“A nurse or a social worker in the home has so much influence on the individual’s care model,” Broussard said. “They have so much influence because it’s convenience, they see the holistic aspect of how an individual is living and they build a deeper relationship.”
Tuesday, July 23, 2019
Ionis PT Lowered to $95 at BMO Capital, Lowers Spinraza Estimates
BMO Capital analyst Do Kim lowered the price target on Ionis Pharmaceuticals (NASDAQ: IONS) to $95.00 (from $96.00).
Intra-Cellular down 31% on cancellation of Ad Com meeting
Intra-Cellular Therapies (ITCI -30.9%) plummets on more than a 7x surge in volume in reaction to the cancellation of an FDA advisory committee meeting to review and discuss its marketing application for lumateperone for adults with schizophrenia citing “new information” pertaining to the filing. The meeting was scheduled for Wednesday, July 31.
The FDA says that it will “continue evaluating the application” and announce future meeting dates “as needed” in the Federal Register. The agency’s action date for its review is September 27.
On July 8, the company announced results from two Phase 3 studies, one successful and one not.
FDA OKs Pfizer Biosimilar RUXIENCE for Certain Cancers, Autoimmune Conditions
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2
“Biosimilars like RUXIENCE have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, Global President, Pfizer Oncology. “The FDA approval marks our third oncology biosimilar to be approved in the U.S. this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”
The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.3
“Rituximab became one of the first monoclonal antibody (mAb) cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time,” said Dr. Jeff Sharman, medical director, US Oncology Hematology Research. “With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy.”
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to create a more sustainable healthcare system. With more than 10 years of global in-market experience and seven approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. RUXIENCE is Pfizer’s third oncology mAb biosimilar to be approved by the FDA this year.4,5 RUXIENCE has also been filed for regulatory approval with the European Medicines Agency (EMA) and is under review.
Senators Introduce Bill to Cap Drug-Price Increases Under Medicare
The Senate Finance Committee’s highest-ranking members are pushing legislation to restrain drug-price increases by placing some caps on out-of-pocket spending in the federal Medicare program.
Committee Chairman Sen. Chuck Grassley (R., Iowa) and ranking member Ron Wyden (D., Ore.) said their bill could save the government $85 billion on the Medicare program over 10 years, based on a Congressional Budget Office Analysis.
The budget office analysis also said that Medicare beneficiaries could save $27 billion in out-of-pocket costs over the same ten-year period, as well as another $5 billion in federal Medicare premiums.
The bill generally would cap Americans’ drug costs at a fixed level in the Medicare drug-benefit program called Part D. It also would cap the growth of government subsidies in the program at the consumer inflation rate.
The legislation is among an array of competing proposals offered by various members of Congress and by the Trump administration. Sen. Grassley’s office said he is seeking the Republican administration’s support for this legislation. Drug prices are already at the center of the 2020 presidential election, and promise to remain so.
This bill, if it gains sufficient congressional support, is among those that could have the greatest impact on prices, but it is expected to be opposed by the drug industry.
PhRMA, which represents the drug industry in Washington, didn’t immediately respond to requests for comment on the legislation.
Aaron S. Kesselheim, a Harvard medical professor who has been prominent in U.S. drug-safety and pricing issues, called the bill “an important step forward.”
“Caps on price increases for drugs could be significant,” he said. “It does not seem reasonable that pharmaceutical manufacturers should have carte blanche to raise prices each year based on what the market will bear without bringing any relevant new information to the market about the value of the drug.”
Humana CEO: Medicare Advantage could fix what ‘Medicare for All’ tries to solve
Humana CEO Bruce Broussard doubled down on his support for Medicare Advantage (MA) when asked to discuss “Medicare-for-All” proposals Monday.
The leader of the Louisville, Kentucky-based insurance giant was addressing the Better Medicare Alliance Medicare Advantage Summit in D.C. when he was asked about his thoughts on the national conversation around Medicare for All and other public option proposals. He remained coy about outright discussion of any proposals but has previously avoided disavowing public option proposals like many of his counterparts at other insurers. He has said he opposes any move that would make MA or other private insurance plans illegal.
“When I think about where Medicare Advantage is, if we do our work the right way, I can see Medicare Advantage being the payment model that is being used where we want to fill that need where people don’t have an employer plan and they’re not being covered by Medicaid,” Broussard said. “I’m biased as hell. But I just think Medicare Advantage has all the elements, and how can we take that and bring that in line with other coverage, cost and quality.”
MA has become a big line of business for Humana as well as for other insurers. In May, Humana announced a strong start in the first quarter of 2019 driven by better-than-expected growth in MA plans. The company raised its full-year expected individual growth for MA to between 415,000 to 440,000 members, representing 14% growth in 2019. Humana initially projected an increase of between 375,000 and 400,000 MA members for 2019.
Through MA, Humana members have reported 7% less emergency department visits and 5% fewer hospital stays. In addition, there has been an 11% lift in colorectal screenings and 10% more breast cancer screenings.
Home care evolution
Broussard also addressed why Humana has been focusing more of its business on care in the home.
Last July, Humana, along with TPG Capital and Welsh, Carson, Anderson & Stowe, completed the acquisition of Kindred Healthcare. Under the deal, initially announced in 2017, Kindred’s home health, hospice and community care businesses will be separated into a standalone business called Kindred at Home, 40% of which is owned by Humana.
“We see home [care] evolving in a few ways. We see home evolving first, moving from a therapy-based model that reimbursement has always oriented to therapy—and that’s really where the rewards were—to a nursing model where you can take care of a more expensive population—COPD, CHF, diabetes. This evolvement is, for one just around how you pay for it and pay for outcomes, not for procedures or for how many episodes you have. So you see the organization today, we’re in six states now, moving in that direction,” Broussard said.
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