This Week in Managed Care: May 11, 2018

Another report shows the uninsured rate is rising, FDA confirms shortages of the EpiPen, and a Senate panel examines the need for transparency in insulin pricing.

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

Uninsured Rates are Rising

For the first time since the Affordable Care Act took full effect, uninsured rates are rising in some states. The Gallup Sharecare Well-being Index surveyed 160,000 people in all 50 states throughout 2017 and asked, “Do you have health insurance coverage?”

The country’s average uninsured rate reached 12.2% by the last quarter of 2017, up from 10.9% the prior year. Seventeen states had noteworthy increases, and no state had a decrease. The Gallup report comes after the recent Commonwealth Fund study also showed a rise in the uninsured rate.

Learn more.

FDA Confirms EpiPen Shortage

The FDA reports intermittent shortages of the EpiPen, an autoinjector device that delivers epinephrine to counter anaphylaxis for those with severe allergies. But the manufacturer, Mylan, insists the delay will be short and is due to the supply of third-party components.

FDA added the EpiPen to its drug shortages list this week, although until now Mylan had been saying that supplies may vary from pharmacy to pharmacy. A unit of Pfizer ships both branded and unbranded versions of the devices, and a spokesman reiterated in an email to AJMC® that the product is still available.

He wrote: “We are currently shipping product and our shipments have been increasing over the last few months, with April shipments exceeding expectations. The constrained supply of EpiPen is due to supply of certain third-party components, along with process changes implemented which have temporarily limited capacity at our manufacturing facility.”

FDA issued warning letters to Mylan last year for violating manufacturing requirements and ignoring complaints about operating problems with EpiPens.

Transparency in Insulin Pricing

Dr William Cefalu, the top medical officer with the American Diabetes Association (ADA), led a group of witnesses this week when a Senate panel took testimony about the causes of rising insulin prices. Cefalu presented findings from an ADA working group that found that the distribution of rebates across the insulin supply chain is not well understood, and that broad transparency among all stakeholders is needed.

He said today’s insulins are much improved but pricing problems keep them from helping some patients in need. The findings were also published in Diabetes Care.

Said Cefalu: “There’s a flow of money that we don’t quite understand. It’s the uninsured patient who has to pay the list price. The most vulnerable patients are subsidizing the system.”

Daratumamab as Frontline Treatment in Multiple Myeloma

Daratumumab, marketed as Darzalex by Johnson & Johnson, received FDA approval this week for frontline treatment in patients with multiple myeloma who are ineligible for autologous stem cell transplant.

The FDA approved daratumumab in combination with bortezomib, melphalan and prednisone for these patients, based on findings from the ALCYONE study, published in February. Patients taking the daratumumab combination had an 18-month progression free survival rate of 71.6% compared with 50.2% for a control group taking a combination of melphalan, bortezomib and prednisone without daratumumab.

Said the study’s clinical investigator, Dr Andrzej Jakubowiak: “This approval is significant as we now have the first antibody-based regimen for treating newly diagnosed multiple myeloma patients who are not eligible for a stem cell transplant. In clinical studies, patients who received treatment with daratumumab experienced a lower risk of disease progression and higher rates of response.”

Single-Payer Health System For Mental Health Care

Finally, a panel appearing last weekend at the American Psychiatric Association in New York City said a single-payer system would best meet the needs of the most seriously ill patients with mental health issues. Only 20% of children and youth with mental health disorders get treatment, and speakers said insurance companies create barriers to care and make payment for services so low that many facilities lose money unless they cut back on services.

Said Dr J. Wesley Boyd: “Any time I have called for a prior authorization, I set aside 40 minutes to do that. … I’m counting on being transferred at least twice before I get the person I need.”

Administrative hurdles created by the shift to value-based care are hastening burnout, the panel said.

Check out full coverage of the American Psychiatric Association meeting.

For all of us at the Managed Markets News Network,

I’m Laura Joszt, Thanks for joining us.