Zepbound on Track to Transform 2025's Healthcare Landscape

Zepbound on Track to Transform 2025's Healthcare Landscape

The demand for glucagon-like-peptide-1 (GLP-1) medications, used for both diabetes and weight loss, has surged significantly, showing no signs of slowing down. Anticipated new drugs in the GLP-1 category, along with additional indications for existing drugs, are expected to add 1% to the projected 9% increase in employer-sponsored healthcare costs for 2025, according to data released by Aon in August 2024.

Wegovy vs Zepbound: The Ultimate Showdown in Weight Loss Medications

Although many GLP-1 drugs have gained popularity in recent years, Zepbound is poised to become a leading medication in 2025. This is due to improved availability, a new treatment indication and positive head-to-head trial results. The first head-to-head trial comparing the popular GLP-1 weight loss medications, Zepbound and Wegovy, has shown that Zepbound users lost 47% more weight than those on Wegovy, according to Eli Lilly. This data reveals that, under identical trial conditions, Zepbound, which mimics two hormones, is more effective for weight loss than Wegovy, which has a single hormone mechanism of action. Currently, many doctors prescribe the drugs based on availability at the pharmacy due to intermittent supply shortages. These results may impact product selection more in the coming year as shortages improve.

Zepbound Pioneering a New Era in Sleep Apnea Treatment

On December 20, 2024, the FDA approved Zepbound as the first drug treatment option for obstructive sleep apnea (OSA). Zepbound is approved for treating moderate to severe OSA in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. OSA is a condition where a person's upper airway becomes blocked, leading to pauses in breathing during sleep. While it can affect anyone, OSA is more prevalent in individuals who are overweight or obese.

Similarly, Wegovy received a secondary indication in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. As both of these expanded indications are related to the medications' weight loss outcomes, coverage still depends on a payer's decision to cover weight loss medications. In some instances, a plan may choose to allow coverage for the expanded indications only.

FDA's Removal of Tirzepatide from Shortage List Sparks Legal Battle

The Food and Drug Administration (FDA) announced the removal of tirzepatide (Zepbound/Mounjaro) from the shortage list in October 2024. This means compounded versions would no longer be allowed, as the FDA restricts compounding drugs that are commercially available. Following the announcement, the Outsourcing Facilities Association, a trade organization for compounding pharmacies, filed a lawsuit challenging the FDA’s decision. They claimed the decision was made without proper notice and disregarded evidence indicating that a shortage still persists. They argued that this action benefits Eli Lilly at the expense of the users.

On December 19, 2024, the FDA maintained its position but provided ample notice to compounding pharmacies and their users to make appropriate transitions. State-licensed 503A compounding pharmacies have been given 60 days, until February 18, 2025, to discontinue tirzepatide compounding. Outsourcing 503B compounding pharmacies have been given 90 days, until March 19, 2025. As of December 19, tirzepatide is the only GLP-1 product being removed from the FDA’s shortages list, while dulaglutide (Trulicity), semaglutide (Ozempic/Wegovy) and liraglutide (Victoza/Saxenda) remain listed as “in shortage.”

Victoza Goes Generic

As of June 2024, Teva launched its generic version of the diabetic GLP-1 medication Victoza, liraglutide. Teva was the authorized generic distributor for the initial six-month exclusivity period. By late December 2024, at least one additional generic distributor had launched their product, with more expected to follow. Liraglutide is currently listed as in shortage, but additional generic distributors should help reduce the supply deficit and drive lower prices through competition. The Teva product saw a 16% to 17% reduction in price. As a once-daily injection, Victoza relinquished significant market share in recent years to newer products like the once-weekly Ozempic, making it unlikely to substantially impact payer costs.

However, liraglutide, being one of only two available generic GLP-1 medications, could be a favorable option where cost has been a barrier in diabetes treatment. The FDA also approved a generic version of Byetta (exenatide), but its utilization has diminished in favor of newer agents like Victoza. The next expected generic GLP-1 would be Trulicity, with a patent expiring in 2027. For more popular drugs like Ozempic/Wegovy, patent expiration in the US isn’t expected until 2032, and for the recently launched Zepbound/Mounjaro, expiration isn’t set until 2039.

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PBM Reform: A System Under Pressure

PBM Reform: A System Under Pressure

Pharmacy benefit managers (PBMs), the intermediaries in the pharmaceutical supply chain, are facing increased scrutiny and calls for reform. PBMs negotiate drug prices, decide which medications are covered by insurance plans and control much of the flow of prescription drugs. While their role was intended to lower costs and streamline access, some stakeholders argue they’ve become a source of rising drug prices and limited transparency.

