Pemazyre Wins Cost-Effectiveness Thumbs Up For Rare Bile Duct Cancer In England
NICE Said No To Bavencio For Urothelial Cancer
Executive Summary
Bavencio, Taltz, Cosentyx, and Opdivo plus Yervoy were this week also the subject of final recommendations from the health technology assessment body, NICE, on whether or not they should be used on the National Health Service for certain indications.
Heath technology assessment (HTA) body NICE has reversed its refusal in May to recommend making Incyte’s Pemazyre (pemigatinib) available on the National Health Service in England for treating cholangiocarcinoma, a rare form of bile duct cancer.
NICE said it was now backing the use of the recently approved drug after Incyte provided further information to address the uncertainties its appraisal committee previously had about the treatment. (Also see "No To Five, Yes To Three: NICE Decides On Funding For Drugs In England" - Pink Sheet, 14 May, 2021.)
It said that while the cost-effectiveness estimates for Pemazyre were uncertain, they were “likely to be within the range that NICE considers a cost-effective use of NHS resources,” for a life-extending treatment at end of life.
The latest decision was published in the form of final NICE guidance on 22 July.
Final NICE guidances were also published this week for several other drugs: Bavencio (avelumab), Taltz (ixekizumab), Cosentyx (secukinumab), and Opdivo (nivolumab) plus Yervoy (ipilimumab).
The latest decision on Pemazyre “comes after the company was able to work with us in addressing the concerns highlighted by the committee in the previous draft guidance,” said Meindert Boysen, deputy chief executive at NICE and director of the organization’s Centre for Health Technology Evaluation. “This recommendation is a great example of how NICE and companies, by working closely and collaboratively, can really help make a difference to patients,” Boysen declared.
Uncertainty Considered Acceptable
The final guidance recommends that Pemazyre is used within its conditional marketing authorization, which was granted by the UK regulator, the MHRA, in April, for the treatment of locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. The drug is an option for adults whose cancer has progressed after chemotherapy.
According to the guidance, clinical evidence suggests that Pemazyre works better than current treatments at this stage of cancer. “However, there is some uncertainty in the evidence because the cancer is rare and so the number of people who could take part in clinical trials is small, making collecting robust comparative data difficult.” Therefore, NICE says, “the uncertainty is considered acceptable.”
The list price of Pemazyre is £7,159.04 ($9,852) for a pack of 14 x 13.5mg tablets, which is an annual cost of £124,430. Incyte has a commercial arrangement (simple discount patient access scheme) that makes the drug available to the NHS with a confidential discount.
According to NICE, “there are around 50 people who will be eligible for the treatment.” Boysen said that “treatment options for this form of cancer have not improved in a long time and we recognise there is an urgent unmet clinical need for people who have this disease.”
Final guidance documents from NICE are usually subject to a short appeal period. The guidance for Pemazyre is expected to be finalized on 25 August.
The Other Guidances
As for the other final guidances from NICE this week, these relate to the use of:
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Bavencio, from Merck, as maintenance treatment of advanced urothelial cancer after platinum-based chemotherapy – the HTA body recommended against using the drug on the NHS for this indication.
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Taltz, from Eli Lilly, for treating axial spondyloarthritis after NSAIDs – NICE recommended in favor of using the drug in this indication.
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Cosentyx, from Novartis, for treating non-radiographic axial spondyloarthritis – NICE recommended in favor of using the drug in this setting.
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Opdivo with Yervoy, both from Bristol Myers Squibb, for previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency – NICE recommended in favor of using the drugs together for this indication.
When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales generally must provide funding and resources for it within two months of the guidance being published.