Welcome to the Week in Review.
1. Urgent Need for Drug Negotiations
- A recent report from The Commonwealth Fund underscores the issue at the heart of our work at Patients For Affordable Drugs: Americans are paying 3 to 8 times more for brand-name prescription medications than residents of comparable countries. For instance, diabetes treatment, Novolog Flexpen, is “$19.86 per unit after rebates, which is more than 3 times higher than Switzerland’s second-highest list price of $5.36”. This stark contrast, revealed in an analysis of the 10 drugs selected for negotiation under the Inflation Reduction Act, emphasizes, once again, the pressing need for effective drug price negotiations to lower costs for patients. We know drugs don’t work if people can’t afford them. The new drug prices coming out of Medicare drug price negotiations, anticipated to be disclosed by September, carry substantial implications for healthcare costs among the millions of people on Medicare. Meanwhile, as Medicare prepares to continue negotiations in 2024, nine pharmaceutical companies are actively pursuing legal challenges to block the process and keep prices high. Oral arguments in the AstraZeneca case in Delaware will be heard on January 31st. (Commonwealth Fund, AJMC, Bloomberg, STAT, Georgetown University)
2. New Bipartisan Legislation Targets Patent Thickets
- Drug companies secure as many patents as possible to artificially prolong monopoly periods and deter competitors. These “patent thickets” can prevent competition for years, keeping prices high and drugs out of reach for patients. On January 11th, Senators Braun, Klobuchar, and Welch introduced bipartisan legislation in the Senate aimed at addressing patent thickets, a move that would limit pharmaceutical companies asserting just one patent per thicket in litigation. Patients For Affordable Drugs joins Protect Our Care to endorse this crucial legislation, recognizing it as a significant complement to other bipartisan bills, such as Cornyn-Blumenthal, currently advancing through the Senate. The endorsement underscores our commitment to ensuring that patents are wielded to encourage innovation rather than prolong unjustified monopolies and safeguard quality patents that improve existing drugs, benefiting patients, while lowering the litigation barrier for generics and biosimilars to enter the market. (i-MAK, S.3583, S.150)
3. Debunking Pharma’s Claims
- Amidst discussions at the J.P. Morgan Healthcare Conference, pharmaceutical stakeholders advocated for a 13-year grace period for small-molecule drugs (which currently have 9 years) before they are eligible for price negotiations, which would equalize the periods for small-molecule drugs and biologics, which currently have 13. However, if pharma wants incentives for all drugs to be equal, Congress should put them both at no more than nine years of exemption from negotiation, which is the current exclusivity period for small-molecule drugs. David Mitchell, P4AD founder and a cancer patient, challenged the pharmaceutical industry’s claims in an op-ed for STAT last year. Mitchell debunked the notion that the Inflation Reduction Act disadvantages small-molecule drugs, emphasizing that many drug companies continue to invest in small-molecule drugs due to their value. Biologics were given additional years of market and data exclusivity compared to small-molecule medicines because the pharmaceutical industry insisted on receiving seven years more market exclusivity for biologics than for small-molecule drugs when the Biologics Price Competition and Innovation Act (which was included in the Affordable Care Act) was being structured. The Inflation Reduction Act achieves a fair solution for the benefit of patients with a balanced approach in incentives since both small-molecule and biologic drugs are crucial for the benefit of patients. (Biospace, STAT News, STAT News, FDA)
BONUS: Senate Democrats, led by Sen. Bernie Sanders, are investigating soaring asthma inhaler costs. The probe addresses the stark U.S. price disparities, emphasizing concerns for patients who often face high costs and rationing. The inhalers sell for hundreds of dollars in the U.S. but much less abroad. (The Hill)