As is expected in the fall of each year, PBMs are set to release the anticipated updates to their dreaded drug exclusion lists. Express Scripts was the first to announce this year, with 48 more drugs excluded compared with last year’s list. CVS and other PBMs are likely to follow in the coming weeks with their own exclusion announcements. However, Express Scripts’ move was not merely an expansion of exclusions for categories already on the list, but instead marked a dramatic expansion in categories, including new disease areas thought too sensitive or rare to be managed by something as blunt as an exclusion list. In short, Express Scripts’ new exclusion update is one of the most aggressive in years.

Perhaps most surprising was the inclusion of several rare disease categories that have largely escaped aggressive payer management in the past. HIV and hereditary angioedema both saw one drug excluded each, and hemophilia saw several exclusions. Increased competition in these categories was likely one reason for these exclusions, with increased spend playing a role as well. The 2017 drug trend report from Express Scripts flagged HIV as having double digit trend growth in 2017 and anticipated a similar forecast through 2020. Hemophilia and hereditary angioedema, while not leading spend categories, are known for having high-cost drugs. Coupled with CVS’ exclusion of certain oral oncology agents last year, the PBM industry appears increasingly willing to make disruptive moves regarding sensitive rare disease categories.

On the primary care side of the business, the exclusion of both Pradaxa and Savaysa marks increased pressure on a class already incurring exclusions by CVS. These anticoagulants are important as they test a PBM’s need to generate savings while also ensuring continuity of care. Patients on anticoagulants are commonly started on these agents in the hospital after suffering events like stroke or DVT. Once discharged, patients could experience a lapse in therapy if their prescription was denied and required prior authorization. If Express Scripts plans to expand exclusions in categories that are started in a different setting of care and in emergent situations, Express Scripts will need to ensure that patients can continue therapy without interruption, even if the drug is excluded.

Express Scripts also seems to be paying attention to changes in list prices and may be providing rewards in certain cases. Excluded in 2018, HCV medication Zepatier recently had its price reduced by Merck by 60%. Zepatier was then announced to be returning as a preferred drug in 2019. The market controversy of rebates and lack of transparency may be requiring PBMs like Express Scripts to improve access to certain drugs with lower list prices, albeit not consistently.

Express Scripts says that patients currently on excluded medications in some drug categories, including the newly added rare diseases, will be grandfathered. Despite this, the new exclusion updates demonstrate that Express Scripts does not view any category with viable competition to be beyond exclusions. For drug manufacturers, the update requires several points of action:

  1. Do not assume that any disease is too sensitive or rare to suffer exclusions, especially if competition is present.
  2. Monitor PBM trend reports for clues on future management risks. Having a category listed is concerning; receiving a special callout in a report is a red flag.
  3. Focus on differentiation in the value-based marketplace. The addition of a category to a drug exclusion list indicates that the PBM feels there is not enough differentiation to warrant covering every drug. It is up to the manufacturer to prove to the payer that a drug has differentiating clinical, economic, and value attributes.

A final point is warranted. PBMs watch what their competitors do and will replicate successful strategies. Express Scripts’ moves will be emulated by others. It is imperative that manufacturers engage PBMs with value messaging and tactics that minimize risk and maintain access.