Access to High Cost Medicines in Australian Hospitals
Abstract: In the public hospital sector in Australia there is no dedicated scheme to offset costs associated with high cost medications (HCMs) to the institution or the public. (1) Concerns exist as to the equity of access and appropriate mechanisms to manage access to HCMs in public hospitals. (2) There are gaps in the literature as to how decisions are made, and in particular, decision-making processes by which ethical, clinical and economic considerations maybe taken into account. To date, limited work has been conducted regarding the use and funding of HCMs in public hospitals. There are no published data on perceptions, concerns and attitudes, among health care decision-makers or among the community-at-large about access to HCMs in public hospitals. The research reported in this thesis describes the decision-making process and criteria used by health care decision-makers to allocate resources to HCMs in public hospitals. The investigation triangulated quantitative and qualitative methods used to collect and analyse data. Four studies were conducted to describe the decision-making process and explore the perceptions, concerns and attitudes of health care decision-makers and the perceptions of members of the general public regarding access to HCMs in public hospitals. The first study, reported in Chapter Three, was a review of individual patient use (IPU) requests for non-formulary HCMs. This study showed that these requests had a significant impact on the capped expenditure of a public hospital. Subsequent to this review, a new policy and procedure for managing requests for HCMs for IPU was established. A high-cost drugs subcommittee (HCD-SC) operating under the auspices of the Drug and Therapeutics Committee (DTC) was created. The second study, reported in Chapter Four, described the operations of the newly formed HCD-SC. This study also evaluated the decision-making process using the ethical framework “accountability for reasonableness”. (3) Different factors were involved in decisions about access to HCMs and decisions were not solely based on effectiveness and cost. HCD-SC members considered it was important to have consistency in the way decisions were being made. The evaluation of this process allowed identification of good practices and gaps which were considered as opportunities for improvement. The third study, reported in Chapter Five, found that health care decision-makers in an Area Health Service echoed the concerns and agreed about the problems associated with access to HCMs expressed by the HCD-SC members. These studies concluded that the majority of decision-makers wanted an explicit, systematic process to allocate resources to HCMs. These studies also identified tensions between funding systems and hospital decision-making. According to participants there were no mechanisms in place to systematically capture, analyse and share the lessons learned between the macro level (ie. Federal, Pharmaceutical Benefits Scheme - PBS) and the meso level (ie. Institution, public hospital) regarding funding for HCMs. Furthermore, decision-makers considered there are strong incentives for cost-shifting between the Commonwealth and the States. Health care decision-makers also acknowledged the importance of public participation in decision-making regarding allocation of resources to HCMs in public hospitals. However the results of these studies showed that those decisions were not generally made in consultation with the community. Decision-makers perceived that the general public does not have good general knowledge about access to HCMs in public hospitals. A survey of members of the general public, reported in Chapter Six, was then conducted. The survey aimed to gather information about the knowledge and views of members of the general public about access to HCMs in public hospitals. Results of this fourth study showed that respondents had good general knowledge but were poorly informed about the specifics of funding of hospitals and HCMs in private and public hospitals. The results also offered support for the development of a process to involve community members in discussion on policy on the provision of treatment and services within health care institutions and specifically, to seek the views of members of the public on the provision of HCMs and expensive services within public hospitals. In summary, the research reported in this thesis has addressed the gaps in the literature as to how decisions are made, and in particular, the decision-making process and criteria used by health care decision-makers to allocate resources to HCMs in public hospitals. In a move towards more explicitness in decision-making regarding the allocation of scarce health care resources, the findings from these studies provide an evidence base for developing strategies to improve decision-making processes regarding access to HCMs the public sector Table of Contents STATEMENT OF ORIGINALITY ACKNOWLEDGEMENTS COMMUNICATIONS ARISING FROM THIS THESIS ABSTRACT LIST OF FIGURES LIST OF APPENDICES GLOSSARY OF ABBREVIATIONS PREFACE. 