HR+/HER2- Breast Cancer Pricing, Reimbursement, and Access
HR+/HER2- Breast Cancer Pricing, Reimbursement, and Access
Despite a high level of concern regarding spend on breast cancer medicines, access restrictions remain only mild to moderate. Spend in the indication is in the top three in oncology due to both medicines’ cost and high disease prevalence
Author: Astrid Kurniawan
Publisher: Datamonitor Healthcare
- High expenditure on breast cancer medicines has not resulted in stricter access limitations, with most payers not implementing restrictions. Cultural sensitivities and public perception limit payers’ willingness to restrict access for fear of a backlash.
- CDK 4/6 inhibitors will become the goldstandard first-line treatment in this indication, but the selection of a preferred compound still remains unclear. Payers have instead resorted to deep discounts and price-volume agreements in the class of compounds as a whole, rather than opting to contract for one compound.
- Safety and price will drive preference among the CDK 4/6 inhibitors. Given similar efficacy results, payers will look towards pricing and secondary product attributes such as safety profile variations and the need for additional monitoring as ways to differentiate among the CDK 4/6 inhibitors.
- Demonstrating quality of life benefits or delayed time to chemotherapy can support value propositions in the adjuvant and neoadjuvant setting in the absence of evidence of survival benefit upon approval.
- Payer acceptance of intermediary endpoints such as PFS2 and time to subsequent therapy is growing due to long survival times. Manufacturers that invest in such evidence development could secure a better positioning in the treatment algorithm.
Key Questions Answered
- What access controls are currently in place for breast cancer medicines?
- What safety attributes do payers prioritize in selecting preferred CDK 4/6 inhibitors?
- How likely are payers to contract for CDK 4/6 inhibitors, and, if likely, when will they implement such processes?
- What are payer views on the use of neoadjuvant and adjuvant therapies?
- What role will PARP inhibitors play in the HR+/HER2- breast cancer pathway?
Spend on breast cancer medicines is a high-level concern for payers, but few access restrictions are in place
Despite a high level of concern regarding spend on breast cancer medicines, access restrictions remain only mild to moderate. Spend in the indication is in the top three in oncology due to both medicines’ cost and high disease prevalence; however, most payers have not implemented access restrictions. Some European payers have narrowed patient populations eligible for reimbursement, but most are in line with clinical trial inclusion and exclusion criteria, while US payers report an especially challenging environment to control access to breast cancer medicines. Payers also note cultural factors such as sensitivities and public image regarding this indication that limit their willingness to propose access restrictions, for fear of public backlash.
Selection of preferred CDK 4/6 inhibitors based on pricing may occur in the future
The selecting of preferred breast cancer medicines, including within the class of CDK 4/6 inhibitors, is not common, despite the high spend in the indication. Payers affirm that it is still too early to state preferences, and they have instead sought deeper discounts to reduce spending. German payers obtained a national rebate of 50% for the price of Ibrance, with an additional confidential discount. Meanwhile, Spanish payers have national cap agreements for Kisqali and for Ibrance, with additional caps and discounts at regional and local levels, respectively. With growing competition, some payers may begin to restrict access and select one or two preferred agents as a means of controlling expenditure.
Price and safety will be key determinants of preferred CDK 4/6 inhibitors
Without head-to-head trials, decisions as to the preferred CDK 4/6 inhibitors – Ibrance, Kisqali, or Verzenio – will be based on price and safety attributes. Ibrance’s first-to-market status and greater familiarity among physicians, coupled with an acceptable safety profile, will give the drug an advantage over the later entrants. Meanwhile, Kisqali’s cardiac testing requirements will reduce its chances of securing a preferred formulary position unless Novartis offers impressive discounts over its competitors. Payers may use soft control measures, such as advocating for the most inexpensive option after accounting for clinical needs, rather than blunt-force formulary exclusions.
