I received notice today from the area’s Reckitt-Benckiser rep that the company has secured a mini-coup of sorts, requiring state of WI Medicaid subscribers on buprenorphine to use the Suboxone Film formulation. Here is the notice I received:
Wisconsin State Medicaid has as of December 1st today added Suboxone Sublingual Film as the preferred delivery system. I have attached a file description. Because of some of you large geography and some limited stocking in certain areas. I would suggest you begin prescribing the Film to all your Medicaid patients as soon as possible to insure pharmacy coverage moving forward. All pharmacies can receive for stocking and distribution to your patients with 24 hour notice.
For PA requests for Suboxone tablets, providers are required to indicate clinical information about why the member cannot use Suboxone film and why it is medically necessary that the member received Suboxone tablets instead of Suboxone film.
Ironically, I just completed a survey (not sure who sponsored it) asking my opinion about ‘Suboxone Film’—i.e. whether I think it is an important step forward, whether patients like it, etc. I shared my thoughts- that it is essentially a marketing gimmick, and one that is apparently successful—at least when used on the people who run WI Medicaid.
The supposed advantage of the film is that each dose is wrapped separately in a foil pouch. This in theory makes it more difficult for a child to inadvertently swallow a handful of the tablets. In reality, this is only beneficial if one limits his imagination to a scenario where a bottle of prescription medication is left out and available to a young child, and the child is somehow able to defeat the child-proof features of the cap. I can envision another scenario—mom keeps several packets of Suboxone film in her purse, and her child pulls one out while looking for gum, tears it open, and decides to see what it tastes like.
One could argue that there would be LESS exposure to buprenorphine in the case of the film, as only one strip would be opened as opposed to a child swallowing a handful of tablets. But the partial agonist nature of buprenorphine makes the number of tablets irrelevant. One Suboxone tablet or film contains 8000 micrograms of buprenorphine—a huge dose. A child would need to go to the hospital for observation whether one or 10 doses were ingested, and the effects from the medication would likely be the same in either case.
Let’s say I allow, though, that the requirement that people use the film will reduce the risk of accidental ingestion in children by at least some amount. And let’s ignore the fact that we are taking away the choice that patients enjoy with other medications; we are talking about ‘addicts’ after all, right? No need to treat addicts like ‘regular,’ responsible people! And let’s tell the people who don’t like the gooey, slowly-dissolving nature of the film, or the rubbery aftertaste that some have described, that they are just ‘SOL.’ They’re addicts, so again, who cares? And let’s tell the people who complain about their dose blowing away in the wind that they should learn to take it in a more reasonable place.
After we do all those things, what’s the big deal?
The big deal is for Reckitt-Benckiser. The big deal is that the state of Wisconsin won’t allow people on Medicaid to use the almost-tasteless generic formulation of buprenorphine—something that many patients prefer—and that the state won’t save a few million dollars in medication costs. Reckitt-Benckiser had to sacrifice a small amount; they cut 50 cents off the $6 charge for one tablet of Suboxone. But in return, they essentially hold hostage every patient getting medication through public assistance. Talk about an effective marketing campaign! And if they can use the bogus safety argument to fool the State people, who knows—maybe they can get private insurers to fall for it as well. RB has already managed to use fears of IV diversion to push insurers away from approving generic buprenorphine. RB also prevents insurers from placing generic buprenorphine on formularies by keeping brand-name Subutex priced very high (insurers fear that if they approve generic Subutex, some people will end up getting the real, ridiculously-expensive Subutex due to pharmacy shortages of the generic).
The bottom line is that RB has eliminated the forces of ‘market competition’ that would otherwise force the price of buprenorphine downward. If Dell, Gateway, and Sony could use this type of fear-mongering to control the market, we would all be paying fifty grand for a laptop!
And in a field where access is limited by resource costs, the excess profits gained by RB translate into fewer patients treated, one way or the other. And ‘fewer patients treated’ translates into ‘death.’
THAT’S what I meant in an earlier post by ‘blood on their hands,’ by the way. Congratulations, RB, on Suboxone Film.
thankfulmom · December 2, 2010 at 7:48 am
I agree with you completely with regards to the change in dosage form being a blockbuster for the manufacturers. It happens all of the time. And I do believe in patient choice. That said, my son prefers the film. He says it dissolves extremely fast, almost instantly, which makes dosing easier. He also thinks that maybe he gets better absorption with the film and can use less product. I suppose this at some point might lead to a reduced cost.
