Immuno-oncology holds great promise for the future of oncological care, especially in terms of treating and curing those types of cancer that have traditionally had the worst prognoses. However, many physicians and other experts worry that the costs involved with these treatments will prove prohibitive. Therapies developed by the field of immuno-oncology bolster the body’s natural immune defense and help bodily processes to target cancerous cells. However, these treatments are largely personalized according to body chemistry and the needs of each patient, which involves price tags in the six figures. Many drug development firms are pursuing immuno-oncology therapy development precisely to obtain market share in the field, which is projected to be worth up to $35 billion.
At many biotech firms across the world, immuno-oncology has become the central focus of research and development efforts. The push is especially true in the United States, where Dr. Richard Pazdur of the Office of Oncology and Hematology Products at the Food and Drug Administration offered to cut the traditional regulatory pathway short through a new process for “breakthrough” treatments. This new pathway has allowed companies to compress their clinical trials for new drugs in almost unprecedented ways. With effective new treatments for melanoma through immuno-oncology, such as nivolumab from Bristol-Myers Squibb and Keytruda from Merck, the most recent push is to create similar drugs for other types of cancer.
The Rising Outrage About Pharmaceutical Prices
The vast majority of immuno-oncology therapies that have come to the market have cost upwards of $100,000, which could make the treatments inaccessible to the people who need them most. Of course, cancer treatments in general are very expensive. Many treatments cost an exorbitant amount of money. In the last decade, the average monthly costs for oncological care have more than doubled. Some drugs have increased even more than that. For example, when Imatinib (Gleevec) hit the market in 2001, it cost $30,000 annually, but the price tag rose to $92,000 in 2012.
Some physicians, worried about the fate of their patients at a time when medical insurance is undergoing rapid changes, have stood up to the biopharmaceutical companies. One of the most outspoken voices is Dr. Hagop Kantarjian of the University of Texas M.D. Anderson Cancer Center. He wrote a piece for the medical journal Blood outlining the shocking number of patients who chose to forego treatment after learning of the price or stopping treatment because out-of-pocket expenses became too high. In short, high prices are actually reducing the survival rate of patients with cancer in this country. Other oncologists have joined Dr. Knatarjian and have expressed outrage at the astronomical prices.
Some of the newest and most promising drugs are simply unavailable to people who cannot afford to buy them out of pocket. For example, some of the best drugs for patients with chronic myeloid leukemia are very expensive. Ponatinib costs $138,000 each year, and bosutinib is $118,000. Another promising drug, omacetaxine, starts at $28,000 per treatment, with maintenance rounds costing $14,000.
Doctors have achieved some victories with their protests. A few years ago, Memorial-Sloan Kettering Cancer Center doctors refused to use ziv-aflibercept with their patients due to the price. These doctors published an opinion piece in the New York Times about the cheaper therapies that served as substitutes. As a result, the drug’s manufacturer reduced the price by 50 percent.
The Challenges of Pricing Immuno-Oncology Therapies
For those drugs that are saving lies and addressing relatively rare diseases, a six-figure price tag is not uncommon, which may be rationalized by considering the limited number of people who will need the therapy. With many of the new immuno-oncology drugs entering the market, however, the benefit is only marginal, meaning that people pay more than $100,000 for maybe another couple months of life. Of course, this debate raises an important ethical question that many people in the industry do not want to address, which is how to place value on life. Unfortunately, this question has largely gone unaddressed, and most drugs get approved with a free-market attitude where pricing depends not on medical value, but on what patients will actually pay.
Immuno-oncology therapies are game changers for many patients, but the frontline drugs like Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo both have a six-figure price tag. However, not all companies look at drug development with a free-market mentality. Curis, a biotech company based in Massachusetts, has begun developing immuno-oncology drugs with the explicit goal of making the therapies affordable to the people who need them most. Curis has partnered with Indian firm Aurigene to create several new drugs with mechanisms similar to those of Keytruda and Opdivo, both of which work by inhibiting a specific immune “checkpoint.” The two companies are working to create a small-molecule drug that can be administered in pill form. The current therapies are injected or infused adding to the cost of treatment and negatively impacting patient compliance.