An obscure institute that most people have never heard of threatens to impose unwarranted restrictions on medically-advised treatments for patients. The Institute for Clinical and Economic Review, or ICER as it is commonly known, assesses whether medicines are cost effective, based on ICER’s definition, of course.
These assessments are intended to influence which drugs are made available to patients. From a patient perspective, it is disconcerting that an outside group, which is not an attending doctor, is influencing which FDA approved drugs are appropriate.
Worse, the problems plaguing NICE in the U.K. (a government-sponsored version of ICER) foreshadow ICER’s likely future. NICE’s recommendations are routinely criticized by practitioners as “detached from day-to-day general practice” and not in patients best interest.
In its self-appointed role as arbiter of cost-effectiveness, ICER has chosen to examine whether the value provided by abuse-deterrent opioids (ADF) are worth the costs. The results from their draft study exemplify why patients and doctors should be wary of ICER’s recommendations.
The U.S. is suffering from a large and growing opioid abuse and diversion problem. Approximately 2.1 million people were addicted to opioids as of 2012. The abuse of opioids were involved in over 16,000 deaths (as of 2013), and annually impose $72 billion in medical costs.
However, the problem of opioid abuse should not be separated from the even larger problem of managing chronic pain.
Around 76 million Americans over the age of 20 have endured pain that has lasted more than 24 hours. And, for those patients suffering the most, chronic pain can lead to other health problems. These include problems of severe depression, and adverse impacts on the cardiovascular, immune, and musculoskeletal systems.
There are also financial consequences, as people who suffer from chronic pain miss work more often, and are less productive at work due to their chronic pain. All told, the financial cost of chronic pain has been estimated to be between $560 billion and $635 billion.
Effectively treating chronic pain is difficult, but opioids clearly have a role to play. Under the new CDC guidelines, opioids are the standard of care for certain patients such as for patients undergoing cancer treatment, palliative care, and end-of-life care. For other pain patients, the option to prescribe opioids is valuable, although not always appropriate.
It is this intersection between the need for pain patients to receive opioid medications when these medicines can effectively manage pain, and the problem of opioid abuse and diversion, which needs more effective management.
There are no silver bullets, to this problem; but, ADFs are a promising medical technology that has helped carefully balance the need to ensure that opioids are available to the patients who need them, and help reduce the problems created by opioid abuse and diversion.
While not abuse-proof, as described by the FDA, ADFs work by targeting “the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject”.
Further, studies that have examined the impact from ADFs on opioid abuse have found these new medical technologies to be effective. In its Draft Report, ICER comes to a different conclusion. But, several decisions by ICER when conducting the ADF study raise concerns.
For example, at the start of the research process, ICER’s final scoping document specifies that the study intended to evaluate OxyContin ADF, which is the only ADF with real world results to evaluate.
The study also intended to evaluate the net benefits from ADFs that includes any potential benefits from a reduction in abuse and diversion. Of course, this makes sense. The purpose of ADFs is to enable patients to receive needed medications while reducing the incidence of opioid abuse and diversion.
An article under review in the Journal of Managed Care and Specialty Pharmacy that was validated by ICER replicates ICER’s original methodology, and found that OxyContin ADF significantly reduced the number of opioid abusers, and reduced medical expenditures, on net, by $208 million over 5 years.
Simply put, the study found that ADFs help reduce the opioid abuse problem. These results confirm that, based on ICER’s original methodology, ADFs provide net benefits.
However, without justification, ICER meaningfully changed its methodology toward the end of the research process – including expanding the drugs evaluated to include ADFs without sufficient results; and, eliminating the diversion and societal cost considerations, which are precisely the benefit that ADFs are supposed to provide. By ignoring these potential benefits, ICER is severely biasing its results. Not surprisingly, the biased results show little value from ADFs.
While the methodological change appears unwarranted, if there was a flaw with ICER’s original methodology, then the correct thing to do would be to start over. It is inappropriate to change the methodology so late into the research process.
More broadly, the ADF study illustrates why an independent board that is far removed from the examination room should not be making decisions regarding whether medicines are appropriate for patients.