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As of July 2016, funding from England's Cancer Drugs Fund (CDF) is dispensed based on the results of National Institute for Health and Care Excellence (NICE) technology appraisal guidances instead of independent CDF appraisals (1). As part of this transition, NICE is reconsidering drugs previously funded through the CDF (2). This analysis examines CDF reconsiderations conducted between the inception of the new process in July and the end of 2016 to identify any possible trends.
We collected all NICE final technology appraisal guidances (3) completed before the end of 2016 and noted whether each drug was a CDF reconsideration, what the final decision was, and which factors impacted the decisions.
We identified twenty-one NICE oncology reviews competed between July 2016 and the end of 2016. Of these reviews, eight were reconsiderations of drugs previously funded through the old CDF; the rest were new reviews. Only one drug evaluated in the reconsiderations received a negative decision. All the reconsiderations included confidential manufacturer discounts and all noted updated clinical data. End of life (EOL) criteria expanded the acceptable incremental cost-effectiveness ratio (ICER) range for some of the CDF reconsiderations.
All the reconsiderations included updated clinical data and analyses, though it does not appear that updated clinical data were sufficient to bring ICERs to acceptable levels. This is to be expected as the old CDF process served as an alternate funding source for many drugs that did not or were unlikely to fare well under NICE's evaluations. The updated clinical data may have at least increased NICE's confidence in the accuracy of the ICERs. All of the reconsiderations included confidential manufacturer discounts to reach acceptable ICER ranges. The results of this first round of reconsiderations suggest that manufacturers prefer offering their drugs at lower prices to potentially losing National Health Service (NHS) reimbursement entirely.
As of July 2016, funding from England's Cancer Drugs Fund (CDF) is dispensed based on the results of National Institute for Health and Care Excellence (NICE) technology appraisal guidances instead of independent CDF appraisals (1). NICE can recommend providing temporary CDF funding for drugs that have potential to demonstrate cost-effectiveness after further data collection (2). This analysis examines drugs considered for temporary CDF funding since the start of this new process in July 2016.
We collected all final NICE oncology technology appraisal guidances completed before the end of 2016 and noted whether each drug was considered for or awarded CDF funding and which factors impacted the decision to give or withhold CDF funding (3).
We identified twenty-one NICE oncology reviews completed between July 2016 and the end of 2016. Of these reviews, only one was recommended for temporary funding under the CDF because further data collection had the potential to significantly reduce incremental cost-effectiveness ratios (ICERs). Three further reviews were considered for temporary CDF funding but ultimately received negative decisions. In all three cases, NICE found no potential for further data collection to sufficiently improve ICERs. The evaluations also noted that the manufacturers either did not intend or did not have sufficient time to prepare a case for CDF funding.
NICE focused strongly on evidence maturity in making CDF funding decisions. The only drug recommended for CDF funding had immature trial data with uncertainties that could be resolved by further data collection. The three drugs that did not receive CDF funding had relatively mature evidence that would not be improved through further data collection. Timing was also an issue: two reviews specifically noted that the manufacturers had insufficient time to prepare strong cases for CDF funding. The CDF historically had significant budget issues, so NICE may be trying to be more judicious in allocating CDF funding.
Immunotherapies are a relatively new innovative class of drug that have garnered excitement in the fight against cancer. In 2011, the immunotherapy drug, ipilimumab, was approved. Since then, four additional drugs have gained approval. This analysis evaluates the initial reception of immunotherapies by Health Technology Assessment (HTA) agencies.
The Context Matters Data Model was used to evaluate the regulatory and HTA agency decisions surrounding the five approved immunotherapies through November 2016: atezolizumab, elotuzumab, ipilimumab, nivolumab, and pembrolizumab. Thirty-three labels from Australia, Canada, Europe, and the United States, and ninety-two assessments from Agenzia Italiana del Farmaco (AIFA), Gemeinsamer Bundesausschuss (Federal Joint Committee; G-BA), Haute Autorité de Santé (French National Authority for Health; HAS), Institute for Clinical and Economic Review (ICER), Institute for Quality and Efficiency in Health Care (IQWiG), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), pan-Canadian Oncology Drug Review (pCODR), and Scottish Medicines Consortium (SMC) were found. Using a sample t-test and a chi-squared test, reimbursement agencies’ decisions were evaluated, and the clinical and economic factors that went into these decisions were examined.
Of the evaluated reviews: sixty-four were for melanoma indications, fourteen were for non-small-cell lung cancer (NSCLC) indications, and seven were for kidney cancer indications. Many of the reviews did not reach any decision, but 75 percent of HTA decisions (n = 72; p = .0000) reached were positive. Elotuzumab, approved for multiple myeloma, received a positive decision from G-BA and a negative one from SMC. There was an association between different disease conditions or drugs and the rate of positive decisions.
For reviews that had clinical reasons for their decisions, 72.9 percent (n = 59; p = .0000) had positive clinical rationales that were associated with positive decisions (p = .000). Economic rationales for decisions were more mixed, with only 48.4 percent (n = 31; p = .0000) receiving positive decisions. Positive economic evaluations were also associated with positive decisions (p = .000). Atezolizumab, approved only in the United States at the time of this writing, has yet to be reviewed by any of the HTA agencies.
Immunotherapies are promising new options for the treatment of cancer. Thus far, reception by HTA agencies has generally been positive.
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