AMA Applauds White House Mental Health Parity Recommendations

“Consumers have repeatedly faced discrimination in the way insurers reimburse for mental health services. The AMA has pushed – and Congress has agreed – to move toward parity,” said AMA President Andrew W. Gurman, MD. “The need for parity has taken on even greater urgency because of the opioid epidemic that has resulted in a huge demand for substance use disorder treatment – care that often comes with nonmedical usage limits, high co-pays or other restrictions that are not placed on medical benefits. These new policies – if followed by payers and enforced by state officials – will provide much-needed relief to patients who have suffered for far too long.”


https://www.ama-assn.org/ama-applauds-white-house-mental-health-parity-recommendations

Federal Panel Calls For Stricter Enforcement Of Mental Health Care Parity Law



http://www.npr.org/sections/health-shots/2016/10/31/500056803/federal-panel-calls-for-stricter-enforcement-of-mental-health-care-parity-law

Please explain. I haven't noticed any additional shares in the float.

Final Rule: Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance

As of October 28th, it is federal law that:

-A plan or insurer may not impose prior authorization or “fail-first” requirements for drugs used for treating opioid addiction if these requirements are not imposed on drugs used for treatment of medical/surgical conditions that have similar risks or indications;

-A plan or insurer may not impose prior-approval for 30 day refills of opioid addiction treatment drugs, a requirement not consistent with nationally recognized treatment guidelines, if it follows nationally recognized treatment guidelines for requiring prior authorizations for medical/surgical drugs; and

-Plans and insurers may not exclude coverage for court-ordered SUD treatment if they do not exclude coverage for court ordered medical/surgical treatment, but may require that court-ordered treatment be medically necessary.




http://healthaffairs.org/blog/2016/10/30/new-rule-on-excepted-benefits-short-term-coverage-mental-health-and-substance-use-faqs/

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-26162.pdf

Social Innovation Requires Collaboration - The Multidisciplinary Approach To End The Opioid Epidemic

It's getting harder and harder to reconcile the positive news with the falling stock price. I'm really at a loss to explain it.


http://www.forbes.com/sites/toriutley/2016/10/29/social-innovation-requires-collaboration-the-multidisciplinary-approach-to-end-the-opioid-epidemic/#148dd1e7e5de

Minnesota insurers agree to ease access to anti-opioid drug



https://www.mprnews.org/story/2016/10/27/minnesota-insurers-suboxone-opioid-treatment-access

FYI...

Zacks downgraded BDSI from hold to sell based on the poor performance of its buprenorphine film.

Perhaps TTNP is caught up in the selling somehow, as Zacks covers TTNP as well?

https://www.thecerbatgem.com/2016/10/27/zacks-investment-research-downgrades-biodelivery-sciences-international-inc-bdsi-to-sell.html

I think what is going on is election related jitters more than anything else.

https://www.bloomberg.com/gadfly/articles/2016-10-19/clinton-vs-trump-biotech-investors-worry-too-much

When I divide the share price by the market cap, I come up with 21,198,879 shares...the same number reported outstanding as of June 30th. So I don't think they've issued any new shares through the "at the market" offering or by conversion of warrants.

Really weird.

Not that much volume, but you can just feel a lot of folks saying screw this I'm outta here.

By the way, press releases that could help right now but will not be issued because Titan's management did not deliver:

1. That, as TTNP promised, non-clinical testing for Parkinsons's was completed in the 3Q.
2. That, as TTNP promised, and IND has been filed for Parkionson's.
3. That, as TTNP promised, a Phase I-IIA study for Parkinson's has been commenced.
4. That, as TTNP promised, a meeting has occurred with the EMA regarding probuphine's application in the EU.

If anyone's interested, the link provides a little more background.

http://www.ag.ny.gov/press-release/ag-schneiderman-announces-national-settlement-cigna-discontinue-pre-authorization

New York might be setting the parity precedent

http://www.behavioral.net/blogs/julie-miller/policy/new-york-might-be-setting-parity-precedent

This is really significant in that, if all insurance companies fall in line with Cigna (and the NY AG has request for coverage information on MATs out to all of them), it will remove the preauthorization obstacle which Behshad Sheldon has described as the biggest challenge Braeburn has faced in marketing probuphine. No preauthorization requirement removes all doubt over whether doctors are going to be reimbursed for treatment.

