Greg Cook Associate Director, Market Access, Bristol-Myers Squibb Australia

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Squibb Australia Disclaimer: The views expressed in

1 NICE PBAC PBS CADTH Access Challenges Greg Cook Associate Director, Market Access, Bristol-Myers Squibb Australia Disclaimer: The views expressed in this presenta5on are those of the author not his employer

Trials (Phase III ) Regulatory Evaluation Reimbursement Evaluation Patient Access 0 yrs 3 yrs 6 yrs 9 yrs 12 yrs 15 yrs Source: Pre.

2 Obtaining subsidised pa.ent access for new medicines has become increasingly difficult From bench to patient Discovery Pre-Clinical Testing Clinical Trials (Phase 1) Clinical Trials (Phase II ) Clinical Trials (Phase III ) Regulatory Evaluation Reimbursement Evaluation Patient Access 0 yrs 3 yrs 6 yrs 9 yrs 12 yrs 15 yrs Source: Pre.um 2013 Payer Specialists Consumer Groups Evaluation Unit Local Health Economics & Reimbursement Local Medical Regulatory Affairs Politicians Gov t Relations Corporate Affairs Local Health Economics & Reimbursement Local Medical Regulatory Affairs Payer Evaluation Unit Early 2000's 2000 s Head Office Today Now Consultants - Statistical - Modelling Head Office, Other Int l Offices

Technical issues speciﬁc to cancer medicines exacerbate this problem Clinical trial design - single- arm, non- randomised,

ve - surrogate endpoints - Quality of Life (QoL) measures Biomarker/ targeted medicines Diﬀering mechanisms of ac.

Dendri5c B7 CD28 T cell + + + cell B7 CTLA- 4 - - - CTLA- 4 pathway 250 indica*ons across 114 chemical en**es currently in

3 Technical issues speciﬁc to cancer medicines exacerbate this problem Clinical trial design - single- arm, non- randomised, open label - pa.ent cross- over - adap.ve - surrogate endpoints - Quality of Life (QoL) measures Biomarker/ targeted medicines Diﬀering mechanisms of ac.on Periphery (expansion) Tumour microenvironment Ac5va5on (cytokines, lysis, prolifera5on, migra5on to tumour) MHC TCR Dendri5c B7 CD28 T cell cell B7 CTLA CTLA- 4 pathway 250 indica*ons across 114 chemical en**es currently in Phase II and III clinical development by 16 major pharmaceu*cal companies in oncology T cell TCR ADC MHC PD- 1 PD- L PD- 1 PD- L PD- 1 pathway Tumour cell Source: DAE 2013 Access to cancer medicines in Australia

4 Why? q Key stakeholder mo.va.ons payer, pa.ent, industry q Oncology/ I- O technical issues q Payer, pa.ent, industry Poten.al Solu.ons

5 Stakeholder Mo5va5ons Payer ACCESS Patients Industry

6 Payer Motivations Payer Value & Certainty Australian Govt Budget Headline surplus (+) / deficit (- ) [$millions] Jun 96 Jun 12

Payer Motivations q bevacizumab for various cancers reimbursement capped at accumulated dose of 10,000mg. Sponsor pays thereader. Payer Value & Certainty q bortezomib for mul5ple myeloma retrospec.

ents subsequently required surgery for benign prosta.c hyperplasia ader one full year of medical therapy. q ipilimumab for metasta5c melanoma - implementa.on of a mechanism to verify the an.

q eculizumab for ahus - a structured program to collect ongoing evidence to assess long term outcomes, including poten.al for rebates to the Commonwealth. Sources: hjp://www.pbs.gov.

7 Payer Motivations q bevacizumab for various cancers reimbursement capped at accumulated dose of 10,000mg. Sponsor pays thereader. Payer Value & Certainty q bortezomib for mul5ple myeloma retrospec.ve payer reimbursement for non- responders; defined as <50% reduc.on in serum paraprotein levels by the 4 th cycle. q finasteride for benign prosta5c hyperplasia full cost rebate if pa.ents subsequently required surgery for benign prosta.c hyperplasia ader one full year of medical therapy. q ipilimumab for metasta5c melanoma - implementa.on of a mechanism to verify the an.cipated overall survival benefits of ipilimumab in real world clinical prac.ce in Australia. q ivacawor for cys5c fibrosis - pay for performance arrangement along with the risk share arrangement. q eculizumab for ahus - a structured program to collect ongoing evidence to assess long term outcomes, including poten.al for rebates to the Commonwealth. Sources: hjp:// mee.ngs/psd hjp:// suni.nib- for- the- firstline- treatment- of- advanced- andor- metasta.c- renal- cell- carcinoma- pdf hjp:// cell- carcinoma- bevacizumab- sorafenib- suni.nib- and- temsirolimus- final- appraisal- determina.on3 Adamski et al. BMC Health Services Research doi: /

