Submissions

National Medicines Strategy Submission from the Breast Cancer Aotearoa Coalition (BCAC) in Response to Medicines Strategy Consultation 13 April 2007

1. Background to this Submission                                                                 

            1.1 Access to Medicines Coalition                                                        

            1.2 Breast Cancer in New Zealand                                                       

2. Response to Consultation Questions                                                

3. Conclusion                                                                                 

1. Background to the BCAC Submission

1.1 Access to Medicines Coalition

BCAC is a member group of the Access to Medicines Coalition (ATM) and endorses the ATM response to this strategy document.  In particular, BCAC stresses the importance of the issue of access to subsidised medicines for all New Zealanders, irrespective of their ability to pay.  BCAC hopes that this is given more than lip service by your review. 

Our submission includes a number of issues illustrated by examples that BCAC wishes to raise in its own right.  BCAC hopes that the issues raised will serve to augment the ATM response.  In particular, BCAC would like to provide more commentary on issues surrounding the entire New Zealand Medicines Strategy as it pertains to the treatment of breast cancer in New Zealand.

1.2 Breast Cancer in New Zealand

Cancer is the leading cause of death in NZ women aged 25-74 years with breast cancer being the most common cause of cancer death in women.  In New Zealand, 2500 are diagnosed with breast cancer annually and over 600 NZ women die from it.  The chances for developing breast cancer are 20% higher for Māori than non-Māori women, and Māori women are 68% more likely to die from it.  This disease touches many New Zealand families.

Treatment for breast cancer usually involves surgery, radiotherapy, chemotherapy and/or hormonal therapy.  Treatment is determined by the characteristics of the tumour and how far the cancer has spread.  Breast cancer may be confined to the breast, have spread to the lymph nodes near the breast or to other parts of the body.  Surgery involves removal of the tumour and usually removal and testing of lymph nodes in the region of the breast.  Based on the characteristics of the tumour (determined by pathologist examination) and the extent of spread of cancer, the most appropriate combination of treatments is chosen for an individual woman. 

Over the last 30 years, a better understanding of breast cancer has enabled much more targeted treatment to be given.  The objective of treatment in women with early breast cancer (i.e. cancer that has not spread to other parts of the body) is to kill all remaining cancer cells and prevent recurrence i.e. curative.  Once cancer has already spread to other parts of the body (either at diagnosis or as a recurrent cancer), chemotherapy, hormonal therapy and other targeted treatments such as trastuzumab (Herceptin) can extend life but cure is not possible.

Many breast cancer patients require chemotherapy and hormonal treatment. Those who progress to metastatic disease from breast cancer must access palliative care that includes medicines used to control symptoms and pain.  The availability and appropriate administration of medicines is therefore an important component of treatment for most New Zealand women with breast cancer. 

2. Response to Consultation Questions

Objectives of Strategy (Q2 & Q3)

BCAC agrees with the aim of proposing a set of objectives and principles to guide the policies, structures and systems in the future.  There are substantial problems with the current policies, structures and systems that need to be urgently addressed so that health outcomes can be improved for all New Zealanders including those with breast cancer. 

Breast cancer is not an isolated example of limited access to medicines.  Our interaction with other patient groups indicates that major systemic problems are preventing New Zealanders from accessing essential medicines in a timely and affordable way.  For this reason, BCAC believes that affordable access to medicines is a pressing issue that must be addressed.  Equitable access, regardless of ability to pay, is clearly important but at present those whose medicine is listed on the schedule receive preferential access compared to those whose medicine is not. The latter are thus restricted in their access and burdened with cost.  BCAC refers to the ATM submission for a clear articulation of the broad range of issues requiring attention.

Optimal use of medicines is also in need of attention by policymakers.  A key issue in this area is the lack of evidence on whether medicines are currently being optimally used or not.  These issues are also addressed in this submission.

Quality, safety and efficacy issues have not (in our experience) presented major problems for our constituency.  This part of the system appears to be working well and will not be further addressed in our submission.  BCAC would like to see other components of the system working well so that New Zealand patients can have confidence in a robust process for evaluation of the efficacy, safety and quality of medicines.

