Emerging Immune Checkpoint Inhibitors May Find the Road to Optimal Market Access Rocky

BURLINGTON, Mass., Aug. 1, 2017 /PRNewswire/ -- Decision Resources Group finds that, despite mixed fortunes in health technology assessment (HTA) across the EU5 (France, Germany, Italy, Spain, and the United Kingdom), the most recently marketed immune checkpoint inhibitors, Bristol-Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab), are enjoying healthy uptake across approved indications among surveyed oncologists, with that of Opdivo strengthened by additional approval in combination with fellow classmate, Bristol-Myer's Squibb's Yervoy (ipilimumab) for metastatic malignant melanoma. However, payer and prescriber insight also reveals reimbursement/local level coverage issues and cost-related restrictions to be key constraints to increased prescribing in all five countries. Interviewed payers report that manufacturers of emerging immune checkpoint inhibitors must learn from the experiences of existing agents, stressing that unequivocal proof of added benefit of novel agents over appropriate standard-of-care comparators, demonstrable cost effectiveness, and flexible pricing strategies are essential for favorable HTA, optimal sustained market access, and maximum return on investment.

Learn more about the full report here:
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Other key findings from the Immune Checkpoint Inhibitors in Key Oncology Indications | Access and Reimbursement | EU5 analyses include:

• Opdivo is the patient-share leader for BRAF wild-type malignant melanoma in France, Italy, and Spain (34-40%) and garners share comparable to that of other class members in Germany and the United Kingdom. Considerable uptake in squamous and nonsquamous NSCLC is also evident, as is impressive use in renal cell carcinoma, just a year after EC approval.
• Surveyed EU5 prescribers' use of Opdivo plus Yervoy for first-line unresectable/metastatic malignant melanoma, is more restricted than their use of single-agent immune checkpoint inhibitors. The impact of nonclinical constraints is especially notable in Italy and Spain, where 42-58% of respondents report that reimbursement hurdles/ongoing P&R negotiations/local coverage issues and budgetary impact restrict their prescribing of the combination.
• Although most surveyed oncologists plan to prescribe Roche's Tecentriq plus Zelboraf and Cotellic first line for BRAF-mutation-positive unresectable or metastatic malignant melanoma, more than half in Italy, Spain, and the United Kingdom, and more than one quarter in France and Germany echo interviewed payer concerns of likely reimbursement hurdles/local coverage issues.

Insights from Yulia Privolnev, M.A., Principal Market Access Analyst at Decision Resources Group:

• "Manufacturers must balance pricing with uptake potential for emerging immune checkpoint inhibitors, particularly in malignant melanoma. National-, regional-, and local-level budgets in the EU5 are highly constrained, and payers have concerns that widespread first-line use of these therapies will add considerable pressure. As a result, manufacturers must be willing to enter into cost-sharing and risk-sharing schemes to pave the way for optimal market access."

Insights from Aarushi Kashyap, Ph.D., Senior Insights Analyst at Decision Resources Group:

• "Impressive uptake of Opdivo in renal cell carcinoma, a market saturated by established and new small-molecule drugs, has been facilitated by this immune checkpoint inhibitor's demonstration of significant overall survival improvements—the top driver of prescribing decisions among surveyed medical oncologists and, indeed, a key lever for favorable HTA and optimal pricing and reimbursement terms."

About Decision Resources Group
DRG, a subsidiary of Piramal Enterprises Ltd., is the premier source for global healthcare data and market intelligence. A trusted partner for over 20 years, DRG helps companies competing in the global healthcare industry make informed business decisions. Organizations committed to the developing and delivering life-changing therapies to patients rely on DRG's in-house team of expert healthcare analysts, data scientists, and consultants for critical guidance. DRG products and services, built on extensive data assets and delivered by experts, empower organizations to succeed in complex healthcare markets.

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Decision Resources Group 
Whitney Goldstein 
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