Immunotherapies offer incredible promise as anti-oncological agents. However, their incredibly high costs, which can be anywhere from thousands to millions of dollars, could prevent patients from obtaining the necessary care. Reforming dysfunctional laws and bureaucracy might help to alleviate some of the issues.
A new tool has emerged in the battle against cancer. The latest addition to the old paradigm of surgery, chemotherapy and radiation is immunotherapy. Immunotherapy has achieved extremely successful results, curing traditional terminal illnesses like metastatic melanoma and offering great promise for treating other cancers. Checkpoint inhibitors like Nivolumab and Pembrolizumab were the first immunotherapies to complete clinical trials and be introduced into mainstream practice, generating excellent results and improving the effects of other traditional therapies. The burgeoning diversity of this field only seems to increase with every development, producing such modalities as CAR-T cells and potentially even cancer vaccines that have shown incredible promise. Despite the clinical success of immunotherapies, a crucial factor is limiting the enthusiasm by which our health-care system and others adopt these treatments; the prohibitively high costs.
Debate began with the advent of the checkpoint inhibitors, which block the inhibitory effects of cancer cells on the immune system. Although immunotherapies (IO) of this variety tend to cost more then chemotherapies for the same disease, studies demonstrate that IO produces benefits worth the cost. CAR-T cells represent even greater potential benefits that could offer entirely new methods for cancer treatment at similar cost.
Using the word drug to describe CAR-T cells could be seen as a misnomer. CAR-T therapy actually involves the acquisition and engineering of the patient’s own cells and their administration to deliver enhanced immune cells back into the patient. This intensive and individualized process requires specialised facilities which explains the high costs. Earlier this month and with approval from Health Canada, Novartis gave the green light to several facilities in Quebec to begin generation of these therapies for eligible patients. This development came only after two caveats were successfully implemented: that the drug be made available interprovincially via a standardized system, and that the manufacturer drop the price by half.
This surfaces several (and perhaps age old) conundrums. Should the government continue to compel pharmaceutical companies to drop the prices of these therapies to cure these devastating diseases? How would this affect the incentive for future drug research and development? From where are the costs being transferred in our health-care budget to pay for these therapies? If patients are forced to pay for these therapies, how could they possibly afford to do so? Although this is only an example of one therapy in one part of a single province, the rapid rate of development of CAR-T cells and the great promise they hold will only ensure that they become more of a main stay of oncological treatment. Still, cancer drugs have increased from an average cost of $10,000 in 2000 to $120,000 in 2015. Although not as excessive as our American counterparts, Canadians must learn to confront this issue of treatment cost in a practical and sustainable fashion.
A classic explanation of these high prices is that pharma companies must recoup the costs of research and development on an ongoing basis. It cannot be denied there is tremendous risk in the drug development process in which one out of every several thousand compounds tested finds clinical success. This, in conjunction with stringent (but necessary) regulation by Health Canada serves to exacerbate the costs. Yet this does not exactly hold up to rigorous statistical analysis, at least not in this form. Costs tend to run into the hundreds of millions or low billions, compared to a return on capital in the tens of billions, much greater than technological companies which also spend similarly on research and development.
Instead, what truly elevates the prices of pharmaceuticals is the monopoly system imposed by the regulation surrounding patents. To be fair, the patent system is essential for encouraging investment, such that an innovator may rest assured that cheap knock offs do not flood the market and deprive them of their hard work. However, this is ultimately a gradient and artificial form of external intervention into the market that can be rectified and addressed to promote more effective competition. The fact that the return on capital is far greater than that spent of research and development alone is proof that pharma has benefited from monopolizing to a much greater degree then might be considered appropriate.
Furthermore, the fact that therapies such as CAR-T cells are more costly compared to definitive drug molecules should also be considered in the process since much of the excess costs arise during the production process. Unlike with medications which have fixed production costs, more competition could serve to drive down costs in the varying development process of immunotherapies. Regardless, these exorbitantly high costs cannot be sustained if they become the norm for oncological treatment. More attention must be directed towards reforming the current patent system so that patients can receive the life-saving treatment they so desperately need.