Principles for Decision-Making and System Design (Q4 & Q5)

The proposed principles as outlined in the strategy are:

• Excellent Systems
• Equity of Access and Outcome
• Effectiveness
• Trust and Confidence
• Value for Money and
• Affordability

The principles requiring more emphasis are in the area of ‘trust and confidence in decision-making and system design’:

• Stakeholder Involvement – a key principle that requires more emphasis is the meaningful integration of stakeholders such as patients into the decision-making and implementation processes.  BCAC believes that consumers are deliberately marginalised or excluded altogether in the current system.
• Accountability – the current system appears neither transparent nor accountable for its decision-making.  The system becoming more transparent is of itself not sufficient.  There must be transparency around the decision-makers and accountability for the quality and consistency of the decisions for which they are responsible.
• Integration of Social Values – it is important that society’s values are integrated into the processes and systems.  The recent petitions on Herceptin and the media interest in this issue showed that a large number of New Zealanders support funded access for patients with early breast cancer.  It is simply unacceptable for the values and the wishes of thousands of New Zealanders to be ignored.  BCAC believes that Herceptin has provided a rallying cry.  There are many other health conditions where funded access to medicines is falling far short.  PHARMAC’s proposal to fund an unproven 9 week treatment regimen for Herceptin on the basis of the weak data provided by a sub-group analysis in the FINHER study in order to  make this problem go away would not only be inappropriate but also neglectful of the systemic problems that affect so many New Zealanders.
• Consistency of Decision-Making – in addition to transparency, BCAC would like to see evaluation of decision-making to ensure consistency.
• Fair Process and Opportunity for Review – BCAC believes a key element in rebuilding trust and confidence will be a fair process with the opportunity for formal review of decisions.  A judicial review should be a last resort.  Such action is expensive and time-consuming and patients battling life threatening illness should not be forced down this path as the only recourse.

There must also be trust and confidence in the process by which effectiveness and value for money are evaluated.  Our experience with the current system has inspired little trust or confidence in the process whereby PTAC, PHARMAC and their advisers make recommendations on these aspects.  BCAC believes this is due to the conflict of roles in the current system.

Key Elements of Implementation (Q6)

Stakeholder Involvement

It is important that all stakeholders are integrated into the implementation of the Medicines Strategy. BCAC supports the principle of cross-sector involvement to progress the development of a Medicines Strategy. However, BCAC qualifies this by stressing the need for both significant review and change to structural elements (as outlined in the ATM submission) before such work can be done in a meaningful way.

Consumers are not meaningfully integrated into the current processes and it is essential that improvements be made in this area. We support the ATM’s comments about the Consumer Advisory Committee of PHARMAC.

Getting Started - Access to Medicines (Q7)

BCAC agrees that access to medicines through services as well as through individual products must be assured.  There is scant information available on access to breast cancer services across different regions of New Zealand.  BCAC therefore supports the development of research to determine those areas where access is optimal and identify others where there are issues requiring attention.  For example, BCAC has consistently advocated for extension of the Auckland Breast Cancer Register to other regions.  The Register records information on patients with breast cancer and the services or treatments (including medicines) they access in both the public and private sectors in the Auckland region.  The Register offers service providers a valuable resource to better understand current treatment strategies and helps define areas for further research.  Currently, the New Zealand Breast Cancer Foundation funds this resource.  Little is known about access to services in those regions of New Zealand not covered by the Register and anecdotal evidence would suggest there are regional disparities.  Therefore, BCAC supports research on service access because it cannot be assumed that structural changes to the health system will necessarily enable better access to services especially in secondary or tertiary care.

A further concern goes beyond access to services. What happens to those patients who do access primary care services?  Is the detection and treatment of breast cancer adequate and does it follow best practice guidelines?  This is an area addressed later in our submission because the lack of evidence-based guidelines to advise doctors on current best practice is a pressing issue.

BCAC believes that the subsidised access to individual products is the key deficiency in the current system.  The way in which pharmaceuticals are funded is impeding affordable access by New Zealanders to products that are needed for optimal treatment. 

Budget Setting Processes and Funding Path (Q8)

The strategy document confines its questions on budget-setting processes to community pharmaceuticals.  This focus is too narrow.  The budget set for all pharmaceuticals (community and hospital) including pharmaceutical cancer treatments must take into account the needs for treatment and the availability of treatments for consumers in New Zealand.

Pharmaceutical cancer treatments (PCTs) are currently funded by DHBs from the “cancer treatments basket”, but this budget will be transferred to PHARMAC in 2007-08.  Since 2002, PHARMAC has been assessing new PCTs and advising DHBs on funding.  Adding a new PCT or widening access requires the agreement of the 21 DHBs.  This process is also in need of review as part of the Medicines Strategy.

