Decision-making on listing new medicines for public funding in New Zealand: the case of 'new' type 2 diabetes medications.

Introduction New medicines for the management of type 2 diabetes became available internationally in 2005, yet only in 2018 did the first of these become available in New Zealand. Access to these new medicines in New Zealand is largely dependent on decisions made by the Pharmaceutical Management Agency (PHARMAC). Aim This study sought to describe the decision-making processes to better understand access to new medicines in New Zealand. Methods We conducted an analysis of publicly accessible information on therapeutic committee deliberations, prices of medicines and registration and formulary listing dates. Results Prices for the new diabetes medicines in New Zealand are lower than comparator countries, but access to them takes longer. Discussion Given that knowledge on efficacy, safety and quality is widely available to support decision-making on new medicines, differences in access to them between nations appears to depend on the fourth hurdle of cost. However, we suggest that a rush to market is the norm, that activities of the pharmaceutical industry and regulatory agencies are less transparent than desirable, and that greater focus on availability of safety data is required. Deliberations of PHARMAC therapeutic committees are robust yet protracted. Opportunities to expedite decision-making, as well as resolving inequities, may be worthy of examination.

New Zealand patients' understanding of brand substitution and opinions on copayment options for choice of medicine brand.

Objective The aim of the present study was to better understand the views and experiences of New Zealand patients on switching between brands of prescription medicines and on alternative funding options for the provision of medicines, including an increase in copayments. Methods A self-administered questionnaire was offered to selected patients through participating community pharmacies. Pharmacies were stratified according to level of deprivation of the community served before random selection and invitation for involvement in the study. Patient understanding of and rationale for brand substitution was assessed. Preference for different copayment options was elicited, together with demographic and other explanatory information. Results In all, 194 patient-completed questionnaires were returned. Some gaps in patient knowledge and understanding of brand changes were evident. Most respondents indicated a preference for the existing subsidy arrangements with little desire expressed for alternatives. Around half were willing to contribute towards paying for a choice of brand other than the subsidised brand; however, the maximum contribution nominated was disproportionately lower than real cost differences between originator brand and generics. Conclusion The findings of the present study suggest that although most patients have experienced brand changes without any problems occurring, a lack of knowledge about substitution does persist. There may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing to reinforce the benefits of the Pharmaceutical Management Agency (PHARMAC) purchasing model. What is known about the topic? Generic reference pricing is used as a mechanism to make savings to pharmaceutical budgets; however, reticence to the use of generic medicines persists. What does this paper add? Most New Zealand patients experience brand changes without any problems occurring; however, a lack of knowledge about substitution does persist. The dollar value patients indicate they would contribute for brand choice is lower than the true cost difference between brands. What are the implications for practitioners? Opportunities exist for healthcare professionals to reinforce generic policies and there may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing.

An Evaluation of Health Service Impacts Consequent to Switching from Brand to Generic Venlafaxine in New Zealand under Conditions of Price Neutrality.

OBJECTIVE: To study the health impact on adult New Zealand patients who switch from originator brand to generic venlafaxine. METHODS: The national pharmacy database was used to select patients using venlafaxine for at least 6 months. Switchers and nonswitchers were identified, and switch behavior was compared for a 12-month follow-up period. Change in health service use following switching was also compared between switchers and nonswitchers including use of the emergency department, hospital, and specialist outpatient services over the same period. RESULTS: Approximately 12% of all originator brand users switched to generic venlafaxine, at least half of whom continued to use the generic throughout the follow-up period to August 1, 2012. Almost 60% of new users of the generic venlafaxine, however, switched to using the originator brand. Aside from a slight reduction in the use of outpatient services among switchers, there were no significant differences in health services use between switchers and nonswitchers for either existing or new venlafaxine users. CONCLUSIONS: Although both products remain fully subsidized and available, there is little incentive for prescribers, pharmacists, or patients to switch to the less expensive generic brand. If savings to the national New Zealand budget are to be realized, additional policy measures should be implemented to minimize incentives for multiple and reverse switching, and prescribers, as key opinion leaders, could take the lead in promoting generics to their patients.

