Buprenorphine Monthly Injection: Sublocade

 

 

 

 

 

 

 

 

 

 

 

Late last year the FDA approved Sublocade, the brand name of a monthly buprenorphine injection, marketed by Indivior, the same company that sells Suboxone brand sublingual films. Sublocade is expected to be commercially available by February or March of this year.

This medication is indicated for patients with moderate to severe opioid use disorder who have stabilized on transmucosal buprenorphine products for at least seven days. Sublocade comes in a pre-filled syringe, and is injected into the subcutaneous tissue over the abdomen. This viscous liquid forms a solid deposit containing buprenorphine, and the medication is released over a month, giving therapeutic plasma levels of buprenorphine.

Thus far, we have two studies, one a randomized controlled trial and another that was an open-label study, that both show Sublocade, compared with placebo, was significantly more likely to result in fewer positive drug screens for illicit opioids and in fewer self-reports of illicit opioid use.

Of note, the manufacturer warns against attempts to inject this preparation intravenously, because the solid mass that forms can block a blood vessel, or travel in the vessel to the lungs, possibly causing death from a pulmonary embolus. To reduce the risk of this bad outcome, the medication will only be distributed to healthcare professionals, and not to patients.

Sublocade comes in two doses; a 300mg dose and 100mg dose. Patients should receive 300mg per month for the first two months, then drop to 100mg per month. This is the indicated dose for patients on the equivalent of sublingual buprenorphine 8 to 24mg per day. If patients have inadequate response after dropping to 100mg, the dose may be increased to 300mg in some patients, if the physician feels this is indicated. At the manufacturers website, they say Sublocade delivers a dose adequate to block opioid receptors to the degree that if other opioids are used, they will have no effect.

Steady state is established after 4-6 months of treatment. Steady state is a term describing the pharmacokinetic state where the drug’s intake is in dynamic equilibrium with the drug’s elimination from the body. Usually this occurs after four to five times the drug’s half-life. After steady-state has been achieved, buprenorphine may be detected in patients for up to 12 months after dosing stops. It is unknown how long buprenorphine will remain detectable in urine testing.

After this medication is stopped, the patient should be monitored for opioid withdrawal symptoms for several months, since blood levels will drop slowly.

Indivior recommend checking liver function tests at baseline, then monthly.

Because of the possible harm of intravenous use of this product, Indivior created a REMS (Risk Evaluation and Management Strategy) protocol. Healthcare settings seeking to dose Sublocade and pharmacies wishing to dispense Sublocade must be certified by the REMS program for this medication.

I tried to go to the website mentioned on the Indivior website regarding the REMS requirements, but the link wasn’t working for me.

I’m excited about this new option because it can reduce diversion of buprenorphine products. At the opioid treatment program, we have a fair number of patients who attempt to divert or misuse sublingual forms. At present, if I have unmistakable evidence a patient is trying to divert medication, I can no longer prescribe it. I can offer to switch the patient to methadone, but that’s unattractive for several reasons to many patients. But if we can administer subcutaneous buprenorphine, it gives us another option. It would be difficult to divert, and it isn’t as complicated to administer as the Probuphine implants.

I do have some concerns. First, how do the financial aspects work? Since it can only be dispensed to the healthcare provider for administration to the patient, I suspect the facility or physician owner of the practice will need to buy the medication and pay up front. What if a patient’s insurance company refuses to pay? What if a patient refuses to pay, or only pays part of the drug cost? Could the physician lose money treating patients if this happens?

Currently, with sublingual buprenorphine products, the physician isn’t in the middle. The patient pays the pharmacy directly.

I was thrilled to learn that North Carolina’s Medicaid program will pay for this medication, without even requiring a prior authorization. That’s wonderful, but many private buprenorphine practices don’t treat Medicaid patients, due to low reimbursement rates. But this will be good for facilities who do accept Medicaid as payment.

