PHARMAC's response on gemcitabine and transparency [1]

New Zealand Medical Journal

Volumn 118, Issue 1225, 2005, Pages

  Crausaz, Steffan ^a   Metcalfe, Scott ^b  

^a Pharmaceutical Management Agency   (New Zealand)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

GEMCITABINE;

ADVANCED CANCER; BLADDER CANCER; CANCER CHEMOTHERAPY; CANCER CONTROL; CONSULTATION; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG RESEARCH; FINANCIAL MANAGEMENT; HOSPITAL CARE; HUMAN; INTERNET; INTERPERSONAL COMMUNICATION; LETTER; QUALITY ADJUSTED LIFE YEAR;

EID: 27944431701     PISSN: 11758716     EISSN: 11758716     Source Type: Journal    
DOI: None     Document Type: Letter

References (18)

1. PHARMAC and the DHBs are currently streamlining the decision-making process, by agreeing a national budget each year for hospital cancer treatments (including baseline funding for existing treatments and funding for new investments) that will be managed by PHARMAC. This will require a consistent national dataset on current usage before this process can occur. It is currently proposed that the streamlined process start from 1 July 2007.
2. Applications considered by PTAC during 2004 and 2005 to date.
3. Historically the pharmaceutical industry has lobbied for greater transparency in PHARMAC's processes. However, when PHARMAC has consulted on making changes - such as publishing PTAC minutes as soon as signed off by the committee, or publishing hospital pharmaceutical assessments directly and openly on the PHARMAC website - the pharmaceutical industry has argued against such publication, citing right of review as a reason.
4. HPAD analyses are undertaken for DHB hospitals as part of the Hospital Pharmaceutical Assessment Process (HPAP). HPAP was established in 2002 as part of the National Hospital Pharmaceutical Strategy, to reduce duplication of work and increase discussion on the costs and benefits of new pharmaceuticals by distributing hospital pharmaceutical assessments nationally. These assessments are distributed to DHBs as confidential documents, which is at the request of and agreement with the pharmaceutical industry. PHARMAC has recently undertaken a review of the HPAP; feedback from DHBs who responded indicated that many considered that the HPAP had improved transparency, facilitated review and improved the consistency and quality of assessments. Further information on the purpose of HPAP and PHARMAC's role in the distribution of discussion documents can be found on the PHARMAC website - www.pharmac.govt.nz/hospital§rategy.asp
5. New Zealand Public Health and Disability Act 2000, Section 49 Pharmac to consult in implementing objectives and carrying out functions
6. PHARMAC. Operating policies and procedures of the Pharmaceutical Management Agency ("PHARMAC"), 2nd 0edition. January 2001. http://www.pharmac.govt.nz/pdf/opps.pdf Section 4.2 Consultation.
7. PHARMAC. Operating policies and procedures of the Pharmaceutical Management Agency ("PHARMAC"), 2nd edition. January 2001. http://www.pharmac.govt.nz/pdf/opps.pdf Section 3.3.3 "PHARMAC will carry out appropriate consultation on the classification of pharmaceuticals into therapeutic sub-groups and its application of reference pricing in respect of a particular sub-group."
8. 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
9. Taxonomy of economic analyses undertaken by PHARMAC
10. table is presented.
11. Preliminary analyses are based on the principles used by PHARMAC for pharmacoeconomic evaluations as described by the Recommended Methods to Derive Clinical Inputs for Proposals to PHARMAC (http://www.pharmac.govt.nz/pdf/61396.pdf) and PHARMAC's Prescription for Pharmacoeconomics (available online at http://www.pharmac.govt.nz/pharmo_economic.asp). These principles include: the use of overall health sector costs and direct patient costs when measuring effects on costs overall; measuring QALY gains; discounting both costs and QALY gains according to PHARMAC's current discount rate [8%]; use of univariate and multivariate sensitivity analyses; and the systematic identification, synthesis and presentation of relevant clinical input data.
12. Note however that with preliminary analyses that many data are derived opportunistically, not systematically.
13. Mathers C, Vos T, Stevenson C. The burden of disease and injury in Australia. Australian Institute of Health and Welfare. Canberra: AIHW, 1999. http://www.aihw.gov.au/publications/health/bdia.html
14. Murray CJL, Lopez AD (eds). The global burden of disease: a comprehensive assessment of mortality and disability from disease, injuries, and risk factors in 1990 and projected to 2020. Harvard School of Public Health on behalf of the World Health Organisation and the World Bank. Boston: Harvard University Press, 1996.
15. Stouthard MEA, Essink-Bot M, Bonsel GJ, Barendregt PGN, et al. Disability weights for diseases in the Netherlands. Rotterdam: Department of Public Health, Erasmus University, 1997.
16. Robinson P, von der Maase H, Bhalla S, et al. Cost-utility of the GC versus MVAC regimens for the treatment of locally advanced or metastatic bladder cancer. Expert Rev Pharmacoeconomics Outcomes Res 2004; 4: 27-38.
17. In the M-TAG/Eli Lilly analysis (Robinson et al 2004), oncology healthcare professionals were surveyed to estimate difference in quality of life between the treatment arms. The survey used willingness-to-trade-time (WTTT) as the primary measure (in weeks), reflecting the degree to which clinicians would be willing to trade reductions in life expectancy with improvements in toxicity during treatment. The total estimated WTTT included the following adverse events: febrile neutropenia requiring hospitalisation or neutropenic sepsis; alopecia (hair loss); mucositis; diarrhoea; weight loss. This gave a WTTT of 25.4 weeks, which equated to 0.13 QALYs gain (over life expectancy). However, actual utility values for each treatment arm were not derived (or at least not reported in the Robinson et al 2004 paper).
18. Extending access to gemcitabine in the Pharmaceutical Schedule for patients with advanced bladder cancer. PHARMAC Technology Assessment Report No. 66, August 2005. Official Information Act (OIA) version witholding confidential information (author's and reviewer's names and gemcitabine price information, under sections 9(2)(a) and 9(2)(b) of the OIA).