1. THE AUSTRALIAN HEALTH CARE SYSTEM AND HIGH COST MEDICATIONS (HCMS) 1.1 Introduction 1.2 The Australian Health Care System 1.3 Pharmaceuticals 1.3.1 Availability of Pharmaceuticals in Australia 1.3.2 Registration 1.3.3 Subsidy 1.3.3.1 The Pharmaceutical Benefits Scheme (PBS 1.3.3.1.1 Section 85 1.3.3.1.2 Section 100 Highly Specialised Drug Program (S100-HSD 1.3.4 Other Categories of Access 1.3.4.1 Orphan Medications 1.3.4.2 Lifesaving Medications 1.3.4.3 Unapproved medications 1.3.4.3.1 Special Access Scheme (SAS 1.3.4.3.2 Clinical Trials (CTN and CTX Schemes) 1.3.4.3.3 Importation for personal use 1.3.5 Hospitals 1.3.5.1 Access to pharmaceuticals in private hospitals 1.3.5.2 Access to pharmaceuticals in public hospitals 1.4 High Cost Medications (HCMs 1.4.1 Definitions of HCMs in Australia 2. DECISION-MAKING AND PRIORITY SETTING IN HEALTH CARE 2.1 Introduction 2.2 Levels of Decision-making priority setting in health care 2.2.1 Macro – Government level 2.2.2 Meso – Hospital or Institution 2.2.2.1 Hospital Drug and Therapeutics Committees (DTCs) 2.2.2.2 Australian Hospital Drug and Therapeutics Committees 2.2.3 Micro- Individual 2.3 Decision-making priority setting in health care and the general public 2.4 Decision-making priority setting in health care and ethics. 3. THE FINANCIAL IMPACT OF APPROVAL OF MEDICATIONS FOR INDIVIDUAL PATIENT USE (IPU) IN A PUBLIC HOSPITAL 3.1 Introduction 3.2 Aim 3.2.1 Methods 3.2.1.1 Setting 3.2.2 Data Collection 3.2.3 Data Analysis and Statistics 3.3 Results 3.4 Discussion 4. ALLOCATING RESOURCES TO HIGH COST MEDICATIONS (HCMS) IN PUBLIC HOSPITALS. THE ROLE OF A HIGH COST DRUG SUBCOMMITTEE (HCD-SC 4.1 Introduction 4.2 Aim 4.3 Methods 4.3.1 Selection of methods 4.3.1.1 Quantitative research 4.3.1.2 Qualitative research 4.3.1.3 Case study 4.3.1.3.1 Triangulation in Case Studies 4.3.1.3.2 Semi-structured Interviews in Case Studies 4.3.1.3.3 Direct Observations in Case Studies 4.3.1.3.4 Document Review in Case Studies 4.3.2 Data Collection 4.3.2.1 Ethical considerations 4.3.3 Data analysis 4.3.3.1 Demographic data 4.3.3.2 Transcription and thematic analysis 4.3.3.3 Validity 4.3.3.4 Reliability 4.4 Results 4.4.1 Document Review and Observations 4.4.2 Interviews 4.5 Discussion 5. DECISION-MAKERS’ VIEWS ABOUT ACCESS TO HIGH COST MEDICATIONS (HCMS) IN PUBLIC HOSPITALS. 5.1 Introduction 5.2 Aims and objectives 5.3 Methods 5.3.1 Selection of methods 5.3.1.1 Grounded Theory 5.3.1.2 In-depth interviews 5.3.2 Setting 5.3.3 Sampling 5.3.4 Recruitment 5.3.5 Data collection 5.3.5.1 Interview Process 5.3.5.2 Demographic characteristics 5.3.6 Data analysis 5.3.6.1 Qualitative data 5.3.6.2 Validity and reliability 5.3.6.3 Quantitative data 5.3.7 Ethics 5.3.8 Funding 5.4 Results 5.4.1 Study participants 5.4.2 Themes 5.4.2.1 High Cost Medications 5.4.2.2 Cost 5.4.2.3 The decision-making process 5.4.2.3.1 Consistency and Transparency 5.4.2.4 Criteria 5.4.2.5 Problems and concerns 5.4.2.6 Solutions 5.5 Discussion 5.5.1 High Cost Medications 5.5.2 The decision-making process 5.5.2.1 Consistency and Transparency 5.5.3 Criteria 5.5.4 Problems and concerns 5.5.5 Solutions 6. ACCESS TO HIGH COST MEDICATIONS (HCMS) IN PUBLIC HOSPITALS. PERCEPTIONS OF MEMBERS OF THE GENERAL PUBLIC. 6.1 Introduction 6.2 Aim 6.3 Methods 6.3.1 Selection of Method 6.3.1.1 Self-administered surveys 6.3.2 Sample selection 6.3.2.1 Sample size 6.3.3 Eligibility criteria 6.3.4 Questionnaire development 6.3.5 Pilot testing 6.4 Data Collection and Analysis 6.4.1 Quantitative data 6.4.2 Qualitative data 6.5 Ethics 6.6 Results 6.6.1 Demographics 6.6.2 Health and health services 6.6.3 Knowledge about access to HCMs in public hospitals 6.6.4 Factors & choices 6.7 Discussion 6.7.1 Knowledge 6.7.2 Factors and choices 6.7.3 Demographics 7. SUMMARY AND FUTURE DIRECTIONS REFERENCES LIST OF APPENDICES Access to High Cost Medicines in Australian Hospitals (Tiếp cận với thuốc Chi phí cao trong các bệnh viện Úc)
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249
List of appendices
APPENDIX 4.1...................................................................................................... 250
Summary of decisions and rationales by the High Cost Drug Subcommittee
(HCD-SC). (December 2002 – December 2003) ............................................... 250
APPENDIX 4.2...................................................................................................... 259
Designation of levels of evidence ...................................................................... 259
APPENDIX 4.3...................................................................................................... 260
Terms of reference of the HCD Sub Committee of SVH Drug Committee 2002 260
APPENDIX 5.1...................................................................................................... 261
Invitation to participate in decision-makers study .............................................. 261
APPENDIX 5.2...................................................................................................... 262
Reminder letter decision-makers’ study............................................................. 262
APPENDIX 5.3...................................................................................................... 263