I’m amazed our state can afford this. Perhaps they got a much better deal from the drug company, Indivior, than the quoted priced of $1500 to $1800 per month. One month’s worth of generic monoproduct buprenorphine, dosed at 16mg per day, costs about $105 per month at the cheapest retail pharmacy, according to goodrx.com. That means this new subcutaneous injectable formulation costs fourteen times more than the cheapest form of buprenorphine on the market.

That’s quite a difference. I’m assuming the state’s willingness to pay this expense is based on expectation of a marked decrease in diversion of this medication. Apparently, the lump of buprenorphine can be cut out if it’s done within the first 14 days, but that seems an unlikely extreme for patients. In other words, with the monthly injection, the medication will reach the patient for whom it is prescribed.

At this point we could launch into a discussion about whether diversion of buprenorphine – possibly the safest opioid available – is a good or bad thing. Law enforcement types see diversion as bad, but arguing a pure harm reduction viewpoint, one could say that diverted, black market buprenorphine might be saving lives by giving people with untreated opioid use disorder a safer option. Note that I said safer, not safe. But that whole debate is an entire blog post so I’ll keep the focus on this new way of delivering buprenorphine.

About half of my office-based patients are self-pay, with no Medicaid or private insurance. They pay out of their own pocket for my office charges, and pay for their medication at their pharmacy. I think Sublocade’s price will make it an unworkable alternative for these people. About half my patient have private insurance, and most have Blue Cross/Blue Shield. I plan to make some phone calls, to get information about their payment policy for Sublocade.

I’m eager to try this new preparation at the opioid treatment program. It sounds like this will be workable for Medicaid patients.

But that brings up my second concern: how can I get patients to come for weekly counseling sessions if they only get medication once per month? I was pondering this idea in a group Email yesterday when I was informed (by someone who knows these things) that soon, a competitor of Indivior will be releasing a weekly injection form of buprenorphine. He envisioned weekly injections for new patients, with gradual decreasing of frequency of visits as the patient stabilizes, eventually moving to monthly treatment and counseling sessions, when clinically appropriate.

I like this idea. This sounds workable. And as I emailed him…let’s hope there’s a price war, with both companies lowering their prices to attract patients.

I’m happy about any new options for patients, and I’m eager to use this product. I just hope cost won’t be a deal-breaker for patients and their insurers.

 

37 responses to this post.

  1. Posted by Theodore D Fifer MD FACS on January 15, 2018 at 12:35 am

    My Indivior® rep says that the REMS website wil go live Jan 23 of this month.
    I’m told the physician and the clinic are just recipients of the shipped product and the payors wil be directly on the hook prior to shipment.
    This will allow our patients to bypass the retail pharmacy monthly, avoiding the rude and judgmental treatment to which they’re frequently subjected.
    This will be a very good thing for our patients

    Reply

    • That’s good to know! But I hate the thought of keeping records that will meet DEA requirements. Anytime docs store controlled substances, as you know, we have to keep detailed records. Also, I hear those practices are more likely to be inspected by the DEA.

      Reply

  2. Posted by Andrew on January 15, 2018 at 4:00 am

    I wonder how long till people are trying to cut the blob of medication from under the skin. Some patients may do well on this. Sounds like absolute hell to get off of. If my doctor said it was this product or nothing I may contemplate quiting suboxone. Someone somewhere will get a syringe and will try to inject it. I suppose I am glad someone is trying to come up with new tool for addicts. Time will tell is this method will work.

    Reply

  3. Posted by Alan Wartenberg MD on January 15, 2018 at 3:12 pm

    Jana, as a retired physician who does not have the opportunity to see this product “go live,” I am greatly looking forward to hearing of your experience with it. Agree that price is going to be the big issue (just as it was initially with Suboxone®, where costs (particularly vs. methadone) was an enormous issue. Great column, as usual!!

    Reply

    • Posted by Jamey Summers on October 18, 2018 at 5:58 pm

      It is not only the price. I had to jump through many small hoops to get this treatment. I feel like this is something that the average addict wont be able to do or want to do.

