In recent decades, medical science has madespectacular advances in treating life threatening diseases like cancer. A growingpercentage of new chemotherapy treatments are now in the form of oral drugs, immunotherapy is being used more widely, and gene altering therapiesarebecoming ever more promising. Advances in other fields of medicine are just as spectacular. But, and there always seems to be a but, these new treatments are incredibly expensive and getting more so.
Our ability to increase our knowledge about treating life threatening diseases is outstripping our ability to make their costs reasonable. This dilemma is ethically challenging as well as being a major public policy challenge. Some European countries use a cost-effectiveness standard to approve some very expensive cancer treatments. If a treatment costs hundreds of thousands of dollars but only adds a few months of life expectancy, it may not be approved. As a society, we find this type of rationing abhorrent. At the same time, we have not resolved how best to handle the high price of new life saving drugs which also are regressive and result in involuntary rationing.
Pharmaceutical companies probably come in for more criticism for high drug prices than they deserve. Some price drivers are beyond their control. Developing new drugs is expensive and some research suggests that only 1 in 10 new drugs prove safe and effective. The cost of failures needs to be recovered or a company will go out of business. The cost of drug development for companies that develop multiple cancer drugs can range from $2 to $5 billion per drug.
The largest cost in new drug development comes from regulatory requirements to prove a drug is safe and effective. FDA requires preclinical testing and then three clinical trials before applying for approval. This whole process can take 10 years. After approval, a company has to monitor for side effects and conduct related tests.
Although there are a number of pharmaceutical companies, the only competition is in who can get to the market first with a FDA approved drug. Once a drug is approved and under patent there is a legal monopoly. Price is based on what the market will bear because there is no competition. Manufacturers maintain a monopoly until their patents expire but too often generics are priced close to the patented drug price. Again, no competition because usually only one firm is approved to manufacture the generic.
Manufacturers give steep discounts—30% or more—to private purchasers like Sams, Pharmacy Benefit Managers (PBM) that administer prescription drug programs for employers, insurance companies and Medicare Part D, and hospitals. With a lack of pricing transparency and poor communication, these drug providers can charge above competitive prices. PBM’s for example, receive a share of the discounts they negotiate, so they have an incentive to keep list prices high.
Since the price of these specialty drugs is less in many foreign countries than in the US, it is clear that lower prices can be achieved here.
Since manufacturers are monopolies, they should be regulated as other monopolies are. The utility regulation model might be a useful approach. A body similar to State Corporation Commissions would approve prices charged and the rate of return that recognized risk and the need to recapture R&D expenses. Strong but reasonable returns would provide the incentive for continued investment.
The cost of FDA approval is the major component in drug pricing. But FDA is highly risk adverse. It doesn’t get blamed for the consequences of delays on bringing drugs to market but it does when a drug has unintended consequences. Reducing red tape, streamlining the clinical trial process, modifying agency incentives would reduce approval costs. In approving applications to produce generics, FDA should conduct a form of “dutch auction” where awards go to one or more firms that offer to charge the lowest retail price.
Insurance companies should be required to provide patients with information about the prices that a range of suppliers charge and explain better their formulary tiers and the rationale for drugs included in them. Greater transparency about sources of supply and prices will engender greater competition. The FTC should regularly review the vertical prescription drug structure to identify anti-competitive and anti-trust actions that are taking place. Currently, each component in the supply chain has an incentive to keep prices high and to limit transparency.
Finally, barriers to drug importation should be reduced and Medicare/Medicaid should be allowed to negotiate prices like other sources do.
The insurance and drug lobbies are clear examples of Bootlegger and Baptist actions that result in poorer treatment for life threatening diseases.