Two salbutamol brands to remain funded – Pharmac

Media release

Two salbutamol brands to remain funded – Pharmac

People will continue to have a choice of funded brands for salbutamol asthma inhalers, Government drug-funding agency PHARMAC announced today.

Medical Director Dr Peter Moodie says PHARMAC has decided to subsidise both Salamol and Ventolin at the same level of $4 per inhaler for the next two years.

PHARMAC had earlier said it would review the decision to implement sole supply of salbutamol inhalers from 1 July 2005.

However, PHARMAC remains committed to obtaining the best price for off-patent medicines, he says.

The decision to continue funding both inhalers is in response to concerns expressed by patients and would give people with asthma more time to consider the choices available.

“A number of people raised issues with PHARMAC and Medsafe about Salamol, so we moved to address those concerns,” Dr Moodie says.

“Salamol was found to be safe and effective by Medsafe in its original registration evaluation. We have asked Medsafe to retest the inhalers and this work is on-going. We will await Medsafe’s report which will be released by them, Dr Moodie says.

Salamol has been funded in New Zealand since January 2005, and has sales of about 600,000 inhalers per month in the UK.

Salbutamol is the most commonly-used asthma reliever inhaler used in New Zealand, with over half a million prescriptions written every year. PHARMAC also subsidises an alternative to salbutamol such as terbutaline sulphate (Bricanyl).

ENDS

Q: Why has PHARMAC decided to maintain two brands?

A: A number of complaints were received from patients about Salamol brand of salbutamol inhalers. PHARMAC has asked for testing to determine whether any of the complaints raise safety issues. Some of the comments indicate that patients are not comfortable with the change from an inhaler they have used for many years. Having two funded brands available will give people a choice of two products that are safe and effective.

Q: Is Salamol a safe product?

A: Salamol has been registered by Medsafe, the NZ Government drug safety agency, as being as safe and effective as other salbutamol inhalers. Salamol is widely used internationally in countries such as the United States, the UK, Ireland (its country of manufacture) Belgium, Germany, and the United Arab Emirates. In the UK Salamol has sales of about 600,000 inhalers per month.

Q: Why is PHARMAC backing away from sole supply?

A: PHARMAC remains committed to using the annual tender for the purchasing of off-patent medicines in the long term. This decision is in response to issues that have been raised by patients about the Salamol inhalers. Sole supply is an effective way of maintaining access to medicines and achieving a good price.

Q: What has the testing shown?

A: We are currently awaiting final advice from Medsafe on the outcome of testing of Salamol inhalers. Once the testing is complete Medsafe will be in a position to release the results.

Q: Will there be a cost to patients?

A: People who use Salamol will notice no difference in the cost they pay at the pharmacy. Salamol will be fully subsidised with people paying only the co-payment. People choosing to use Ventolin may have to pay a small manufacturer’s surcharge of about $3.50 per inhaler in addition to their patient co-payment.

Q: How will this decision benefit patients?

A: People will have a choice of funded salbutamol inhalers. Both these products have been assessed as being as safe and effective as each other. While some people have commented that they prefer to remain on Ventolin, other patients have commented that they prefer to use the new inhaler.

Q: What issues were raised about Salamol?

A: Comments included the taste and alcohol content, and that some inhalers became clogged. PHARMAC asked for testing to be carried out to determine whether any of these concerns raised safety issues. We are currently awaiting final advice from Medsafe on the results of testing.

Salamol contains a small amount of alcohol that is used to keep the active ingredient (salbutamol) in suspension. This may contribute to the difference in taste that some people have commented on. A number of medicinal products contain alcohol, including cough mixtures, liquid paracetamol for children. The amount of alcohol in Salamol is very small and insufficient to have any effect on people.

It’s notable that Salamol is approved for use in a number of predominantly Muslim countries, including the United Arab Emirates and Kazakhstan.

Air Flow Products, the supplier of Salamol, recommends cleaning inhalers regularly to prevent blockages.

Q: What other products are subsidised to relieve asthma symptoms?

A: Salbutamol is the most commonly used inhaler for the relief of asthma symptoms. Terbutaline (Bricanyl) is another fully funded option for patients to use.

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