How does the operation of PHARMAC's 'Community Exceptional ...

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concerned and restricted to determining whether the public body, namely PHARMAC, acted lawfully. To illustrate this point, Justice Gendall drew from two cases 48 of judicial review proceedings. He reminded participants that the Court cannot substitute its own factual conclusions for that of the consent authority in this case, PHARMAC. It merely determines, as a matter of will, whether the proper procedures were followed by PHARMAC, with all relevant and no irrelevant considerations taken into account. The court must determine that the decision was one which, upon the basis of the material available to it, a reasonable decision maker could have made. The weight to be given to particular relevant matters is one for the decision-maker, not the court to determine, but there must be some material capable of supporting the decision (Paragraph 27 Walsh v. PHARMAC BC200860616). The Relevant Functions of PHARMAC The judge described the functions of PHARMAC as managing the Pharmaceutical Schedules which contain the list of all pharmaceuticals subsidised by the DHBs. PHARMAC also made decisions about which pharmaceuticals should be listed, the subsidies that should be paid for them and the eligibility criteria for the provision of subsidies. In order to maintain and manage the schedules, PHARMAC managed a notional budget which is set by the Minister of Health (e.g., following consultation between PHARMAC and the DHBs). This budget is notional because, apart from $3 million, it was not in fact PHARMAC who paid the subsidies, it was the DHBs. PHARMAC and the DHBs’ had come to an arrangement whereby the funding of cancer treatments was decided by PHARMAC on behalf of the DHBs. The judge reported that from the 1 st July 2007, PHARMAC established a notional budget for pharmaceutical cancer treatments of $48-$53 million. This budget level was accepted by the DHBs. Therefore, the rules regarding DHBs obligations in relation to pharmaceutical cancer treatments were contained in the PHARMAC Schedule. These rules state that DHBs provided access to pharmaceutical cancer treatments for use in 48 Progressive Enterprises Ltd v North Shore City Council [2006] NZRMA 72 and Pring v Wanganui District Council [1999} NZRMA 519 (CA) 132
the treatment of cancer in the DHB hospitals and/or in association with outpatient services provided in the DHB hospitals. The DHBs could not fund pharmaceuticals for the treatment of cancer if the treatments were not listed in the Schedule, unless the unlisted pharmaceuticals met certain criteria. However, the DHBs did provide access to unlisted pharmaceuticals for the treatment of cancer where the unlisted pharmaceutical has Cancer Exceptional Circumstances (CaEC) approval, Community Exceptional Circumstances (CEC) approval or Hospital Exceptional Circumstances (HEC) approval. The DHBs also funded the treatment under Exceptional Circumstances policies if the treatment was being used as part of a bona fide clinical trial which had Ethics Committee approval. The other criteria were that the drug could be provided by the DHB if it was being used as part of the paediatric oncology service and was prescribed to treat a child before or on 21 st July 2005. The most important factor was that if PHARMAC listed a cancer treatment on the Schedule, DHBs had no option but to fund it. Conversely, if the treatment was not on the Schedule but the drug has CaEC (or other CEC or HEC) approval from PHARMAC, the DHBs had the option to fund, or not to fund, depending on their own allocative priorities. PHARMAC’s Herceptin Decision Making The decision to fund Herceptin was referred by the PHARMAC Board to the PHARMAC Community Advisory Committee (CAC). It was also sent for examination to the Cancer Treatment Subcommittee of PHARMAC (CaTSoP). This was a panel of experts made up of cancer specialists and including other senior physicians from the New Zealand public health service. This committee was a subcommittee of PTAC. The material before the CAC included information on clinical trials, the likely cost of Herceptin and PHARMAC decision making criteria in its ‘Operating Policies and Procedures’ manual. The CAC was chaired by a community health advocate, Ms. Sandra Coney. The following is a quote from the minutes of the CAC committee meeting: The committee noted the benefits of Herceptin may not be as great as stated by the patient community groups lobbying for funded access. The 133
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How does the operation of PHARMAC
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Applying the Test-Questions .......
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Appendix 9: Analysis of Material Re
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List of Abbreviations ABS Australia
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Attestation of Authorship I hereby
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I gratefully acknowledge Major Camp
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Abstract This thesis explores how g
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Chapter 1: Introduction What is thi
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making? Should a person’s level o
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there is no mathematical calculatio
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health, disability, treatment of ol
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I then moved to the subject of rati
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In Chapter 3, New Zealand’s past
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Chapter 2: Background Introduction
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The following journals have no auto
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Technological and pharmaceutical di
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in every sense, and attenuates the
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waiting time for first (or subseque
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Macro-Level Distributions Macro-lev
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(2000) in a report for the Ministry
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level, too many to discuss here. On
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effectiveness of treatment. However
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surgical treatment for ectopic preg
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In a study conducted by the Commonw
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They claim that health inequities c
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these presentations are correct, th
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waiting list for patient priority.
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care within finite resources. The c
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to pay for this co-operation. In 20
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Other results showed that 81% of th
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may be grounds for litigation. Henc
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determine if decisions on the appli
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Chapter 4: Philosophical Framework
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extra person with a good or service
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just actions by individuals. The th
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among the members of the society, a
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example of well off and powerful pe
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necessarily much advantaged over a
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among individuals and communities.