trastuzumab for MBC Gardasil for HPV pemetrexed for MPM

pembrolizumab for MM ivacador for CF eculizumab for PNH Patients

ent Requests for Access Beginning Earlier This is the brave new

sufficient understanding of poli5cal processes and the

8 Patient Motivations Pa.ent Demands for Subsidised Access is Increasing & Evolving trastuzumab for MBC Gardasil for HPV pemetrexed for MPM abiraterone for PC ipilimumab, vemurafenib, nivolumab, pembrolizumab for MM ivacador for CF eculizumab for PNH Patients Early Access Pa.ent Requests for Access Beginning Earlier This is the brave new world of health advocacy, where many pa5ent groups possess sufficient understanding of poli5cal processes and the machina5ons of pharmaceu5cal reimbursement to have moved from the sidelines onto the playing field. Source: John Morton, MD Ethical Strategies; Pharma Dispatch: Nov registra.on reimbursement

Industry Motivations Industry Broad Access @ Premium $ q Clinical research for cancer medicines takes an average of 1.5yrs longer than treatments for other diseases.

9 Industry Motivations Industry Broad Premium $ q Clinical research for cancer medicines takes an average of 1.5yrs longer than treatments for other diseases. Source: Boston Healthcare 2012; Recognizing Value in Oncology Innova.on q Cost of developing a new drug and bringing to market has risen from $0.413 billion in 1980s to $1.044 billion in 1990s- early 2000s to $2.558 billion in 2000s- early Source: TUFTS Center for the Study of Drug Development; Cost of developing a new drug: Nov 18, 2014

10 Oncology/ I-O Technical Issues Clinical Trial Design - single- arm, non- randomised, open label - pa.ent cross- over - adap.ve - surrogate endpoints - QoL measures Biomarker/ Personalised Medicine Differing Mechanisms of Ac.on

Oncology/ I-O Technical Issues Clinical Trial Design Clinical trial design for cancer medicines is providing real challenges to the reimbursement process, par.cularly in the areas of pa.

Pa5ent Cross- Over: Although PBAC has accepted that trials with switching are approved by Human Research Ethics Commijees, it has not accepted that switching must be incorporated into

11 Oncology/ I-O Technical Issues Clinical Trial Design Clinical trial design for cancer medicines is providing real challenges to the reimbursement process, par.cularly in the areas of pa.ent cross- over and surrogate outcomes. Oncology CTs Non- Oncology CTs Single arm 62.3% 23.8% Open label 87.8% 47.3% Nonrandomised 63.9% 22.7% Source: Hirsch et al 2013 AJAMA Intern Med:1-8. Pa5ent Cross- Over: Although PBAC has accepted that trials with switching are approved by Human Research Ethics Commijees, it has not accepted that switching must be incorporated into trials for ethical reasons. Source: PBD Oct 2014; Examining the Consequences of Bias Caused by Treatment Switching in Randomised Trials for Submissions to the Pharmaceu.cal Benefits Advisory Commijee

Oncology/ I-O Technical Issues Biomarker/ targeted medicines The increasing use of biomarkers in oncology to assess and predict treatment response is a posi.ve step in improving pa.ent health outcome.

12 Oncology/ I-O Technical Issues Biomarker/ targeted medicines The increasing use of biomarkers in oncology to assess and predict treatment response is a posi.ve step in improving pa.ent health outcome. However the requirements to fulfil both the PBAC and MSAC processes add complexity and evalua.on.me. Source: DAE 2013 Access to cancer medicines in Australia Differing mechanisms of ac5on Cancer Immunotherapy Their mechanism of ac.on is so dis.nct, both mechanis.cally and temporally, compared with conven.onal cytotoxic drugs, that they cannot be expected to perform according to standards developed a genera.on ago, even though the results may ul.mately be cura.ve. Source: Mellman et al Cancer immunotherapy comes of age. Nature, Vol 480: PFS OS

13 Potential Solutions PAYERS Solutions-orientated partnership approach to HTA decision making e.g. earlier, broad stakeholder engagement. Decision making to take into account evolving CT design & unique characteristics of cancer/ I-O therapies e.g. earlier approval with managed entry / coverage with evidence development systems. Policy systems to protect/ encourage innovation and support future advances - e.g. NICE value based pricing; Cancer Drug Fund. PATIENTS Increased Education ~ R & D process & cost to Industry; HTA process & cost to Governments. Greater transparency of decision-making process and greater involvement. Societal input into determination of relative value of medicines e.g. end of life vs total life. Payers ACCESS Industry Consumers INDUSTRY Look at ways to reduce cost of medicine development without compromising data. Clinical trials to incorporate endpoints relevant to payers - e.g. Quality of Life, Patient Reported Outcomes. Greater commitment to post-marketing data collection e.g. input into oncology data registry.

Single Technology Appraisal (STA) Nivolumab for adjuvant treatment of resected stage III and IV melanoma

Single Technology Appraisal (STA) Nivolumab for adjuvant treatment of resected stage III and IV Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) Comment: