Pradaxa - Extension of Pharmaceutical Benefits Scheme Listing

Issue

Extension to the Pharmaceutical Benefits Scheme (PBS) listing of dabigatran (Pradaxa^®).

Response

The Australian Government understands the importance of effectively and safely treating people with atrial fibrillation at risk of stroke.

On 30 September 2011, following advice from the Pharmaceutical Benefits Advisory Committee (PBAC), the Government commissioned a review into the use of anticoagulation therapies in atrial fibrillation.

The PBAC is the independent, expert advisory body comprising doctors, other health professionals and a consumer representative, which makes recommendations to the Australian Government about PBS listings. The Government cannot list a medicine on the PBS unless the PBAC makes a recommendation in favour of its listing.

At its March 2011 meeting, the PBAC recommended to extend the PBS listing of Pradaxa for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation (a condition associated with an abnormal heart rhythm) on the basis of acceptable cost-effectiveness.

While the PBAC recommended listing Pradaxa, it also raised a number of concerns that require further investigation and assessment. These issues include:

the fact that Pradaxa derives its advantage over warfarin when warfarin is not taken as prescribed or the dosage for the patient is not correct; and
the benefit of Pradaxa observed in the clinical trial may or may not be reflected for every patient.

Given these concerns and the major cost associated with listing this drug on the PBS, which was estimated could be close to $1 billion over the next four years, the Government has a responsibility to ensure limited health resources are used in the most effective way.

The Government commissioned Emeritus Professor Lloyd Sansom AO, the former Chair of the PBAC, to conduct a further analysis to inform the Government on options for improving the health outcomes of patients treated with anticoagulation therapies, including optimising the use of currently available treatments in Australia as well as the future role of newer therapies for the treatment of atrial fibrillation, such as Pradaxa.

The Report of the Review of Anticoagulation Therapies in Atrial Fibrillation is available on the Department’s PBS website.

This review has highlighted that there are differences between the outcomes from clinical trials and how the medicine is used in routine practice. Some use of Pradaxa in routine practice has been different to the clinical trial evidence presented to the PBAC in March 2011, including:

the average age of patients who are likely to use it;
the dose that people are likely to use; and
the treatment that patients would otherwise be receiving.

The review also found that patients would benefit greatly if the use of existing therapies such as warfarin was better managed and supported. Further, the review found that Australians need to be made more aware of the seriousness of atrial fibrillation.

The PBAC considered the Report on 13 December 2012. The PBAC concluded that there is a role for Pradaxa and the other new anticoagulant medicines. However, based on the new information about this drug’s use in routine practice, the PBAC was concerned about whether Pradaxa represented value-for-money at the price offered by the company. The PBAC asked the sponsors of all new anticoagulation therapies, that is Pradaxa and two other medicines (rivaroxaban and apixaban), to provide further economic analyses. The PBAC received submissions from all three pharmaceutical companies and considered these at its March 2013 meeting.

At this meeting the PBAC recommended the PBS listing of rivaroxaban for stroke prevention in patents with atrial fibrillation as cost-effective compared to warfarin. The PBAC also recommended Pradaxa and apixaban on a cost minimisation basis compared to rivaroxaban. In other words, the PBAC advised that all three medicines (rivaroxaban, dabigatran and apixaban) provide similar health outcomes and should have the same price. Outcomes from the March 2013 PBAC meeting have been available on the PBS website as of 26 April 2013.

A positive PBAC recommendation is a very important step in the listing process. However, other steps generally need to be taken before a listing is achieved, such as pricing negotiations with the product’s sponsor, finalisation of the conditions for listing, quality and availability checks and consideration by the Cabinet.

The new anticoagulants are very high-cost medicines. The Government will endeavour to ensure that matters related to the listing of Pradaxa and the other new anticoagulants are resolved in as timely a manner as possible.

The National Prescribing Service (NPS), an independent source of medical information, has prepared a fact sheet on Pradaxa for stroke prevention in patients with non-valvular atrial fibrillation. In this fact sheet it mentions that the safety and efficacy of Pradaxa have not been established in patients at high risk of bleeding and that the safety data for Pradaxa are limited to two years of follow-up.

The NPS has also launched a series of clinical decision support tools to help health professionals safely manage their patients who require oral anticoagulation. Further information is available on the NPS website.

The Government is committed to a sustainable PBS and delivering better health services for all Australians. The Government’s strong support for bringing forward new medicines to the PBS is demonstrated by approving the listing of over $5 billion worth of new drugs since 2007 and the Memorandum of Understanding signed with Medicines Australia in 2010.