Patients With Relapsed and Refractory Multiple Myeloma Face Uncertainty in Their Future Treatment After NHS England Decision

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Celgene

04 Sep, 2015, 13:30 GMT

UXBRIDGE, England, September 4, 2015 /PRNewswire/ --

For UK consumer, medical and pharmaceutical industry trade media

  • Both REVLIMID®▼ (lenalidomide) and IMNOVID®▼ (pomalidomide) will be cut from the Cancer Drugs Fund (CDF) from 1st November 2015 by NHS England, denying some patients with relapsed and refractory multiple myeloma (RRMM) access to life-extending treatment options[1],[2]
  • This puts patients with RRMM in England at a disadvantage compared with the rest of the UK - patients in Scotland are able to receive both lenalidomide and pomalidomide on the NHS and the All Wales Medicines Strategy Group (AWMSG) approved pomalidomide for use on the NHS in Wales last month

NHS England has confirmed that it is de-listing REVLIMID® (lenalidomide) and IMNOVID® (pomalidomide) from the CDF, meaning that relapsed and refractory multiple myeloma (RRMM) patients in England will not be able to access these life-extending medicines[1],[2] on the NHS from 1st November 2015.  Lenalidomide may still be accessed for patients who have received at least two prior therapies.

Eric Low, Chief Executive of Myeloma UK, commented, "The news that life-prolonging myeloma drugs are being removed from the Cancer Drugs Fund is awful and represents a massive step backward. If this trajectory of travel continues, we'll be back to the 1800s in the treatment we're offering patients.

"Since the creation of the Cancer Drugs Fund, Myeloma UK has consistently argued that it is not a long-term solution to accessing cancer drugs on the NHS and does not address the reasons why drugs were not approved by NICE in the first place. The Government has been far too slow to address the critical flaws of the Cancer Drugs Fund and has let things develop to the stage where important and life-prolonging drugs are being delisted from the Fund. The reality is that it is patients that are going to suffer as a consequence of this idleness.

"The issues underlying the Cancer Drugs Fund are endemic of a wider problem in cancer commissioning and in the end-to-end development and access of drugs in the UK. Sustainable, system-wide solutions need to be developed, and the top-down Government cost-cutting rather than cost-saving pressures needs to be stopped, otherwise the goal in the new cancer strategy to save 30,000 lives a year is merely a pipe dream."

Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system.[3] It is the second most common type of blood cancer[4] and approximately 4,800 new cases of multiple myeloma are diagnosed in the United Kingdom each year.[5]

Before today's decision, pomalidomide in combination with dexamethasone was included on the CDF list for the treatment of adult patients with RRMM who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.[6] Lenalidomide was included on the list for the second-line treatment of multiple myeloma in patients who have contraindications to the use of bortezomib or who have received bortezomib in the first line setting.[2] The removal of pomalidomide and lenalidomide from the national CDF list leaves very few options remaining for RRMM patients.[7],[8]

Between April 2013 and March 2015 the CDF received 1,068 funding requests for pomalidomide and 498 for lenalidomide[9],[10] - demonstrating that the CDF listing of these drugs fulfils an important unmet need. This is supported by trial data demonstrating that both lenalidomide and pomalidomide in combination with dexamethasone significantly improve progression-free survival compared with dexamethasone alone.[2],[11]

Wim Souverijns, General Manager, Celgene UK & Ireland, said: "We are hugely disappointed that both REVLIMID® and IMNOVID® will be removed from the CDF. Multiple myeloma is an incurable disease, but treatment can halt its progression for periods of time. Those with relapsed and refractory multiple myeloma have a very poor life expectancy. For this reason, it is essential that effective treatments are available so that we are able to help patients affected by the disease to live longer."

He continued: "The way in which cancer drugs are commissioned for use in England is not fit for purpose. By arbitrarily removing drug funding using a scoring system that fails to recognise that in some cancers there are still high levels of unmet need, NHS England has created a scenario where life sciences investment and innovation in the UK is being put in genuine jeopardy. And we need to invest, because cancer survival rates in the UK are still worryingly poor compared with the rest of Europe. Celgene remains committed to working with NHS England and we call for greater collaboration among all key stakeholders to help find solutions for patients affected by such devastating diseases."

NOTES TO EDITORS 

For further information about lenalidomide and pomalidomide, including safety information, please see the Summary of Product Characteristics (SmPC) available from: http://www.medicines.org.uk/emc/

Celgene's ABRAXANE® also cut from CDF list

ABRAXANE® (nab-paclitaxel), another cancer drug manufactured by Celgene, has also been de-listed from the CDF.

ABRAXANE® (nab-paclitaxel) is indicated for first-line use in advanced pancreatic cancer when used in combination with gemitabine.[12] Pancreatic cancer is the tenth most common cancer in the UK,[13] with almost 9,000 people newly diagnosed every year.[14]

About Celgene Limited 

Celgene Limited, located in Uxbridge, United Kingdom, is a wholly owned subsidiary of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit http://www.celgene.co.uk

References 

  1. Morgan G. et al. Pomalidomide plus low-dose dexamethasone (POM plus LoDEX) versus high-dose dexamethasone (HiDEX) for relapsed or refractory multiple myeloma (RRMM): Overall survival (OS) results of MM-003 after adjustment for crossover. Journal of Clinical Oncology, 2014 ASCO Annual Meeting Abstracts. Vol 32, No 15_suppl (May 20 Supplement), 2014: 8593
  2. REVLIMID®, Summary of Product Characteristics. Aug 2015.
  3. Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046-60
  4. Munshi NC, Anderson KC. New strategies in the treatment of multiple myeloma. Clin Cancer Res. 2013;19(13):3337-44
  5. Cancer Research UK, http://www.cancerresearchuk.org/cancer-info/cancerstats/types/myeloma/incidence/uk-multiple-myeloma-incidence-statistics. Accessed August 2015
  6. IMNOVID®, Summary of Product Characteristics. May 2015
  7. European Medicines Agency. Assessment Report for pomalidomide. Procedure No.: EMEA/H/C/002682. May 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002682/WC500147721.pdf. Accessed August 2015
  8. National Institute for Health and Care Excellence. Evidence summary: new medicine (ESNM32). Relapsed and refractory multiple myeloma: pomalidomide. 2014. Available at: http://publications.nice.org.uk/esnm32-relapsed-andrefractory-multiple-myeloma-pomalidomide-esnm32. Accessed August 2015
  9. Quarterly figures - including notifications and Individual Cancer Drug Fund Requests (ICDFRs) Report: April-March 2013/14
  10. Quarterly figures - including notifications and Individual Cancer Drug Fund Requests (ICDFRs) Report: April - March 2014/15
  11. San Miguel J. et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial. Lancet Oncology. 2013;14(11):1055-66

  12. ABRAXANE®, Summary of Product Characteristics. August 2015
  13. Pancreatic Cancer Action, https://pancreaticcanceraction.org/about-pancreatic-cancer/stats-facts/incidence-mortality/. Accessed September 2015
  14. Cancer Research UK, http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/pancreatic-cancer. Accessed September 2015

Contacts:
Media:
Charlotte Dawkins, Senior Corporate Affairs and Patient Advocacy Manager, Celgene: +447919-298248
cdawkins@celgene.com

Job code: UK-IMN150012
Date of preparation: September 2015