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I n n ova t i ve Pricing Ag reements to
Enhance Access Pro s p e c t s

IN THE FACE OF RISING DEMAND FOR INCREASINGLY “In some count r ie s, risk-sharing is becoming popular because EXPENSIVE HEALTHCARE PRODUCTS AND SERVICES, there is a common desire to make sure that patients getaccess to the medicines they need. As the industry moves PAYERS AROUND THE WORLD HAVE RESPONDED WITH A forward, into a future where risk-sharing schemes are going RANGE OF COST- C O N TAINMENT MEASURES DESIGNED TO to be more common, it’s my belief that we need to makes u re that we offer true partnerships in which we ge nu i ne l y REIN IN ESCALATING EXPENDITURE. PHARMAC E U T IC A L S s h a re risk or commit to de mo ns t rate the value of our pro duc t s.
– IN PARTICULAR EXPENSIVE NEW TREATMENTS – In return there should be mechanisms in place to reward HAVE BEEN KEY TARGETS IN THIS RESPECT. MARKET value for genuinely innovative medicines and to reflect thechanging value of a medicine throughout its lifecycle.
ACCESS CONDITIONS HAVE BECOME INCREASINGLY HARSH – AND MAY BECOME HARSHER IN WHAT MAY “It’s becoming very clear that we need to be aware thatpayers are increasingly unwilling to accept uncertainty. It PROVE TO BE A PROTRACTED ECONOMIC DOWNTURN. may be uncertainty about trial efficacy, or around how thattranslates into effectiveness in the real world. It may be In the light of this, strategic approaches are being utilised around the safety of the product, around modelling, the with increasing frequency, as industry explores alternatives methods or the link between surrogate endpoints and to ma i ns t ream pric i ng and re i m b u r s e me nt applic a t io ns in an long-term outcomes. It may be around cost-effectiveness, attempt to gain covera ge for new pro duc t s. Such appro a c he s are also proving to be of interest to hard-pressed payers,as me a ns to cont rol costs (and other risks) while fa c i l i t a t i ng “One thing that is certain is that willingness to accept some form of access for innovative treatments. The recent uncertainty is absolutely polarised by price. The higher the NextLevel Pharma confere nc e, Pharmaceutical & Medical Device price, the less willing the payer is to accept that level of Risk-Sharing and Value-Based Pricing & Reimbursement u nc e r t a i nt y. Risk-sharing deals try to deal with unc e r t a i nt y t o S c h e m e s, staged in Brussels, pro v ided a forum for discussio n a level whe re it becomes acceptable to the payer,” said Wa l ker.
of the role of innovative agreements – and in particular, In the view of Gustav Ando, Director, Healthcare Practice, r i s k - s h a r i ng agre e me nts – in the curre nt clima t e. Mick Maroney Global Insight, achieving “normal” market access for a new presents the first of two reports on an event that attracted a t re a t me nt, whe re regulatory approval is followed imme d ia t e l y high level of interest from industry, payers and other stake h o l d e r s. by drug pric i ng and launch, is an inc re a s i ngly ra re phe no me no n.
Health econo m ics is being used with inc re a s i ng sophistic a t io n THE RISE OF RISK-SHARING
by reimbursement authorities, which is in turn requiringi nc re a s i ngly flexible and creative pric i ng and re i m b u r s e me ntarrangements.
Mel Wa l ke r, Dire c t o r, Global Health Outcome s, Onc o l o g y, withG l a xo S m i t h K l i ne, chaired the confere nce and pro v ided some In line with others who spoke at the me e t i ng, Ando observed i n i t ial observatio ns on factors affecting the rise of inno v a t i v e that there are essentially two approaches to risk-sharing: a g re e me nt s. “With org a n i s a t io ns such as NICE [the Na t io na l financial and outcomes-based schemes. “Finance-based Institute for Health and Clinical Excellence] in the UK and schemes are conditioned by a set of pre-specified budget PBAC [the Pharmaceutical Benefits Advisory Committee] in caps, discounts or restrictions that can either be based on Au s t ra l ia leading the way, payers are becoming inc re a s i ng l y a particular patient or on the disease population,” said willing to make difficult decisions about drug funding. And Ando. These can include price-volume agreements (as in they are doing this within a framework of opportunity cost France), expenditure caps (as in Australia and the US),price cuts that are attached to forecasted spend (Japan) – if they pay for one medicine, it will prevent them paying and conditional discounts (as in Italy and the UK).
for another. Pharmaceuticals may offer easier targets forcost-containment than other components of healthcare.
