Named Patient Pharmaceutical Assessment (NPPA) The new “exceptions” scheme Dr Dilky Rasiah Deputy Medical Director

Some Benefits and New Features of NPPA 1.Rarity no longer a criterion. 2. A new pathway for consideration of applications requiring urgent assessment. 3. Reduction of clinician workload by the following:  publish the outcome of funding applications  PHARMAC determining which NPPA pathway to best progress the application through  streamlined application process, apply electronically

4. Some medicines funded through NPPA while those medicines are under consideration for Schedule listing. 5. Closer alignment of NPPA and full Pharmaceutical Schedule assessments, benefiting patient populations over time. Some Benefits and New Features of NPPA cont

History of Exceptional Circumstances (EC) Recent: Section 48(b) NZPHD Act 2000 PHARMAC’s role in exceptional circumstances: including in exceptional circumstances providing for subsidies for the supply of pharmaceuticals not on the pharmaceutical schedule. Past: Regional Health Authorities-Health Funding Authority management.

Background to the EC Review We undertook a review of Exceptional Circumstances for several reasons:  Medicines New Zealand Strategy  Report of the High-Cost, Highly-Specialised Medicines Review Panel  Response to criticisms of the previous EC schemes Consultation round 1 August 2010; Formulated draft policy; Consultation round 2 January 2011; Draft policy revised, approved June 2011.

The New Scheme Named Patient Pharmaceutical Assessment (NPPA); individuals rather than populations. Purpose? An opportunity to be heard. Relationship to Schedule listing process. Three possible pathways. Prerequisites for all NPPA pathways: alternative funded treatments. Role of Decision Criteria

Unusual Clinical Circumstances Purpose: patients whose clinical circumstances are so unusual that PHARMAC is unlikely, for administrative reasons, to consider listing treatments for these circumstances on the Schedule. Unlikely to see other such patients. Not a mechanism for funding for new treatments for a group of patients.

Urgent Assessment Purpose: treatments for patients where PHARMAC is also considering or is likely to consider the treatment for Schedule listing, but the patient’s clinical circumstances justify urgent assessment, prior to a decision on Schedule listing. Key features of : Urgency, seriousness, significant deterioration/missed opportunity for significant improvement.

Hospital Pharmaceuticals in the Community Purpose: to allow DHB hospitals to fund a medicine for a patient in the community if this is more affordable for the DHB than paying for the treatment that would otherwise need to be provided. Not for long-term funding of community treatments.

How will applications be made and processed? Applications made electronically via our website. Later access, complete in real-time using EMR/PMS. Information requested from applicant. Role of clinical advice. Decisions by PHARMAC staff not advisory panel.

What Now? Providing information via Schedule, website, mailouts. Looking forward to feedback on practical workings of NPPA

Questions? Comments?