Footnotes

Chapter 1 - Introduction

[1]        Medicines Australia (MA), Committee Hansard, 20 April, p. 1.

[2]        Department of Health (DOH), Submission 197, p. 1.

[3]        Cancer Drugs Alliance (CDA), Submission 53, p. 1.

[4]        See: Herald Sun, Melbourne woman pays $5k for drug PBS doesn't cover for her type of cancer, 14 December 2014, http://www.heraldsun.com.au/news/victoria/melbourne-woman-pays-5k-for-drug-pbs-doesnt-cover-for-her-type-of-cancer/story-fni0fit3-1227155867412 (accessed 8 June 2015); News.com.au, Lifestyle, Cancer sufferer Chris Brugger's family spend $16,000 every three weeks just to keep him alive, 20 April 2015, http://www.news.com.au/lifestyle/health/cancer-sufferer-chris-bruggers-family-spend-16000-every-three-weeks-just-to-keep-him-alive/story-fneuzlbd-1227312367195 (accessed 8 June 2015)

[5]        Journals of the Senate, No. 73-3 December 2014, p. 1966.

[6]        Journals of the Senate, No. 75-9 February 2015, p. 2054.

[7]        On 25 March 2015, the reporting date was extended to 17 June 2015, Journals of the Senate, No. 89—25 March 2015, p. 2399; on 17 June 2015, the reporting date was extended to 4 August 2015, Journals of the Senate, No. 97—17 June 2015, p. 2686; on 4 August 2015 the  reporting date was extended to 9 September 2015, Journals of the Senate, No103—10 August 2015, p. 2856; on 9 September 2015 the reporting date was extended to 15 September 2015, Journals of the Senate, No. 113—p. 3070; and on 15 September 2015 the reporting date was extended to 17 September 2015, Journals of the Senate, No. 116—p. 3120.

[8]        See: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs.

[9]        CDA, Submission 53, p. 1.

[10]      Australian Institute of Health and Welfare (AIHW) (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 48.

[11]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 51. The increased number of deaths does not correspond to the number of deaths per 100,000 people: 168 in 2014 to 209 in 1982 (a decrease of 20 per cent).

[12]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, pp 15 and 17. These estimates do not include certain carcinomas which are not required to be notified to public health authorities.

[13]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 19.

[14]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 16.

[15]      AIHW (2012), Cancer incidence projections, Australia 2011 to 2020, Cancer Series No. 66, Cat. no. CAN 62, Canberra: AIHW, p. viii.

[16]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 49.

[17]      AIHW (2014), Cancer in Australia, An overview 2014, Cancer Series No. 90, Cat. no. CAN 88, Canberra: AIHW, p. 50.

[18]      See: International Agency for Research on Cancer, World Health Organisation, The GLOBOCAN Project, http://globocan.iarc.fr/Default.aspx (accessed 23 January 2015).

[19]      See: International Agency for Research on Cancer, World Health Organisation, All Cancers (excluding non-melanoma skin cancer): Estimated Incidence, Mortality and Prevalence Worldwide in 2012, http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx (accessed 23 January 2015). This estimate did not include non-melanoma skin cancer.

[20]      See: International Agency for Research on Cancer, World Health Organisation, Australia, http://globocan.iarc.fr/Pages/fact_sheets_population.aspx?country=36 (accessed 23 January 2015).

[21]      See: International Agency for Research on Cancer, World Health Organisation, Australia, http://globocan.iarc.fr/Pages/fact_sheets_population.aspx (accessed 23 January 2015). The average world rate for 2012 was 102 per 100,000 people.

[22]      CDA, Submission 53, p. 2.

[23]      DOH, Submission 197, p. 5.

[24]      Submission 197, p. 5

[25]      Submission, 197, p. 8.

[26]      Submission 197, p. 22. Herceptin is a treatment for breast cancer.

[27]      Submission 197, p. 8.

[28]      Submission 197, p. 22.

[29]      DOH, Health Technology Assessment, What is Health Technology Assessment (HTA), http://www.health.gov.au/internet/hta/publishing.nsf/Content/about-1 (accessed 14 June 2015).

[30]      Deloitte Access Economics,  Medicines Australia Oncology Industry Taskforce, 'Access to cancer medicines in Australia', July 2013, Submission 142a, p. v.

[31]      http://www.health.gov.au/internet/hta/publishing.nsf/Content/commonwealth-1 (accessed
14 June 2015) 

[32]      DOH, Therapeutic Goods Administration, How the TGA regulates, https://www.tga.gov.au/how-tga-regulates (accessed 7 June 2015).

[33]      DOH, Therapeutic Goods Administration, How the TGA regulates, https://www.tga.gov.au/how-tga-regulates (accessed 7 June 2015).

[34]      Department of Parliamentary Services, Parliamentary Library, Growth in expenditure on high cost drugs in Australia, Research Paper Series, 2014-15, 7 January 2015,

[35]      DOH, Submission 197, p. 7.

