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Many New Cancer Drugs in the United Kingdom Are Facing Negative NICE Rulings

Myeloma UK, Edinburgh, United Kingdom

To the Editor:

We read with great interest the article by Drummond and Mason.¹ We thought it necessary to point out that their observation that cancer drugs reviewed by the National Institute for Health and Clinical Excellence (NICE) "have fared quite well, with most recommendations being positive" appears to be out of date, given recent final appraisal determinations (FADs) and appraisal consultation documents (ACDs) of various cancer medications.

We do not deny cancer medications have fared quite well in NICE appraisals based on an examination of decisions up to the cutoff point of all guidance examined by Drummond and Mason. However, examination of NICE decisions made since their observations, both ACDs and FADs paints a bleaker picture for cancer medications. Examination of the 11 published NICE recommendations for cancer medications following Drummond and Mason's observations, and the further 11 technology appraisals currently in development² with a published ACD or FAD indicates that more than one half (13 of 22) have received a negative decision (Table 1). This is in stark contrast with the guidance examined by Drummond and Mason.

Examination of the preliminary decisions of the 11 NICE technology appraisals still in development paints a far more negative picture for cancer medications with 10 negative decisions. These were treatments for head and neck cancer, lung cancer, glioma, multiple myeloma, lymphocytic leukemia, mesothelioma, and cancer treatment-induced anemia. It should be pointed out that these decisions are not yet final, in that they have not been published as NICE guidance. Specifically, five were at the ACD stage, with the remainder having reached the FAD stage and went on for appeal. It is therefore possible that these negative decisions could be reversed. However, it is not unreasonable to conclude that, while in the past cancer medications have fared quite well through NICE, the future looks less certain for cancer patients awaiting NICE guidance on new treatments.

Another interesting pattern appears to be emerging for treatments of rare cancers and orphan drugs. Specifically, treatments for glioma, relapsed multiple myeloma, lymphocytic leukemia, and mesothelioma have all received negative preliminary decisions from NICE. Indeed, NICE have themselves indicated that they do not consider that any changes to its processes are needed for the appraisal of conventional orphan drugs.³ This should be considered alongside the fact that many new and innovative cancer therapies that are specifically targeted at smaller populations are being developed, and hence will be designated as orphan medicines. Despite the incentives offered by the European Commission for the development of orphan medications, there is a likelihood that, unless NICE is prepared to change its processes for the appraisal of orphan medications, patients with rarer cancers or subtypes of cancer in the United Kingdom may not get access to the treatments they need.

Author's Disclosures of potential Conflicts of Interest

The author(s) indicated no potential conflicts of interest.

ACKNOWLEDGMENTS

Myeloma UK is an Investor in People. Eric Low is writing on behalf of Myeloma UK.

REFERENCES

1. Drummond MF, Mason AR: European Perspective on the costs and cost-effectiveness of cancer therapies. J Clin Oncol 25:191-195, 2007[Abstract/Free Full Text]

2. National Institute for Health and Clinical Excellence: Cancer. http://www.nice.org.uk/guidance/topic/cancer/?View=All&template=diseasetax.aspx

3. National Institute for Health and Clinical Excellence: Appraising orphan drugs. 2006. http://www.nice.org.uk/page.aspx?o=296850

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Low, E. Search for Related Content PubMed PubMed Citation Articles by Low, E. Social Bookmarking                            What's this?