With regards to the cost of Suboxone, I really hope that our new health care reform recognizes addiction as a disease worth treating. If we were to catch addiction early and treat people with respect (just like any other disease), Suboxone and therapy could be wonderful tools to save lives. In more ways that one.
We have so many good people in our country, ready to lend a helping hand. When a storm hits a city with thousands of people, the government, churches and medical communities give of their time and money. When the storm hit my family there was no one to help. My husband and I were scared, hurt, angry and depressed. I cried so much and so hard that my dr was afraid that I was going to dehydrate. We knew nothing about addiction and did not know what to do. And our son’s life was in danger. We were desperate. We raided our retirement accounts to put him in the best rehab we could find (with our limited knowledge and knowing that with each day our son was getting sicker and sicker). I just wanted him someplace where he would be safe while we sorted things out. My son has kept up with a couple of people from his rehab. One guy, a beautiful, sweet, ex-serviceman, is on methadone. Why is he having to go to a methadone clinic every day? He cannot afford the Suboxone.
moman · December 2, 2010 at 11:26 am
Another triumph of governmental interference with medicine….no benefit to the patients or taxpayers, but a boost for crony capitalism. What progress!
moman · December 3, 2010 at 6:27 am
I believe hoping the new “health care ‘reform'” will do anything other than screw up things is pointless. Every advocacy group will add to the parade of lobbyists trying to get their pet project covered. There are no funds!
Matt2 · December 3, 2010 at 10:38 am
thankfulmom, when I read your response all I could do was think about how difficult things had to of been for my parents. Neither my parents or I knew anything about the success rates of going through a week long inpatient rehab. It was at the time all we thought was available. So when I finally agreed to go inpatient to the treatment facility I ended up having problems with my parent’s health insurance and my parents were told that they would have to pay $5,000.00 upfront in order for me to be processed. I’ll never forget the look on my mom and dad’s faces when they were told, in essence that me getting better depended on them being able to pay ALOT of money of money I knew they didn’t have. They still somehow managed to come up with the money but needless to say I felt incredibly aweful for being responsible for the whole situation, especially when my younger brother ended up having to make do with a drastically reduced number and quality of christmas presents that year.
I finally found out about Suboxone 4 months later after I got out of that treatment center and in the course of that 4 months every person I had been in treatment with (that I stayed in touch with) had relapsed. I remember thinking why in the hell didn’t anyone at the treatment center think about telling me or my parents about Suboxone? It could have saved me and my family so much money! Not to mention how much it helped me physically and psychologically with cravings and helping me to know that “using” would just be a waste of money… But I suppose it’s water under the bridge I’ve just been really dissapointed about nearly everything about the vast majority of “treatment centers” and the huge need for greater access to treatments like Suboxone/aka buprenorphine maintenance that are backed by science rather than the oh so cliche 12 step programs.
I’m just totally blown away though by a company that is making money off other people’s suffering. I’m just disgusted at what has happened in Wisconsin! For God’s sakes would it really kill someone to let addicts have any kinds of choice concerning their treatment? R&B is now on my blacklist…… I’m literally physically sick to my stomach thinking about how they ran around preying on the fears of others. Did they really not already make enough money! My God I remember before generic Subutex came out I was paying $200.00 a month for just a 30count bottle of 8mg tabs! Anywho I need to get to class but I appreciate Dr. Junig for bringing such an issue to our attention….. It’s just disgusting to see a company pull such ugly stunts!
thankfulmom · December 6, 2010 at 6:16 am
Matt2, the best gift you can give your parents is to keep getting better. That’s all they really want. The good news is that I think my family has grown in ways that would not have been possible any other way. We are better people, we are closer to each other, and my son has become a better person. I cried when I thought I had lost him. I thought that the essence of him that I loved so much was gone. It was like a death and I grieved. But now, he has come back. He is different but he is better. I think Suboxone has allowed him to grow by putting his addiction in remission.
I want to spread the word that opiate addiction is not a death sentence. It doesn’t have to ruin another life. It does not have to cause financial ruin.
rachel7224 · January 31, 2011 at 11:52 am
I just tried my first dose of suboxone film, picked it up from the pharmacy this morning. Well it doesn’t taste any less nasty than the tablets do. But it does deliver a greater amount of the medicine into my body. I usually can’t tell when I’ve taken the medicine, but with the film there is a definite “feeling” I can detect.
