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pan-­‐Canadian	
  	
  
Pharmaceu0cal	
  Alliance	
  Office	
  	
  
Canadian	
  Expert	
  Pa0ents	
  in	
  HTA	
  (CEPHTA)	
  	
  
Value-­‐Based	
  Pricing:	
  Challenges	
  &	
  
Opportuni0es	
  	
  	
  
November	
  8,	
  2016	
  	
  
1	
  
pCPA	
  Objec0ves	
  	
  
The	
  objec0ves	
  of	
  the	
  pCPA	
  are	
  to	
  provide	
  value	
  to	
  the	
  broader	
  health	
  care	
  
systems	
  of	
  the	
  Par0cipa0ng	
  Organiza0ons	
  and	
  to	
  improve	
  pa0ent	
  care	
  by	
  
nego0a0ng	
  drug	
  reimbursement	
  collec0vely	
  to:	
  
	
  
1.  Increase	
  access	
  to	
  clinically	
  effec0ve	
  and	
  cost	
  effec0ve	
  drug	
  
treatment	
  op0ons;	
  
2.  Improve	
  consistency	
  of	
  decisions	
  among	
  Par0cipa0ng	
  Organiza0ons;	
  
3.  Achieve	
  consistent	
  and	
  lower	
  drug	
  costs	
  for	
  Par0cipa0ng	
  
Organiza0ons;	
  and	
  
4.  Reduce	
  duplica0on	
  of	
  effort	
  and	
  improve	
  use	
  of	
  resources.	
  
2	
  
Brand	
  Nego0a0ons	
  Process	
  
6	
  
pCPA	
  Ac0vity	
  
2010	
  -­‐	
  2014	
  
2015	
  	
  
2016	
  
(10	
  months)	
  	
  
55	
  (completed)	
  
41	
  (completed)	
  
100	
  (37	
  completed	
  +	
  37	
  ac9ve	
  +	
  	
  
26	
  post-­‐HTA)	
  	
  
Brand*	
  	
   Generics**	
  	
  Biosimilars*	
  
1	
  (completed)	
  
0	
  
4	
  (1	
  completed	
  +	
  2	
  
ac9ve	
  +	
  1	
  post-­‐HTA)	
  
*Brand	
  /Biosimilars	
  –	
  number	
  of	
  products	
  nego1ated.	
  	
  Note	
  -­‐	
  does	
  not	
  
include	
  ALL	
  nego1a1on	
  ac1vity	
  of	
  pCPA	
  (i.e.	
  other	
  ac1vity	
  includes	
  decisions	
  
to	
  not	
  nego1ate	
  collec1vely	
  a@er	
  considera1on	
  of	
  a	
  product	
  and	
  nego1a1ons	
  
for	
  products	
  that	
  are	
  not	
  based	
  on	
  recent	
  HTA	
  recommenda1on)	
  
0	
  
108	
  
341	
  
CADTH	
  Recommenda9ons	
  
2013/14:	
   	
  53	
  	
  
2014/15:	
   	
  47	
  
2015/16:	
   	
  71	
  
5	
  
Time	
  Since	
  HTA	
  
Recommenda/on	
  
pCPA	
  Considera.on	
   Ac.ve	
  Nego.a.on	
  
	
  Completed	
  LOIs	
  
since	
  Jan.	
  1	
  2016	
  
Brilinta	
  (AE)	
   Yondelis	
   Imbruvica	
  (MC)	
   Keytruda	
  
Invokamet	
   Sunvepra	
  	
   Praluent	
  	
   Inspiolto	
  Respimat	
  	
  
<3	
   Descovy	
   XigDuo	
   Cotellic	
  
Months	
   EgriNa	
   Kyprolis	
   Opdivo	
  (NSCLC)	
  
