Experts Lounge
Colchicine
The use of colchicine in the treatment of gout predates ancient times with estimates of over 1,500 years.
Doctors have prescribed the compound for centuries. For a long time, colchicine cost $ 10 Cents per tablet until 2010 when the price suddenly jumped by 2,000 per cent to sell at Sh500($ 5) per tablet.
This happened after URL Pharma made a decision to carry out safety and efficacy tests on colchicine under the 2006 compliance program.
As in the case of Daraprim, the company was granted exclusivity to marketing rights. The US Food and Drug Administration( FDA), says there are over 1,000 unapproved drugs in the US market; sadly, some of these products maybe potential for abnormal price hikes in the coming days.
EpiPen
EpiPen is an injection containing epinephrine which is marketed in the US for treatment of severe allergic reactions to insect stings or bites, foods, drugs, and other allergens. The allergic condition is called anaphylaxis.
EpiPen invented in the 1970s, is a pen-like device that delivers a premeasured dose of the hormone epinephrine in emergency situations. In the US, such epinephrine auto-injectors, though obtainable only by prescription, may be stocked at home or school for self-injection by a person with a history of severe allergic reaction.
The case of EpiPen is as intriguing as the others, if not more. The price for a two-pack of EpiPens is Sh60,900($ 609), up by 400 per cent from Sh12,400($ 124) seven years ago.
At close analysis, it’ s not the drug being delivered that is costly— epinephrine is a cheap generic, going for as low as Sh20 per ampoule in Kenya. Why this big price difference? The cost trickery is in the delivery system which is designed, developed and manufactured by Mylan, the“ EpiPen”.
Mylan acquired the auto-injector— EpiPen, in 2007 from Merck Group at the time of the acquisition, the cost was Sh5,700($ 57). At Sh60,900($ 609), many cannot afford EpiPen, yet it’ s an essential drug. As a result, many have resorted to desperate measures.
It is reported that even though an EpiPen could save a patient’ s life, some allergy sufferers are forgoing them because they are too expensive. Others are keeping expired EpiPens hoping that they work in the event of an emergency. From 2009, Mylan has increased the price of EpiPen 15 times as shown in the graph below.
What underlies the price increases?
In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled“ Marketed Unapproved Drugs— Compliance Policy Guide”.
This outlines its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. Unapproved drugs are those that came into market before the current testing regime at FDA. In the case of colchicine, the drug was in the market earlier than the enforcement of this policy meaning that FDA had not approved its use.
For such medicines, FDA has been encouraging companies to comply with this policy. This ongoing initiative is designed to bring all unapproved medications to modern-day safety, efficacy, labeling, and quality standards. If the products are compliant and approval is granted, the owners are rewarded with licenses that can temporarily give them monopoly pricing power as most rivals are kicked out of the market. This program got underway in 2006 and is the only one among several reasons why prices of old generic drugs have been rising in the US.
Attention to pharmaceutical prices has been on new drugs for treatment of cancer, hepatitis C, high cholesterol and such other diseases, but there is a growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment.
It appears that some of the price increases are motivated by a new business strategy of buying old neglected drugs and turning them into high-priced‘ specialty’ drugs.
In this way, some pharmaceutical manufacturers have acquired niche medicines and shortly after raised prices even without any rebranding.
Other explanations for price increases include mergers and acquisitions among competing companies as well as price increment as a means to drive revenue growth. Mergers and acquisitions stifle competition and result in monopoly, occasioning price increments.
10 November-December 2016