First, the manufacturer is being sued by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes. The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise. Believing, of course, that they are more sinned against than sinning, Indivior took to their web site to issue a statement that they will vigorously defend themselves against the charges. I'm not sufficiently informed to weigh in on the merits of the suit. I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general.
Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized. A research letter published last week in the Journal of the American Medical Association shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds. In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:
- California: 7
- Florida: 11
- Massachusetts: 22
- Michigan: 7
- New York: 11
- Pennsylvania: 18
- Texas: 10
Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic. So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have.
Why is this? Why the law suit? Why the lack of utilization of existing capacity?
Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS.
The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy).
The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself.
Follow the money. Follow the patients. The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two.
Michael
On Twitter @PRIUM1
Subutex (buprenorphine sublingual tablets) is available as a generic and could be an alternative, albeit without an abuse deterrent formulation.
ReplyDeleteSuboxone (buprenorphine + naloxone) improved on their abuse deterrent formulation by changing from sublingual tablets to the film. The naloxone in the formulation is only to prevent drug abuse via injection.
This drug formulation change has a lot of similarity to the OxyContin reformulation that was near universally praised and resulted in the same result as the Suboxone formulation change, delay of generic introductions.
Burprenorphine can be abused just like any other opioid and should be treated as such. If I recall there were some very loud voices against a generic OxyContin that did not have abuse deterrent properties, it would be inconsistent for these same voices to speak differently about Suboxone...