Devidas Menon,  PhD,  MHSA  &  Tania  Stafinski,  PhD,  MSc

From  building  networks  to  collaboration

BUILDING  A  NETWORKWhat  is  a  network?A  group  of  interconnected  people who  interact  with  one  another  to  

exchange  information  and  develop  contactsGovernment

Patients  and  families

Health  professionalsAcademic  

researchers

Industry

BUILDING  COLLABORATIONWhat  is  collaboration?

Working  with  various  stakeholder  groups  to  jointly  achieve  a  shared  outcome

Policy  options  that  facilitate  

sustainable  access  to  effective  therapies

WHAT  ABOUT  PRISM?• An  example  of  the  importance  of  both

Network

Collaboration

Goal“To  create  a  knowledge  base  for  supporting  the  design  of  public  

policies  and  processes  that  enable  the  development  and  introduction  of  health  technologies  for  rare  diseases  which  optimize  both  outcomes  and  the  use  of  

healthcare  resources  in  Canada”

Right  drugs

Right  patients

Right  time

Right  place

HOW  HAS  PRISM  TRIED  TO  ACHIEVE  THIS?

HOW  HAS  PRISM  TRIED  TO  ACHIEVE  THIS?• A  multi-­‐disciplinary,  international  team  of  people  from  all  

stakeholder  communities

• A  combination  of  independent  domain  projects  and  integrated  (multi-­‐domain)  projects

• Reliance  on  PRISM  network

• Need  for  collaboration

• A  technology  lifecycle  approach

HOW  HAS  PRISM  TRIED  TO  ACHIEVE  THIS?

PROJECTS  RELYING  ON  PRISM’S  NETWORK

•Analyses  of  orphan  drug  development  costs  and  revenues  

• Exploration  of  the  use  of  revenue  caps  based  on  risk  and  capital  adjusted  costs

Industrial  policy:  R&D  costs  and  incentives

•CF  therapies  case  study,  jurisdictional  scan,  and  review  of  relevant  scholarly  methods  work

•Analysis  of  the  work  of  European  groups  within  the  Canadian  context

Regulatory  policy:  Clinical  trial  design:  Measuring  efficacy  and  effectiveness

• International  comparison  of  pharmaceutical  access  policies  (including  HTA  and  centralized  drug  reviews)

• Pan-­‐Canadian  jurisdictional  scan  of  processes  and  availability  of  specific  orphan  drugs

Reimbursement  policy:    HTA  

processes  and  coverage  options    

• Consider  whether  reliance  on  safety  net  programs  is  sustainable

• What  about  managed  access  programs  ?

• Optimize  the  role  of  public  insurance  as  a  key  player  in  creating  a  market  for  innovation  

• Build  on  the  work  of  European  groups

• Need  to  examine  willingness  to  accept  uncertainty  in  benefits  and  harms

PROJECTS  BUILT  ON  COLLABORATION

•Citizens  juries  to  gauge  public  sentiment  around  access  to  high  cost  therapies  that  benefit  small  populations

• Involved    multi-­‐stakeholder  panel  sessions  and  trade-­‐off  exercises

Societal  values  to  inform  public  

policies

•Workshops,  focus  groups  and  webinars  involving  patients  and  families

•Analysis  of  international  experience  with  MAPs•Patient-­‐led  development  of  MAPs  checklist  

Patient-­‐developed  model  for  managed  access  programs  

(MAPs)

•Workshop  for  provincial  drug  plan  managers•Preparation  of  document  containing    PRISM  related  research  findings  around    evidence,  access  and  communications

Support  to  the  inter-­‐provincial  working  group

• It  isn’t  all  about  numbers

• It  is  about  ensuring  that  the  gain  in  quality  of  life  is  significant    

• Views  on  MAPs  are  mixed  – great  idea,  buthard  to  implement

• Checklist  contains  questions  to  ask  when  developing  a  MAP

• Continued    provision  of  information  that  reflects  the  best  available  evidence  to  support  the  group’s  work  

WHAT  HAVE  WE  LEARNED?

• Developing  the  level  of  trust  needed  to  engage  in  meaningful  multi-­‐stakeholder  work  takes  time

• We  need  to  be  innovative  but  also  realistic  in  our  approaches  to  industrial,  regulatory  and  reimbursement  policies  

• We  now  have  a  shared  and  solid  foundation  of  knowledge  on  which  to  build

WHAT  HAVE  WE  LEARNED?• It  isn’t  all  about  

numbers• It  is  about  ensuring  

that  the  gain  in  quality  of  life  is  significant    

• Views  on  MAPs  are  mixed  – great  idea,  buthard  to  implement

• Checklist  contains  questions  to  ask  when  developing  a  MAP

• Continued    provision  of  information  that  reflects  the  best  available  evidence  to  support  the  group’s  work  

• Developing  the  level  of  trust  needed  to  engage  in  meaningful  multi-­‐stakeholder  work  takes  time

• We  need  to  be  innovative  but  also  realistic  in  our  approaches  to  industrial,  regulatory  and  reimbursement  policies  

• We  now  have  a  shared  and  solid  foundation  of  knowledge  to  build  on

MORE  INFORMATION• It  isn’t  all  about  

numbers• It  is  about  ensuring  

that  the  gain  in  quality  of  life  is  significant    

• Views  on  MAPs  are  mixed  – great  idea,  buthard  to  implement

• Checklist  contains  questions  to  ask  when  developing  a  MAP

• Continued    provision  of  information  that  reflects  the  best  available  evidence  to  support  the  group’s  work  

• Website  address:    www.prismfive.org

• Email:  menon@ualberta.ca

THANK  YOU!