Senate extends funding for mental health clinics

The Senate on Thursday passed a two-month extension of a Medicaid demonstration enabling innovative mental health centers in eight states to offer broad, coordinated services for serious mental illness and substance use disorders.

Advocates hope the House will approve the temporary funding measure next week as a routine, consent calendar item.

The Senate bill, sponsored by Sen. Roy Blunt (R-Mo.), would provide about $60 million to the program through Sept. 13. It previously was delayed by holds by Republican senators. Two-year funding for the $1 billion certified community behavioral health clinic (CCBHC) ended on July 14.

Centers in Minnesota, Missouri, Nevada, New Jersey, New York, Oklahoma, Oregon and Pennsylvania have notified staff and patients about layoffs and service cuts. But none of the programs have shut down yet, according to the National Council for Behavioral Health.

Blunt and Sen. Debbie Stabenow (D-Mich.), the original sponsors of the CCBHC demonstration program, have pushed to renew the program and expand it to 11 additional states, including California and Texas. Advocates hope longer-term funding will be included in a broader government spending package in the fall.

Earlier this month, Blunt said the CCBHC program in Missouri has helped in preventing patients from having to go to emergency departments to deal with mental health crises. He urged Congress to extend the program through the end of the current fiscal year because it’s helping reduce overall healthcare costs.

CCBHCs received enhanced, cost-based reimbursement from Medicaid through a global payment per patient model, while reporting 22 quality measures.

The enhanced funding enabled the clinics to cover the costs of support services such as outreach, case management, housing, legal and employment services. The Substance Abuse and Mental Health Services Administration projected that the current 67 CCBHCs would serve more than 380,000 people at 372 sites.

A funding cut-off would mean that nearly 3,000 staff at 67 CCBHCs around the country could lose their jobs and more than 9,000 patients receiving medication-assisted treatment for substance abuse could lose access to that treatment, the National Council for Behavioral Health has estimated.

The CCBHC demonstration, created by the Excellence in Mental Health Act of 2014, was the biggest federal investment in many years in improving community-based mental healthcare.

The demonstration tested a new, multidisciplinary model for delivering community-based mental health and addiction treatment. Participating clinics were required to provide nine types of evidence-based services, including 24-hour crisis care, substance abuse services such as medication-assisted treatment and detox, care coordination and integration with physical healthcare.

A key benefit of the CCBHC model is offering a broad range of services in a single setting, so patients with disabling disorders don’t have to navigate the system on their own.

Experts say it’s critical to expand and strengthen community-based behavioral and addiction services as a proactive alternative to the current patchwork of treating patients with advanced serious mental illness in emergency departments, jails or prisons.

https://www.modernhealthcare.com/medicaid/senate-extends-funding-mental-health-clinics

Walgreens adds Dexcom, Propeller to digital marketplace

• Walgreens said it has added Dexcom, maker of the G6 continuous glucose monitoring (CGM) system, and Propeller Health, whose sensors monitor usage on a patient’s inhaler, to a growing list of healthcare product and service providers on its Find Care digital marketplace.
• The new additions mark an expansion into chronic care management with connected devices for patients with diabetes, asthma and chronic obstructive pulmonary disease (COPD).
• Walgreens said it has added a number of healthcare offerings from new and existing customers since launching the platform last year.

The pharmacy retailer introduced Find Care a year ago with the goal of directing customers to lower-cost health services including telemedicine and urgent care centers within its stores. The platform promotes transparency, listing prices for various services. Find Care is accessible through the health services section of the company’s mobile app and online at www.walgreens.com/findcare.

Since the launch of the marketplace, Walgreens has added collaborations with Vanderbilt Health, Aspen Dental, Partners in Primary Care, Norton Healthcare, Community Health Network and Houston Methodist, offering services such as primary care, telehealth and dental.

Roughly 30 million adults have Type 1 or Type 2 diabetes, about 25 million U.S. adults and children have asthma and more than 15 million adults have COPD. Walgreens said the platform can help patients learn to better manage these conditions.

These patient populations are ripe for conversion to new technologies such as CGM and monitored asthma inhalers.

Dexcom’s continuous glucose monitor gives patients real-time glucose information via a sensor implanted under the skin that sends data to a wireless device through a transmitter, without the need for finger sticks. The water-resistant sensor can also provide customizable alerts warning patients when blood sugar highs and lows are possible and can be worn up to 10 days.

G6 received marketing authorization early last year as the inaugural devicepermitted under FDA’s iCGM (integrated continuous glucose monitoring) label.

Propeller works by attaching a sensor to a patient’s existing inhaler to track medication use, sending that information to a mobile app. The system includes medication medication adherence reminders, air quality forecasts and symptom insights to help with disease management. The platform can also share information with the patient’s physician between appointments.

And inhaler monitoring systems like Propeller’s have been found to lower COPD hospitalizations, according to a recent study.

