Expensive Cancer Drugs – is there a change ahead?

Posted in: Blog | February 2, 2015

Will a recent decision by the US Food and Drug Administration lead to better availability of previously prohibitory expensive cancer therapies?

We frequently see stories about how the newest cancer treatments are judged to be too expensive for use by the NHS. There are many reasons for the huge price tags placed on these potentially life saving or life extending drugs. However, the single most important reason for the high cost of these treatments is that initially the rights to produce and sell a new therapeutic drug lie solely with the inventing pharmaceutical company. Giving them a monopoly on making money with the new drug. At least for the duration of the patent document that protects it.

 

Patents are legal documents the give the inventing company sole rights to sell the drug for the lifespan of the patent. The typical lifespan of a patent is 20 years although this can be extended for a further 5 years in some instances. This may seem like a long time for the company to make money, however the clock usually starts ticking down before the expensive process of clinical trials begin. These trials can take many years to pass sometimes leaving the inventing company with as little as 5-7 years to make money on the drug before the patent protection expires. It is the need to recover many years of development costs and to produce profits for the company’s share holders that drives up the sometimes eye watering cost of treating even a single patient with a new therapeutic drug.  

 

Usually other manufacturing companies are waiting in the wings for the drugs patent to expire so they can sell their own copy of the drug. The approval and availability of copies of patent expired drugs, so called “generic drugs”, breaks the inventing company’s monopoly and this market competition usually coincides with a huge drop in the price, which typically results in the drugs wider availability to cancer patients.

 

Avastin

 

The image shows the biologic drug Avastin an approved treatment for several types of adult cancer that is currently in clinical trials for the treatment of neuroblastoma in children. Avastin is one of 16 life-extending drugs recently made unavailable for use in treating certain cancers through the government’s flagship Cancer Drugs Fund (January 2015).

 

In the past the approval of generics copies was relatively straightforward as typical drugs are usually small molecules that can be copied exactly by chemists within other pharmaceutical companies. Unfortunately the face of drug discovery has changed dramatically in recent years, with an ever-increasing number of new drugs being based on large complex proteins produced by living cells.  This new generation of biopharmaceutical drugs are collectively known as “biologics” and they are proving to be powerful weapons in the fight against cancer in children and adults.

 

 

The problem with biologics is that unlike small molecule drugs it is almost impossible to make an exact copy, as the final drug produced by the cells is sensitive to differences in the manufacturing process.  Drug companies face many challenges when copying patent expired biologic drugs as they have little or no knowledge of how the drug was manufactured. This also causes problems for the drug regulators since different manufacturing processes can lead to impurities and breakdown products, which may have serious health implications.  European drug regulating bodies have been quick to adapt their approval processes for new versions of patent expired biologics and have already approved many biologic drug copies over the last decade. It has taken some time for the US regulatory bodies to catch up and play their part in bringing down the price of biologics drugs. However, the move by an advisory panel of the US Food and Drugs Administration on the 7th of January 2015 to approve its first biologic drug copy should be seen as another major step forward in driving down the price of these powerful new treatments.

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