The future of market access – the national picturePresentation Transcript
The future of market access – the national picture PM Society / Wellards Forum London 29 November 2012 Meindert Boysen Programme Director Technology Appraisals & PASLU National Institute for Health and Clinical ExcellenceNo part of this talk can be reproduced without the expressed permission of NICE
Health and Social Care Act - 2012: paying for value
Outcomes Framework and Standards
Current NICE products & servicesBRAND MAP HERE
New system relationships
NHS constitution 2012 • You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.
• We will introduce a NICE Compliance Regime to reduce variation and drive up compliance with NICE Technology Appraisals.• We will require that all NICE Technology Appraisal recommendations are incorporated automatically into relevant local NHS formularies in a planned way that supports safe and clinically appropriate practice.• We will establish a NICE Implementation Collaborative to support prompt implementation of NICE guidance.• We will develop and publish an innovation scorecard to track compliance with NICE Technology Appraisals.
Use of NICE appraised medicines in the NHS in England – 2010 and 2011Experimental publication of the Health and Social CareInformation Centre 2012
Value Based PricingThe Government view:“We need a system that encourages the development ofbreakthrough drugs addressing areas of significant unmet need.And we need a much closer link between the price the NHS paysand the value a new medicine delivers, sending a powerful signalabout the areas that the pharmaceutical industry should target fordevelopment.”“Most importantly, using our cancer drugs fund in the interim, andvalue-based pricing for the longer-term, we will move to an NHSwhere patients will be confident that where their clinicians believea particular drug is the right and most effective one for them, thenthe NHS will be able to provide it for them.“ Quote from A. Lansley in Guardian 29 Oct 2010
Overview of rationale for VBPCurrent Process Issues VBP solutionsDoes drug give enough We may care more about Apply QALYbenefit* to justify moving some patients… weightingsfunds and depriving some • eg with severe • Burden of Illnessother patients of their condition, large • Therapeutic Innovationtreatment? and Improvement unmet need Right decision if: Treatments affect people Include “Wider Societal • Care equally about beyond patients Benefits” all patients • Effect on contribution • Family, carers • Only care about to society… patients • Beneficiaries of • …and use of goverment spending society’s resources *measured in Quality-Adjusted Life Years (QALYs), the universal unit of health gain
VBP key features• Applies to new medicines on the market from 1 Jan 2014• Government to set out a range of thresholds or maximum prices reflecting different values that medicines offer• Use of a (basic) cost effectiveness threshold• Use of QALYs• Application of weighting to benefits implying of maximum price thresholds• Higher price thresholds for medicines that tackle disease of high unmet need or severity• Higher price thresholds for medicines demonstrating greater therapeutic improvement and innovation• Higher price thresholds for medicines that can demonstrate wider societal benefits• Categories and weights will be determined by the Secretary of State, on the basis of expert advice, within a framework determined in advance. VBP consultation 2010/11
So, how about NICE?“As enshrined within the NHS Constitution, the NHS in Englandwill continue to fund existing drugs that have been recommendedby NICE. And that right will continue and will apply to newmedicines to which VBP applies.“NICE will examine the evidence on the potential clinical andcost effectiveness of new drugs as they become available;drawing on its world-leading expertise in the field.“And, importantly, under the new system of VBP, NICE will nolonger be obliged to make yes/no decisions on access, based onits own cost per QALY thresholds.“Instead, youll be free to focus on the rigorous appraisal ofevidence to show the relative benefits of a new medicine.Andrew Lansley, Secretary of State for HealthNICE Conference, 17 May 2012
Procedural Principles s le ne s so n ab r r ea o i ty f bil ou nta cAc
