Regulatory Focus™ > News Articles > NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta

NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta

Posted 22 June 2016 | By Michael Mezher 

The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).

The drugs include two cancer drugs from Novartis, Zykadia (ceritinib) and Mekinist (trametinib); two PCSK9 inhibitors, Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolucumab); AbbVie's Humira (adalimumab); and GlaxoSmithKline's Benlysta (belimumab).

NICE Recommendations


Zykadia (ceritinib)

Advanced anaplastic lymphoma kinase positive non-small cell lung cancer in adults who have previously been treated with Xalkori (crizotinib)


Mekinist (trametinib)

Unresectable or metastatic melanoma in adults with a BRAF V600 mutation in combination with Tafinlar (dabrafenib)


Praluent (alirocumab)

Primary hypercholesterolemia or mixed dyslipidemia


Repatha (evolucumab)

Primary hypercholesterolemia or mixed dyslipidemia


Humira (adalimumab)

Moderate to severe hidradenitis suppurativa in adults whose disease has not responded to conventional systemic therapy


Benlysta (belimumab)

Add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults.

All six recommendations come after NICE received additional discounts on the drugs from their manufacturers, and in all five cases the agency said that the drugs will only be covered by NHS "when the company provides [the drug(s)] with the discounts agreed in the patient access scheme[s]."

NICE originally refused to cover both Repatha and Praluent in draft guidance released in November 2015 and February 2016, respectively. In both cases, NICE said it recognized the drugs' ability to reduce levels of LDL cholesterol, but found the drugs were not cost effective in light of lacking evidence of the drugs impact on cardiovascular outcomes.

However, in May, NICE reversed its course on Repatha and Praluent after reaching an agreement with their manufactures to receive additional discounts from their list price of more than £4000 per year in Europe, which is already significantly lower than the more than $14,000 both drugs retail for in the US.

Despite the discounts, Carole Longson, director of the NICE Centre for Health Technology Evaluation called both drugs "relatively expensive" compared to Zetia (ezetimibe), which costs roughly £350 per year.

Similarly, in October 2015, NICE said it did not recommend Zykadia "as the calculated incremental cost-effectiveness ratios were above the range considered a cost-effective use of NHS resource."

While the other drugs were all recently approved for the indication NICE has recommended them for, GSK's Benlysta has been on the market in Europe since 2011. Since receiving approval from the European Medicines Agency (EMA), Benlysta has undergone multiple consultations by NICE, each time being rejected for cost-effectiveness reasons.

However, NICE's recommendation for Benlysta comes with several caveats. For a patient to receive Benlysta through NHS, NICE says a patient must have evidence of serological disease activity and have a score of 10 or greater on the Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI). Additionally, for NHS to cover Benlysta beyond 24 weeks, a patient's score must improve by four or more points on the SELENA-SLEDAI scale.


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