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WHow should drugs be valued? What should we be prepared to pay? Evidence-based pricing XXW (The market for pharmaceuticals is flawed))$) |The industry has chosen to ignore large markets Lack of true competition Informational asymmetry Imbalance of market power - those who most need are least able to afford drugs Divergence of interests of customers and investors At prices offered new drugs often offer small marginal gains for large marginal costs (seldom seen in other technology and knowledge-based industries) J| PZ l2Z|} 8Pharmacoeconomics$ Usually relates the net benefits to the net costs, and the price is a given cost-effectiveness ratios can be used to generate  indicative prices that represent  value for money in different communities/contexts the application of economic utility theory and consideration of social opportunity cost is consistent with marked variation in prices in different communities/contexts"} P}| 7Pharmacoeconomics $ The argument that a drug 'does not represent value for money' is different from saying it is 'not affordable The first is a confident statement from a potential customer The second an expression of helplessness n Pf P P Pnf      <Pharmacoeconomics  an example$ Drug X saves 1 life for every 10 treated Each survivor lives 10 years Drug X costs $2000 (in Australia) It costs 10*$2000 to gain 10 life years, so the cost/LYG is $2000 Does Drug X offer  value for money in Australia? > PK!   The same drug in another country!!!  Drug X saves 1 life for every 10 treated Each survivor lives 10 years For every 10 persons treated we gain 10 life years (LYG) Assume an  acceptable cost-effectiveness ratio in country 2 is $200/LYG Then the indicative  value for money price in that country is $200 pF0 PZK0 PZ2 PZZ   .What does 'value for money' mean in country 2?/K/$. The  acceptable ratio in country 2 is $200/LYG v $2000/LYG in Australia The opportunity cost of $2000 is too high in country 2 Committing $200/LYG in country 2 is a good investment compared with other life-saving interventions : P " A case study using ACE-inhibitors##$" VBasic assumptions underlying the analysis: Set  value of LYG as equivalent to a proportion of per capita GNP (A proxy measure of value) not a judgment of intrinsic worth H+ 2   Estimates of benefit of ACE-Is " $ JDerived from systematic (Cochrane) reviews In treatment of hypertension - no evidence of benefit over diuretics / $-blockers In congestive heart failure - clear benefit over placebo In patients with left ventricular dysfunction after heart attack - clear benefit over placebo + P-; P P-# P_ P-O  *   ! Magnitude of the benefit"$   "Other assumptions in the model$ Use of ACE-s is 90% for hypertension, 8% for CHF, 2% for post-MI (base case) Treatment of hypertension requires one DDD, of CHF 2DDDs, post-MI 3DDDs 0 P2 #Method$ From estimates of LYGs derived from the meta-analyses, combined with . . . value of LYG, set to a proportion of per capita GNP . . . calculate an implied incremental cost-effectiveness ratio, and from this . . . an indicative price (the price which would have resulted in this ICER) D P*   $Results$   >-(Results (2) 80% HT, 15% CHF, 5% post MI () $'  &Limitations of the methodology  $ >Per capita GNP as proxy measure of affordability is arbitrary (and probably not linear) Method dependent on the quality/applicability of evidence Any effect modifiers should be included The present example takes no account of cost offsets Must be supported by underlying data collection systems to inform the context dX PZ0 PZ- PZZ?? (Advantages of the methodology  $ Places PE in context Establishes nexus between price, value and evidence of benefit Price not derived from cost of R&D or production Can be used in price/volume agreements EBM foundation is empowering6 P-Zk * Sources of evidence "$ Blood Pressure Lowering Triallists' Collaboration. Effect of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Lancet (2000);356:1955-1964 Psaty et al. Health outcomes associated with anti-hypertensive therapies used as first-line agents. JAMA (1997);277:739-745. The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractionsand congestive heart failure. NEJM (1991);325:293-302. Pfeffer et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. NEJM (1992);327:669-677. 