The expenditure on pharmaceuticals in New Zealand is substantially lower compared with other countries.  When PHARMAC was established in 1993, New Zealand spent 11% of the NZ health budget on pharmaceuticals (as confirmed by PHARMAC’S annual reports).  Since then, the amount spent on drugs has fallen steadily to less than 6%.  In that period the total health spending has increased by 244% while the pharmaceutical spend has risen only 24%.  Currently, Australia spends $420 per person per year on pharmaceuticals while New Zealand spends only $190. (Total spend on pharmaceuticals (hospital and community) is approx NZ$760 million New Zealand and AU$8.5 billion Australia. Source: IMS Health).  Between 2000 and 2006 Australians have been given access to 58 new medicines that New Zealanders do not have (Wonder 2006).  The drugs that are funded here take on average 14 months longer than Australia to be approved.

In breast cancer, there are substantial deficiencies in New Zealand compared to other equivalent countries in access to particular medicines.  These deficiencies in access can be manifested by: 

1. lack of any funded access to individual medicines (e.g. exemestane),
2. delays in access to others (e.g. taxanes)
3. narrower indications for access compared with other equivalent countries (e.g. aromatase inhibitors and trastuzumab). 

Examples in primary treatment of early breast cancer alone include 6 medicines where there is inferior access to treatment in New Zealand compared with equivalent countries.    All these medicines that have poorer access in New Zealand have been proven to significantly improve survival in early breast cancer.  These examples may be found in our case studies in the ATM submission.

Yet further examples may be found in the areas of ancillary treatments such as treatments for bony metastases (e.g. bisphosphonates), treatments for nausea (e.g. aprepitant), haemopoietic growth factor treatment (e.g. G-CSF), palliative care (e.g. treatments for pain such as tramadol) etc.  In addition, chemotherapy agents gemcitabine and liposomal doxorubicin (Caelyx) are funded for treatment of advanced breast cancer in Australia but not in New Zealand. 

BCAC fails to understand why forward allocation of funds is not made in preparation for the arrival of innovative new products on the pharmaceutical market.  Trastuzumab (Herceptin) is a case in point.  PHARMAC has had more than 18 months to plan for the availability of trastuzumab for the treatment of early breast cancer. The absence of adequate process to allocate budget for advance funding of such a therapy is inexplicable. 

Likewise, taxanes (docetaxel and paclitaxel) were recommended by the Cancer Treatments Subcommittee of PTAC for funding in early breast cancer in December 2004.  Why was this important treatment not put into the budget for the subsequent financial year?

It seems that there is a lack of forward planning for the budget.  Surely, the budget setting process should include some form of forward estimate based on horizon scanning for new products.  This could be further refined once advice has been received on priority for funding.

BCAC agrees with ATM that this process is confused and contradictory. A poor system standard of public sector decision-making prevents PHARMAC and the DHBs from giving full effect to their mandate under the Act. BCAC agrees with ATM and recommends significant structural change to avoid the conflict of roles.  It is a question of not only planning but also transparency in the way in which the budgets are being set.  The current processes are vague and there is no clarity about how many medicines are waiting for funding.

A further issue surrounds the government and PHARMAC’S public estimates of how much funding is required for particular interventions.  For example, the Minister of Health is on record as stating that trastuzumab (Herceptin) would cost $300 million annually.  This was clearly an incorrect figure, which was subsequently challenged and amended to $25M to $30M and more recently to $20M to $25M. 

BCAC would like to see a regularly published list of all pharmaceuticals waiting for subsidy, the priority assigned to them and how much they are likely to cost.  This will be an important step in providing increased transparency in the system for consumers.

Budget Setting for Pharmaceuticals (Q9 & Q11)

Once again, the focus of the consultation on the community pharmaceutical budget is too narrow. The Medicines Strategy should encompass all pharmaceuticals, not just those delivered in the community.  Our experience suggests the process for allocating funding to pharmaceuticals is clearly inadequate at present. The process has resulted in chronic under-funding of pharmaceuticals that has severely limited patient access to treatment. Value for money/cost-effectivenessand affordability of treatment for patients are both worthy of consideration in budget setting. However, the processes used for both recommending pharmaceuticals and budget setting need a broader focus and must integrate all principles agreed for decision-making and systems design.

