Main highlights:
- FDA authorized ‘Auvelity’ for major depressive disorder
- The pricing and reimbursement issues for Auvelity
The FDA authorized Auvelity (dextromethorphan/bupropion) extended-release tablets from Axsome Therapeutics in August for the treatment of major depressive disorder (MDD) in adults. Dextromethorphan, a cough suppressant, and bupropion, an antidepressant, are the two active chemicals of Auvelity, which have both been around for more than two decades. Nevertheless, Auvelity represents the market entry of oral medication with a unique mechanism of action for MDD in more than 60 years.
A breakthrough in the MDD market, where there is an unmet need for medications that can exhibit quick antidepressant benefits, can be shown in Auvelity’s quick beginning of the action. Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors are currently the standards of therapy (SNRIs). After several weeks of treatment, these drugs start to have an antidepressant effect.
The fact that consuming Auvelity was not linked to weight gain in a Phase 3 study supports the drug’s rapid and (probably) long-lasting antidepressant benefits. There are many anti-depressants on the market now that can cause weight gain.
The GEMINI placebo-controlled study and the ASCEND research contrasting Auvelity and bupropion sustained-release tablets provided crucial evidence for the approval of Auvelity. Notably, the ASCEND research, a comparison trial, revealed that Auvelity outperformed bupropion on the key outcome metric by a statistically significant margin.
An oral antidepressant that requires a prescription is called Auvelity. Major depressive disorder (depression) in adults is a condition that is FDA-approved to treat. Dextromethorphan and bupropion are both present in it as an extended-release (ER) tablet.
The FDA’s priority list seemed to have this drug combination at the top of the list. Auvelity was designated a breakthrough therapy by the FDA before approval. Additionally, they performed a priority review evaluation of the drug.
The manufacturer of Auvelity is the American pharmaceutical business Axsome Therapeutics.
The pricing and reimbursement issues for Auvelity’s
Despite Auvelity’s advantages that have been shown in clinical trials, pricing and reimbursement issues will arise for this new pharmaceutical, as they do for the majority of newly licensed medications in classes where there are several (less expensive) therapy options. Axsome hasn’t yet disclosed its cost, but it is believed that it will be more expensive than generic SSRIs and SNRIs, which are already well-known on the MDD market. Due to its anticipated high cost, payers may limit the use of Auvelity to second and subsequent lines of therapy.
Not that Auvelity won’t be covered—far from it. If Axsome Therapeutics participates in the Medicaid Drug Rebate Program, it will likely be added to formularies by many commercial insurers as well as by all Medicaid plans. Additionally, because it is an antidepressant, it qualifies as a protected medication class and should be covered by all Medicare Part D plans.
Coverage, though, is a complicated affair. Being included in the formulary or being omitted is not the only option for coverage. Most recently approved medications eventually land on the formulary. But what really matters is where they stand on the formulary.
The terms of reimbursement that payers impose, such as patient cost-sharing, prior authorization, step edits, quantity caps, and indication restrictions, influence access in this case. These reimbursement requirements also depend on a variety of elements, including the cost per unit, rebates, the therapeutic interchangeability of the product with other ones, clinical and financial effectiveness, and fiscal implications.
The sponsor of Auvelity, Axsome Therapeutics, will face difficulties in overcoming barriers to market access. But a strong efficacy and safety profile will probably make it easier for patients to get access.
