- Of 91 new therapies approved for solid tumours between 2002 and 2016, the median overall survival benefit was little more than two months.
- Yet the annual price tag per patient now regularly exceeds $100,000.
Paul Workman, Giulio Draetta, Jan Scellens and Rene Bernards wrote an article, How Much Longer Will We Put Up With $100,000 Cancer Drugs? DOI: http://dx.doi.org/10.1016/j.cell.2017.01.034
- The spiraling cost of new drugs mandates a fundamentally different approach to keep lifesaving therapies affordable for cancer patients.
- As early as 2012, 12 of the 13 newly-approved cancer drugs were priced above $100,000 annually, and the situation has only gotten worse since (Light and Kantarjian, 2013, Mailankody and Prasad, 2015). For instance, the cost of the combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA4) is priced around $252,000, exceeding the median cost of a US home ($240,000 in 2016).
- With a lifetime risk of developing cancer of close to 40%, the problem is clear.
- The pharmaceutical industry has traditionally defended these high prices by pointing at the high attrition rate during clinical drug development and the cost of large registration studies.
- If development cost would be a major factor in the pricing structure, a simple law of economics would have mandated a considerable reduction in price when the eligible patient population increases, but that has hardly happened.
- This is a recurring theme in pharma. For instance, trastuzumab was first approved for advanced breast cancer and later also for early disease (adjuvant) without a reduction in price. Healthcare payers should not accept this lack of price-volume relationship.
- Moreover, there is very little relationship between drug price and clinical benefit (Mailankody and Prasad, 2015). This has sparked widespread criticism, alleging that cancer drug pricing is primarily based on “what the market will bear.”
- There is a clear and urgent necessity to lower cancer drug prices to keep lifesaving drugs available and affordable for patients. As one patient advocate recently put it: “Innovation is meaningless if nobody can afford it.”
- Much has been written about the reasons behind the exorbitant drug prices and what to do about it. One recurring theme is the notion that the US federal government is prohibited by law from negotiating drug prices as a result of the 2003 Medicare Prescription Drug, Improvement and Modernization Act.
- Considering that Medicare and Medicaid spend $ 140 billion on medicines annually, this represents a serious impediment in driving down drug prices. Lack of competition and a general absence of a connection between drug price, sales volume, and clinical performance are other arguments in the drug pricing discussion (Jaffe, 2015).
- Indeed, lack of competition and bargaining power made US prices of cancer drugs among the highest in the world, increasing by 10% annually between 1995 and 2013, far above the average inflation rate (Howard et al., 2015).
- While negotiations may bring prices down, a recent cost comparison in EU countries shows that the ability of individual nations to negotiate discounts is limited, most likely due to the modest market sizes of the EU countries (van Harten et al., 2016).
Beware the Medical-Industrial Complex
- “. we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military industrial complex.” Dwight D. Eisenhower, 34th President of the United States (1953-1961). Farewell Address, January 17, 1961.
- If Ike were with us today, he might well expand his views on power and influence to include modern American medicine. The corporatization of health care in the United States has moved rapidly in recent years.
- New developments in cancer treatment include expensive technological “bells and whistles” which physicians must ultimately evaluate objectively, despite lush advertisements from companies with obvious vested interests, and authoritative testimonials from biased investigators who presumably believe in their own work to the point of straining credulity and denying common sense.
- The 3-D image that was created by a computer may look beautiful (and cost accordingly), but it is hard to believe that it can fundamentally change the outcome of patients when it does not add any new data that bear on basic issues.
- Thus, new equipment will be exploiting issues of convenience, efficiency, and increased throughput (translate: economic improvement, not biological superiority).
- We must remember that every new therapy costs money ….
- Improvement in cancer cure rates has been frustratingly slow. We work against a clever, tenacious adversary – both in the clinic and in the corporate board room. It is our responsibility to tout our accomplishments, admit our failures, and provide progressively better basic and clinical research with an eye toward future improvements in outcome. We must not be seen as yet another special interest come to drink at the well of public spending, but as advocates for the public good.
The prince and the pauper. A tale of anticancer targeted agents.
- Cancer rates are set to increase at an alarming rate, from 10 million new cases globally in 2000 to 15 million in 2020.
- Regarding the pharmacological treatment of cancer, we currently are in the interphase of two treatment eras. The so-called pregenomic therapy which names the traditional cancer drugs, mainly cytotoxic drug types, and post-genomic era-type drugs referring to rationally-based designed.
- Although there are successful examples of this newer drug discovery approach, most target-specific agents only provide small gains in symptom control and/or survival, whereas others have consistently failed in the clinical testing.
There is however, a characteristic shared by these agents: their high cost.
Anticancer Drug Development: The Way Forward.
- Cancer chemotherapy celebrated its fiftieth anniversary last year. It was in 1945 that wartime research on the nitrogen mustards, which uncovered their potential use in the treatment of leukaemias and other cancers, was first made public.
- Fifty years later, more than sixty drugs have been registered in the USA for the treatment of cancer, but there are still lessons to be learnt.
- One problem, paradoxically, is that many anticancer agents produce a response in several different classes of the disease. This means that once a new agent has been shown to be effective in one cancer, much effort is devoted to further investigations of the same drug in various combinations for different disorders.
- While this approach has led to advances in the treatment of many childhood cancers and some rare diseases, a plethora of studies on metastatic colon cancer, for example, has yielded little benefit. 5-fluorouracil continues to be used in trials, yet there is no evidence for an increase in survival.
- The lesson to be learnt is that many common cancers are not adequately treated by present-day chemotherapy, and most trials of this sort are a waste of time.
- Significant increases in survival will only occur if the selectivity of present-day anticancer agents can be increased or new classes of more selective agents can be discovered.