The process proposed in the consultation document suggests that DHBs and PHARMAC explicitly base their budget setting recommendations solely on the principles of value for money and affordability (Pages 46 and 47). This is clearly inconsistent with the inclusion of other principles outlined earlier in the consultation document for decision-making and systems design. The approach suggested appears to be a continuation of the current system as it fails to integrate principles such as excellent systems, equity, effectiveness, trust and confidence and others into decision-making about the budget. Priorities for funding need to be assigned based on all the principles and this needs to flow through the system into budget setting. Otherwise the disconnect between needs, priorities and budget setting will remain.

Options Proposed to Increase Understanding of Decision-Making (Q12)

The published strategy correctly identifies the need to increase understanding of decision-making on funding of medicines.  The current system fails to adequately account for who makes recommendations and who makes decisions.  The current system is claimed to be transparent because of the publication of PTAC’s minutes on the PHARMAC website.  However, PTAC makes recommendations, not decisions. 

It is PHARMAC that makes decisions and these decisions are only known when a product is about to be listed on the Pharmaceutical Schedule or there is a decision to decline funding.  This leaves a large number of products sitting in limbo (after a PTAC recommendation) with no decision by PHARMAC whether to list or not to list.

BCAC would therefore recommend that there should be a time frame around decision-making.  It is not satisfactory to delay a decision for inordinate periods of time. 

The effect of such failure to make a decision in a timely manner has an impact on patient health.  The lack of a decision to fund a drug such as Herceptin in early breast cancer results in lack of access for the patient and therefore it is, by default, a decision by PHARMAC not to subsidise their treatment.  Patients do not have the option of waiting the years that it may take PHARMAC or its Board to make a decision to fund the treatment they need on the Pharmaceutical Schedule.  In the case of Herceptin, failure to treat the aggressive HER2 positive breast cancer when it is in the early (curable) stage leads, in many cases, to the progression of the disease to metastatic and incurable (50% mortality over 10 years).

Provision of Free and Frank Advice to the Decision-Making Process (Q13)

The decision-making process needs free and frank advice, particularly in specialist areas such as breast cancer.  BCAC promotes the involvement of consumers or carers because of their unique perspective from the receiving end of treatment.

Our recent experience with PHARMAC would suggest that the culture of the organisation discourages open discussion with stakeholders.  The justification for the secretive approach appears to be to enable advantage in commercial negotiations.  This assumption needs to be vigorously challenged.

Other Options to Increase Understanding of Decision Making (Q14/15)

Our response to this group of questions is covered in ATM’s submission with recommendations for the separation of roles so that decisions about clinical matters are separated from budget management and procurement decisions.

Other Issues that Need to be Addressed to Improve Access to Medicines (Q20)

Changes need to reach further than just increasing the transparency of decisions. It is also important that the decisions made are of high quality and consistent with society’s expectations. Some of these expectations are explicit and overt. For example, on 16 March 2006 the Anne Easter Hayden Herceptin Petition presented to Parliament the signatures of 18,166 people who appealed to Government to fund the drug Herceptin immediately. This petition was launched because women were begging for funding to have this life-saving treatment. They are still begging and the signatories are still waiting.

BCAC believes that PHARMAC has a current conflict of roles that inhibits fair and transparent approaches to the evaluation of new pharmaceuticals.  As outlined in the ATM submission, BCAC believes the conflict of roles at PHARMAC leads not only to inadequate transparency but also to poor decision-making.  BCAC believes it is important that a range of inputs to decision-making (e.g. effectiveness, cost-effectiveness and equity) be based on advice that is independent of PHARMAC.

PHARMAC places a high emphasis on its management under a fixed budget and there is consequently too much temptation to interfere with the advice of PTAC or its sub-committees.  The deliberations on Herceptin provide an example of this.  PHARMAC advised CATSOP they were not willing to fund a 12-month course of Herceptin and this committee was therefore forced to choose between recommending an unproven 9-week regimen or no funded access to Herceptin for early breast cancer in New Zealand.

BCAC believes that this conflict of roles is also evident in the PHARMAC practice of conducting internal cost-utility analyses.  These analyses are not published and can only be obtained under the Official Information Act (OIA).  This secrecy constitutes a lack of transparency around the analyses.  BCAC also has concerns about the quality of the analyses themselves and the conclusions drawn from them. 

Authorities in other OECD countries examined the Herceptin data closely, developed predictive models, calculated the incremental cost of QALYs and determined that the investment was worthwhile.  By contrast, PHARMAC has reached a negative conclusion. This compels an evaluation as to why PHARMAC places a lower value on a New Zealand life than its equivalent bodies in other developed countries.  The Land Transport Safety Authority estimates the “value of a life”, or the amount it estimates New Zealanders are prepared to spend to modify a road to save one life, at $3.05 million.  Our pharmaceuticals expenditure is seriously out of step with this.  PHARMAC’S thresholds are also out of step with World Health Organisation (WHO) recommendations on what represents value for money.  Clearly more debate is needed on this issue.