Consent form ..................................................................................................... 263
APPENDIX 5.4...................................................................................................... 264
Participant information sheet ............................................................................. 264
APPENDIX 5.5...................................................................................................... 266
In-depth Interview Study - Interview Guide ........................................................ 266
APPENDIX 5.6...................................................................................................... 268
Example of Transcript File ................................................................................. 268
APPENDIX 6.1...................................................................................................... 269
Questionnaire used in general public survey ..................................................... 269
APPENDIX 6.2...................................................................................................... 275
Participant information statement general public survey ................................... 275
250
Appendix 4.1
Summary of decisions and rationales by the High Cost Drug
Subcommittee (HCD-SC). (December 2002 – December 2003)
Decision 1. Temozolomide in Acute Myeloid Leukaemia as second line therapy.
Individual request (IPU) for two patients.
A Phase I study was presented. Results showed that nine of the 20 patients treated
with temazolomide for relapse/refractory acute leukaemia had a significant
decrease in bone marrow blasts. The medication was thought to be less cardiotoxic
than alternative available treatment. The medication was an oral treatment.
Due to concerns about the potential number of eligible patients that could be
treated, the committee decided to give approval for use of temazolamide in five
patients in a given year for up to two courses of therapy each. A report of outcomes
was required to be submitted to the HCD-SC before further courses would be
provided. The cost of temozolamide was approximately A$5,000 per patient per
year compared to approximately A$3,500 for traditional therapy.
Decision 2. Linezolid for MRSA (Methicillin-Resistant Staphylococcus aureus).
(IPU)
Treatment with linezolid was requested for a 72-year-old patient who developed
MRSA infection of hip prosthesis. The request was for linezolid 600 mg twice a day
for six weeks. Previous therapy included vancomycin for three weeks plus
rifampicin and fusidic acid for three weeks. Rifampicin was thought to be associated
251
with a severe skin rash. After consultation with the head of Division of Microbiology,
approval was given for the patient to receive linezolid (cost A$15,170). The
Committee considered this was the only option for the patient. It was considered
appropriate that the patient should have rifampicin desensitisation in the future.
Decision 3. Infliximab for severe refractory Crohn’s disease.
The DTC committee had previously added Infliximab to the SVH formulary for
refractory severe Crohn’s ileocolitis and fistulizing Crohn’s disease with the
following conditions:
• Only one authorised prescriber and an Individual Patient Use Request form
was required.
• A multidisciplinary team was going to be responsible for each approval (Dr.
XX , Prof YY, a surgeon and a pharmacist)
• Criteria needed to be developed.
• The number of doses and regimen required for maintenance had to be
specified before the application would be considered.
• A maximum of A$50,000 was allocated to this program in one year.
Treatment was requested for two new patients (case 1 and 2) and one ongoing
(case 3). The Unit had A$50,000 allocated for this program in a given year. The unit
had already spent A$46,000.
252
Case 1. Eighteen year old patient with severe refractory Crohn’s disease, on
steroids and azathioprine, with active and difficult to control disease. His family
decided to pay for infliximab and he received his first dose in December 2002 with
good initial response. Physician wrote “His family is likely to continue scraping
money together for the maintenance doses but it is obviously a big financial impost.
I appreciate that the high cost drug committee is in an invidious position but is there
any possibilities of supporting this man and his family?”
Case 2. Thirty six year old HIV patient with refractory fistulising perianal Crohn’s
disease. Physician wrote “Apart from infliximab therapy the only other option is
diverting stoma. There is little data re infliximab in HIV patients. The goals of the
treatment are to stop fistulae discharge and recurrent perianal sepsis, allow better
qol (Quality of life), avert need for diverting stoma and return to work in unbroken
[sic] fashion. “
Case 3. Patient started treatment a year ago and physician reported positive
outcome with treatment. “Brilliant response, needing only two doses in 12 months.”
After two meetings considering these cases the committee decided to approve
ongoing supply for case three. Treatment for cases one and two were approved if
infliximab supply was within the approved A$50,000 per year budget assigned to
the program for Crohn’s disease.
