Clinuvel Pharmaceuticals Ltd advised on Appeal Against NICE Recommendation in England


Clinuvel Pharmaceuticals Ltd (ASX: CUV) and other three consultee organisations representing the erythropoietic protoporphyria  patients (EPP patients) and expert physician requested the appeal hearing appointed by NICE (National Institute of Health and Care Excellence) at London for not using  SCENESSE on English NHS for adult patients diagnosed with EPP which is a rare metabolic disorder. The final evaluation document was the outcome of more than 2 years of discussions with CUV and the HST committee (highly specialised technology committee). The appeal made to NICE has allowed the consultees to go for HST evaluation and lodging appeal to final evaluation document (FED) which will then be evaluated by panel of chair and 4 other members. Appeal was made under 2 categories. First was Failure in assessment, if NICE doesn’t act fairly or exceeds its power; and secondly HST committee’s decision against SCENESSE for no reimbursement if found unreasonable. [optin-monster-shortcode id=”wxhmli4jjedneglg1trq”]

The appeal panel has made a formal judgement in regards to the evaluation that is to be remitted to the HST committee in order the take reasonable steps for the following issues:

  • Unable to represent a member of IPPN in next HST committee meeting.
  • The panel viewed that under Equality act 2010, SCENESSE failed to demonstrate adequate considerations on legal duties. Further concerns were expressed on methodology of evaluation of drug.
  • Moreover the panel stated that the view of the committee on SCENESSE showed that small benefits were unreasonable.

The findings of the appeal was that in the evaluation of SCENESSE HST committee failed to perform few of its function in proper manner and as per Mr Hay, the committee will be reaching out to all sources and access all avenues in order to ensure proper outcome for  EPP patients in England.

CUV shows a very good performance since its inception showing a positive performance report of 803.07%. in one-year it shows a performance of 186.76%. By 5 years the performance was 1142.04% and by 10 years it was 733.96%. The quarterly cash and cash equivalent of the company was A$ 36.198 million. The company currently holds a total assets worth A$ 42,904,617 with corresponding total liabilities of A$ 3,488,629 showing strong ability to pay long term obligations. Also total shareholder equity value is worth A$ 39,415,988.

Today, the share traded at A$ 19.73 with market cap of A$ 933.23 million and PE ratio of 70.40x. Also the moving average convergence and divergence line cutting the signal line from the top indicated that prices might go down.

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