances that have improved CLL / SLL patients’ overall survival rates. Black patients remain 64% more likely to die than their white counterparts.
Policy changes impacting access to care for CLL / SLL patients will almost certainly have a disproportionately deleterious impact on people of color. CLL Society’s Policy Institute will aim to gain a more granular understanding of health inequities in CLL / SLL, reach out to equity stakeholders, and ensure that CLL Society can articulate how its policy objectives facilitate equitable care.
OUR ACCESS-RELATED POLICY WORK:
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Access
Addressing government policy changes that negatively impact access to care for those living with CLL / SLL is a very important part of our Policy Institute work. We are dedicated to addressing health equity initiatives, as not all patients have equal access to the care they need. Certain communities such as those with low-income levels, persons of color, and those who live in rural settings often face systemic social, economic, and environmental disadvantages that directly impact their ability to receive quality care. CLL Society’s Policy Institute aims to gain a more granular understanding of health inequities that exist for those with CLL / SLL, look at ways to break down barriers to care that patients often encounter, increase accessibility to clinical trials, reach out to equity stakeholders, and ensure that CLL Society can articulate how its policy objectives facilitate equitable care.
The following are some examples of the efforts that fall under the Policy Institute's ‘Access’ pillar:
Inflation Reduction Act of 2022 (IRA) Implementation.
The recently enacted landmark healthcare law empowers the Centers for Medicare & Medicaid Services (CMS) to negotiate lower prescription drug prices and purports to make drugs more affordable, resulting in a savings of up to one billion dollars over ten years.
CLL Society’s Policy Institute aims to carefully identify provisions within this law that will potentially impact both patients and healthcare providers. Our efforts will begin with an overarching assessment of key provisions within this law and identifying their potential impact upon the CLL / SLL community.
The mechanisms for identifying the medications that will be subject to drug price negotiation and the factors implicated in those negotiations will be critical too. We anticipate the need to articulate the value of innovative treatments for patients through a dialogue with Congress, CMS, Payers, and the Institute for Clinical and Economic Review (ICER) if needed.
Provider Economics.
As we discover more about provider economics and how the Inflation Reduction Act (IRA) and other policies change the incentive framework for healthcare providers, CLL Society is concerned about the impact on treatment patterns. Progress in improving survival outcomes for CLL / SLL patients requires patient-specific treatment decisions and a sequential approach to therapeutic options that occurs through shared decision making between the patient and their healthcare provider.
Any downstream impact that slows innovation or artificially influences treatment pathways between a patient and their healthcare provider could substantially slow drug development advances that have extended patient lives and could even reverse previous progress made to date.
In addition, the newly revamped Enhancing Oncology Model (EOM) will launch in July of 2023, and continue for 5 years. Given that one of the focus areas for EOM is chronic leukemias, CLL Society plans to utilize the Policy Institute’s strategic framework to work alongside healthcare providers to gain a better understanding of how the bundled payment levels were set. We also aim to determine whether the model is meeting its goal of improving the care experience for CLL / SLL patients, and the impact it is having on patient care.
Pharmacy Benefit Manager (PBM) Practices.
PBMs have been a focus for policymakers and other stakeholders, particularly around the cost of medications. Congress, regulators, and market disrupters are interested in pursuing solutions to address PBM practices that have led to consolidation, lack of transparency, and spread pricing.
Some proposed legislative efforts include a Medicaid bill to prohibit PBMs from adding premiums to the cost of drugs, rebates have also been a significant driver of overall drug prices, and the Federal Trade Commission may launch a formal inquiry into PBM practices. In late 2022, The Centers for Medicare and Medicaid Services (CMS) proposed to require that the ACA Plans include generic formularies on the generic tier, circumventing PBM practices to extract larger rebates for preferential tiering of branded products.
Payer Models.
Some drug manufacturers provide copay assistance programs, copay coupons, and copay cards to patients in order to help reduce their out-of-pocket costs. Copay accumulators would allow insurers and PBMs to exclude financial support from a drug manufacturer in calculating a patient’s deductible or annual out-of-pocket maximum. These programs are sometimes called “copay accumulator” or “copay maximizer” programs. The maximum value of the manufacturer’s coupon/card is then applied evenly throughout the benefit year, and the patient may remain responsible for a drug copayment throughout the year.
Alternative payment models are meant to incentivize low-cost, high-quality care. For CLL / SLL patients, it will remain important to review the contours of each proposed model and its incentive framework to identify potential pitfalls that might compromise patient care, monitor the implementation of models, evaluate results, and understand potential implications for patients. CLL Society’s understanding is that many efforts have already been underway with other leading patient advocacy organizations. However, there has been growing frustration given limited successes. We look forward to engaging those who are leading such efforts and consider ways in which we can substantively provide support.
Utilization Management.
Utilization management efforts, including prior authorization and step-therapy, continue to take more aggressive forms that can undermine patient care. Treatment decisions for CLL / SLL patients are never one-size-fits-all, as each patient can have a type of disease that is unique to them. Implementing burdensome documentation requirements to, for example, diverge from a payer’s step-therapy protocol takes valuable time away from healthcare providers and makes it more difficult for them to appropriately treat their patients using a shared-decision model of care.
Health Equity.
Black patients with CLL / SLL have significantly lower overall survival compared to other racial groups according to findings presented at the 2022 American Society of Clinical Oncology’s Annual Meeting. Moreover, the survival disparities for Black patients have remained consistent despite recent advances that have improved CLL / SLL patients’ overall survival rates. Black patients remain 64% more likely to die than their white counterparts.
Policy changes impacting access to care for CLL / SLL patients will almost certainly have a disproportionately deleterious impact on people of color. CLL Society’s Policy Institute will aim to gain a more granular understanding of health inequities in CLL / SLL, reach out to equity stakeholders, and ensure that CLL Society can articulate how its policy objectives facilitate equitable care.
OUR ACCESS-RELATED POLICY WORK:
