Background: Access to &quot high-cost medicines&quot under Australia's Pharmaceutical Benefits Scheme (PBS) is characterised by strict eligibility criteria. The PBS access scheme for the anti-rheumatic biologicals (etanercept, infliximab, and adalimumab) was examined for concordance with Australia?s National Medicines Policy. Methods: Semi-structured interviews with a range of stakeholders were conducted. National, aggregated prescription and expenditure data from Medicare Australia and dispensing data from the Drug Utilisation Sub-Committee were analysed. Access to biologicals was also examined from an ethical perspective. Results: Interviewees agreed that controlled access to high-cost medicines was broadly equitable and practical but specific concerns included: timeliness of access; bureaucracy of the process; contentious cases of individual patients being denied access; insufficient patient information; the quantum of resources required to administer the access scheme; inadequate stakeholder consultation. The access requirement of a history of failure of conventional anti-rheumatic drugs was supported. Recommendations included proactive review of the access criteria and outcomes; greater transparency and formal stakeholder involvement to increase public confidence in the definition of &quot target patient population" and a formal appeal mechanism to increase the fairness and accountability of the PBS. Establishment of an appeal mechanism is supported by &quot accountability for reasonableness&quot framework grounded in procedural justice. Data needed to examine the health outcomes associated with the use of biologicals on a national level was not easily available. This shortcoming is discordant with National Medicines Policy. Utilisation of biologicals over the first two years of PBS-subsidy was conservative but with considerable variability across States and Territories (an 8-fold difference between the jurisdictions), usage roughly correlating with access to rheumatologists. Introduction of PBS-subsidised biologicals did not alter the trends in utilisation of non-biological anti-rheumatic drugs. Conclusions: This research suggests that policy-makers focus upon: explicitly considering ethical principles and formally involving stakeholders when developing policies on access to high-cost medicines; improving communication and providing information based on increased transparency; and establishing formal mechanisms for review of and appeals against PBS decisions. The comprehensive evaluation of medicine use and outcomes post-subsidy is critical for the future of the PBS. The National Medicines Policy has proved a useful framework for evaluating this access scheme.

Background: Access to &quot high-cost medicines&quot under Australia's Pharmaceutical Benefits Scheme (PBS) is characterised by strict eligibility criteria. The PBS access scheme for the anti-rheumatic biologicals (etanercept, infliximab, and adalimumab) was examined for concordance with Australia?s National Medicines Policy. Methods: Semi-structured interviews with a range of stakeholders were conducted. National, aggregated prescription and expenditure data from Medicare Australia and dispensing data from the Drug Utilisation Sub-Committee were analysed. Access to biologicals was also examined from an ethical perspective. Results: Interviewees agreed that controlled access to high-cost medicines was broadly equitable and practical but specific concerns included: timeliness of access; bureaucracy of the process; contentious cases of individual patients being denied access; insufficient patient information; the quantum of resources required to administer the access scheme; inadequate stakeholder consultation. The access requirement of a history of failure of conventional anti-rheumatic drugs was supported. Recommendations included proactive review of the access criteria and outcomes; greater transparency and formal stakeholder involvement to increase public confidence in the definition of &quot target patient population" and a formal appeal mechanism to increase the fairness and accountability of the PBS. Establishment of an appeal mechanism is supported by &quot accountability for reasonableness&quot framework grounded in procedural justice. Data needed to examine the health outcomes associated with the use of biologicals on a national level was not easily available. This shortcoming is discordant with National Medicines Policy. Utilisation of biologicals over the first two years of PBS-subsidy was conservative but with considerable variability across States and Territories (an 8-fold difference between the jurisdictions), usage roughly correlating with access to rheumatologists. Introduction of PBS-subsidised biologicals did not alter the trends in utilisation of non-biological anti-rheumatic drugs. Conclusions: This research suggests that policy-makers focus upon: explicitly considering ethical principles and formally involving stakeholders when developing policies on access to high-cost medicines; improving communication and providing information based on increased transparency; and establishing formal mechanisms for review of and appeals against PBS decisions. The comprehensive evaluation of medicine use and outcomes post-subsidy is critical for the future of the PBS. The National Medicines Policy has proved a useful framework for evaluating this access scheme.

This study used the Andersen Model for Health Services Utilization to examine a pharmacist-provided telephone MTM program among Medicare Part D beneficiaries. Predisposing (age, gender, race) and need factors (number of medications, number of chronic diseases, medication regimen complexity) were assessed. The health behavior, MTM utilization, distinguished the intervention and control groups. The health outcomes were change in number of medication-related problems, change in medication adherence [using the medication possession ratio (MPR)], and change in total drug costs. Medication knowledge, medication adherence (using the Morisky Scale), and patient satisfaction were also measured in the intervention group. The intervention and control groups were not significantly different in age (71.2 ± 7.5 vs. 73.9 ± 8.0 years), number of medications (13.0 ± 3.2 vs. 13.2 ± 3.4), number of chronic diseases (6.5 ± 2.3 vs. 7.0 ± 2.1), and medication regimen complexity [21.5 (range 8 – 43) vs. 22.8 (range 9 – 42.5)], respectively. For the subset of problems that was evaluated in the intervention and control groups, 4.8 (± 2.7) and 9.2 (± 2.9) problems were identified at baseline and 2.7 (± 2.3) and 8.6 (± 2.9) problems remained at the 3-month follow-up, respectively. Cost-related and preventative care needs and drug-drug interactions were the three most common problems identified. Multivariate regression analysis revealed that the intervention group had significantly more problems resolved (p < 0.0001) when compared to the control group, while controlling for predisposing and need factors. Significantly fewer problems were resolved (p = 0.01) as number of diseases increased and significantly more problems were resolved (p = 0.01) as medication regimen complexity increased. There were no significant predictors of change in MPR or total drug costs from baseline to the 3-month follow-up. Medication knowledge and medication adherence measured by the Morisky scale did not change significantly from baseline to the 2-week follow-up. However, patients were very satisfied with the service. A pharmacist-provided telephone MTM program was an effective method for identifying and resolving medication and health-related problems. A longer follow-up period may be necessary to detect the impact of pharmacist provision of MTM on adherence, total drug costs, and knowledge. / text