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NICE ASSESSMENT OUTCOMES | 2023 (1/N) United Kingdom | Healthcare | Pharma | News | iPharmaCenter

Updated: Jul 5, 2023

Yescarta has been recommended for adults with diffuse large B-cell lymphoma (DLBCL) after one treatment and is currently indicated as the standard of care after two or more systemic therapies.

Tecartu is recommended for treating adults aged 26 years and above with B-cell acute lymphoblastic leukemia.

Chemotherapy and immunotherapy are the current standard of care, and

Tecartus is now added as another option. The clinical evidence suggests that the administration of Tecartus may extend patients' lives or at least prolong the time until relapse. NICE estimates that almost 90 patients will be eligible for treatment with Tecartus.

The decision to fund Keytruda for advanced cervical cancer was made after the drug was reviewed by the UK cost watchdog, National Institute for Health and Care Excellence. NICE concluded that the drug was clinically effective and provided value for money but noted that more data was needed to determine its long-term effectiveness.

The availability of Keytruda through the Cancer Drugs Fund is good news for patients with advanced cervical cancer, as it means that they now have access to a treatment that could potentially extend their lives.

Keytruda works by blocking a protein called PD-1, which helps cancer cells avoid detection by the immune system.

It is estimated that nearly 400 patients are eligible for treatment with Keytruda.

The final draft guidance from NICE recommends using Lynparza (olaparib) for treating early breast cancer and metastatic prostate cancer after new commercial deals have been made.

After negotiations with AstraZeneca, the pharmaceutical company that manufactures Lynparza (olaparib), NICE has updated its guidance to recommend the drug for certain breast and prostate cancer patients. Olaparib is a PARP inhibitor that prevents DNA from repairing itself, leading to the death of cancer cells.

The guidance recommends olaparib for use in certain patients with early-stage breast cancer that is HER2 negative and have mutations in BRCA1 and BRCA2 following treatment with chemotherapy and surgery. It is also recommended for use in certain patients with metastatic prostate cancer previously treated and with BRCA mutations.

These recommendations were made after new commercial deals were reached between the pharmaceutical company and the National Health Service (NHS). The latest deals ensure that the drug is available to patients at a lower cost than before.

NICE hoped that the availability of the drug would improve outcomes for patients with these types of cancer and help to extend their lives.

NICE has published the guidance recommending Wegovy (semaglutide) for treating adults for weight management, in addition to a reduced-calorie diet and physical activity. It is recommended for only two years and has at least one weight-related co-morbidity. NICE recommended stopping semaglutide if weight was reduced by 5% versus baseline.

Being overweight is managed along with lifestyle changes and with special management services. It was shown that people on semaglutide and weight management support lost more weight than weight management support alone. Further, more patients on semaglutide lost weight versus liraglutide. Semaglutide can also reduce the risk of cardiovascular diseases.

The company submitted a cohort-transition model to demonstrate the cost-effectiveness. NICE agreed that cost-effectiveness estimates are at the lower end of the CE threshold, and the drug can be recommended.

NICE recommended using Roche's Polivy (polatuzumab vedotin) combined with rituximab, cyclophosphamide, doxorubicin, and prednisolone for diffuse large B-cell lymphoma as a fist line therapy. Roche agreed to give a discount to NHS to support the recommendation.

The recommendation was based on the POLARIX study, a Phase 3, double-blind, placebo-controlled trial. In the trial, Polivy plus R-CHP was compared versus R-CHOP. Progression-free survival was the primary endpoint; the 24-month progression-free survival was 76.7% in the Polivy arm versus 70.2% in patients on R-CHOP. NICE was unsure if there was any benefit on overall survival versus R-CHOP.

The company has submitted a 3-state partitioned survival model to estimate the cost-effectiveness of Polivy plus R-CHP versus R-CHOP. Polivy plus R-CHP has not met the end-of-life criteria. NICE considered that Polivy plus R-CHP was likely to be cost-effective.

NICE recommended Polivy plus R-CHP only if the company agrees to a commercial agreement.


Lundbeck's Vyepti (eptinezumab) was recommended for preventing migraine in adults. It is recommended only if adults have four or more migraine days a month and at least three preventing drug treatments have failed.

NICE has previously recommended erenumab, fremanezumab, and galcanezumab, administered under the skin. Vyepti is recommended as an infusion into a vein. Vyepti is considered as effective as the other three therapies. NICE recommended using the least expensive therapies among the recommended drugs.

Lundbeck submitted the cost comparison with the other drugs, and Vyepti was considered the least expensive.


Kite's Yescarta (axicabtagene ciloleucel) was recommended for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed or refractory disease. It is recommended for patients treated after two or more systemic therapies.

The new recommendation was based on additional evidence from the Cancer Drugs Fund.

There are no effective therapies for patients treated with two or more systemic therapies. Salvage chemotherapy is the standard of care. The new evidence from the clinical trial, ZUMA-1, suggests that the patients treated with Yescarta liver longer than those on chemotherapy.

Further, NICE agreed that Yescarta meets the NICE's criteria to be a life-extending treatment at the end of life. Kite agreed with a commercial agreement to support recommendation.


NICE recommended using Amvuttra (vutrisiran) for adults with hereditary transthyretin-mediated amyloidosis with stage 1 or 2 polyneuropathy. The annual cost of treatment is £383,500.

Vutrisiran has some improvements over patisiran, including less frequency of administration and subcutaneous dosage form.

The efficacy was demonstrated in HELIOS-A, an open-label study to compare the clinical benefits of vutrisiran with patisiran. Vutrisiran demonstrated non-inferiority versus patisiran in the reduction of serum TRR levels.

