Radar on Specialty Pharmacy
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As Step Therapy Use Grows, Opinions Vary on Its Usefulness
Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs.
But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders, including providers, patients and manufacturers.
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Many Payers Will Parity Prefer Xtandi, Chemotherapy in mHSPC
In December, the FDA gave another indication to Pfizer Inc. and Astellas Pharma Inc.’s Xtandi (enzalutamide) for the treatment of men with metastatic castration-sensitive prostate cancer. Many commercial payers have indicated that they may parity prefer Xtandi with chemotherapy for this indication, which is also known as metastatic hormone-sensitive prostate cancer (mHSPC), according to Zitter Insights research.
Drug Is Used in Other Prostate Cancers
The Dec. 16 approval, which had priority review, is Xtandi’s third in prostate cancer (RSP 1/20, p. 8). The FDA initially approved the drug in August 2012 for metastatic castration-resistant prostate cancer (RSP 9/12, p. 9); approval for use in nonmetastatic castration-resistant prostate cancer came in July 2018 (RSP 7/18, p. 10).
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CLL Has Many Effective Drugs, And Costs Are Expected to Rise
Among the different forms of leukemia, chronic lymphocytic leukemia (CLL) is one of the most common in adults. The FDA has approved multiple treatments for the condition, making it a potential target of value-based contracts — assuming manufacturers would be amenable to such deals.
According to the American Cancer Society, about one-quarter of new leukemia cases are CLL, which is one of the more than 60 subtypes of non-Hodgkin lymphoma.
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Multiple Myeloma, Multiple Sclerosis, Breast Cancer Drugs Are Among Those Going Off Patent in 2020
AIS Health asked various industry experts about what specialty drugs are expected to see patent expiration — and potentially generic or biosimilar competition — in 2020. Here’s what Martin Burruano, R.Ph., vice president, pharmacy services at Independent Health; April M. Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC; and Mesfin Tegenu, R.Ph., president of PerformRx, LLC, told us: -
Pipeline Boasts First-in-Class Entries, Drugs in Crowded Areas
More and more of the pharma pipeline consists of specialty drugs. Going forward in 2020, areas that may see a lot of activity include biosimilars, orphan drugs and gene therapies, as well as potentially the first FDA-approved drug for Alzheimer’s and the first for nonalcoholic steatohepatitis (NASH).
More orphan drugs are expected to launch this year, continuing a trend examined in an issue brief by America’s Health Insurance Plans (AHIP) released in August 2019. Researchers found that 10% of all drug approvals in 1998 were orphan products, but by 2017, that percentage had risen to 44%.
