Access to Abraxane to be reconsidered by the National Institute for Health and Care Excellence (NICE)

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Celgene suabraxane_celgene_lung_cancerpports a decision taken by NICE to expedite a review of guidance regarding the use of Abraxane® (paclitaxel formulated as albumin bound nanoparticles; nab-paclitaxel), in combination with gemcitabine, for the first-line treatment of metastatic pancreatic adenocarcinoma (metastatic pancreatic cancer). This decision is a result of a number of factors and follows a period of stakeholder consultation; Celgene is now able to make a re-submission to NICE, approximately two years earlier than previously scheduled.
Commenting on the decision, Ali Stunt, Founder and Chief Executive of Pancreatic Cancer Action said: “We are delighted that eligible pancreatic cancer patients in England may have the chance to benefit from Abraxane®, in combination with gemcitabine, via the NHS in the near future. Pancreatic cancer is not a rare disease, around 9,400 cases were diagnosed in 2013, yet there are few treatment options available. It is vitally important that NICE recognises the importance of extra time for people whose life expectancy has already been cut devastatingly short by this disease.”

Wim Souverijns, Vice President and General Manager at Celgene UK & Ireland adds: “As a company, we are committed to working with NICE and other healthcare technology appraisal bodies during the review of all of our medicines, and we have worked hard to collate data to further demonstrate the cost-effectiveness of Abraxane® in combination with gemcitabine. We are pleased that NICE has agreed to re-consider patient access to this medicine, approximately two years ahead of schedule, and will continue to collaborate with the organisation throughout the forthcoming appraisal process.”

Celgene’s commitment to ensuring patient access to nab-paclitaxel, in combination with gemcitabine for the first-line treatment of metastatic pancreatic cancer in England is part of their global fight against pancreatic cancer. The company is conducting studies and supporting investigator initiated trials in various stages of the disease.

Celgene’s commitment to ensuring patient access to nab-paclitaxel, in combination with gemcitabine for the first-line treatment of metastatic pancreatic cancer in England is part of their global fight against pancreatic cancer. The company is conducting studies and supporting investigator initiated trials in various stages of the disease.

Q&A
1. Why has NICE expedited a review of guidance regarding use of nab-paclitaxel, in combination with gemcitabine, for the first-line treatment of metastatic pancreatic cancer?
The review of this guidance has been expedited as a result of a number of factors and following a period of stakeholder consultation. Celgene is committed to helping ensure patient access to the medicine via the NHS in England, and since the publication of final guidance in October 2015 the company has worked with a number of stakeholders to collate further data. This evidence aims to remove uncertainty around the impact of nab-paclitaxel (in combination with gemcitabine for the first-line treatment of metastatic pancreatic cancer on patient quality of life) and usage within the clinical setting. This evidence will be submitted to the Appraisal Committee for consideration as part of the company’s review submission.  Additionally, Celgene has submitted a Patient Access Scheme, the details of which are confidential.
2. What are the timings for final guidance to be issued?
A second Single Technology Appraisal (STA) process is to be undertaken regarding the use of nab-paclitaxel, in combination with gemcitabine, for the first-line treatment of metastatic pancreatic cancer in England. Timings are to be confirmed, since a review of the guidance is to be planned into the existing NICE schedule of work. Celgene is committed to working with NICE throughout the upcoming appraisal process.
3. Why did Celgene not submit a Patient Access Scheme as part of the earlier NICE review process?Following the earlier NICE appraisal process regarding use of nab-paclitaxel, in combination with gemcitabine, for the first-line treatment of metastatic pancreatic cancer, it became apparent that a Patient Access Scheme would help enable NHS use of the treatment in England. Celgene is committed to working collaboratively with NICE and acted as promptly as possible to propose a suitable scheme, the details of which are confidential.
4. What further data will be provided by Celgene as part of this expedited review of the single technology appraisal?
Since the publication of final guidance by NICE in October 2015,5 Celgene has worked with stakeholders to source further information and evidence which aims to remove uncertainty around the impact of nab-paclitaxel, in combination with gemcitabine, on patient quality of life and usage within the clinical setting. This evidence will be submitted to the Appraisal Committee for consideration as part of the company’s review submission.

REFERENCES:
1 National Institute For Health And Care Excellence. RPP decision paper. Review of TA360; Paclitaxel as albumin-bound nanoparticles in combination with gemcitabine for previously untreated metastatic pancreatic cancer. Issued May 2016
2 Abraxane 5 mg/ml powder for suspension for infusion. Summary Of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000778/WC500020435.pdf Last accessed May 2016
3 Celgene (2014) Annual report; innovation, impact, results. Available at: http://files.shareholder.com/downloads/AMDA-262QUJ/337267111x0x825208/A1003DD5-7CDE-4073-AF4F-ED7EB1D28E73/Celgene_2014_Annual_Report.pdf. Last accessed May 2016
4 European Federation of Pharmaceutical Industries and Associations (2015). The pharmaceutical industry in figures. Available at: http://www.efpia.eu/uploads/Figures_2015_Key_data.pdf. Last accessed May 2016
5 National Institute For Health And Care Excellence (2015) . Paclitaxel as albumin-bound nanoparticles in combination with gemcitabine for previously untreated metastatic pancreatic cancer, NICE technology appraisal guidance [TA360]. Available at: https://www.nice.org.uk/guidance/ta360. Last accessed May 20156