Based on the cost-effectiveness analysis, it was established that vutrisiran is associated with less administrative costs and has similar efficacy. NICE has recommended vutrisiran over patisiran for England patients.


NICE recommended using Bayer's Stivarga (regorafenib) for adult patients with metastatic colorectal cancer who are either intolerant or ineligible to available therapies, including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy.

NICE agreed that the survival rates are poor in patients with metastatic colorectal cancer. There is an unmet need for treatments that improve survival rates and quality of life. The best supportive care and trifluridine–tipiracil were considered appropriate comparators.

The company has submitted CORRECT and CONCUR trials to support the assessment. Both trials were placebo-controlled and were tested in patients whose disease progressed following standard treatment. Overall survival was the primary endpoint for both trials. In the CORRECT trial, the median overall survival was 6.4 months versus five months in patients on placebo. In the CONCUR trial, the median overall survival was 8.8 months in Stivarga versus 6.3 months in patients on placebo.

Based on the indirect comparison, NICE agreed that Stivarga provides similar benefits as trifluridine–tipiracil.

Bayer submitted a three-stage partition survival model to demonstrate the cost-effectiveness. Further, Stivarga could be considered cost-effective versus standard of care and trifluridine–tipiracil.


February 08, 2023

Opdivo plus fluoropyrimidine and platinum-based chemotherapy combination was recommended for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

NICE recommended using Opdivo, fluoropyrimidine, and platinum-based chemotherapy combination for adults with untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma with PD-L1 expression of greater than 1%. It is recommended only if Keytruda plus chemotherapy is not suitable for patients.

The recommended action was based on the CheckMate 648, a Phase-3 open-label study that evaluated the efficacy of Opdivo, cisplatin, fluorouracil combination, Opdivo plus Yervoy, versus cisplatin plus fluorouracil. NICE agreed that Opdivo plus chemotherapy improves progression-free survival and overall survival versus chemotherapy alone. NICE concluded that with indirect comparison, it could not decide on efficacy versus Keytruda.

NICE further considered that Opdivo is less cost-effective when compared to Keytruda. However, it agreed that it is cost-effective versus chemotherapy in patients in whom Keytruda is unsuitable.

NICE further recommended assessing the PD-L1 status to avoid delaying the initiation of Keytruda and Opdivo therapy. It stated that testing PD-L1 status for administering Opdivo is easier than Keytruda.


February 01, 2023

Enhertu was recommended for HER2-positive unresectable or metastatic breast cancer following one or more anti-HER2 treatments.

NICE recommended Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for treating adult patients with HER2-positive unresectable or metastatic breast cancer following one or more anti-HER2 treatments. Enhertu was recommended with managed access, and the company has agreed to a commercial agreement.

The current standard of care for HER2-positive breast cancer is trastuzumab emtansine and a taxane for untreated patients; trastuzumab emtansine is considered for second-line treatment.

Daiichi Sankyo submitted the Phase 3 trial results of DESTINY-Breast03 to support the recommendation. The progression-free survival is the primary endpoint, and overall survival is the secondary endpoint. The PFS was not reached in the Enhertu arm versus 6.8 months in the patients on trastuzumab deruxtecan. Median overall survival was not reached in both arms.

The company has submitted a partitioned survival model to determine the cost-effectiveness. NICE has considered that the ICER values are not within the usual range and cannot be recommended for routine commissioning. NICE recommended Enhertu with managed access.


February 01, 2023

Rinvoq is recommended for non-radiographic axial spondyloarthritis.

NICE recommended using Rinvoq (upadacitinib) for treating non-radiographic axial spondyloarthritis patients whose disease was not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDS). Rinvoq is recommended only if the disease is intolerant or has an inadequate response to TNF-alpha inhibitors. Further, NICE recommended assessing the efficacy at 16 weeks, and the treatment has to be only continued if there is evidence of response.

The recommendation was based on the SELECT-AXIS 2, a Phase 3 trial, which evaluated the efficacy of Rinvoq versus placebo. The key endpoints evaluated are Assessment in Spondyloarthritis International Society 40% (ASAS40) response, BASDAI 50 score, and total back pain score. Rinvoq showed improvement versus placebo in all three endpoints. There was a significant improvement in Ankylosing Spondylitis Quality of Life (ASQoL) versus placebo.

The company submitted a cost-comparison analysis, which evaluated the costs of upadacitinib, secukinumab, and ixekizumab over five years. NICE agreed with the cost-comparison analysis submitted by AbbVie. NICE agreed that the efficacy of Rinvoq is comparable to secukinumab or ixekizumab; the cost of Rinvoq is either equal to or lesser than the costs of secukinumab or ixekizumab.

Considering the efficacy and cost-comparison analysis, NICE recommended using Rinvoq in adults with non-radiographic axial spondyloarthritis.


January 26, 2023

NICE recommended Yescarta for DLBCL and PMBCL patients for routine use.

NICE recommended the use of Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). It is indicated in patients treated with two or more lines of systemic therapy.

NICE recommended using Yescarta for routine use; Yescarta was previously available under the Cancer Drugs Fund.

Between December 2018 and October 2021, 318 people were treated with Yescarta under Cancer Drugs Fund. In the data collected over 36 months, the median overall survival in patients on Yescarta was 28.5 months, and 45% of patients were alive after three years.

In England, nearly 5,500 people are diagnosed with DLBCL, an aggressive type of blood cancer. It is commonly diagnosed in patients 65 years and over. Almost 450 people in England will be eligible for Yescarta.


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