On June 22, 2023, the FDA granted approval to Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), this is the first gene therapy for the treatment of patients 4 through 5 years of age with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene. Sarepta announced the pricing for Elevidys at $3.2 million for the one-time treatment. On June 29, 2023, the FDA also approved BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec-rvox), the first gene therapy for the treatment of adults with severe hemophilia A. BioMarin stated that Roctavian will be commercially available in 2 months at a wholesale acquisition cost (WAC) of $2.9 million for the one-time treatment.

Although Humira will remain on ProAct’s preferred formulary at least until January 1, 2024, ProAct is continuing to monitor the biosimilar space as more Humira biosimilars launch to market this summer. The main two scenarios we are evaluating leading to January 1st include:

1. Humira continues to remain preferred along with some of its biosimilars, considering AbbVie's ability to provide a manufacturer-specific bundle Humira, Rinvoq, and Skyrizi together, or
2. Humira loses preferred formulary status and some of the lower cost Humira biosimilars options become preferred on ProAct’s formulary.

In both scenarios, we expect Humira plan spend to decrease in the coming years due to the introduction of competition. Based on recent settlement agreements, Stelara will be one of the next major drugs in the anti-inflammatory space to face biosimilar competition in early 2025. There are several manufacturers that may have biosimilar versions of both Humira and Stelara on the market in 2025, including Amgen and Teva, so we could see a manufacturer-specific biosimilar bundle in the future. Estimates show upwards of a 65% shift away from Stelara to biosimilars by 2027. Additional considerations for Stelara include several newer agents in the same class. These newer agents are designed to demonstrate superiority over Stelara in Crohn’s Disease, in which Stelara has the largest representation. Based on the studies' results, we could see a negative impact to Stelara utilization and transition to a newer agent.

Drug therapy can bring a complexity to a diabetic’s healthcare and every day life as there are many different types of drugs that work in different ways to help keep blood sugar under control.…

New research from America’s Health Insurance Plans (AHIP) shows the cost of medication, when administered in a hospital or physician’s office, was much higher than if that same medication was purchased directly by the patient through a specialty pharmacy. 

Some specific findings from the research include:

• Costs per single treatment for drugs administered in hospitals were an average of $8,200 more than those for the same drug purchased through specialty pharmacies.
• Drugs administered in physician offices were an average of $1,500 higher than for the same drugs purchased through specialty pharmacies.
• Hospitals, on average, charged 118% more for the same drugs, compared to specialty pharmacies.
• Physician offices, on average, charged 23% more for the same drugs, compared to specialty pharmacies.

For more information related to this research, please visit https://www.ahip.org/news/press-releases/new-research-details-prescription-drug-pricing-pain-for-patients-as-average-hospital-prices-are-8-200-higher-than-specialty-pharmacies-per-single-treatment.

On March 29, 2023, the Food and Drug Administration approved the first naloxone product available without a prescription. Naloxone is a medication that rapidly reverses the effects of and is the standard treatment for opioid overdose. Emergent BioSolutions anticipates its Narcan (naloxone hydrochloride) 4 mg nasal spray will be available for consumers to purchase over-the-counter by August 2023. Pricing information has not yet been released. Currently, prescription versions will remain available through pharmacies (via standing order or co-prescription laws) and other community distribution methods.
For more information visit: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

Photo Credit: Giovanni Cancemi - http://stock.adobe.com