The commissioning guidance (seen here in box 4) sits within the NHS outcomes framework and is underpinned by NICE guidance and the quality standards. They are evolving to include an outcomes approach to commissioning along with an integrated evidenced based, they promote cost effectiveness and high quality care. Commissioning support comes from NICE in 2 forms.
This replaces the previous ‘this is what we are and what we do’ slides Can be used to exemplify the ‘guidance-plus’ nature of NICE’s expansion
Funding direction ; current NICE guidance & new VBP! New active substances ; on market > Jan 2014! Orphan drugs; no different? Burden of illness; equity implications ! Pricing by indication ; not feasible? Therapeutic innovation; breakthrough / rare! Double counting? Work programme to develop weights; external experts / stakeholders / published in full! Insufficient evidence; contingent price ? PAS ? Timeliness ; interim pricing arrangements in some cases? Reviews ; as per NICE! Cancer drugs fund medicines ? Devolved administrations ?
From 1 March 2000 to 31 August 2012, NICE published 109 single technology appraisals , and 156 multiple technology appraisals; 265 appraisals in total, containing 493 individual recommendations. Six of the recommendations were subsequently withdrawn: on three occasions where the regulator revoked the marketing authorisation due to safety concerns on one occasion where the product was no longer produced by the manufacturer on two occasions when a nationally funded-programme for a technology rendered the guidance obsolete. Twelve recommendations could not be made in the absence of a submission from the manufacturer (‘ non-submission ').
“ An idea, service or product, new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied.”(Innovation Health and Wealth) “… the product [is] new, constitutes an improvement on existing products, offers something more: is a step-change in terms of outcomes for patients” (Kennedy) “ Innovation is not simply there or not; it is a matter of degree and can be present in any one or more of numerous different dimensions” (Mestre-Ferrandiz et al, OHE/ABPI) “ If an innovation is cost ineffective it cannot – so far as the NHS is concerned – be an innovation” (Rawlins)
Additional health-related benefits that impacted on the decision (2 cases): TA192 - Lung cancer (Non small cell, first line) gefitinib: “The benefits derived from gefitinib’s favourable adverse events profile were included in the economic model. Treatment with gefitinib may reduce the amount of time spent in hospital towards the end of life, which is likely to be important for patients’ quality of life and for their carers. The Committee concluded that these benefits were not fully captured in the utility values used in the economic model. The Committee concluded that these quality of life benefits were an important aspect of treatment with gefitinib and that taking these into account would have reduced the ICERs for gefitinib.” TA226 - Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma: “The Committee was aware that the model did not include the utility associated with delaying chemotherapy, and that if it were included, it would decrease the ICER (that is, improve the cost effectiveness) to an estimate which would be considered as a cost-effective use of NHS resources.” (NB: this appraisal was in progress when the analysis was conducted. The wording here has been taken from the summary table of the final guidance.)
These are the schemes that were referred to NICE before PASLU was established.
These are the schemes that went through the PASLU process and were subsequently put into operation as part of a positive recommendation. To note the Gloimumab, Nilotinib and Tocilizumab schemes were each approved for different indications by PASLU each of which went through TA separately, but is the same scheme. And that there are 10 schemes that were referred by DH to NICE (including pre-PASLU) but did not lead to positive recommendations. And that there are again 9 schemes that have been referred by DH to NICE and are still under consideration for what concerns their impact on clinical and cost effectiveness, and ultimately Committee’s recommendations. And that on 4 occasions the DH has not referred a PAS for consideration by NICE.
The future of market access – the national picture
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
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
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?