Make a Difference

March 21, 2016

Kelli Metz
Clinical Services Pharmacist
Colorado Department of Health Care Policy and Financing
1570 Grant Street
Denver, CO. 80203

RE:  April 5 PDL Drug Class Review (Abuse-Deterrent Formulations)

Dear Kelli,

On behalf of thousands of Coloradans who live with life-altering and debilitating pain, we urge you to protect and enhance access to safe medications.  It is critical that Colorado Medicaid cover the full range of treatments available for pain in the safest possible way which includes covering recently approved “Abuse-Deterrent Prevention” (ADP) formulations.  This is incredibly important because there is a higher amount of abuse in the Medicaid population than commercial population.

Colorado presently ranks at the top of the list in terms of misuse, abuse, and diversion of controlled substances, particularly opioids.  We believe anything that can be done to ensure safety and optimize efficacy of these medications should be strongly considered.

When prescribed and monitored appropriately, most patients do extremely well on these types of medications, and experience improvements in pain, function and quality of life.  There are instances, however, where medications are used inappropriately.  The disastrous consequences of inappropriate use can lead up to and include death.  In fact, over 16,000 of roughly 22,000 prescription drug overdose deaths annually are associated with opioids.

The path to opioid overdoses, in many cases, begins with the misuse of prescription pain killers. These pills are most frequently passed along by family or friends or sold on the street and then crushed, melted or otherwise altered to get a more powerful effect.  Over 70% of abusers of prescription pain relievers got them from friends or relatives.  The slow release over time that occurs when the pill is swallowed whole – can be felt at once when the pill is altered for snorting or injection.  A useful pain killer is thereby instantly turned into a potentially lethal narcotic.

While it is not possible to entirely eliminate this occurrence, It is our belief that abuse-deterrent formulations should be part of a multi-faceted approach to decrease abuse.  Although ADPs do not prevent users from simply consuming too much of a medication, they may help reduce the public health burden of prescription opioid abuse in Colorado by making it harder to abuse in other ways.

The consequences of opioid abuse, including emergency room episodes, treatment admissions and overdose deaths are staggering and it is a behavior that is starting in adolescence.

• 1 in 4 teens reports having misused or abused a prescription drug at least once in their lifetime.
• Nearly two-thirds of American teens who abuse pain relievers say they got it from family members and friends.
• This behavior has deadly consequences:  overdose deaths involving prescription opioids quadrupled over a decade from 4,030 deaths in 1999 to 16,651 in 2010.
• Due to the increase in prescription drug abuse, drug overdoses now exceed car crashes as the number one cause of accidental death in the United States.

The Food and Drug Administration (FDA) wrote in a 2013 ADP guidance for drug makers that the “FDA considers the development of these products a high public health priority.”  In fact, in February 2016 the FDA announced that they will now mandate that any new opioid go before an outside committee of experts, unless the product has abuse-deterrent properties.

Additionally, a study published in the Journal of Pain Medicine found that the first ADP formulation of oxycodone was associated with a $430 million reduction in medical costs, an almost $100 million reduction in criminal justice costs and a $476 million increase in workplace productivity.  Results such as these have prompted five governors, 29 attorneys general and 22 members of Congress to oppose the production of opioids without the use of ADP.

Colorado does not have ADP formulations available on their formulary even though 42 states currently do.   A Medicaid patient must try and fail on an opioid without abuse-deterrent properties before they can get an abuse-deterrent medication, even if their physician feels that an ADP medication is best for the situation.

We believe in the sacred doctor patient relationship and request that Colorado have an ADP available for each class of medication.  It is our hope that these issues be taken into consideration when Colorado’s P&T Committee meets on April 5.  Should you have any questions please contact the International Pain Foundation at 480-882-1342.

Sincerely,
Barby Ingle
President
International Pain Foundation