The 2016 formulary exclusion lists have been announced by CVS Caremark and Express Scripts. The lists feature additional product removals in 2016, with Express Scripts increasing its list of product removals to 80, up from 66 in 2015 and 48 in 2014. CVS Caremark will exclude 124 products in 2016, up from 95 in 2015 and 72 in 2014.
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Targeted brands typically include those with branded or generic clinically equivalent alternatives, with PBMs targeting MS in both 2015 and 2016. Interestingly, Express Scripts excluded Betaseron for the treatment of MS, but has removed it from exclusion in 2016. CVS Caremark increased its number of excluded MS products in 2016; Rebif was excluded in 2015, while now Avonex, Extavia, and Plegridy are planned for exclusion in 2016. The removal of Betaseron and Rebif from PBM exclusion lists may suggest that this approach is bringing manufacturers back to the table for more aggressive contracting discussions. The trends towards specialty drug exclusions is likely to accelerate in the coming years with the looming emergence of biosimilars and as branded competition intensifies.
Recent industry activity and HIRC research findings indicate that this trend in formulary management will continue to permeate into health plan managed formularies. Competition in the hepatitis C category has lead to exclusions of newer treatments, and some plans have taken an even more aggressive approach -- in late 2014, Harvard Pilgrim announced its closed formulary option, which excludes Rebif, Simponi, Orencia, and Xeloda.
Results from HIRC's annual survey with 57 commercial health plan pharmacy and medical directors in early 2016 revealed that 18% of plans currently exclude specialty medications from their formulary, and that another 34% were planning to implement one in the future. Currently, excluded product lists target few therapy classes and are in the form of a closed formulary, to which only a portion of their business may elect.
Regardless, health plans see opportunity to expand this tactic as categories become more crowded. One-third of HIRC’s interview panel (5 of 15 pharmacy and medical directors) see the opportunity to engage in exclusive contracting for the upcoming PCSK9 inhibitors, as two similar options, Sanofi/Regeneron’s PRALUENT and Amgen’s REPATHA have been approved for very similar cardiovascular indications.
In this new era of formulary management, it is critical that manufacturers continue to demonstrate product value propositions with evidence of improved patient outcomes to maintain market access – and be prepared to contract when necessary.
