STAT News: Facing Criticism, CVS May Modify Its New Cost-Effectiveness Program for Covering Some Drugs
An article in STAT News notes that CVS may consider changes to its new cost-effectiveness program as a result of backlash from over 90 leading advocacy organizations representing patients, people with disabilities, physicians, and caregivers. Spearheaded by the Partnership to Improve Patient Care (PIPC), stakeholder groups criticized CVS Caremark’s decision last month to incorporate the Institute for Clinical and Economic Review’s (ICER)”quality-adjusted-life-year” metric in some of its coverage choices. “From a clinical care perspective, QALY calculations ignore important differences in individual patient’s needs and preferences,” the letter states. “From an ethical perspective, valuing individuals in ‘perfect health’ more highly than those in ‘less than perfect’ states of health, is deeply troubling.” Dr. Troyen Brennan, a CVS executive vice president and chief medical officer, responded to the letter saying that “It behooves us to spend some time to understand the concerns of the disability community and, if necessary, modify the measures so the process treats every life as being of equal value. We’ll go with the program we have now, but we’re looking for ways that we might modify it down the line.”
An article in BioPharmaDive highlights the latest pushback on efforts to establish quantitative frameworks for valuing medicines. These efforts, spearheaded by the Partnership to Improve Patient Care (PIPC), criticized CVS Caremark’s decision last month to “incorporate value-based drug pricing analyses in some of its coverage choices.” The letter, composed by many prominent groups including the American Association of People with Disabilities, the National Alliance on Mental Illness, and Vietnam Veterans of America, argues that their “main issues with ICER’s framework are not new and mirror some of the criticisms laid out by the drug industry’s trade lobby PhRMA. The article highlights that Tony Coelho, President of PIPC and former Congressman who led efforts to pass the Americans with Disabilities Act, took a strong stance on CVS’ decision characterizing it as an “outdated policy that has no place being referenced as a value-based initiative.”
An article in BioCentury highlights the Partnership to Improve Patient Care (PIPC)’s recent letter to CVS Health Corp, which voices the importance of a reconsideration of a new formulary that would be restricted to drugs deemed cost effective by the Institute for Clinical and Economic Review (ICER). This formulary, the article states, would “allow clients to exclude from their plan any drug with a launch price that exceeds a cost-effectiveness ration of $100,000 per-quality adjusted life year (QALY) gained as determined by ICER.” The letter, composed by 94 patient groups and individuals, criticized ICERS’s cost effectiveness analysis by arguing that cost effectiveness inherently ignores existing differences among patients. “CVS spokeperson Christine Cramer told BioCentury that the firm believes as more PBM clients adopt such programs, manufacturers will begin to moderate lunch prices,” the article states
An article in the Washington Examiner highlights the Partnership to Improve Patient Care (PIPC)'s recent letter to CVS Caremark, which voices opposition to CVS' use of quality-adjusted-life-year metric. Joined by over 90 stakeholder groups, PIPC criticizes CVS for ignoring important differences among patients while relying on a flawed one-size-fits-all assessment. "Cost-effectiveness analysis discriminates against the chronically ill, the elderly and people with disabilities, using algorithms that calculate their lives as 'worth less' than people who are younger or non-disabled," the letter states.
PIPC Chairman Tony Coelho has penned a new blog in Real Clear Health that criticizes CVS Caremark’s use of the quality-adjusted life year (QALY) metric when deciding treatment coverage. “CVS touted its program as an ‘innovation,’ but it is anything but. Under the new policy, CVS would offer employers policies that exclude drugs from their formularies if they exceed a subjective ‘cost-effectiveness’ threshold. CVS would rely on a deeply flawed value assessment model developed by the Institute for Clinical and Economic Review (ICER) in determining whether treatments fall below a $100,000 ‘cost per quality-adjusted-life-year’ limit. Patient advocates have been down this road before. In the early 1990’s Oregon proposed using a similar ‘cost-effectiveness’ formula in Medicaid, but ultimately backed away from it in part due to concern that it discriminated against people with disabilities and would violate the Americans with Disabilities Act.”
