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Extracted Text (OCR)
There may be significant delays in obtaining reimbursement for newly approved drugs, and
coverage may be more limited than the purposes for which the drug is approved by the FDA or
similar regulatory authorities outside the United States. Moreover, eligibility for reimbursement
does not imply that any drug will be paid for in all cases or at a rate that covers a portfolio
company’s costs, including research, development, manufacture, sale and distribution. Interim
reimbursement levels for new drugs, if applicable, may also not be sufficient to cover a portfolio
company’s costs and may not be made permanent. Reimbursement rates may vary according to
the use of the drug and the clinical setting in which it is used, may be based on reimbursement
levels already set for lower cost drugs, and may be incorporated into existing payments for
other services. Net prices for drugs may be reduced by mandatory discounts or rebates required
by government healthcare programs or private payors and by any future relaxation of laws that
presently restrict imports of drugs from countries where they may be sold at lower prices than
in the United States. Third-party payors often rely upon Medicare coverage policy and payment
limitations in setting their own reimbursement policies. A portfolio company’s inability to
promptly obtain coverage and profitable payment rates from both government-funded and
private payors for any approved products that a portfolio company may develop could have a
material adverse effect on its operating results, its ability to raise capital needed to
commercialize products and its overall financial condition. This, in turn, could negatively affect
the performance of the Fund.
Political Risk; Current and Future Healthcare Reforms
Political events can have an impact on pharmaceutical and biotechnology companies. There can
be no guarantee that government'’s role in the healthcare industry will not adversely impact the
performance of the Fund.
In both the U.S. and foreign markets, sales of healthcare products and services and their success
will depend in part on the availability of reimbursement from third-party payors such as
government health administration authorities, private health insurers, and other organizations.
The levels of revenues and profitability of providers of healthcare products and services may be
affected by the continuing efforts of governmental and third-party payors to contain or reduce
the costs of health care. Significant uncertainty exists as to the reimbursement status of newly
approved health care products. There can be no assurance that a company’s proposed products
or services will be considered cost-effective or that adequate third-party reimbursement will be
available to enable a company to maintain price levels sufficient to realize an appropriate return
on its investment.
Moreover, there continues to be significant interest among policy makers and government and
private payors in the United States and foreign jurisdictions in promoting changes in healthcare
systems to contain healthcare costs and improve the overall quality of care and wellness.
For example, on March 23, 2010, President Obama signed into law the Patient Protection and
Affordable Care Act, which Congress modified pursuant to the Health Care and Education
Reconciliation Act of 2010 (collectively, the “Act”). The Act expands insurance coverage to
more individuals, which could have a negative impact on the pharmaceutical industry. Among
the aspects of the Act that may have an adverse impact on the Fund are (i) mandatory annual
fees on pharmaceutical manufacturers, (ii) discounts of 50% on brand name prescription drugs
for certain Medicare Part D beneficiaries (i.e., those who are required to pay 100% of their
60 CONTROL NUMBER 257 - CONFIDENTIAL
HOUSE_OVERSIGHT_024071
Extracted Information
Dates
Document Details
| Filename | HOUSE_OVERSIGHT_024071.jpg |
| File Size | 0.0 KB |
| OCR Confidence | 85.0% |
| Has Readable Text | Yes |
| Text Length | 3,842 characters |
| Indexed | 2026-02-04T16:53:02.088126 |