FDA Expanding Patent Information Available to Generic Drug Manufacturers
June 18, 2019 – Allison Inserro
June 18, 2019 – Allison Inserro
June 18, 2019 – Jaime Rosenberg
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June 17, 2019 – Sara Karlovitch
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June 17, 2019 – Wallace Stephens
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This Week in Managed Care: May 31, 2019
This week, the top managed care news included the FDA's approval of a $2.1 million gene therapy; a study revealing that the worldwide need for palliative care will nearly double by 2060; the FDA granting priority review to Amarin’s Vascepa for a cardiovascular indication.
FDA approves a gene therapy with a $2 million price tag, global palliative care efforts must grow over the next several decades, and Amarin's Vascepa receives a priority review designation for a cardiovascular indication.
Welcome to This Week in Managed Care, I’m Laura Joszt.
FDA Approves $2.1 Million Gene Therapy
FDA last week approved a gene therapy for spinal muscular atrophy, or SMA, that costs 2.1 million dollars, the most expensive treatment to ever hit the market. The drug, to be sold as Zolgensma, will fill an unmet need for children under age 2. SMA is caused by a mutation in the survival motor neuron 1 gene. The condition causes motor neurons to die, leaving children with debilitating and often fatal muscle weakness.
AveXis, a Novartis company, said it will work with payers on outcomes-based agreements and payment-over-time options, which are expected to become more common over the next decade.
Said Novartis chief executive officer (CEO) Vas Narasimhan: “Zolgensma is a historic advance for the treatment of SMA and a landmark 1-time gene therapy. Our goal is to ensure broad patient access to this transformational medicine and to share value with the healthcare system.”
Serious Health-Related Suffering to Nearly Double by 2060
The worldwide need for palliative care will nearly double by 2060, with 48 million people dying with serious health-related suffering by that time. Data reported in the journal Lancet Global Health estimated that this 87% increase in serious illness will bring significant burdens because 45% of countries have no access to palliative care.
The authors wrote: “Palliative care and the relief of suffering have been described as one of the most neglected dimensions of global health. In 2018, the Lancet Commission on Palliative Care and Pain Relief stated that no other important health intervention is as lacking or inequitably distributed as pain relief, the pillar of palliative care.”
Increases in cancer, lung disease, dementia, and cerebrovascular disease will drive the increase in health-related suffering, with most of the deaths happening in low- and middle-income countries.
For more, visit ajmc.com.
FDA Grants Priority Review for Amarin's Vascepa
Amarin’s icosapent ethyl, a derivative of an omega-3 fatty acid sold as Vascepa, has been accepted by FDA for priority review for a cardiovascular indication, with a Prescription Drug User Fee Act goal date set for September 28th.
The action is based on results of the REDUCE-IT trial, which found a 25% reduction in initial cardiovascular events. The results were presented last November at the American Heart Association.
It is unclear whether an advisory panel will be required. The FDA has added cardiovascular indications on other drugs without requiring panel hearings.
Said Amarin President and CEO John F. Thero: “We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy.… We believe the unprecedented REDUCE-IT results position Amarin to lead a transformational change in clinical practice for preventative treatment of cardiovascular disease.”
Enhancing Primary Care While Avoiding Low-Value Care
Making primary care accessible must be balanced with steps to avoid overuse of low-value care. That's the message in this month’s issue of The American Journal of Managed Care® (AJMC®), which features a commentary from Betsy Cliff, MS, and co-editor in chief Mark Fendrick, MD.
They note that while increasing access to primary care has upsides, such as boosting preventive care, it can have unintended consequences, and these are rarely assessed. They write: “The screen door analogy makes plain the need to explicitly decouple high- from low-value care. Without targeted incentives for both kinds of services, their use is likely to continue to move in tandem.… Success is more likely if both provider and patient incentives are aligned.”
For the full article, visit ajmc.com.
American Society of Clinical Oncology Annual Meeting
Finally, AJMC® will be in Chicago this weekend for the biggest cancer gathering of the year, when more than 40,000 people attend the annual meeting of the American Society of Clinical Oncology.
Look for our coverage on the following managed care topics:
- How to bring the primary care physician back into cancer care
- Is there a role for cannabis in symptom management?
- How do payers, including CMS, view oncology reimbursement reform?
For all of us at the Managed Markets News Network, I’m Laura Joszt. Thanks for joining us.