Access to cancer drugs: The role for a stakeholder alliance?

Transcription

1 Access to cancer drugs: The role for a stakeholder alliance? John Zalcberg Co-Chair, Cancer Drugs Alliance (CDA)

2 Disclosures Research support, travel support and honoraria from a wide variety of pharmaceutical companies including: Roche, MerckSerono and Pfizer

3 Cancer context 1 in 2 Australians are expected to develop cancer in their lifetime Approx. 134,000 new patients will be diagnosed with cancer in 2017 Over 45,000 Australians die each year from cancer Cancer accounts for approximately 19 per cent of the total disease burden, greater than any other disease Australian Institute of Health and Welfare. Cancer in Australia Cat. no. CAN 100

4 Access to cancer medicines TGA approval Average: 31 months1 Max: months PBS listing Patients: limited access/out-of-pocket Industry: resubmissions/patient familiarization programs Clinicians: decision about what to offer 1. Deloitte Access Economics. Access to cancer medicines in Australia July 2013

5 PBAC outcomes *Wonder Drug Consulting. Analysis of PBAC submissions and outcomes for medicines for patients with cancer ( )

6 Personal examples Herceptin for metastatic breast cancer Herceptin as adjuvant therapy for early breast cancer Herceptin for gastric cancer Imatinib for GIST Sunitinib for advanced pancreatic NET Cetuximab for advanced colorectal cancer Crizotinib for advanced lung cancer

7 Access to cancer medicines Australian cancer patients need, expect and deserve timely and affordable access to new, innovative and effective cancer drugs, in a system that is fair, equitable and sustainable Can this be achieved through the existing arrangements? Cancer Drugs Alliance: Improving Access to Cancer Medicines White Paper 2015

8 A global issue: how does Australia compare? New and subsequent listings ( ): Comparable (25% of new cancer medicines do not secure reimbursement) Lower Higher (but Cancer Drugs Fund led to major improvement in England) Mean time from registration to listing longer than in most other countries Poorer access to new medicines for colorectal cancer, non small-cell lung cancer and breast cancer Michael Wonder. Reimbursement success rates and timelines for new medicines for cancer; an international comparison. February 2014

9 About the CDA - structure Patients Industry Clinicians

10 About the CDA - first report The CDA aims to draw much-needed attention to the serious issue of inequitable, unaffordable and delayed access to cancer medicines in Australia, which is seeing many Australian cancer patients denied new cancer medicines that are readily available in other countries

11 CDA priorities Building a meaningful and impactful consumer voice for cancer patients Reducing the burden of red-tape on healthcare professionals and removing unnecessary processes Improving the current system of access with better processes within the current system Exploring and developing innovative access models that take into account the complexity of cancer, while looking at international best practice models Establishing a national chemotherapy registry to provide a database of outcomes following the use of chemotherapy and targeted medicines

12 CDA activities

13 Realistic solutions The annual level of spending on the PBS is approximately AU$10.8 billion, almost doubling in the past decade Exclusive of high-cost drug recoveries, which comprised AU$1.6 billion in the financial year Australian Government Department of Health Annual Report

14 Cancer Drugs Access Committee Multidisciplinary membership includes clinicians, patients, industry and health economics input Cross-sectional industry sponsorship Emphasis on collaboration and consultation Support from PwC

15 Broader context: progress to date Two new pathways to registration on the ARTG Increased use of Managed Entry Schemes Review of PBAC guidelines including consideration of evidence requirements Some progress towards formalising patient and clinician involvement Some linkage of PBS and MBS data Deloitte Access Economics: A collaborative assessment of access to cancer medicines in Australia. 2016

16 Broader context: ongoing challenges Enabling infrastructure to bring real world evidence into common practice Policy for provisional listing of medicines based on RWE and forthcoming RCTs Reviewing approaches to consideration of value of cancer medicines Systematic reform to patient, clinician and community involvement in the review process Deloitte Access Economics: A collaborative assessment of access to cancer medicines in Australia. 2016

17 Broader context: ongoing challenges George Institute for Global Health. Re-imagining the funding wheel: sustainable access to medicines. April 2017

18 George Institute forum on sustainable access to medicines Concepts: Health Insurance Patient co-payment Drug levy (akin to the Medicare levy) Improve the PBS model

19 George Institute forum on sustainable access to medicines Concerns: Drug pricing Undermining the existing system Community rating/risk rating for health insurance Patient co-payment Equity

20 Broader context: lessons from elsewhere Continuous patient involvement in pcodr process Separation of evaluation of cancer medicines from the Common Drug review pcodr considers clinical, economic and patient evidence on cancer medicines Patient and Clinician Engagement (PACE) in the SMC assessment process Citizens Councils to consider value judgements that inform NICE principles England Cancer Drugs Fund Companies must commit to performing studies to assess real life effectiveness after reimbursement Consideration of therapeutic value including public health benefit and innovation Four pathways for FDA registration Real world data registers Deloitte Access Economics: A collaborative assessment of access to cancer medicines in Australia. 2016

21 Broader context: Australian developments Department of Health (DoH): Reform of Regulation of Medicines and Medical Devices Medicines Australia: Managed Access Program TGA: Provisional Approval Pathway for prescription medicines Enhanced medicines vigilance DoH: CDAC process

22 CDA submission to the TGA Reform Process Criteria to prioritise new applications (accelerated/breakthrough etc) Shorter timeline for review and approval where review completed by an accredited overseas agency Mechanism for expedited review and approval for drugs already approved for another indication Priority and Provisional Review designation of 150 calendar days not 150 working days (where data are available from other approved regulators)

23 CDA submission to the TGA Reform Process (cont.) Consider the impact of expedited TGA pathways on the PBS Ensure processes do not disadvantage applications for drugs for rare and less common cancers Include consumer and clinician reference groups early in decisionmaking Require post-marketing analysis of drug safety and efficacy for drugs approved under the Provisional pathway in most, if not all instances

24 Next priorities TGA Reform Impact on the PBS Rare cancers pay for performance Data registries and access to data Other programs Orphan, Life-saving Disinvestment Compassionate Access Programs

25 Questions