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Unread 07-12-2013, 09:09 AM   #1
NancyB
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Default CVS removes Suboxone Film from Caremark's formulary for 2014

http://www.businessweek.com/news/201...l-london-mover

Reckitt Benckiser Falls on CVS’s Suboxone Removal: London Mover

Reckitt Benckiser Plc (RB/) fell the most in more than a year after CVS Caremark Corp. (CVS:US) removed the film version of the company’s opiod-dependency drug Suboxone from its list of covered medications, jeopardizing sales and profits at a unit that makes up one-fifth of the company’s earnings.

The stock tumbled 4.7 percent to 4,700 pence in London trading, the biggest intraday drop since May 2012, and was down 3.5 percent to 4,757 pence at 11:30 a.m. in London. Spokeswoman Andraea Dawson-Shepherd confirmed that Suboxone film was removed from CVS Caremark’s formulary, a list of medicines covered by insurance in the drug plans it manages for big companies.

The move, effective January 2014, led Credit Suisse to cut its earnings estimate by 5 percent for 2014 and by 10 percent for 2015. Credit Suisse also reduced its valuation of Suboxone by about two-thirds to 1.1 billion pounds ($1.7 billion).

Suboxone accounted for 21 percent of Slough, England-based Reckitt Benckiser’s profit last year, yet the business now faces threats from generic and branded competition after several years of dominating the $1.7 billion opiod-dependence treatment market. Analysts including Andrew Wood at Sanford Bernstein have said that Chief Executive Officer Rakesh Kapoor should look to sell the business.

Woonsocket, Rhode Island-based CVS Caremark “clearly appears to have decided that film and tablet are effectively the same product and so is steering its customers to the cheaper version,” Credit Suisse analyst Charles Mills said in a note today. “The fear is that others follow suit and Suboxone profits fall sharply.” Reckitt Benckiser stopped selling the tablet version of the drug in March.

Withdrawal Symptoms
Suboxone combines the medicines buprenorphine and naloxone to ease withdrawal symptoms and block the high of opioids. Reckitt Benckiser claims that its film version, introduced in 2010, is preferred by patients, who stick with their treatment longer on it. Two generic copies of the tablet version of Suboxone emerged in March, and have eroded the product’s U.S. prescription volume. The generics attract cash-paying Suboxone users, who account for about 15 percent of the market. CVS Caremark’s move could lure “a decent proportion” of those on insurance plans, who make up 70 percent of users, Mills said.

Dawson-Shepherd said Suboxone sales through CVS Caremark prescription-drug plans were “small,” comprising less than 10 percent of all Suboxone insurance-plan provider sales in the U.S. The company also does not have a contract with CVS Caremark, as it does with other pharmacy-benefit managers such as Express Scripts Holding Co. (ESRX:US) She declined to disclose Suboxone’s sales through CVS Caremark-managed drug plans.

Materially Worse
Credit Suisse estimates that CVS Caremark accounts for as much as 20 percent of the market, managing prescription drug plans for corporations and managed-care companies. Mills estimates Reckitt Benckiser will lose half of Caremark’s insured patients in 2014, which is “materially worse than we had before.” Credit Suisse maintained its recommendation to hold the stock, yet dropped its price target to 4,650 pence from 4,900.

“If they are 20 percent of the market, there could be a domino effect,” said Eamonn Ferry, an analyst at Exane BNP Paribas. “It’s not impossible that substantially all of the film business evaporates in a short space of time.” CVS Caremark spokeswoman Christine Cramer did not respond to a call made before typical business hours.

Dawson-Shepherd said the company is not concerned that other drug-plan managers, who do have contracts with Reckitt Benckiser, will follow CVS Caremark’s lead. “It’s a unique situation with CVS,” she said.

Potential Sale
CVS Caremark’s move should also not influence any decision by Reckitt Benckiser to sell Suboxone, according to Canaccord Genuity analyst Alicia Forry. “We think a sale is two or three years away” and is more likely to happen once more generics and alternative products come on the market, allowing prospective buyers to properly value Suboxone, she said.

Suboxone also faces competition from Orexo AB (ORX)’s tablet Zubsolv, which won U.S. regulatory approval this month. Orexo, which specializes in reformulating drugs in sublingual form, estimates Zubsolv will hit drugstores by September and has a market potential of at least $500 million in annual sales.

The FDA rejected a buprenorphine implant called Probuphine in April from Titan Pharmaceuticals Inc. (TTNP:US) The regulator asked for more data on the effect of higher doses of the medication and training for doctors on insertion and removal of the implant.
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Unread 07-12-2013, 10:12 AM   #2
JustinBe
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What´s the conclusion of this article? They think that RBs sales will decrease and for example Zubsolv will take a large part of the market?
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Unread 07-12-2013, 10:20 AM   #3
NancyB
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Quote:
Originally Posted by JustinBe View Post
What´s the conclusion of this article? They think that RBs sales will decrease and for example Zubsolv will take a large part of the market?
Hi JustinBe, yes, RB's sales will decline because of being eliminated from the Caremark formulary. Unless people love the film so much they all decide to pay cash, which is extremely unlikely.

As for Zubsolv, I think it would depend on the price point as to whether it will be in the Caremark formulary along with the generic tablets. If Zubsolv is more expensive than the generic Suboxone, then they'll probably just stick with the generic, I would imagine. If it's priced competitively, then maybe they'll include it in their formulary.

That's how I'm reading it anyways.

Nancy
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Unread 07-12-2013, 11:44 AM   #4
JustinBe
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Thanks Nancy!

I heard a presentation from the company Orexo today and the president Nikolaj answeard that they will stay at the same pricelevel as the othe brands. That´s really good news!
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Unread 07-12-2013, 11:55 AM   #5
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http://financialhearings.nu/130712/orexo/
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Unread 07-12-2013, 04:38 PM   #6
julie48
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Hi, I have CVS Caremark and just got off the phone with them.
Right now, there tablets will remained covered. As for the film, the computer there showed nothing about the film being removed, but that could be because the news has not caught up with the agents. Good luck. I have never had a problem with Caremark. I get 75 tablets a month for $24. Julie
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Unread 07-12-2013, 05:13 PM   #7
gotoffmdone
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.................. after several years of dominating the $1.7 billion opiod-dependence treatment market..................

They've had a good run and I'd say some hefty bonuses for the top tier of the company. 1.7 billion, with a B, is pretty good.

wayne
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Unread 07-12-2013, 05:27 PM   #8
TIM
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I wouldn't be surprised if Caremark eventually favors Zubsolv over the generic tablets as it will be the only Bup/Nx tablet which comes in child resistant packaging, especially now that we know they plan to match the prices of the generics.
Tim

Its also possible we will see RB put the tablets back on the market but this time in child resistant packaging. It's hard to believe they would accept this switch to tablets-only and not have something to offer. (for those who don't know RB took Suboxone tablets off the market citing concern over accidental pediatric exposure)
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Unread 07-12-2013, 05:58 PM   #9
bizzby45
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I'll still be buying my 2 films a month from rb. I'm not interested in switching when I'm almost off.
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Unread 07-13-2013, 05:41 AM   #10
gotoffmdone
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Afterall these years where dithe sydden importance of child restraint packaging come from. Yiu donlt hear of oxycontin, methadone, fentanyl suckers the many many names for hydrocodone, etc... being touted as being in an almost bank safe like comditions.

The mgf can only do so much, its up to the people that use the stufff to make it child resistent, It is how and where it is stored. Methadone in liquid form looks like cherry koolaid and the take homes they give you are anything but child resistent once the box is unopened.

After all these years I wonder if this is just chasing a rabbit down the rabbitt hole or a red herring. There has to be something else driving this. I get generic Subutex in the same exact type bottle as all my other medications. I don't need a combination or like a kid do I need to learn to operate a pair of scissors.

I don't know what is really going on but pediatric exposure? Overblown in my opinion. For small children to be safe, they need to put virtually al medications in child restraint containers, even OTC meds used soley for kids. Hydrogen peroxide ans alcohol needs to me put in a lock box.

Pediatric exposure starts and ends with the adults in their lives, not at the drug makers factory. They make it sound as if there is an epidemic of child Sub abuse when I'd bet anything that, as I write this, there is way more other narcotic and non narcotic medication sitting around for the taking. I just cannnot see pediatric children of such a young age requiring more than the child resistant containers that has been in use for years. I recall the time when my grandkid foirst figure out how to open a child resistent tx bottle. She had reached the age to where opening it was the thrill because it was something she had learned anew. She was also old enough to know you just don;t pop stuff such as medicine in your mouth.

A younger kis would almost have to find meds on the floor and pick it up and put it in her mouth like they do every other thing to be exposed to it. In that case you cannot legislate carefullness all you can do is educate and use God given common sense.

