White Paper – Tracking Biomarker Testing
at the Global Level

 

While market trackers provide product share data over time, some provide this data with less volatility, more accuracy, and more frequency than others.

In oncology, what else should a pharmaceutical company track to understand market progress?

With the rapid development of targeted therapies, monitoring the uptake of biomarker testing becomes paramount to understanding product uptake and performance. As an example, the graph below shows the evolution of biomarker testing for the NSCLC market in Top-5 Europe.

 

Evolution of Biomarker Testing Top 5 EU(Source, LiveTracker®-NSCLC, monthly analysis of 1,000 NSCLC patient cases across top 5 Europe)

 

ALK Testing has become a standard in Europe

Aside from the EGFR testing, which is conducted almost systematically for all non-squamous tumors and which drives prescription of targeted therapies such as Erlotinib, Afatinib or Gefitinib; ALK testing has now become a standard in Europe. Although the occurrence of the ALK mutation is low (around 5-6% of patients), if found positive, it opens and restricts a segment of this fiercely competitive market to only four manufacturers: Pfizer with Crizotinib, Novartis with Ceritinib, Roche with Alectinib, and soon Takeda with Brigatinib.

 

PD-L1 Testing Clearly On the Rise

On the other hand, one can also notice a very clear uptake of the PD-L1 testing, in particular since Keytruda® from Merck obtained authorization for first-line usage when the PD-L1 expression is superior to 50%. In September for Top 5 EU, the percentage of patients tested for PD-L1 has jumped to 59%, and if you consider only Germany up to 69%, where Keytruda® first line usage was first authorized in February, 2017.

In Germany, Keytruda® obtains the lion’s share when PD-L1 expression is over 50%, capturing close to 80% of this segment’s first-line patients. But it is also totally absent from the other segments, resulting in a market share directly linked to the prevalence of this biomarker expression.

Patient Share According to PD-1 Expression - Germany(Source, LiveTracker® NSCLC Germany – monthly analysis. 198 NSCLC patient cases in Germany)

 

In fact, as can be seen in the graph below, in Germany since July 2017, PDL1 testing has taken over EGFR testing in NSCLC and today is the first test performed by oncologists and pulmonologists to determine their course of action.

 

Biomarkers Tested - NSCLC Germany Nov. 2017

(Source, LiveTracker® NSCLC Germany  – monthly analysis. 198 NSCLC patient cases in Germany)

 

T790M and EGFR Mutations

The same is true for other biomarkers such as T790M which, if expressed, gives carte blanche to the prescription of Tagrisso® (Osimertinib), the only drug with a label that directly associates it to T790M. With Tagrisso® moving to first line therapy after being granted breakthrough designation by the US FDA, it will be interesting to see how this T790M test evolves.

Japan is another interesting country with high expression of EGFR mutations in the population (as in the general Asian population). As can be seen in the graph below, in September 2017, 40% of NSCLC patients were tested positive for EGFR (and up to 55% in the non-squamous segment), while in the Caucasian population this rate is around 20%.

 

Biomarker Test Results Japan(Source, LiveTracker® NSCLC Japan – monthly analysis. 202 NSCLC patient cases in Japan)

 

Biomarker Testing As Main Lever to Increase Sales

In many therapeutic areas of oncology, biomarker testing has become the main lever to increase sales, especially if usage of the product is dependent upon a positive test. Market shares of many new drugs are now confined within the boundaries of biomarker expression, and the potential of any new product must be assessed keeping this component in mind.

Maximizing the number of physicians requesting the test of a biomarker, increasing  test access in the labs, making the test available to pathologists; ensuring that insurance, social security or patients will pay for the test,  become as important (if not more important) than promoting the drug.

 

Where Biomarker Access is a Challenge, Pharma is Subsidizing Tests

This explains why in countries where biomarker access is a challenge, pharmaceutical companies are subsidizing the tests. As shown in the table below, in Latin America, EGFR testing is almost always subsidized by Roche (manufacturer of Erlotinib) or AstraZeneca (Gefitinib and now Osimertinib). Pfizer, on the other hand is subsiding ALK tests, which is the only condition to see Crizotinib prescribed.

Roche is certainly the most active in subsidizing tests in Latin America, with financial help offered to patients on BRAF, EGFR and HER2.

Finally, it is noteworthy that Merck (MSD) does subsidize PD-L1 testing, which offers an opportunity to favor Pembrolizumab in first line, while BMS is not pushing this test, as it is not required to prescribe Nivolumab.

 

Pharma Companies Subsidizing Biomarker Tests - LatAm

(Source, LiveTracker® NSCLC Latin America – monthly analysis. 970 NSCLC patient cases in Top 5 Latin America)

 

Once the testing of a companion biomarker becomes ubiquitous, little can be done to increase the size of the market.

This explains why tracking biomarker testing is becoming paramount for many pharmaceutical companies and why any pharmaceutical company should include such metrics in all relevant oncology and hematology trackers.

 

Background on Information Presented

The information presented in the white paper is derived from the analysis of 6,330 patient charts for the period of Q4 2016 to Q3 2017. Medimix’ LiveTrackerTM provides the physician AND the patient share of testing by biomarker, and it delivers this information monthly within 5 days of month’s end, to give you a meaningful trend.  Please don’t hesitate to ask us for more information on how LiveTrackerTM can improve your market intelligence with the goal of increased product sales.

LiveTrackerTM is now available in 35 countries and 22 oncology and hematology indications.

 

This paper was authored by Henry Gazay, Medimix CEO, and Steve Murdock, Medimix BD Partner

All information contained in this whitepaper is from research conducted by and proprietary to Medimix International.

 

For more information on how LiveTrackerTM and other innovative methodologies can help you maximize your success, please contact:

Kathryn McAdam, Global BD Director
kmcadam@medimix.net

Tel. + 1 786-363-4602