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

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Strech, Persard, Marckmann, and Danis (2009) conducted a meta-analysis of 15 quantitative surveys on rationing experiences of doctors from Canada, Italy, The Netherlands, Norway, Sweden, Switzerland, the United Kingdom and the USA. The research showed ambivalence by physicians toward micro-level rationing. The doctors demonstrated a willingness to set limits on health care to patients generally, however their willingness decreased considerably when they were asked specifically about rationing decisions informed by their own judgment of individual patients (Strech, et al., 2009). These authors concluded that considerable barriers are erected by physicians when they are required to engage in explicit micro-level rationing decisions. In a similar Swiss study conducted among 1,184 physicians by Perneger, Martin and Bovier (2002) in primary care and hospital practice, doctors were asked in a mail survey about the acceptability of making treatment choices in various rationing scenarios. The doctors were asked if they believed that micro-level rationing should be based on cost-benefit considerations alone or in combination with equity considerations. They were also asked who should make such decisions. The results showed that the Swiss doctors were more concerned about equity than cost-utility. The doctors showed stronger preferences for the equitable allocation of health services than for the maximising of health in the broader society using cost-benefit as a benchmark. Despite their strong dislike for explicit micro-level rationing on the basis of cost- benefit calculations, they preferred that physicians were in charge of all rationing decisions (Perneger, et al., 2002). Oberlander (2006) critiqued the Oregon Health Plan experience and stated that the opportunity for physicians to be open about rationing does not offer enough opportunities to reveal justice arguments. Oberlander stated that there is a real distinction between medical and non-medical determinants of distributive justice and the Oregon Health Plan failed to address the latter. To make such decisions explicitly, for example, to supply life-preserving intensive treatment or life-prolonging pharmaceuticals, requires physicians and managers to make morally defensible decisions. Swenson (1992) described how the principles of distributive justice can be used to make these calls, however concedes that denying care to patients who need care is seen as purposeful neglect which offends the doctors duty of care and in some countries (e.g., the USA), this 46
may be grounds for litigation. Hence, the great reluctance by clinicians to be open about such decision making. PHARMAC’s ‘Community Exceptional Circumstances’ Policy PHARMAC has three systems of micro-level rationing of medicines to individuals who have rare diseases or high-cost pharmaceutical needs that fall outside the national formulary. They are the Exceptional Circumstances policies; Hospital Exceptional Circumstances, Cancer Exceptional Circumstances and the Community Exceptional Circumstances scheme. Exceptional Circumstances funding has been in existence since 1994, initially provided for under Section 99 of the Medicines Act 1981 and administered by the Ministry of Health. When PHARMAC came into existence in 1994 as a shared buying agency owned by the four RHAs, the responsibility for deciding on the Exceptional Circumstances schemes was given to PHARMAC. In 2000, PHARMAC was restructured into a Crown Agency and continued to operate the Exceptional Circumstances scheme. The Community Exceptional Circumstances scheme is the focus of this thesis because it involves an individual person applying to PHARMAC for a drug subsidy. The other two schemes (Hospital and Cancer Exceptional Circumstances) are administered by PHARMAC but through decision making layers within the DHBs. PHARMAC’s Community Exceptional Circumstances policy has a clear application process, there is one committee which makes the decisions, there are appeal procedures, there is a fixed budget and there are published criteria on which the committees make their decisions. The Application Form used 12 by physicians to facilitate applying, on behalf of the patient, requires a clear identification of a wide range of information. Partially or inadequately filled out applications are not processed. The application form asks for information on the medicine being requested, the entry criteria the application is being made under and evidence of the clinical benefit 12 Available on http://www.pharmac.govt.nz/2009/06/03/1%20Application%20form%20for%20Community%20Exceptional%20Circumst ances.pdf 47
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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
Page 9 and 10: Attestation of Authorship I hereby
Page 11 and 12: I gratefully acknowledge Major Camp
Page 13 and 14: Abstract This thesis explores how g
Page 15 and 16: Chapter 1: Introduction What is thi
Page 17 and 18: making? Should a person’s level o
Page 19 and 20: there is no mathematical calculatio
Page 21 and 22: health, disability, treatment of ol
Page 23 and 24: I then moved to the subject of rati
Page 25 and 26: In Chapter 3, New Zealand’s past
Page 27 and 28: Chapter 2: Background Introduction
Page 29 and 30: The following journals have no auto
Page 31 and 32: Technological and pharmaceutical di
Page 33 and 34: in every sense, and attenuates the
Page 35 and 36: waiting time for first (or subseque
Page 37 and 38: Macro-Level Distributions Macro-lev
Page 39 and 40: (2000) in a report for the Ministry
Page 41 and 42: level, too many to discuss here. On
Page 43 and 44: effectiveness of treatment. However
Page 45 and 46: surgical treatment for ectopic preg
Page 47 and 48: In a study conducted by the Commonw
Page 49 and 50: They claim that health inequities c
Page 51 and 52: these presentations are correct, th
Page 53 and 54: waiting list for patient priority.
Page 55 and 56: care within finite resources. The c
Page 57 and 58: to pay for this co-operation. In 20
Page 59: Other results showed that 81% of th
Page 63 and 64: determine if decisions on the appli
Page 65 and 66: Chapter 4: Philosophical Framework
Page 67 and 68: extra person with a good or service
Page 69 and 70: just actions by individuals. The th
Page 71 and 72: among the members of the society, a
Page 73 and 74: example of well off and powerful pe
Page 75 and 76: necessarily much advantaged over a
Page 77 and 78: among individuals and communities.
Page 79 and 80: needs. This was because distinguish
Page 81 and 82: systematic and transparent. In her
Page 83 and 84: why PHARMAC would subsidise unecono
Page 85 and 86: parents refusing treatment for thei
Page 87 and 88: The first two test-questions covere
Page 89 and 90: There was no clarity provided by th
Page 91 and 92: good may be served by their not rec
Page 93 and 94: 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
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that the disclosure is commercially
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6. Producing the report The final o
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The following tables outline the no
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Table 3: Tree Nodes Used in NVivo A
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At this point, I stopped using NViv
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Chapter 6: Research Findings Introd
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DHBs were given the role of funding
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These measures were in response to
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Table 5: The Submitters to the Heal
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towards New Zealand and for them to
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monopolies as such. In their opinio
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for the delivery of such services (
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NCWNZ that S42(a) of the Bill, requ
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contentious among Maori Iwi. Any Ma
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Dugdale further advised that if non
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cumbersome and recommended that PHA
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following text, I have individually
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Herceptin. The plaintiffs forwarded
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the treatment of cancer in the DHB
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eligible people in New Zealand and
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confirmation that the DHB hospital
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the eight women involved in this ca
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the plaintiffs adequate opportunity
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Judge’s Concluding Remarks The fi
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A Selection of the Media Stories Ca
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Case 4: “Worn out by endless figh
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Case 6: “PHARMAC scolded for MS-d
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The drug to treat Pompe’s Disease
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The Voice of Patients and Family Me
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Sclerosis Society did this three ti
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was suffering would not pass the ra
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Eight of the twelve persons approac
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Part II: The Key Informant Intervie
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agreed this was done. Secondly, PHA
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the pharmaceutical schedule. The or
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No we have never thought that $3 mi
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Insights were given as to the indep
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and Now some people can say that’
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Q Be a voice for the family? A Yes,
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key issue here. Some clinicians wer
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I deeply suspect that Community Exc
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should be developing the capacity o
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make. And so PHARMAC has been a hug
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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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279
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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
Page 319 and 320:
Romano, C. (2009). Amartya Sen Shak
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Swedish Parliamentary Priorities Co
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