Radar on Specialty Pharmacy

  • Study Finds PBC Drug’s Real-World, Trial Side Effects Are Similar

    A recent study of a new drug to treat primary biliary cholangitis (PBC) found that common symptoms experienced by real-world patients were similar to those experienced by people in clinical trials for the agent.

    PBC is a chronic disease that causes the liver’s small bile ducts to be destroyed, resulting in permanent liver damage and putting people at risk for liver failure and death. There is no cure for PBC, and the goal of treatment is to slow progression of the condition and manage its symptoms, which most commonly are itching, also known as pruritis, and fatigue.

  • New FDA Approvals: The FDA Approved Amneal’s Alymsys

    April 13: The FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.
  • News Briefs: TG Therapeutics Withdraws Pending Applications for Ublituximab/Ukoniq Combo

    TG Therapeutics, Inc. said April 15 that it voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma. The company said it made the decision based on updated overall survival data from the UNITY-CLL Phase III trial. The company also said that it voluntarily withdrew Ukoniq from sale for two indications: (1) for adults with marginal zone lymphoma who have received at least one anti-CD20-based regimen, and (2) for adults with follicular lymphoma who have received at least three prior systemic therapies. The FDA gave the drug accelerated approval for those indications on Feb. 5, 2021. On Feb. 3, 2022, the company disclosed that the FDA was investigating a possible increased risk of death with Ukoniq based on initial findings from the UNITY clinical trial. The FDA had scheduled an April 22 meeting to discuss the sNDA for the combination therapy, as well as Ukoniq’s accelerated approvals. Following TG Therapeutics’ withdrawal of the BLA/sNDA and Ukoniq’s existing indications, the agency cancelled the meeting. The FDA is expected to make a decision on the BLA for ublituximab in relapsing forms of multiple sclerosis by Sept. 28, 2022.
  • A Look at Third-Party Oncology Clinical Pathways

    In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.
  • CMS Targets Patient-Assistance Programs; Rule Could Curtail Aid

    CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from Best Price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

    The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ Best Price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

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