PHARMAC's response on temozolomide and funding costly medicines that prolong life shortly [3]

New Zealand Medical Journal

Volumn 118, Issue 1227, 2005, Pages

  Metcalfe, Scott ^a   Crausaz, Steffan ^a   Moodie, Peter ^a   McNee, Wayne ^a  

^a PHARMAC ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

TEMOZOLOMIDE; TRASTUZUMAB;

BREAST CANCER; BUDGET; CANCER PATIENT; CANCER SURVIVAL; COST BENEFIT ANALYSIS; DRUG COST; DRUG INDUSTRY; ECONOMIC EVALUATION; GLIOBLASTOMA; HEALTH CARE COST; HEALTH CARE ORGANIZATION; HEALTH PROGRAM; HOSPITAL COST; HUMAN; LETTER; LIFE EXPECTANCY; MEDICAL DECISION MAKING; MEDICAL SOCIETY; NEW ZEALAND; RESOURCE ALLOCATION; TREATMENT OUTCOME;

EID: 29844442729     PISSN: 11758716     EISSN: 11758716     Source Type: Journal    
DOI: None     Document Type: Letter

References (9)

1. PHARMAC. Operating policies and procedures of the Pharmaceutical Management Agency ("PHARMAC"), 2nd edition. January 2001. http://www.pharmac.govt.nz/pdf/opps.pdf Section 2.2 Decision Criteria
2. PHARMAC. A prescription for pharmacoeconomic analysis (version 1.1). September 2004. URL: http://www.pharmac.govt.nz/pdf/pfpa.pdf
3. Milne R. Valuing prevention: discounting health benefits and costs in New Zealand. N Z Med J. 2005;118(1214). URL: http://www.nzma.org.nz/journal/118-1214/1443/
4. Metcalfe S, Brougham M, Moodie P, Grocott R. PHARMAC responds to Richard Milne on discounting health benefits and costs. N Z Med J. 2005;118(1219). URL: http://www.nzma.org.nz/journal/118-1219/1601/
5. Milne R. Richard Milne responds to PHARMAC on discounting future health benefits and costs. N Z Med J. 2005;118(1220). URL: http://www.nzma.org.nz/journal/118-1220/1620/
6. Metcalfe S, Dougherty S, Brougham M, Moodie P. PHARMAC measures savings elsewhere to the health sector. N Z Med J. 2003;116(1170). URL: http://www.nzma.org.nz/journal/116-1170/362/
7. Stupp R, Mason WP, van den Bent MJ, et al; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concurrent and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987-96. Abstract online at http://content.nejm.org/cgi/content/full/352/10/987
8. Athanassiou H, Synodinou M, Maragoudakis E, et al. Randomized phase II study of temozolomide and radiotherapy compared with radiotherapy alone in newly diagnosed glioblastoma multiforme. J Clin Oncol. 2005;23:2372-7.
9. PTAC reviewed the application from Schering-Plough and advice received from CaTSoP at its November scheduled meeting. PTAC considered both the Stupp et al 2005 and Athanassiou et al 2005 RCTs - both being on the use of temozolomide as adjunctive therapy in combination with radiotherapy in patients with newly diagnosed glioblastoma multiforme, but with their patient populations differing in the extent of disease progression at randomisation (the patients in the study by Stupp et al had a generally higher performance status than those in Athanassiou et al). PTAC considered that the patient population in Athanassiou et al would be more representative of the patients presenting with glioblastoma multiforme in NZ. PTAC considered that the available evidence demonstrated that some patients obtain a considerable benefit, with an additional 15% of patients surviving at 2 years compared with radiotherapy alone (median survival benefit 2.5-5.7 months). However, PTAC considered the majority of patients would obtain little benefit from treatment with temozolomide, and that it was appropriate to examine targeting of treatment to those patients likely to benefit from treatment with temozolomide. PTAC considered that, from the data provided, patients with higher performance status (Karnofsky score >80, WHO score 0 or 1) obtained significant benefit with temozolomide treatment; tumour resection (rather than biopsy with no resection) was also predictive of a response. PTAC recommended that temozolomide should be listed on the Pharmaceutical Schedule for the adjuvant treatment of newly diagnosed glioblastoma multiforme in combination with radiotherapy. PTAC recommended that subsidy should be targeted to this patient group possibly by means of a Special Authority. PTAC considered that patients should have a good performance status (Karnofsky score >80 or WHO score 0 or 1) at diagnosis, and preferably a resectable or partially resectable tumour. PTAC gave a high priority to this recommendation. PTAC considered that CaTSoP should review any criteria. PTAC considered that a low priority should be given to funding under criteria that included a poor performance score (Karnofsky score <80 or WHO score 2). PTAC also recommended that approvals for funding should be restricted to the initial treatment in combination with radiotherapy followed by a maximum of six cycles of temozolomide.