      Reply

  4. Jana, I mentioned to our rep that I felt this would be very difficult from a practical standpoint as I do not want to have to order medication to the office and then have to pay for it. I don’t have the cash flow to do that sort of thing. Also, I don’t know how hard the abdomen prep will be, but I already book my patients for 15 to 20 minutes for med management. I can’t add another 10-15 minutes in medication prep time. In addition, it has to be at room temp for at least 1 hour before. It sounds like a bit of a loose gorilla. I like the idea but I don’t know how practical it will be.

    Reply

    • I think I can manage the prep time so long as I can think ahead and get the medication at room temperature – and the patient shows up. I just hate the idea of having to keep records sufficient for the DEA to be satisfied. That’s not a problem at the OTP, where I have very efficient nurses who know how to keep inventories. But it would be a challenge in my office-based practice.

      Reply

  5. Posted by William Taylor on January 15, 2018 at 10:58 pm

    This may be the answer to the vexing problem of incarcerated patients having severe withdrawal. Way safer than methadone, while avoiding the diversion challenges that go with sublingual buprenorphine in this situation.

    Reply

  6. Posted by John on January 27, 2018 at 4:16 pm

    I have a question, What happens if the patient needs emergency surgery or emergency pain relief from a accident or trauma? As it stands now we can simply not take our medication for a couple of days prior to any scheduled surgery, but I have a huge fear of being able to get pain relief now just from 8mgs, I can’t even imagine how freaked out I would be if I had a month of medication in me. I have been down this road and the majority of ER docs have no clue about suboxone much less something new.

    Reply

  7. Posted by Cassie Jewell on January 27, 2018 at 10:25 pm

    I’ve been following your blog for a year or so now. I’m an LPC in VA; heroin addiction runs rampant here. I’ve lost dozens of clients. (I’m currently working with the SMI population, but previously worked at a long-term residential facility, a modified TC, for nearly 4 years.) I’m starting a blog and have listed your blog in the resource section. Thank you so much for what you do!

    https://mindremakeproject.blogspot.com/p/helpful-links-and-resources.html

    Reply

  8. As of 01.28.2018 1900hCST the sublocaderems.com site is not live.

    Reply

  9. Posted by Jamie on June 7, 2018 at 6:19 pm

    Im trying to locate treatment centers in dayton ohio that offers this any help would be appreciated thank you

    Reply

  10. Posted by Tony on August 22, 2018 at 2:54 am

    I know this is an older post, but the medication is just hitting the market good. I am a patient and will be starting Sublocade tomorrow. My insurance paid for all but $38 without wanting a prior authorization. The prescription was sent to a specialty pharmacy and I paid them via credit or debit card prior to them shipping it to my physician. I hoping this is the medication everyone is counting on because I just do not do well with the tablets and addictive dosing math.

    Reply

    • Thanks for writing! I am eager to hear of your experiences, if you could give us an update after starting.

      Reply

      • Posted by Tony on August 24, 2018 at 9:08 pm

        Okay, as requested, an update on the beginning of my Sublocade journey. The injection itself is painful with an extreme burning sensation. The burn and pain are gone very quickly however. I noted feeling the effects of the meds at about 20 minutes after receiving it. I am only on day 3 but I have had 3 amazing days. Waking up normal without feeling over or under medicated. No trying to keep enough meds on my person to not feel bad or run out. If this remains the same for the entire 28 days then it will be the miracle I have been waiting for!

      • Great news! Please keep us informed.

    • Posted by Jim on November 2, 2018 at 11:21 pm

      Hi, would it be possible to know the contact information of your physician who administers Sublocade for you? Thank you!

