IPLEDGE program
Although the goal of the program is to prevent pregnancies of women who take the drug, male patients must also participate in anti-pregnancy restrictions, primarily due to fears that male isotretinoin users might share their prescriptions with females without their physicians' knowledge. There has been no link to birth defects from Accutane associated with males using the drug, though male sexual dysfunction has been suggested by one study. As this has not been conclusively proven, this is not acknowledged as a side effect in the official literature accompanying the medication.
Prescription drug prices in the United States
Prescription drugs known as "specialty" drugs have become integral to the treatment of certain complex diseases including certain cancers and autoimmune diseases. Additionally, some notoriously treatment-resistant infectious diseases such as HIV and Hepatitis C have now become manageable (and the latter curable) using so-called “specialty pharmaceuticals”. “Specialty pharmaceuticals” are generally classified as such by possessing  one or more of the following characteristics: high cost, high complexity, or high touch (ie requiring special monitoring, follow-up, or administration technique or assistance). The number of specialty pharmaceuticals has increased dramatically since 1990 when only ten were available; by 2015, 300 specialty products were available with more than 700 in development (Pew 2016). The high costs of specialty pharmaceuticals, in addition to the generally high costs of prescription drugs in the United States, have generated a great deal of debate. It is becoming increasingly difficult, at both the individual and societal level, to afford to pay for such medications, as the use of specialty pharmaceuticals continues to increase along with their cost, which had, through 2015, risen faster than inflation for many consecutive years (AARP 2015). In 2015, 1-2% of the US population used specialty drugs, but these drugs represented 38% of drug expenditures for that year. A path forward must be found that provides specialty drugs to those who need them in an affordable, sustainable manner. A recent policy change by the Centers for Medicare and Medicaid Services will allow Medicare Advantage Plans to utilize formulary management tools used in commercial plans, such as step therapy requirements, in order to manage drug costs, including specialty pharmaceuticals  Chambers et al may have identified one path to identifying the value of Specialty Pharmaceuticals using cost-effectiveness analysis:“Conducting cost-effectiveness analyses may be desirable to convey the value of a medication relative to a previous standard of care. Even if a new therapy is expensive, its incremental cost-effectiveness may be within a willingness-to-pay threshold, as specialty drugs, though more expensive, often are also associated with the greatest gains in QALYs.”