IsoRay Gets FDA OK for Treatment of Recurrent Brain Cancers

IsoRay, Inc. (NYSE American: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers and GT Medical Technologies, Inc., today announced the receipt of FDA 510(k) regulatory clearance for the brachytherapy technology, known as GammaTile™ Therapy that incorporates proprietary Cesium-131 seeds within customizable collagen-based carriers for the treatment of recurrent brain tumors.

IsoRay Medical, Inc., a wholly owned subsidiary of IsoRay, Inc., and GT Medical Technology had previously executed a collaborative development agreement and an exclusive ten-year supply agreement for GammaTile Therapy.  GammaTile leverages Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure to surrounding tissue.  The Centers for Medicare and Medicaid Services (CMS) has already clarified the coding for GammaTile in the hospital setting by assigning GammaTile Therapy to a new, specific ICD-10-PCS code.  Now that the FDA has issued regulatory clearance for GammaTile, the therapy can be made available in the near future to patients served by hospitals throughout the United States.

The new technology add-on (NTAP) program would qualify us for additional payments in the inpatient hospital setting under Medicare beyond what is currently available.  However, the date of the FDA clearance will not qualify for the current NTAP application cycle.  Therefore, GammaTile will need to re-submit for consideration under the NTAP program for fiscal year 2020, which begins on October 1, 2019.

“We are very excited that our partnership with IsoRay Medical has resulted in this new opportunity to provide an innovative solution for the hundreds of thousands of patients with recurrent brain tumors,” said Matthew E. Likens, President and CEO of GT Medical Technologies.  “As we worked to gain approval, GammaTile Therapy was implanted in over 100 patients in an IRB- approved study at the Barrow Neurological Institute in Phoenix, AZ.  We believe that experience will be a solid foundation for us to expand access to this important advancement in brain tumor therapy.”

“GammaTile Therapy utilizes Cesium-131 brachytherapy seeds to deliver a fast-acting therapeutic dose to the tumor bed,” said Lori Woods, Interim Chief Executive Officer of IsoRay, Inc. “The unique properties of Cesium-131 have started to revolutionize brain brachytherapy treatment, and GammaTile Therapy should help to accelerate the adoption of these procedures.  We look forward to working closely with GT Medical Technologies to support access to this critical treatment for patients with recurrent brain tumors.”

https://bit.ly/2J69BA0

Community Care Physician Network, UnitedHealth Join to Serve NC Medicaid

Community Care Physician Network LLC (CCPN) and UnitedHealthcare have established a new Advanced Care Medical Home and care management network relationship, giving North Carolina Medicaid beneficiaries access to CCPN’s 2,200 independent primary care providers in counties across the state under the new managed care system that will launch in 2019.

As a sign of the value they see in the relationship, UnitedHealthcare and CCPN will work closely together on innovative approaches to enhancing patient care and reducing health care costs.

“We’re excited to bring the benefits of CCPN’s high-performing primary care practices to UnitedHealthcare’s Medicaid beneficiaries with this new relationship,” said Steve Wegner, M.D., J.D., CEO of CCPN. “Our clinicians in counties across the state are ready to work hand-in-hand with UnitedHealthcare to enhance quality, patient experience, health outcomes and physician satisfaction.”

CCPN clinicians currently deliver health care services to 700,000 North Carolina Medicaid beneficiaries – more than 40 percent of people enrolled in Medicaid, the primary care case management program. These practices provide critical health care services in urban and rural counties across the state and care for a significant portion of North Carolinians with unique and complex health care needs.

“We are the first health plan to establish a definitive Advanced Care Medical Home relationship with CCPN because we believe our work together will lead to innovative approaches to meeting the needs of the people we serve across the state,” said Anita Bachmann, CEO of UnitedHealthcare Community Plan of North Carolina. “CCPN delivers high-quality health care and, most importantly, understands its patients, their unique health care needs and the communities it serves. We believe CCPN’s longstanding history of physician-driven and patient-focused care will complement UnitedHealthcare’s local and national experience and innovative programs.”

