Reimbursement and Payer Management of Immune Checkpoint Inhibitors, 2018 - Immunotherapy Drugs Present an Opportunity for Contracting, but Payers Await More Competition

Dublin, June 26, 2019 (GLOBE NEWSWIRE) -- The "Reimbursement and Payer Management of Immune Checkpoint Inhibitors" report has been added to's offering.

Payers are concerned about the budget impact of immunotherapies

As immune checkpoint inhibitors continue to gain approvals in expanded patient populations, interviewed payers express concern surrounding the potential budget impact of the drug class. Considering the high c.of these treatments in comparison to standard chemotherapy, HTA and reimbursement agencies stress the requirement for solid survival data and highlight that price will be a major factor during negotiations.

Price-volume and expenditure ceilings are frequently used across Europe

Price-volume and budget ceiling agreements are becoming increasingly popular for immunotherapies in France, Italy, and Spain, and payers in other European countries may follow suit in the future. These arrangements have been used in the past for high-impact indications such as hepatitis C; however, payers are imposing these spending caps more explicitly in the case of immunotherapies. Payers indicate that further cost-control mechanisms could be introduced for immunotherapies in the future, including per patient caps on pricing implemented at an indication-by-indication level.

Price reductions are frequently required following label expansions into new populations

Label expansions of immune checkpoint inhibitors into new treatment lines consistently trigger new pricing and reimbursement assessments across Europe, with many of these assessments leading to price reductions or new price-volume agreements based on increased patient numbers and budget impact. Furthermore, considering the rising competition among the immunotherapy drug class and the growing overlap in patient populations, companies are having to price their therapies strategically to facilitate reimbursement and patient access versus competitors, while maximizing overall revenue.

Immunotherapy drugs present an opportunity for contracting, but payers await more competition

Immune checkpoint inhibitors present an attractive target for future contracting due to the high budget impact of the class. However, products must be deemed therapeutically equivalent across a wide breadth of indications before these practices can take place. Therapies that gain approvals in the most prevalent indications are expected to be at a significant advantage when it comes to contracting, as payers will be able to negotiate higher discounts across more expansive patient populations.

Combination therapies pose challenges for payers as many markets do not have a clear path for HTA and price negotiation

Payers are likely to implement new strategies to manage price negotiations for immunotherapy combinations in the future. Mechanisms allowing for the negotiation of different prices for combinations are absent at the moment, but several payers report that the establishment of new tools is likely to emerge in the near future. The new tools will be used to ensure that the cost of individual components is lower when used in combination compared to use as a monotherapy, and as a result the maximum net price that can be achieved will be lower.

Key Topics Covered:


Payers are concerned about the budget impact of immunotherapies
Price reductions are frequently required following label expansions into new populations
Tendering is likely to be used as a method of cost control in the future
Payers want new methods to control the cost of immuno-oncology combinations
PD-L1 stratification is likely to be advantageous despite lack of payer consensus on the advantages of biomarker selection
Keytruda has maintained a significantly higher price than competing immunotherapies across Europe
Payers in the US and UK prefer overall survival rate at different time points as an endpoint for immune checkpoint inhibitors

Payers report minimal reimbursement controls for immunotherapies in the US
Clinical pathways may have an increasing influence on prescribing in the future
Contracting for immunotherapies is difficult under the current buy-and-bill reimbursement

Immunotherapies are recommended under the conditions of improved cost effectiveness

Price premiums are awarded for added benefit or innovation
Opdivo received a 60% pricing premium
Opdivo's price was cut dramatically following its label expansion into NSCLC
Reimbursement reforms in 2018 crack down on drug pricing
Opdivo and Keytruda subject to further price decreases in 2018

Price-volume and budget ceiling agreements are used to control the cost of immunotherapies in France
Exclusion from the liste en sus is the biggest threat for immunotherapies
Tecentriq is not yet available on the French market
Pricing and HTA decisions in France

Pricing negotiations are the main access lever in Germany
Each immunotherapy has received at least one considerable added benefit rating
Pricing and HTA decisions in Germany

Immunotherapies benefit from innovative status
AIFA uses expenditure ceilings and price-volume agreements to control spend on immunotherapy drugs
Pricing and HTA decisions in Italy

Immune checkpoint inhibitors tend to be recommended for reimbursement nationally
Regional and local authorities can introduce further reimbursement requirements

Immune checkpoint inhibitors are recommended by NICE under the conditions of a patient access scheme
Many immune checkpoint inhibitors gain initial funding through the Cancer Drugs Fund
Keytruda's approval in NSCLC triggered the 20m budget impact test
Immunotherapy prices are determined by their cost effectiveness in the lowest-value indication
Contracts for immunotherapies are likely to be introduced in the next 12 months
Treatment algorithms will have an increasing influence on prescribing in oncology in the future
NICE frequently imposes stopping criteria for immune checkpoint inhibitors

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