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needs. This was because distinguish
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systematic and transparent. In her
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why PHARMAC would subsidise unecono
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parents refusing treatment for thei
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The first two test-questions covere
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There was no clarity provided by th
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good may be served by their not rec
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Evans (2003) ranked the various typ
Page 95 and 96: The Use of the Test-Questions in Th
Page 97 and 98: Qualitative research methods were d
Page 99 and 100: equirements and considerable politi
Page 101 and 102: material and by working through the
Page 103 and 104: and printed copies of Hansard are a
Page 105 and 106: PHARMAC was criticised in 16 of the
Page 107 and 108: I tried to find an interviewee from
Page 109 and 110: The flow of discussion in the inter
Page 111 and 112: that the disclosure is commercially
Page 113 and 114: 6. Producing the report The final o
Page 115 and 116: The following tables outline the no
Page 117 and 118: Table 3: Tree Nodes Used in NVivo A
Page 119 and 120: At this point, I stopped using NViv
Page 121 and 122: Chapter 6: Research Findings Introd
Page 123 and 124: DHBs were given the role of funding
Page 125 and 126: These measures were in response to
Page 127 and 128: Table 5: The Submitters to the Heal
Page 129 and 130: towards New Zealand and for them to
Page 131 and 132: monopolies as such. In their opinio
Page 133 and 134: for the delivery of such services (
Page 135 and 136: NCWNZ that S42(a) of the Bill, requ
Page 137 and 138: contentious among Maori Iwi. Any Ma
Page 139 and 140: Dugdale further advised that if non
Page 141 and 142: cumbersome and recommended that PHA
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Page 145: Herceptin. The plaintiffs forwarded
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Page 151 and 152: confirmation that the DHB hospital
Page 153 and 154: the eight women involved in this ca
Page 155 and 156: the plaintiffs adequate opportunity
Page 157 and 158: Judge’s Concluding Remarks The fi
Page 159 and 160: A Selection of the Media Stories Ca
Page 161 and 162: Case 4: “Worn out by endless figh
Page 163 and 164: Case 6: “PHARMAC scolded for MS-d
Page 165 and 166: The drug to treat Pompe’s Disease
Page 167 and 168: The Voice of Patients and Family Me
Page 169 and 170: Sclerosis Society did this three ti
Page 171 and 172: was suffering would not pass the ra
Page 173 and 174: Eight of the twelve persons approac
Page 175 and 176: Part II: The Key Informant Intervie
Page 177 and 178: agreed this was done. Secondly, PHA
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Page 181 and 182: No we have never thought that $3 mi
Page 183 and 184: Insights were given as to the indep
Page 185 and 186: and Now some people can say that’
Page 187 and 188: Q Be a voice for the family? A Yes,
Page 189 and 190: key issue here. Some clinicians wer
Page 191 and 192: I deeply suspect that Community Exc
Page 193 and 194: should be developing the capacity o
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and PHARMAC is not above rationing
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This case demonstrated that the cos
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and budget management. It says this
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Q Do you recall the Kaletra issues
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Q Can I ask you about PHARMAC’s c
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….successfully…for things espec
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This was also done for the hard cop
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The Ministry of Health could not lo
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consultation documents which relate
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The following information was recei
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with the application. The discharge
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Again no report was attached from t
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The patient was also prescribed pre
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circumstances described were not su
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treatment was not unusual and the c
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their clinical circumstances would
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Theme 1. Theme 2. Theme 3. Theme 4.
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Chapter 7: Discussion Introduction
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the intellectual property to recove
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The use of QALY’s was tested in t
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Test-Question 2 “Is this distribu
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claimants (and unsuccessful drug co
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(2011-2012) in an open and transpar
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The cost-utility analysis system ha
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Another form of decision making use
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discuss how (or if) PHARMAC meets t
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Test-question 4 also raises the pro
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when there is no profound evidence
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for example value for money, equity
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Community Exceptional Circumstances
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Interferon available to a limited n
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challenges are multiple: to identif
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The data from the research showed h
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PHARMAC could be more open about st
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Chapter 8: Conclusions Introduction
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Limitations to the Research The ite
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There is no one set of indefeasible
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to alcohol and drug treatment or th
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well placed to lead further researc
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utilitarian principles of attemptin
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stand up to the same rigorous clini
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Appendices: Appendix 1: Ethics Appr
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Appendix 2: Key Informant Participa
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Appendix 3: Key Informant Consent F
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Appendix 4: Sample Interview Questi
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Appendix 5: OIA Request Greg Coyle
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Appendix 6: OIA Response from PHARM
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Appendix 7: Community Exceptional C
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Appendix 8: Community Exceptional C
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Ashton, T., & St John, S. (2008). N
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Cohen, G. A. (2008). Rescuing Justi
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Dew, K., Cumming, J., McLeod, D., M
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Glubb, N. (2011). Official Informat
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Holt, S., Harwood, M., Aldington, S
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Lindblom, C. E. (1959). The Science
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http://www.moh.govt.nz/moh.nsf/ea60
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Cash Flows (Ed.), Government of New
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PB/132 National Council of Women of
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Romano, C. (2009). Amartya Sen Shak
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Swedish Parliamentary Priorities Co
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