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Ovarian Cancer Pricing, Reimbursement, and Access Report, 2018 - ResearchAndMarkets.com

May 14, 2018

DUBLIN--(BUSINESS WIRE)--May 14, 2018--The “Ovarian Cancer Pricing, Reimbursement, and Access” report has been added to ResearchAndMarkets.com’s offering.

Ovarian cancer medicines have traditionally been subject to low restrictions, as most patients usually start and remain on inexpensive platinum-based therapies. However, beginning with the launch of vascular endothelial growth factor inhibitor Avastin, followed by poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza, payers are seeing an uptick in spend for the indication.

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.

Key Topics Covered:

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

Andaluca’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

For more information about this report visit https://www.researchandmarkets.com/research/9mkd35/ovarian_cancer?w=4

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Related Topics:Women’s Health

KEYWORD:

INDUSTRY KEYWORD: WOMEN HEALTH CONSUMER GENERAL HEALTH

SOURCE: Research and Markets

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PUB: 05/14/2018 11:31 AM/DISC: 05/14/2018 11:31 AM

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