[36]      DOH, National Medicines Policy Document, 2000, p. 1.

[37]      The Hon Sussan Ley MP, 'Pharmaceutical Benefits Scheme to be reformed', 27 May 2015, https://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley063.htm (accessed 16 September 2015).

[38]      The Hon Sussan Ley MP, 'Pharmaceutical Benefits Scheme to be reformed', 27 May 2015, https://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley063.htm (accessed 16 September 2015).

[39]      Senator Hon Jan McLucas, Senate Hansard, 23 June 2015, p. 4159.

[40]      DOH, Pharmaceutical Benefits Advisory Committee (PBAC), http://www.pbs.gov.au/info/industry/listing/participants/pbac (accessed 30 May 2015).

[41]      Prior to the 2014-15 Budget, pricing of pharmaceuticals was managed by the Pharmaceutical Benefits Pricing Authority (PBPA). The abolition of the PBPA was expected to help streamline the PBS listing process.

[42]      DOH, Submission 197, p. 13.

[43]      Subsidised access is provided to eligible patients under section 32B of the Financial Framework (Supplementary Powers) Act 1997 and schedule 1AA of the Financial Framework (Supplementary Powers) Regulations 1997, item number 415.009 (Targeted Assistance – Pharmaceuticals). See DOH, Life Saving Drugs Programme, Post Market Review, Issues Paper, April 2015, p. 7.

[44]      DOH, Life Saving Drugs Programme (LSDP), Post Market Review, Issues Paper,
April 2015, p. 7.

[45]      DOH, LSDP, Post Market Review, Issues Paper, April 2015.

[46]      DOH, Orphan drugs, https://www.tga.gov.au/orphan-drugs, (accessed 1 June 2015)

[47]      Medicines Australia (MA), Submission 142, p. 22.

[48]      Deloitte Access Economics, Medicines Australia Oncology Industry Taskforce, 'Access to cancer medicines in Australia', July 2013, Submission 142a, p. 49.

[49]      Cancer Drugs Alliance, Submission 53, p. 4.

[50]      MA, Supplementary Submission 142, p. 8.

[51]      Medicines Australia (MA), Submission 142, p. 22–23.

[52]      MA, Submission 142, Attachment 2, p. 9.

[53]      MA, Submission 142, p. 22.

[54]      United States Food and Drug Administration, Fast Track, September 2015, http://www.fda.gov/forpatients/approvals/fast/ucm405399.htm (accessed 16 September 2015).

[55]      Merck Sharp and Dohme (MSD), Submission 120a, p. 4.

[56]      United States Food and Drug Administration, Fast Track, September 2015, http://www.fda.gov/forpatients/approvals/fast/ucm405399.htm (accessed 16 September 2015).

[57]      MSD, Submission 120a, p. 2.

[58]      United States Food and Drug Administration, Breakthrough Therapy, September 2015, http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm (accessed 16 September 2015).

Chapter 2

[1]        Cancer Drugs Alliance (CDA), Submission 53, p. 5.

[2]        Medicines Australia (MA), Submission 142, p. 18; Cancer Council Australia/Clinical Oncology Society of Australia (CCA/COCSA), Submission 145, p. 18.

[3]        Submission 197, p.18.

[4]        Clinical Oncology Society of Australia, Answers to Questions on Notice, p. 2.

[5]        Submission 197, p.18.

[6]        Submission 196, p. 11.

[7]        Submission 138, p. 2.

[8]        Melanoma Institute Australia, Understanding Melanoma, www.melanoma.org.au

[9]        DOH, Submission 197, p. 9.

[10]      Merck Sharp and Dohme, Submission 120b, p. 2.

[11]      Submission 151, p. 4.

[12]      Submission 120b, p. 2.

[13]      Mr Anthony Steele, Head of Blood Cancer Support, Leukaemia Foundation of Australia, Committee Hansard, p. 12.

[14]      Submission 150, p. 2.

[15]      Mr Christian Sellars, Director, Market Access, Merck Sharp and Dohme, Committee Hansard, p. 23,

[16]      Cancer Council Australia and Clinical Oncology Society of Australia, Answer to Questions on Notice, p. 2.

[17]      Submission 120a, p. 5.

[18]      Submission 197, p. 38.

[19]      Committee Hansard, pp 22-23.

[20]      Committee Hansard, p. 23.

[21]      See for example: Deloitte Access Economics, MA Oncology Industry Taskforce, ' Access to cancer medicines in Australia',  July 2013, Submission 142a, p. ix.

[22]      MA, Submission 142a, p. ix;  Medical Oncology Group of Australia (MOGA), Submission 108, p. 2.

[23]      MOGA, Submission, 108, p. 2; Rare Cancers Australia, Additional information (received 16 September 2015).