“ O u t c o mes-based agre e me nts are cond i t io ned by a However, restricting the use of innovative medicines may pre-specified endpoint or definition of response that have a broader impact on healthcare budgets or outcomes dictates whether the payer will cover the treatment on an that is often not taken into account,” commented Walker.
ex post facto basis. These can include outcomes guarantees (as in the UK and the US) and form the traditional model f ree for the first three mo nt hs and are then reimbursed in full of risk-sharing agre e me nt s, as payme nt is weig hted ent i re l y if they prove to be effective. “This is not a risk share as I would against the performance of the drug,” said Ando. see it, but the short-term evalua t ion involved effectively me anst he pro duct is listed once it proves effectivene s s,” said To w s e.
“The type of risk-share agreement varies significantly bygovernment – and by company – in terms of what type ofarrangements the parties prefer, or indeed are prepared to UK DEVELOPMENTS
e ng a ge in,” said Ando. “What is not in doubt, ho w e v e r, is thatt hey are on the rise. In Au s t ra l ia, the first of f ic ial risk-sharing The UK has been at the forefront of developments in agreement was signed in October 2003, but it has since E u rope (see P P R April 2009, p95; Ma rch 2009, pp73-74 et al) .
grown into a regular pricing strategy, and five years later Perhaps the most famous (or infamous) scheme in the UK t he re were 60 such agre e me nts in place or in de v e l o p me nt .” dates back to 2002, when the multiple sclerosis initiative In Ando’s view risk-sharing is a “developed world phe no me no n”.
At the moment, the “hot spots” are in the UK, France, “This is a complicated scheme, lasting for 10 years and Germany, Italy, the US, Canada, Australia, New Zealand andJapan. However, it is likely that they will be adopted in key i n v o l v i ng a complex arra nge me nt of cont racts with a nu m b e r emerging markets such as China and Brazil, as well as of competing companie s,” ex p l a i ned To w s e. “The re are ma ny issues with this scheme. There have been difficulties withre c r u i t me nt and with mo n i t o r i ng, and we still have an unt r ie dreconciliation and adjudication process. The scheme has EUROPEAN PERSPECTIVES
s c a r red the Departme nt of Health (DH): for a while, risk sharee q ualled MS equalled nig ht ma re. It has had a very substant ia l Adrian Towse, Director of the Office of Health Economics in adverse effect on the payer’s view of risk-sharing schemes.
the UK, discussed some of the European findings of work I’m sure the Departme nt is advising payers aro u nd Europe and carried out with Professors Sean Sullivan and Lou Garrison e l s e w he re to be very careful when ent e r i ng sche mes as the y of the University of Washington, Seattle.
can be extremely burdensome in terms of administrationa nd cost. They also pose a cons ide rable political challenge. ” Ac c o rd i ng to To w s e, risk-sharing agre e me nts can be divide di nto perfo r ma nce gua ra ntee sche mes and those of f e r i ng covera gewith evidence development. An example of the former is a OFT ACKNOWLEDGEMENT
s c he me in which Pa r ke-Davis (now Pfizer) agreed to rebate alocal health authority in the UK if a patient population did Despite such conc e r ns, ackno w l e dge me nt of the inc re a s i ng l y not achieve de f i ned targets after using statins (see Table 1).
important role played by innovative agreements in the UK “This is performance-related, but this is an intermediate came in February 2007, when the Office of Fair Trading ma r ke r, so we don’t know what impact that is having on the (OFT) produced a critical study of the Pharmaceutical Price number of patie nts who have my o c a rd ial infa rc t ion,” said To w s e.