Although it could be argued that transparency will ultimately lead to better evaluations and better decision-making, BCAC believes that resolving the conflict of roles issue (alongside improvements in transparency) is a more effective way to restore trust and confidence in the system.

The access to new products via clinical trials – an important aspect of breast cancer treatment – also requires review.  The advances occurring in targeted therapies require evaluation of clinical outcomes.  For many patients, trials provide a mechanism for access to cutting-edge therapies and they must be encouraged.  BCAC would like to see a policy setting that takes into account the encouragement of necessary and ethical research on treatments, particularly for patients with breast cancer.  Therefore, impact of reimbursement policy and decisions on access to clinical trials needs to be taken into account when formulating policy.

A distinction must be made between a wider policy setting that encourages international research projects to include centres of excellence in New Zealand, and PHARMAC’S role in funding medicines for New Zealanders.  BCAC is concerned over PHARMAC’S recent decision to allocate $3.2m from its budget to fund a clinical trial of breast cancer patients in other countries when New Zealand patients are seriously disadvantaged by not having subsidised access to proven treatments that are necessary to maximise their chance of survival.  BCAC does not believe this is consistent with PHARMAC’S statutory obligations to treat New Zealanders. 

The current policy setting has seen a reduction in the multinational pharmaceutical industry in New Zealand.  BCAC believes, for various reasons, that there is now a considerable disincentive for companies to seek subsidy for products on the Pharmaceutical Schedule unless the level of sales is substantial.  Given that treatments in breast cancer are becoming more targeted, BCAC has a concern about the future availability of products in New Zealand.  Companies making submissions to Pharmac are principally driving the current system.  Policy needs to encourage access to necessary medicines if no commercial interests are promoting them.

Optimal Use of Medicines (Q21-23)

Without research, it would be inappropriate for our organisation to state an opinion on where the greatest gains in optimal use of medicines may be made.  BCAC believes that there is a lack of adequate information at present on how patients are using medicines for the treatment of particular conditions including breast cancer.  For example, more research on New Zealand regional variations in prescribing for particular conditions would be advantageous. 

BCAC believes there is also a need for further research on the impact of non-compliance on health outcomes and the reasons for poorer outcomes in certain patient groups.  Under the NZ Health Strategy, Government seeks an improvement in the health status of those currently disadvantaged and acknowledges the special relationship between Māori and the Crown.  Closing the gaps for Māori is a major aim of the Cancer Control Strategy. 

The recent Unequal Impact report shows that Māori women have a 21% higher incidence of breast cancer, are 30% less likely to present early, and 68% more likely to die of the disease (Robson, Purdie & Cormack, 2006. Unequal Impact: Māori and non-Māori Cancer Statistics 1996 – 2001). Earlier data showed that Māori women are more likely to develop breast cancer at a younger age when the disease is likely to be more aggressive (McCredie et al. 1999).

BCAC is actively developing networks to enable us to consult with Māori women to discover what resources are needed for progress.  At a recent meeting with the Hurungaterangi iwi of Te Arawa, BCAC representatives were told that breast awareness, enrolment in the BSA programme and treatment follow-through after a cancer diagnosis must be promoted by trusted women within the iwi.  There has been little quantitative or qualitative research on whether optimal use of medicines could be one of the reasons for poorer outcomes for Māori or whether one of the areas for development could be a strategy for improving the use of medicines.

Use of Evidence-Based Guidelines in Clinical Practice (Q25)

One of BCAC’s objectives is to ensure consistent, high quality detection and treatment of breast cancer throughout New Zealand by promoting the development and implementation of evidence-based best practice clinical guidelines.  BCAC therefore supports the development of such guidelines and is actively participating in this process.

The policies on reimbursement of medicines must be consistent with a best practice approach.  A policy connect between guidelines being developed under the auspices of the New Zealand Guidelines Group and the Ministry of Health and the approach to reimbursement by PHARMAC and the DHBs is required.

3. Conclusion

The Breast Cancer Aotearoa Coalition (BCAC) hopes that this consultation will result in necessary focus on the issues that currently affect New Zealanders requiring access to medicines.  We believe that an effective National Medicines Strategy can be developed that will ensure better access to medicines for all New Zealanders.

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