253
Decision 4. Infliximab for Rheumatoid Arthritis (RA). (IPU)
It was previously agreed that the hospital could no longer provide infliximab for
ambulatory arthritis patients. The physician wrote in his application that this patient
was in a desperate situation. “We have the means to break the downward spiral
and with care and proper support we could salvage this patient to the benefit not
only to himself but society” This patient had severe RA of the hands and feet and
hepatitis C related to his past history of heroin addiction, which he had overcome.
However his hepatic function had deteriorated due to alcohol abuse and he could
not continue treatment with methotrexate. The physician wanted to break the pain
cycle by using infliximab, allowing the liver to recover and the patient to cease
drinking. “according to xxxx and with support, we could get him off alcohol and back
on methotrexate” (physician). After discussion the committee reaffirmed the general
policy and was strongly opposed to providing ongoing supplies of infliximab to RA
patients. However due to the nature of the request “to break the pain cycle” three
injections of infliximab were offered and it was determined that, regardless of the
response, no further supplies would be made available. The patient and physician
signed a consent form stating the terms of approval.
Decision 5. Darbepoetin alfa in severe anaemia secondary to HIV infection. (IPU)
Two applications for use of darbepoetin alfa for severe anaemia secondary to HIV
infection were reviewed. Both patients had received blood transfusions and had
failed their retroviral therapy. It was proposed (by the physicians) that treatment
would provide better outcomes compared to blood transfusion.
254
The maximum estimated cost per year in the worst case scenario was A$18,000
per patient per year. The subcommittee considered the cost of blood transfusion
compared to treatment with darbepoetin alfa. If more patients required this
treatment it was going to be a huge burden for the hospital. It was decided that the
HIV unit should incur the cost of treatment for these two patients. A three month
report to the HCD-SC reporting outcomes of these two patients was required. Costs
were to be monitored.
Decision 6. Sildenafil in pulmonary hypertension. (IPU)
The subcommittee decided to approve a four to six week trial to relief the symptoms
and improve the patients’ quality of life until the patient undergoes pulmonary
endarterectomy. However if symptoms do not improve treatment should be
stopped. The patient needed to sign a consent stating the terms of approval. (No
extra medication was going to be provided if symptoms did not improve)
Decision 7. Sirolimus for prevention of renal transplant rejection.
Evidence of efficacy came from two randomised, double blind, multicentre,
controlled trials. The subcommittee approved its use and suggested a protocol
should be developed and suggested that diltiazem could be used as a sirolimus
sparing agent.
Decision 8. Sirolimus for prevention of lung transplant rejection (IPU)
Ongoing use was granted for patient xxx (IPU) on compassionate grounds.
However since evidence of efficacy came from case series, the committee decided
that sirolimus was not going to be approve for further patients. Due to the lack of
255
evidence of effectiveness (no head to head trials with sirolimus and other first line
agents in lung transplant patients). The members thought that it was appropriate to
require higher quality evidence before considering spending A$5110 per patient per
year.
Decision 9. Sirolimus for prevention of heart transplant rejection in patients with
failing renal function.
The committee felt sympathetic with the proposal to use sirolimus in heart
transplant patients failing renal function, but felt that the issue of the promised
savings (based on reduced number of patients coming to dialysis) needed to be
explored further. The cost was A$60,000 per year.
Decision 10. Sirolimus for progression or development of transplant coronary
artery disease (CAD)
The cost was A$153,300 per year for 20 patients. There was only anecdotal
experience. In the absence of evidence the HCD-SC decided not to support funding
for this particular indication. If the evidence can be produced, the issue would be
revisited.
Further evidence was produced at a later stage. The committee considered the
evidence and decided that the number of patients that could be treated at any one
time with low dose sirolimus for prophylaxis against transplant related CAD could
be increased to 20. Costs year 1 $51 k extra, year 2 $92 k, year 3 $130 k if all
patients survive.
256
Decision 11. Bosentan in pulmonary hypertension.
The Therapeutics Goods Administration (TGA) approved Bosentan in pulmonary
hypertension but the PBAC did not approve it for funding as an S-100 medication.
The subcommittee recognised this was an effective medication. However it was a
very expensive one, $40-50 000 per annum, and the hospital was not able to fund
ongoing therapy. Therefore no new patients were to receive treatment with
Bosentan. Since there were different groups of patients receiving it, through the
programs stated in the results section. Consents were developed to cover all
scenarios. “They should all clearly state ‘If I am not Medicare eligible and drug
becomes unavailable on PBS I won’t be able to access and hospital may not be
able to pay.” It was important that patients understood the circumstances under
which they were supplied this medication.
The first of March 2004 Bosentan was listed in the PBS under Section 100 for the
treatment of pulmonary arterial hypertension (PAH).