“An example of coverage with evidence development is the “This was a competition authority discussing the appro p r ia t e case in France where the healthcare authority agreed to environment in which a publicly-funded insurer should be cover J&J’s schizophre n ia tre a t me nt, Risperdal Consta. This buying medicines, and how it is appropriate to regulate is a particularly int e re s t i ng one, being linked to complia nc e,” that in a way that gives the payer value in a competitive observed Towse. Some schemes can be classified as both environment,” said Towse. “The OFT had a very clear view p e r fo r ma nce gua ra ntees and covera ge with evide nce of risk-sharing. If the data at time of launch is insufficient development. This applies in the case of the well-known to take an informed view of cost-effectiveness, then in a multiple sclerosis risk-sharing sche me in the UK, he ex p l a i ne d.
limited number of cases a scheme should be adopted. It Towse noted that there are also schemes based on proven said it is particularly appropriate for chronic conditions short-term effectiveness. An example is the Alzheimer’s where final outcomes may only become clear after several drugs scheme in Italy, under which products are provided Table 1: Examples of European Risk-Sharing Agreements Disease area
population did not achieve a lowdensity lipoprotein cholesterol concentration target after using statins.
(cetuximab) used for patients whodo not achieve a pre-agreedclinical outcome at up to 6 weeks.
(cyclosporin), Myfortic (mycophenol)acid) or Certican (everolimus) if a patient loses his/her donor kidney.
guarantee for Aclasta (zoledronat) if an osteoporosis-related fracture occurs.
do not respond after four cycles oftreatment with Velcade. Respondingpatients receive additional four cycles.
price if J&J performed studies to show on medication. Otherwise, J&J willreimburse a proportion of the money spent on the drug.
Source: Adrian Towse, based on Pharmaceutical Outcomes Research & Policy, University of Washington T he OFT also addressed no n - l i near pric i ng – differe nt prices fo r to obtain ma r ket access,” observed Furniss. NICE re c o m me nde d d i f f e re nt ind ic a t io ns or differe nt patie nt gro u p s, in the same c o v e ra ge of the pro duct as a tre a t me nt for multiple my e l o ma ma r ke t p l a c e, for the same pro duct. “This is not risk-sharing, on the basis of a two-year cap on treatment costs, after but it is ano t her example of a competition authority putting which the company, Celgene, will pay (see PPR June 2009, fo r w a rd innovative ideas about ways in which European payers p184 et al). The recommendation was also based on NICE’s s hould be thinking about paying appro p r iately for me d ic i ne s.” new end-of-life criteria (see PPR March 2009, p89 et al). Another example discussed by Furniss was that of Sutent THE NEW PPRS
(sunitinib) for the first-line treatment of advanced and/ormetastatic renal cell carcinoma. “In this case, Sutent was As discussed by Jim Furniss, Director of Market Access in effect extracted from the MTA [Multiple Technology Solutions with Bridgehead International, the 2009 PPRS Appraisal] process and treated as if it was an STA [Single addresses issues raised by the OFT on both risk-sharing and Technology Appraisal],” said Furniss. The outcome was flexible pricing (see PPR January 2009, pp4-7 et al). “The that in one indication, for a specific patient group, a risk new 2009 PPRS scheme provides a framework for these share was agreed, despite a cost per QALY of more than schemes in the UK. It may not offer guidelines as such, but at least is going some way forward,” said Furniss.
The risk share was based on the first cycle of treatment T he patie nt access sche mes discussed in the PPRS need to be b e i ng free to the NHS. Along with the applic a t ion once again clinically robust, plausible, appropriate and monitorable, of NICE’s end-of-life criteria, the patient access prov i s io n he adde d. “They need to be mo n i t o rable by the NHS witho u t resulted in a re c o m me nda t ion for covera ge. Ho w e v er, N IC E i n v o l v i ng undue complex mo n i t o r i ng, costs or bure a uc ra c y,” d id not re c o m me nd other re nal cell carc i no ma drugs for s a id Furniss, re f l e c t i ng Towse’s observation on the impact of treatment: Avastin (bevacizumab) and Nexavar (sorafenib) t he MS sche me, as well as other ex p e r ie nce in It a l y, for exa m p l e.
p roved unacceptable at respective costs-per QA LY of £82,700and £65,900, even taking into account end-of-life criteria.