But aside from that, what I wanted to mention was that the generic formulation available is only subutex. That is suboxone but without the blocker naxolin. Which would make this medicine easily abused by addicts in recovery. Let’s face it, I am a recovering addict. I myself can admit that there are still days that my physical pain is so bad that I would use narcotic pain meds if not for the naxolin. The point is that actual suboxone isn’t available in a generic formulation. Not in tablets or film. So to state that certain Rx coverage should allow generic form of suboxone is an incorrect and misleading thing to state.
SuboxDoc · February 15, 2011 at 7:17 pm
Thanks Rachel, but actually the generic form of Suboxone HAS been approved by the FDA; it just hasn’t hit the shelves yet. As for the generic for Subutex, the absence of naloxone has absolutely no effect on the action of the medication– unless it is injected. Naloxone is not active in sublingual OR swallowed form– it is there for one reason only– to prevent injection of the drug. And while that might be an issue for some people, it is a small issue for most. Why? Because buprenorphine is not that great of an IV drug. It still has the same ceiling effect, for example; naloxone has nothing to do with that. So a person tolerant to Suboxone or buprenorphine, who injects buprenorphine, feels nothing– nothing at all, just like they don’t feel it when they dose sublingually.
snells · February 18, 2011 at 12:48 pm
I was reading on the forward health wi website
“Program Name: BadgerCare Plus and Medicaid Handbook Area: Pharmacy
Prior Authorization : Preferred Drug List
Clinical Criteria for Opioid Dependency Agents
Suboxone® film is a preferred drug that requires clinical PA (prior authorization) in the opioid dependency agents drug class.
Effective for DOS (dates of service) on and after February 1, 2011, PAs for Suboxone® tablets for BadgerCare Plus Standard Plan, BadgerCare Plus Core Plan, Medicaid, and SeniorCare members are no longer valid. Prescribers should switch members’ prescriptions to Suboxone® film or provide clinical documentation about why the member cannot use Suboxone® film and why it is medically necessary the member receive Suboxone® tablets instead of the film.
PA requests for Suboxone® and buprenorphine will be approved for a maximum of 183 days per request and may be renewed for up to a maximum of two years. PA requests for Suboxone® and buprenorphine will not be approved for use outside treatment for opioid dependence. A diagnosis of opioid-type dependence should be indicated on claims and PA requests for Suboxone® and buprenorphine.”
Is this stating that they will now only pay for Suboxone Film for 2 years? If it is do the two years start now in Feb or are they going to go back to when they first started paying for your Suboxone or Subutex? Just a little nervous about my next visit. Thanks
talkzonelurker · March 9, 2011 at 10:39 pm
Dr J, I have been reading your posts for awhile, and appreciate your discussion of your personal experience as an addict, and your medical and treatment advice. I especially appreciate your strong advocacy for maintenance treatment of opioid dependence, and your criticism of the federal patient limits that force addiction specialists like yourself to turn away patients seeking help.
I am de-lurking finally to address something that has been bothering me. I’m baffled at how angry you are at Reckitt Benckiser . I’m sure they are paying rebates to the insurance companies to cover the new Film version with the new patent life. So what? That’s what happens in the real world of pharma companies and insurance coverage. If the generic of Subutex was recommended for outpatient use, the plans would be thrilled to give it preference on their formularies, because all they care about it saving money. But it’s not. The generic buprenorphine tablet & the brand buprenorphine tablet (Subutex) are recommended for “observed” administration only, as well as recommended for induction. That’s how the FDA approved both the generic and brand labeling, so why isn’t your beef with the FDA? If there was sufficient research to support off-label use (i.e. RXing Subutex outpatient rather than inpatient), data indicating that buprenorphine without naloxone wouldn’t be more widely abused by injection, then the prescription benefit plans would absolutely put it on formulary. Don’t you think they’d like to save money? But they can’t do it, because there isn’t any data to support that decision. There is plenty of global data about buprenorphine monotherapy being injected, as well as the reports from Europe of people mixing it with benzos and injecting it and killing themselves. And that buprenorphine+naloxone deters injection, versus pure buprenorphine. That’s the reality. There are a number of studies in recent years that support the use of the combination tablet —and a new small study of the Film— being used for induction dosing, so most of the plans will cover Suboxone tablets/film for induction, despite the PI recommendation of Subutex for induction. Don’t you think they’d also cover Subutex off-label for outpatient use, if they could justify it?
