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Thursday, June 7, 2018

New fed law may spur Medicare Advantage plans to avoid sick enrollees


Insurance companies may decline to offer additional benefits outlined in a new federal law in an effort to dissuade frail seniors from joining their Medicare Advantage programs, according to a new analysis published Wednesday.
The Chronic Care Act, which passed earlier this year, allows insurance companies offering MA plans to pay for non-medical services like installation of raised toilet seats and grab bars in bathrooms or provision of hearing aids, scooters or personal care services. Experts have predicted that covering these services would reduce emergency department use and readmissions.
The law’s goal was to integrate coverage and access to both medical and non-medical services. Under the statute, Medicare Advantage plans can offer these new benefits starting in 2020.
But insurance companies may decline to offer the expanded coverage to stop severely ill seniors who need costly care from joining their plans, according to the analysis in the New England Journal of Medicine. The piece was co-authored by a professor at University of Maryland School of Public Health and a scientist at Johns Hopkins Bloomberg School of Public Health.
There are significant Medicare spending differences for beneficiaries with functional impairment and those without such impairment, according to the co-authors..
To avoid this disincentive from offering new benefits, lawmakers should require fee-for-service Medicare to cover non-medical services too, according to David Lipschutz, senior policy attorney at the Center for Medicare Advocacy.
“It’s a matter of basic equity and its leaving the majority of Medicare patients without access to the new services,” Lipschutz said.
But insurance companies said the concerns highlighted in the analysis were overblown.
“The argument being made by these authors is speculative and does not recognize some of the important realities of the Medicare Advantage program,” said Cathryn Donaldson, a spokeswoman for AHIP.
Average spending on Medicare Advantage is roughly equivalent to Medicare fee-for-service and plans regularly work to direct resources to enroll more complex, chronically ill individuals, she added.
In addition, the analysis seems to ignore the existence of Medicare Advantage Dual Eligible Special Need Plans (D-SNPs), according to Dr. Cheryl Phillips, President and CEO SNP Alliance, a trade organization. These plans already enroll and coordinate care for some of the most chronically ill Medicare beneficiaries.
“This article seems to imply that MA plans will avoid high risk and high-cost beneficiaries, yet, that is the very population that SNPs serve,” Phillips said.

Biogen Options Stroke Drug from TMS in Deal That Could Hit $357M


Biogenheadquartered in Cambridge, Massachusetts, signed an exclusive option deal with Tokyo-based TMS for TMS-007 and backup compounds.
TMS-007 is a plasminogen activator associated with the breakdown of blood clots. It is also believed to inhibit local inflammation at the site of thrombosis. The combination gives the drug a shot at being best-in-class for treatment of acute ischemic stroke (AIS). The drug has shown an acceptable safety profile in a Phase I clinical trial and also reduced infarct volume, the among of dead tissue caused by the failure of blood supply, in rodent and primate models. It is currently being evaluated in a double-blind, placebo-controlled Phase II trial in Japan.
Biogen is paying $4 million upfront with an additional $18 million if Biogen exercises its option. TMS will be eligible for up to $335 million in development and commercialization milestones in addition to tiered royalties.
“Stroke represents a compelling opportunity that takes advantage of our deep expertise and capabilities in neuroscience as we seek to make a meaningful difference in patients’ lives,” said Michael Ehlers, Biogen’s executive vice president, Research and Development, in a statement. “Stroke impacts millions of people every year, and is a leading cause of death and long-term disability worldwide. TMS-007 complements our broader efforts in stroke, including our Phase III ready asset BIIB093 (intravenous glibenclamide), which targets prevention and treatment of edema in large hemispheric infarction, one of the most severe types of stroke. By growing our acute neurology portfolio, we aim to make new advances in a disease that in the past decades has seen limited therapeutic innovation.”
While much of the focus on Biogen has been about its ongoing Phase III clinical trial of aducanumab for Alzheimer’s disease, the company has been making a number of smaller investments such as this one to build up its neurology pipeline. It recently expanded an alliance with Ionis Pharmaceuticals to develop RNA-based drugs for brain diseases. It bought glibenclamide when it acquired New York-based Remedy Pharmaceuticals in 2017 for $120 million.
In March, Biogen bought PF-04958242 from Pfizer, a Phase IIb-ready AMPA receptor potentiator for cognitive impairment associated with schizophrenia. In November 2018, Biogen inked a global license and collaboration deal with Alkermes to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate small drug molecule in Phase III to treat relapsing forms of multiple sclerosis (MS). In October 2017, Biogen and Japan-based Eisai Co expanded an existing deal to jointly develop and commercialize aducanumab for Alzheimer’s.
And in April 2017, the company licensed BMS-986168, a Phase II-ready drug for Alzheimer’s and progressive supranuclear palsy (PSP) from Bristol-Myers Squibb.
For some time, investors and analysts have wanted Biogen to make a large transformative deal, ranging from buying Ionis to acquiring Acadia. This is largely because much of the company’s revenues come from its drugs for MS, which are facing stiff competition. However, the company seems content, so far, of staying focused on marketing its MS drugs and Spinraza for spinal muscular atrophy (SMA), which went on the market in 2017, leaning heavily on its aducanumab program, and building up its pipeline for other neurological disorders.

