The tricks companies use to get over-priced drugs on the PBS

Dabigatran’s manufacturer didn’t provide PBAC with data comparing its effectiveness to the most inexpensive medication treating the same conditions. Harveyben

Boehringer Ingelheim, manufacturer of the expensive anti-clotting drug dabigatran, has initiated a lobbying campaign to get it listed on the Pharmaceutical Benefits Scheme (PBS).

The company’s efforts include a website featuring testimony by medical experts, a petition and a list of the number of patients having preventable strokes.

In actual fact, dabigatran has been on the PBS for some time. Its manufacturer’s name is Pradaxa (doctors are encouraged to prescribe using the chemical name rather than advertising name, although drug reps try to promote the opposite).

Dabigatran and the PBS

Dabigatran was placed on the PBS as far back as 2008 for a limited class of complaints in prevention of clots in the legs of patients who had undergone major orthopaedic operations, such as hip replacement or knee surgery.

There’s now an application to extend the indications of the drug, which means a wider range of patients could eligible to take it.

The proposal is to list this medication on the PBS for the prevention of stroke, or clots in the lungs of patients whose hearts fibrillate (contract chaotically).

Incomplete effectiveness test

The marketed drugs that the Pharmaceutical Benefits Advisory Committee (PBAC) decided to compare with dabigatran were warfarin and aspirin, which have a similar function. But in its submission, the manufacturer only produced data from one randomised controlled trial comparing dabigatran with warfarin.

The manufacturer didn’t present any data comparing dabigatran directly to aspirin – aspirin is cheap, warfain is a bit more expensive but dabigatran is extremely expensive.

One of the main issues for the PBS system is that drug manufacturers routinely give the PBAC a limited range of data. In this instance, they’ve given the PBAC only one head-to-head trial against warfarin; they’ve given them no head-to-head trials against aspirin.