The United Kingdom’s Medicines and Healthcare products Regulatory Agency recently approved anastrozole as a treatment for preventing breast cancer in postmenopausal women at medium or high risk of being diagnosed with the disease. Now doctors in the UK can offer this effective preventive option to thousands of women. But as STAT reported, here in the United States, few women may be aware of its availability, much less that it’s a cheap generic drug already FDA approved and in use for treating breast cancer.
This begs the question: Why might women in the United States be unaware of anastrozole as a preventative treatment? It may come down to the lack of marketing for generic drugs. In the United States, doctors and patients are often educated and influenced about new drugs by the pharmaceutical companies that manufacture and sell them. Certainly, the results of clinical trials that are published in medical journals and presented at industry conferences help alert doctors of ongoing research and new drug developments. In addition, pharmaceutical companies invest billions of dollars to market their latest discoveries and influence prescribing. They do this according to strict calculations on projected return on investment and opportunity cost.
Once a drug becomes generic — which means the patents and marketing exclusivities have expired — the drug can be manufactured and sold by any company. The price drops significantly because the supply is larger, and drug companies no longer want to invest the money to market them. Anastrozole was initially FDA approved in 1995 for treating breast cancer. When the patent and marketing exclusivity expired in 2010, other companies started selling generic versions. This competition in the marketplace drove down the cost; anastrozole can now be purchased for as little as $100 for a one-year supply without insurance. It is not financially lucrative for pharmaceutical companies to repurpose generic drugs like anastrozole, expanding their uses for other indications or patient populations, because there might be only a small profit to be made.
As a single-payer health care system, the UK is motivated to decrease health care costs. It is way ahead of the United States in appreciating the opportunity to quickly develop low-cost treatments for life-threatening diseases through generic drug repurposing. Academic researchers at Queen Mary University of London sponsored the definitive clinical trial for anastrozole as a preventative therapy for breast cancer, which was published in 2014 in The Lancet.
However, even after the results were made available 10 years ago, pharmaceutical companies did nothing to promote the drug for regulatory approval and patient use. That’s why the new Medicines Repurposing programme led by the UK National Health Service stepped in and commissioned an anastrozole manufacturer to submit regulatory paperwork to the MHRA for approval. Now that it’s approved for prevention, the NHS will alert prescribers of its value.
The US government should fund the necessary research for generic drugs that show promise in treating diseases other than those for which they were originally developed. It should also ensure that there is awareness of the repurposed treatments that are proven to be safe and effective. In the United States, though anastrozole is FDA approved for treating breast cancer, it does not have approval as a treatment to prevent breast cancer. It could still be widely prescribed by doctors off-label for prevention. Yet due to the fragmented US health care system and lack of a streamlined process for changing the standard of care without a pharmaceutical driver, Americans aren’t able to realize the full potential of repurposed generic drugs like anastrozole.
I started the Boston-based nonprofit Reboot Rx to fix this market failure for generic drug repurposing after I lost my mom to cancer. Around 40 percent of cancer patients in the United States exhaust their life savings within two years of diagnosis. Patients urgently need more effective and affordable treatment options, and thankfully a solution already exists in the form of repurposed generic drugs.
Scientific evidence shows that hundreds of existing and cheap generic drugs could be used for additional indications to help patients live longer and better lives. Generic drugs hold so much untapped potential to be repurposed for cancer and other diseases, yet this is not being realized because of the lack of market incentives and funding. Government and philanthropic support are needed to advance these innovative uses. Americans deserve to know about all effective medical options — especially low-cost and widely available generic drugs that could help mitigate the financial toxicity and health inequities that many patients face — so they can make informed decisions about their care.
Laura Kleiman is founder and CEO of Reboot Rx.