Leaders from Merck, Pfizer and AbbVie call for changes to approval processes of new drugs at Inquiry hearing

Pharma News: The House of Representatives Standing Committee on Health, Aged Care and Sport held its second day of the public hearings on Friday 12 March in Sydney as part of the Committee’s ongoing Inquiry into approval processes for new drugs and novel medical technologies in Australia.

The Chair of the Committee, Mr Trent Zimmerman MP, said that “the Inquiry has received a lot of interest with 185 submissions to date. The Committee is hearing from stakeholders to find out how Australia’s approval systems and funding for new medicines and novel medical technologies will provide the best possible outcomes for all Australians now and into the future.”

Senior leaders from Pfizer, Merck Healthcare, Biogen, MSD, Amgen, AbbVie and Novartis called for improved mechanisms of early input from patients and clinicians to ensure patient needs are understood by Health Technology Assessment (HTA) decision makers prior to approval processes progress in the pathway.

Lead Goodman, Managing Director of Merck Healthcare Australia and New Zealand said “We get to the end of the process and there is uncertainty because the patient real voice hasn’t been heard early enough. Conversations on what the right comparative products and the right population are all discussed way down the end of the process rather than at the beginning to remove the uncertainty and then expedite the process.

“That is one of the reasons why I think the time to market between registration and reimbursement is lengthy for Australia at 391 days. We are actually the second slowest to market between registration and reimbursement in the world, longer than the OECD average, which is 351 days. At the end of the day we want to bring innovative medicines to patients quickly,” she added.

Anne Harris, Country Manager for Pfizer Australia and New Zealand said “Once you move through all of the risk of innovation and bring forward a valuable medicine or vaccine to meet the medical needs of patients in Australia, we want to have a system that recognises the real value of that innovation.”

Chris Stemple, Vice President and General Manager of AbbVie Australia and New Zealand noted that it is critical that companies can afford the risk that innovation requires to ensure future innovative medicines for unmet needs. Consideration of total cost should be removed from PBAC negotiations so that assessment is based on health outcomes provided by the treatment and value for money, rather than budget impact.

Pharma leaders commented that the slow reimbursement process is a product of the current HTA decision making framework. The PBAC’s decision making is not in line with other countries with similar national health systems, such as the UK and Canada. The PBAC is often far more conservative in their assessments causing delays to access to innovative treatments.

Furthermore, PBAC decisions are increasingly creeping beyond the scope of cost-effectiveness assessment to include budgetary cost containment considerations. These types of HTA decisions have resulted in Australian patients missing out on medicines.