Fast track to fund other thyroid drug

A publicly-funded alternative levothyroxine drug could be available in New Zealand by late October, Health Minister David Cunliffe said on Thursday.

He welcomed Medsafe's announcement it would fast-track the assessment of any applications it received for alternative levothyroxine drugs.

In recent months, the Ministry of Health's drug regulatory organisation and the drug-funding agency Pharmac have been under pressure to act on an increasing number of adverse side-effect reports from the only publicly funded levothyroxine drug available, Eltroxin.

The reports followed a change in the formulation of the drug last year (although the active ingredient did not change).

It is used by an estimated 70,000 people throughout the country to treat an under-active thyroid gland (hypothyroidism), mostly without incident, but more than 830 people have reported adverse reactions.

In a statement on Thursday, Medsafe group manager Dr Stewart Jessamine said Medsafe received its first application on September 3 to seek approval for another brand of levothyroxine.

He had been assured an application for a second alternative was due to be submitted in the next week.

This application is believed to be from Abbott Australasia, which has brought in a shipment of a Canadian alternative, Synthroid.

This is now available throughout the country but, because it is not subsidised by the Government, patients prescribed it have to pay.

Pharmac funding and procurement manager Steffan Crausaz said Pharmac would be able to give an update on funding an alternative within the next two weeks.

Dr Jessamine said while any new products would still need to meet the required standards of safety, quality and efficacy before they could be approved, Medsafe would fast-track the assessment of any applications it received for levothyroxine to allow an approved alternative to be made available as promptly as possible.

Mr Crausaz said approval by Medsafe was only the first step in the process of making a funded alternative to Eltroxin available and Pharmac expected to complete negotiations with at least one of the alternative medicine supply companies shortly.

Dr Jessamine said specialist endocrinologists said many adverse reactions were consistent with some patients absorbing lower amounts of levothyroxine (T4).

Blood tests to check the level of thyroid hormone stimulating hormone (TSH), and adjustment of the dose of Eltroxin were recommended.

Dr Jessamine said independent testing of both the old and new formulation of Eltroxin indicated the new Eltroxin tablets were acceptably potent and did not contain unexpected or excessive impurity content, compared with the old formulation, and met the requirements for dissolution.

 

 

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