Truvada	
   Ilaris	
  
Cosentyx	
  (PA)	
   Nucala	
  
Cosentyx	
  (AS)	
   Trulicity	
  
Eylea	
  (MES)	
   Reves.ve	
  
Xolair	
  (AS)	
   Avas.n	
  (PROC)	
   Basaglar	
  	
  	
   Breo	
  Ellipta	
  
Vimizim	
  (MA)	
   Zepa.er	
  	
   Strensiq	
  
3-­‐6	
   Humira	
  (HS)	
   Sovaldi-­‐Harvoni	
  	
   Entresto	
  	
  
Months	
   Pheburane	
   Fycompa	
   Genvoya	
  
Jardiance	
  	
   Grastofil	
  	
  
Blincyto	
   Jakavi	
  	
  
Opdivo	
  (MM)	
   Technivie	
  
Humira	
  (UC)	
   Ferriprox	
  
Naglazyme	
   Xgeva	
  	
   Repatha	
   Revlimid	
   Jardiance	
  	
   Arnuity	
  Ellipta	
  	
  
6-­‐9	
   Spiriva	
  Respimat	
  	
   Iclusig	
  	
  
Months	
   Forxiga	
   Avas.n	
  (CC)	
   Zaxine	
  
Kalydeco	
  	
   Entyvio	
  	
   Lemtrada	
  
9-­‐12	
   Neupro	
  	
   Prolia	
  	
  	
  
Months	
   Cyramza	
  (GC)	
   Ofev	
  
Xolair	
  (CIU)	
   Prezcobix	
   Januvia	
  
>12	
   Sylvant	
   Xeljanz	
  	
  	
  
Months	
   Esbriet	
   Simponi	
  SC	
  
Cimzia	
  
Otezla	
  (PA)	
   Adempas	
  (PAH)	
   Plegridy	
   Vec.bix	
   Cosentyx	
  	
   Tafinlar/Mekinist	
   Zydelig	
  
Brand	
  -­‐	
  Summary	
  as	
  of	
  October	
  31,	
  2016	
  
Value	
  Based	
  Pricing	
  	
  
“Innova0ve	
  Agreements”	
  
6	
  
Performance/Outcome	
  Based	
  Agreements	
  
Data	
  	
   Outcome/Value	
  	
  
Measure	
  	
  
Risk	
  Sharing	
  
Structure	
  	
  
Challenge:	
  
implementa0on	
  –	
  
traceability/tracking	
  
infrastructure	
  	
  
	
  
Opportunity:	
  
small/iden0fiable	
  	
  
pa0ent	
  popula0ons	
  	
  
Challenge:	
  
measurability	
  and	
  
abri-­‐bu-­‐tab-­‐ility	
  	
  
	
  
Opportunity:	
  
demonstrable	
  effect	
  	
  
Challenge:	
  	
  
front-­‐end	
  funding	
  
responsibility	
  	
  
	
  
Opportunity:	
  
structure	
  rebates	
  
around	
  uncertainty	
  –	
  
when	
  highest,	
  rebate	
  
is	
  highest	
  	
  
Joint	
  Approach	
  –	
  Required	
  Roles	
  	
  
Public	
  Drug	
  Plans	
  
•  Increase	
  capacity	
  to	
  use	
  available	
  data	
  	
  
•  Con0nue	
  to	
  remain	
  open	
  to	
  consider	
  proposals	
  	
  
•  Provide	
  guidance	
  on	
  expecta0ons	
  for	
  OBA	
  	
  
Pa0ents	
  
•  Informed	
  consent	
  	
  
•  Ac0vely	
  involved	
  in	
  monitoring	
  	
  
•  Par0cipa0on	
  in	
  research	
  
•  Amenable	
  to	
  change	
  	
  
Manufacturers	
  	
  	
  
•  Invest	
  in	
  study	
  design	
  and	
  data	
  infrastructure	
  	
  
•  Recognize	
  complexity	
  and	
  impact	
  on	
  0melines	
  	
  
7	
  

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Value-Based Pricing Challenges and Opportunities in Canadian Pharma

