July 3, 2024

Key insights: Future Cancer Inquiry

Future Cancer: NICE Medicines Appraisal (Enhertu), HC 739 was discussed with the committee and representatives from Pharma about the changes by NICE in 2022 to assess the cost-effectiveness of drugs.

Health and Social Care Committee’s Future Cancer inquiry convened to scrutinise recent changes by NICE - National Institute for Health and Care Excellence in drug evaluation methods, particularly focusing on the cost-effectiveness criteria for treatments used in life-limiting illnesses like cancer.

NICE replaced the end-of-life criteria with a severity modifier system in 2022. The intent was to broaden the scope beyond cancer to include other conditions. This change has led to a significant reduction in the number of drugs qualifying for high severity classification, affecting their approval, and funding.

The Future Cancer inquiry received evidence from pharmaceutical companies that changes by NICE in 2022 to assess the cost-effectiveness of drugs do not sufficiently weight treatments used in severe diseases, such as advanced cancer. They say that

"As a result some cancer patients may miss out on critical treatments. "

The Health and Social Care committee will consider the impact of changes made by NICE to evaluate drugs used to treat patients with terminal illness like cancer in this session. MPs will also consider the breast cancer drug Enhertu which in draft guidance from NICE has not been recommended for treating HER-2 low advanced/metastatic breast cancer in England.

What is the Impact of NICE Changes on Drug Evaluation?

Classification Issues:

  • Metastatic diseases like breast cancer, previously classified as ‘high severity’ under the end-of-life criteria, are now often categorized as ‘medium severity’.
  • This reclassification restricts the threshold at which they are assessed as cost-effective or not and impacts the approval of funding of treatments for these conditions.

Appraisal Outcomes:

  • Haran Maheson , VP and Head of Oncology, Daiichi Sankyo UK, mentioned that
"Since the introduction of the severity modifier around January 2022, only 2 out of 39 appraisals have reached the highest level of severity."
  • Most conditions are now classified under medium severity or not severe, reducing the likelihood of drug approval.

Impact on Patients:

  • The changes have led to delays and denials in accessing potentially life-saving treatments.
  • Patient advocacy groups argue that the severity of diseases like metastatic breast cancer is not adequately recognized under the new system.

Implications for Research and Development:

  • How rigorously the threshold criteria is applied has raised concerns within the major cancer charities. AstraZeneca and other companies foresee challenges in the approval of new treatments, which may affect their investment in R&D.
  • Without changes, there is a risk that standards of care in the UK may fall behind those in other countries.

International Comparison:

  • Treatments like Enhertu for HER2-low metastatic breast cancer are already available in 16 European countries, including Scotland.
  • The UK's stricter severity criteria make it an outlier, potentially impacting the availability of innovative treatments.

Highlights of the Discussion:

Impact of Removing EOL Criteria and Introducing Severity Modifier:

The discussions centered on the implications of the removal of the End-of-Life (EOL) criteria and the subsequent introduction of the severity modifier (SM). Pharma companies and PAGs argued that these changes are impeding the approval of oncology drugs, particularly those for metastatic diseases, from meeting the cost-effectiveness (CE) willingness-to-pay (WTP) threshold, thereby restricting patient access to these vital treatments.

AstraZeneca’s Pipeline Concerns:

AstraZeneca specifically noted that they have 13 drugs in their pipeline that would have met the previous EOL criteria but do not meet the new 1.7 SM. This significant change implies that these drugs are unlikely to reach patients in England under the current system. AZ’s representatives underscored the impact of these modifications, highlighting that a substantial number of oncology drugs awaiting appraisal could face similar barriers, thus affecting the broader industry and patient care landscape.

Balancing Evaluation Rigor with Patient Needs:

The committee acknowledged the importance of balancing rigorous evaluation methods with the urgent needs of patients with severe conditions. The severity modifier was intended to broaden the scope of conditions eligible for prioritisation, but its conservative application has resulted in fewer drugs qualifying for higher severity status than anticipated.

Disparities in Drug Accessibility Across the UK:

Moreover, discussions highlighted disparities in drug accessibility within the UK, as the same treatments are available in Scotland but not in England. This inconsistency raises questions about equity in healthcare across the UK. The committee and stakeholders called for an urgent review and potential adjustments to the severity modifier thresholds, to ensure that patients with severe conditions, such as metastatic breast cancer, can access new, life-extending treatments.

Call for Re-evaluation of NICE’s Appraisal Methods:

In conclusion, the hearing emphasized the need for a re-evaluation of NICE’s appraisal methods to ensure they align with the goal of providing timely access to innovative oncology treatments. The call for a rapid review of the severity modifier and greater flexibility in its application reflects a shared commitment to improving patient outcomes and maintaining the UK’s position as a leader in pharmaceutical research and development.

Conclusion

The discussion of the cross-party parliamentary select committee hearing centered on Enhertu (T-DXd) for HER2-low breast cancer.

According to the conversation, pharma companies and PAGs voiced concerns that the removal of the End of Life criteria and the introduction of the severity modifier were hindering oncology drugs, particularly those for metastatic diseases, from meeting the cost-effectiveness willingness-to-pay threshold, thereby limiting patient access.

AZ highlighted that 13 drugs in their pipeline, which would have qualified under the EOL criteria, fail to meet the new 1.7 severity modifier, potentially restricting their availability to patients in England. The review of the use of the severity modifier by NICE will be ongoing over 2024/25."

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