“The PPRS makes a very simple distinction on patient “This would suggest,” said Furniss, “that for products access sche mes between those that are essent ially a fina nc ia l going through risk share, for which end-of-life criteria also a r ra nge me nt, whe t her through re s t r ic t io ns on the number of apply, the threshold is somewhere above £55,000.” p a t ie nts tre a t e d, the re s p o nse or the number of doses re q u i re d,and outcome-based schemes. The critical point is that the In Furniss’ vie w, risk-sharing sche mes will re main the exc e p t io n, financially-based schemes are financial arrangements – not rather than the rule, in the UK. However, they may become risk-sharing,” said Towse. “The outcome-based schemes, the preferred pricing mechanism for high-priced products where we are essentially talking about the company and with limited evidence of efficacy or cost-effectiveness.
the NHS having to agree the sort of data that is going to “ Tra ns p a re nc y, ho w e v e r, is a major issue,” said Furniss. Un l i ke be collected in some form and which will be revisited, are in most markets, the terms of the deals will be publicly available. “This may have implications for other markets.” “ T he pro v i s io ns for ‘proven value’ can lead to a price inc re a s e Adr ian Towse was upbeat about the opportunities stemming and in the case of ‘expected value’ can result in a rebate.
f rom the new approach under the PPRS. “The patie nt access T hese have some similarities with what we see in Fra nc e,” said schemes introduce a fast-track route back to the NHS. The Towse. However, in Furniss’ view, the fact that the patient approaches offer the opportunity to introduce schemes on access sche mes are to be cons i s t e nt with ex i s t i ng fina nc ial flows a more regular, systematic basis, superseding the current in the NHS me a ns that this will not be possible. ad hoc approach. Companies will maintain control of pricesetting, but NICE will still be advising on whether or notproducts are affordable. While the DH has set up a group PRACTICAL APPLICATION
to manage these schemes, the critical issue remains theprocedures that will be followed by NICE.” Furniss noted that the risk-sharing aspects of the PPRS area l re a dy being used in pra c t ic e. “Revlimid (lena l ido m ide) is an N ICE has now issued draft process guida nce for cons u l t a t io n exa m p l e. This was a small offer by a pharma c e u t ical company (see Figure 1). “This reflects the intent of the PPRS, Figure 1: NICE Process for Considering a Patient Access THE TIMING OF AGREEMENTS
Whether in the UK or elsewhere, risk-sharing is something that companies should consider as they prepare for market access, continued Furniss. While it may not be appropriatefor all markets, companies may from phase III onwards consider the possibility of an agreement. Ando agreed thatphase III – or sooner – is an appropriate time to look at as c he me. But he cautio ned: “I would favour letting the no r ma l reimbursement process run its course, and then look at thepossibility. There is a danger that this could be seen as asubstitute for the reimbursement process.” In Furniss’ A p p raisal Committee cons ider orig i nal re c o m me nda t io ns or published guidance in light of the scheme v ie w, the re can be value in taking the initiative ra t her than,in the UK for exa m p l e, waiting until NICE has carried out itsa p p raisal (and possibly issued a negative re c o m me nda t ion). Neil Palmer, Vice-President, Pricing & Reimbursement withRTI Health Solutions, advised that early communication isalready established in Canada. “Payers will speak with manufacturers about risk-sharing agreements before they make their assessment. If it is understood that listingcould be based on such an agreement, it helps put pricing into context and informs the payer that the manufacturer is prepared to accept measures to limit the budget impact.
At early-stage me e t i ng s, payers will often offer para meters on the types of agreements they may consider. Such meetings offer the chance to propose some initial concepts, andreceive feedback that can be taken into account when preparing the formal submission and for negotiations of the listing agreement at subsequent meetings.” In Mel Wa l ker’s view: “Risk-sharing is not and should not be seen as a quick fix for a poor clinical de v e l o p me nt pro g ra m me.
We need to be thinking about payers’ needs very early andwe need to build those needs and requirements very earlyinto our clinical development programme. Risk-sharing offers the opportunity to bridge the gap between the varying Source: Guide to the Single Technology Appraisal Process: value recognitions that different markets have.” Patient Access and Flexible Pricing Schemes, Draft forExternal Consultation, June 2009 (NICE) THE RISKS OF RISK-SHARING
although could make clearer that this is a fast-track routeback to NICE at the end of the current appraisal process It is clear that risk-sharing offers potential benefits to and that schemes are not intended to be proposed during payers and providers, as well as manufacturers. For the the appraisal process, which risks gaming on both sides,” manufacturer, an agreement may open up market access for Towse told PPR. “It also needs to be clear how the a product that may otherwise have been denied coverage outcomes-based schemes will be reviewed.” on the grounds of expense or uncertainty about its relative effectiveness when weighed against a relatively high price.
