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

More documents

Recommendations

Info

The rarity is estimated by the GP to be 1:1000. No material was provided to the Panel to substantiate the rarity claim. Notwithstanding the lack of corroborating evidence, 1:1000 is estimated to be 3,500 people suffering this condition in New Zealand at one time. There are more that 10 people suffering asthma or the unusual circumstances the GP describes. The GP did not provide any journal articles to show that Singulair is safe or effective in these clinical circumstances. No specialist report is provided the Panel only a discharge summary from Gisborne Hospital and two GP referral letters. The Panel refused the Community Exceptional Circumstances claim on the grounds that asthma is not a rare condition. There is no comment from the Panel to indicate if the patient’s clinical circumstances are considered rare. Case No. 7 (OIA Document No. 87) June 2010. This claim from a GP was on behalf of a woman who was suffering Barrett’s Esophagus with gastro-oesophageal reflux. The claim was for the drug Losec (Omeprazole) at a projected cost of $169.00 per year. The claim made under the criterion that reaction to an alternative treatment is unusual. The treatments she had tried were Omeprazole, Pantraprazole, Ranitadine and Famotadine which were all ineffective in controlling her reflux. The GP states that the rarity factor is unknown. No journal article is provided to demonstrate that the drug requested is safe and effective treatment for the condition the patient is suffering. A report from an investigative procedure, an Oesophagal–Gastro Duodenoscopy, confirmed very minor evidence of Barrett’s disease and little else was seen. The specialist requested that the patient remain on Omeprazole. In essence this claim was about the patient wanting funding for a different brand of Omeprazole. The claim was denied. The GP was informed that the claim did not meet the criteria for Community Exceptional Circumstances in that the condition was not rare, the response to alternative treatment was not unusual and the clinical 208
circumstances described were not sufficiently unusual. Again, no reason, ground, rationale or elaboration on the criteria by the Panel was given. Case No. 8 (OIA Document No. 88) June 2010. This claim is made by a GP on behalf of a patient who was suffering from psoriatic arthritis and depression. The Community Exceptional Circumstances claim was made for a drug named Lyprinol, otherwise known as New Zealand Green Lipped Mussel Lipid Extract. The patient was taking Ibuprofen and Diclofenac and this medication was giving her diarrhoea and stomach ulcers. The GP wanted to try her on Lyprinol because he claimed that these are unusual clinical circumstances prevailing as a result of the current treatment. The drug Lyprinol is not registered in New Zealand but it is registered for prescription in Australia. PHARMAC have removed the name of the specialist from this document, however the words “Rheumatologist ….refer to OPD letter…” (Exceptional Circumstances Panel 2010) can be made out in the document supplied. This indicates that a specialist letter has been provided to the Panel but has been withheld in the OIA response. This is a shame because the specialist opinion would have been informative about the special circumstances which may or may not have applied. The GP has provided eight published papers including journal articles to support the safety and clinical effectiveness of Lyprinol 66 . These were: 1. An advertising flyer discussing the benefits of Lyprinol. 2. Certificate of Medicine Listing by the Therapeutic Goods Administration , Commonwealth Department of Health and Aging, Australia 67 . 3. Blackmore’s Lyprinol packet information. A study conducted at the Hong Kong Polytechnic University, Hong Kong SAR, China, by Chi-Ho, Hon-Kei Lum, Kin-Cheung Ng, McKay, Kwock-Chu Butt, Wong, and Chun-Lap Lo (2007) was published in eCAM Advanced Access on September 26th 2007. This is a clinical report of a randomised trial testing the effectiveness of Diclofenac, Lyprinol and a control of olive oil. The trial was carried out on adjuvant induced arthritis rats. The study confirmed the anti- 66 In fact the only claimant of the 8 cases discussed in this section to provide journal articles in support of the application. 67 Equivalent to Medsafe in New Zealand 209
Page 1 and 2:
How does the operation of PHARMAC
Page 3 and 4:
Applying the Test-Questions .......
Page 5 and 6:
Appendix 9: Analysis of Material Re
Page 7 and 8:
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 and 60:
Other results showed that 81% of th
Page 61 and 62:
may be grounds for litigation. Henc
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
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
Page 143 and 144:
following text, I have individually
Page 145 and 146:
Herceptin. The plaintiffs forwarded
Page 147 and 148:
the treatment of cancer in the DHB
Page 149 and 150:
eligible people in New Zealand and
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
Page 179 and 180: the pharmaceutical schedule. The or
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
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: The patient was also prescribed pre
Page 225 and 226: treatment was not unusual and the c
Page 227 and 228: their clinical circumstances would
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
Page 251 and 252: when there is no profound evidence
Page 253 and 254: for example value for money, equity
Page 255 and 256: Community Exceptional Circumstances
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
Page 273 and 274:
well placed to lead further researc
Page 275 and 276:
utilitarian principles of attemptin
Page 277 and 278:
stand up to the same rigorous clini
Page 279 and 280:
Appendices: Appendix 1: Ethics Appr
Page 281 and 282:
Appendix 2: Key Informant Participa
Page 283 and 284:
Appendix 3: Key Informant Consent F
Page 285 and 286:
Appendix 4: Sample Interview Questi
Page 287 and 288:
Appendix 5: OIA Request Greg Coyle
Page 289 and 290:
Appendix 6: OIA Response from PHARM
Page 291 and 292:
Appendix 7: Community Exceptional C
Page 293 and 294:
279
Page 295 and 296:
281
Page 297 and 298:
283
Page 299 and 300:
Appendix 8: Community Exceptional C
Page 301 and 302:
Ashton, T., & St John, S. (2008). N
Page 303 and 304:
Cohen, G. A. (2008). Rescuing Justi
Page 305 and 306:
Dew, K., Cumming, J., McLeod, D., M
Page 307 and 308:
Glubb, N. (2011). Official Informat
Page 309 and 310:
Holt, S., Harwood, M., Aldington, S
Page 311 and 312:
Lindblom, C. E. (1959). The Science
Page 313 and 314:
http://www.moh.govt.nz/moh.nsf/ea60
Page 315 and 316:
Cash Flows (Ed.), Government of New
Page 317 and 318:
PB/132 National Council of Women of
Page 319 and 320:
Romano, C. (2009). Amartya Sen Shak
Page 321 and 322:
Swedish Parliamentary Priorities Co
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?