  • 1. pan-­‐Canadian     Pharmaceu0cal  Alliance  Office     Canadian  Expert  Pa0ents  in  HTA  (CEPHTA)     Value-­‐Based  Pricing:  Challenges  &   Opportuni0es       November  8,  2016     1  
  • 2. pCPA  Objec0ves     The  objec0ves  of  the  pCPA  are  to  provide  value  to  the  broader  health  care   systems  of  the  Par0cipa0ng  Organiza0ons  and  to  improve  pa0ent  care  by   nego0a0ng  drug  reimbursement  collec0vely  to:     1.  Increase  access  to  clinically  effec0ve  and  cost  effec0ve  drug   treatment  op0ons;   2.  Improve  consistency  of  decisions  among  Par0cipa0ng  Organiza0ons;   3.  Achieve  consistent  and  lower  drug  costs  for  Par0cipa0ng   Organiza0ons;  and   4.  Reduce  duplica0on  of  effort  and  improve  use  of  resources.   2  
  • 4. pCPA  Ac0vity   2010  -­‐  2014   2015     2016   (10  months)     55  (completed)   41  (completed)   100  (37  completed  +  37  ac9ve  +     26  post-­‐HTA)     Brand*     Generics**    Biosimilars*   1  (completed)   0   4  (1  completed  +  2   ac9ve  +  1  post-­‐HTA)   *Brand  /Biosimilars  –  number  of  products  nego1ated.    Note  -­‐  does  not   include  ALL  nego1a1on  ac1vity  of  pCPA  (i.e.  other  ac1vity  includes  decisions   to  not  nego1ate  collec1vely  a@er  considera1on  of  a  product  and  nego1a1ons   for  products  that  are  not  based  on  recent  HTA  recommenda1on)   0   108   341   CADTH  Recommenda9ons   2013/14:    53     2014/15:    47   2015/16:    71  
  • 5. 5   Time  Since  HTA   Recommenda/on   pCPA  Considera.on   Ac.ve  Nego.a.on    Completed  LOIs   since  Jan.  1  2016   Brilinta  (AE)   Yondelis   Imbruvica  (MC)   Keytruda   Invokamet   Sunvepra     Praluent     Inspiolto  Respimat     <3   Descovy   XigDuo   Cotellic   Months   EgriNa   Kyprolis   Opdivo  (NSCLC)   Truvada   Ilaris   Cosentyx  (PA)   Nucala   Cosentyx  (AS)   Trulicity   Eylea  (MES)   Reves.ve   Xolair  (AS)   Avas.n  (PROC)   Basaglar       Breo  Ellipta   Vimizim  (MA)   Zepa.er     Strensiq   3-­‐6   Humira  (HS)   Sovaldi-­‐Harvoni     Entresto     Months   Pheburane   Fycompa   Genvoya   Jardiance     Grastofil     Blincyto   Jakavi     Opdivo  (MM)   Technivie   Humira  (UC)   Ferriprox   Naglazyme   Xgeva     Repatha   Revlimid   Jardiance     Arnuity  Ellipta     6-­‐9   Spiriva  Respimat     Iclusig     Months   Forxiga   Avas.n  (CC)   Zaxine   Kalydeco     Entyvio     Lemtrada   9-­‐12   Neupro     Prolia       Months   Cyramza  (GC)   Ofev   Xolair  (CIU)   Prezcobix   Januvia   >12   Sylvant   Xeljanz       Months   Esbriet   Simponi  SC   Cimzia   Otezla  (PA)   Adempas  (PAH)   Plegridy   Vec.bix   Cosentyx     Tafinlar/Mekinist   Zydelig   Brand  -­‐  Summary  as  of  October  31,  2016  
  • 6. Value  Based  Pricing     “Innova0ve  Agreements”   6   Performance/Outcome  Based  Agreements   Data     Outcome/Value     Measure     Risk  Sharing   Structure     Challenge:   implementa0on  –   traceability/tracking   infrastructure       Opportunity:   small/iden0fiable     pa0ent  popula0ons     Challenge:   measurability  and   abri-­‐bu-­‐tab-­‐ility       Opportunity:   demonstrable  effect     Challenge:     front-­‐end  funding   responsibility       Opportunity:   structure  rebates   around  uncertainty  –   when  highest,  rebate   is  highest    
  • 7. Joint  Approach  –  Required  Roles     Public  Drug  Plans   •  Increase  capacity  to  use  available  data     •  Con0nue  to  remain  open  to  consider  proposals     •  Provide  guidance  on  expecta0ons  for  OBA     Pa0ents   •  Informed  consent     •  Ac0vely  involved  in  monitoring     •  Par0cipa0on  in  research   •  Amenable  to  change     Manufacturers       •  Invest  in  study  design  and  data  infrastructure     •  Recognize  complexity  and  impact  on  0melines     7