Has anyone ever released statistics on the number of toddler overdose/death cases wherein Sub was the culprit. I never knew there was such a problem or even a concern. I'd be more concerned about showing children the means by which we give them bubble gum or grape flavor tylenol or cough syrup. Way easy to OD on that stuff. And even though the bottle says seek advice of the Dr if they are under a certain age, we are going to try abnd stop that high grade fever with pediatric meds available to us at home. Call a Dr at any hour past office hours and what do you get. A recording telling you the office is closed and to go to nearest ER.

wayne
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Unread 07-16-2013, 09:14 AM   #11
jlmc1978
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Oh no...this isn't good news for me...as I'll have to get my doctor to look at alternatives before the 2014 elimination...since I have CVS Caremark for my insurance on RX...
Time to start shopping.
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Unread 07-17-2013, 02:52 AM   #12
jlmc1978
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Default called my doctor's office

I was a little worried that I may have to change doctors by December, so that in December I could get a generic form of Suboxone..most likely the Zubsolv...and I asked about others being on generics, and said I didn't mean Subutex. Told her there were currently two generics and by September there would be a third...and my insurance was dropping the Reckitt form. She said there are people on generic and it won't be a problem. So I'll be getting the Zubsolv when it hits pharmacy shelves...then I want to try the new cheek style in 2014 when it comes out.
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Unread 07-17-2013, 07:28 AM   #13
NancyB
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Hi jlmc1978, that's good news for you. Phew. In case you haven't seen them and are interested, here's the link for the Zubsolv thread:
http://www.addictionsurvivors.org/vb...ad.php?t=28006

and the BDSI/BUNAVAIL thread:
http://www.addictionsurvivors.org/vb...ad.php?t=26952

BDSI also has a similar product without the naloxone - BEMA Buprenorphine - which is being tested for pain only.
http://www.bdsi.com/BEMA_Buprenorphine.aspx

Glad everything worked out so you can keep your doctor.

Nancy
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Unread 07-17-2013, 07:15 PM   #14
JustinBe
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New study by Orexo emphasizes importance of Zubsolv™ product characteristics in direct comparison to Suboxone® Film

Orexo AB (Orexo) today announced the successful completion of an acceptability study comparing Zubsolv (OX219) to Suboxone Film, which is the leading product for treatment of opioid dependence. The study shows that 9 out of 10 participants would choose Zubsolv over Suboxone Film for a daily treatment.
Zubsolv is a new sublingual tablet formulation of buprenorphine and naloxone for treatment of opioid dependence. The product is based on elements of Orexo’s proprietary sublingual platform technology, which comprises enhanced trans-mucosal absorption of active pharmaceutical ingredients, mucosal micro-particle adhesion, as well as taste masking, formulated in a rapidly disintegrating sublingual tablet. These features are important attributes for pharmaceuticals administered sublingually. Improvement in taste and dissolve time has previously been associated with an enhanced treatment adherence in opioid dependent patients(1).
A previous preference study, which compared Zubsolv to the Suboxone Tablet, demonstrated that 8 out of 1o participants preferred Zubsolv. The current study was undertaken to assess the acceptability of Zubsolv in comparison to the Suboxone Film. The study was a cross-over trial in which 28 participants were given either Zubsolv or Suboxone Film in random order on separate study days. Key results indicate that Zubsolv was preferred by more than 8 out of 10 of the participants on all acceptance parameters tested, i.e. overall acceptability, taste masking, after taste experience, mouth-feel, and ease of administration. The study also confirmed a fast dissolve time for Zubsolv. When asked specifically about which product the participants would choose for a daily treatment, 9 out of 10 participants reported they would select Zubsolv.
Zubsolv has been submitted and has been accepted for review by the FDA, with approval projected for July 2013 and the US launch being planned for September 2013.
"The positive results in this study are very encouraging, and confirm that Zubsolv is well positioned to take a substantial share of the growing USD 1.5 billion market for treatment of opioid dependence. I am confident that the higher acceptability of Zubsolv will translate into an improved treatment adherence, and that it will aid in attracting a higher proportion of the five million patients currently suffering from opioid dependence into treatment. ” said Anders Lundström, President and CEO of Orexo.
On the basis of the results from this study, a comprehensive clinical program designed to fully explore and document the therapeutic potential of Zubsolv is being initiated. The first wave of studies will cover treatment initiation, treatment adherence and patient experiences during treatment of opioid dependent people with Zubsolv, and will help further differentiate Zubsolv from its competitors.
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Unread 07-21-2013, 09:25 AM   #15
NVSubutex
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Default hurray for Reckitt going downhill and the end of treatment monopoly.

I am so excited that there are generic alternatives to the costly name brand suboxone. I myself, have always taken genetic subutex and have recently been prescribed a concentrated 100% lozenge of buprenorphine. No fillers or any extra crap. It comes on several different flavors to. Awesome. Not chalky as it is essentially a gummy treat. It's called Butro. As far as I know, Las Vegas is the only place to get it. I was lucky enough to have doctors who will let me do a partial fill of the generic subutex tabs, some I the lozenges,and try the new generic suboxone if I want. I'm just so glad the monopoly of Reckkitt on suboxone is now coming to an end. Cheers! There's your Karma a-holes for profiting like crazy off of addicts.
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