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Challenges and opportunities in New Zealand’s pharmaceutical scene Kevin Sheehy – Chief Executive, Medicines New Zealand Dalton Kelly – Chief Executive, New Zealand Cancer Society Assoc. Prof. Ken Whyte – University of Auckland Medical School
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Changes & opportunities in NZ Pharmaceutical Scene: An individual clinician’s view. Ken Whyte Respiratory, Transplant & Sleep Physician
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Demographic time bomb Christensen K et al, Lancet 2009;374:1196
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Increasing demands: kidney dialysis projections
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Pharmac & NZ successes Controlling pharmaceutical spending For majority of conditions has delivered adequate therapies & benefits at reduced cost Developed a “commercial” model that both sides (funder & Pharmaceutical Industry) understand Clinicians griped but could live with system for most therapies – system struggled with genuinely “new” therapies and high cost treatments. Pharmac overall has “Brownie points” in the bank with the health system (providers/funders/users)
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Pharmac & NZ weaknesses? Treasury small – Health budget finite Minimal resource for health economic analysis: Poor costing data for NZ health & disability costs Total lack of University health economic departments to train & offer analytical resource for Pharmac/Industry/Government/Patient groups Pharmac very limited resource ( MOH similar) Failure to debate the ethics of health funding and delivery.
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Ethical approach – not clear? Utilitarianism the greatest good for the greatest number The worst off have no priority Maxmin Principle (Rawls – Justice as Fairness) to the greatest benefit of the least advantaged, open to all under conditions of fair equality of opportunity In health care (+/- social care) – should a life saving or altering therapy, (even if very expensive) take priority over treating a lesser problem in a larger number? Variety of tools tried to measure but crude tools in reality & struggle to assess life altering/saving therapies. Precedent, equity & transparency – if one high cost treatment funded ($/QUALY) then others of same benefit should be funded
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The Clinician’s dilemma Advocate for individual patient In rare or very disabling conditions often no other advocates for the patient group Awareness of resources and societal demands Pharmac’s response: Exceptional circumstances Now named patient approach (NPPA) from 1/3/12 In past no clear societal decision in health funding re Utilitarianism versus more “graded” approach
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Looming threats Break down of the Pharmaceutical model: In short term many therapies will come off patent so $$$ looks good Large pharmaceutical companies portfolios shrinking Small niche companies (often funded by venture $$) - targeted & often “individual” therapies (small volume & great cost) Shrinking room for Pharmac to trade over a portfolio to allow new therapies affordable entry in NZ Dramatically life altering & saving replacement therapies This leads to an increasingly complex and probably insoluble dilemma around allocation of resources. Orphan diseases*: rare, yet many (estimated 5000-7000) & both randomised trials and cost benefit analysis not feasible as such small numbers – yet up to 2+% of population suffer when all added together! * life-threatening or chronically debilitating diseases which are of such low prevalence that special combined efforts are needed to address them
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Replacement therapies? Pompe’s disease (progressive muscle weakness leading to disability & death): algluosidase alfa drug, Lumizyme© - “adult” $250,000 per year for initial improvement & slowing of progression Societal costs of care altered by therapy? Cystic Fibrosis – disabling, fatal 25-40yrs with very poor quality of life & huge cost: For some sufferers – prospect of replacement therapy from infancy with dramatically altering life quality & expectancy: Therapy for life - ?1-75 yrs Cost versus benefit – normal versus disabled life.
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Go forth and multiply?
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Medical Devices? Triumvirate of material scientists/smart engineers/health scientists near limitless “new” developments Rapid redundancy – limited time for trials Traditional RCT model difficult: Placebo difficult Time frames to assess QALY often long Cost benefit analysis for in-patient devices (theatre, wards etc) differ for individual services & different hospitals. “Publicly” funded utility trials rather than manufacturer funded?
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Pharmac & NZ future? Pharmac model needs to be pro-active & change before “melt-down” & loses credibility? Pharmac taking on Medical devices maybe a step too far? Pharmac has always been under-resourced (proud & lean is not always productive!) NZ Society has to debate the ethics & make decisions – Pharmac can only delay
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