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.
Highlights
- 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?