      Reply

      • Posted by Tony on November 3, 2018 at 3:15 pm

        Hey Jim…the physician I was getting Sublocade from did it for one month and then took me off it, he is no longer doing it. My guess is because he sees patients every week to two weeks but with the injection it went to monthly and everyone loved it. I am with a new doc that is considering it. I live in Coastal South Carolina so if I hear of anyone doing Sublocade I will let you know. Thanks…

  11. Posted by James on August 22, 2018 at 6:10 pm

    This is ridiculous. I would never try this if you paid me. Just get rid of Suboxone and keep Subutex. Suboxone causes a lot of problems for some people. If the naloxone doesn’t really keep people from shooting it up then why give it to people who have never shot up? I used to be on Subutex, now Suboxone. Suboxone makes me depressed and anxious and itchy and you name it. It gives me cravings as to where Subutex never did. I took my meds as prescribed and never diverted, and Nope, won’t give Subutex, even with a hypersensitivity/allergy. This is mispractice in my opinion. They’ll give you a months worth of Methadone but not Subutex. Something has to give.

    Reply

    • Posted by James on August 22, 2018 at 6:19 pm

      I live near Centerville, OHIO myself.

      Reply

    • Posted by Tony on August 25, 2018 at 7:21 pm

      Why would this be ridiculous? Sublocade is more like Subutex as it doesn’t have Naloxone in it, and it is a subcutaneous injection not an IV medication. It is extremely slow leaving the body, therefore making it much more easily discontinued. I have read all the paperwork to include the studies prior to making my decision. Many will not like this medication because they can not bump their dose occasionally (not saying you, but many will do this). As for me, I am 4 days into it and I am very happy with my decision.

      Reply

  12. Posted by Tony on September 18, 2018 at 8:14 pm

    Hello, I am now a month into my injection and I feel amazing. It set me free for the month, no medicine bottle, no pills, no broken willpower and running short. It has been the best month I have had in 15 years. I say all of this to say, my doctor has now informed me that he isn’t going to continue the injections. I am the only person he has on Sublocade, I am a huge success the first month and now he decides not to continue. I don’t know what he will do but I am beyond disappointed, my wife is also. I don’t know how a physician can do this. Every time and I do mean every time, we find something that works, he immediately changes it. It’s almost like he is trying to see how far he can push me before I break. Several patients have left for other doctors due to his unrealistic expectations. Good guy, probably a great general practice doctor but no understanding of addiction at all.

    Reply

  13. About the doxtors who discontinue Sublocade- My guess is that doctors would rather see patients weekly. It’s simply more money. This is a ‘hate the game not the player’ situation of economics.

    And I can promise you that it will only be a matter of time before somebody dissects out the solid deposit. Lidocaine is much easier to get than Sublocade, and addicts are more clever than people think.

    Reply

  14. Posted by Christopher M Vayda on November 26, 2018 at 12:17 am

    While a fantastic idea it’s price definitely makes it impossible …for the poor average Joe it’s another cruel joke by big pharma who most of us can say whilst not completely their fault , certainly had their hand in helping get us here to begin with . I have no Medicaid (Florida) so no help there yet but theese meds should be made available to people who need it . End of story.. Whether by state or government we need the help available ..by another addict..

    Reply

  15. Posted by David on October 2, 2019 at 2:48 pm

    I received the Sublocade shot exactly 1 month ago but my doctor has now switched me to the Suboxone pill, my question is, how long will it take for the bump on my belly to go away? FYI: It was the 1st time I had ever received the Sublocade shot.

    Reply

  16. Hi, I have been on Sublocade for 9 months now, I was the 8th person in Australia to go onto it. My doctors rooms call me usually 2 days before the injection is due and I pay for it in advance. This seems to work well for everybody. He has the injection ready in his office when I go in for my appointment. I find the injection to be extremely painful. I have stayed on the 300mg dose as the 100 just didn’t cover me for the full month. I am having the injection more for my chronic back pain than opioid addiction. When I started on Suboxone and Subutex in hospital it relieved my pain so much that we decided to try the Sublocade, and it has improved my back pain so much that after 2 1/2 years I am now back at work full time. The biggest problem I have is the lumps it is leaving in my stomach. I now have 9 and they are not going away. Some of them are quite painful to touch. My doctor has about another 10 patients on it and seems pretty dedicated to providing this treatment option. I would love to know if anyone knows of a blog or internet based support group that I could contact so that I can discuss issues with other people on it. 🙂

    Reply

    • Thanks for your comment. I’ve heard a few reports of these lumps. SInce I have not yet used Sublocade for my patients, I don’t have any information for you about these lumps, but I’ll go to the manufacturer’s website to see what they have to say about it.