This new partnership provides the industry expertise, data and support that will enable CCPN to treat patients using an innovative value-based model focused on helping keep people healthy. UnitedHealthcare shares data with CCPN about patients’ underlying medical conditions, past treatments, missed care opportunities, medications prescribed and future care needs. This takes the burden off patients from having to connect information from each of their doctor’s visits themselves, and reduces duplicative tests and improves care coordination across specialties and care settings.

CCPN and UnitedHealthcare – which has served North Carolina for more than 20 years – collectively serve nearly 3 million people statewide.

https://bit.ly/2ufhde0

Bovie Medical in deal to sell core business

Bovie Medical Corp.’s stock BVX, +4.81% soared 10% toward a 20-month high in premarket trade Monday, after the medical device company said it reached a deal to sell its “core” business and the Bovie brand for $97 million in cash to Symmetry Surgical Inc. As part of the deal, which is expected to close in the third quarter of 2018, Bovie said it will enter into transition services, patent licensing, disposables supply and generator manufacturing and supply agreements with Symmetry. “This is a milestone moment for the Company, one that creates significant value for our shareholders by significantly enhancing our balance sheet with the addition of more than $70 million in estimated net cash proceeds after taxes and transaction related expenses and allowing us to further focus the organization on our strategic objective of commercializing our J-Plasma/Renuvion technology in the cosmetic surgery market,” said Chief Executive Charlie Goodwin. Separately, the company said it expects second-quarter revenue of $11.2 million to $11.5 million, above the FactSet consensus of $10.1 million. The stock has rocketed 92% year to date through Friday, while the S&P 500 SPX, +0.76% has gained 3.2%.

https://on.mktw.net/2NAqeHj

Teva Launches Generic for Ulcerative Colitis in U.S.

Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the launch of a generic version of Uceris®1 (budesonide) extended-release tablets, 9 mg, in the U.S.

Budesonide extended-release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

“The launch of generic budesonide extended-release tablets signals an important addition to Teva’s portfolio,” said Brendan O’Grady, EVP and head of North America Commercial. “We continue to be focused on bringing affordable generic treatment options to our customers, including those living with chronic, life-long conditions like ulcerative colitis.”

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Uceris® had annual sales of approximately $196 million in the U.S., according to IMS data as of May 2018.

https://bit.ly/2J8dap3

Vertex spars with UK’s May over cystic fibrosis med pricing

• Vertex is reaching high in its attempt to get U.K. reimbursement for its cystic fibrosis medications by writing to request “urgent intervention” from Prime Minister Theresa May, citing it as “a test case for the Government’s delivery of accelerated access to innovative medicines in the U.K.”
• The letter contends Vertex made what the company describes as “the most innovative and best offer in the world to NHS England,” but that the NHS did not accept the offer.
• Vertex has its international HQ in London and an R&D site near Oxford. The letter suggests Vertex’s future in the U.K. could be in question, referring to the company “questioning this ecosystem” and that “any future biotech investment in the U.K. is at significant risk.”

Vertex’s cystic fibrosis sales are climbing, with the franchise up 33% year-on-year in the first quarter of 2018. Still there are concerns that the price for Orkambi (lumacaftor and ivacaftor) is too high. In the U.S., the price tag for Orkambi is about $272,000 a year, and a May 2017 report from the Institute for Clinical and Economic Review said that would have to come down more than 70% to be affordable. Vertex shot back a letter to the ICER, accusing the review process of being a “sham” and the body being reliant on “flawed scientific methodology.”

Orkambi was approved in Europe in November 2015. However, in July 2016, the National Institute for Health and Care Excellence stated that Orkambi was “not recommended, within its marketing authorisation, for treating cystic fibrosis in people 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.”

