A robust pipeline, and the approval of other PARP inhibitors Zejula (in the US and EU) and Rubraca (in the US), has made some payers worried about the potential budget impact. With the anticipated approvals of checkpoint inhibitors Bavencio and Tecentriq, payers will seek to enact access control measures. Most payers however will wait for the ovarian cancer market to mature before they deploy any contracts for preferred products. In the meantime, US payers report an ongoing challenging environment for enacting restrictions, as there is an obligation to reimburse drugs according to the FDA label, as well as for off-label uses that are associated with strong guideline recommendations. European payers also report relatively minor access restrictions, although some markets such as the UK and France have restricted access to Avastin and Lynparza to control expenditure.
Table of Contents
OVERVIEW
EXECUTIVE SUMMARY
REGULATORY LABELS
Marketed ovarian cancer products in the US, Japan, and five major EU markets
Bibliography
GLOBAL ACCESS LEVERS AND BARRIERS
Insights and strategic recommendations
Budget for ovarian cancer medicines less of a concern for payers
Access to ovarian cancer medicines is relatively unrestricted
Combination treatments may present a particular challenge in the future
VALUE AND EVIDENCE
Insights and strategic recommendations
Overall survival remains the gold standard endpoint for ovarian cancer
PFS is an acceptable endpoint for certain patient populations
Real-world evidence can be used to supplement PFS data
OS remains the gold standard endpoint for immunotherapies
ACCESS TO RECENTLY LAUNCHED AND PIPELINE PRODUCTS
Insights and strategic recommendations
Lynparza is reimbursed in major markets with little restriction
Access conditions for Zejula and Lynparza in wtBRCA population likely to vary by market
Payers unlikely to compare safety and efficacy of PARP inhibitors for HTA decision making
Contracting for PARP inhibitors unlikely for the foreseeable future
Immuno-oncology drugs are managed as part of the wider oncology indication
PD-L1 stratification is likely to be advantageous despite lack of payer consensus on advantages of biomarker selection
Tecentriq/Avastin combination may have an advantage over Bavencio in markets where Avastin is already standard of care
Developers of pipeline immunotherapies need to ensure checkpoint inhibitor schedule is aligned with chemotherapy
US PRICING
US REIMBURSEMENT
Insights and strategic recommendations
Commercial formularies are similar in terms of formulary positioning for ovarian cancer drugs
Medicare formularies largely include ovarian cancer drugs
Prior authorization is the key utilization management tool used in ovarian cancer
AIM Specialty Health outlines ovarian cancer pathway
NCCN follows FDA label for most of the approved ovarian cancer medicines
Lynparza in BRCAm+ patients is the only cost-effective PARP inhibitor according to ICER
Payers question ICER’s influence on pricing
Payers are unlikely to contract for PARP inhibitors in the near term
Lax utilization management of checkpoint inhibitors negates necessity to have biomarker testing
Contracting for PD-1 inhibitors unlikely to happen until multiple drugs have broad overlapping indications
Bibliography
JAPAN
Pricing of launched ovarian cancer treatments
Bibliography
PRICING IN THE FIVE MAJOR EU MARKETS
FRANCE
Insights and strategic recommendations
ASMR rating has an impact on pricing
Avastin received minor added benefit for use in first-line patients only, no added benefit in other settings
Lynparza received minor added benefit from the TC
Lynparza likely to have minor added benefit in both BRCAm+ and wtBRCA patient population
Oral medicines face fewer access barriers in France
Tecentriq and Bavencio likely to have smooth path to reimbursement, but price-volume agreements and budget ceilings will limit commercial potential overall
Payers and KOLs express preference towards combination therapy with Avastin/Tecentriq and chemotherapy over Bavencio and chemotherapy
Bibliography
GERMANY
Insights and strategic recommendations
Positive assessment from the G-BA will impact price negotiations
Orphan drugs have an added benefit by law regardless of the available evidence
G-BA does not have specific thresholds for overall survival; relative improvement is most important
Zejula will be given an added benefit in the first G-BA assessment, but the price is likely to be below Lynparza’s
Bavencio and Tecentriq will undergo full benefit assessment; OS data will be crucial to demonstrate added value
