Medicines Australia is now not answering critical questions on the Health Technology Assessment Review options paper but its enthusiasm for the controversial document appears to be waning.
On 28 January, in response to the Health Technology Assessment Review options paper, Medicines Australia chief executive and reference committee member Liz de Somer said, "The recommendations put forward in the HTA review options paper are welcomed by industry."
While acknowledging that the "devil is in the detail", the industry's response could hardly be more enthusiastic, with the association's chair describing the options paper as a "significant achievement" and a "substantial set of options for bold reform" that should be 'celebrated'.
The association's tone quickly became more subdued, with Ms de Somer telling BioPharmaDispatch within a week of releasing that options paper that she had dissented on some of the controversial proposals.
"I said I do not think that this will land," she said, referring to the proposed pathway under which the reimbursement of cost-minimisation submissions would only be streamlined if sponsors offered a price reduction.
"It's not the purpose of HTA to create price-saving measures. HTA is to determine the fair value cost. Minimisation is not a pathway that should be used to create price savings. So, I have made it clear that that is not what HTA is about," said Ms de Somer.
The communique of the reference committee meeting held on 19 January, released yesterday, says the purpose was to "work through the latest draft of the Options Paper to be published in the week starting Monday 22 January 2024 as part of Consultation 2."
It says the changes discussed included the organisation and structure of the options paper, refining timeframes were specific options "to ensure they are clear and practical".
Most significant is where the communique says the reference committee discussed the options to ensure consistency with the scope of the review and its collective agreement on the proposed options.
It highlights discussion on early resolution mechanisms for submissions of significant new therapeutic advances in areas of high unmet clinical need, mechanisms to be used when there is an impasse in price negotiations, selection of the comparator for submissions claiming non-inferiority, and changes to the standard base-case discount rate for health interventions.
"The Committee agreed to finalise the Options Paper out-of-session following the meeting," it says.
The communiqué does not mention any discussion on the proposed pricing policies, which have alarmed companies, and it indicates that the committee "agreed to finalise the Options Paper out-of-session following the meeting."
BioPharmaDispatch asked Medicines Australia whether Ms De Somer endorsed the communiqué as reflecting what was discussed at the meeting.
“The Reference Committee agreed on including the proposed options in the options paper to be released for consultation. This does not mean the Committee agreed on the merits of any of the options proposed," said Ms de Somer.
The association did not respond to whether it communicated to the reference committee between 19 January and the options paper release on 25 January its opposition to the proposed price reduction policies.
