Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
FDA Approves Marijuana-Based Drug for Seizures
Epidiolex (cannabidiol) was approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. These are two very rare forms of epilepsy and FDA officials said this drug reduces seizures when used in tandem with other anti-seizure products.1 This product will not likely be a pharmacy budget buster due to the relatively small number of patients, however, the manufacturer, GW Pharmaceuticals, has not set the price.
Epidiolex is the first prescription drug made from marijuana so there are still hurdles to address before this product will be available on the pharmacy shelves. The active ingredient (cannabidiol or CBD) is considered a Schedule I substance by the Drug Enforcement Agency (DEA). A Schedule I product is defined as drugs or substances with no currently accepted medical use and a high potential for abuse.2 The DEA will need to reclassify CBD (which is expected soon) before it can be made available.
FDA Approves OLUMIANT® (baricitinib) 2-mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
Olumiant® (baricitinib) joins a crowded rheumatoid arthritis (RA) category. This once-daily tablet is in the JAK (Janus Kinase) inhibitor category and joins Xeljanz (tofacitinib) as another option for rheumatoid arthritis.3 Similar to other products indicated to treat RA, there will likely be follow-on indications for other inflammatory related conditions.
Eli Lilly, makers of Olumiant, have set the AWP at about half of the once daily Xeljanz XR ($82.18 per tab vs. $163.83 per tab). Payors will want to keep an eye out on this specialty category to see how their PBM treats this product. Will there be a chasing of rebates or will there be a focus on lower ingredient cost? Considering inflammatory conditions (e.g. RA) are typically the top spend category, this approach to pricing for this new market entrant has the potential to have significant impact.
Analysis of Part D Spending on Brand Name Products
The Office of Inspector General (OIG) reviewed the trends for Medicare Part D spending on brand name drugs over the past several years. The results are not surprising while at the same time eye-opening. Of note, this analysis found an increase in net reimbursement (accounting for manufacturer rebates) for Medicare Part D of 62% from 2011 to 2015 - outpacing inflation by nearly 6 times. During this same time period, the number of prescriptions for brand name drugs decreased by 17%.
As a Part D plan, as well as any plan sponsor, it is critical to evaluate your pharmacy benefit contract as often as possible through market checks or full RFPs to ensure your PBM performance is adjusting to the quickly changing pharmacy landscape.
Amazon is buying online prescription company PillPack
It was announced on June 28, that Amazon is purchasing PillPack. PillPack is an online pharmacy that provides pre-sorted medications to consumers taking multiple prescriptions. Currently, PillPack is not a huge player in the over $400 billion prescription market, however this move is Amazon's first point of entry. How quickly will Amazon be able to disrupt this space? What is their next move? There are many remaining questions but this move reaffirms Amazon’s intent to operate in this market.