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Generic drugs campaign update
Professor John Duncan, former medical director for Epilepsy Society, talks about our successful ‘Count Epilepsy Out’ campaign to exclude anti epileptic drugs (AEDs from the Government’s Pharmaceutical Price Regulation Scheme (2009).
While it is good news that Government proposals to substitute prescribed branded drugs for cheaper generic versions for people with epilepsy have been dropped, there is no room for complacency until anti epileptic drugs (AEDs) are permanently excluded from any future substitution plans.
If the scheme had gone ahead, pharmacists would have been expected to automatically substitute a generic version of a prescribed drug where a branded drug is named on the prescription. This could have had potentially devastating effects for people living with epilepsy, as well as costing the NHS more.
Every year 30,000 people develop epilepsy. Two thirds will respond to anti-epileptic drugs (AEDs) but the remaining third will continue to have seizures. The annual cost of AEDs to the NHS is £165 million - 0.94% of the total drugs budget.
The case against generic AED medication
But not all AEDs are the same, bioequivalence does not equate to the therapeutic benefit. Switching from one generic to another may result in a 56% change of available AED. Even if bioavailability is the same, confusion and anxiety may occur amongst patients. Epilepsy is different from other conditions. A single seizure has severe consequences. It impacts on the ability to drive, employment, well being and increases the risk of injury, harm and death.
Issues can also occur around the appearance of the drugs and packets, leading to confusion for patients. As epilepsy has a high incidence among people with learning difficulties this can only add to the confusion. The confusion caused by different appearance or packaging may affect adherence with the prescription.
The economic debate
There is no doubt that prescribing generic drugs reduces expenditure on medication. These savings could allow spending on other aspects of epilepsy. However, prescribing generic AEDs could result in hidden costs such as extra clinic appointments and time to explain formulation changes, the cost of infrequent but serious adverse effects and medico-legal issues.
The pricing and availability of generic drugs is also volatile. For some drugs there are only small numbers of licence holders and price competition may not arise. Manufacturers are not obliged to continue producing drugs with a low profit margin. There have been problems with the continuous supply of some generic preparations.
The evidence and the Ontario study
Generic formulations can fail to meet bioequivalence standards. There have been a series of reports of increased seizures associated with generic substitution.
Compulsory generic switching of AEDs was undertaken in Ontario, Canada. AEDs were only prescribed as generics. The study aimed to quantify the switchback rates from generic to branded AEDs, in comparison to other long term drugs and document the potential adverse clinical consequences of generic switching.
The study found that the switchback rate for AEDs was greater than for non AEDs – 21% rather than 2.9%. The Ontario data also suggested poor acceptance of switching AEDs to generic compounds and also indicated increased clinical problems as a result of switching to generic AEDs.
In conclusion
• Switching between formulations introduces risk and undermines the message of consistency
• Data about long term cost and clinical effectiveness of generics use in epilepsy are lacking
• Consequences of transient treatment failure can be devastating
• The financial savings of generic AEDS need to be balanced against the possibility of the consequences of breakthrough seizures, adverse events, unpredictable effects on levels of other AEDs and patient confusion and errors in compliance
There needs to be an evidence based approach with clinically relevant, adequately powered, randomised controlled trials to see if generic prescribing in epilepsy is safe and whether observed risks can be justified by significant and sustained cost savings. It is very unlikely that such a study would be approved by Ethics Committees, or for there to be equipoise between the treatment arms.
Advice to physicians
• Maintain patients on the lowest dose of AED which controls seizures
• Do not switch between brands or non branded generics, stick to the same formulation
• If a switch is made, both patient and prescriber should be made aware
• If breakthrough seizures occur, think to ask about changes in treatment brand