Cigna Ends Preauthorization for Medication to Treat Opioid Addiction

From WSJ. This will turn a lot more investors heads that Popular Science

http://www.wsj.com/articles/cigna-ends-preauthorization-for-medication-to-treat-opioid-addiction-1477064103

Cigna ends preauthorization requirement to treat opioid addiction

To paraphrase our new Nobel Laureate Bob Dylan, you don't have to be a weatherman to know which way the wind blows.

Best news I've seen in a long time.

http://www.reuters.com/article/us-cigna-opioid-idUSKCN12L1WH

Hmmm...low 5's. It's deja vu all over again I guess.

Market may not like us, but "Popular Science" thinks probuphine is the bees knees.

http://www.popsci.com/12-greatest-health-innovations-year

Syracuse man gets implant in arm to treat heroin addiction

http://www.syracuse.com/health/index.ssf/2016/10/implant.html

Hey guys, just a quick note...Braeburn's back at training. Can't get the link to work, but it looks like Baltimore and Salt Lake City are next.

Mount Sinai Study Advances the Use of a New Implanted Device to Treat Opioid Addiction

http://blog.mountsinai.org/blog/mount-sinai-study-advances-the-use-of-a-new-implanted-device-to-treat-opioid-addiction/

Hey folks, had some spare time and couldn't help myself from checking in on TTNP. I thought this was hopeful.
"According to the National Institute of Drug Abuse of the National Institutes of Health, medicine given as a maintenance treatment in combination with recovery support is more effective than short-term detoxification programs aimed at abstinence.

"There’s probably a large untapped population of people being seen in primary care and elsewhere for whom this medication may be an excellent solution,” says Dr. Rosenthal. He adds that additional research is needed among broader populations of patients and to address the rate and predictors of relapse after the six months of implant use is discontinued.

Through the Center for Addictive Disorders and The Friedman Brain Institute, the Mount Sinai Health System treats at least 8,000 drug addiction patients annually, of whom 6,300 receive help for opioid addiction.

Unfortunately, I had to sell some shares finally to cover some medical expenses...I hated to do it at this level, but onward and upward. Holding the rest long-term, and for my mental health I'm taking a break from watching TTNP for a couple of weeks. Talk to you guys in a month or so...good luck.

Thanks for posting.

The Numbers...Good or Bad?

It depends on whose estimates you look at. Zacks predicted around $9m of sales this year, $97m in 2017 and $154m in 2018. Roth predicted around $2m this year, $25m in 2017 and $71m in 2018.

Through the 3Q, about 300 implants sold, average sales price after rebates, etc. probably around $3,700, for about $1.1 million in sales. 4Q? Let's say 600 implants sold for $2.28 million, and total sales for 2016 of around $3.3 million.

50% higher than Roth, but about 60% lower than Zacks.

Until I see some evidence that probuphine will actually be prescribed in meaningful numbers, I don't see the point in training more doctors. Let's hope that at the time of ER they can give us an update on the rate of prescriptions.

It's possible, but more likely this is just standard corporate housekeeping: they were working without employment agreements up until now (previous agreements expired in 2013). Payout on change of control is one year's salary, which is reasonable in my opinion.

So...per the last conference call, all preclinical testing necessary to submit the IND for ropinirole for parkinsons should have been completed by now. Be nice if we got a press release to that effect rather than having to wait until earnings in November.

Yes, but slowly. I don't think there are any big catalysts left this year which would provide a motivation to cover.

We know sales numbers for the 3Q won't be all that high. They are supposed to meet with the EMA in the 4Q about probuphine in the EU, but if the amount of press we've had over the Summer doesn't move the stock price, then I doubt that will. We should also get some news about Pro Neura for Parkinsons (submission of the IND?), but that will probably get a big "so-what" shrug from the market.

I'm thinking a ROW Partner deal (with an upfront payment) in the 1Q is what could push the price up a bit.

Oops...my bad.

I have no idea, but it's from the article. I was assuming about 50% of patients would go for a second treatment.