As Chairman of the Partnership to Improve Patient Care (PIPC), I have seen tremendous progress in the patient-centeredness movement, particularly in changing the culture of medical research. Yet, our leaders should know that we still have a long way to go to give patients, people with disabilities, veterans and caregivers a voice in how we deliver care that patients value. They deserve a seat at the table in any discussion of health care policy, as well as meaningful opportunities to voice their unique and real experiences
By: Janni Lehrer-Stein
I learned recently, many weeks after its early June announcement, that the Institute for Clinical Economic Review (ICER) based in Boston will develop a report assessing the cost effectiveness of a new cure for blindness, a gene therapy for vision loss associated with a form of retinal disease. By the time I learned about it, the comment period had closed to allow stakeholders to share key information relevant to the first phase of development of the evidence report. While ICER said it would contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of this new treatment option, I had never heard about it when I could have had a voice in the initial phase of the study. It’s not clear how hard they worked to get the patient perspective, and I certainly have a perspective to share
In an op-ed published in RealClearHealth, PIPC Chairman Tony Coelho examines the limitations of quality-adjusted-life-years (QALYs) and how this tools for value-assessment may systematically discriminate against patients and individuals with disabilities. As he writes, "Underlying all this is the key question we must ask ourselves when considering any policy related to the payment and delivery of health care: for whom are we creating this policy? Who is the ultimate stakeholder? If the answer is not the people served by health systems -- patients and people with disabilities -- then we have a serious problem."
Chairman's Corner: Patient Voices, Patient Value: Stepping Out of the Ivory Towers into the Real World
In a blog published by The Huffington Post, Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho urged members of the new Congress and new administration to listen to real patients and embrace health care solutions for that cater to all patients, caregivers and people with disabilities. "Patients wanted a voice in research and in health care policymaking, because, too often, traditional research is irrelevant to the goals we have for our health and our lives," Coelho wrote. Coehlo also noted that while Congress continues to focus on improving the "value" of healthcare, it is crucial for patients to have a voice in defining this value in their healthcare plans.
As a new president prepares to assume office in January, the continuing evolution of our health care delivery system — from a traditional fee-for-service payment system to a more “value-based” payment arrangement — shows no signs of slowing down.
Given the emphasis being placed on the “value of care” — who defines “value,” how the “value” of individual patient care is being judged and applied and how this assessment could deny access to treatments or services — is what motivated Lung Cancer Alliance and more than 60 groups representing patients and people served by health systems, to write an open letter to state that “value” should first and foremost be considered through the eyes of patients and people with disabilities — who are the ultimate beneficiaries of health care.
In an op-ed published in Morning Consult, Lung Cancer Alliance president and CEO Laurie Fenton Ambrose highlights their participation in a recent Open Letter, in which PIPC and over 60 other healthcare stakeholder joined to state that “value” should first and foremost be considered through the eyes of patients and people with disabilities. As she explains, "Every one of us has individual needs, unique characteristics and personal preferences that factor into our health care decisions. We do not fit neatly into one-size-fits-all models and assessments that can drive certain clinical decisions on benefits, cost and effectiveness of treatments," she notes. "That is why we must have a meaningful role in the discussion of value as only we can offer real world input on what matters to us when faced with medical decisions that impact our quality of life."
The Partnership to Improve Patient Care (PIPC) and over 40 organizations representing patients, people with disabilities and providers submitted a letter to the Institute for Clinical and Economic Review (ICER) in response to their request for input on their value assessment process. In the letter, the organizations stated, “Simply put, if we aren’t paying for care that patients’ value, we aren’t really paying for value-based care.”
Hon. Tony Coelho
PIPC Chairman, Patient Advocate
Proposals for Medicare and private payers to use CER are understandable, but concerning. Understandable because the challenge of rising costs is real, and policy-makers naturally reach for familiar policy tools. Concerning because it would pull CER away from individualized patient decisions and back towards centralized payer decisions. The end result would be limited choice of treatments based on one-size-fits-all determinations of 'value' for the average patient.
As the foundation of the healthcare policy landscape undergoes a tectonic shift that promises to reward “value” in care rather than “volume” of services, stakeholders of all types have cautiously applauded these changes as needed reforms. Yet, when patients see these principles applied – as is the case with a recent Medicare Part B Drug Payment Model – we can’t help but ask: “value to whom?
Health insurers, public and private, should support the provision of care that taxpayers, employers – people – find valuable to optimizing health. However, all too often payer perspectives don’t align with those of patients, caregivers, and clinicians.
In an op-ed published in Morning Consult, Donna Cryer, a President and CEO of the Global Liver Institute, a PIPC member, discusses how ICER's payer-focused perspective could harm patients by limiting patient access to medications. "It is unacceptable when payers, instead of patients and providers, use these reports to drive clinical decision-making based on mathematical assessments of so-called 'average value' – although I’ve never met an 'average' patient," she explains. "It is even more frustrating to think that public programs could sidestep patient protections embedded in the Medicare law through a nationwide 'demonstration project' that would allow these assessments to define treatment value."