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H  0޽h ? ̙33   I(  x  c $     0 ?P    0 >   0  /Base case: 90% hypertension, 8% CCF, 2% post-MI0 20/ x  <A C??G CH  0޽h ? ̙33 , :2p(  p p c $`0    p 0ث ?P  x p <A ??uk H p 0޽h ? ̙33  P(  x  c $س     c $` P  ,mv H  0޽h ? ̙33  0P(  x  c $     c $$   ,mv H  0޽h ? ̙33  PP(  x  c $     c $p  ,v H  0޽h ? ̙330 G?0(  d  <1?    Z0Gxaxa1?`  K1   d  <1?`Pd  <1?P   Z1 ?     3 rKxaxa1 ? @   " H  0޽h ? ̙33 0   4W (  4d 4 <1?   4 Zxaxa1?`  K6   d 4 <1?`Pd 4 <1?P  4 Z1 ?    \ 43 r\xaxa1 ? @T  <4___PPT9 ^LSimilar problems not apparent in other technology and knowledge-based markets No true market in pharmaceutical products; market failure is massive and widespread Affordability crisis is due to this market failure Allowing a flawed market to 'set' prices concentration of drug use among the rich or privately insured even in wealthy nations For instance, some elderly Americans can afford TVs and cars, but not important drugs Situation worse than for other consumer goods. Government intervention is an appropriate response to market failure N P PF P PN % ,$  H 4 0޽h ? ̙33d 0 $\(  \^ \S     \c $c @T  <4___PPT9 fThis represents  value for money in Australia  it compares favorably with a wide range of other life saving interventions 2} P}| H \ 0޽h ? ̙33 0 d,(  d^ dS     dc $ @   " H d 0޽h ? ̙33 0  lF(  l^ lS     lc $ @   <The  acceptable CER is $200/LYG cf $2000/LYG in Australia Does not mean that a LYG in country 2 is worth less than in Australia  not an absolute judgment Means that a commitment of $200 to gain a life year in country 2 represents a good investment compared with other life-saving interventions in that country The OC of spending $2000 to save 1 life year (using the Australian price) in country 2 is too high  more life years can be gained by spending the $2000 in other ways*; 2!   H l 0޽h ? ̙330 d\@|(  |^ |S    V |c $ @   dBasic assumptions underlying the analysis Need to set a benchmark as basis for comparing ability to pay Set  value of LYG as equivalent to per capita GDP A proxy measure of what is affordable - NOT a judgement of intrinsic worth The GDP here is a mesaure of national wealth  the figure used here were obtained from the the World Bank website and derived from the total GDP divided by the population. All are based on 1999 data. N   &   H | 0޽h ? ̙330 `^(  ^ S     c $ݸ P   TWe use ACE-inhibitors for a variety of indications. If we use Ace-inhibitors only for hypertension then deriving a cost-effective price for them is straightforward,- there is no benefit over thiazide diuretics- therefore based on the principle of cost-minimisation there should be no difference or increment in the price  provided the indication remains HT But, for other indications as seen here, in CF and post-MI there is good evidence of a benefit, in this case relative to placebo N   4    H  0޽h ? ̙330 wo(  ^ S    i c $    In hypertension no incremental benefit has been demonstrated vis a vis thiazide diuretics or Beta blockers In CHF and post-MI comparator is placebo2G   C H  0޽h ? ̙33|0 <4(  ^ S    . c $t    XWe also know that the doses used for differ for the different indications  so in this analysis I have assumed that the dose used in HT is equivalent to 1 DDD, in CCF to 2 DDDs and in post-MI to 3DDDs  this is consistent with the doses used in the trials from which the clinical effects were derived--2  | H  0޽h ? ̙330 ZR(  ^ S    L c $  @   LBut it s a reasonable starting point if we think about what is meant by per capita GDP Ie wealthy countries have more flexibility in expenditure than poorer countries  and this may reflect inefficiencies (corruption, poor infrastructure) also Limitations of the evidence where evidence is drawn from for example trials reporting only surrogate endpoints, trials in different populations/settings etc Dependent on the quality/applicability of the evidentiary basis . . . 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