Recent Trends in Oncology Appraisal Decisions: NICE vs. SMC
By Xcenda
England’s NICE and Scotland’s SMC are responsible for issuing appraisal guidance for reimbursement of new health technologies in their respective countries. Xcenda wanted to understand the similarities and differences in approaches to oncology decision making between NICE and SMC.
HTA QUARTERLY | SPRING 2018
Recent Trends in Oncology Appraisal Decisions: A Comparison Between the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC)
England’s NICE and Scotland’s SMC are responsible for issuing appraisal guidance for reimbursement of new health technologies in their respective countries. While both agencies consider clinical and cost-effectiveness in their decisions, they have unique policies and procedures that may yield different outcomes. To better understand the similarities and differences in approaches to oncology decision making between NICE and SMC, Xcenda conducted an analysis of past appraisal decisions by the agencies to compare results.England’s NICE and Scotland’s SMC are responsible for issuing appraisal guidance for reimbursement of new health technologies in their respective countries. While both agencies consider clinical and cost-effectiveness in their decisions, they have unique policies and procedures that may yield different outcomes. Previous research has evaluated the agreement between NICE and SMC guidance on recommendations for rare diseases. An assessment of single technology appraisals by NICE and SMC between 2008 and 2010 found overall 56.4% of decisions between the agencies were concordant, 15.4% were concordant following resubmission, and 28.2% were in disagreement. This research found NICE had a higher rate of favorable recommendations following the initial submission compared to SMC and suggested the difference may be explained by 2 possible factors: 1) less detailed evidence required by SMC; or 2) manufacturers using submissions to SMC as a “trial run” with shorter timelines before submitting to NICE. However, there is no research examining the levels of agreement between NICE and SMC oncology appraisal decisions. To better understand the similarities and differences in approaches to oncology decision making between NICE and SMC, Xcenda conducted an analysis of past appraisal decisions by the agencies to compare results.
For this analysis, oncology appraisal decisions from January 2012 to May 2017 were identified on the SMC website and Xcenda’s Health Technology Assessment (HTA) Decision Map, a catalogue of HTA decisions across Australia, Canada, France, Germany, and the UK dating back to 2012; the data included in Xcenda’s HTA Decision Map are pulled from the website of the HTA agency for each country. The appraisal decisions for both agencies were evaluated and categorized as favorable, unfavorable, or mixed (ie, both favorable and unfavorable) based on whether the recommendation moved the product toward the path of reimbursement in the respective market. Additional aspects were compared, including the incremental cost-effectiveness ratio (ICER) and tumor type for each decision. SMC decisions that were classified as withdrawn or superseded were not included, and only the most recent decision published for each agency was considered.
After analyzing the data, a total of 91 decisions were identified for NICE, of which 64.8% (59) were favorable, 3.3% (3) were mixed, and 31.9% (29) were unfavorable. SMC, on the other hand, had 110 decisions during the same time period, of which 40.9% (45) were favorable, 26.4% (29) were mixed, and 32.7% (36) were unfavorable (Figure 1). SMC had more mixed/restricted decisions when compared to NICE, which generally has a higher percentage of favorable/recommended decisions.
Figure 1. Summary of NICE and SMC Decisions
As part of the appraisal process, both NICE and SMC consider the economic value of drugs in terms of cost-effectiveness as measured by the ICER. Based on publicly available information, the ICER submitted by the manufacturer to SMC and the ICER calculated by the Evidence Review Group (ERG) for the NICE committee were analyzed. Comparing the cost-effectiveness of these evaluations, all 18 NICE decisions with reported ICERs from the ERG of less than £30,000 received favorable guidance; however, the guidance from SMC was more varied. For the 28 SMC decisions with a reported ICER of less than £30,000, 46% (13) were favorable, 43% (12) were mixed, and 11% (3) were unfavorable (Table 1).
