Introduction to Aplisol
Aplisol, also known as tuberculin purified protein derivative (PPD), is a diagnostic tool used to aid in the detection of tuberculosis (TB) infection. It is administered via an intradermal injection and is one of the two FDA-approved PPD tuberculin antigen solutions, the other being Tubersol by Sanofi Pasteur[4].
Market Context and Demand
The demand for Aplisol is driven by the need for TB diagnosis, particularly in high-risk populations such as recent contacts of individuals with TB disease, those born in or frequently traveling to countries with high TB prevalence, and individuals living in large group settings like homeless shelters and correctional facilities.
Shortages and Their Impact
Historically, the market for Aplisol has been affected by supply shortages. For instance, in 2019, the CDC announced a 3 to 10 month shortage of Aplisol due to a supply interruption by the manufacturer, Par Pharmaceuticals. This shortage led to recommendations for substituting interferon-gamma release assay (IGRA) blood tests and prioritizing TST allocations for high-risk groups[1].
Similar shortages occurred in 2012-2013 when Tubersol was out of production, leading to increased demand for Aplisol and subsequent shortages of this product as well[4].
Pricing and Cost Considerations
The cost of Aplisol can vary depending on the quantity and the pharmacy. Here are some key pricing points:
Patient Assistance and Copay Programs
While there are no specific patient assistance programs (PAPs) available for Aplisol, patients can benefit from general drug discount programs. For example, the Drugs.com Discount Card can save patients up to 80% on prescription medicines, including Aplisol[2].
Market Dynamics and Recommendations
Substitution and Alternatives
During periods of shortage, the CDC recommends substituting IGRA blood tests for TSTs. IGRA tests, such as QuantiFERON-TB Gold Plus, offer an alternative method for detecting Mycobacterium tuberculosis infection, although the criteria for test interpretation differ from those of TSTs[1].
Prioritization and Allocation
Healthcare providers are advised to prioritize TST allocations based on risk factors, consulting with state and local public health authorities. Routine serial testing should be deferred in settings with low TB exposure risk, and annual testing of healthcare personnel is not recommended unless there is a known exposure or ongoing transmission[1].
Price Projections and Future Outlook
Supply Stability
The stability of Aplisol supplies is crucial for maintaining consistent pricing. Historical data indicate that shortages can lead to temporary price fluctuations and instability in supply chains. As supplies approach normal levels after a shortage, prices are likely to stabilize[4].
Regulatory and Market Factors
Price projections for Aplisol are influenced by regulatory actions, manufacturing capacity, and market demand. Given the essential nature of TB diagnosis, any significant changes in regulatory policies or manufacturing capabilities could impact pricing.
Economic Considerations
The cost-effectiveness of Aplisol compared to other diagnostic methods, such as IGRA tests, also plays a role in pricing. As healthcare systems aim to optimize resource allocation, the economic viability of Aplisol will be a key factor in its market positioning.
Key Takeaways
- Supply Chain Stability: Consistent supply is crucial for stable pricing and market reliability.
- Regulatory Recommendations: CDC guidelines on substitution and prioritization during shortages help manage demand and supply imbalances.
- Pricing Variability: Prices can fluctuate based on quantity, pharmacy, and availability.
- Patient Assistance: General discount programs can help reduce costs for patients.
- Market Dynamics: The market is influenced by the availability of alternatives like IGRA tests and regulatory recommendations.
FAQs
1. What is Aplisol used for?
Aplisol is used as an aid in the diagnosis of tuberculosis (TB) infection through an intradermal injection.
2. Why have there been shortages of Aplisol?
Shortages have occurred due to supply interruptions by the manufacturer and increased demand when other PPD tuberculin antigen solutions, like Tubersol, are unavailable.
3. What alternatives are recommended during Aplisol shortages?
The CDC recommends substituting IGRA blood tests for TSTs and using Tubersol as a substitute for skin testing if available.
4. How much does Aplisol cost?
The cost of Aplisol is around $111 for a 1 milliliter supply, with discounts available through certain programs.
5. Are there any patient assistance programs for Aplisol?
While there are no specific PAPs for Aplisol, patients can use general drug discount programs to reduce costs.
Sources
- CDC Health Alert Network: Aplisol Shortage Prompts CDC to Issue New Recommendations for TB Testing[1].
- Drugs.com: Aplisol Prices, Coupons, Copay Cards & Patient Assistance[2].
- PubMed: Extent and effects of recurrent shortages of purified-protein derivative tuberculin skin test antigen solutions[4].
