Bill Overview
Title: Hatch-Waxman Improvement Act of 2022
Description: This bill extends through FY2026 provisions that establish a period of market exclusivity for certain new drugs with single enantiomers (i.e., one of a pair of molecules that are mirror images of one another).
Sponsors: Sen. Marshall, Roger [R-KS]
Target Audience
Population: People dependent on drugs with single enantiomers for treatment
Estimated Size: 10000000
- The bill extends market exclusivity for certain new drugs, potentially impacting patients who might benefit from these drugs, including those with specific medical conditions treatable by single enantiomer drugs.
- Market exclusivity can limit the availability of generic alternatives, affecting drug prices and accessibility.
- The pharmaceutical industry, including manufacturers of both brand name and generic drugs, will be impacted as it affects their market competition strategies.
- Healthcare providers may also be impacted as they navigate prescribing options and managing patient access to medications.
Reasoning
- The target population primarily consists of individuals reliant on single enantiomer drugs, which are likely to be more expensive due to market exclusivity. Thus, the policy will majorly affect their costs and access to medication, possibly impacting their wellbeing depending on economic conditions and insurance coverage.
- Healthcare providers and pharmaceutical companies are secondary stakeholders, experiencing indirect effects such as prescribing changes and market strategy adjustments respectively.
- In the population, a fair segment may not be affected if they don't require such medications, thereby representing the low or no-impact group.
- Considering the significant US pharmaceutical market and insurance dynamics, the cost trends and health outcomes for these drugs would vary. Individuals with insurance may see minimal direct cost hit versus those without or with less coverage, who may experience significant economic strain.
Simulated Interviews
Pharmacy Technician (New York, NY)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I rely on my medication daily, and I'm worried the exclusivity might make it more expensive.
- The company’s focus on profit could put my health at risk if prices rise too high for me to afford, even with insurance.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 5 | 7 |
| Year 5 | 5 | 6 |
| Year 10 | 4 | 6 |
| Year 20 | 5 | 6 |
Medical Sales Representative (Chicago, IL)
Age: 57 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Exclusivity limits our ability to introduce generics, reducing competition and potentially raising prices.
- Our industry thrives on bringing affordable options to the market, and this policy complicates that goal.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 4 | 6 |
| Year 5 | 5 | 6 |
| Year 10 | 5 | 5 |
| Year 20 | 6 | 5 |
Primary Care Physician (Omaha, NE)
Age: 42 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 4/20
Statement of Opinion:
- This policy might limit drug options for some of my patients.
- Access to newer, potentially more effective drugs may be restricted to those who can afford them, affecting treatment decisions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 7 | 8 |
| Year 5 | 6 | 8 |
| Year 10 | 6 | 7 |
| Year 20 | 7 | 7 |
Software Engineer (Houston, TX)
Age: 35 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 0.0 years
Commonness: 7/20
Statement of Opinion:
- I haven't seen this affect me personally, so it's not on my radar.
- If it leads to higher healthcare costs overall, that might show up in my insurance premiums eventually.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 9 |
| Year 3 | 8 | 9 |
| Year 5 | 8 | 9 |
| Year 10 | 8 | 8 |
| Year 20 | 7 | 8 |
Hospital Administrator (Miami, FL)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- Changes like this could increase our procurement costs for certain drugs.
- I have to navigate these costs while maintaining quality care without transferring too much burden onto patients.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 5 | 7 |
| Year 20 | 6 | 6 |
Pharmaceutical Researcher (Seattle, WA)
Age: 46 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This is both an opportunity and a challenge in developing drugs with enough innovation to deserve exclusivity.
- My work focuses on innovation, and this shifts the competitive landscape significantly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 7 | 8 |
| Year 5 | 7 | 8 |
| Year 10 | 7 | 7 |
| Year 20 | 8 | 7 |
Small Business Owner (Los Angeles, CA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 6.0 years
Commonness: 5/20
Statement of Opinion:
- My main concern is how this affects my brother, who needs a specific drug that could get pricier.
- If costs go up, we might need to adjust our family budget or look for alternative solutions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 5 | 6 |
| Year 5 | 4 | 6 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 5 |
Journalist (Denver, CO)
Age: 32 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- This exclusivity period expands pharma profits but constrains consumer choice and potentially raises costs.
- Understanding the nuances helps me report comprehensively on how people are affected, regardless of personal impact.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Graduate Student (San Diego, CA)
Age: 29 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 0.0 years
Commonness: 2/20
Statement of Opinion:
- The policy provides an interesting perspective on how market dynamics are controlled by exclusivity.
- It's crucial to analyze both economic models and patient outcomes as part of my thesis.
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 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Investment Analyst (Boston, MA)
Age: 34 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 4/20
Statement of Opinion:
- This affects investment portfolios focusing on pharmaceuticals, particularly company-specific risks due to exclusivity.
- Long-term outlooks may hinge on how these exclusivity periods affect competitive positionings.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 6 | 7 |
Cost Estimates
Year 1: $75000000 (Low: $70000000, High: $80000000)
Year 2: $78000000 (Low: $72000000, High: $84000000)
Year 3: $81000000 (Low: $75000000, High: $87000000)
Year 5: $87000000 (Low: $80000000, High: $94000000)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- The extension of market exclusivity can lead to higher drug costs and delayed entry of generics, impacting healthcare affordability.
- There will be a sustained impact on healthcare payers, including governmental programs such as Medicare and Medicaid, as a result of continued high drug prices.
- Considering the prevalence of chronic conditions requiring medication, affected individuals could experience financial strain, potentially influencing adherence to treatment and healthcare outcomes.