Bill Overview
Title: PRICED Act
Description: This bill allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period. This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.
Sponsors: Rep. Schakowsky, Janice D. [D-IL-9]
Target Audience
Population: People who may need biologic medications
Estimated Size: 250000000
- The legislation impacts the pharmaceutical market, specifically the availability of biosimilars.
- Biosimilars are typically used as alternative, often more affordable, versions of biologic drugs.
- By reducing market exclusivity from 12 years to 5 years, the bill allows biosimilars to enter the market sooner, potentially lowering drug costs.
- Lower drug costs can impact a large number of individuals who require biologic medications for various conditions, including chronic diseases such as diabetes, cancer, and autoimmune disorders.
- Patients currently or potentially needing biologic drugs will be affected directly in terms of drug availability and pricing.
- Biosimilars are used globally, so any changes in US legislation can impact global markets due to the US's role in pharmaceutical innovation and regulation.
Reasoning
- The policy affects primarily those who depend on expensive biologic medications, including people with chronic conditions such as cancer, diabetes, and autoimmune disorders.
- The shortened exclusivity period should increase the availability of biosimilars, potentially lower prices, and increase accessibility to life-saving medications.
- Accessibility of more affordable medications will not immediately reach everyone; hence, the impact may vary based on socioeconomic status, geographic location, and the presence of chronic illnesses.
- The policy may drive pharmaceutical innovation as companies adjust to the new competitive landscape which could lead to new drug development pathways.
- There will be people who see little to no immediate impact, such as those who do not use biologic drugs or those with strong insurance coverage that already covers biologics.
- For those heavily relying on biologics, the reduction in exclusivity could mean significant savings and improved access, thus improving overall well-being.
Simulated Interviews
Teacher (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- I am really hopeful that this policy will make my medication more affordable.
- Biosimilars could help me manage my condition without worrying as much about the costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 9 | 5 |
Retired Engineer (New York)
Age: 60 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 15.0 years
Commonness: 10/20
Statement of Opinion:
- Reducing drug costs is critical as I worry about my savings.
- The cost of cancer treatment is astronomical, and any reduction or savings would be helpful.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Software Developer (Texas)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 15/20
Statement of Opinion:
- I don't use biologics, so this doesn't directly affect me.
- I know many who might benefit, and that could help lower overall healthcare costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Graduate Student (Illinois)
Age: 28 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 12/20
Statement of Opinion:
- This could be beneficial for friends or family who need expensive medications.
- More access to biosimilars is good, but it really depends on what drugs people need.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Small Business Owner (Florida)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- Access to more affordable medications would be a relief.
- It's painful to balance health needs with business expenses.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Retired (Ohio)
Age: 72 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 18/20
Statement of Opinion:
- I'm on a fixed income; any savings could help in the future if I need it.
- It's good for those who might need these treatments but unsure of immediate personal impact.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Marketing Specialist (Virginia)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 14/20
Statement of Opinion:
- I like the idea of more competition in the drug market.
- Though I don't need these drugs now, one never knows about the future.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Non-profit Director (Washington)
Age: 55 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Access and innovation for biologics are crucial given my family's medical history.
- Preparedness is key—this could be beneficial if I need it later.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 8 |
Laborer (Massachusetts)
Age: 40 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 20.0 years
Commonness: 8/20
Statement of Opinion:
- I struggle to afford my medications; biosimilars may help.
- Cost is a big boundary for managing my chronic condition.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 7 | 4 |
Legal Assistant (Georgia)
Age: 52 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 7.0 years
Commonness: 13/20
Statement of Opinion:
- If I need biologics, the cost needs to be manageable.
- I am hopeful but cautious about the actual changes this brings about.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $10000000 (Low: $5000000, High: $15000000)
Year 2: $11000000 (Low: $6000000, High: $16000000)
Year 3: $12000000 (Low: $7000000, High: $17000000)
Year 5: $14000000 (Low: $9000000, High: $19000000)
Year 10: $20000000 (Low: $15000000, High: $25000000)
Year 100: $50000000 (Low: $25000000, High: $75000000)
Key Considerations
- The policy will primarily affect new biologics going forward, as already approved biologics will retain their exclusivity timelines.
- There is inherent uncertainty about market dynamics, such as how quickly biosimilars will enter and effectively compete, and the reactions of brand-name manufacturers, which can impact cost savings.