Decision 12. Recombinant Factor VIIa in life threatening bleeding.
The evidence came from case reports and small series in non-haemophiliac
patients with life threatening bleeding. Double–blind randomised control trial was
conducted with patients with haemophilia. The subcommittee approved it with
stringent controls, a protocol was developed and approval from haematology was
needed for each patient before use.
257
Decision 13. Risperidone depot in schizophrenia
The data available was limited and it appeared to be as effective as oral
Risperidone in controlling positive and negative symptoms. It had not been
compared against conventional depot injection. Randomised control trials were
needed to fully asses the effects of this new preparation. The subcommittee
considered it could only be used for patients with no other alternatives; it was 90%
more expensive than current phenothiazones. No extra budget was going to be
made available for this medication, only two psychiatrists were able to authorise
approval and a protocol needed to be developed.
Decision 14. Sildenafil and/or Iloprost in patients undergoing pulmonary
endaterectomy.
Approximately 50% of patients undergoing the procedure might need some
short/long term pulmonary vasodilatation treatment. Cost was estimated as
A$10,000 per patient per year for sildenafil. The subcommittee decided that the
physician such seek special state funding since this procedure was only performed
in three centres around Australia.
Decision 15. Thalidomide in different indications
The Therapeutics Goods Administration (TGA) approved thalidomide as
maintenance therapy for prevention and suppression of cutaneous manifestations
of erythema nodosum leprossum (ENL) and recurrence and treatment of multiple
melanoma after failure of standard therapies. Usage of thalidomide at SVH was
reviewed and off label indications included graft versus host disease (GVDH) and
Crohn’s disease. TGA approval required all patients to be registered with the
258
pharmaceutical company risk management program. Usage and cost were going to
be monitored initially for three months and then again at six months. The HCD-SC
expected that few patients would be prescribed this medication.
259
Appendix 4.2
Designation of levels of evidence
I evidence obtained from a systematic review of all relevant randomised controlled
trials.
II evidence obtained from at least one properly designed randomised controlled
trial.
III-1 evidence obtained from well-designed pseudo-randomised controlled trials
(alternate allocation or some other method).
III-2 evidence obtained from comparative studies with concurrent controls and
allocation not randomised (cohort studies), case control studies, or interrupted time
series with a control group.
III-3 evidence obtained from comparative studies with historical control, two or more
single-arm studies, or interrupted time series without a parallel control group.
IV evidence obtained from case series, either post-test or pre-test and post-test.
Adapted from the NHMRC Guidelines (385)
260
Appendix 4.3
Terms of reference of the HCD Sub Committee of SVH Drug Committee
2002
Aim/Terms of Reference should include:
• To define criteria and a process for decision making re high cost drugs
• To set up a management process for handling these drugs
• To consider applications for high cost drugs and to advise the Drug
Committee of recommendations and decisions.
• To set up a review process to ensure that drugs are not continued beyond
the designated trial period unless positive outcomes of therapy are
demonstrated.
• To consider the $s which should be allocated to High Cost drug therapies
• To consider strategies for controlling spending on high cost drugs
• To produce and distribute and Executive Bulletin re process for making
applications to prescribe High Cost Drugs at SVH
• To consider Ethical questions re choosing one high cost drug over another
• To keep the Board informed re issues (Ethical and Financial) arising from
marketing of new high cost drug therapies
• To work with NSW Therapeutic Assessment Group (TAG) to lobby
appropriate funding programs for high cost drug therapies
261
Appendix 5.1
Invitation to participate in decision-makers study
Date
Person’s name
Position
Institution
Dear (salutation)
We are currently conducting a research project aimed to develop novel approaches
for management of High Cost Medications in the public hospital setting.
As a first stage of the project we would like to explore views, perceptions, concerns,
problems and solutions regarding access to high cost medications and the current
approaches for management.
In order to do so we will be conducting interviews with individuals who have
different roles within the South Eastern Sydney Area Health Service (SESAHS).
Therefore we would really appreciate it if we could have a 30-minute conversation
that will be recorded with your consent. The data collected during the interview will
be confidential. The Human Research Ethics committee of the University of Sydney
has approved this project.
Your collaboration will be greatly appreciated and we thank you in anticipation for
considering this request.
Yours sincerely
Gisselle Gallego
PhD Candidate
The University of Sydney.
Phone: 83822053
Email: giselle@pharm.usyd.edu.au
Enclosed
• Semi-structured interview.
262
Appendix 5.2
Reminder letter decision-makers’ study
Date
Person’s name
Position
Institution
Dear (salutation)
Re: Invitation to participate in the High Cost Medication (HCM) Research project.
This is a follow up to a letter sent to you in November, inviting your participation in a
research project. The overall aim of the research is to develop novel approaches for
management of High Cost Medications in the public hospital setting.
