Radar on Specialty Pharmacy

The FDA recently expanded the use of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include its use in the treatment of a hematologic cancer. The agent is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 1, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes. CLL is the most common adult leukemia.

People receiving injectable fertility drugs through a specialty pharmacy order review program expressed high satisfaction with the offering, found a recent study by AllianceRx Walgreens Pharmacy and Walgreen Co. Researchers also observed that the services helped reduce waste due to incorrect storage and prevented late or missed doses, producing savings of almost $50,000.

In 2012, AllianceRx Walgreens started the Fertility Order Review (FOR) program to assist people who are self-administering injectable fertility medications, helping ease the anxiety that these patients often deal with. On the day a person’s first order arrives, a fertility nurse calls them to go over the order’s contents, including each item’s purpose and proper storage; direct them to online patient guides available in English and Spanish on administration, medication and fertility education; alert them to expiration dates; educate them about setting up refill reminders; and answer any patient questions.

On May 3, Option Care Health, Inc., the largest independent provider of home and alternate site infusion services in the U.S., revealed that it was acquiring Amedisys, Inc., which provides home health, hospice and high-acuity care, for $3.6 billion. While opinions on the deal differed, one industry expert contends that the transaction offers multiple long-term benefits within the ever-evolving health care space, especially the home setting.

The deal comes less than a week after Option Care unveiled its wholly owned subsidiary Naven Health, Inc., a nationwide home infusion nursing network and platform employing more than 1,500 nurses and serving all 50 states.

April 11: The FDA expanded the patient population of Takeda’s HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) to include the treatment of primary immunodeficiency in people between the ages of 2 to 16 years. The agency first approved the drug on Sept. 12, 2014. Subcutaneous dosing can be administered at home or in an infusion center every three or four weeks after a ramping-up period. The volume administered is based on weight and trough level. Drugs.com lists the price of 160 u/mL for 105 milliliters as more than $2,464.

April 14: The FDA expanded the label of Novartis Pharmaceutical Corp. unit Sandoz Inc.’s Hyrimoz (adalimumab-adaz) for the treatment of moderate-to-severe hidradenitis suppurativa in adults. The agency initially approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Oct. 30, 2018. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. Drugs.com lists the price of two 40 mg/0.4 mL kits and two 40 mg/0.8 mL kits of Humira, each with two devices, as more than $7,299. Sandoz has said it will launch Hyrimoz on July 1 per the settlement of patent litigation with AbbVie.

Celltrion Healthcare Co. launched Vegzelma (bevacizumab-adcd), the company said on April 17. The FDA approved the injectable last September for multiple types of cancer, including colorectal and non-small cell lung cancer. It is the fourth FDA-approved biosimilar of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group, to launch in the U.S. While the company has partnered with other companies in marketing biosimilars in the U.S., its Celltrion USA unit is taking full responsibility for this launch.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-1 that AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) should be limited to people whose tumors have a BRCA mutation. The FDA accepted a supplemental New Drug Application for a broader approval in mCRPC for the poly (ADP-ribose) polymerase (PARP) inhibitor last August. The class of drugs — which also includes GDK’s Zejula (niraparib) and Rubraca (rucaparib), whose rights Clovis Oncology, Inc. recently sold to pharma& Schweiz GmbH a few months after it filed for Chapter 11 bankruptcy — have been under some scrutiny after they withdrew some of their indications.