Wednesday, June 1, 2016

qotd: ICER: Does it work, and is it worth it?

Institute for Clinical and Economic Review (ICER)

About

ICER is a trusted non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system.  To accomplish this goal ICER performs analyses on effectiveness and costs; develops reports using innovative methods that make it easier to translate evidence into decisions; and, most distinctively, fills a critical gap by creating sustainable initiatives with all health care stakeholders that can align efforts to use evidence to drive improvements in both practice and policy.  Through all its work, ICER seeks to play a pivotal role in creating a future in which collaborative efforts to move evidence into action provide a foundation for a more effective, efficient, and just health care system.


An example: Treatment Options for Relapsed or Refractory Multiple Myeloma:

Evidence report: Multiple Myeloma:

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USA Today
May 26, 2016
Health insurers find back door to limit choice
By Jeff Stier

Lost in the noise of political posturing over health care, there's one widely accepted principle: the importance of the doctor-patient relationship in medical decision-making.

Yet we've all heard stories where insurance companies won't fully cover a drug that both the doctor and patient believe is the right medical choice. Why not? It's pretty simple: the insurance companies don't want to pay.

As cutting edge drugs come to market, insurance companies are scrambling to find ways to justify not paying for them.

Insurers will tell you (if you can get them on the phone) the drug isn't covered because it's not on their formulary, their own list of preferred medicines. Kids have a term for this: "Sorrynotsorry." Don't let the circular reasoning fool you.

Almost as bad, doctors often have to get pre-authorization before prescribing something that is on the formulary. (Because we all need more paperwork.)

The flawed justification was normalized by President Obama in 2009, when he oversimplified pharmacoeconomics, saying, ���If there's a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half price for the thing that's going to make you well?"

Insurance companies are using this concept to cut costs by excluding the red pills. To do so,they've cooked up a clever way to justify exclusions from formularies by founding and funding a group called the Institute for Clinical and Economic Review, or ICER.

ICER does a version of something called "comparative effectiveness" to determine whether, across the population, the drugs are worth the cost compared to other treatments. It releases the findings around the same time drugs come to market, just in time for insurance companies, who, not coincidentally, serve on ICER's governing board, to justify excluding FDA approved drugs from the formulary based, in part, on ICER's "independent" math.

ICER's approach appears to be modeled on the United Kingdom's National Institute for Health and Clinical Excellence (NICE) model, which tries to judge the cost-effectiveness of therapies, in order to help determine which health services the government should provide. ICER and NICE share more than just three letters; ICER's president, Steven Pearson, was awarded an Atlantic Fellowship by the British Government and acted as Senior Fellow at NICE.

If insurers get to play the role the British government does, determining which pills are cost-effective, we'll have taken a huge step not only toward rationing, but toward stifling innovation.


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Business Wire
May 25, 2016
The Center for Medicine in the Public Interest Says ICER's Proposed Value Assessment for New Cancer Medications Would Cost Thousands of Lives and Stifle Innovation

The Center for Medicine in the Public Interest (CMPI) – a not-for-profit organization that advocates for consumer access to medical innovation – today challenged so-called value frameworks being proposed by the Boston-based Institute for Clinical and Economic Research (ICER). A white paper authored by Robert Goldberg, Ph.D, vice president and co-founder of CMPI, concludes that under ICER's plan, 44,000 fewer patients with the cancer multiple myeloma will be alive within the next five years than if access to new medicines continues to grow at historical levels. At the same time, the CMPI report projects a serious drain on the U.S. economy from this loss of life, costing more than $12 billion in health expenditures and lost productivity.

The CMPI report, Not at Any Price: How ICER Robs Myeloma Patients of their Hope, challenges ICER's assessment of the value of recently approved therapies for multiple myeloma, a rare cancer of cells in the bone marrow. ICER has also announced plans to conduct similar assessments of new treatments for lung cancer, multiple sclerosis and other serious diseases in the coming months.

Based on a thorough review of ICER's assessment and its calculations, the CMPI report questions ICER's evaluation on a number of grounds. One major concern is that ICER applies a measure called the QALY, quality adjusted life year, to determine how much insurers and health systems should pay for additional years of life relatively free of disease. Therapeutics that exceed the QALY threshold are considered too expensive to be used unless prices are lowered.

"In practice, QALYs lead to rationing," Dr. Goldberg stated. "Due to the reliance on QALYs, ICER ignores the value patients place on novel medicines that extend their lives when they are faced with certain death."


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Comment by Don McCanne

ICER (Institute for Clinical and Economic Review) is a non-profit organization that analyzes effectiveness and costs of medical tests, treatments (including drugs) and delivery system innovations thereby "creating sustainable initiatives with all health care stakeholders that can align efforts to use evidence to drive improvements in both practice and policy." These collaborative efforts "provide a foundation for a more effective, efficient, and just health care system."

The majority of ICER's funding is from private, non-profit foundations. Stakeholders do provide input and feedback in developing the reports, but they are not responsible for the final contents of the reports nor should they be assumed to support any part of the reports which are "solely the work of the ICER team and its affiliated researchers." As an example of the integrity of the organization, two of the panel members are our esteemed friends, Aaron Carroll, MD and Harold Pollack, PhD (though Pollack still has concerns about single payer feasibility).

The function that ICER is attempting to fulfill is desperately needed in the United States. We spend far more on health care than other nations yet have a system that is noted, on average, for its mediocrity. We need objective evaluation of old and new technology and the comparative effectiveness of various options for medical management. We also need to better understand whether the prices we are paying are commensurate with the health care value we are receiving. We have to end the U.S. model of paying too much for inferior technology - a model that is made possible by pretending that the markets will automatically improve value though that is nearly impossible when vested interests are preventing transparency. It's time to turn on the lights.

NICE, the National Institute for Health and Care Excellence in England and Wales, is a leader in providing guidance on efficiency and cost effectiveness. Although an excellent source of such information, it has been under continual attack in the United States by anti-government conservatives and by stakeholders who profit from the dysfunction in our system. We frequently see claims that the British National Health Service is killing people by withholding life saving drugs or procedures. In fact, NICE recommendations are resulting in better care at lower prices.

We are now seeing this attack replicated on ICER. The USA Today article excerpted above is from the National Center for Public Policy Research, a conservative think tank founded by Amy Ridenour. The Business Wire article is from The Center for Medicine in the Public Interest, an organization co-founded by Robert Goldberg from the Manhattan Institute and Peter Pitts from the Pacific Research Institute, conservative and libertarian organizations. Their expressed opinions are driven by right-wing ideology and by greedy stakeholder interests, not by the public good.

Other similar articles are appearing now, and we will see many more telling us that ICER is rationing our health care. What they will not tell us is that ICER will help us select the most beneficial care while preventing outrageous price gouging. If that is rationing, then bring it on.

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