[24]      Review of Medicines and Medical Devices Regulation, Report on the regulatory framework for medicines and medical devices, March 2015, www.health.gov.au

[25]      See for example: MA, Submission 142, p. 3; CDA, Submission 53, p. 4.

[26]      Submission 142, p. 14.

[27]      Submission 142, p. 14.

[28]      MA, Committee Hansard, 20 April 2015, p. 2.

[29]      Committee Hansard, p. 21.

[30]      PBAC, Submission 196, p. 3.

[31]      Committee Hansard, p. 80.

[32]      Ms Adriana Platona, Committee Hansard, p. 82.

[33]      Submission 142, p. 16.

[34]      Submission 142, p. 16.

[35]      Submission 87, p. 23.

[36]      MA, Submission 142, p. 17.

[37]      CDA, White Paper, p. 18; Mr Timothy James, Chief Executive Officer, MA, Committee Hansard, p. 2; Ms Nicola Richards, Head of Public Affairs, Merck Sharp and Dohme, Committee Hansard, p. 27.

[38]      Mr David Pullar, Roche Products, Committee Hansard, p. 22.

[39]      Committee Hansard, p. 38.

[40]      Submission 197, p. 12; Submission 196, p. 8.

[41]      Submission 196, p. 8.

[42]      Mr Christoph  Lorez, Committee Hansard, p. 25.

[43]      Dr Suzanne Hill, Committee Hansard, p. 75.

[44]      Mr James, MA, Committee Hansard, 20 April 2015, p. 6.

[45]      MSD, Submission 120ss, p. 3.

[46]      MA, Submission 142, p. 17.

[47]      Dr Nigel Rawson, Has pCODR Improved Access to Oncology Drugs? Timeliness and provincial acceptance of pan-Canadian Oncology Drug Review recommendations, June 2014, p. 3, http://www.fraserinstitute.org/uploadedFiles/fraser-ca/Content/research-news/research/publications/has-pCODR-improved-access-to-oncology-drugs.pdf (accessed 6 June 2015).

[48]      CDA, Improving Access to Cancer Medicines, White Paper, March 2015, p. 16.

[49]      Committee Hansard, p. 82.

[50]      The Medical Services Advisory Committee (MSAC) is an independent expert committee that provides advice to the Minister for Health relating to the comparative safety, clinical effectiveness and cost effectiveness of any new or existing medical service or technology, and the circumstances under which public funding should be supported through listing on the Medicare Benefits Schedule (MBS). Co-dependent and hybrid pharmaceuticals are currently considered separately by PBAC and MSAC using difference approaches to assessing evidence against the HTA criteria because listing needs to occur under two separate funding programs. See DOH, Co-dependent and Hybrid Technologies, http://www.health.gov.au/internet/hta/publishing.nsf/Content/co-1 (accessed 14 June 2015).

[51]      Cancer Council Australia and Clinical Oncology Society of Australia and (CCA/COSA) Submission 145, p. 4.

[52]      DOH, Submission 197, p. 12.

[53]      Mr James, MA, Committee Hansard, p. 4.

[54]      Submission 197, p. 12.

[55]      Committee Hansard, p. 4.

[56]      MA, Supplementary Submission 142, p. 4.

[57]      It is not clear how many oncological drugs in the sample size cited by Novartis utilised the parallel process. Novartis Oncology Australia New Zealand (Novartis), Submission 87, p. 10.

[58]      Mr James, Committee Hansard, p. 4.

[59]      Committee Hansard, p. 83.

[60]      Submission 196, p. 11.

[61]      Committee Hansard, p. 26.

[62]      MA, Answers to Questions on Notice, p. 5; Submission 145, p. 4, MSD, Submission 120, p. [2].

[63]      Review of Medicines and Medical Devices Regulation, Report on the regulatory framework for medicines and medical devices, March 2015, p. 169.

[64]      Submission 142, p. 17. See also Amgen, Submission 119, pp. 5-6.

[65]      Submission 196, p. 12.

[66]      Committee Hansard, p. 85.

[67]      Committee Hansard, p. 84.

[68]      Submission 87, p. 23.

[69]      Submission 146, p. 4.

[70]      Submission 196, pp 7-8.

[71]      Dr Katherine Nielsen, Committee Hansard, p. 10.

[72]      Committee Hansard, p. 14.

[73]      Submission 196, p. 13.

[74]      Committee Hansard, pp 71-72.

[75]      MA, Answer to Question on Notice, 20 April 2015, p. 10 (received 25 May 2015).

[76]      Ms Simone Leyden, Committee Hansard, p. 44.

[77]      Professor Brendon Coventry, Research Director, Australian Melanoma Research Foundation, Committee Hansard, p. 17.

[78]      Merck, Sharp and Dohme, Submission 120a, p. 5.

Chapter 3 - Affordable access –assessing cost effectiveness

[1]        Department of Health (DOH), Submission 197, p. 11.

