Zosia Chustecka

June 10, 2015

CHICAGO — With the skyrocketing of prices of new cancer drugs, the buzz word within oncology circles has become "value," with consideration given to the cost of therapy and to clinical benefits and side effects. Both of the big oncology societies have been working on ways in which to measure value. Now, the European Society of Clinical Oncology (ESMO) has unveiled its new tool, and the American Society for Clinical Oncology (ASCO) plans to announce its strategic value initiative within the next few weeks.

ESMO says that its Magnitude of Clinical Benefit Scale (MCBS) offers a rational, structured, and consistent approach to "stratify" a drug's clinically meaningful benefit.

Details of ESMO's MCBS were published online May 30 in the Annals of Oncology to coincide with a presentation at a special session on value at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.

"As the international organization committed to the interest of the oncology community at large, we are concerned about some anticancer medicines approved by the European Medicines Agency [EMA] not being available or affordable to patients when prescribed," commented ESMO president Rolf A. Stahel, MD, in a statement.

"With the ESMO-MCBS, we aim to signal the drugs with a large magnitude of clinical benefit which should be endorsed across Europe for rapid patient access," he said.

ESMO says that it intends to apply the scale prospectively to new anticancer drugs that will be approved by the EMA. Drugs obtaining the highest scores on the MCBS will be highlighted in the ESMO Clinical Practice Guidelines, with the hope that they will be rapidly made available by health authorities across the European Union.

Structured and Rational Approach

The MCBS incorporates a "structured, rational, and valid approach to data interpretation and analysis that reduces the tendency to have judgments affected by bias, uninformed and/or idiosyncratic data interpretation," ESMO said in a statement.

"In the absence of a standardized approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed, and very modest incremental advances have often been presented, discussed, and promoted as major advances or 'breakthroughs,' " commented Elisabeth de Vries, MD, PhD, from the Department of Medical Oncology at the University Medical Center Groningen, in the Netherlands, and cochair of the ESMO-MCBS Task Force.

"Application of the MCBS will reduce the likelihood that statements of clinical benefit will be distorted by either overestimation or overstatement on one extreme or nihilism at the other," Dr de Vries said in a statement.

In her presentation at the ASCO meeting, Dr de Vries outlined how the scale was developed and then field tested on 77 cancer drugs across 10 cancer types.

There are several underlying premises, for example:

  • Cure takes precedence over deferral of death.

  • Direct endpoints, such as overall survival and quality of life, take precedence over surrogates such as progression-free survival (PFS) and response rate (RR).

  • Disease-free survival in curative disease is a more valid surrogate than PFS and RR in noncurative disease.

In addition to these measures of efficacy, the prognosis of the condition and the toxicity of the drug are taken together to make the assessment about the magnitude of clinical benefit, she explained.

"Cost was not taken into account," she noted, because there is a significant variation in the price of the same medicine across different European countries.

Treatment was considered separately for curative and noncurative settings, because of the "profound differences" between the two settings, she said. In the curative setting, the highest score on the scale is A, whereas in the noncurative setting, it is 5.

Giving some examples from the field testing, Dr de Vries noted that in the breast cancer field, neoadjuvant treatment with trastuzumab and chemotherapy in the HERA trial scored an A, whereas TDM-1 vs capecitabine plus lapatinib in the second line after trastuzumab failure in metastatic disease in the EMILIA study scored a 5. However, the use of eribulin vs other chemotherapy used as third-line therapy after chemotherapy and taxanes in metastatic disease in the EMBRACE study scored only 2.

The MCBS will be able to determine which drugs are immediately required in Europe, she said. It can also be used to support clinical decision making and in counseling patients, and it may also help with editorial commentaries.

It is a "lively instrument" that is now in its first version, and it will need fine-tuning as more mature data become available and as new drugs and new indications become available, she said.

Ann Oncol. Published online May 30, 2015. Abstract

American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. Presented on May 30, 2015.

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