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This Week in Managed Care: March 9, 2018

This week, the top managed care stories included Cigna's deal to buy Express Scripts; Seema Verma, Alex Azar, and Scott Gottlieb, MD, made the rounds at health conferences; an analysis finds FDA's accelerated approval pathway has been a success with hematology and oncology drugs.


Cigna and Express Scripts announce another healthcare mega-deal, CMS makes a push for sharing health data, and rebates are seen as a barrier for biosimilars.

Welcome to This Week in Managed Care, I’m Laura Joszt.

Cigna–Express Scripts Deal

Health insurer Cigna announced Thursday it would buy Express Scripts, the nation’s largest pharmacy benefit manager, for $67 dollars in cash and stock. The deal includes Cigna assuming 15 billion dollars in debt.

It’s the latest deal involving healthcare giants, after CVS and Aetna announced merger plans. Traditional players are bracing for the arrival of Amazon after the online retailer announced in January it would team up with Berkshire Hathaway and JP Morgan Chase to form an independent healthcare venture.

Improving Interoperability, Access to Health Data

By most accounts, the movement to electronic health records has fallen short of its promise, in part because health systems and platforms can’t talk to each other.

CMS Administrator Seema Verma said this week the Trump administration is determined to fix this problem, known as interoperability. Past efforts that offered incentives for health IT investment hit roadblocks, because companies tried to profit by keeping data under their control.

Speaking in Las Vegas at the annual meeting of the Healthcare Information and Management Systems Society, Verma unveiled plans for My-Health-E-Data, which she said will put power over data with the patient.

Said Verma: “At a time when healthcare data is being generated from so many sources, too often that data runs into the hard walls of closed systems that hold patients, and their information, hostage.”

Earlier in the week, HHS Secretary Alex Azar said patients had the right to control their records in a user-friendly format. He said, “When they arrive at a new provider, they should have a way of bringing their records.”

While Verma offered few specifics, she said CMS will be developing a timeline and rules for the initiative.

Gottlieb on Biosimilars

Rebates between pharmaceutical companies and pharmacy benefit managers are holding back development of the biosimilar market, FDA Commissioner Scott Gottlieb, MD, said this week. Speaking at the National Health Policy Conference of America’s Health Insurance Plans, Gottlieb said the lack transparency and weak incentives have hurt competition.

Said Gottlieb, “Current rebating and contracting practice—combined with the increased consolidation that we’re seeing in many segments of the drug supply chain—has produced some misaligned incentives.”

He noted that 3 pharmacy benefit managers control two-thirds of the market, and 3 wholesalers control 80% of the market. Biologics, Gottlieb said, are an area where he has “significant concerns about the long-term impact of the pricing and rebating mischief.”

Read the full story.

Diabetes Treatment Disagreement

A disagreement has emerged over how aggressively doctors try to control blood sugar in patients with type 2 diabetes.

The American Diabetes Association calls for keeping A1C below 7%, and the American Association of Clinical Endocrinologists recommends 6.5%.

But now, the American College of Physicians, which represents internists, has said doctors can aim for a less aggressive goal of between 7% and 8%. The diabetes specialists strongly disagree. However, most people with type 2 diabetes are not treated by specialists, but in primary care.

The president of the American College of Physicians suggested the trend toward quality measurement may have played a role in the change. When insurers expect all patients to fall under a certain A1C, said Jack Ende, MD, MACP, that may not be consistent with the best evidence.

He said, “These changes should in no way be interpreted as diabetes is unimportant. Diabetes is such a prevalent problem, and there are so many guidelines and conflicting information out there, we wanted to do an assessment that would give our members the best possible advice. Also, A1C targets are being used now as a performance measure."

Success With Accelerated Approvals

A new paper says the FDA’s experience with accelerated approvals for hematology and oncology drugs has been a success.

The paper in JAMA Oncology reviews 25 years of experience of approvals that balanced uncertainty with the need for faster approval for agents in areas of unmet need for life-threatening diseases.

The accelerated pathway, created in response to the HIV crisis, has led to approval for 64 hematology and oncology drugs for 93 indications. These drugs are studied in postmarketing trials to ensure their clinical benefits are confirmed.

Key therapies approved through the accelerated process include:
  • Pembrolizumab, sold as Keytruda, for melanoma and non-small cell lung cancer
  • Cetuximab, sold as Erbitux, for metastatic colorectal cancer
  • Palbociclib, sold as Ibrance, for metastatic breast cancer
Fifty-one of the 93 indications have completed their postmarketing requirements to verify their benefit, taking an average time of 3.4 years.

Coverage of ACC

Healthcare delivery will get plenty of attention this weekend at the American College of Cardiology’s (ACC) 67th Scientific Session in Orlando, Florida.

While many attendees will await results from the ODYSSEY trial for Sanofi’s PCKS9 inhibitor, Praluent, several sessions will highlight how both practice and payment changes have improved outcomes for patients.

Doctors Jagmeet Singh, deputy editor of JACC: Clinical Electrophysiology, and Fred Bove, editor-in-chief of Cardiology magazine discuss the healthcare delivery issues to be presented at ACC in an AJMC podcast, which you can find here.

For full coverage of ACC, visit our conference page, which includes preview coverage.

For all of us at the Managed Markets News Network, I’m Laura Joszt.

Thanks for joining us.

 
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