[2]        DOH, Submission 197, p. 1.

[3]        DOH, Submission 197, p. 11.

[4]        Medicines Australia (MA), Submission 142, p. 3; Roche Products, Submission 114, p. 3; Merck, Sharp and Dohme (MSD), Submission 120a, p. 3;

[5]        Pharmaceutical Benefits Advisory Committee (PBAC), Submission 196, p. 5.

[6]        DOH, PBAC Guidelines, Version 4.4, Rationale and basis for economic evaluation, http://www.pbac.pbs.gov.au (accessed 15 September 2015)

[7]        DOH, PBAC Guidelines, Version 4.4, Rationale and basis for economic evaluation, http://www.pbac.pbs.gov.au (accessed 15 September 2015)

[8]        Submission 196, p. 5.

[9]        DOH, PBAC Guidelines, Version 4.4, Rationale and basis for the economic evaluation, www.pbac.pbs.gov.au (accessed 15 September 2015)

[10]      Submission 196, pp 5-6.

[11]      Submission 197, p.7.

[12]      DOH, Pharmaceutical Benefits Advisory Committee Guidelines Review, www.pbs.gov.au (accessed 15 September 2015)

[13]      Submission 196, p. 6.

[14]      DOH, Submission 197, p. 17.

[15]      Submission 197, p. 5.

[16]      Submission 197, p. 16.

[17]      MA, Submission 142, p. 17.

[18]      DOH, Submission 197, p.7.

[19]      DOH, PBAC Guidelines, role of the Pharmaceutical Benefits Advisory Committee, 1.2.2 General guidelines followed by PBAC, www.pbac.pbs.gov.au (accessed15 September 2015)

[20]      Submission 197, p. 13.

[21]      Committee Hansard, p. 87.

[22]      Ms McNeill, Submission 147, p. 2.

[23]      MSD, Submission 120, p. 6

[24]      Novo Nordisk, Submission 147, p. 2.

[25]      See for example, MA, Submission 142, pp 11-12.

[26]      Rare Cancers Australia, Submission 92, p. 16.

[27]      Amgen, Submission 119, p. 7.

[28]      Submission 92, p. 1..

[29]      Submission 120, p. 6.

[30]      Submission 119, p. 4.

[31]      Submission 191, pp 2-3.

[32]      Merck, Sharp and Dohme, Submission 120, p. 6.

[33]      DOH, Submission 197, p. 13.

[34]      DOH, Submission 197, p. 13.

[35]      Submission 196, p. 6.

[36]      Submission 196, p. 6.

[37]      Submission 128, p. 6.

[38]      Submission 197, p. 22.

[39]      Submission 196, p. 3.

[40]      Submission 196, p. 3.

[41]      Committee Hansard, p. 71.

[42]      MA, Submission 147, p.35

[43]      Submission 142a, p. vii.

[44]      See for example: Amgen, Submission 119, pp 2-3.

[45]      Roche Products, Submission 114, p. 13.

[46]      Committee Hansard, p. 26.

[47]      NN, Submission 147, p. 2.

[48]      Submission 147, p. 7.

[49]      DOH, Submission 197, pp 11-12.

[50]      Answer to question on notice, 20 April 2015 (received 25 May 2015), p. 2.

[51]      Submission 114, p. 13.

[52]      DOH, PBAC Guidelines, Version 4.4, Rationale and basis for the economic evaluation, pbac.pbs.gov.au

[53]      MA, answer to question on notice, received 25 May 2015, p. 1.

[54]      Submission 147, p. 2, MA, answer to question on notice, 20 April 2015 (received 25 May 2015), p. 1.

[55]      CCA/COSA, Committee Hansard, p. 55.

[56]      Submission 140, p. 10.

[57]      Submission 123, p. 6.

[58]      Submission 145, p. 6.

[59]      Submission 145, p. 1.

[60]      Submission 16, p. 2.

[61]      Answer to question on notice, 20 April 2015 (received 25 May 2015), p. 2.

[62]      Submission 114, pp 13-14.

[63]      Submission 145, p. 7.

[64]      Committee Hansard, p. 55.

[65]      Committee Hansard, p. 54.

[66]      MA, Submission 142, p. 4.

[67]      Submission 53, pp 5-6.

[68]      Committee Hansard, p. 87.

[69]      Department of Parliamentary Services, Parliamentary Library, Growth in expenditure on high cost drugs in Australia, Research Paper Series, 2014-15, 7 January 2015, p. 10.

[70]      DOH, Submission 197, p.7

[71]      DOH, PBAC Guidelines, Version 4.4, Rationale and basis for the economic evaluation, 1.3 Assessing suitability for listing, www.pbac.pbs.gov.au

[72]      Cancer Voices Australia, Submission 49, p. 5.

[73]      Amgen, Submission 119, p. 6; MA, Submission 142, p. 4.

[74]      Roche Products, Submission 114, p. 15.