Biomarker testing poses an access issue in Germany
Bibliography
ITALY
Insights and strategic recommendations
Avastin and Lynparza are subject to AIFA web monitoring
Ovarian cancer drugs assessed and reimbursed by AIFA are found in Emilia-Romagna regional formulary
Emilia-Romagna does not recommend Avastin with carboplatin and gemcitabine in first recurrence
Emilia-Romagna recommends use of Avastin in first-line advanced ovarian cancer patients
Lynparza recommended for use in subset of BRCAm+ platinum-sensitive patients
PARP inhibitors unlikely to be innovative according to AIFA regulations
PD-1 immuno-based therapies likely to be reimbursed by AIFA but could face local access hurdles
Pricing for immunotherapies unlikely to change with additional indications
Tecentriq’s combination therapy with Avastin may be at an advantage over Bavencio
Bibliography
SPAIN
Insights and strategic recommendations
National reimbursement decisions are not a barrier to access
Regional access to ovarian cancer treatments varies in Spain
Andalucía’s therapeutic committee excludes Avastin from formulary
Catalonia’s regional therapeutics committee restricts use of Avastin and Lynparza
PARP inhibitors are unlikely to be used outside of the BRCA mutated population
Payers foresee having preference for one PARP inhibitor when three are in the market
Payers recommend immunotherapy treatments tailored to specific subgroups
Bibliography
UK
Insights and strategic recommendations
NICE approval is a key market access barrier
Avastin’s unlicensed dose is reimbursed via the CDF in first-line patients with ovarian cancer
Access to Lynparza restricted to use after failure with three chemotherapy regimens, with a PAS
NICE rejects Zejula in ovarian cancer, but recommends application to the CDF
Zejula’s pricing at launch is key to market penetration
Price competition for PARP inhibitors could occur in the future when multiple drugs launch
AstraZeneca has a narrow window of opportunity to utilize its first-to-market advantage by lowering Lynparza’s price
New Cancer Drugs Fund addresses inefficiency issues with former fund mechanism
Tecentriq/Avastin and chemotherapy combination may face higher access hurdles compared to Bavencio and chemotherapy
UK payers want biomarker stratification for PD-L1 inhibitors
Cost effectiveness in lowest-value indication drives the price for checkpoint inhibitors
Bibliography
METHODOLOGY
Primary research
Price assumptions
Exchange rates
Bibliography
List of Tables
Table 1: Marketed products and approved indications for ovarian cancer in the US, Japan, and five major EU markets
Table 2: Levers impacting access to ovarian cancer drugs in the US and five major EU markets
Table 3: Market access controls for Lynparza
Table 4: Market access scenario for Zejula and Lynparza in the wtBRCA population
Table 5: Efficacy and safety comparison of PARP inhibitors in selected studies
Table 6: US pricing of key marketed ovarian cancer drugs, 2017
Table 7: Formulary placement of ovarian cancer medications in selected commercial formularies
Table 8: Formulary placement of ovarian cancer medications in selected Medicare formularies
Table 9: Prior authorization criteria for ovarian cancer drugs in major health insurers and PBMs
Table 10: AIM Specialty Health Oncology Pathway
Table 11: NCCN guidelines for ovarian cancer medicines
Table 12: PARP inhibitor drug pricing compared to ICER value-price benchmarks
Table 13: Japan - pricing premiums given to medicines that can demonstrate benefit over comparators
Table 14: Pricing of key marketed ovarian cancer drugs in Japan
Table 15: Pricing of key ovarian cancer drugs in the five major EU markets, by country, 2017
Table 16: Transparency Committee’s ASMR ratings and pricing implications
Table 17: Transparency Committee's SMR ratings and pricing implications
Table 18: Transparency Committee's assessment of ovarian cancer treatments
Table 19: G-BA assessment of key ovarian cancer therapies
Table 20: Reimbursement conditions for ovarian cancer treatments in Italy
Table 21: Italian regional formulary decisions for ovarian cancer drugs
Table 22: Therapeutic positioning reports for ovarian cancer drugs in Spain
Table 23: Spanish Society of Hospital Pharmacy ratings
Table 24: Regional MADRE assessments for ovarian cancer drugs
Table 25: NICE assessments of key ovarian cancer therapies
Table 26: SMC decisions on key ovarian cancer therapies
Table 27: Price sources and calculations for the US
Table 28: Price sources and calculations for the EU
Table 29: Exchange rates used for calculating branded drug prices
Companies Mentioned
- AstraZeneca
