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The Academy of Managed Care Pharmacy (AMCP) Nexus 2017

Looking Ahead at the Specialty Drug Pipeline After an Active Year of Approvals

Christina Mattina
Aimee Tharaldson, PharmD, of Express Scripts kicked off the Academy of Managed Care Pharmacy (AMCP) 2017 Nexus, held October 16-19 in Dallas, Texas, with a presentation on the pipeline of specialty pharmaceuticals in development.
Aimee Tharaldson, PharmD, of Express Scripts, kicked off the Academy of Managed Care Pharmacy (AMCP) 2017 Nexus, held October 16-19 in Dallas, Texas, with a presentation on the pipeline of specialty pharmaceuticals in development.
 
Tharaldson, who is senior clinical consultant of Emerging Therapeutics at Express Scripts, highlighted the continued trends in the specialty drug market, which include increasing competition from novel molecules, generics, and biosimilars. The latter in particular will take on even greater importance as more regulatory and litigation hurdles are eliminated, she predicted.
 
This year has yielded additional guidance on the naming of biosimilar drugs, but not on the interchangeability requirements. Once those regulations are known and biosimilar drugs can be deemed interchangeable, Tharaldson anticipates they will produce greater cost savings. Biosimilars “are really acting like competing brands,” she said.
 
Another trend has been a spike in cancer drug approvals; 13 have been approved so far this year, compared with just 4 in 2016. However, Tharaldson noted, drug prices are not dropping even as more options enter the market. Similarly, orphan drugs, which constitute a growing percentage of the specialty drug pipeline, cost an average of 5 times more than nonorphan drugs. Although orphan drugs are used to treat rare conditions, 30% of drugs in this category are considered “blockbusters” as they bring in $1 billion or more each year.
 
Tharaldson provided a brief overview of the current specialty drug market in light of several new approvals. These drugs are responsible for 37% of per-member-per-year pharmacy benefit spending, a proportion that is expected to grow as the roster of available drugs grows longer. She mentioned in particular a handful of specialty drugs that received FDA approval this year but are expected to receive additional indications or be joined by competitors in coming years.
 
For example, dupilumab was approved for atopic dermatitis this year, but Tharaldson forecasts another approval next year for severe asthma. According to Tharaldson, this is an important drug to keep an eye on, as it is “definitely going to expand in its use.”
 
She mentioned another “interesting approval,” that of tisagenlecleucel (Kymriah), which became the first approved chimeric antigen receptor (CAR) T-cell treatment for cancer in late August. Its high price tag has made headlines, but its response rates and efficacy are also impressive, leading Tharaldson to predict “there’s going to be more competition in the CAR T space.”
 


 
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