Long survival times necessitate the use of intermediary endpoints such as PFS2, and time to subsequent therapy or chemotherapy
Long patient survival times in breast cancer present a further challenge to the collection of overall survival data, but intermediary endpoints could help support value propositions in the interim. Payers and regulators are increasingly more open to the use of PFS2 (the time from randomization to objective tumor progression on the next line of treatment or death from any cause) or time to subsequent therapy in both regulatory and reimbursement evaluations, especially due to the recent EMA guidance. Going forward, the endpoints will gain increasing importance with growing treatment complexity and products targeting early breast cancer. Manufacturers that invest in such evidence development could secure a better positioning in the treatment algorithm.
7 REGULATORY LABELS
7 Marketed HR+/HER2- breast cancer products in the US, Japan, and five major EU markets
16 GLOBAL ACCESS LEVERS
16 Breast cancer spend is among the highest for oncology medicines
17 Access to HR+/HER2- breast cancer medicines is subject to mild restrictions
23 Contracting and price cap agreements are expected to be used more widely in the future
25 VALUE AND EVIDENCE
25 Importance of breast cancer clinical trial endpoints in the US and five major EU markets
28 Median OS remains the gold-standard endpoint for breast cancer, but PFS is typically accepted
30 Quality of life plays a secondary role to OS and PFS, but can support added benefit assessments in some markets
31 Intermediary endpoints such as PFS2 and time to second subsequent therapy or chemotherapy are valued as proxies
32 Launch of CDK 4/6 inhibitors in the first line has raised the bar for pipeline agents
34 ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS
34 CDK 4/6 inhibitors to become hallmark drugs for HR+/HER2- breast cancer
36 Pricing for Kisqali and Verzenio will be referenced to Ibrance
36 Safety and price, rather than efficacy, will drive preference among the CDK 4/6 inhibitors
48 Tablet strength differences and linear versus flat pricing are not major differentiators for the CDK 4/6 inhibitors
50 Continuous dosing is an asset for most clinicians for adherence purposes, but has a limited impact on payer perception
51 Discounting at the local or regional level may drive CDK 4/6 inhibitor preference
54 Lackluster results may affect Lynparza’s reimbursement prospects in the EU
56 Talazoparib shows early sign
67 Insights and strategic recommendations
68 Insights and strategic recommendations
69 Insights and strategic recommendations
69 Japan’s pricing strategy is reliant on premiums for innovative medicines
71 Insights and strategic recommendations
71 ASMR rating has an impact on pricing
74 Insights and strategic recommendations
75 Positive assessment from the G-BA will impact price negotiations
76 Insights and strategic recommendations
78 Insights and strategic recommendations
78 National reimbursement decisions are not a major access barrier in Spain
78 Regional access to breast cancer treatments varies in Spain
80 Insights and strategic recommendations
80 NICE approval is a key market access barrier
82 Primary research
82 Price assumptions
83 Exchange rates
LIST OF FIGURES
83 Figure 1: Price sources and calculations, by country
LIST OF TABLES
8 Table 1: Marketed products and approved indications for HR+/HER2-breast cancer in the US, Japan, and five major EU markets
20 Table 2: Levers impacting access to breast cancer drugs in the US and five major EU markets, by country
26 Table 3: Summary of important key endpoints in breast cancer clinical trial design, by country
38 Table 4: Differentiating factors among the CDK 4/6 inhibitors, by country
54 Table 5: Contracting and other financial agreements for the CDK 4/6 inhibitors
65 Table 6: Pricing of key HR+/HER2- breast cancer drugs in the US, Japan, and five major EU markets, by country
70 Table 7: Japan – pricing premiums given to medicines that can demonstrate benefit over comparators
72 Table 8: Transparency Committee’s ASMR ratings and pricing implications
72 Table 9: Transparency Committee’s SMR ratings and pricing implications
77 Table 10: AIFA web registry and managed entry agreements for HR+/HER2- breast cancer drugs
84 Table 11: Exchange rates used for calculating drug prices
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