In this stage of the project we are exploring perceptions, concerns and attitudes regarding
access to high cost medications among health care providers.
In order to do so we have been conducting interviews with individuals who have decision-
making roles within the South Eastern Sydney Area Health Service (SESAHS). This project
has the support of the SESAHS Area Chief Executive Officer, Ms Deborah Green.
Participation in the project involves a 30-minute conversation that will be recorded with your
consent. The data collected during the interview will be confidential. The Human Research
Ethics committee of the University of Sydney has approved this project.
We would be happy to answer any queries you have about any aspect of this research
project. Gisselle will contact you in the next week to seek your involvement. Your
assistance is greatly appreciated.
Yours sincerely
Gisselle Gallego
PhD Candidate
The University of Sydney
Phone: 83822053
Email: giselle@pharm.usyd.edu.au
Jo-anne Brien
Professor of Clinical Pharmacy
St. Vincent’s Hospital
263
Appendix 5.3
Consent form
CONSENT FORM
Faculty of Pharmacy, University of Sydney
Tel: (02) 9351 5818, Fax: (02) 9351 4391
I, ………………………………………………………………………………………………………..
of ……………………………………………………………………………………………………….
hereby voluntarily consent to participate in the study entitled Re: “Access to High Cost
Medications.”
This project is being conducted by the researcher Ms Gisselle Gallego under the
supervision of Professor Jo-anne Brien from the Faculty of Pharmacy, University of Sydney.
I understand that any data collected for the purpose of this study will remain strictly
confidential. The fact that I may be audiotaped during the interview has been explained to
me. I have been informed that the information obtained from this research will be used in
future research, and may also be published.
Details of this study have been clearly explained by the researcher. Any questions that I
have had to date have been answered to my satisfaction. I am aware of the purpose of this
project and what my involvement entails. I have read the Participant Information attached. I
understand that my participation is entirely voluntary. I have been informed of my right to
question any part of the procedure or withdraw from the project at any time.
Name: …………………………………………………………………………………………………..
Signature: ………………………………………………………………………..……….……………
Date: ……………………………………………………………………………...……….……………
Witness Name: …………………………………………………………….…………………………
Signature:………………………………………………………………………………………………
Date: ……………………………………………………………...……………………………………
14th March 2003, Version 1 Page 1 of 1
High Cost Medications
264
Appendix 5.4
Participant information sheet
Faculty of Pharmacy, University of Sydney
Tel: (02) 8382 2053, Fax: (02) 9351 4391
SUBJECT INFORMATION STATEMENT
Research Project
Title: “Access to High Cost Medications”
(1) What is the study about?
Currently the burden of high cost medications in public hospitals is borne by
individual institutions. The future management of costs of pharmaceuticals may be
influenced by current discussions in relation to reforms in the Australian political
system and consideration of expansion of the role of the Pharmaceutical Benefit
Scheme. In addition the roles of state-based and Area Health services in
consideration of high cost pharmaceuticals may evolve. However, there is likely to
remain a need for an efficient, evidence-based, transparent and accountable
process to manage local decisions regarding high cost medications. This pilot
project is planned to elucidate aspects of the process at the
institutional/area/state/national level. We wish to explore your views, perceptions,
concerns, problems and solutions regarding high cost medications and the current
approaches for management. This may assist in the development of novel
approaches for management of High Cost Medications.
(2) Who is carrying out the study?
The study is being carried out by the Faculty of Pharmacy, University of Sydney,
under the supervision of Professor Jo-anne Brien.
(3) What does the study involve?
If you choose to be involved in this study, you will be invited to participate in a single
interview with the researcher. During this interview your discussion will be tape
recorded to help the researcher collate the results of this study, however data will
be de identified
29 Apr 2003 Version 2 Page 1 of 2
265
(4) How much time will the study take?
The interview will last up to 60 minutes
(5) Can I withdraw from the study?
Being in this study is completely voluntary - you are not under any obligation to
consent.
(6) Will anyone else know the results of my interview?
The information obtained from this study may be published, and will be used to
develop future research. All data collected will remain strictly confidential and all
information will be de identified
(7) Will the study benefit me?
No direct benefits to you are likely to occur as a result of this study. However
information obtained through this research may improve access and equity to High
Cost Medications.
(8) Can I tell other people about the study?
Yes
(9) What if there's a problem?
If you require further information or have any other questions, please contact
Professor Jo-anne Brien at the Therapeutics Centre St. Vincent’s Hospital on (02)
8382 2605
29 Apr 2003 Version 2 .Page 2 of 2
High Cost Medications
Any person with concerns or complaints about the conduct of a research study can
contact the Manager for the Ethics Administration, University of Sydney on (02) 9351
4811
266
Appendix 5.5
In-depth Interview Study - Interview Guide
INTRODUCTION - background to study, purpose of research, what happens
during/after interview
· Broad, open-ended questions
High Cost Medications
1. What do you think are the problems with HCMs? (Access)
2. Do you deal with High Cost Medications at your hospital? Could you give me
some specific examples?
