Are PBM Formulary Exclusion Lists Beneficial for the Industry?

Excluded drugs and step therapy requirements can create hurdles for patients to access needed treatments.

Recently, the 2 largest pharmacy benefit managers (PBMs), CVS Pharmacy and Express Scripts, have labeled their formulary exclusions list as a positive for customers and the pharmaceutical industry.

Thus far in 2016, CVS has raised its number of excluded drugs to 124, while Express Scripts raised their excluded drugs to 80. Yet, both entities claim this will not affect the patients filling their prescriptions at these pharmacies.

In a commentary published in PM360 Panorama, researchers said that PBMs use different tactics to get patients to use their preferred drugs.

One approach is called step therapy. In this case, the non-preferred drug can only be authorized for use after 1 or more drugs have been tried and deemed ineffective for the patient.

With this process, patients could be spending an unnecessary amount of money, as well as taking drugs with side effects that could negatively affect the patient. This method goes beyond trying the generic before the brand option as well, the commentary noted.

In theory, patients could see a decline in their health depending upon how long this process takes.

The second approach is called clinical criteria, where the patient can be authorized but only after an acceptable and documented medical need is proven.

PBMs describe the exclusion lists as necessary to combat coupon programs operated by pharmaceutical manufacturers. CVS Health specifically stated that these coupons were why the exclusion list was introduced in 2011.

After analysis of the drugs on the exclusion list, researchers found that some brands with coupons remained off the lists, while some brands without coupons were put on the exclusion list.

PBMs claim that their excluded drugs will always have an equivalent available for the patients.

“We will only exclude medications from our formulary when clinically equivalent alternatives are already covered on our formulary,” Steve Miller, chief medical officer of Express Scripts states in the commentary. “In 2016, fewer than 0.5% of our members will be asked to use a different medication that achieves the same health outcome.”

Because a drug has a claimed equivalent outcome does not necessarily mean that it will work for everyone who is prescribed it. For some patients, their only option may be a drug that is on the exclusion list, the commentary noted.

The commentary authors said that while Miller makes 0.5% seem like a small figure, in reality, that figure represents more than 100,000 people who were unable to receive a drug that they could need to save their life or keep their disease from progressing.

In order for the pharmaceutical industry to become more patient-focused, the authors wrote that PBMs need to limit their exclusion lists, among other things. The industry should be taking the patient’s health needs into consideration, rather than how much it will cost them.

The commentary concluded that PBMs are primarily focused on short-term views and how will it affect them, rather than how excluding certain drugs will affect the lives of patients and the population as a whole.