Most technologies are worth using ... 80% o recom f NICE mend s are Single Multiple posit ation Recommendation ive categories Technology Technology Total Appraisal Appraisal Recommended 63 (58%) 234 (64%) 297 (62%) Optimised 15 (14%) 68 (19%) 83 (18%) Only in Research 3 (3%) 22 (6%) 25 (5%) Not Recommended 27 (25%) 43 (11%) 70 (15%) Total 108 (100%) 367 (100%) 475 (100%)Based on 493 recommendations published in 265 technology appraisal guidancebetween March 2000 and October 2012
Clarification Evidence Review CHMP + 8 weeks Evidence Submission CommitteeDecision Preliminary meetingProblem 8 weeks recommendations Experts (incl PCT) Invitation Clarification MA Including Consultation compan Review y 4 weeksScoping MA Final guidance Committee Publication meeting Meet compan [ 26-34 weeks] y Experts? IncludingSTA Appeal (or not) company?Process
The Quality Adjusted Life Year 1 Initial QALY loss due to side effectsHealth-related quality of life New treatment Current treatment QALYs gained 0 Length of life (years)
Fixed Budget & Opportunity Cost
Consideration of cost effectiveness: threshold rangeless between than £20,000 and more than £30,000£20,000 £30,000 perper per QALY gainedQALY QALY gainedgained Make explicit reference to these factors:Probably • Certainty Need to identify ancost • Health related increasingly strong caseeffective Quality of life with regard to same factors. adequately captured? • Innovative nature technology
Application of the ‘end-of-life’ advice in 2009 - 2012 End-of life criteria 37 considered Criteria met & 10 recommended Criteria met & not 6 recommended Criteria not met & not 21 recommended
“different ways of doing things which bring improved outcomes” (Cooksey) “new, constitutes an improve- ment on existing products , step-change” (Kennedy) “…a plausible gain of at least 1 QALY would be a reasonable threshold for judging the usefulness of a supposedly innovative technology…” (Ferner et al, 2010) “…..whether a new medicine represented a significant improvement relative toFerner R., Hughes D. and Aronson J. ‘NICE and new: existing treatments...” (DHappraising innovation’ BMJ 2010; 340: 245-247. Consultation Paper on VBP)
How often were the HR-benefits not captured in the QALY? 30 published appraisals or consultation documents* 7 some HR-benefits not captured in the QALY 2 5 Impact on decision No impact on decisionHR-benefits of reduced hospital (changing utility values hadvisits in last year of life little effect on ICERs)HR- benefits of delaying toxicchemotherapy*July 2010 to January 2011
Schemes in operation in England and Wales Pre-PASLUNICE Product & clinical area DetailsTAG*129 Bortezomib (Velcade) – multiple myeloma Rebate for non-responders155 Ranibizumab (Lucentis) – age related macular oedema Dose cap162 Erlotinib (Tarceva) – non-small cell lung cancer Simple discount169 Sunitinib (Sutent) – renal cell carcinoma Free stock171 Lenalidomide (Revlimid) – multiple myeloma Dose cap176 Cetuximab (Erbitux) – colorectal cancer Rebate179 Sunitinib (Sutent) – gastro intestinal stromal tumour Free stock180 Ustekinumab (Stelera) – psoriatic arthritis Free stock185 Trabectedin (Yondelis) – soft tissue sarcoma Dose cap186 Certolizumab pegol (Cimzia) – rheumatoid arthritis Free stock192 Gefitinib (Iressa) – non-small cell lung cancer Single fixed price *See http://www.nice.org.uk/guidance/ta/published/index.jsp
Quality evidence submissions; a real challenge ...
Highly Specialised Technologies a ie a n o d S bc e y n re tim lin ti lit y a C nd nlef ts t f se u im po cti lini ris iafe o pa abi rit ca k ty in a la ve n r pa Ne ov ch ting t Se s g fo & ti ed at an ov n t ne l in ial ss so ent s o ion d he r th ci s a f al pr te ve C et n y d fe ef Patients’ B e de a c Need pr st . oV or c l c en st Eciv ct lin l in af p ral at co co m polu da t an os t Ac Co effseon ri ice ica al m onrtue fbili d t e im ver p ge o n i ce f nt icirviomg in l pe e r a te pa e nitor ty ps prin e c i t iv to st o ro o u n e c h Av rn re y y c ge bal sivi viis cy e f a b di o an isit tyoo O l i gr c oyn nf es at d st pa rib ap ed an ut hi d io c cl n
The ‘new’ challenge for HTA; ‘adaptive licensing’!Eichler et al. 2012 www.nature.com/cpt
For discussion …?• How will the new commissioning structure in the NHS deal with, and shape, NICE’s approach to technology appraisals?• What is to (further) gain in market access from VBP knowing that the majority already receives positive guidance.• Will VBP reflect all value, and if not, how much of a role should there be for a deliberative process?• Do patient access schemes have a future in the context of VBP and sPPRS?• How different is (should) the situation (be) for highly specialised technologies?