U.S. Physician and Payer Forum

August 2013

Ovarian and Endometrial Cancer: How Will U.S. Prescriber and Payer Attitudes Toward Emerging Antiangiogenics and Other Targeted Anticancer Agents Shape the Treatment Landscape?

Report Authors
Karen Pomeranz, M.Sc., Ph.D.

Introduction:

There are currently no FDA-approved targeted therapies for ovarian and endometrial cancer. Roche/Genentech/Chugai’s Avastin (bevacizumab) was approved for first-line advanced ovarian cancer (CaO) in Europe in December 2011 and received a subsequent European approval in October 2012 for recurrent platinum-sensitive ovarian cancer. In the United States, where Avastin has not yet received formal approval, interviewed oncologists report off-label use in all settings; however, they state that gaining reimbursement for the drug’s use in CaO can be challenging despite recommended use by the NCCN guidelines. In both ovarian and endometrial cancer (EMC) current treatment is dominated by chemotherapy. Treatment guidelines for endometrial cancer also recommend the use of hormone therapy and Avastin is mentioned in the NCCN treatment guidelines for endometrial cancer.

Key products covered in this report:

- Roche/Genentech/Chugai’s Avastin (bevacizumab) is a monoclonal antibody that targets VEGF and is used off-label in advanced CaO.

- Janssen Biotech’s Doxil, a pegylated liposomal doxorubicin (PLD) that is indicated for treatment of CaO after failure of platinum-based chemotherapy.  This agent is also often used as a monotherapy for treatment of advanced/recurrent EMC.

- The taxanes—paclitaxel (Bristol-Myers Squibb’s Taxol, generics) and docetaxel (Sanofi’s Taxotere, generics) are commonly used to treat CaO and EMC in particular in the front-line and most commonly in combination therapy, typically with platinum agents.

- The platinum agents—carboplatin (generics) and cisplatin (generics) play an important role in treatment of CaO and EMC. Most commonly these agents are prescribed in the first-line setting; frequently in combination with taxanes. Patients typically receive platinum-based therapy for as long as their disease is perceived to be responsive to platinum-based treatment (i.e., may receive multiple lines of therapy with platinum agents).   

- Merck & Co/Endocyte’s vintafolide, a folate molecule conjugated to the vinca alkaloid microtubule destabilizing agent, is an emerging therapy aiming  to gain approval for platinum-resistant advanced CaO.

- GlaxoSmithKilne’s Votrient (pazopanib), a small-molecule multi-tyrosine kinase inhibitor, is being examined in a Phase III trial for treatment of advanced CaO as maintenance therapy following treatment in the first-line setting with platinum-containing chemotherapy regimen.

- Boehringer Ingelheim’s nintedanib, a kinase inhibitor of VEGFR, PDGFR, and FGFR, is an emerging therapy which is being examined in a Phase III trial in first-line advanced CaO.

- Amgen/Takeda Bio’s trebananib, a  Tie-2 receptor and angiopoietin-1 (Ang-1)- and angiopoietin-2 (Ang-2)-inhibiting peptibody, is being examined in three Phase III trials in CaO spanning three patient populations—first-line advanced CaO,  recurrent platinum sensitive CaO, and recurrent platinum-resistant CaO.

- AEterna Zentaris’s AEZS-108, a conjugate of doxorubicin and LHRH, is being examined in second-line advanced EMC in a Phase III trial.

In this report, we explore the use and formulary status of key current therapies for CaO and EMC and the likely reception of key emerging therapies in a survey of 103 oncologists, and 30 managed care organization directors. By understanding the attitudes and expectations of prescribers and payers toward current and emerging CaO and EMC therapies, stakeholders can gain an understanding of the treatment paradigm and changing reimbursement climate for CaO and EMC.

Questions Answered in This Report:

  *   How extensive is the off-label use of Avastin in CaO and EMC? In which patient populations is Avastin most frequently prescribed? What are the drivers for prescribing of Avastin? What are the obstacles and barriers that oncologists encounter when prescribing Avastin for CaO? Do surveyed oncologists think it is likely that Avastin will gain regulatory approval in CaO? How will Avastin gaining regulatory approval in CaO and EMC affect prescribing habits of this agent?

  *   What is the current state of reimbursement for key CaO and EMC therapies? What restrictions, if at all, are in place on prescribing of Avastin in CaO and EMC?

  *   What efficacy attributes would secure routine high use of an emerging therapy in first-line advanced CaO? What is surveyed physicians opinion on emerging therapies for CaO and how will they likely incorporate these agents into the treatment paradigm, if approved?  What do surveyed oncologists believe will constrain their prescribing of novel agents for CaO?

  *   What access and reimbursement hurdles and MCOs likely to implement on novel agents for in CaO and EMC? What factors are important to payers for formulary inclusion and favorable tier status in CaO?

Scope:

Markets covered: United States.

- Primary research: 103 medical oncologists, 30 MCO pharmacy/medical directors.

- Epidemiology: 2013 and 2021 U.S. CaO drug treatable patient populations— early-stage advanced CaO, first-line advanced CaO, second-line platinum-sensitive CaO, second-line platinum-resistant CaO, third-line advanced CaO, fourth-and subsequent-line advanced CaO.

- Population segments: Where appropriate, our data and analyses are segmented in CaO by line of therapy (early-stage CaO to fourth- and subsequent-lines advanced CaO). For EMC we segment patient where appropriate based on stage of the disease (early and advanced EMC, as well as recurrent EMC).


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