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Insurance Coverage For Orphan Drugs ? True or Not?

Orphan drug is defined as a pharmaceutical agent that has been developed specifically to treat rare medical conditions among which are highly chronic and life-threatening diseases.

How can health insurers justify spending hundreds and thousands of dollars per patient per year on what we so call orphan drugs when the money spent for such can provide benefits for a greater number of patients if spread out among others? Such spending decisions reflect on the people’s “rule of rescue” which is defined as the value that our society places on saving lives in immediate danger at any expense.

Upon the implementation of the Orphan Drug Act of 1983, the number of orphan drugs has dramatically increased. Also, in response to patient advocacy and public pressure, it has provided an incentive for orphan drug development in the United States.

Experts regarding the matter proposed an ethical framework to help insurers justify the money they spend on these orphan drugs based on a critical analysis of arguments embedded in the rule of rescue.

The first argument, according to the experts, is that people have a greater impulse to help patients when they are seen as individuals rather than as anonymous members of groups. Appeals to identifiability can be very unethical. According to them, this gives an unfair advantage to patients whose conditions produces visible signs of illness.

The second argument is that people should always prioritize saving people whose lives are endangered. Experts conclude that this argument cannot always justify coverage for orphan drugs and that people should consider the outcomes first. They suggest that those orphan drugs or therapies that restore or maintain capacities central to functioning in society should be covered and those that do not achieve these health outcomes should not be covered.

The third argument concerns opportunity costs. Advocates of orphan drugs have presumed that opportunity costs of expensive orphan drugs are low due to a small number of people using them represents a small overall expense to an insurer. However, the experts no longer believe this statement and say that it is already inaccurate as more orphan drugs enter the research pipeline. They said that opportunity costs should be explicitly and transparently be included in any coverage decision.

The experts stated that future medical cares will continue to grow in number together with its corresponding costs which offer benefit only to small populations. They also stated that this framework will help in decision making practices about coverage for orphan drugs.

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