Novartis UK response to NICE Appraisal Consultation Document (ACD) for Piqray (alpelisib) for advanced breast cancer patients

• Novartis UK is disappointed by the initial recommendation from the National Institute for Health and Care Excellence (NICE) not to recommend Piqray® (alpelisib)
• Alpelisib represents a significant step forward in targeted therapy and more than 20 years of research and development into the role of PIK3CA mutations in breast cancer
• Novartis UK is committed to working closely with NICE in order to secure access to alpelisib for those eligible patients in England and Wales that could benefit

We at Novartis UK are disappointed by the initial recommendation from the National Institute for Health and Care Excellence (NICE) not to recommend Piqray® (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive(HR+), human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy.¹

We are committed to securing access to alpelisib for those patients in England and Wales that could benefit from the treatment, and will continue to work closely with NICE to address outstanding areas of uncertainty.

The PIK3CA mutation is a known driver of endocrine resistance, ² an area of significant concern in the treatment of advanced breast cancer. Endocrine resistance affects approximately 40% of HR+/HER2- advanced breast cancer patients,³ and may lead to faster disease progression for patients, and a worse prognosis.^2,4

In the UK, breast cancer is the most common type of cancer, with around 55,000 women diagnosed each year.^5,6 Approximately 30% of women with earlier stages of breast cancer will develop advanced disease.⁷Approximately 64% of women with metastatic breast cancer in the UK have hormone-receptor positive, HER2 negative disease,⁸ and an estimated 30-40% of this group having PIK3CA mutations.⁹

Next steps of the NICE appraisal for alpelisib

This guidance is draft and open for consultation until 21 April 2022 during which time anyone wishing to comment can do so on the NICE website: https://www.nice.org.uk/guidance/indevelopment/gid-ta10825.

After the consultation there will be a second appraisal committee meeting to address any remaining uncertainty. The NICE appraisal committee will then develop a final draft guidance in the form of a final appraisal determination (FAD). If there are no appeals at this stage, the FAD forms the basis of the final guidance that NICE issues to the NHS.

About Piqray®  (alpelisib)

Piqray is a kinase inhibitor developed for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen. 

In July 2020, European Medicines Agency (EMA) approved alpelisib for use in combination with fulvestrant for advanced breast cancer patients with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.¹⁰As this EMA licence did not include patients who had received prior endocrine and CDK4/6 inhibitor combination treatment, Novartis applied to the MHRA for a broader licence to ensure greater access for all eligible patients in Great Britain, which was approved in December 2021.¹¹ Novartis has also made a submission to the Scottish Medicines Consortium (SMC) and are expecting to hear the outcome of this review later this year.

As of March 31, alpelisib is now approved in 71  countries, including the US and EU member states, with regulatory submissions under review in several additional markets. The approved European indication applies to all 27 EU member states plus Northern Ireland (UK), Iceland, Norway and Liechtenstein.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.  Reporting forms and information can be found at mhra.gov.uk/yellowcard.

About Novartis 

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of nearly 140 nationalities work at Novartis around the world.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk                                                                                                           

Novartis UK is on Twitter. Sign up to follow @NovartisUK at www.twitter.com/novartisuk.

reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing

UK | MARCH 2022 | 199547

References

[1] Data on file

2 Miller TW, Hennessy BT, Gonzalez-Angulo AM, et al. Hyperactivation of phosphatidylinositol-3 kinase promotes escape from hormone dependence in estrogen receptor-positive human breast cancer. J Clin Invest. 2010;120(7):2406-2413.

3 Sabine VS_J Clin Onocol_pg2951-2958_2014.

4 Sobhani N, Roviello G, Corona SP et al. The prognostic value of PI3K mutational status in breast cancer: a meta-analysis. J Cell Biochem. 2018;119(6):4287-4292.

5 NHS Choices (2019). Overview - Breast cancer in women. NHS. Available from: https://www.nhs.uk/conditions/breast-cancer/. [Accessed March 2022].

6 Cancer Research UK. Breast cancer incidence (invasive) statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Zero [Accessed March 2022].

7 O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 2005, 10(suppl.): 20-29.

⁸ NICE. (2017) Resource impact report: Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor positive, HER2-negative, locally advanced or metastatic breast cancer (TA495). Accessed September 2018.

⁹ Kratz J, Burkard M, O’Meara T, Pusztai L, Veitch Z, Bedard PL (2018) Incorporating Genomics Into the Care of Patients With Advanced Breast Cancer. American Society of Clinical Oncology. Volume 38, 56-64. Accessed September 2018.

¹¹ Piqray SmPC. EMA. Available at: https://www.medicines.org.uk/emc/product/11684/smpc#gref. [Accessed March 2022]

¹² Piqray SmPC. MHRA. Available at: https://mhraproducts4853.blob.core.windows.net/docs/0f47a7079806f9bde9fc3cc231006ef277be4b62. [Accessed March 2022]