Multiple Myeloma Pricing, Reimbursement, and Access

Report
85 Pages
March 2019
Region: Global
Citeline
ID: 3797421

Highlights:

The budget impact of multiple myeloma is set to increase
While multiple myeloma represents a relatively small patient population in comparison to other cancers, payers are concerned about the rising spend on the indication. New biologic therapies are increasingly gaining label expansions in earlier treatment lines, and with life expectancies improving, patients are requiring treatment with expensive therapies for longer durations of time. Furthermore, with patients often treated with triple regimens, and many quadruple combinations of newer market entrants making up the late-stage pipeline, payers express concern surrounding the increasing use of combination regimens within multiple myeloma. Combination therapies are a particular challenge for payers, as most markets lack the tools for effective pricing and reimbursement negotiations for these products.
Various expenditure controls are in place for multiple myeloma therapies across Europe
While not specific to multiple myeloma therapies, various control mechanisms are in place across the five major European markets (France, Germany, Italy, Spain, and the UK) to limit overspending on therapeutics in general.

Interviewed payers highlight pricing negotiations with manufacturing companies as a key cost-control measure, ensuring pricing premiums are only granted to therapies demonstrating significant improvements in patient outcomes in comparison to existing alternatives. In contrast, payers in the US have limited power to control expenditure on multiple myeloma therapies, despite the imposition of utilization management mechanisms. Manufacturing companies are relatively free to set the prices of their multiple myeloma treatments, with payers reluctant to impose prescribing and access restrictions within high-severity oncology indications.

OVERVIEW

REGULATORY LABELS

Bibliography

GLOBAL ACCESS LEVERS

Payers are concerned about the rising cost of multiple myeloma treatment
Expenditure controls are in place to varying extents across Europe, but these are not specific to multiple myeloma therapies
Payers are concerned about the high use of combination regimens within multiple myeloma
The complexity of the multiple myeloma treatment paradigm somewhat prevents payer restrictions
Oral regimens could be favored in certain markets if several therapies are considered therapeutically equivalent
Multiple myeloma therapies may be an attractive target for outcomes-based risk-sharing agreements

EVIDENCE AND VALUE

Importance of multiple myeloma clinical trial endpoints in the US and five major EU markets
OS is considered the most valuable endpoint, but payers recognize the difficulties involved in obtaining the data
Complete response rates are generally valued in the front-line transplant-eligible setting
Payers understand the value of MRD negativity, but the endpoint is not yet accepted as a surrogate for survival
Payers want to impose stopping criteria for multiple myeloma therapies, but require supportive clinical trial data
Intermediary endpoints such as PFS2 and TSST are valued by payers in several markets, but they must be properly defined
Payers desire long-term survival data to assess the curative nature of novel therapeutics

ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS

New therapies launching in overlapping patient populations may suffer negative pricing consequences following Velcade’s patent expiry
Front-line multiple myeloma treatments
Relapsed/refractory multiple myeloma treatments
While CAR-T therapies hold promise in multiple myeloma, physicians are skeptical about their ability to provide durable remission

PRICINGUS

Insights and strategic recommendations

ICER reviews are unlikely to have a major impact on reimbursement in the near future
Clinical pathways will likely have an increasing influence on prescribing in future

CANADA

Insights and strategic recommendations

JAPAN

Insights and strategic recommendations
Japan’s pricing strategy is reliant on premiums for innovative medicines
Bibliography

FRANCE

Insights and strategic recommendations

GERMANY

Insights and strategic recommendations

ITALY

Insights and strategic recommendations

SPAIN

Insights and strategic recommendations

Insights and strategic recommendations

METHODOLOGY

Primary research
Price assumptions
Exchange rates
Bibliography

List of Figures

Figure 1: Price sources and calculations, by country

LIST OF TABLES

Table 1: Marketed multiple myeloma products and approved indications in the US, Japan, and five major EU markets
Table 2: Access levers for multiple myeloma treatments in the US and five major EU markets
Table 3: Pricing, market access, and reimbursement strategies for combination therapies
Table 4: Use of treatment algorithms and pathways to streamline prescribing within multiple myeloma across the US and five major EU markets
Table 5: Payer views on route of administration of multiple myeloma therapies
Table 6: Importance of multiple myeloma clinical trial endpoints in the US and five major EU markets
Table 7: Likely reimbursement of Darzalex in the front-line setting for transplant-ineligible multiple myeloma patients in the US and five major EU markets
Table 8: Reimbursement of Empliciti plus Rd in the second-line setting across the five major EU markets
Table 9: Reimbursement of Ninlaro plus Rd in the second-line setting across the five major EU markets
Table 10: Reimbursement of Darzalex plus Rd in the second-line setting across the five major EU markets
Table 11: Likely pricing and reimbursement of Venclexta in multiple myeloma across the US and five major EU markets
Table 12: Pricing premiums given to medicines in Japan that can demonstrate benefit over comparators
Table 13: Exchange rates used for calculating drug prices

Table of Contents

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