Prices for TKIs Well Aligned With Added Benefits for Patients; Prices for PD-1s Too High

Boston, Mass., November 1, 2016– The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Meeting Summary on the comparative clinical effectiveness and value of PD-1 immunotherapies and tyrosine kinase inhibitors (TKIs) for treatment of advanced non-small cell lung cancer (NSCLC). The report incorporates a summary of evidence votes taken during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), as well as key policy implications stemming from discussion with a panel of patients, clinical experts, and a major insurer.

The Final Report is accompanied by a “Report-at-a-Glance” document, which summarizes key points of the evidence review and economic model, value-based price benchmarks for each drug, voting results, and policy implications. The report also includes a supplement analyzing late-breaking new clinical data on some of the medications of interest.

“As confirmed by votes of the Midwest CEPAC, the evidence on TKIs and PD-1 immunotherapies demonstrates important clinical benefits for patients over previous options.  PD-1 immunotherapies, in particular, offer substantial improvements in both length of life and in quality of life outcomes most important to patients,” noted David Rind, MD, MSc, Chief Medical Officer of ICER. “But even as helpful as PD-1 immunotherapies can be for many patients, their list prices outstrip the range needed to provide reasonable long-term value for money.  Our major challenge is therefore how to reward this kind of innovation and bring it into practice without breaking the bank.  Our Final Report captures key perspectives from the policy roundtable on ways to align pricing, payment, and coverage policies for these drugs to help patients get access to them in a manner that is more affordable – for them, and for the entire health care system.  Ultimately, we hope our report will spur productive conversation between all stakeholders to find solutions that will help as many patients as possible benefit from these treatments.”

Highlights of the meeting, as summarized in the Final Evidence Report, include:

Comparative Clinical Effectiveness and Value


TKIs in patients with epidermal growth factor receptor positive (EGFR+) NSCLC

The Council voted that for patients with EGFR+ advanced NSCLC, the net health benefit of first-line treatment with a TKI is greater than that of treatment with platinum doublet chemotherapy, due to improved survival and better tolerability with TKIs. Most Council members also considered the long-term value for money of TKI therapy to be intermediate. This assessment of value accounts for numerous factors, including net health benefit, cost, benefits or disadvantages of the treatment, and other contextual considerations.

PD-1s in patients with EGFR- advanced NSCLC

A majority of the Council also voted that for patients with EGFR- advanced NSCLC, second-line treatment with PD-1 immunotherapy provides greater net health benefits than treatment with docetaxel. This was due to the better tolerability of PD-1 immunotherapy, as well as the marked improvements in survival for the minority (approximately 20-40%) of patients who respond to such therapy.Despite the impressive clinical benefits of PD-1 immunotherapy, the Council found that the high-priced PD-1 immunotherapies only provided low or intermediate value.

Policy Implications

During the meeting, the Council discussed policy implications of their evidence votes with a panel of subject-matter experts, including patient, physician, and payer representatives.  Several key policy themes emerged from this discussion, many of which focused on the financial burden that NSCLC patients currently struggle with.  Among the key implications are the following:

  • Patients and advocacy groups should seek action by manufacturers, insurers, and policymakers to address the affordability of treatments for lung cancer.
  • In conjunction with a movement toward a more value-based pricing system, purchasers and insurers should design insurance plans that protect patients from significant financial toxicity.
  • Purchasers and insurers may consider incentives for clinicians that encourage the use of high-value care options when clinically equivalent alternatives exist.  Efforts should be taken to share the benefits of more cost-effective care options with patients by reducing their financial burden.
  • Patients, clinicians, and researchers should take steps to increase the number of patients enrolling in clinical trials and enhance the patient role in identifying key outcome measures for future research.
  • Clinicians may consider first-line PD-L1 testing for all patients, while insurers should consider coverage of such testing. Testing may help guide appropriate care for all patients.

A more detailed discussion of the recommendations can be found in the full report. The final report can be found on the ICER website, along with the Report-at-a-Glance.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.