[75]      Committee Hansard, p. 67.

[76]      Submission 123, p. [9]

[77]      Committee Hansard, p. 11.

[78]      Impact of cost-per-QALY reimbursement criteria on access to cancer drugs. IMS Institute for Healthcare Informatics report, December 2014, cited in Submission 87, p. 28.

[79]      Submission 114, p. 15.

[80]      Committee Hansard, p. 40.

[81]      See for example: Melanoma Patients Australia, Submission 116, p. [3]; MSD, Submission 120, p. [5]; Ovarian Cancer Australia, Submission 137; MA, Submission 142, p. 4;

[82]      DOH, PBS, PBAC Meeting Agenda and Consumer Comments, http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-consumer-comments (accessed 15 September 2015)

[83]     

[84]      DOH, PBAC Guidelines, Version 4.4, Role of the Pharmaceutical Benefits Advisory Committee, www.pbac.pbs.gov.au.

[85]      MA, Submission 142, p. 4.

[86]      Committee Hansard, p. 51.

[87]      Committee Hansard, pp 28-29.

[88]      Submission 151, p. 2.

[89]      Cancer Voices Australia, Submission 49, p. 5.

[90]      Cancer Drugs Alliance, Improving Access to Cancer Medicines, White Paper, March 2015 (CDA White Paper), pp 12-13.

[91]      CDA White Paper, p. 12.

[92]      CDA White Paper, p. 13.

[93]      Submission 196, p. 13.

[94]      Committee Hansard, p. 74.

[95]      Committee Hansard, p. 75.

[96]      Minister for Health, the Hon Sussan Ley MP, More consumer consultation in PBS process, Media Release 13 March 2015.

[97]      Submission, 196, p. 13.

[98]      See for example, MA, Submission 142, p. 4; Pharmaceutical Society of Australia, Submission 176, p. 6; Dr Katherine Nielsen, Ovarian Cancer Australia, Committee Hansard, p. 10; Mr David Pullar, Roche Products, Committee Hansard, p. 22; CVA, Submission 49, p. 4.

[99]      Submission 142, p. 21.

[100]    Submission 196, p. 15.

[101]    Submission 122, p. 6

[102]    Submission 142, p. 22.

[103]    The members of the Citizens Council reflect the age, gender, socioeconomic status and ethnicity of the people of England and Wales. Councillors are recruited by an independent organisation and for a period of three years, with one third retiring each year.

[104]    National Institute for Health and Care Excellence, Citizens Council, https://www.nice.org.uk/get-involved/citizens-council (accessed 6 June 2015).

[105]    National Institute for Health and Care Excellence, Citizens Council, https://www.nice.org.uk/get-involved/citizens-council (accessed 6 June 2015).

[106]    Submission, 142, pp 22-23.

[107]    CADTH pan-Canadian Oncology Drug Review, https://www.cadth.ca/pcodr/about-pcodr

[108]    Current Oncology, Meaningful patient representation informing Canada's cancer drug funding decisions: views of patient representatives on the Pan-Canadian Oncology Drug Review, October 2014, 21(5) 263-266, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189566/

Chapter 4 - Impact of delayed access to cancer medicines on cancer patients

[1]        Cancer Voices Australia, Submission 49, p. 5.

[2]        De Angelis R et al, Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE 5—a population-based study. Lancet Oncol 2014; 15:23-34, cited by Novartis Oncology, Submission 87, p. 28.

[3]        Pharmaceutical Society of Australia, Submission 176, p. 6.

[4]        See for example: Mr Paul Hobson, Submission 6, p. 2.

[5]        Submission 30, p. [1].

[6]        Submission 25, p. [1].

[7]        Medicines Australia, Answer to question on notice, 20 April 2015 (received 25 May 2015), p. 3.

[8]        Ms Karen Cowley, Submission 11, p. 1.

[9]        Medicines Australia, Answer to question on notice, 20 April 2015 (received 25 May 2015), p. 3.

[10]      Cancer Drugs Alliance (CDA), Improving Access to Cancer Medicines, White Paper, March 2015, p. 8.

[11]      Committee Hansard, p. 61.

[12]      Bowel Cancer Australia, Submission 149, p. 6.

[13]      Ovarian Cancer Australia, Submission 137, p. [11].

[14]      Mr Scott Beyer, Submission 104, p. 1.

[15]      See for example: Mr Andrew Warden, Submission 7, p. 5; Mr David Prestridge, Submission 5 [1]; Ms Natalie Cook,

[16]      Submission 12, p. [1].

[17]      CDA White Paper, p. 8.

[18]      Submission 90, p. 6.

[19]      Submission 92, p. [8].

[20]      Committee Hansard, p. 9.

[21]      Submission 139, p. 2.