Opioid Implant

The opioid addict next door: Drug abuse where you least expect it

http://www.usatoday.com/story/news/nation-now/2016/09/26/opioid-addict-next-door-drug-abuse-where-you-least-expect/89360610/

VA/FSS Purchase Order Form

Hopefully this means VA and Federal Supply Schedule orders are coming soon.

http://braeburnaccessprogram.com/wp-content/uploads/2016/09/Braeburn-VA-Govt-FSS-Ordering-Form-9-9-2016_PR0054-002_15SEP16.pdf

New "Institution" Purchase Order Form

In the CNBC article, Sheldon alluded to institutional sales, and this was posted two days ago.

http://braeburnaccessprogram.com/wp-content/uploads/2016/09/Braeburn-Probuphine-Institutional-Order-Form-9-8-2016_PR0087-002_19SEP16.pdf

When insurers deny treatment for drug addiction

I didn't realize many insurers require prior authorization for every prescription of sublingual buprenorphine...all which would seem to direct patients towards a "hassle-free" implant. From the article...

A newly approved drug, Probuphine, an extended-release mix of buprenorphine and naloxone implanted into the skin (ensuring a patient gets treatment and the drug isn't resold on the black market), may be more readily covered by insurers.

“I’ve been in this business for more than 30 years and this is the first time insurance companies are calling us,” said Behshad Sheldon, CEO of Braeburn Pharmaceuticals, the maker of Probuphine.

Like most addiction treatments, Probuphine isn’t cheap. A six-month dose costs $4,950 and about 85 percent of patients will need to be on it for the rest of their lives.

http://www.cincinnati.com/story/news/2016/09/24/when-insurers-deny-treatment-drug-addiction/86176136/

U.S. states sue opioid-maker Indivior, alleging anticompetitive practices

http://www.reuters.com/article/us-states-indivior-antitrust-idUSKCN11S2IC

Update on Braeburn's Canadian Sublicensee

I didn't realize they were development stage, but they have a lot of cash behind them.

http://www.biotuesdays.com/features/2016/9/14/knight-therapeutics-to-get-real-as-it-builds-its-commercial-operations

Market Breakdown

Probuphine is expressly excluded because of its implant status, but this is the best summary of the current market I've seen.

http://www.imshealth.com/files/web/IMSH%20Institute/Reports/Healthcare%20Briefs/IIHI_Use_of_Opioid_Recovery_Medications.pdf

Okay, I don't think it's likely this is happening at all, but I do tend to love a good "conspiracy theory"...

Braeburn has made a point of not disclosing sales numbers or projections, and at the time of approval said it was "too early" to make any projections. They also pointed out it would take "a few months" for insurance issues to be ironed out. Probuphine was covered by about a dozen insurers by the end of July, which gradually rose to over 180 by last week, and pretty much all of them require "prior approval."

Sheldon is smart. She realizes in order for a sale to occur, a doctor has to go through probuphine REMS training, locate a patient stabilized on 8mg or less, determine insurance coverage (which wasn't available in most cases until the last 30 days), see the patient, recommend probuphine, obtain pre-approval from the insurer, arrange for an appointment with the patient to insert the implant, order probuphine from Braeburn, and then perform the procedure.

So given all of that, is 239 sales really a disappointment at this early stage? Most insurers have covered probuphine for less than a month. Most buprenorphine patients see their doctors once a month for the refill. Has there really been time for a flood of sales to occur? If so, what possible advantage is there to air that publicly? For a CEO to say "Wow, my projections were dead wrong" and sales have not met expectations.

Maybe if you have a vested interest in a certain company's stock price not becoming too expensive to buy in the near future.

Wouldn't that be something...just speculation, but let's say Braeburn wants to buy Titan, Titan says no we think we are worth more and we have an at the market offering to raise cash as we need it, so Braeburn tanks the stock price.

In my opinion, fear of being stuck with the bill for the implant is the main reason doctors aren't prescribing. Why should they act as the "bank" for both Braeburn and the patient? It's a big flaw in Braeburn's commercialization plan, and I don't believe first-time CEO Sheldon (who comes from a pill-centric world) saw it coming. Hopefully, they can address it quickly.

Yes, time will tell. In terms of the most efficient allocation of resources, I don't think more training is needed. After all, 2,400 doctors are trained, and very few are prescribing.

If I were running Braeburn, I would not train more doctors later this year, and instead use the funds for a marketing/direct-contact campaign to make sure a human being spoke to every doctor currently trained to inform him or her of:

-All insurance coverages in his or her state, including any necessary co-pays;and
-That Braeburn will cover up to $1,500 of any co-pay.

I would also stop the practice of requiring the doctor to pay for the implant, and then wait for insurance coverage to reimburse him or her. Instead, once prior approval is obtained by the insurer, ship product to the doctor and let the insurer directly compensate Braeburn, taking the risk out of the equation for the doctor.