Current PBM Landscape

PBMs hold significant power over drug pricing and accessibility. They determine which medications are covered by the insurance plans, negotiate rebates from manufacturers and often own or affiliate with pharmacies. Recent developments, including the Federal Trade Commission's (FTC) report and subsequent lawsuit in 2024, have highlighted several concerns:

  1. Steering Members to Preferred Pharmacies: PBMs often direct members to their own affiliated pharmacies, potentially limiting options for consumers.
  2. Drug Selection: Some argue that PBMs may prioritize drugs with higher rebates, potentially benefiting their bottom line and plan sponsors net costs while exposing members to higher costs.
  3. Rebate Systems: Drug manufacturers pay PBMs rebates to secure favorable placement on insurance formularies. However, members often don’t see the savings, as these rebates go to PBMs or plan sponsors.

For example, a patient with a 20% copay on a $500 medication pays $100 out of pocket, even if a rebate reduces the real cost to $250. These savings rarely make their way directly to the patient.

Failed Legislation and Future Pressure

Recent efforts to reform PBMs, like Section 227 of the HR II bill, did not achieve the intended outcomes. The bill proposed that PBMs earn money through fixed fees instead of rebates but left terms like "fair market value" unclear. It also kept incentives tied to drug prices and added complicated reporting requirements that could drive up costs without addressing core concerns. Employers and plan sponsors, who often use rebates to lower premiums or fund other benefits, also expressed reservations about the change. This structure continues to result in higher out-of-pocket costs for employees purchasing their prescriptions.

The Importance of a Pharmacy Consultant

Understanding the complexities of PBM practices and pharmacy plans requires specialized expertise. A pharmacy consultant simplifies this process, acting as a trusted advisor to help employers and members make informed decisions.

Key benefits include:

  1. Clarifying Plan Details: Consultants analyze pharmacy plans and contracts to uncover hidden fees and ensure an understanding of the terms.
  2. Rebate Analysis: They evaluate rebate structures to determine where savings go and advocate for models that prioritize member benefits.
  3. Enhanced Transparency: By simplifying PBM operations, consultants can help ensure fair prices and better access to medications.

A pharmacy consultant can help organizations gain a clearer, more transparent view of their pharmacy plan, which could lead to better outcomes for their workforce.

Future Considerations: What's Next?

The ongoing discussion around PBM reform remains under intense public and regulatory scrutiny. Calls for transparency and fairness in drug pricing will likely lead Congress to revisit the issue. For a successful outcome, future reforms must consider:

  1. Prioritize Members: Ensure that savings from rebates directly lower costs for members, not just employers or PBMs.
  2. Increase Transparency: Mandate clear reporting of drug pricing and rebate allocations.
  3. Simplify Systems: Reduce unnecessary bureaucracy while fostering fair competition.

The spotlight on PBMs is growing, with rising calls for transparency and lower costs. While reforms have fallen short, pharmacy consultants play a crucial role in helping employers and members navigate complex benefit plans. By simplifying plans, clarifying costs and advocating for fairness, pharmacy consultants can help to ensure a more transparent and patient-focused healthcare system.

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ACA Updates for 2025

ACA Updates for 2025

The Affordable Care Act (ACA) requires non-grandfathered plans to cover certain preventive items and services at a $0 cost share to their members. For 2025, new additions include HIV pre-exposure prophylaxis (PrEP) based on recommendations from the US Preventative Services Task Force (USPSTF). Currently, Truvada and its generic tenofovir disoproxil fumarate and emtricitabine are considered preventative (for PrEP).

Recently, the USPSTF recommended two more medications for prevention, Descovy and Apretude. There are no generics currently available for these two medications, and as of January 1, 2025, most carriers have included these products in their ACA coverage when specified for approved use in PrEP. Note that Aetna has made the decision not to make any changes to their ACA list at this time.

PrEP Medication Overview

The table below shows the three formulations currently approved for PrEP and another formulation anticipated to launch later in 2025.

PrEP Medications:

Drug Maintenance Dosage Dosage Form Generic Available?
Truvada Once Daily Oral Yes
Descovy Once Daily Oral No
Apretude Once every two months Injection No
Pipeline: Lenacapavir
Anticipated launch 2025		 Once every six months Injection N/A

ACA Contraceptive Coverage Updates

There are frequent proposals to change components of the ACA's required preventive coverage. As stated above, the ACA mandates that non-grandfathered group health plans and health insurance issuers provide certain women’s preventive health services without cost-sharing, including FDA-approved contraceptive services and products deemed medically appropriate by a woman's healthcare provider.

During Trump's first administration, employers could be exempted based on religious beliefs or moral convictions. In 2023, the Biden administration proposed removing the moral exemption rule to expand access to contraception, making it harder for employer-sponsored health plans and insurers to exclude birth control coverage. However, as of late December 2024, the Biden administration withdrew these regulations, allowing employers to opt out of providing contraceptive coverage based on moral convictions, thus maintaining the previous rules.

Given the regular changes to the ACA, employers may have questions about their coverage requirements and related costs. It is recommended to consult with a dedicated Rx Solutions consultant for any questions regarding ACA coverage or obtain an updated list from their PBM.

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