Striking Changes in Express Scripts' Formulary

Updated on March 16, 2016.

Just ahead of CVS Caremark, Express Scripts finalized its 2016 formulary with some noteworthy inclusions and exclusions.

The nation’s largest pharmacy benefits manager (PBM) will move 20 drugs to its list of excluded medications and include about 10 drugs that it decided not to cover in 2015.

Express Scripts finalizes its formulary by appointing an independent group of physicians to review clinical data and determine the most clinically effective and cost-effective drugs in different therapeutic categories.

The PBM claims that the exclusions in 2016 will save $1.3 billion for its preferred customers.

Here are the notable drugs that best exemplify exclusive, inclusive, and static formulary trends at Express Scripts:

After being excluded in Express Scripts’ 2015 formulary, this chronic obstructive pulmonary disease drug will now be included for 2016.

As Pharmacy Times previously reported, the FDA expanded Breo Ellipta’s indication in April 2015 for the once-daily treatment of asthma in patients 18 years and older.

Hepatitis C drugs Harvoni and Sovaldi will continue to be excluded from Express Scripts’ 2016 formulary.

Both drugs have been at the center of a high-profile debate over cost effectiveness versus clinical efficacy of new specialty drugs.

Praluent is the first FDA-approved, cholesterol-lowering PCSK9 inhibitor.

Express Scripts will cover the drug for patients who provide diagnostic evidence that they meet the FDA’s criteria, which limited the drug’s use primarily to patients with a hereditary form of high cholesterol and heart disease.

Praluent could prove to be the latest budget-busting specialty drug, and the PBM has said it will revise its formulary after a forthcoming competing drug, Repatha, is approved.

Olysio is yet another hepatitis C drug excluded from Express Scripts’ formulary in favor of the PBM’s exclusive option, AbbVie’s Viekira Pak.

Olysio is approved for use in conjunction with also-excluded Sovaldi, but Johnson & Johnson recently submitted a request to the FDA for a label update.

This type 2 diabetes drug was dropped from Express Scripts’ 2016 formulary alongside another AstraZeneca diabetes drug, Kombiglyze.

In April, an FDA advisory panel recommended adding a warning about the potential risk for heart failure to the labels of both drugs following new clinical data.

Express Scripts is including type 2 diabetes treatment Tradjenta on its formulary.

Weight-loss drug Qsymia is the only high-profile drug to be excluded in its therapeutic category.

In a blog post regarding the updated formulary, Express Scripts described how excluding “me-too” drugs that “have no clinical benefit beyond what’s provided by more affordable alternatives” gives the PBM “leverage to negotiate more effectively with manufacturers and ultimately achieve lower drug prices.”

7.Zohydro ER (Pernix Therapeutics)

Chronic pain treatment Zohydro ER, an opioid with abuse-deterrent properties, will make its debut on Express Scripts’ 2016 formulary.

This drug was the subject of controversy prior to the integration of the abuse-deterrent properties amid surging rates of opioid-related overdoses.

8. Repatha (Amgen)

The FDA approved PCSK9 inhibitor Repatha (evolocumab) in August as an adjunct to both diet and statin therapy for adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease who need extra help to lower their LDL cholesterol.

Express Scripts Chief Marketing Officer Steve Miller previously said the effect of PCSK9 inhibitors on formularies could be enormous. "Think about a lifetime drug that's probably going to cost greater than $10,000 annually times 71 million people."

CVS Caremark President Jon Roberts similarly noted, "We think they're going to be highly prescribed and they're going to be very expensive."

Both PBMs have opted to add Repatha to their 2016 formularies.

9. Tresiba (Novo Nordisk)

In March 2016 Express Scripts officially announced that Novo Nordisk's basal insulin option Tresiba (degludec injection) would be designated as a "non-preffered" option available on a higher copayment tier than Sanofi's best-selling Lantus and other insulins.

Novo Nordisk has tried to edge Tresiba into the insulin market-share battle by touting trial data that demonstrated a lower risk of hypoglycemia when compared with Lantus and the other cornerstone insulin options.

The FDA originally refused to approve Tresiba and another diabetes drug, Ryzodeg (insulin degludec/insulin aspart), 2 years ago, citing concerns about the drugs' adverse cardiovascular effects. Tresiba and Ryzodeg were ultimately approved in September 2015 after an agency panel review.