Propeller was acquired earlier this year by respiratory device maker ResMed in a $225 million transaction.

https://www.healthcaredive.com/news/walgreens-adds-dexcom-propeller-to-digital-marketplace/559425/

FDA delays AdComm for Nektar’s pain drug a month ahead of decision deadline

In May, Nektar Therapeutics handed off its lead pain drug to its new subsidiary Inheris so it could focus on its cancer and immunology pipeline. Now, that company is hitting a roadblock as the FDA puts off an advisory panel meeting for the drug, a mu-opioid agonist.

The FDA told Nektar in a General Advice letter Tuesday that it would postpone the advisory committee meeting, originally scheduled for Aug. 21, the company revealed in a Securities and Exchange Commission filing. The FDA will keep reviewing the submission for the drug, NKTR-181, with an eye on the Aug. 29 PDUFA date, but said it could miss that deadline. Nektar’s stock dropped nearly 11% Thursday.

The agency is delaying the meeting as it “continues to consider a number of scientific and policy issues relating to this class of drugs,” Nektar said in the filing. “The Letter stated that the FDA’s reason for postponing the advisory committee meeting for NKTR-181 is not unique to the NKTR-181 product.”

The setback comes amid a reckoning for opioids and the companies that make them. The attorneys general of Massachusetts and New York filed lawsuits earlier this year accusing Purdue Pharma of aggressively pushing to expand the market of OxyContin, even after the company admitted in 2007 that it had “misrepresented the drug’s addictive qualities and potential for abuse.”

NKTR-181 is a long-acting mu-opioid agonist designed to east pain without triggering the euphoria that can lead to abuse and addiction. It does this by crossing the blood-brain barrier more slowly than conventional opioids. It bested placebo in improving pain scores for patients with chronic low back pain, meeting its primary endpoint in a phase 3 study.

“While it’s still certainly possible that the FDA can complete its review of NKTR-181 in time for a potential launch in early 2020, we believe there’s a reasonable chance that the launch will now be delayed while the agency formalizes its position on opioid analgesics in the coming months,” wrote Jefferies analysts David Steinberg and Edward Chung in a note Thursday.

“Given this unusual situation and dearth of historical examples to use as templates, our ‘best guess’ is to now assume a one year delay for NKTR-181 and project product launch in 1H21. Importantly, there is no indication that the FDA will no longer approve opioids for pain management at this point—although that always remains a possibility given the severity of the current crisis.”

The analysts still consider NKTR-181 a “meaningful, safer treatment option” for patients with chronic pain, but dropped their peak sales estimate for the drug from $500 million to $350 million thanks to “ongoing contraction in the opioid market.”

https://www.fiercebiotech.com/biotech/fda-delays-adcomm-for-nektar-s-pain-drug-a-month-ahead-decision-deadline

GW Pharma Receives EU Regulatory Agency Panel Backing For Epidiolex

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) is inching closer to clearing another regulatory hurdle with respect to its cannabidiol drug Epidiolex, potentially opening up a market opportunity in Europe.

What Happened

The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP,  issued a positive opinion on Epidiolex, the company said Friday.

The panel is recommending approval of Epidiolex for use as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome, or LGS — or Dravet syndrome in combination with clobazam — in patients two years and older.

Epidiolex is an oral solution containing highly purified cannabidiol with a novel mechanism of action. It has an Orphan Drug Designation from the EMA for treating seizures associated with LGS, Dravet syndrome and tuberculosis sclerosis complex.

The drug received FDA approval in June 2018 and launched commercially in the U.S. in November 2018

The product fetched GW Pharma sales of $33.5 million in the first quarter of 2019.

The company submitted the marketing authorization application to the EMA in December 2017, with the agency accepting it for review in February 2018.

“We are excited by the potential to bring patients and physicians a rigorously tested and evaluated cannabis-based medicine with a documented safety and efficacy profile, manufactured to the highest standards and approved by a medicines regulator,” CEO Justin Grover said in a statement.

The CHMP opinion is positive for GWPH, Cantor Fitzgerald’s Elemer Piros said in a Friday note.

The label inclusion of clobazam is unlikely to deter prescriptions in the EU, given the high unmet medical need and numerous positive Phase 3 data reported from GWPH, the analyst said.

“On the pricing front, GWPH does not believe pricing will be impacted, and remains confident on obtaining reimbursement in key markets.”

Cantor Fitzgerald has an Overweight rating on GW Pharma with a $229 price target.

What’s Next

The European Commission is expected to a make a final decision on the regulatory application in about two months.

The approval, if it comes through, will authorize the company to market the drug in 28 EU nations, alongside Norway, Inceland and Liechtenstein.

https://www.benzinga.com/analyst-ratings/analyst-color/19/07/14142330/gw-pharma-receives-eu-regulatory-agency-panel-backing-for-epidiolex

Ra Medical launches new laser for skin treatments

Ra Medical Systems (RMED) announces the commercial launch Pharos, Optimized, a next-generation excimer laser that, it says, enhances physician and patient experiences with faster treatments for psoriasis, vitiligo (blotchy skin) and atopic dermatitis.

https://seekingalpha.com/news/3482386-ra-medical-launches-new-laser-skin-treatments

Achillion adds to ACH-5228-stoked rally

Achillion Pharmaceuticals (ACHN +24.4%) is up on a 6x surge in volume. Shares have rallied 102% this week after it announced encouraging Phase 1 data on complement factor D inhibitor candidate ACH-5228.

