Tag Archives: Rebekah Bayram

Pharmacy Briefing: March 2020

Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.


  • Express Scripts publishes “2019 Drug Trend Report”
  • FDA issues 2019 Novel Coronavirus (COVID-19) statement, warns of potential supply chain disruptions
  • Clarivate identifies 11 potential blockbuster drugs in 2020 edition of “Drugs to Watch” list 
  • OptumRx publishes “Drug Pipeline Insights Report”
  • Four indicted in prescription scam involving compounding pharmacy and physicians

FDA Approvals and Launches

  • A generic version of ProAir HFA (albuterol sulfate), one of the most commonly prescribed asthma inhalers, is approved.
  • Nexletol (bempedoic acid), a once-daily oral medication, is approved to treat high cholesterol as a secondary option to statin therapy.
  • Voltaren (diclofenac gel) and Pataday (olopatadine ophthalmic solution) are approved for over-the-counter (OTC) use for pain/inflammation and allergic conjunctivitis, respectively.
  • Pizensy (lactitol) is approved for the treatment of chronic idiopathic constipation.
  • Twirla (levonorgestrel/ethinyl estradiol) transdermal patch is approved for use as once-weekly contraceptive.
  • Trulicity (dulaglutide) receives additional indication to reduce cardiovascular events in patients with type 2 diabetes with or without established cardiovascular disease.
  • Nurtec ODT (rimegepant) orally disintegrating tablets are approved for the acute treatment of migraines.
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Pharmacy Briefing: February 2020

Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.


  • Allergan reaches $300 million settlement in pay-for-delay lawsuit
  • California budget proposal includes the possibility of creating the state’s own generic drug label and a drug pricing system invoking a “most-favored-nation” clause 
  • Celgene rescinds $55 million settlement agreement in class-action lawsuit involving Thalomid (thalidomide) and Revlimid (lenalidomide)
  • Express Scripts to cover new diabetes treatment Rybelsus (oral semaglutide)
  • Pfizer announces introduction of three new biosimilars
  • Coronavirus outbreak may affect the U.S. drug supply chain

FDA Approvals and Launches

  • Palforzia (peanut [arachis hypogaea] allergen powder-dnfp) is approved for the mitigation of allergic reactions due to peanut exposure in children.
  • Reyvow (lasmiditan), a novel treatment for patients with acute migraines, launches at a list price of $640 per eight pills.
  • Trijardy XR (empagliflozin/linagliptin/metformin) is approved to treat patients with type 2 diabetes.  
  • Ozempic (semaglutide) receives additional indication to reduce risk of major cardiovascular events in patients with type 2 diabetes and heart disease.
  • Valtoco (diazepam) nasal spray is approved as an acute treatment for epilepsy.
  • Ajovy (fremanezumab-vfrm) receives approval for administration through an auto-injector dose delivery system.
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CMS proposed rules would impact Part D drug costs and plan designs

On November 16, 2017, the Centers for Medicare and Medicaid Services (CMS) released 713 pages of proposed changes to Medicare Advantage (MA) and the Medicare Part D prescription drug benefit. The proposed changes (file code CMS-4182-P) would take effect for contract year 2019 and are intended to manage utilization of opioids, reduce costs, and provide more plan choices. The updates present major changes to the way the programs operate. According to CMS, “the proposed changes would result in an estimated $195 million in savings a year for the Medicare program over 5 years (2019 through 2023).”

Some significant impacts on Part D that plans need to be aware of would include:

Midyear formulary changes: Plans would have more flexibility to immediately incorporate generic drugs as soon as they are available.

• Plans could assess the cost impact of each new generic drug based on member utilization to weigh against administration and disruption issues.
• This proposed rule could be significant, especially if the increases in generic approvals continue. According to Milliman’s internal research, there were about 14 and 31 significant first generic launches in 2015 and 2016, respectively. And this year the U.S. Food and Drug Administration (FDA) has continued to speed up the generic approval process.

Opioid treatment: Plans would be able to restrict access and manage opioid utilization. The proposed rules codify and expand upon the current Part D Opioid Drug Utilization Review Policy and Overutilizing Monitoring System.

Biosimilars: Plans would be able to categorize certain low-cost biosimilars as generics for low-income subsidy (LIS) cost sharing and non-LIS catastrophic cost sharing. Because the LIS copays in 2018 will be $3.35 for generics and $8.35 for brands, this is likely not to have a large impact on 1) lowering member costs, or 2) increasing biosimilar utilization.

Point-of-sale costs: The proposal includes a request for information (RFI) regarding applying price concessions and rebates at the point of sale, which could lower member cost sharing when taking brand medications that offer rebates, but may increase premiums and government cost.

Meaningful differences testing: With the elimination or modification of this testing, plans may be able to add more enhanced alternative Part D plans to their product portfolios in the same region.

A link to the Fact Sheet issued by CMS can be found here. CMS is accepting comments until January 16, 2018.

Are essential health benefits here to stay?

With the American Health Care Act scheduled to be up for a vote, and Republicans still negotiating elements of the bill, the fate of essential health benefits (EHBs) is uncertain. Rebekah Bayram and Barbara Dewey’s recent paper “Are essential health benefits here to stay?” explores how consumer choices are affected by mandating benefits, explores the potential effects on premiums, and identifies areas to watch as Congress debates healthcare reform.

The paper has also been referenced in a number of recent media articles. Below is a wrap-up of coverage from the past two days:

• Bloomberg article by Zachary Tracer: Health rules targeted by GOP could upset U.S. insurance market
• Los Angeles Times column by Michael Hiltzik: Eliminating essential health insurance benefits is a lousy idea that won’t save money. Here’s why.
• Business Insider opinion piece by Josh Barro: Republicans may gut an overlooked provision of Obamacare — and disrupt health insurance

Employee group waiver plans

While the ongoing healthcare reform debate creates a great deal of uncertainty for employers, there is one certainty: Healthcare costs continue to be a concern. With this in mind, many employers are seeking more economical ways to structure their benefits.

One tactic that is gaining momentum is the use of employee group waiver plans (EGWPs). A new briefing paper by Brian Anderson and Rebekah Bayram examines EGWPs and how employers can use them in their approach to Medicare Part D.