The Pharmaceutical Benefits Advisory Committee has spoken out against a perception that delays in access to the listing of cancer (and other) medicines are due to PBAC processes.
PBAC informed the Senate Community Affairs References Committee Inquiry into the availability of new, innovative and specialist cancer drugs in Australia that in fact, delays are often due to the failure of pharmaceutical companies to apply for listing, or to reach agreement with government on the conditions of supply.
Some cancer medicines are never submitted to the PBAC.
When the PBAC does not recommend the listing of a new drug, this is most often because the benefit of the drug has not been demonstrated or is too small relative to the proposed price, it says.
The benefits of cancer drugs are assessed in terms of effects on overall survival, progression free-survival, response to treatment and quality of life and toxicity. Many new cancer drugs produce only very small gains in survival, less than three months, and have very little impact on quality of life, or negative impacts due to side effects, the PBAC said in its submission.
The PBAC is concerned that there is often a mismatch between the public perception of the value of cancer medicines (often developed through the media) and the data presented by the sponsor on a confidential basis to the PBAC.
This confidentiality requirement is at the insistence of the pharmaceutical industry.
In the committee’s opinion, bypassing the PBAC process to “expedite” access to new cancer drugs would greatly increase the cost to the community and diminish the sustainability of the PBS without any commensurate gain in health outcomes. It would also lead to justified resentment among patients with other diseases.
PBAC lists its recommendations:
- To improve transparency, patients and clinicians should be given access to sponsor submissions, and to the evaluation of these data by PBAC and its subcommittees, including the details of the recommendations.
- Funding of the secretariat and of independent consumer groups needs to be enhanced to support greater stakeholder consultation.
- Data on the outcomes of all patients treated with new drugs should be collected nationally, and monitored on a real-time basis.
- Community consultation should be carried out to ascertain the value placed by society on very small improvements in survival or progression free survival for patients with cancer.
- Processes should be developed to generate plain language presentations for lay and professional audiences on the benefits, harms and costs of new drugs.