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Radar On Market Access: Specialty Drug Pipeline Holds Promise Amid High Costs

Posted by Judy Packer Tursman on Jan 24, 2019

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Blockbuster pharmaceuticals scheduled for launch in 2019 are expected to have a significant impact in treating certain cancers, spinal muscular atrophy, inflammatory conditions and some mental illnesses, according to Express Scripts Holding Co. With specialty medications managed through the pharmacy benefit now accounting for 41% of health plans' total pharmacy spend, the PBM asserts it is crucial for plans to understand the product pipeline and create strategies to manage new, costly drug therapies, AIS Health reported.

On the new drug front, Prime Therapeutics, in its December 2018 monthly update on the specialty pipeline, cites an annual wholesale acquisition cost (WAC) of $203,100 for Pfizer’s Daurismo (glasdegib), an oral drug approved by the FDA in combination with intravenous low-dose cytarabine to treat newly diagnosed acute myeloid leukemia in elderly and certain other adult patients. The Blues-affiliated PBM also points out that Loxo Oncology's Vitrakvi (larotrectinib), approved by the FDA to treat adult and pediatric patients with certain solid tumors, has an average annual WAC for an adult patient of $393,600.
 
On the plus side for payers, Express Scripts notes some major drugs are coming off patent protection this year. This means, through the end of 2019, there is also opportunity for several blockbuster medications, including Advair Diskus, EpiPen and Lyrica, to face first-time generic competition.

Moreover, Express Scripts spokesperson Jennifer Luddy says, "We believe there is a $54.4 billion saving opportunity between 2017 and 2022 if [a dozen] biosimilars come to market when the originator patents expire."

In a recent blog post, Express Scripts singled out two specialty drugs to watch in 2019:

(1) AVXS-101, a DNA-based gene therapy that delivers a functional copy of a human survival motor neuron 1 (SMN1) gene to treat children with spinal muscular atrophy (SMA) Type 1. It is expected to cost between $1 million and $3 million for the one-time IV infusion. The FDA action date is June 18, 2019, but early approval is expected, the PBM says.

(2) Tafamidis meglumine, which is expected to be the first drug approved for the treatment of cardiomyopathy caused by transthyretin-mediated amyloidosis. The drug’s approval is expected in mid-2019, and Express Scripts says it "could rapidly become the standard-of-care for these patients."

Many pharmaceutical launches this year will treat a variety of cancers, with cancer therapies representing about one-third of all specialty drugs in the pipeline.


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Topics: Specialty, Product Release