      Reply

  17. Posted by Tony Keen on October 28, 2019 at 2:26 am

    I haven’t been on here for a while but the article seems to be busy lately. It took me a year but I was able to find a doctor to start me on Sublocade. My first time was when my doctor gave me one injection and then stopped. My new doc is great. I am three weeks into my second injection and doing fantastic. I do feel occasionally like I either have too much medicine or not enough but the feelings usually fade quickly. I also have the lumps but my first one is almost gone. The second is still very sore and bruised even 3 weeks later. The medicine is worth it to me though. I hope everyone else does well on it and it is what we all have hoped it will be. I know it ya already changed my life for the better.

    Reply

  18. Posted by Harald F on November 1, 2019 at 12:36 pm

    Hi. I went on Sublocade 2 months ago. It has been okay. I am getting used to being pretty much level all the time instead of up and down on the films. But the company that distributes it to my doctor is extremely erratic. They insist on talking to me by phone before they ship the medication to my doc. It is odd. I feel like I’m in a James Bond movie. They ask me my D.O.B. and zip code. But even with that, it has been a decent experience. But now, on the verge of my third dose, when my appointment came up, I went and they had not received the medication yet, due to them not having spoken to me personally. So they spoke to me personally. Now, yesterday, they say my insurance company won’t pay until a week from now. So that’s 2 weeks late. My patience is getting thin. I realize this whole situation is my doing, as I committed the original sin of playing with fire, but will I be okay for another week? I was given 300 for my last dose. Or should I get a script for the film just in case?

    Reply

    • Posted by Tony on November 6, 2019 at 7:52 pm

      Hi Harold, I have the same experience with Accredo Pharmacy. The pharmacy has to get your permission to ship the medication to your physician. They can’t just charge you for it and send it without your okay. This medicine if only good for 7 days after coming out of the refrigerator and it can’t be sent back. It’s just like getting medicine from any pharmacy. Anyway, that’s not your question. I would imagine you would be perfectly fine for one week extra if you’re on the second 300mg dose. I would however get a prescription just in case. If you don’t need it, don’t fill it. My doctor called me in a one week supply of strips the last week of my first month because I was going into withdraw, however this is the end of my second month and I am going strong. Your insurance should pay for it every 26-28 days depending on how the script is written, either way after the first month it will be filled every 28 days anyway so hopefully the problem resolves. Also, we all put ourselves here in this giant boat. You have to forgive yourself before you can move on. The medication is the smallest part of recovery and is there to allow you to recover and move on into sobriety. Good luck and let us know how it turns out and if you needed the films during that extra week.

      Reply

  19. Posted by Tony Keen on May 26, 2020 at 9:02 pm

    I know this is an older blog, however I would like to say that after many months of steady Sublocade treatment that I LOVE IT. I have been in treatment for over 12 years now, some successful years and some not so successful. The change from suboxone to Sublocade is day and night. After the first 2 months and the habit of “taking the pill” everyday was broken, it became amazing. I would always be on a count down until my next refill, but for the last few months I have had to set an appointment reminder. I no longer obsess over my medicine, and it has set me free from my pill bottle that I carried religiously. I am now moving my injection back one week every visit and I am up to 7 weeks between injections, and it is not noticeable at all. Sublocade, for me, has changed my life and my friends, family and co-workers have noticed it. Also, I have asked how the very few other patients on Sublocade in my doctors office are doing in comparison, and out of the 4 of us, I am up to 7 weeks between injections, two are just starting but so far doing good, and the fourth hasn’t come back for an injection in almost 3 months now but is still seeing the doctor and is still successful.

    Reply

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