3. How were decisions made in each of those cases?
4. What do you think of this approach?
Current problems and limitations- at your hospital/in your experience
5. Does the Drug and Therapeutic Committee (DTC) have the total responsibility
of dealing with these High Cost Medications? Would you give me more
information on how these decisions are made and on who takes responsibility?
6. Do you think the decision-making process for approval of High Cost Medications
in public hospitals in your experience is an explicit and transparent one? If no,
What problems do you encounter? What are your concerns?
7. If you were personally in the role of a decision-maker regarding approvals for
HCMs what would be the main difficulties/challenges/concerns for you?
8. What do you perceive are the main problems for the hospital/institution in
approving a high cost medication for public hospital use?
Solutions
9. Do you have any suggestions or possible solutions to the problems that you
have indicated?
10. Have you any mechanisms or processes that you could suggest for the
prescriber/institution/area health service/state/nationally to address the
problems you’ve been talking about and any other problems you are aware of?
11. Do you think there should be criteria? If so what are would you suggest as
important points? How would you rank these? why?
12. Should outcomes be tracked and evaluated for HCMs differently to other
drugs/expensive services?
13. What is the role for Economic Evaluation?
267
Costs
14. What are your perceptions about the costs if these HCMs?
15. If the same amount were being spent for a large number of patients would that
amount still be a problem?
16. Do you have any comments on how these medications could be subsidised /
funded?
Public
18. What do you think could be the role of the public when it comes to HCMs?
That is the last question, is there anything that you would care to add?
Do you have any questions for me?
Would you like to receive a summary of findings?
Thank you for your time today. I appreciate you giving up your time to talk to me....
NOTES:
268
Appendix 5.6
Example of Transcript File
Subject:
Topic: Perceptions, concerns, and attitudes of decision-makers
Date:
Place:
Time:
Relevant Information:
Position:
Professional Background/education:
Gender:
Age:
Special Circumstances:
269
Appendix 6.1
Questionnaire used in general public survey
Questionnaire for research study:
Access and Equity for High Cost Medications – Public Perspectives.
The purpose of this questionnaire is to explore your views about access to high cost
medications in public hospitals. The survey is expected to take approximately 15 minutes to
complete. Your privacy whilst participating in this study will be maintained at all times. The
information you provide in this survey will be identifiable via numerical code only. If you
have any questions regarding this survey, please contact Gisselle Gallego on 8382 2053 or
Prof Jo-anne Brien on 8382 2605.
1. How would you rate your current state of health?
Please tick one box
Excellent
Very good
Good
Fair
Poor
2. In the past 12 months have you or any of your family members been a patient in a
public hospital?
Please tick one box
Yes
No ) Go to question 5
3. How many times have you or any members of your family been a patient in a public
hospital in the last 12 months? __________
4. Thinking of your most recent hospital visit, were you or your family member:
an inpatient?
an outpatient?
an emergency room patient?
Version 1 04May2004 .Page 1 of 6
270
We would like to know how much you know about paying for high cost medications
in public hospitals.
The following statements are true or false. Please tick one box
5. Public hospitals have unlimited resources for high cost medications.
True False
6. The Commonwealth Government funds public hospitals directly.
True False
7. All Australian permanent residents have the right to public hospital treatment at no
charge.
True False
8. There is no difference between public and private hospitals when it comes to access to
high cost medications.
True False
9. Public hospitals may restrict high cost medications by supplying them only to people
from the hospital’s area.
True False
10. Public hospitals provide medications regardless of their cost.
True False
Comments: (if any)
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
Version 1 04May2004 .Page 2 of 6
271
In this section you will be given choices about allocating resources to high cost
medications.
11. What factors are the most important in deciding who should get a high cost mediation?
Draw a line between the numbers on the left (1 being the most important) and the
four most important factors on the right.
Age
1 Socioeconomic status
Current health status
2 Life expectancy
Quality of Life
3 Family commitments
Lifestyle
4 Treatment outcomes
Other (specify)_______________
The following are some hypothetical examples of the types of decisions that need to
be made
Scenario 1
12. There is a limited budget for medications in a public hospital. Two patients need to be
treated with a high cost medication for cancer but there is only enough money to treat
one of them. How do you think the hospital should choose which one receives the
treatment?
by choosing
[Please tick one box only]:
one of them randomly
the one who would benefit most in terms of quality and length of life
the youngest
the one whose work contributes more to society
the one who has more family members to support
don’t know
Scenario 2
13. There is a limited pool of money to be spent on medications. Medication A costs $40
dollars per patient per month and could prevent heart attacks. Medication B costs $
4,000 per patient per month and could improve the quality of life of a patient with cancer
and lengthen that person’s life.
