E-drug: BMJ: Access to high cost drugs in Australia
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Editorial
Access to high cost drugs in Australia
http://bmj.bmjjournals.com/cgi/content/full/329/7463/415?etoc
Risk sharing scheme may set a new paradigm
The Australian pharmaceutical benefits scheme provides universal
subsidised access to a wide range of medicines (www.health.gov.au/pbs/).
Consumers make a co-payment of $A23.70 (�8.90; {euro}13.50) per
prescription ($A3.80 for patients who get concessions) for medicines
that cost the government more than this amount (and pay in full for
medicines that cost less than $A23.70). Prescription medicines are
assessed by the Pharmaceutical Benefits Advisory Committee, which
evaluates incremental cost effectiveness (including quality adjusted
life years) of the product compared with other treatments that the new
treatment could replace.(1) Expenditure of the pharmaceutical benefits
scheme has been rising at some 10% per year, a rate greater than any
other federal health programme, and this situation is considered by many
to be economically and politically unsustainable.(2-3) Recent listings
of costly medicines used for relatively common conditions,
underestimates of prescribing rates for drugs such as celecoxib and
omeprazole, and prescribing beyond the approved restrictions have
contributed to the increased expenditure.(4,5)
Payers in the public and private health systems face the challenge of
increasing demands for effective but expensive medicines. One approach
has been to target a subset of individuals in whom acceptable cost
effectiveness has been shown. The recent listing of etanercept for the
treatment of rheumatoid arthritis illustrates an attempt to balance
competing health, economic, societal, and ethical demands.
The listing of etanercept in the pharmaceutical benefits scheme costs
government $A1888 per month per patient.(6) It emerged from a unique
collaboration between the key stakeholders�the Pharmaceutical Benefits
Advisory Committee, the sponsor (Wyeth), rheumatologists, and consumers
(Arthritis Foundation of Australia and Arthritis Research TaskForce).
These stakeholders addressed issues of efficacy, cost effectiveness, and
possible arrangements for access. They agreed on eligibility criteria
for the initial prescription and for continuation of treatment beyond
three months.(6,7) Prescribing rights were limited to rheumatologists
and evidence was required that patients agreed to abide by a decision to
stop treatment at three months if response criteria were not met. The
Pharmaceutical Benefits Advisory Committee felt that etanercept would
achieve acceptable cost effectiveness if listed under these
restrictions.
The annual expenditure for the pharmaceutical benefits scheme from this
endeavour was predicted to be up to $A140m by the government. Wyeth
believed that outlays would "not exceed $A100m" and agreed to pay for
expenditure above this figure.(8) This risk sharing agreement provided
incentives to the sponsor to promote the drug in accordance with the
restrictions and to prescribers and consumer organisations, to avoid
leakage to individuals outside the restrictions. Other risk sharing
arrangements have been adopted elsewhere�for example, in the United
Kingdom for access to interferon beta and glatiramer acetate for
multiple sclerosis.(9)
Several questions emerge as this novel programme of access evolves. Will
the collaboration of stakeholders remain intact as the programme is
implemented? Will the agreement process for patients be acceptable and
effective? How concordant was the prediction with actual usage of the
drug and the number of eligible patients according to the criteria? How
effective will be the risk sharing agreement in containing costs but
achieving desired patient health outcomes? How does the system manage
patients who received the drug as part of a clinical trial or an early
access programme and who have shown a benefit but do not meet the
eligibility criteria for subsidy?
The key to evaluation will be accurate and timely data. National
datasets will provide information on prescription rates, but these are
not linked currently to information on health outcomes in individual
patients. The Australian Rheumatology Association has recently
established a national database to track patient outcomes over the long
term. These data will allow the stakeholders to determine whether the
restrictions are achieving the desired clinical responses.
Arrangements for access will need revision as new data emerge and other
drugs in the group are listed. The importance of the rheumatoid factor
status as a modifier of the treatment effect and the decision to exclude
patients who are negative for rheumatoid factor has been contentious.
Broadening access criteria will depend on the government's confidence
that predictions of usage are accurate, and that all stakeholders,
including those at the grass roots, embrace criteria for starting and
stopping etanercept. The unique consultation process that achieved a
consensus on access to etanercept in Australia may set a new paradigm
for ensuring equitable distribution of limited resources based on
evidence and ethical practice. It may thus allow sustainability of
publicly subsidised access to effective but expensive treatments.
Whether the collaboration is durable as the programme unfolds and the
lessons learned used to improve the system will have far reaching
consequences for publicly funded formularies such as the pharmaceutical
benefits scheme.
Christine Y Lu, postgraduate student
(Christine.lu@student.unsw.edu.au)
Ken Williams, deputy director, Ric Day, director
Therapeutics Centre, Xavier Level 2, St Vincent's Hospital,
Darlinghurst, NSW 2010, Australia
Lyn March, associate professor
University of Sydney, Institute of Bone and Joint Research, Department
of Rheumatology, Royal North Shore Hospital, St Leonards, NSW 2065,
Australia
Lloyd Sansom, chair
Pharmaceutical Benefits Advisory Committee, 39 Burnbank Grove,
Athelstone, SA 5076, Australia
James Bertouch, head
Department of Rheumatology, Prince of Wales Hospital, Randwick, NSW
2031, Australia
Competing interests appear on bmj.com
References
1. Commonwealth Department of Health and Ageing. 1995 guidelines for the
pharmaceutical industry on preparation of submissions to the
pharmaceutical benefits advisory committee: including major submissions
involving economic analyses.
www.health.gov.au/pbs/general/pubs/pharmpac/gusubpac.htm (accessed 17
Dec 2003).
2. Australian Institute of Health and Welfare. Health expenditure
Australia 2001-02. Canberra AIHW, 2003. (Health and expenditure series
no. 17)
3. Pharmaceutical benefits scheme expenditure and prescriptions.
www.health.gov.au/pbs/pharm/pubs/pbbexp/ (accessed 8 Oct 2003).
4. Rickard M, Social Policy Group. The pharmaceutical benefits scheme:
options for cost control, 28 May 2002. Department of the Parliamentary
Library, Parliament of Australia.
www.aph.gov.au/library/pubs/CIB/2001-02/02cib12.pdf (accessed 10 Oct
2003)
5. Kerr SJ, Mant A, Horn FE, McGeechan K, Sayer GP. Lessons from early
large-scale adoption of celecoxib and rofecoxib by Australian general
practitioners. Med J Aust 2003;179: 403-7.
6. Australian Government. Department of Health and Ageing. Schedule of
pharmaceutical benefits for approved pharmacists and medical
practitioners. www.health.gov.au/pbs/ (accessed 28 Aug 2003)
7. Authority to supply etanercept (Enbrel) through the Pharmaceutical
Benefits Scheme under section 85 (adults) and section 100 (juveniles) of
the National Health Act 1953. Health Insurance Commission.
www.hic.gov.au/providers/forms/pbs/mp/etanercept.htm (accessed 17 Dec
2003).
8. Noble T. Expensive arthritis drug to be subsidised. The Age 2003 June
30
www.theage.com.au/articles/2003/06/29/1056825277986.html?from=storyrhs
(accessed 17 Dec 2003).
9. Sudlow CL, Counsell, CE. Problem with UK government's risk sharing
scheme for assessing drugs for multiple sclerosis. BMJ 2003;326: 388-92.
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