Results showed that the higher doses (120 mg – 200 mg twice-daily) achieved near-complete and sustained Alternative Pathway (AP) inhibition.

Factor D, originally identified as adipsin, is an essential enzyme (serine protease) in the AP of the complement system (part of the innate immune system). Inhibiting AP may have potential in treating complement system-related disorders like paroxysmal nocturnal hemoglobinuria (PNH), C3 glomerulopathy (kidneys malfunction leading to excess levels of protein in urine) and immune complex-mediated membranoproliferative glomerulonephritis (kidney malfunction due to inflammation of tiny filters called glomeruli).

https://seekingalpha.com/news/3482408-achillion-adds-achminus-5228-stoked-rally-shares-24-percent

Herceptin drops on contracting ahead of U.S. biosim; Roche sales strong anyway

Biosimilars to Roche’s top-selling cancer drugs Herceptin and Avastin entered the U.S. last week. But thanks to PD-L1 inhibitor Tecentriq, hemophilia drug Hemlibra and multiple sclerosis therapy Ocrevus, Roche is still counting on sales growth this year.

In the U.S., Herceptin sales in the second quarter dropped 8%—versus an increase of 3% in Q1—to 718 million Swiss francs ($727 million) “on the back of contracting ahead of biosimilar entry,” Wolfe Research analyst Tim Anderson noted in an investor’s report Thursday.

Amgen launched Avastin biosim Mvasi and Herceptin copycat Kanjinti at 15% discounts last week after a U.S. district court judge in Delaware denied Roche’s motions for an injunction against them. Roche is currently appealing the decision in the hope of protecting a combined $5.9 billion in 2018 U.S. sales.

It’s too early to tell how much those biosims will affect Roche’s brands—or how quickly. Roche Pharmaceuticals chief Bill Anderson said Thursday that the company hasn’t “seen much disruption in the market” so far.

The thing is, biosimilars, in general, have suffered much slower launches in the U.S. than in Europe, and Roche executives have explicitly said they don’t expect the same 40% to 50% sales declines its drugs are seeing in the EU.

Declines for those key drugs are expected to show in the second half of the year, though. Or as ODOO BHF analyst Pierre Corby put it in a Thursday note, this is “possibly the last good quarter for some time.” Nevertheless, Roche has dialed up its forecast for 2019 on the upbeat Q2. It now expects group sales to grow in the mid- to high-single digits, up from the previous mid-single digits, despite the biosimilars attack.

Why? Its newer drugs are delivering strong numbers.

Roche’s immuno-oncology drug Tecentriq is the obvious growth engine. Its sales jumped 32.7% quarter-over-quarter to CHF 446 million, which topped analysts’ expectations by an impressive 17%. The solid sales got a boost from two first-in-class approvals in first-line extensive-stage small cell lung cancer and triple-negative breast cancer.

Tecentriq was already making “significant” inroads in SCLC before the approval came mid-March, Anderson said. The drug has penetrated about half of the patient population in the U.S. for the indication, but “there is probably some considerable room to go because there’s some question around eligible population, and I think that may be expanding,” he added.

As for TNBC, he estimated the testing rate for those relative biomarkers is just reaching 70%, and within them, Tecentriq has nabbed around 70% of patients.

It was not all good news for the immuno-oncology therapy, though. The Swiss drugmaker capped two Tecentriq trials in castration-resistant prostate cancer, according to a pipeline update. And AstraZeneca’s rival PD-L1 Imfinzi could enter SCLC soon.

Meanwhile, the hemophilia launch Hemlibra, with a second-quarter haul of CHF 316 million, did 23% better than expected, driven mainly by a new approval in the U.S. non-inhibitor market. In the EU, Roche is still “very early” in its reimbursement talks for non-inhibitor use, Anderson said.

MS drug Ocrevus also came in slightly ahead of analyst expectations at CHF 899 million—a whopping 59% increase over the same period last year. So far, Ocrevus has steadily grown its new-to-brand share in the U.S. toward 40%, making it the No.1 disease-modifying treatment for MS patients starting a new therapy. It did that despite the recent launch of Novartis’ Mayzent, and Roche seems confident it will hold the ground.

“Yes, we have seen an impact [from competitive launches]—the impact is that Ocrevus share goes up,” Anderson said during the call. “We hope there are more competitive launches like that.”

All told, Roche’s pharma division brought in CHF 12.27 billion for the quarter, up 11% year over year, while its entire group sales, including diagnostics, hit CHF 15.64 billion.

https://www.fiercepharma.com/pharma/herceptin-drops-contracting-ahead-u-s-biosim-but-roche-raises-outlook-anyway