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Our Take: A big week for Pharma

Mar 25, 2019

This week’s focus is on pharma, where we saw the approval of the first drug for postpartum depression, extraordinary clinical trial results about a pharmaceutical-grade fish oil and disheartening news about a once-promising treatment for Alzheimer’s disease. Here’s Our Take on three noteworthy pharma developments in an otherwise unremarkable week of health care news.

The FDA approved the first drug to treat postpartum depression: Sage Therapeutics’ Zulresso (brexanolone).

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

There is reason to cheer the new treatment, which the FDA designated as a breakthrough therapy and granted priority review status. But, Sage has hurdles to overcome if the drug is to have a successful launch. For one, Zulresso is administered intravenously under medical supervision in a certified health care facility over a 60-hour period. That means patients will require a stay at a hospital or an outpatient infusion center with overnight capabilities.

FiercePharma reported that Sage has 55 key account managers on board to identify and call on targeted centers where Zulresso can be administered, and another 180 sales representatives to educate psychologists and OB-GYNs.

Zulresso will be available only through a Risk Evaluation and Mitigation Strategies (REMS) program. The drug will have a list price of $34,000, but payers should expect substantial rebates.

Amarin Corp. presented updated results for its ongoing Vascepa (icosapent ethyl) clinical trial, REDUCE-IT, at the American College of Cardiology Annual meeting last week in New Orleans.

Vascepa is a novel compound derived from fish. It consists of the omega-3 fatty acid EPA in ethyl-ester form and is indicated as an adjunct to diet to lower triglyceride levels in adults with hypertriglyceridemia.

Last September, Amarin reported top-line results from REDUCE-IT, a global study of 8,179 statin-treated patients with elevated cardiovascular risk. Patients in the Vascepa cohort had a 25% relative risk reduction in major cardiovascular events—a major finding. The results were subsequently published as a leaarticle in The New England Journal of Medicine.

With the positive news from the trial last fall, Amarin’s stock price soared on Sept. 24, from about $3.00 per share to $16.00 per share.

But Vascepa has proved to be even more impressive, based on results released last week. In the same trial, patients in the Vascepa cohort had a 30% reduction in the combined rate of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, coronary revascularization and hospitalizations for unstable angina.

Vascepa also cut the rate of second events by 32% and the rate of four or more events by 48%.

“With this drug, we are not only preventing that first heart attack, but potentially the second stroke and maybe that third fatal event,” stated Dr. Deepak Bhatt, the study’s lead investigator, professor of medicine at Harvard Medical School and executive director of Interventional Cardiovascular Programs in the Heart and Vascular Center at Brigham and Women’s Hospital in Boston. “Prevention of such subsequent cardiovascular events could improve patient outcomes and quality of life, and may lower the total cost burden of medical care.”

Analysts say Vascepa’s annual sales could top $1 billion by 2023. This year, it’s projected to bring in about $350 million.

Biogen is scrapping its lead compound, aducanumab, an investigational treatment for Alzheimer’s disease, and is canceling its Phase III ENGAGE and EMERGE clinical trials. The compound was being developed in collaboration with Eisai.

In a statement, Biogen said it decided to stop the trials based on results of a futility analysis indicating that the trials were unlikely to meet their endpoint. The trials were not halted for safety reasons, Biogen emphasized.

“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience,” said Biogen CEO Michel Vounatsos.

Biogen shares closed down 29% Thursday, erasing nearly $16 billion in market value.

Aducanumab is the latest of many drugs designed to reduce beta-amyloid plaques, proteins that clump between neurons and are thought to be related to the progression of Alzheimer’s disease. All of these drugs have failed in clinical trials.

Most recently, Roche and AC Immune announced in January that they were stopping trials of rival Alzheimer’s antibody crenezumab after their own futility analysis indicated little chance of a positive outcome.

The question for Biogen is: What now? The Cambridge, Mass.-based biotech firm had bet heavily on aducanumab, resisting calls from analysts to investors not to rely on a high-risk Alzheimer’s drug. Stifel analyst Paul Matteis noted that there is “no clear growth driver in [Biogen’s] pipeline” and that Biogen may look to acquire a smaller company aligned in neurosciences, such as Sage Therapeutics.

What else you need to know
Ascension CEO Anthony Tersigni said he will retire at the end of the year, according to a statement by Board Chairman Stephen Dufilho. Tersigni will continue to serve Ascension as a member of the executive committee of Ascension’s healthcare investment fund and will provide consultative services. In January, St. Louis-based Ascension announced that three other senior executives would be stepping down. Ascension Healthcare President and CEO Patricia Maryland is leaving on June 30, after serving in various roles for 15 years. Similarly, John Doyle, Ascension’s executive vice president, and Dr. David Pryor, Ascension’s chief clinical officer, will retire on June 30, the end of the company’s fiscal year.

Participation in the BPCI Advanced program dropped 16% in its first five months, new CMS data show. When the agency rolled out the Bundled Payments for Care Improvement Advanced model in October, participants included 832 acute care hospitals and 715 physician group practices. Participants could leave the program by March 1 with no penalty; 117 hospitals and 135 physician group practices decided to withdraw.

Meanwhile, Health Affairs reported that physician-led ACOs are leaving the Medicare Shared Savings Program (MSSP) at higher rates than are hospital-led ACOs—despite the new Pathways to Success rule CMS released late last year. A goal of the new rule was to make it easier for smaller ACOs and those led by physicians to participate by giving “low-revenue” ACOs greater flexibility. However, an analysis found that only about half of small, physician-led ACOs are likely to qualify as low revenue. Another key component of the new rule is accelerated transition to downside risk, which could exacerbate departures among this category of ACOs. Overall, 74 ACOs (13%) left MSSP at the end of 2018.

Nearly all eligible clinicians (95%) participated in the Merit-based Incentive Payment System (MIPS) in 2017, the first year of the Quality Payment Program, according to CMS data released Wednesday. More than half (54%) participated as part of a group, 12% participated as individuals and the rest participated through an Advanced Alternative Payment Model. Among those who participated, 93% earned a positive payment adjustment, 2% had a neutral adjustment and the remaining 5% had a negative payment adjustment.

Five pharmacy benefit managers (PBMs) have agreed to testify before the Senate Finance Committee on April 9. Executives from Cigna, CVS, Humana, OptumRx and Prime Therapeutics will participate in the hearing about prescription drug costs, The Hill reported on Thursday. This hearing will be the third this year to probe factors contributing to rising costs.

Kevin Mahoney has been named the new CEO for the University of Pennsylvania Health System, effective July 1. Mahoney is currently executive vice president and chief administrative officer for the health system and the executive vice dean for integrative services for the Perelman School of Medicine. He succeeds Ralph Muller, who has been the health system’s CEO since 2003.

What we’re reading
When Patients Become Innovators. MIT Sloan Management Review, Spring 2019

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