The Institute for Clinical and Economic Review (ICER) recently conducted an assessment of insurance coverage policies for 11 prescription drugs.
This analysis focused on formularies from the 10 largest commercial payers in the U.S., alongside the Veterans Health Administration (VHA), covering an estimated 57 million individuals.
The evaluation aimed to determine how closely these policies aligned with ICER's fair access criteria, emphasizing cost-sharing, clinical eligibility, step therapy, and prescriber restrictions.
Drugs and Scope of Review
The drugs assessed included Mounjaro, Wegovy, Qsymia, Saxenda, Contrave, Cosela, Veozah, Radicava ORS, Zynteglo, Hemgenix, and Roctavian.
The focus extended to gene therapies such as Zynteglo (for beta thalassemia), Hemgenix (for hemophilia B), and Roctavian (for hemophilia A), due to their significant economic and clinical impact.
Fair Access Domains
ICER’s review targeted five key areas:
Cost-sharing and tier placement
Timeliness of prior authorization protocols post-FDA approval
Clinical eligibility requirements
Step therapy protocols
Prescriber qualifications
Findings
1. Cost Sharing
Three medications – Mounjaro, Wegovy, and Qsymia – were determined to be priced within acceptable cost-effectiveness levels. Mounjaro achieved full concordance (100%) for cost-sharing, consistently placed on the lowest formulary tiers. Wegovy and Qsymia saw concordance rates of 70% and 73%, respectively, with certain insurers (HCSC, Highmark, and UnitedHealth) listing them as non-preferred brands.
2. Clinical Eligibility
Most coverage policies (96%) adhered to fair access criteria regarding clinical eligibility. However, certain deviations were noted:
Qsymia: One insurer imposed restrictions related to bariatric surgery.
Mounjaro: The VHA required excessive documentation of previous glycemic control attempts.
Saxenda and Wegovy: The VHA added restrictive criteria involving drugs not recommended by clinical guidelines.
3. Step Therapy
All assessed policies (100%) complied with step therapy guidelines, with no more than three steps required for drug access.
4. Prescriber Restrictions
No restrictions were found for most obesity and diabetes medications. Specialist prescribers were required for drugs like Cosela (oncologists), Zynteglo (hematologists), and Radicava (neurologists), aligning with appropriate clinical guidelines.
Concordance by Payer
Cost-sharing concordance varied widely (33% to 100%), while eligibility criteria ranged from 57% to 100%. Step therapy and prescriber qualifications achieved universal alignment across all payers. Some discrepancies, particularly for obesity medications, stemmed from insurers placing them in non-preferred tiers.
Patient Experience and Accessibility
Filling prescriptions varied significantly by drug. Mounjaro prescriptions for diabetes had high success rates, while obesity medications like Wegovy and Qsymia faced lower fill rates (15-23% on the first attempt). Additionally, many prescriptions were paid in cash, reflecting limited insurance coverage for obesity treatments.
Out-of-Pocket Costs
Out-of-pocket expenses ranged from $20 to $30 for drugs like Mounjaro and Wegovy, likely due to manufacturer assistance programs. However, costs for medications such as Qsymia and Contrave were often higher ($50 to $250).
Cash Payments and Barriers
Cash prescriptions were prevalent, particularly for obesity drugs. Many patients bypassed insurance or paid out-of-pocket following coverage rejections. This trend highlighted ongoing barriers in access to weight management treatments.
Conclusion
ICER’s analysis demonstrated high compliance with fair access standards in clinical eligibility, step therapy, and prescriber restrictions. However, cost-sharing policies for obesity treatments revealed notable inconsistencies. Addressing these disparities remains essential to ensuring equitable access to essential medications across various patient populations.
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