Table 1. Oncology Appraisal Decision by ICER, January 2012-May 2017
Pairs of decisions between NICE and SMC were compared when both agencies evaluated a single drug for the same indication. These decision pairs were classified into 3 categories based on their level of agreement between the appraisal result: matched (ie, both decisions were the same), similar (ie, one agency’s decision was favorable and the other agency’s decision was mixed), or discordant (ie, one agency’s decision was unfavorable and the other’s was favorable/mixed). Between agencies, 53 pairs of decisions matched across 14 tumor types and indications; of those, 33 (62.3%) matched exactly, 7 (13.2%) were similar, and 13 (24.5%) were discordant (Figure 2).
Figure 2. Agreement of NICE and SMC Decisions
Upon analyzing the decisions by tumor type, the most common NICE and SMC oncology decisions were for non-small cell lung cancer (NSCLC) with 10 decision pairs, followed by melanoma with 9 decision pairs (Table 2).
Table 2. NICE and SMC Appraisal Agreement by Cancer Type
The analysis of NICE and SMC oncology appraisals provides useful insights, but there are a few important limitations to recognize. First, the ICERs utilized in this analysis were from publicly available sources, and manufacturers often provide confidential discounts to NICE and SMC as part of a patient access scheme (PAS). As a result, the final ICER accepted by the HTA agency is often unknown and likely is lower than reported publicly. Secondly, NICE and SMC guidance may designate specific subpopulations or include other access restrictions that should be considered when comparing the agencies’ decisions. Lastly, the time between NICE and SMC decision pairs varied and may reflect different clinical and economic evidence if new data were generated between submissions.
Conclusion
Overall, NICE and SMC are largely aligned when considering appraisals across tumor types, with the majority (75.5%) of oncology HTA decisions being the same or similar. However, compared to NICE, there appears to be less association between the reported ICERs and SMC appraisal decision results. This observed difference may result from NICE having both the manufacturer-submitted ICER and the ICER proposed by the ERG, whereas SMC has only the manufacturer-submitted ICER for consideration. Compared to previous research on rare-disease decisions, the recommendation rate (favorable or mixed) observed in oncology compared to rare diseases was lower for NICE (68.1% vs 76%, respectively) but higher for SMC (67.3% vs 60%, respectively). While this analysis demonstrates the concordance between NICE and SMC oncology HTA decisions that have been observed in other therapeutic areas and previous research, this study found the agencies still disagreed on approximately 25% of decisions. These findings highlight the need for manufacturers seeking access in the UK to develop a comprehensive strategy that addresses each country’s market-specific evidentiary requirements.
Sources
- Cairns J. Providing guidance to the NHS: the Scottish Medicines Consortium and the National Institute for Clinical Excellence compared. Health Policy. 2006 Apr;76(2):134-143.
- Campbell D, Clark R, Meyer K. Trends in oncology appraisal decisions: a comparison between the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). Presented at: ISPOR 20th Annual European Congress; November 4-8, 2017; Glasgow, Scotland.
- Garcia Sanchez JJ, Marshall J, Hill C. Review of the recommendations made by NICE and SMC relating to treatments for rare diseases. Presented at: ISPOR 19th Annual European Congress; October 31–November 2 2016; Vienna, Austria.
- HTA Decision Map. Xcenda. http://www.xcenda.com/hta-decision-map. Accessed September 2017.
- Leonard SA, Brooks-Rooney C, Kusel J, Costello S. To what extent does advice from the SMC agree with that published by NICE. Presented at: ISPOR 14th Annual European Congress; November 5-8, 2011; Madrid Spain.
- National Institute for Health and Care Excellence. https://www.nice.org.uk/. Accessed September 2017.
- Scottish Medicines Consortium. SMC advice directory. https://www.scottishmedicines.org.uk/SMC_Advice/Advice_Directory/SMC_Advice_Directory. Accessed September 2017.
- Scottish Medicines Consortium. What we do. https://www.scottishmedicines.org.uk/About_SMC/What_we_do. Accessed September 2017.
- Timm B, Leonard S, Haynes S. Assessing agreement between patient access schemes—review of SMC and NICE guidance. Presented at: ISPOR 17th Annual International Meeting; June 2-6, 2016; Washington DC.
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