[22]      Department of Health, Therapeutic Goods Administration, Special access scheme, www.tga.gov.au (accessed 15 September 2015)

[23]      Council of Australian Therapeutic Advisory Groups, Rethinking medicines decision-making in Australian Hospitals, Guiding Principles for the quality use of off-label medicines, November 2013, p. 6.

[24]      Submission 152, p. 7.

[25]      Council of Australian Therapeutic Advisory Groups, Rethinking medicines decision-making in Australian Hospitals, Guiding Principles for the quality use of off-label  medicines, November 2013, p. 4; Department of Health, Submission 197, p. 20.

[26]      Council of Australian Therapeutic Advisory Groups, Rethinking medicines decision-making in Australian Hospitals, Guiding Principles for the quality use of off-label medicines, November 2013, p. 6.

[27]      Committee Hansard, p. 15.

[28]      MA, Submission 142, Appendix C, Deloitte Access Economics, Access to cancer medicines in Australia, Medicines Australia Oncology Industry Taskforce, July 2013, p. 51

[29]      Submission 142, p. 25.

[30]      Submission 142, p. 25.

[31]      Submission 142, p. 25.

[32]      Submission 142, p. 26.

[33]      Committee Hansard, p. 2.

[34]      Melanoma Patients Australia, Submission 116, p. [2].

[35]      Submission 137, p. 4.

[36]      Kadcyla is a treatment for HER2-positive metastatic breast cancer

[37]      Ms Karen Cowley, Submission 11, p. 1.

[38]      Committee Hansard, p. 19.

[39]      Mrs Lesley Royle, Submission 113, p. 2.

[40]      Submission 142a, Deloitte Access Economics, Access to cancer medicines in Australia, July 2013, p. 48;

[41]      Submission 142a, Deloitte Access Economics, Access to cancer medicines in Australia, July 2013, p. 47; see also: Link Healthcare, Submission 125.

[42]      Deloitte Access Economics, p. 47.

[43]      Submission 152, p. 10.

[44]      Submission 146, p. 3.

[45]      Submission 125, pp 5-6.

[46]      Submission 125, p. 4.

[47]      Submission 152, p. 10.

[48]      CCA/COSA, Submission 145, p. 5; Melanoma Patients Australia, Submission 116, p. 3.

[49]      Submission 137, p. 4.

[50]      Mr Andrew Warden, Submission 7, p. 3.

[51]      See for example: Cancer Voices SA, Submission 150, p. 3;

[52]      Committee Hansard, p. 11.

[53]      Submission 150, p. 2.

[54]      Submission 159.

[55]      Committee Hansard, p. 10.

[56]      Committee Hansard, p. 17.

[57]      Submission 90, p. 7.

[58]      Joint Media Release, The Hon Sussan Ley MP, Minister for Health and The Hon Ian Macfarlane, Minister for Industry and Science, Australian-first website to connect more patients with clinical trials, 20 May 2015. See www.australianclinicaltrials.gov.au (accessed 15 September 2015)

[59]      Melanoma Patients Australia, Submission 116, p. 2.

[60]      Submission 152, p. 11.

[61]      ANZHCHOG, Submission 152, p. 13.

[62]      See for example personal accounts provided in the following submissions: Mr Jason Noble, Submission 19, Rare Cancers Australia, Submission 92, p. 19 and p. 23; Mr Matthew Story, Submission 201, p. 2.

[63]      See for example: Ms Maureen Austin, Submission 98, p. [1].

[64]      Committee Hansard, p. 10.

[65]      Submission 92, p. 1.

[66]      Submission 92, p. 9.

[67]      Cancer Medicines Fund, www.sickortreat.org.au (accessed 7 September 2015)

[68]      Submission 92, p. 1.

[69]      Submission 142, p. 25.

[70]      Submission 130, p. 2.

[71]      Submission 108, p. 2; Submission 123, p. 12.

[72]      Submission 123, p. 12. The Leukaemia Foundation undertook a survey on new and innovative drugs of 675 blood cancer patients (or their carer) in February 2015, Submission 123, p. 2.

[73]      Submission 123, p. 12.

[74]      The Kids Cancer Project, Submission 192, p. 9.

[75]      Submission 114, p. 11.

[76]      Submission 79, p. 1.

[77]      MOGA Submission 108, p. 3.

[78]      Cancer Action Victoria, Submission 151, p. 5.

[79]      MOGA Submission 108, p. 3.

[80]      Dr Christopher Fraser, Chair, Australian and New Zealand Children's Haematology and Oncology Group, Committee Hansard, pp 35 -36.

[81]      Department of Health, Submission 197, p. 20.

[82]      Submission 25, p. 1.

[83]      Committee Hansard, p. 12.

[84]      Committee Hansard, p. 41.

[85]      Submission 187, p. 1.

[86]      Additional Information, received 16 September 2015.

[87]      Additional Information, received 16 September 2015.

[88]      The Australian New Zealand Children's Haematology/Oncology Group in partnership with The Kids Cancer Project, The Kids Cancer Alliance and the Children's Cancer Institute (ANZCHOG) Submission 152, p. 1

[89]      Submission 146, p. 2.