Reckitt has promoted for years that the combination tablet was less abusable than the monotherapy tablet because the data supports that. Reckitt priced Subutex higher, to encourage use of the less abusable tablet Suboxone. How could Reckitt know 8 years ago that there would someday be a generic of the Subutex version available, and no generic of the Suboxone version? The patent for both versions expired at the same time. The fact that no generic manufacturer has been able to make the Suboxone tablet, get it approved, and get it on the market is not an evil plot of Reckitt’s, as far as I can tell. As a public company, Reckitt would have to disclose if they were paying a generic manufacturer to delay introduction of a Suboxone generic (the “pay to delay” strategy). They are not. They disclosed in their 2009 investor statements that they fully expected generics of both Suboxone & Subutex to come on the market as soon as their patent expired in October 2009. I think it’s a shame that you keep reporting rumor as fact, and since last August, have been stating that Teva has gotten a generic of Suboxone approved, and just doesn’t have it on the shelves yet. It’s just not true. Read Teva’s web site and press releases and investor statements. They would be shouting it from the rooftops if they had FDA approval for generic buprenorphine-naloxone tablet, and it would be widely reported in pharmaceutical news sites, investor sites. The FDA announcement of the approval would obviously be a public document and available on the web. I have been watching for this closely. I can find NO published reports of FDA approval of any generic Suboxone, just plenty of rumors, with your posts leading the way. Maybe it will be next week, Teva (or some other company) succeeds and their NDA is approved and this happens. As soon as a generic Suboxone IS on the pharmacy shelves, Wisconsin Medicaid, and EVERY insurance plan will put the cheapest version (or the one that rebates the best) on their formulary. Believe me, it’s highly unlikely the plans will care one whit about whether patients prefer the taste and faster dissolution of the Film, or that there are some public health benefits to the packaging, and formulation. It will be about lowest cost. End of story. Patients will get lower copays, or save money if they pay out of pocket. Great!
What is the point of being so hostile that Reckitt is trying to compete with the (eventual) generic, by making an improved version of the product, with some clear benefits, that is still patent protected, and also providing lower pricing to the insurance plans to put it on formulary? Perhaps you see the improvements as very minor, and not worth it, but some patients and doctors really do see benefits to the new formulation & packaging and prefer the Film, and they can’t all have been hypnotized by Reckitt to see value where none exists.
Why shouldn’t Reckitt try try to keep their business alive and keep their people employed? They are the first and only pharmaceutical company to specialize in addiction and they are trying to bring other medications to the market in this stigmatized and marginalized field of medicine (one that Big Pharma has no interest in). What if you let go of the anger, and agree that they’ve made mistakes, and aren’t perfect either, but are trying to be a successful business, and because they are, they have helped physicians like you save thousands of lives?
Everyone makes mistakes, and I believe that you have nothing but your patients’ best interests at heart. Maybe you could go back and update your posts that a generic of Suboxone has been approved with the accurate information, that as of today, one has not? And while you have every right to assert your belief that Subutex is just as safe as Suboxone, tastes better, etc. etc. I wish you would cite the research that supports that it is abused no more than Suboxone on the street, rather than anecodotal stories. I don’t know of any data backing your belief there, but I’d like to see it if there is any.
I think you should in all conscience, admit that there is a valid reason for the buprenorphine-naloxone combination, and doctors who refuse to prescribe Subutex off-label are not all dupes of Reckitt salespeople, but could sincerely want to follow the PI recommendations. What if the Reckitt salespeople (some of whom are in recovery themselves, and many of whom were once counselors or worked in social services) might not all be evil money-grubbers who try to mislead doctors, but might be doing what pharma salespeople do— selling a medication based on the package insert and the published data? Encouraging doctors to get certified, trying to educate providers and payers that opioid dependence is in fact a chronic disease, and trying to increase access to life-saving treatment?
Thanks for allowing me to post to your forum, even though I disagree with you in this one area.. I saved up my comments for so long, they ran too long!