For Wa l ke r, the re are also common risks to take into account .
As noted by Mel Walker, an agreement may also allow a “A hu ge amo u nt of re s o u rce needs to go into these sche me s, company to start recouping the costs of its research from the company and the payer. Data systems need to be investment, while speeding up patient access.
i m p l e me nted to collect info r ma t ion and to me a s u re complia nc e For payers, aside from the obvious opportunity to reduce with the agre e me nt. A payer in the UK observed that if suc h the cost associated with the introduction of an expensive s c he mes become common, pharmacy de p a r t me nts in ho s p i t a l s new product, the benefits of risk-sharing are “all about may have to start employing people to monitor them.
covering a product with reduced uncertainty. They also “Stakeholder involvement is also an issue. Once a scheme want to minimise the cost of non-response, and minimise has been agreed, physicians will be the ones who bear the burden of implementation. You need to talk to them. If “Although payers are motivated to make new medicines you don’t involve them, you could be upsetting a very rapidly available for the benefit of patients, there can also important customer group,” said Walker.
be a lot of political pressure around such decisions – it canreflect positively on a payer when they are able to re i m b u r s ea new drug for a particular disease,” comme nted Wa l ke r. “The re BUILDING RELATIONSHIPS
may be some shared benefits in developing a risk-shareagreement when clinical efficacy is accepted but there is S uch cons ide ra t io ns will play an important role in ex p a nd i ng the some disagreement on costs. Such schemes offer faster u p t a ke and covera ge of innovative agre e me nt s. As discussed access for patients suffering from conditions with high by Gustav Ando, public pressure may play a significant role unmet needs such as cancer – particularly where there areno other treatment options,” he observed. “And we should in this respect: calls for patient access led to the MS remember that payers are hungry for data. This is a good s c he me, as well as others in the UK. “Several of these had an e l e me nt of public backlash associated with them, fo l l o w i ngan initial rejection,” commented Ando, “so relationships These potential benefits of course need to be set against with patient access groups could be influential.” the risks which by definition characterise such schemes. Inmost cases, it is clear that ma nu fa c t u rers are taking on board As noted by Jim Furniss, the preference will always be to an eleme nt of fina nc ial risk: in the view of Gustav Ando, the re try to gain access without such an agreement. However, if is the da nger that the risk is tra ns f e r red to the pharma c e u t ic a l it seems appropriate to consider one in therapy areas or company, which in effect is transformed into a payer. Ando ma r kets in which such agre e me nts have yet to be impleme nt ed, also suggested that there is the risk that a company may it may pay companies to explore at national, but also local call into question the clinical effectiveness of a product, l e v e l s, whe t her the re are arra nge me nts that may be possible, and its status, relative to others – particularly if other and that may address payers’ needs at those levels.
countries reference an agreement in their own evaluations.
Walker noted related concerns: “There may be a concern As Mel Walker observed: “Many people in the industry that we are setting a precedent – that a payer may expect remain concerned about the sharing of risk in such the same approach on other products, or indications.” schemes – that they may be based simply on the payer’s Pa y e r s, too, are open to risks. If a drug proves to be hig h l y perspective of driving down costs. However, while some effective, it may result in greater long-term costs than had payers may be focused very much on cost, others are been envisaged. On the other hand, if a drug is ineffective, focused on efficiency and on improving standards of care.
shorter-term costs may be wasted. Walker noted a number “A key cons ide ra t ion is the re l a t io nship with payers. The re is of risks on the payer side: “For payers there are risks a need to establish and ma i ntain good re l a t io ns; to build trust around budgets, outcomes and evidence. There are risks and work with them on ways of de mo ns t ra t i ng the value of ne w that other companies may expect similar agreements, andthat some may start to try and use such sche mes as a way to t re a t me nt s, befo re we int ro duce the idea of risk-sharing. Suc h get aro u nd no r mal re i m b u r s e me nt pro c e s s e s, and establishe d re l a t io nships will stand us in good stead, should we find that we need to develop an agreement,” concluded Walker PPR



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