[90]      See for example: Best Pharmaceuticals for Children Act, 2002, Paediatric Research Equity Act, 2003, and European Paediatric Medicine Regulation, 2007.

[91]      Name withheld, Submission 115, p. 2. The submitter is 12 years old. Her six year old sister Eva died from rhabdomyosarcoma in 2014.

[92]      Submission 192, p. 6.

[93]      Submission 152, p. 1.

[94]      ANZCHOG, Submission 152, p. 1.

[95]      Submission 152, p. 1

[96]      Kids Cancer Project, Submission, 192, p. 15.

[97]      Submission 152, p. 10.

[98]      Kids Cancer Project, Submission 192, p. 5; CanTeen, Submission 146, p. 3.

[99]      Ms Michelle Stewart, Head of Research Strategy, Cure Brain Cancer Foundation, Committee Hansard, p. 14.

[100]    Submission 146, p. 3.

[101]    Submission 192, p. 6.

[102]    Submission 146, p. 2.

[103]    Quoted in Bowel Cancer Australia, Submission 149, p. 4.

[104]    Mr Paul Hobson, Submission 6, p. 2.

[105]    Takeda Pharmaceuticals Australia Pty Ltd, Submission 122, p. 4.

[106]    Cure Brain Cancer Foundation, Submission 187.

[107]    Committee Hansard, p. 10.

Chapter 5 - Alternative access models for new and innovative cancer drugs

[1]        See for example: Rare Cancers Australia (RCA), Submission 92; p. 10; Pharmaceutical Society of Australia (PSA), Submission 176, p. 6.

[2]        Department of  Health (DOH), Submission 197, p. 17.

[3]        Angela Rocchi, Isabelle Chabot and Judith Glennie, Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review, Clinicoecon Outcomes Res. 2015, 7:287-289, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4461134/ (accessed 7 September 2015)

[4]        See for example, Mr Peter Carr, Submission 13, p. 1; See also Cancer Drugs Alliance, Improving Access to Cancer Medicines, White Paper, March 2015, p. 25.

[5]        Submission 117, p. 4.

[6]        Submission 188, p. 4.

[7]        Mr Timothy James, Committee Hansard, p. 6.

[8]        See for example: Rare Cancers Australia, Submission 92, pp 10 – 12; Unicorn Foundation, Submission 130, p. 4; Cancer Drugs Alliance (CDA), Submission 53, p. 1; Tasmanian Government, Submission 188, pp 4-5.

[9]        Submission 188, p. 5.

[10]      CDA, Improving Access to Cancer Medicines, White Paper, March 2015, p. 25.

[11]      CDA, Improving Access to Cancer Medicines, White Paper, March 2015, p. 25. In March 2014, the CDA hosted a forum of stakeholders from across the cancer community to discuss and build strategies to support both short and long-term access to cancer medicines. The CDA Forum identified five priority areas for improving access to cancer medicines for Australian patients and established work-streams to address these. The outcomes of these work-streams are set out in the White Paper; www.cancerdrugsalliance.org.au (accessed 7 September 2015)

[12]      See for example, Mr Andrew Warden, Submission 7, p. 2.

[13]      Submission 92, pp 10-11.

[14]      See for example, Pharmaceutical Society of Australia, Submission 176, p. 6; Dr Agnes Vitry, Submission 128, p. 8.

[15]      Submission 145, p. 10.

[16]      Submission 112, p. 2.

[17]      Submission 112, pp 7-8.

[18]      Submission 114, p. 16.

[19]      Committee Hansard, p. 45.

[20]      DOH, Submission 197, p. 17.

[21]      NHS England, Answer to written question on notice, received 15 June 2015, p. [2]

[22]      NHS England, Answer to written question on notice, received 15 June 2015, p. [2]

[23]      NHS England, Answer to written question on notice, received 15 June 2015, p. [2]

[24]      NHS England, Answer to written question on notice, received 15 June 2015, p. [2]

[25]      See for example: Janssen-Cilag Pty Ltd, Submission 140, p. 10.

[26]      Submission 114, p. 13.

[27]      DOH, The Pharmaceutical Benefits Scheme, Framework for the introduction of a Managed Entry Scheme for submissions to the Pharmaceutical Benefits Advisory Committee, www.pbs.gov.au (accessed 10 June 2015).

[28]      See for example: Dr Katherine Nielsen, Director, Research and Advocacy, Ovarian Cancer Australia, Committee Hansard, p. 10.

[29]      Submission 196, p. 14.

[30]      Submission 123, p. 7.

[31]      Submission 197, p. 1.

[32]      Submission 197, p. 21

[33]      Submission 197, p. 20.

[34]      Mr Timothy James, Chief Executive Officer, Medicines Australia, Committee Hansard, p. 8.

