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