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

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The review was initiated following the recommendations of the Report of the High-Cost, Highly Specialised Medicines Review Panel commissioned by the Minister of Health in 2009. PHARMAC stated that the Review of PHARMAC’s Exceptional Circumstances Policy was an opportunity to measure its implementation of the Medicines New Zealand Strategy document of the Ministry of Health and the accompanying action plan Actioning Medicines New Zealand. The strategy states that the government aims to take “account of and balanced against other health priorities, the medicines system is required to be responsive to individual variation, within a population focus” (Ministry of Health, 2006). PHARMAC sought a broad range of feedback for industry and community stakeholders on the purpose of providing Exceptional Circumstances funding, a description of what constitutes exceptional and the preferred operational arrangements for the administration of funding under the Exceptional Circumstances policy. In January 2011 PHARMAC published a document named the Review of Exceptional Circumstances; Consultation on Proposed Changes. In this document, PHARMAC outlined the nature of the feedback it had received in the review and the proposed changes to the existing Exceptional Circumstances policy. PHARMAC is seeking more feedback on these proposed changes and intends to have final Board recommendations available by late 2011. In the consultation document PHARMAC proposed to abandon the current Exceptional Circumstances schemes (Hospital Exceptional Circumstances, Cancer Exceptional Circumstances and Community Exceptional Circumstances) and replace them with one new policy: Named Patient Pharmaceutical Assessment (NPPA). This scheme would have three pathways: 1. Unique Clinical Circumstances (UCC) 2. Urgent Assessment (UA) 3. Hospital Pharmaceuticals in the Community (HPC) The UCC scheme is proposed to provide for individuals with serious and unique clinical conditions. These patients would not be part of a similar group in that 212
their clinical circumstances would differ from all others seeking that particular treatment. It appears PHARMAC is recommending an abolition of the ‘10 cases’ rule to determine rarity and instead are recommending that clinical uniqueness be the entry criteria. PHARMAC states that in order to meet its statutory obligations, PHARMAC will assess whether they should fund treatments for people in this position. The scheme makes no reference to the principles of distributive justice. The details of how UCC claims will be assessed have not been determined yet, but it is likely that PHARMAC will appoint a Panel to decide on each claim against its nine decision making criteria. Unless there is explicitness as to why the Panel reaches their decisions and openness in communicating these decisions to the claimants and the public, little will have changed from the current operation of the Community Exceptional Circumstances policy. The UA scheme is a proposed pathway for individuals with serious conditions who might experience a rapid deterioration in their health or lose the opportunity for a quality of life improvement unless the treatment is provided. The patients in this category would be part of a group of patients with similar conditions where the treatment is potentially life-saving. It is likely that the treatment being applied for under the UA would also be subject to a full Schedule listing approval process. In these terms, the UA is to manage the requests for urgent treatment before the drugs can be listed on the Schedule. If the drug is assessed for listing on the Schedule and declined, then the UA subsidy for individuals who have been granted treatment under UA would be discontinued. PHARMAC state that this is because a patient in this position would be in no different position than a patient waiting for the Schedule approval for any other drug. PHARMAC also proposed to set out the prerequisite criteria before an application can even be considered under the three new proposed schemes. Meeting the prerequisite conditions would not guarantee the approval of the claim; it simply means that the claim would be passed to the relevant panel for assessment. In future, PHARMAC will not consider any application for UCC if the drug in question is pending a decision for listing on the Pharmaceutical Schedule. 213
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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
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The Use of the Test-Questions in Th
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Qualitative research methods were d
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equirements and considerable politi
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material and by working through the
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and printed copies of Hansard are a
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PHARMAC was criticised in 16 of the
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I tried to find an interviewee from
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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
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
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Page 195 and 196: make. And so PHARMAC has been a hug
Page 197 and 198: and PHARMAC is not above rationing
Page 199 and 200: This case demonstrated that the cos
Page 201 and 202: and budget management. It says this
Page 203 and 204: Q Do you recall the Kaletra issues
Page 205 and 206: Q Can I ask you about PHARMAC’s c
Page 207 and 208: ….successfully…for things espec
Page 209 and 210: This was also done for the hard cop
Page 211 and 212: The Ministry of Health could not lo
Page 213 and 214: consultation documents which relate
Page 215 and 216: The following information was recei
Page 217 and 218: with the application. The discharge
Page 219 and 220: Again no report was attached from t
Page 221 and 222: The patient was also prescribed pre
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Page 225: treatment was not unusual and the c
Page 229 and 230: Theme 1. Theme 2. Theme 3. Theme 4.
Page 231 and 232: Chapter 7: Discussion Introduction
Page 233 and 234: the intellectual property to recove
Page 235 and 236: The use of QALY’s was tested in t
Page 237 and 238: Test-Question 2 “Is this distribu
Page 239 and 240: claimants (and unsuccessful drug co
Page 241 and 242: (2011-2012) in an open and transpar
Page 243 and 244: The cost-utility analysis system ha
Page 245 and 246: Another form of decision making use
Page 247 and 248: discuss how (or if) PHARMAC meets t
Page 249 and 250: Test-question 4 also raises the pro
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Page 253 and 254: for example value for money, equity
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Page 257 and 258: Interferon available to a limited n
Page 259 and 260: challenges are multiple: to identif
Page 261 and 262: The data from the research showed h
Page 263 and 264: PHARMAC could be more open about st
Page 265 and 266: Chapter 8: Conclusions Introduction
Page 267 and 268: Limitations to the Research The ite
Page 269 and 270: There is no one set of indefeasible
Page 271 and 272: to alcohol and drug treatment or th
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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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