[35]      Committee Hansard, p. 40.

[36]      Committee Hansard, p. 44.

[37]      Submission 196, p. 14.

[38]      The Hon Sussan Ley MP, Minister for Health, Media Release, New breast and lung cancer drugs available from today, 1 July 2015.

[39]      See paragraphs 4.56 and 4.70 respectively.

[40]      PBS, Crizotinib; 200 mg capsule, 60 and 250 mg capsule, 60; Xalkori®, Public Summary Document – November 2014 PBAC Meeting, p. 2, www.pbs.gov.au (accessed 7 September 2015).

[41]      Committee Hansard, pp 75-76.

[42]      The Access to Medicines Working Group was formed by DOH and MA as part of the PBS reforms announced in 2006 to assist them to work together more effectively and to consider issues regarding timely and appropriate access to new medicines for the PBS. The membership of the working group comprises DOH and MA, but has agreed to consult with other stakeholders when issues may impact on them. See: DOH, Access to Medicines Working Group, www.health.gov.au. (accessed 15 September 2015).

[43]      DOH, The Pharmaceutical Benefits Scheme, March 2015 PBAC Minutes for the Managed Access Program Framework, www.pbs.gov.au (accessed 15 September 2015).

[44]      See for example: Ovarian Cancer Australia, Answer to question on notice, 20 April 2015 (Received 22 may 2015).

[45]      DOH, The Pharmaceutical Benefits Scheme, Step 7, Entering agreements to share risk, www.pbs.gov.au (accessed 15 September 2015).

[46]      Submission 145, p. 10.

[47]      Submission 114, p. 15.

[48]      Submission 120, pp 4-5.

[49]      Submission 92, p [14]

[50]      Submission 92, p. [14].

[51]      CDA White Paper 2015, p. 27.

[52]      Newpin Social Benefit Bond is a long-term, centre-based, intensive support program that works with families to improve parenting so children can live safely at home. The CDA White Paper states that in August 2014 it was reported that Newpin's maiden return to investors had a yield of 7.5 per cent on the $7 million bond.

[53]      CDA White Paper 2015, footnote d, p. 26.

[54]      See for example: Delivering Affordable Cancer Care: A Value Challenge to Health Systems, Report of the World Innovation Summit for Health (WISH) Delivering Affordable Cancer Care Forum 2015, cited in DOH, Submission 197, p. 16.

[55]      See for example, Cancer Voices Australia, Submission 49, p. 1; MSD, Submission 120b, pp 5-6; CCA/COSA, Submission 145, p. 10; Cancer Voices SA, Submission 150, p. 2

[56]      See for example: CDA White Paper, p. 19.

[57]      Submission 145, p. 7.

[58]      SHPA, Answer to question on notice, 22 April 2015 (received 22 may 2015).

[59]      Committee Hansard, p. 52.

[60]      DOH, The Pharmaceutical Benefits Scheme, Post-Market Reviews of Pharmaceutical Benefits Scheme Subsidised Medicines; www.pbs.gov.au (accessed 15 September 2015)

[61]      The Hon Sussan Ley MP, Minister for Health, Media Release, Positive progress and achievement from AMWG, 18 March 2015.

[62]      CDA White Paper, p. 6.

[63]      Committee Hansard, p. 28.

[64]      CDA White Paper, pp 22- 23.

[65]      Submission 120, p.5.

[66]      Ms Carlene Todd, Director, Market Access and Pricing, Roche Products, Committee Hansard, p. 28.

[67]      COSA, Answer to question on notice, 20 April 2015 (received 22 May 2015),

[68]      Committee Hansard, p. 75.

[69]      Submission 196, p. 15.

[70]      Committee Hansard, p. 64.

[71]      Australian Institute of Health and Welfare, Australian Cancer Database (ACD), www.aihw.gov.au (accessed 15 September 2015).

[72]      Submission 197, p. 16.

[73]      LFA, Answer to question on notice, 22 April 2015, (received 22 May 2015), p. 3.

[74]      Committee Hansard, p. 17.

[75]      Committee Hansard, p. 10.

[76]      LFA, Answer to question on notice, 22 April 2015, (received 22 May 2015), p. 3. LFA referred the committee to the Biogrid Annual Report 2013-14: http://biogrid.blob.core.windows.net/assets/uploads/files/BioGrid_Annual_Report_2013_2014_v2.pdf (accessed 15 September 2015).

[77]      LFA, Answer to question on notice, 22 April 2015, (received 22 May 2015, pp 2- 3.

[78]      Submission 123, p. 10

[79]      Submission 49, p. 2.

[80]      Submission 150, p. 2.

[81]      Committee Hansard, p. 18.

Chapter 6 - Conclusions and recommendations

[1]        Review of Medicines and Medical Devices Regulation, Report on the regulatory framework for medicines and medical devices, March 2015, www.health.gov.au (accessed 14 September 2015).