Gilead's Yescarta and Merck's Keytruda Denied Reimbursement by Scottish Health Authority

Recently, Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) and Merck Sharp & Dohme’s Keytruda have been confirmed by ScotlandPharmaceuticalsThe association rejected its inclusion in the Scottish healthcare system, meaning patients in Scotland cannot access the drug through the National Health Service. However, Novartis’s Kymriah, also a CAR-T therapy, was approved this time.

This decision to reject also means that patients in Scotland who have potentially exhausted all treatment options for aggressive non-Hodgkin lymphoma (including relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma) will not be able to access Yescarta through the National Health Service (NHS) in Scotland. Previously, this personalized cell therapy had been launched in England and Wales within the UK, but it did not achieve the same outcome in Scotland. Dr. Alan MacDonald, Chair of the Scottish Medicines Consortium (SMC), explained, “Although our Patient and Clinician Engagement (PACE) process provided additional flexibility in the appraisal of Yescarta, based on the evidence currently submitted by Gilead Sciences, the SMC Committee could not accept that the long-term benefits and cost-effectiveness of this medicine for lymphoma had been demonstrated.”

Hilary Hutton Squire, General Manager for the UK and Ireland at Gilead Sciences, Inc., commented on the decision, stating, “Just as Gilead has strived to support children with acute lymphoblastic leukemia (ALL), we hope that the Scottish Medicines Consortium can help adult patients with diffuse large B-cell lymphoma (DLBCL) gain access to Yescarta. Gilead remains committed to working closely with the Scottish Medicines Consortium to provide Yescarta to eligible patients in Scotland, just as we have done for patients in England and Wales.”

Gilead believes that in many cases, such patients have no treatment options available and are unlikely to survive beyond six months. Yescarta was previously rejected by the National Institute for Health and Care Excellence (NICE) in England and Wales, but was ultimately approved in late 2018 for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.

Regarding other indications, the Scottish Medicines Consortium (SMC) has approved Novartis’s CAR-T therapy Kymriah (tisagenlecleucel) for the treatment of children and young adults with acute lymphoblastic leukemia who are refractory to or have relapsed after prior therapy. Novartis has also provided a confidential discount for this indication. The drug was accepted following approval through the SMC’s Patient and Clinician Engagement (PACE)* process. In its guidance document, the SMC stated that “Kymriah offers the potential for long-term disease remission, and this therapy may represent a life-saving treatment option.” The agency is also scheduled to make a decision on Kymriah for another indication (diffuse large B-cell non-Hodgkin lymphoma) in March 2019.

In September 2018, shortly after Kymriah received approval from the European Commission, a similar pricing agreement ensured its inclusion in the UK National Health Service (NHS), enabling reimbursement for the treatment. As one of the fastest-approved therapies under the NHS, Novartis listed the price for a single course of this CAR-T therapy in the UK at £282,000.

CAR-T therapies such as Yescarta and Kymriah leverage the patient’s own immune system to detect and destroy cancer cells. The treatment process involves collecting the patient’s white blood cells, genetically reengineering them in the laboratory to target and combat tumor cells, and then infusing them back into the patient. Although this comprehensive treatment workflow has led to certain supply constraints, Kymriah has still demonstrated robust performance, with sales of $76 million in 2018, including $26 million in the fourth quarter alone. Yescarta has also been adopted rapidly, achieving total sales of $264 million in 2018, with $81 million generated in the fourth quarter.

In addition, the Scottish Medicines Consortium (SMC) has approved Novartis’ Tafinlar (dabrafenib) for the treatment of advanced melanoma, meaning that patients in Scotland with stage III BRAF-positive melanoma will, for the first time, have access to an orally administered BRAF-targeted therapy covered by insurance reimbursement; Pfizer’s Xeljanz (tofacitinib citrate) has been recommended by the SMC for the treatment of moderately to severely active ulcerative colitis; and Bayer’s Xarelto (rivaroxaban) has been recommended by the SMC for use in combination with aspirin in specific types of coronary artery disease.

During this review process, the Scottish Medicines Consortium (SMC) rejected the combination of Merck Sharp & Dohme’s blockbuster drug Keytruda (pembrolizumab) with chemotherapy for the treatment of advanced lung cancer, citing excessive uncertainty in the evidence provided by Merck regarding the relationship between treatment costs and health benefits. Furthermore, the Committee concluded that reimbursing this drug would not constitute an optimal use of National Health Service (NHS) resources. Ipsen’s Cabometyx (cabozantinib), as a first-line treatment for advanced renal cell carcinoma (kidney cancer), also failed to pass the PACE procedure, primarily due to significant uncertainties in the company’s evidence on cost-effectiveness compared to existing treatment regimens.

*The PACE program is designed to improve patient access to new drugs for end-of-life care and ultra-rare diseases.(Sina Medicine compiled by Fan Dongdong)

Source:

1、Scotland says no to Yescarta, but backs Kymriah

2、NHS Scotland's February 2019 Funding Decisions

3、Yescarta rejected among other SMC decisions

Source: Sina Medical News