Specialty Pharmacy

In 2021, prescription drugs accounted for a median of 21% of large employers’ health care costs, and a full 100% of firms said they were concerned about prescription drug spending trends, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.

Yet the rising cost of specialty medications — which are often covered by medical rather than pharmacy benefits — has forced companies to think differently about how to curtail drug spending, the organization found. According to the survey, specialty medications account for 56% of all pharmacy spending by polled employers.

In 2021, prescription drugs accounted for a median of 21% of large employers’ health care costs, and a full 100% of firms said they were concerned about prescription drug spending trends, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.

Yet the rising cost of specialty medications — which are often covered by medical rather than pharmacy benefits — has forced companies to think differently about how to curtail drug spending, the organization found. According to the survey, specialty medications account for 56% of all pharmacy spending by polled employers.

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.

Two new drugs to treat plaque psoriasis are adding to the topical options available to treat the condition. Both payers and dermatologists have expressed interest in the agents, according to Zitter Insights, and the class remains a high priority for payer management.

On May 23, the FDA approved Roivant Sciences subsidiary Dermavant Sciences, Inc.’s Vtama (tapinarof) cream for the topical treatment of plaque psoriasis in adults, regardless of disease severity. The company said the agent is the first and only FDA-approved steroid-free topical medication in its class. Dosing of the aryl hydrocarbon receptor agonist is once daily on affected areas, and the drug has no restrictions on length of use. The price for one tube of the drug is $1,325.

In its latest drug pipeline report, UnitedHealth Group-owned PBM Optum Rx takes a look at two high-priced gene therapies that are slated for FDA approval soon. But those are far from the only gene therapies that payers should be watching, an Optum Rx executive tells AIS Health.

Both drugs highlighted in Optum’s report, Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel), are manufactured by bluebird bio, Inc., a Massachusetts-based biotech company. An FDA advisory panel in June recommended both drugs for approval. Currently, only two gene therapies are on the U.S. market: Luxturna and Zolgensma.

Two recent studies of specialty-drug treated conditions examined the impact of adherence on hospitalizations and medical costs. Findings of the studies — one on cystic fibrosis (CF) and the other on ulcerative colitis (UC)/Crohn’s disease — from AllianceRx Walgreens Prime (which changed its name to AllianceRx Walgreens Pharmacy in late June) demonstrate the importance of specialty pharmacy interventions in helping keep patients adherent to therapy.

The study posters were presented at the recent International Society for Pharmacoeconomics and Outcomes Research 2022 Conference held in Washington, D.C.

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

As Congress again proposes drug pricing efforts, many of its members, as well as a couple of government agencies, have pharma manufacturers in their crosshairs for a somewhat related reason: their patent processes. The FDA and the U.S. Patent and Trademark Office (USPTO) recently said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

The move follows President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

Following the U.S. Supreme Court’s recent reversal of Roe v. Wade, some people with autoimmune conditions are having access issues with certain medications, including methotrexate, according to Medical News Today. While that drug can be used to treat conditions such as rheumatoid arthritis, lupus and some cancers, it also is used to induce abortions to terminate ectopic pregnancies. Some pharmacists are not dispensing it for fear of being charged with a crime in states that have banned it for ending pregnancies. It also can lead to birth defects, so people of child-bearing age are advised to be on two forms of birth control while taking it, and some rheumatologists are no longer prescribing it due to the risk of accidental pregnancy and the inability for patients to get an abortion. The American College of Rheumatology released a statement noting that it is “aware of the emerging concerns surrounding access to needed treatments such as methotrexate after the recent decision in Dobbs v. Jackson Women’s Health Organization. We are following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate, or if any initial disruptions are potentially temporary due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.