Radar on Specialty Pharmacy

  • Some Payers Say They May Allow Off-Label Use of Jelmyto

    On April 15, the FDA approved the first drug for patients with low-grade upper tract urothelial cancer, UroGen Pharma Ltd.’s Jelmyto (mitomycin). It offers patients a nonsurgical option for a condition that often requires numerous surgeries (see brief, p. 8). While most commercial payers surveyed about its management said they will manage it per its FDA label, a handful said they are likely to manage it less restrictively.

    The cancer is rare and develops in the lining of the upper urinary tract, ureters and kidneys. Because of the complexity of the anatomy of the urinary tract system, the condition can be challenging to treat. According to UroGen, “The current standard of care includes multiple surgeries and most patients require a radical nephroureterectomy, which includes the removal of the renal pelvis, kidney, ureter and bladder cuff.” That most diagnoses are made in people at least 70 years old complicates their treatment as well, as many of them have compromised kidney functionality, and major surgery may result in additional complications.

  • Biosimilars May Be Impacting Payers’ Medical Benefit Spend

    Over the past decade, commercial per-member per-month (PMPM) drug spend under the medical benefit has almost doubled, according to Magellan Rx Management, a division of Magellan Health, Inc.

    The company just released the 10th edition of its Medical Pharmacy Trend Report, which also found that 61% of payers were concerned with their medical benefit spend, up from 32% of payers who said this in the inaugural edition of the report.

  • Amid COVID-Spurred Shifts in Home Infusion, Model May Morph

    With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space.

    “If you can do infusion at home, you need to do it there,” maintains Ashraf Shehata, KPMG national sector leader for Healthcare & Life Sciences. “This is about controlling infection risk in the near term, and many home infusion candidates are in a high-risk category. Longer term, there has been a shift toward delivering care in the most economical and clinically appropriate setting, largely driven by payers.”

  • Groups Call on CMS to Modify Medicare Home Infusion Benefit

    As people are urged to stay home during the COVID-19 pandemic, CMS has been relaxing a series of health care service policies in support of this need. But one change it hasn’t made is to allow home infusion to be fully covered for all Medicare beneficiaries. Numerous industry stakeholders and members of Congress are pushing for a waiver to allow this to happen.

    Traditionally, Medicare reimbursed for home infusion drugs but not the professional services associated with the infusions themselves. This changed in December 2016 with the signing of the 21st Century Cures Act, which established a reimbursement structure for the professional services that are provided with home infusion therapies (RSP 2/18, p. 1). However, this does not take effect until Jan. 1, 2021. But the Cures Act also changed the payment methodology for Medicare Part B drugs furnished through durable medical equipment (DME) starting Jan. 1, 2017, with a handful of drugs seeing a steep decline in reimbursement.

  • News Briefs

     Herzuma (trastuzumab-pkrb) launched on March 16, bringing the total number of Herceptin (trastuzumab) biosimilars to four. Herzuma, from Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare Co., Ltd., is approved for all the indications of its reference product, which is from Genentech USA, Inc., a Roche Group company. Herzuma’s wholesale acquisition cost for a 150 mg vial is $1,402.50, while a 420 mg vial is $3,927, both 10% less than Herceptin’s WAC. Visit www.herzuma.com.

     Prime Therapeutics LLC launched its PreserveRx gene therapy reinsurance solution on April 6. The company is working with BCS Insurance Co., a subsidiary of BCS Financial Corp., on the product, which will give Blues plans financial protection for five gene therapies: the already-available $850,000 per person one-time therapy Luxturna (voretigene neparvovec-rzyl) and $2.1 million PP one-time therapy Zolgensma (onasemnogene abeparvovec-xioi), as well as valoctocogene roxaparvovec (valrox), LentiGlobin and GT-AADC, three products expected to gain FDA approval this year. PreserveRx also has a clinical services component that will help forecast the products’ financial impact and potential use and ensure appropriate utilization. Contact Jenine Anderson at Jenine.Anderson@primetherapeutics.com.

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