What would you do?
Please tick one box only
Spend all the money on Medication A for 1000 patients
Spend all the money on Medication B for 10 patients.
Spend some of the money on Medication A for 500 patients and some of
the money on Medication B for 5 patients.
Spend some of the money on Medication A for 800 patients and some of
the money on Medication B for 2 patients.
Version 1 04May2004 .Page 3 of 6
272
What are your reasons? :
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
14. If decisions need to be made about who has access to high cost medications in public
hospitals, who should make these decisions?
Please tick one box only
Hospital doctors
Nurses
Pharmacists
Managers of health services
Politicians
Patients
Patient’s family
General Public
Other (specify) ________________
Don’t know
15. Would you like to be involved in decisions regarding access to high cost medications in
public hospitals?
Please tick one box
Yes
No
Don’t know
16. Would you be willing to pay more taxes to subsidize access to high cost medications in
public hospitals?
Please tick one box only
Yes
No
Don’t know
Version 1 04May2004 .Page 4 of 6
273
We would like you to answer some questions about yourself.
17. What is your age? _________ years
18. What is your sex?
Please tick one box
Male
Female
19. What is your marital status?
Please tick one box
Single
Married
Divorced
Widowed
20. What is the main language you speak at home?
Please tick one box only
English
Vietnamese
Cantonese/Mandarin
Arabic
Italian
Greek
Other ______________
21. What is your economic activity?
Please tick one box
Working for money (full or part time)
Not in paid employment
22. What is the highest level of schooling you have had?
Please tick one box
Never attended school
Primary school
Intermediate or school certificate
Leaving or higher school certificate
Certificate or diploma
Currently at university
University degree
Other (please specify): ______________
23. What is your postcode?
___ ___ ___ ___
Version 1 04May2004 .Page 5 of 6
274
24. What is your combined annual household income?
Please tick one box
< $30, 000
30,000 – 50,000
50,000 – 75, 000
75,000 – 100,000
>100,000
25. Do you have private health insurance?
Please tick one box
Yes
No
Version 1 04May2004 .Page 6 of 6
275
Appendix 6.2
Participant information statement general public survey
Access to High Cost Medications – Public perspectives
Faculty of Pharmacy, University of Sydney
Tel: (02) 8382 2053, Fax: (02) 9351 4391
PARTICIPANT INFORMATION STATEMENT
Research Project
Title: “Access to High Cost Medications – Public perspectives”
(1) What is the study about?
The future management of costs of medications may be influenced by current
discussions in relation to reforms in the Australian healthcare system. Health care
practitioners are increasingly aware of pressures (and limitations) on funding for
health care services, and specifically for high cost medications. A high cost
medication has been defined as a medication that has a financial impact on the
public hospital medication expenditure. Our research to date has focussed on the
perceptions, attitudes and concerns of health care practitioners regarding equity of
access to high cost medications. The views of the general public are less well
understood. It is appropriate that the perspective of the broader community is
sought to inform future programs regarding equity of access to high cost
medications. Therefore we wish to explore your views regarding funding for high
cost medications in public hospitals and the criteria used in decision making
regarding access to these medications.
(2) Who is carrying out the study?
The study is being conducted by Gisselle Gallego and will form the basis for the
degree of Doctor of Philosophy at the University of Sydney under the supervision of
Professor Jo-anne Brien, Professor of Clinical Pharmacy.
(3) What does the study involve?
09 July2004 Version2 Page 1 of 2
276
If you choose to be involved in this study, you will be invited to fill out a survey. All
data collected will be de identified
(5) How much time will the study take?
Filling out the survey could take up to 30 minutes.
(5) Can I withdraw from the study?
Being in this study is completely voluntary. If you agree to participate you can
withdraw at any time.
(6) Will anyone else know the results of my survey?
The information obtained from this study may be published, and will be used to
develop future research. All data collected will remain strictly confidential and all
information will be de identified
(7) Will the study benefit me?
No direct benefits to you are likely to occur as a result of this study. However
information obtain through this research may improve access and equity to High
Cost Medications.
(8) Can I tell other people about the study?
Yes
(9) What if there's a problem?
If you require further information or have any other questions, please contact
Professor Jo-anne Brien at the Therapeutics Centre St. Vincent’s Hospital on (02)
8382 2605
09 July2004 Version2 Page 2 of 2
Any person with concerns or complaints about the conduct of a research study can
contact the Manager for the Ethics Administration, University of Sydney on (02) 9351
4811
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