Introduction to QUVIVIQ
QUVIVIQ, developed by Idorsia Pharmaceuticals US Inc., is a groundbreaking oral treatment for insomnia, specifically targeting the biological cause of overactive wake signaling. Approved by the FDA in 2022, QUVIVIQ (daridorexant) is a dual orexin receptor antagonist, distinguishing itself from traditional insomnia medications by its unique mechanism of action and favorable safety profile[1].
Market Position and Growth
Current Market Performance
Since its launch in May 2022, QUVIVIQ has shown promising growth. In the first nine months of 2024, the drug generated total product sales of CHF 39 million across several countries, including the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, and France. In the US alone, net sales increased by 41% compared to the same period in 2023, reaching CHF 21 million[2].
Prescription and Patient Metrics
As of the end of the third quarter of 2024, over 165,000 patients in the US have been treated with QUVIVIQ, with more than 500,000 prescriptions dispensed and nearly 50,000 healthcare professionals prescribing the drug. This indicates a strong uptake and acceptance within the medical community[2].
Market Share and Competitors
QUVIVIQ has quickly become a leading branded insomnia medicine in the US, surpassing other branded insomnia treatments in new-to-brand prescriptions (NBRx) and total prescriptions (TRx) in the commercial market. It competes with other dual orexin receptor antagonists like Merck’s Belsomra (suvorexant) and Eisai’s Dayvigo (lemborexant), but its unique safety profile and efficacy have helped it gain significant market share[5].
Pricing and Accessibility
Wholesale Acquisition Cost (WAC)
The wholesale acquisition cost (WAC) for QUVIVIQ is around $490 for a 30-tablet pack. However, eligible patients with insurance may pay as low as $0 for the first 30-day prescription and as low as $25 for each subsequent 30-day refill, making the drug more accessible to a broader patient population[1].
Reimbursement and Coverage
Idorsia has made significant progress in securing reimbursement for QUVIVIQ. By the end of 2023, the company had achieved over 65% reimbursement in the commercial sector in the US, which has continued to improve. This increased access has been a key factor in the drug's growing market presence[3].
Market Projections and Forecast
Revenue Projections
For 2024, Idorsia expects QUVIVIQ net sales to be around CHF 55 million, excluding unforeseen events. This projection is part of a broader financial outlook that includes significant investments in research and development and sales, general, and administrative (SG&A) expenses[2][3].
Long-Term Market Potential
The overall market for insomnia treatments in the US is projected to total $6.3 billion by 2030, according to Allied Market Research. Given QUVIVIQ's strong performance and growing market share, the drug is forecasted to reach blockbuster revenues. Idorsia CEO Jean-Paul Clozel has stated that a market penetration of just 15% to 20% could lead to significant revenue, with forecasted revenue for QUVIVIQ in 2026 estimated at $1.05 billion[1].
Competitive Landscape and Market Trends
Dual Orexin Receptor Antagonists
The insomnia market is increasingly dominated by dual orexin receptor antagonists (DORAs), with QUVIVIQ, Belsomra, and Dayvigo leading the charge. These drugs are gaining patient share from traditional hypnotics, such as Z-drugs, benzodiazepines, and low-dose sedating antidepressants[4].
Global Market Growth
The insomnia market across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) is expected to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032. This growth will be driven by the increasing adoption of DORAs and the introduction of new pipeline products[4].
Regulatory and Legal Considerations
Descheduling Efforts
Idorsia is actively pursuing a citizen petition to deschedule the DORA class of chronic insomnia medications, which could further enhance the accessibility and market potential of QUVIVIQ. Progress on this front is ongoing and could have significant implications for the drug's future market position[2][3].
Financial Outlook and Challenges
Operating Expenses and Losses
Despite the positive market performance, Idorsia is expected to incur significant operating expenses and losses in 2024. The company anticipates a non-GAAP operating loss of around CHF 420 million and a US GAAP operating loss of CHF 340 million, which includes a one-off benefit from the Viatris deal[2][3].
Cost Management and Funding
To manage costs and extend its cash runway, Idorsia has implemented cost reduction initiatives and is exploring non-dilutive funding opportunities. The company remains optimistic about its financial future, driven by the growing success of QUVIVIQ and other pipeline products[3].
Key Takeaways
- Strong Market Uptake: QUVIVIQ has quickly become a leading branded insomnia treatment in the US, with significant prescription and patient metrics.
- Pricing and Accessibility: The drug is priced competitively, with favorable reimbursement rates making it accessible to a broad patient population.
- Market Projections: Forecasted to reach $1.05 billion in revenue by 2026, with long-term market potential driven by growing demand for DORAs.
- Competitive Landscape: QUVIVIQ competes effectively against other DORAs, gaining market share from traditional insomnia treatments.
- Regulatory Efforts: Ongoing efforts to deschedule DORAs could further enhance QUVIVIQ's market position.
FAQs
Q: What is the mechanism of action of QUVIVIQ?
A: QUVIVIQ is a dual orexin receptor antagonist, which moderates the sleep/wake signal rather than inducing a knockout effect like older prescription products[1].
Q: How much does QUVIVIQ cost?
A: The wholesale acquisition cost (WAC) for QUVIVIQ is around $490 for a 30-tablet pack, but eligible patients may pay as low as $0 for the first prescription and $25 for subsequent refills[1].
Q: What is the current market performance of QUVIVIQ?
A: As of the third quarter of 2024, QUVIVIQ has generated CHF 39 million in sales, with over 165,000 patients treated and more than 500,000 prescriptions dispensed in the US[2].
Q: What are the long-term market projections for QUVIVIQ?
A: QUVIVIQ is forecasted to reach $1.05 billion in revenue by 2026, with the overall insomnia market projected to total $6.3 billion by 2030[1].
Q: Is QUVIVIQ available in other countries besides the US?
A: Yes, QUVIVIQ is commercially available in several countries including Germany, Italy, Switzerland, Spain, UK, Canada, Austria, and France, with further launches planned[2][3].
Sources
- Pharmaceutical Executive: "A Sleeping Giant?: Quviviq"
- Biospace: "Idorsia announces financial results for the first nine months of 2024"
- Idorsia: "Idorsia announces financial results for the first quarter 2024"
- Clinical Trials Arena: "Dual orexin receptor antagonists to drive insomnia market across 7MM"
- Idorsia: "Idorsia announces financial results for the first quarter 2023"
