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News & Trends - Pharmaceuticals

The reimbursement process is failing us, say patient advocacy groups at Inquiry hearing

Health Industry Hub | April 23, 2021 |

Pharma News: On Thursday 22 April 2021 the House of Representatives Standing Committee on Health, Aged Care and Sport held its public hearing in Melbourne as part of the Committee’s ongoing Inquiry into approval processes for new drugs and novel medical technologies in Australia.

The representatives from several patient advocacy groups voiced the lack of transparency and inadequate involvement from patients in the Health Technology Assessment (HTA) processes for the reimbursement of novel medicines and medical devices.

Deidre MacKechnie, Executive Officer of Australian Patient Advocacy Alliance, addressed the Committee “In our view there is no one more qualified to speak to a disease or a condition than someone living with it. Patients have unique knowledge, perspectives and experiences and these are essential in the HTA process.

“Patient organisations should be given access to sponsor submissions provided to the Pharmaceutical Benefits Advisory Committee (PBAC)  and Medical Services Advisory Committee (MSAC). This will ensure patient organisations have the information they need about a new treatment, as well as additional time to consult with our communities and inform our contribution, more fully.

“All stakeholders, including patients and patient organisations should be brought together at the beginning of the HTA process to consult, debate and confirm key elements such as population, impact and areas of uncertainty. To enhance transparency, the HTA process should also share feedback with patient organisations on how the submitted information was used in the deliberations, as well as how future responses could be improved,” she added.

Professor Andrew Spencer, haematologist at the Alfred Hospital and representing the Myeloma and Related Diseases Registry, said “We consider ourselves a first world nation, yet we have second world nation access to drugs. That’s exemplified by the fact that for the past 14 years, until the start of this year, there were only two classes of drugs available to treat myeloma.

“In that timeframe, half a dozen other drugs have been approved in other first world countries with different mechanisms of action to treat myeloma, but not in Australia. We now have a new drug available to us, the first new one in 13 years yet the paradigm for its utilisation in combination with another drug that we’ve been afforded is the cheapest and most toxic combination.

“It seems to me that this approach from the PBAC is being driven by accountants. The modelling is based on cost thresholds that are 30 – 40 years out of date. It’s not being driven by people that actually are looking at the evidence and saying what is the best option for these patients.

“The result is that it took five years to get this recent drug approved. There are several drugs where the pharma companies don’t even bother trying to get reimbursed in Australia because it’s a waste of their time.

“The process is failing on so many levels. Unless we change, we are going to fall further and further behind in terms of drugs and therapies for cancer,” he said.

There is also a need to review and co-create HTA related materials for patients to ensure they are fit for purpose. For example, on the current PBS website, there is a tab for clinicians and industry but no tab for patients. Given the complexity of submissions, a detailed summary template could be co-developed with patients ensuring it’s written in consumer language, similar to the processes in Scotland.

The Chair of the Committee, Mr Trent Zimmerman MP, enquired whether there is a perception that some of the sponsor companies like to ‘use’ patient advocacy groups to their own commercial advantage.

“We need to ensure that the voice of the patient organisations is heard, but we need to ensure that we’re not just there as the mouthpiece of the pharmaceutical company. The challenging part is not having any idea of what is included in the sponsor submission and so flying blind when making a submission,” noted Ms MacKechnie.

The Deputy Chair of the Committee, Dr Mike Freelander MP, noted that the current HTA process doesn’t include the ‘family voice’ in any of the decision-making processes. A targeted consultation during the HTA processes may be beneficial as families are almost as directly impacted by their loved one living with the condition, as the person living with the condition.

Health policies and programs are strongest when they are co-designed with the people that aim to benefit from these recommendations. Optimal patient involvement will strengthen the effectiveness of consumer engagement in the HTA process, which is critical to delivering timely and considered access to novel medicines and medical technologies.

You may also like Leaders from Merck, Pfizer and AbbVie call for changes to approval processes of new drugs at Inquiry hearing and Medtronic, Stryker and Edwards scrutinise approval processes for novel medical technologies at Inquiry hearing


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