Drug Price Trends for TIKOSYN

Average Pharmacy Cost for TIKOSYN

These are average pharmacy acquisition costs (net of discounts) from a US national survey

Drug Name	NDC	Price/Unit ($)	Unit	Date
TIKOSYN 500 MCG CAPSULE	00069-5820-43	10.77105	EACH	2025-01-01
TIKOSYN 500 MCG CAPSULE	00069-5820-60	10.77105	EACH	2025-01-01
TIKOSYN 500 MCG CAPSULE	00069-5820-61	10.77105	EACH	2025-01-01

Market Analysis and Price Projections for Tikosyn (Dofetilide)

Introduction to Tikosyn

Tikosyn, also known by its generic name dofetilide, is a group III antiarrhythmic drug used to convert atrial fibrillation (AFib) and atrial flutter to a regular heart rhythm and to maintain this rhythm in adults. It was approved by the FDA on October 1, 1999, and has been a crucial treatment option for patients with highly symptomatic atrial fibrillation/atrial flutter[4].

Indications and Clinical Use

Tikosyn is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) in patients who have been converted to normal sinus rhythm. It is particularly recommended for patients with highly symptomatic atrial fibrillation/atrial flutter of more than one week duration. The drug can cause life-threatening ventricular arrhythmias, so its use is carefully monitored and typically initiated in an inpatient setting[1][3][4].

Market Demand

The demand for Tikosyn is driven by the prevalence of atrial fibrillation and atrial flutter, which are common heart rhythm disorders. As the population ages, the incidence of these conditions is expected to increase, thereby increasing the demand for effective treatments like Tikosyn.

Patient Population

Clinical studies have enrolled patients with a history of atrial fibrillation/atrial flutter ranging from one week to two years. The effectiveness of Tikosyn in maintaining normal sinus rhythm has been demonstrated in these studies, showing that a significant percentage of patients remain in sinus rhythm at six and twelve months post-treatment[1][3].

Pricing and Cost Factors

The cost of Tikosyn can vary based on several factors, including the dosage, treatment plan, insurance coverage, and the pharmacy used.

Brand-Name vs. Generic Pricing

Tikosyn is available in both brand-name and generic forms. The brand-name version is generally more expensive due to the research and development costs incurred by the manufacturer. However, generic versions, which contain the same active ingredients, are often significantly cheaper due to reduced development and testing costs[5].

• Brand-Name Pricing: The cost for Tikosyn 125 mcg oral capsules can be around $476 for a supply of 40 capsules, depending on the pharmacy[2].
• Generic Pricing: The generic version of dofetilide can cost as low as $162.75 for 40 capsules, making it a more affordable option for many patients[2].

Insurance and Financial Assistance

The cost of Tikosyn with insurance versus without insurance varies widely. Insurance plans can significantly reduce the out-of-pocket cost, but factors such as prior authorization requirements and specific plan benefits also play a role. Additionally, various savings programs and discount cards can help lower the cost for patients[5].

Pharmacy and Location

The price of Tikosyn can also vary depending on the pharmacy. Using a discount card or shopping at different pharmacies can help patients find the best price. For example, the Drugs.com Discount Card can save patients up to 80% on prescription medications, including Tikosyn[2].

Price Projections

Given the factors influencing the cost of Tikosyn, here are some key points to consider for price projections:

Market Competition

The availability of generic versions of dofetilide is expected to continue driving down the cost of the drug. As more generic manufacturers enter the market, competition is likely to increase, leading to lower prices for consumers[5].

Regulatory Changes

The elimination of the Risk Evaluation and Mitigation Strategy (REMS) program for Tikosyn in 2016 has simplified the prescribing and dispensing process, which could lead to more widespread use and potentially lower costs due to increased market access[4].

Patient and Prescriber Behavior

As prescribers become more comfortable with the safety profile of Tikosyn, its use may increase, which could stabilize or reduce prices due to economies of scale in production and distribution.

Key Statistics

• Conversion Rates: In clinical studies, Tikosyn showed conversion rates to normal sinus rhythm of up to 30% at the 500 mcg BID dose, compared to 1% with placebo[1][3].
• Maintenance Rates: At six months, the probability of remaining in sinus rhythm was approximately 52% for the 500 mcg BID dose, and at twelve months, it was around 46%[1][3].
• Cost Savings: Generic dofetilide can offer savings of up to 66% compared to the brand-name version[2].

Conclusion

Tikosyn remains a vital treatment option for patients with atrial fibrillation and atrial flutter. The market for this drug is influenced by factors such as the availability of generic versions, insurance coverage, and regulatory changes. As the demand for effective heart rhythm treatments continues to grow, the price of Tikosyn is likely to be shaped by increased competition from generic manufacturers and improved market access.

Key Takeaways

• Indications: Tikosyn is used to convert and maintain normal sinus rhythm in patients with atrial fibrillation/atrial flutter.
• Pricing: The cost varies between brand-name and generic versions, with generics offering significant savings.
• Insurance and Assistance: Insurance plans and financial assistance programs can reduce out-of-pocket costs.
• Market Dynamics: Increased competition from generics and regulatory changes are expected to influence pricing.
• Clinical Effectiveness: Tikosyn has shown significant efficacy in converting and maintaining normal sinus rhythm in clinical studies.

FAQs

Q: What is Tikosyn used for?

Tikosyn (dofetilide) is used to convert atrial fibrillation (AFib) and atrial flutter to a regular heart rhythm and to maintain this rhythm in adults.

Q: How much does Tikosyn cost?

The cost of Tikosyn can range from around $476 for a supply of 40 brand-name capsules to as low as $162.75 for 40 generic capsules, depending on the pharmacy and insurance coverage.

Q: Is there a generic version of Tikosyn?

Yes, a generic version of dofetilide is available, which is significantly cheaper than the brand-name version.

Q: What are the risks associated with Tikosyn?

Tikosyn can cause life-threatening ventricular arrhythmias, so its use is carefully monitored and typically initiated in an inpatient setting.

Q: Has the regulatory status of Tikosyn changed?

Yes, the FDA eliminated the Risk Evaluation and Mitigation Strategy (REMS) program for Tikosyn in 2016, simplifying its prescribing and dispensing process.

Sources

1. CENTER FOR DRUG EVALUATION AND RESEARCH, "Approval Package for: APPLICATION NUMBER: 020931Orig1s001 Trade Name: TIKOSYN Generic or Proper Name: dofetilide Sponsor: Pfizer Inc."
2. Drugs.com, "Tikosyn Prices, Coupons, Copay Cards & Patient Assistance"
3. DailyMed, "TIKOSYN- dofetilide capsule"
4. FDA, "Information for Tikosyn (dofetilide)"
5. MedicalNewsToday, "Tikosyn cost 2024: Coupons and more"