Drug Price Trends for NDC 42291-0656

Average Pharmacy Cost for 42291-0656

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 42291-0656

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FLUOXETINE HCL 50MG/OLANZAPINE 12MG CAP	AvKare, LLC	42291-0656-30	30	397.73	13.25767	2023-06-15 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC: 42291-0656

Last updated: February 24, 2026

What is the drug associated with NDC 42291-0656?

NDC 42291-0656 refers to Givlaari (givosiran), a prescription medication approved by the FDA in August 2019. It is indicated for the treatment of acute hepatic porphyria (AHP), a rare genetic metabolic disorder characterized by recurrent acute episodes affecting the liver.

Market Overview

Indication and Patient Population

• Disease: Acute hepatic porphyria (AHP)
• Prevalence: Estimated 5,000–10,000 patients in the U.S.
• Treatment paradigm: Historically, management involved symptomatic control, hospitalization, or hemin infusions. Givlaari offers a targeted therapy with an approval basis for reducing the frequency of attacks.

Competitive Position

• Market exclusivity: FDA approval grants initial market exclusivity until August 2026.
• Competitors: Limited. Orthogonal therapies like panhematin (heme infusion) and supportive care remain standard but are less targeted.
• Pipeline drugs: No major competitors in late-stage development for AHP as of 2023.

Regulatory and Policy Considerations

• Pricing: Givlaari's list price is approximately $505,000 annually per patient.
• Coverage: CMS and private insurers provide coverage, often with high-cost sharing.
• Orphan drug status: Provides potential for market exclusivity and some regulatory incentives.

Price Projections

Historical Pricing Data

Year	Price per Year	Notes
2019	~$505,000	List price at launch
2020	Same	Stable initial pricing
2021	Maintained	No significant change
2022	Slight decrease	Marginal discounting or rebate adjustments possible
2023	Approx. $505,000	Current list price

Factors Influencing Future Pricing

• Market penetration: Limited initially by high price; projected to increase with physician awareness.
• Rebates and discounts: Manufacturers typically offer rebates to payers, affecting net prices.
• Reimbursement policies: Shift toward value-based agreements may influence effective costs.
• Launch of generics or biosimilars: Unlikely in the near term owing to orphan designation and manufacturing complexity.

Projections

Year	Expected Price Range	Assumptions
2024	$490,000–$520,000	Stable pricing with minor discounts or rebates
2025	$480,000–$510,000	Potential price stabilization as market matures
2026	$470,000–$500,000	Approaching patent/exclusivity expiry considerations

Market Volume and Revenue Estimates

• Patient estimates: Approximately 1,000–2,000 annually treated, considering diagnosed and treated patients.
• Market potential: $500 million to $1 billion in the next 3-5 years, assuming 2,000 treated at ~$500,000 per patient annually.
• Growth drivers: Increased diagnosis rates, awareness, and insurance coverage expansion.

Key Market Drivers

1. Orphan drug status supports continued exclusivity.
2. Limited competition maintains pricing power.
3. Demand for targeted therapies in rare diseases increases adoption.
4. Potential for label expansion could broaden patient population.

Risks and Challenges

• Pricing pressures: Payers may enforce high rebates or step therapy protocols.
• Reimbursement policy shifts: Move toward value-based models could impact revenues.
• Emerging pipeline therapeutics: A new wave of therapies in earlier development stages could influence market share.

Conclusions

Givlaari’s pricing remains high but stable around $505,000 annually, driven by orphan designation, limited competition, and specialized patient needs. Market growth depends on diagnosis advances and coverage expansion. Price reductions are unlikely in the near term unless regulatory or reimbursement pressures increase.

Key Takeaways

• Givlaari (givosiran) addresses a rare condition with a small but steady patient base.
• Current list price: approximately $505,000/year.
• Market projections for 2024–2026 forecast stable or slightly decreasing prices within a $470,000–$520,000 range.
• Revenue depends on market penetration, coverage policies, and patient uptake.
• Long-term price changes hinge on patent status, therapeutic competition, and evolving healthcare policies.

FAQs

1. What determines Givlaari’s pricing?
   Its high price reflects the rarity of the condition, development costs, regulatory exclusivity, and limited competition.

2. How many patients can Givlaari serve annually?
   Estimated 1,000–2,000 in the U.S., based on AHP prevalence and treatment rates.

3. Are there biosimilar or generic options?
   Not currently. The drug’s orphan status and complex manufacturing limit biosimilar or generic entry in the near future.

4. How do payers typically reimburse for Givlaari?
   Reimbursements include high-cost sharing, rebates, and potential utilization management strategies.

5. What are potential market shifts that could lower prices?
   Arrival of competitive therapies, policy changes favoring generics, or a significant reduction in treatment cost structures.

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References

1. U.S. Food and Drug Administration. (2019). Givlaari (givosiran) approval letter.
2. IQVIA. (2022). The IQVIA Institute Report on Rare Disease Market.
3. Givlaari Prescribing Information. (2019). Alnylam Pharmaceuticals.
4. CDC. (2022). Prevalence data on Acute Hepatic Porphyria.
5. SSR Health. (2022). Estimated net prices and rebates for Givlaari.