Infusion Therapy

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

When the COVID-19 pandemic struck, to say the health care system was disrupted is an understatement. Many people undergoing treatment for cancer rightfully were concerned about their potential exposure to the virus and were hesitant to leave their homes for care. In order to continue treating some patients, Horizon Blue Cross Blue Shield of New Jersey partnered with Rutgers Cancer Institute of New Jersey (CINJ) and RWJBarnabas Health to start a pilot to offer home infusion of cancer treatments and telemedicine support for eligible people, the first such program in the state.

In addition to not putting people at risk of acquiring an illness, home infusion means that people don’t have to travel for treatment. It also provides them with one-on-one care, close monitoring during infusions and the ability to schedule treatments around their personal schedule. These benefits are especially important for people with compromised immune systems.

Since 2011, the FDA has approved multiple therapies for advanced or late-stage melanoma. Recently, the agency granted an additional approval to one of those drugs for the earlier stage melanoma setting, filling an unmet need, industry experts note. However, the condition is complex to treat and may be challenging for health plans to manage.

On Dec. 3, the FDA approved Merck & Co., Inc.’s programmed death receptor-1 (PD-1) inhibitor Keytruda (pembrolizumab) for the adjuvant treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection. The agency also expanded the indication for the agent’s use as an adjuvant treatment of stage III melanoma following complete resection to include pediatric patients at least 12 years old.

While the COVID-19 pandemic continued to impact the specialty pharmacy and home infusion spaces for the second straight year, other events also played a role. AIS Health spoke to some industry experts about 2021’s impact.

AIS Health: Looking back over the past year, what do you think were the most noteworthy occurrences within the specialty pharmacy industry, and why?

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: Some of the noteworthy trends in SP have included the continued rise of the cost of specialty agents within health care expenditures, the continued emergence of ultra-high-cost specialty agents for rare and orphan diseases and the continued vertical integration of specialty pharmacies into health care organizations.

Nov. 12: The FDA approved PharmaEssentia Corp.’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera. It is the first interferon therapy that the agency has approved specifically for the condition. The drug received orphan drug designation for the indication. The recommended starting dose is 100 mcg by subcutaneous injection every two weeks. The dose can be increased by 50 mcg every two weeks up to a maximum of 500 mcg until hematological parameters are stabilized.

Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.