The Impact of the American Health Care Act on Rare Disease Patients

The American Health Care Act, the bill intended to replace the Patient Protection and Affordable Care Act (ACA), is swiftly making its way through House Committees. Dubbed both Trumpcare and Ryancare, the draft bill consists of a number of legislative recommendations by the House Energy and Commerce Committee and the House Ways and Means Committee. Despite President Trump’s claims that the process is moving forward positively, the bill faces opposition from doctors, hospitals, and insurers. Additionally, a number of Republican congressional representatives openly oppose the bill and have vowed to vote against it in its current iteration. Although many of the patient protections achieved unde

What Does The Scrutiny on Orphan Drug Pricing Mean For Manufacturers and Consumers?

Ongoing changes in U.S. healthcare reform and the Congressional inquiry into the Orphan Drug Act’s effect on drug pricing have created a number of emerging risks for the biopharma industry, and especially for manufacturers of rare orphan and specialty products. The shift to value-based reimbursement, industry-wide consolidation, and a potential decrease in access to affordable care are among the market dynamics that require clinical stage companies to anticipate and manage commercial risks much earlier in the drug development phase. The National Organization for Rare Diseases (NORD) estimates that nearly 30,000 Americans suffer from 7,000 rare diseases. Rare diseases are legally defined as d

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