Patent Expiries

In 2012, a variety of new generic brands and companies will be on the market in Australia as many important medicines will have their patent expire.  The patents on Lipitor, Zyprexa, Femara, Seroquel and Arimidex expired in April this year, and Xalatan, Pariet and Cymbalta are due for their patent to expire this year also (7).  This means that generic brands for theses medicines will be available to the public, and the price of some of these may be reduced as the generic brands tend to be much cheaper.  The expiry of these patents means it will save millions of dollars being lost to the brand name companies.  For example, hundreds of millions of dollars have been estimated to be lost to Pfizer which produces Lipitor which has a PBS dispense value of $760 million, and the amount of money lost to this company will begin to decrease once the patent expires (7).

However, the patent expiry may be delayed due to issues such as ever-greening.  The process of delaying the patent expiry is costing us, the taxpayers.  Innovator brands are profiting from the Government’s tax dollars as the Government has to pay for the brands (7).  If generic medicines were available on the market quicker and consumers were purchasing these, the cost to the government would be decreased.  If patients purchase generic medicines over the brand name medicines it costs less to the government, which means the government can pay more money back to the pharmacies.  The use and market of generic medicines enables consumers, the Government and our community pharmacies to gain important savings and reduce their cost of medicines (3). 

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Australia vs. America

The use of generic medicines in Australia differs immensely from that in America.  Kate Lynch, CEO of GMiA, says that in Australia generic medicines are not dispensed as often as they could be which means the Government is missing out on making substantial savings.  The rate of generic substitution in the United States of America is much higher than that in Australia, with 78% of dispensed medicines in the US being generics compared to 38% in Australia (7).   

Alphapharm’s Dr Martin Cross says that in America, the Food and Drug Administration (FDA) supports generic medicines and are willing to put their name to the quality of generics.  In Australia, the Therapeutic Goods Administration (TGA) does not do that, however, the taxpayer is saving money each time a generic medication is dispensed (7).

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Healthcare Expenditure

Healthcare expenditure has the opportunity for significant savings through the use of generic drugs as they may be considerably lower in price than the brand name version.  The Generic Medicines Industry Association (GMiA) claims that from 1995 until present, well over $3 billion have been saved by the PBS as a result of generic medicines, and that this figure will continue to increase as many patents expire on brand name drugs (18).  Hence, generic substitution in prescribing and dispensing generic drugs is often a way of reducing the costs of health care in Australia (19).

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Pharmaceutical Benefits Scheme

The Pharmaceutical Benefits Scheme (PBS) is an initiative which is administered by Medicare Australia, and allows any Australian residents and also eligible visitors to access affordable and reliable prescription medications (15). The cost of prescription medications is subsidised by the Australian Government through the PBS.  However, the government will only offer a subsidy to the cheapest brand of drug in any therapeutic group (4). The cheapest brand of drug will always be a generic, although companies can set the price of brand name drugs at the same price as the cheapest brand (16).

Generic medicines which fall into the same therapeutic group as other brand name drugs must have the same function as the brand name drug (17).  As the brand name drugs are often more expensive, people are costing themselves as they unnecessarily paying more for the brand name drug which performs equivalently.

Policies have been introduced by the Australian Government as a result of the rising cost of the PBS, which support the use of generic drugs.  A price difference between generics and brand name drugs will often arise due to the government paying the same amount for all drugs in the one therapeutic group.  This price difference is known as the Brand Premium Policy (17), which is a cost added onto the price of the drug by the company producing it.  The extra amount does not count towards their PBS safety net threshold (17), so is coming directly out of the patient’s pocket.

A Brand Premium can only be enforced by a company when there is at least one ‘generic’ drug on the market that is equivalent and does not have a premium (3).

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Phamacist’s role in patient views of medication brands

Pharmacists will often try and convert patients to using generic medicines even if they have been using brand name medications for a long period of time. This can often prove very challenging, as patients can be very resistant to change. Patients are often elderly and are very hesitant to accept changes in their medication as they may have been familiar with what they’re taking for a very long time. Their eyesight may not be as good as it used to so they might only be able to recognize the colour and shape of the tablet rather than the packaging. The pharmacist can take steps to prevent this confusion by converting to a brand that has very similar tablets. Patients also can be very wary of their medication, as it may be a particular medication that is vital to their wellbeing and staying alive. Patients sometimes believe their brand of medication will be more effective than generics. This leads the pharmacist to explaining about bioavailability- see chemistry tab. A huge concern for patients is getting confused when changing medication that they may double up or forget to take the medication. The pharmacist can take many steps to approach this situation. When dispensing the medication, key words can be written in bold to make it clear and highlight instructions such as SAME AS LIPITOR can reduce confusion considerably for the patient so they become much more comfortable in taking a different brand. Having patients willing to change brands is all about making them feel comfortable and confident about the change. It is the responsibility of the pharmacist to make sure the patient can feel this way about the medication they are given. (14)

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How do doctors decide?

When doctors prescribe medication, they can chose whether the patient is able to have the generic medication or not by ticking the no generic substitution box on prescriptions. They can do this even without consulting the patient on which they would prefer. It is for this reason that some patients are ineligible to have the generic brand of the medication, even if they wish to. However, if that box is not ticked on the prescription then the patient is free to choose whichever brand they wish.  It is a common belief by patients that the brand the doctor prescribes is the best brand for the patient, however, some doctors prescribe by drug name and others by originator brand name with no preference as to what brand the patients actually gets dispensed in the pharmacy. There are many contributing factors to which brand a doctor prescribes. There are thousands of different manufacturing companies in the world whom all bring out their own generic brands which leads to a lot of confusion between doctors, pharmacists and patients. This creates a nightmare for the healthcare system as there are many opportunities for confusion and mistakes to occur as there are many which look and sound similar. This leads to the way doctors like to prescribe. Doctors can prescribe generic medication as they may be more familiar with the active ingredient to treat the patient, however they may be more familiar with a particular brand, generally the originator brand as this is the most well known so the doctor may favour it for prescribing. Therefore the view from a doctor’s perspective in which brand to go for is often influenced by the safest way to minimize error. (13)

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What do you think? Share your answer with us :))

Posted by HMA 😉

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WITH EXAMPLES IT MAKES MORE SENSE!!

Branded and generics medicines examples,

Lipitor® (Branded)/atrovastatin (generics)

They are both used for prevention of heart attack and treatment of high cholesterol

They both have the same active ingredient: Atrovastatin whose structure shown on the right,

Nurofen® (Branded) / Ibuprofen (generic)

They both are anti-inflammatory and used for pain relief.

They give the same response in the body having the same active ingriedent “Ibuprofen”, shown on the right, 

Diovan® (Branded)/ Valsartan (generic)

They both for hypertension- high blood pressure treatment.

They have the same active ingredient which gives us the same response, shown on the right,

Posted by HMA  🙂

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Patient’s view about generics ;)

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Branded or generic

Posed by HMA 😉

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