How Receptive Are Physicians and Payers to Premium-Priced Emerging Therapies in This Underserved Market?

Patients with advanced/metastatic colorectal cancer (mCRC) typically receive chemotherapy (with or without biologics) as treatment, which increases overall survival (OS) but can also lead to severe toxicities. Patients in the third-line setting have limited therapeutic options and typically have a reduced quality of life; therefore, physicians must carefully balance any efficacy benefit associated with a therapy with its toxicity profile. The launch of regorafenib (Bayer HealthCare’s Stivarga) and the anticipated launch of TAS-102 (Taiho Pharmaceutical’s Lonsurf) in the United States and Europe will increase the number of viable treatment options for these patients, and those who are RAS wild-type can also receive an EGFR inhibitor (such as cetuximab [Bristol-Myers Squibb/Eli Lilly/Merck KGaA’s Erbitux] and panitumumab [Amgen/Takeda Pharmaceutical’s Vectibix]) if they have not received one previously. However, given that the efficacy associated with these therapies is limited, significant opportunity remains for emerging therapies in development for this patient population.

Questions Answered in This Report:

  • A drug’s performance on at least seven efficacy end points, including OS, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European oncologists weight efficacy measures and other drug attributes in their prescribing decisions for third-line mCRC?

  • Regorafenib is the 2013 major-market sales leader for third-line mCRC. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated strengths on the attributes that surveyed oncologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  • OS, overall response rate (ORR), and rate of diarrhea are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new third-line mCRC therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for the treatment of third-line mCRC? Based on the trade-offs in price and performance across key drug attributes that U.S. oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for third-line mCR?

  • Based on its clinical profile, panitumumab is the current clinical gold standard in our Drug Comparator Model in RAS wild-type patients and bevacizumab + 5-FU + leucovorin is the current clinical gold standard in RAS-mutant patients. What attributes do thought leaders believe differentiate these therapies from competing current therapies and emerging therapies? Will any therapies in development challenge panitumumab or bevacizumab + 5-FU + leucovorin as the future gold standard in 2018 or 2023?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for third-line mCRC:

- Median overall survival.

- Median progression-free survival.

- Overall response rate.

- Rate of grade 3/4 neutropenia.

- Rate of grade 3/4 diarrhea.

- Rate of grade 3/4 rash.

- Price per cycle.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for third-line mCRC:

- Effect on median overall survival.

- Effect on progression-free survival.

- Incidence of all grades of diarrhea.

- Incidence of all grades of rash.

Physicians surveyed: 60 U.S. and 30 European oncologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Regorafenib (Bayer HealthCare’s Stivarga)

- Cetuximab (Bristol-Myers Squibb/Eli Lilly/Merck KGaA’s Erbitux) + irinotecan (generics)

- Panitumumab (Amgen/Takeda Pharmaceutical’s Vectibix)

- Bevacizumab (Roche/Genentech/Chugai’s Avastin) + 5-FU (generics) + leucovorin (generics)

- Capecitabine (Roche/Genentech/Chugai’s Xeloda, generics)

Emerging Therapies

- TAS-102 (Taiho Pharmaceutical’s Lonsurf)

- Nintedanib (Boehringer Ingelheim’s Vargatef)

- Sym-004 (Symphogen)

- IMMU-130 (Immunomedics)

- Dabrafenib (Novartis’s Tafinlar) + trametinib (Novartis’s Mekinist) + panitumumab


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