The impact on health outcome measures of switching to generic medicines consequent to reference pricing: the case of olanzapine in New Zealand.

INTRODUCTION: New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. AIM: This study sought to evaluate change in outcome measures of patients switching from originator to generic olanzapine consequent to the introduction of the policy. METHODS: A retrospective study using national health data collections was conducted. Outcome measures included medicines indicators (change in dosage, concomitant therapy and treatment cessation), health care service indicators (use of emergency departments, hospitals and specialist services), surveillance reports of adverse events, and mortality. RESULTS: Subsequent to the removal of funding for originator brand olanzapine tablets, 99.7% of patients meeting the inclusion criteria switched to using generic olanzapine. Limited case reports of suspected therapeutic loss were received in the study time period. No increase in use of additional oral or injectable antipsychotic medication was observed after switching, nor any increase in other unique, non-antipsychotic prescription items. However, a high incidence of multiple switching between available brands was found. No net impact of switching brands on health service utilisation or mortality was found. DISCUSSION: The study shows that a switch can be made safely from originator olanzapine to a generic brand, and suggests that switching to generics should generally be viewed more positively. Generic reference pricing achieves considerable savings and, as a pricing policy, could be applied more widely.

Do users of risperidone who switch brands because of generic reference pricing fare better or worse than non-switchers? A New Zealand natural experiment.

This study evaluated patient health outcomes and any impact on healthcare costs consequent to the implementation of generic reference-pricing of risperidone in New Zealand using national datasets. Reference pricing risperidone reduced the price of the originator brand by 50 % as well as overall expenditure on risperidone tablets. Half of all patients made a single switch to generic risperidone, with the remainder making multiple switches between brands. 1.5 % made a switch-back to the originator brand. No difference was found in use of healthcare services between switchers and non-switchers of the originator brand or versus the comparator group. This refutes the available literature on brand-to-generic and generic-to-generic switching.

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

BACKGROUND: Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. OBJECTIVES: This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. METHODS: A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. RESULTS: Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. CONCLUSIONS: Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

The availability, pricing and affordability of three essential asthma medicines in 52 low- and middle-income countries.

BACKGROUND: Almost 300 million people suffer from asthma, yet many in low- and middle-income countries have difficulty accessing essential asthma medicines. Availability, price and affordability of medicines are likely to affect access. Very few studies have included asthma medicines, particularly inhaled corticosteroids, in these countries. Reflections about international reference prices (IRPs) are generally absent from pricing studies, yet some IRPs may be masking the extent of access problems. OBJECTIVES: Our objective was to determine the availability, pricing and affordability of beclometasone, budesonide and salbutamol, the three asthma medicines on the World Health Organization's Model List of Essential Medicines (EML) in selected low- and middle-income countries and to reflect on the appropriateness of using IRPs. METHODS: A cross-sectional pricing survey was conducted in 52 countries. Data were collected on country demographics including national currency, $US exchange rate and daily wage of the lowest-paid unskilled government worker. Pricing and availability data were collected for salbutamol, beclometasone and budesonide in two private retail pharmacies, the national procurement centre and a main public hospital. RESULTS: Availability was particularly poor for corticosteroids, and worse in national procurement centres and main hospitals. The surveyed strength of beclometasone was only on the EML of ten countries. Considerable variability was found in pricing and affordability across countries. Procurement systems appeared largely inefficient when Asthma Drug Facility prices were applied as references. Some countries appear to be subsidising asthma medicines, making them free or less expensive for patients, while other countries are applying very high margins, which can significantly increase the price for patients unless a reimbursement system exists. CONCLUSIONS: Findings raise important policy concerns. Availability of inhaled corticosteroids is poor; many EMLs are not updated; IRPs can be misleading; health systems and patients are paying more than necessary for asthma medicines, which are unaffordable for many patients in many countries.