Infusion Therapy

FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.


Leqembi Treatment Infrastructure: If Medicare Pays For It, They Will Come

Eisai Co., Ltd. and its partner Biogen, Inc. crossed over the biggest barrier in their quest to commercialize Leqembi (lecanemab) now that Medicare will cover the cost of the Alzheimer’s disease drug. The next hurdles for doctors and patients will be obtaining blood tests and PET scans for confirming amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine — facilities that exist, but not in the numbers and locations needed to serve all of the US patients eligible for treatment.

CMS said that it will cover the cost of Leqembi on July 6, the day that the FDA converted the amyloid protofibril-targeting antibody’s accelerated approval for the treatment of mild cognitive impairment or mild dementia associated with Alzheimer’s disease (AD) into full approval. Eisai and others believe that while uptake of Leqembi will be slow as the health care system catches up with the diagnostic, monitoring and infusion requirements associated with the therapy, Medicare coverage gives providers the confidence they need to offer those services.


Option Care Looks to Offer Broader Home-Based Care Model Through Amedisys Purchase

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.


New First-in-Class Therapy Should Help Ease Disease Burden for People With Follicular Lymphoma

The FDA recently approved a new first-in-class agent for follicular lymphoma, an important development for people with the condition, according to one oncologist. Payers and oncologists both agreed that the drug’s approval should help ease the disease burden somewhat for people suffering from the condition, according to a Zitter Insights survey.

On Dec. 22, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. The drug is a first-in-class CD20xCD3 T-cell engaging bispecific antibody. Dosing for the agent — which can be done in an outpatient setting — is 1 mg via intravenous infusion on day one of cycle one, 2 mg on day eight of cycle one and 60 mg on day 15 of cycle one, each over a minimum of four hours. On day one of cycle two, dosing is 60 mg, and then in cycle three and following cycles, dosing is 30 mg on day one; administration can be reduced to two hours if cycle one infusions were tolerated. Dosing for eight cycles is recommended. If people have a partial response or stable disease after eight cycles, an additional nine cycles may be administered. The drug’s price for eight cycles is about $180,000.


More Complex Specialty Drug Management, Pandemic Pressures and Inflation Reduction Act Were Some 2022 Trends

Both the specialty pharmacy market and the home infusion space continued to grow in 2022. Congress finally passed legislation that will allow Medicare to negotiate drug prices with manufacturers for the first time, and many of the impacted agents are expected to be specialty medications. As payers grappled with their drug costs, some implemented new utilization management strategies. And the COVID-19 pandemic, now approaching its fourth year, remained a disruptor in both the specialty pharmacy and home infusion markets. AIS Health, a division of MMIT, spoke with various industry experts on multiple 2022 issues impacting those industries.


ICER Examines Cost Effectiveness, Clinical Effectiveness of Multiple Sclerosis Drugs

Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.

The findings were part of a larger ICER draft evidence report published on Oct. 17 that examined the clinical effectiveness and cost effectiveness of oral and monoclonal antibody disease modifying therapies (DMTs) for relapsing-remitting MS. About 85% of the 1 million Americans with MS have the relapsing-remitting form.


FDA Approves Gene Therapy, Manufacturer Prices Drug at Record $2.8 Million

After the FDA approved Zynteglo (betibeglogene autotemcel) on Aug. 17, the gene therapy’s manufacturer, bluebird bio, Inc., announced the drug would have a $2.8 million wholesale acquisition cost (WAC). That is the highest WAC for a drug hitting the market in the U.S.

Zynteglo is indicated as a potential cure for patients with transfusion-dependent beta-thalassemia, a rare disorder caused by genetic mutations in cells that carry oxygen throughout the body. Such patients typically require red blood cell transfusions every two to five weeks.


Novartis’ Pluvicto Brings New Option to mCRPC Treatment

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.


Horizon and CINJ Are Piloting Home Infusion Oncology Program

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.


Many Melanoma Therapies Exist, but Treatment Remains Challenging

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.