Pfizer started at buy by Cantor

Cantor analyst Louise Chen initiated Pfizer with an Overweight and $45 price target.

Genetech gets FDA OK for Rituxan for 4th autoimmune indication


Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Rituxan for the treatment of adults with moderate to severe pemphigus vulgaris, a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. The FDA previously granted Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. With today’s FDA decision, Rituxan is now approved to treat four autoimmune diseases.

Ionis Pharma closes on collaboration with Biogen to develop neurological drugs


Ionis Pharmaceuticals, Inc. announced that it closed its expanded strategic collaboration with Biogen to discover and develop novel antisense drugs for a broad range of neurological diseases following receipt of clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Biogen paid Ionis $1 billion in cash, which included $625 million for the purchase of 11,501,153 shares of Ionis common stock at a price of $54.34 per share and a $375 million upfront payment.
On April 20, 2018, Ionis and Biogen announced they would expand their strategic collaboration to develop novel antisense drugs for a broad range of neurological diseases through a new ten-year collaboration. This collaboration capitalizes on Ionis’ leadership in RNA-targeted therapies as well as Ionis and Biogen’s joint expertise in neuroscience research and drug development. It builds upon a productive collaboration that produced Spinraza (nusinersen), the first and only approved treatment for patients with spinal muscular atrophy.
The companies plan to advance programs for a broad range of neurological diseases for which few treatment options exist today. Disease areas include dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.
Ionis will be responsible for the identification of antisense drug candidates based on selected targets, while Biogen will have the option to license therapies arising out of this collaboration and will be responsible for and pay for non-clinical studies, clinical development, manufacturing, and commercialization. In addition, Biogen may pay milestone payments, license fees and royalties on net sales.
Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases.

U.S. antitrust official says worries over limiting vertical deals ‘misplaced’

A top antitrust official at the U.S. Justice Department attempted to reassure investors on Thursday that worries that regulators would crack down on proposed combinations of two companies on a supply chain — known as vertical mergers — were overblown.

Makan Delrahim, the assistant attorney general for antitrust, said that most proposed transactions were either good for consumers or neutral.
But the department’s decision in November to sue to stop AT&T Inc, which owns DirecTV, from buying Time Warner Inc made investors question whether other vertical deals might also meet with scepticism from antitrust enforcers.
Delrahim said that was overblown.
“I understand that some journalists and observers have recently expressed concern that the antitrust division no longer believes that vertical mergers can be efficient and beneficial to competition and consumers,” he said.
Delrahim said that some of these point at the decision to sue to try to stop AT&T from buying Time Warner “as a supposed bellwether,” he said. “Rest assured these concerns are misplaced.”
Two other vertical deals under review are Cigna Co plan to buy Express Scripts Holding Co for $52 billion (£38.7 billion) and CVS Health Corp’s planned merger with Aetna Incfor $69 billion.

4D Pharma Plans Cancer-Treatment Trial With Merck Unit


4D Pharma said it entered into a collaboration agreement with a subsidiary of Merck & Co. Inc. (MRK) to conduct a clinical trial evaluating its anti-cancer drug MRx0518 for use in tandem with a Merck therapy.
The pharmaceutical company said the phase 1 clinical trial will evaluate the effectiveness of MRx0518 in combination with cancer drug Keytruda in patients with renal, bladder and non-small cell lung cancer, as well as melanoma. The study will evaluate the safety, tolerability and preliminary clinical benefits of the drug combination, 4D pharma said.