Vertex and the NHS have been in discussions over the subsequent two years to work out a pricing scheme that will cover Orkambi and Vertex’s other two CF therapeutics, Kalydeco (ivacaftor), and tezacaftor/ivacaftor, as well as other future medicines still in development, and use of the medicines in children. In the House of Commons on May 16, May said she wanted to see a quick resolution to the negotiations.

There is a petition ongoing in the U.K., asking the government “to call for a resolution to ongoing negotiations between Vertex Pharmaceuticals, NHS England and NICE as a matter of the utmost urgency.”

The company met with the NHS last Wednesday, but the two sides failed to reach agreement and each issued combative statements.

Vertex accused NHS England of “placing a lower value on the life of a CF patient than other countries around the world,” and called on to the government to intervene.

The NHS response to the meeting, which had an equally battling tone, supported NICE’s decision: “NICE has been clear that Vertex’s pricing is unsupportable. If Vertex really believe they are offering a reasonable deal they should waive their confidentiality clause and let patients and taxpayers judge whether it is fair.”

The next step was Vertex’s letter from CEO Jeff Leiden to May requesting her urgent intervention.

“We are confident our proposal to NHS England would achieve rapid patient access, budget certainty for the NHS, and fair reward for innovation… We respectfully request, therefore, that you urge NHS England to properly value and realise the potential of our portfolio of cystic fibrosis medicines. It would be disappointing in the extreme that, as the NHS turns 70, it is found to be shutting the door to a new era of precision medicines that stand to revolutionize healthcare.”

https://bit.ly/2NE6SkK

KemPharm pushes ADHD filling to 2019

• KemPharm on Monday announced results from a pivotal trial of its attention-deficit/hyperactivity disorder drug KP415 in children ages six through 12.
• The classroom-style, 150-patient study measured efficacy using both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale. SKAMP is a rating of classroom behaviors in children with ADHD and PERMP is a math test designed to asses a child’s ability to initiate, self-monitor and complete the test.
• The company intends to submit a New Drug Application for the ADHD prodrug in the first quarter of 2019. Previously, KemPharm had been shooting for filing by the end of 2018.

KP415 is an extended release form of d-methylphenidate that uses the company’s ligand activated therapy platform technology. Prodrugs are pharmacologically inactive drugs that become active after being metabolized in the body. KemPharm has claimed the formulation may have lower abuse potential and less variable drug delivery. Its platform strategy is based on turning already approved therapies into prodrugs.

The pivotal study was meant to test both early onset of action and extended duration of therapy. The study showed that KP415 had a statistically significant mean difference in the primary endpoint of SKAMP-combined score change from baseline from one hour to 10 hours compared with placebo.

Depending on what baseline the company used to measure scores — either pre-dose Visit Five or pre-dose Visit Six — the timing of onset of action and length of therapy duration changed. This could be why KemPharm’s stock was off, trading down about 4% in morning trading after shooting higher pre-market.

The Iowa-based biotech intends to collect further clinical data over the course of 2018 ahead of a 2019 NDA submission.

https://bit.ly/2u6zuep

Are your prescriptions contributing to depression?

Hello. I’m Dr Charles Vega, and I am a clinical professor of family medicine at the University of California at Irvine. Welcome to Medscape Morning Report, our 1-minute news story for primary care.

Depression is one of the most common chronic illnesses affecting adults, but can physicians be contributing to the prevalence of depression? An analysis of prescribing habits suggests that the answer is yes.

A new analysis of data from the National Health and Nutrition Examination Survey concluded that more than one third of US adults used a prescription medication that had depression as a potential adverse effect in the previous 30 days.

Concomitant use of three or more of these drugs occurred in almost 10% of adults. And use of meds causing potential suicidal symptoms also increased, with almost a quarter of adults using one of these agents.

Commonly used medications with this adverse effect include beta-blockers, proton pump inhibitors, analgesics, and hormonal contraceptives. The number of medications associated with depression as an adverse event was correlated with a higher prevalence of depression.

This study serves as a reminder that we should all be considering the potential risk for depression when we write routine prescriptions.

https://wb.md/2KUP1HI