ICER Involved in Unlawful Hep C Drug Rationing Scheme?

  • by: Robert Goldberg |
  • 06/02/2016

Ed Silverman at noted that the Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued Friday by a federal judge in Seattle.
In a strongly worded, 12-page opinion, United States District Court Judge John Coughenour agreed with their argument. He wrote that the facts “clearly favor” their contention that state policy violates federal law. In his view, the evidence “establishes that there is a consensus among medical experts and providers that the life-saving [drugs] are medically necessary” for all hepatitis C patients.”
The restrictions were developed by ICER.
Last week ICER’s boss Steve Pearson told attendees at a meeting to vote on the value of new myeloma drugs that ICER’s recommendations are not used by health systems or insurers to make coverage decisions.
In fact, ICER recommended reducing access to Hep C drugs to control spending:
"The budget impact and cost offset figures change substantially under our second treatment
scenario in which only patients with advanced liver fibrosis are started on the new treatment
regimens, with other patients treated with existing pre‐DAA regimens."
"Panel members and outside experts nearly all agreed that for both clinical and cost reasons,
not every patient with hepatitis C needs to be immediately treated with the new drugs.
Informed, shared decision‐making about the timing of treatment should be encouraged.
Given the circumstances, it is reasonable to consider prioritizing treatment with the new
drugs for patients who need urgent treatment and have some evidence of liver fibrosis but
do not have advanced liver disease.
The Washington State Healthcare Authority (WHCA) restricted Medicaid access to Hep C drugs by following the ICER recommendation.
It was sued and a federal judge ordered the WHA to make Hep C drugs available to everyone.
Here’s what the court said about WHA’s hewing to the ICER guidance:
“defendant does not come forward with any specific, credible evidence to show that its decision to apply the HCV Treatment Policy’s exclusion of DAA treatment for patients with F0-F2 fibrosis scoring is based upon medical evidence rather than solely budgetary concerns.
Or concerns of what ICER refers to as health system value. 
ICER claims the provisional health system value is grounded in “the assumption that society would prefer health care costs to grow at a rate that does not exceed growth in the overall national economy. “
Here’s what the court said about THAT:
The WHCA argues that the injunction would double the State’s Medicaid outpatient Pharmacy budget and cause them to reduce Medicaid enrollments, benefits, or provider rates to compensate for the increased expenditure in HCV treatment. (Dkt. No. 29 at 22.) The Ninth Circuit has also addressed the question of balancing the risk of irreparable harm with the risk of financial hardship for the enjoined institution. Posed with this question, the Ninth Circuit held that when “[f]aced with such a conflict between financial concerns and human suffering, we have little difficulty concluding that the balance of hardships tips decidedly in plaintiffs’ favor.” Lopez v. Heckler, 713 F.2d 1432, 1437 (9th Cir. 1983)
ICER’s involvement or influence on WHCA is not just intellectual.  ICER is one of three organizations that WHCA pays to conduct technology assessments:
“The mission of the Washington State Health Care Authority’s Health Technology Assessment Program is to ensure that medical treatments and services paid for with state health care dollars are safe and proven to work.  The program contracts for scientific, evidence-based reports about whether certain medical devices, procedures, and tests are safe and work as promoted, and an independent clinical committee of health care practitioners then uses the reports to determine if programs should pay for the medical device, procedure, or test.  The clinical committee has a legislative mandate to consider, in an open and transparent process, evidence regarding the safety, efficacy, and cost-effectiveness of the technology being reviewed.
In 2012, ICER was named one of the program’s three Technology Assessment Centers and completes one to three assessments a year for the agency.  To date, ICER has completed projects on cervical spinal fusion for degenerative disc disease, cardiac nuclear imaging, proton beam therapy, appropriate imaging for breast cancer screening in special populations, and bariatric surgery.”
ICER has tried to distance itself from the boasts it has made in the past that it serves at the pleasure of PBMs and insurers.  But as my friends at recently pointed out: ICER boss Steve Pearson told "ICER’s framework is specifically designed for payers," Dr. Steven D. Pearson, recently admitted in an interview with Evidence-Based Oncology’s managing editor Surabhi Dangi-Garimella. That statement is a direct quote and says everything patients need to know about the independence and value of ICER's tools.”
And now we know that ICER is a paid consultant to the government agency that used the ICER value framework to ration drugs.  My guess is ICER will not take responsibility for WHCA’s illegal drug rationing and the harm caused to patients that prompted the court’s decision. That assertion, as well as ICER's claim that it is a trusted third party should be regarded with great suspicion.  

As for patients, it's time to follow suit literally, and take legal action against other insurers and government systems that use ICER to justify illegal rationing. 

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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