In 2023 biosimilars finally provided price relief for the costliest pharmaceutical product ever. But then a new class of weight loss medications emerged as a primary cause of increased drug spending. New laws and regulations also grabbed headlines as the federal government gained the ability to negotiate prices for certain drugs. Finally, innovative new medications emerged for Alzheimer’s disease while gene therapies started to become available for more common diseases.
Here’s a wrap-up of the latest trends in pharmacy and how Optum Rx is helping plan sponsors adapt to them.
1. Long-awaited competition for the biggest drug in history
Humira® has been one of the biggest selling drugs in history since launching in 2003.1 Notably, during this time it did not face any direct competition.
This changed in 2023, with as many as nine biosimilar versions of Humira scheduled to hit the market. Some of these biosimilars had received FDA approval as far back as 2016 but had been unable to launch until 2023 due to patent litigation by the manufacturer of Humira.2
Similar to generics, the simple logic behind biosimilars is that increased choice ultimately leads to lower prices. But the reality is more complex. Plan sponsors need to consider many factors, like complicated pricing structures, to get the biggest benefit from the lower-priced biosimilars.
Nonetheless, 2023 will be remembered as a watershed year for biosimilar alternatives to expensive branded drugs. In preparation for more biosimilars coming to market, Optum Rx developed a clear set of biosimilar guiding principles to evaluate them. To provide optionality for prescribers, clients and members, Optum Rx added the first available, first interchangeable and among the first high concentration biosimilars for Humira to our formularies.
2. Weight loss hype meets financial reality
If the arrival of biosimilars represents relief to a longstanding problem, a popular new class of weight loss drugs presents a brand-new challenge for plan sponsors.
Known as GLP-1 agonists, these medications have long been used to treat type 2 diabetes. Subsequent clinical trials indicated that GLP-1 agonists can also be used for weight loss, with some patients reporting body weight reduction of 20% or more.3 As a result, Wegovy® was approved for weight loss in 2021. However, initial supply constraints restricted utilization until the latter half of 2022. Another GLP-1 drug, Zepbound™, was approved for weight loss in November 2023.
With usage of GLP-1 drugs for weight loss now surging, the decision to cover them presents a dilemma for plan sponsors. With an average monthly wholesale price of more than $1,300 per month for Wegovy, plan sponsors must balance affordability against uncertain long-term clinical outcomes.4
Optum Rx Weight Engage is an innovative weight management solution suite that drives appropriate GLP-1 utilization and guides members toward improved health outcomes with behavior change programs.
3. An active year for PBM legislation and rulemaking
The past year produced an onslaught of proposed legislation that has the potential to adversely impact the delivery of pharmacy benefits.
For example, the Senate Finance Committee advanced the Modernizing and Ensuring PBM Accountability Act. The bill focuses mainly on pharmacy pricing and PBM compensation in the Medicare and Medicaid sectors.
Likewise, committees in the House of Representatives advanced legislation that would impact how PBMs operate. Changes could affect PBM spread pricing in Medicaid, plus bills that would place additional reporting and data access requirements on PBMs.
Individual states including Colorado and Florida enacted legislation impacting various pharmacy benefit management tools and contracting methods.
The biggest news came when the Centers for Medicare & Medicaid released a list of 10 Medicare Part D drugs subject to price negotiation by the federal government and manufacturers pursuant.
4. Signs of progress treating Alzheimer’s disease
New glimmers of hope in the search for an effective Alzheimer’s treatment emerged in 2023.
For many years, seemingly promising drug candidates for Alzheimer’s would ultimately fail in clinical trials. That’s why the approval of Leqembi® in July 2023 is noteworthy. Leqembi belongs to a class of medications that seek to remove plaques in the brain that can disrupt and destroy brain cells. Participants in the clinical trials for Leqembi saw a statistically significant slower rate of cognitive decline over 18 months.5
Another amyloid targeting drug, donanemab, has also exhibited promising results in clinical trials and is expected to receive FDA approval before the end of 2023.6
It is also important to note that these amyloid-removing drugs are only indicated for people who have the early or mild form of Alzheimer’s. Furthermore, while they did demonstrate some benefit, it’s unclear how meaningful it is. They also come at a significant price, with the wholesale acquisition cost for Leqembi at $26,500 per year.7
Optum Rx already has plans in place to supply the necessary utilization strategies for plan sponsors.
5. The gene therapy era arrives in earnest
Innovative new gene therapies are beginning to offer hope for people with a broad range of previously untreatable diseases.
The first FDA-approved gene therapy launched in 2017, but only a handful have entered the market. Then, in June 2023, Roctavian™ was approved to treat adults with hemophilia A, an inherited blood clotting disease. In December, the FDA is widely expected to approve a gene therapy for sickle cell anemia.
As revolutionary as these therapies are clinically, they also break new ground financially. For example, the cost of Roctavian is $2.9 million for a one-time dose.8 Gene therapies also come with new logistical and procedural complexities for providers, patients and plan sponsors.
To help plan sponsors adjust to the financial risk in a world where gene therapies are more common, we created Optum Gene Therapy Risk Protection. This risk management approach reduces the volatility presented by catastrophic claims for gene therapies by spreading out the cost into a manageable, predictable per member per month (PMPM) fee.